Common use of Commencement and period of agreement Clause in Contracts

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021 2.3 Pfizer anticipates the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021. 2.4 Pfizer acknowledges their responsibility to adhere as closely as possible to the timelines presented in the document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS England, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate any risks • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England to provide data over the extended period. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs Fund.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021February 2023 2.3 Pfizer anticipates Bristol Xxxxx Squibb anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021February 2023. 2.4 Pfizer acknowledges Bristol Xxxxx Squibb acknowledge their responsibility to adhere as closely as possible to the timelines presented in the document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement (NHSE&I) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England.NHSE&I. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE&I, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHS Digital to provide data over the extended period. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs Fund.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021April 2024 2.3 Pfizer anticipates Xxx Xxxxx and Company Limited anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021.April 2024 2.4 Pfizer acknowledges Xxx Xxxxx and Company Limited acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement (NHSE&I) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England.NHSE&I. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE&I, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHS Digital to provide data over the extended period. 2.12 If Xxx Xxxxx and Company Limited acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.13 In the event that could resolve Xxx Xxxxx and Company Limited do not make a submission to NICE for the uncertainties identified by purpose of updating the technology appraisal committeeguidance, NICE and NHSE NHSE&I will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE&I, patient and professional group stakeholders, with the company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. The presentations from this engagement event will be published on the NICE website. 2.14 NICE and NHSE&I may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update April 2028 2.3 Pfizer anticipates Gilead anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021anticipated April 2028. 2.4 Pfizer acknowledges Gilead acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. . 2.6 The review NICE guidance update will use follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in the guidance review update is issued, which will . These may be no earlier than 4 weeks prior different from the process and methods applicable to guidance updates when entered into the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guidemanaged access agreement. 2.6 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on the NICE website. 2.8 2.9 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 2.11 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.12 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHSE to provide data over the extended period. 2.12 If 2.13 Gilead acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.14 In the event that could resolve Gilead do not make a submission to NICE for the uncertainties identified purpose of updating the guidance, NICE and NHSE will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE, patient and professional group stakeholders, with the technology appraisal committee, company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.15 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreementMAA. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: End of data collection (primary source) * Anticipated company submission to NICE for Cancer Drugs Fund review August 2021January 2025 2.3 Pfizer The company anticipates the results from the additional data collected during the Cancer Drugs Fund managed access period will be incorporated into an evidence submission and the updated economic model by August 2021January 2025. 2.4 Pfizer The company acknowledges their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, develop the scope and schedule a Cancer Drugs Fund review into the technology appraisal NICE work programme to align with the estimated dates for the end of data collection. The review will use the NICE process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission dateparticipate. For further details of the expected timelines for the Cancer Drugs Fund NICE guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreementMAA, the technology will continue to be available through the Cancer Drugs Fund managed access after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the guidance review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund guidance review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement (NHSE&I) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England.NHSE&I. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- real-world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE&I, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHR to provide data over the extended period. 2.12 If The company acknowledges their responsibility to provide an evidence submission for a guidance review for this technology to NICE under all circumstances following a period of managed access. 2.13 NICE and NHSE&I may consider this Data Collection Agreement no longer valid, and withdraw the technology from the MAA for the following, non- exhaustive, grounds: • The primary source sources of data is delayed or no longer reports are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal NICE committee, NICE and NHSE may consider . • Amendments are made to the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs Fundmarketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Data available for development of company submission N/A Anticipated company submission to NICE for Cancer Drugs Fund review August 2021May 2023 2.3 Pfizer anticipates MSD anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021May 2023. 2.4 Pfizer acknowledges MSD acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the exit from managed access into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 The NICE guidance update will exit managed access using the NICE rapid review process. Further details on the rapid review process are available in the NICE manual. 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund rapid review. Further information is available on the NICE website. 2.8 2.9 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data)NHSE. 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks • of further delays. 2.12 MSD acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a period of managed access. 2.13 In the event that MSD do not make a submission to NICE for the purpose of updating the guidance, NICE and NHSE will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an extensionengagement meeting convened by NICE with attendance from NHSE, it may not be possible to amend patient and professional group stakeholders, with the date company presenting the clinical evidence collected during the managed access period and an explanation of the final SACT or real-world data report, although NICE will explore options decision to proceed with Public Health England to provide data over withdrawal of the extended periodguidance. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, 2.14 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021Estimated to be February 2025 2.3 Pfizer anticipates Kite anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021February 2025. 2.4 Pfizer acknowledges Kite acknowledge their responsibility to adhere as closely as possible to the timelines presented in the document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company Kite is responsible for paying all associated charges for the undertaking of a Cancer Drugs Fund review. Further information is available , which are detailed on the NICE website. 2.8 The company Kite must inform NICE and NHS England and NHS Improvement of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandEngland and NHS Improvement. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company Kite should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company Kite should note: • The company Xxxx must submit a written request to NICE and NHS EnglandEngland and NHS Improvement, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England to provide data over the extended period. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE NHS England and NHS Improvement may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update February 2028 2.3 Pfizer anticipates Gilead anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021February 2028. 2.4 Pfizer acknowledges Gilead acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. . 2.6 The review NICE guidance update will use follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in the guidance review update is issued, which will . These may be no earlier than 4 weeks prior different from the process and methods applicable to guidance updates when entered into the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guidemanaged access agreement. 2.6 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on the NICE website. 2.8 2.9 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 2.11 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.12 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHSE to provide data over the extended period. 2.12 If 2.13 Gilead acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.14 In the event that could resolve Gilead do not make a submission to NICE for the uncertainties identified purpose of updating the guidance, NICE and NHSE will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE, patient and professional group stakeholders, with the technology appraisal committee, company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.15 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: End of data collection (primary source) LITESPARK-004: Q2 2025 NHS Digital data sets: Q2 2028 Data available for development of company submission Q4 2028 Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update September 2029 2.3 Pfizer anticipates Merck Sharp & Dohme (MSD) anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021September 2029. 2.4 Pfizer acknowledges MSD acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. . 2.6 The review NICE guidance update will use follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in the guidance review update is issued, which will . These may be no earlier than 4 weeks prior different from the process and methods applicable to guidance updates when this technology entered into the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guidemanaged access agreement. 2.6 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on Note that this includes the ‘change fee’ if the Company does not provide sufficient notice to NICE regarding changes to the evaluation timelines. Please refer to the NICE websitewebsite and Charging Procedure for further information. 2.8 2.9 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 2.11 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.12 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHSE to provide data over the extended period. 2.12 If 2.13 MSD acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.14 In the event that could resolve MSD do not make a submission to NICE for the uncertainties identified purpose of updating the guidance, NICE and NHSE will require the company to agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE, patient and professional group stakeholders, with the technology appraisal committee, company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.15 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021April 2025 2.3 Pfizer anticipates GlaxoSmithKline anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021April 2025 to allow enough time for the data analysis and cost-effectiveness analysis to be updated. 2.4 Pfizer acknowledges GlaxoSmithKline acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme program to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement (NHSE&I) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England.NHSE&I. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example example, if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE&I, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHS Digital to provide data over the extended period. 2.12 If GlaxoSmithKline acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.13 In the event that could resolve GlaxoSmithKline do not make a submission to NICE for the uncertainties identified by purpose of updating the technology appraisal committeeguidance, NICE and NHSE NHSE&I will require the company to agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE&I, patient and professional group stakeholders, with the company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.14 NICE and NHSE&I may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021Q4 2023 IA, interim analysis 2.3 Pfizer anticipates Daiichi Sankyo anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021Q4 2023. The delay between data availability and evidence submission (>2 months) is due to the evidence submission being based on a different trial and model to the original NICE submission. Daiichi Sankyo will therefore need to analyse trial data (DESTINY-Breast02), develop networks for comparative efficacy, develop an economic model, and develop the submission dossier. 2.4 Pfizer acknowledges Daiichi Sankyo acknowledge their responsibility to adhere as closely as possible to the timelines presented in the document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandEngland and NHS Improvement. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandEngland and NHS Improvement, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England to provide data over the extended period. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE NHS England and NHS Improvement may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: End of data collection (primary source) CB100 Commitment to submit CSR to MHRA by 30 June 2023 CB200 Commitment to submit primary analysis CSR to MHRA will be requested for 31 March 2023 Data available for development of company submission March 2023 Anticipated company submission to NICE for Cancer Drugs Fund review August 2021March 2024 2.3 Pfizer Amgen anticipates the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021March 2024. More than 2 months will be required between data availability and evidence submission due to requirement of extensive updates to the existing analyses and update to an economic model with the new clinical trial data. 2.4 Pfizer Amgen acknowledges their its responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement (NHSE&I) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England.NHSE&I. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE&I, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHS Digital to provide data over the extended period. 2.12 If Amgen acknowledges its responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.13 In the event that could resolve Amgen does not make a submission to NICE for the uncertainties identified by purpose of updating the technology appraisal committeeguidance, NICE and NHSE NHSE&I will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE&I, patient and professional group stakeholders, with the company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.14 NICE and NHSE&I may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates . The data collection period is anticipated to conclude in December 2023 (see section 5). The process for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021 2.3 Pfizer anticipates the results from the additional data collected during exiting the Cancer Drugs Fund period will be incorporated into an evidence submission begin at this point and the updated economic model by August 2021review of the NICE guidance will start. 2.4 Pfizer acknowledges their responsibility to adhere as closely as possible to the timelines presented in the document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 2.2 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection period has ended and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review standard timelines described in the addendum to NICE’s guide to the methods and processes of technology appraisalwhen appraising cancer technologies. 2.7 2.3 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.4 Any changes to the terms or duration of any part of the data collection arrangement managed access agreement must be approved by NICE and NHS EnglandEngland as co-signatories to the agreement. 2.10 2.5 If data collection is anticipated to conclude earlier than the estimated dates for data collectiontimelines stated in the managed access agreement, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, allows NICE will explore options endeavour to reschedule the Cancer Drugs Fund CDF guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs outcomes will no longer provide meaningful data). 2.11 2.6 If data collection from an ongoing clinical trial is anticipated to conclude later than the estimated dates for data collectionbe delayed, the company should please note: • The company must submit a written request to NICE and NHS England, with details of the extension requested, including an explanation of the factors contributing England should be informed immediately as co- signatories to the requestagreement • Unless a strong compelling rationale is provided, the CDF guidance review will proceed according to the original timelines outlined in the MAA. • Resource/capacity issues will not be accepted as reasons for delaying the associated CDF guidance review. • It may be necessary for the company to mitigate any risks • In the event of an extension, it may not be possible to amend the date of the final SACT or real-real- world data report, although NICE in which case it will explore options with Public Health England to provide data over be available before the extended periodClinical Study report is completed. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs Fund.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update Q4 2024 2.3 Pfizer Daiichi Sankyo anticipates that the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021Q4 2024. The delay between data availability and evidence submission (>2 months) is due to the time required for Daiichi Sankyo to analyse trial data, update the economic model, and develop the submission dossier based on the final DESTINY-Breast03 data cut. 2.4 Pfizer Daiichi Sankyo acknowledges their its responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. . 2.6 The review NICE guidance update will use follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in of the guidance review update is issued, which will . These may be no earlier than 4 weeks prior different from the process and methods applicable to guidance updates when entered into the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guidemanaged access agreement. 2.6 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on the NICE website. 2.8 2.9 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 2.11 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.12 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHS Digital to provide data over the extended period. 2.12 If 2.13 Daiichi Sankyo acknowledges its responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.14 In the event that could resolve Daiichi Sankyo does not make a submission to NICE for the uncertainties identified purpose of updating the guidance, NICE and NHSE will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE, patient and professional group stakeholders, with the technology appraisal committee, company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.15 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021March 2025 2.3 Pfizer GSK anticipates that the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021March 2025 to allow enough time for data analysis and cost-effectiveness analysis update. 2.4 Pfizer GlaxoSmithKline acknowledges their its responsibility to adhere as closely as possible to the timelines presented in the document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandEngland and NHS Improvement. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandEngland and NHS Improvement, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England to provide data over the extended period. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE NHS England and NHS Improvement may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: End of data collection (primary source) Primary study completion is expected January 2023 Data available for development of company submission Clinical study report is expected in Q4 2023 Anticipated company submission to NICE for Cancer Drugs Fund guidance review August 2021June 2024 2.3 Pfizer AbbVie anticipates the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021June 2024. 2.4 Pfizer AbbVie acknowledges their responsibility to adhere as closely as possible to the timelines presented in the document. 2.5 The review of this guidance, at the end of the managed access period, will be conducted as a full technology appraisal and Abbvie will be required to pay the charges associated with this process. A full technology appraisal will be required to allow data from the CLL13 trial and real-world data collection to be incorporated into the economic model and to ensure sufficient time and resource are allocated to review this new evidence. 2.6 NICE will, as far as is practicable, develop the scope and schedule a Cancer Drugs Fund the review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The guidance review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund a single technology appraisal guidance review see 6.27 of the technology appraisal process guide. 2.6 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 2.9 The company must inform NICE and NHS England and NHS Improvement of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandEngland and NHS Improvement. 2.10 2.11 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.12 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandEngland and NHS Improvement, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England to provide data over the extended period. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, 2.13 NICE and NHSE NHS England and NHS Improvement may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement DCA shall take effect on within 30 days after the publication of the managed access agreementNICE Final Guidance. 2.2 Estimated dates for data collection, reporting and submission for CDF NICE guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021guidance update April 2024 2.3 Pfizer The company anticipates the results from the additional data collected during the Cancer Drugs Fund DCA period will be incorporated into an evidence submission and the updated corresponding economic model by August 2021April 2024. 2.4 Pfizer acknowledges their responsibility The company will be responsible for: • producing or commissioning the development of a data/statistical analysis plan to adhere ensure methods and analytical outputs are clearly outlined and agreed within six months of publication of NICE Final Guidance. • paying a proportionate share of the costs of data collection, validation and analysis • providing a new evidence submission to NICE for this technology at the end of the data collection period • adhering as closely as possible to the timelines presented in the document. • informing NICE and NHSE&I in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. • paying all associated charges for the guidance update. Further information is available on the NICE website. 2.5 Any changes to the terms or duration of any part of the DCA must be approved by NICE and NHSE&I. 2.6 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review guidance update will use the NICE process and methods in place at the time of the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission dateparticipate. For further details of the expected timelines for the Cancer Drugs Fund NICE guidance review update see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS England. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- real-world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.8 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE&I, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHR to provide data over the extended period. 2.12 2.9 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology company withdraws from the Cancer Drugs FundMAA or decides not to proceed with the NICE guidance update, they will still be required to make all new evidence available to NICE, NHSE&I and stakeholders for the purpose of an engagement event. The engagement event will involve a presentation with the new evidence and the implications for patient access, so that stakeholders can be informed of the proposed next steps and the factors contributing to this outcome. The presentations from this engagement event will be published on the NICE website. 2.10 If at the guidance update NICE publish negative final guidance for risdiplam, existing patients may continue to receive treatment until they and their treating clinician consider it appropriate to stop. The company and NHSE&I have agreed how access to treatment will continue in these circumstances: this is detailed within the commercial access agreement.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021April 2024 2.3 Pfizer anticipates Xxx Xxxxx and Company Limited anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021April 2024. 2.4 Pfizer acknowledges Xxx Xxxxx and Company Limited acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandEngland and NHS Improvement. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandEngland and NHS Improvement, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England to provide data over the extended period. 2.12 If Xxx Xxxxx and Company Limited acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.13 In the event that could resolve Xxx Xxxxx and Company Limited do not make a submission to NICE for the uncertainties identified by purpose of updating the technology appraisal committeeguidance, NICE and NHSE NHS England and NHS Improvement will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHS England and NHS Improvement, patient and professional group stakeholders, with the company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.14 NICE and NHS England and NHS Improvement may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update Earliest opportunity after September 2024 2.3 Pfizer GSK anticipates the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021. 2.4 Pfizer September 2024. Data cleaning is required post the data cut. Detailed data analysis and survival analysis will be completed immediately post availability of the data in , and resubmitted in an updated model within . GSK acknowledges their its responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 2.4 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. . 2.5 The review NICE guidance update will use follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in the guidance review update is issued, which will . These may be no earlier than 4 weeks prior different from the process and methods applicable to guidance updates when this technology entered into the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guidemanaged access agreement. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data).• 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks • of further delays. • 2.12 GSK acknowledge its responsibility to provide an evidence submission for this technology to NICE under all circumstances following a period of managed access. 2.13 In the event that GSK does not make a submission to NICE for the purpose of updating the guidance, NICE and NHSE will require the company to agree to submit the clinical evidence collected during the managed access period, and to participate in an extensionengagement meeting convened by NICE with attendance from NHSE, it may not be possible to amend patient and professional group stakeholders, with the date company presenting the clinical evidence collected during the managed access period and an explanation of the final SACT or real-world data report, although NICE will explore options decision to proceed with Public Health England to provide data over withdrawal of the extended periodguidance. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, 2.14 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update Q4 2024 2.3 Pfizer Xxxxxxx Xxxxxx anticipates that the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021Q4 2024. The delay between data availability and evidence submission (>2 months) is due to the time required for Xxxxxxx Xxxxxx to analyse trial data, update the economic model, and develop the submission dossier based on the final DESTINY-Breast03 data cut. 2.4 Pfizer Xxxxxxx Xxxxxx acknowledges their its responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. . 2.6 The review NICE guidance update will use follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in of the guidance review update is issued, which will . These may be no earlier than 4 weeks prior different from the process and methods applicable to guidance updates when entered into the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guidemanaged access agreement. 2.6 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on the NICE website. 2.8 2.9 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 2.11 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.12 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHS Digital to provide data over the extended period. 2.12 If 2.13 Xxxxxxx Xxxxxx acknowledges its responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.14 In the event that could resolve Xxxxxxx Xxxxxx does not make a submission to NICE for the uncertainties identified purpose of updating the guidance, NICE and NHSE will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE, patient and professional group stakeholders, with the technology appraisal committee, company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.15 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update December 2024 2.3 Pfizer Roche anticipates that the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model containing final DFS data from IMpower010, most recent cost and background mortality data, by August 2021March 2024. 2.4 Pfizer A NICE guidance update following a period of data collection is the primary mechanism that will for exiting a MAA. 2.5 The NICE guidance update will follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in the guidance update is issued to the company. These may be different from the process and methods applicable to guidance updates when atezolizumab as an option for treating adjuvant treatment of resected non-small-cell lung cancer was recommended with managed access and/or entered into the MAA. 2.6 Roche acknowledges their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 2.7 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. The review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guide. 2.6 2.8 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 2.9 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on the NICE website. 2.8 2.10 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.11 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 2.12 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • ● Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • ● It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.13 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • ● The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • ● It may be necessary for the company to mitigate the impact of any delay and reduce any risks • of further delays. ● In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHS Digital to provide data over the extended period. 2.12 If 2.14 Roche acknowledges its responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.15 In the event that could resolve Roche does not make a submission to NICE for the uncertainties identified purpose of updating the guidance, NICE and NHSE will require the company agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE, patient and professional group stakeholders, with the technology appraisal committee, company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.16 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund on the following, non-exhaustive, grounds: ● The primary sources of data are delayed, without reasonable justification. ● The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. ● Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF guidance review are: Planned interim analysis Final analysis End of data collection (primary sources) NAVIGATE: PHE data sets: July 2022 Genomics England Analysis NAVIGATE: PHE data sets: July 2023 Anticipated company submission to NICE for Cancer Drugs Fund review August 2021Q2 2023 September 2024 2.3 Pfizer anticipates the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021. 2.4 Pfizer acknowledges Bayer acknowledge their responsibility to adhere as closely as possible to the timelines presented in the document, and to notify NICE and NHS England and NHS Improvement of any delays within 14 days of becoming aware of any timing issues. 2.4 As the data collection involves substantial additional data from new and existing sources over an extended period the following will apply: • An interim review of the data collected will be required. Bayer will be required to provide an evidence submission to enable this review to take place. Xxxxx’x evidence submission will either be the dossier provided to the European Medicines Authority as part of the conditional marketing authorisation or a stand-alone document that includes all appropriate and relevant available evidence about the clinical effectiveness of the technology. NICE and NHS England and NHS Improvement and the company will review all available evidence and, and NICE and NHS England and NHS Improvement will decide whether further data collection is required to resolve the key uncertainties identified by committee, or the data is sufficient to initiate a NICE guidance review. • The guidance review following the managed access period for this topic will be undertaken as a full technology appraisal. For further details of the technology appraisal process see NICE’s guide to the processes of technology appraisal. 2.5 NICE will, as far as is practicable, develop the scope and schedule a Cancer Drugs Fund the review into the technology appraisal work programme to align with the estimated dates for the end of data collection. The guidance review will use the process and methods in place at the time the invitation to participate in the guidance review is issued, which will be no earlier than 4 weeks prior to the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund a single technology appraisal guidance review see 6.27 of the technology appraisal process guide. 2.6 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the Cancer Drugs Fund guidance review single technology appraisal timelines described in NICE’s guide to the processes of technology appraisal. 2.7 The company is responsible for paying all associated charges for a Cancer Drugs Fund review. Further information is available on the NICE website. 2.8 The company must inform NICE and NHS England and NHS Improvement of any anticipated changes to the estimated dates for data collection at the earliest opportunity, and within 14 days of becoming aware of these new dates. 2.9 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandEngland and Improvement. 2.10 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- real-world data report (for example if planned outputs will no longer provide meaningful data). 2.11 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandEngland and Improvement, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to take action to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England to provide data over the extended period. 2.12 If a primary source of data is delayed or no longer reports outcome data that could resolve the uncertainties identified by the technology appraisal committee, NICE and NHSE NHS England and NHS Improvement may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data will not report outcome data for an interim review. • The primary sources are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.

Commencement and period of agreement. 2.1 This data collection arrangement shall take effect on publication of the managed access agreement. 2.2 Estimated dates for data collection, reporting and submission for CDF a guidance review update are: Anticipated company submission to NICE for Cancer Drugs Fund review August 2021a guidance update April 2027 2.3 Pfizer anticipates Xxx Xxxxx and Company Limited anticipate the results from the additional data collected during the Cancer Drugs Fund period will be incorporated into an evidence submission and the updated economic model by August 2021April 2027. 2.4 Pfizer acknowledges Xxx Xxxxx and Company Limited acknowledge their responsibility to adhere as closely as possible to the timelines presented in the this document. 2.5 NICE will, as far as is practicable, schedule a Cancer Drugs Fund review the guidance update into the technology appraisal work programme to align with the estimated dates for the end of data collection. . 2.6 The review NICE guidance update will use follow the process and methods applicable to guidance updates that are in place at the time the invitation to participate in the guidance review update is issued, which will . These may be no earlier than 4 weeks prior different from the process and methods applicable to guidance updates when this technology entered into the anticipated company submission date. For further details of the expected timelines for the Cancer Drugs Fund guidance review see 6.27 of the technology appraisal process guidemanaged access agreement. 2.6 2.7 As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the end of data collection and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance update follows the Cancer Drugs Fund guidance review timelines described in NICE’s guide to the processes of technology appraisalstandard timelines. 2.7 2.8 The company is responsible for paying all associated charges for a Cancer Drugs Fund reviewguidance update. Further information is available on the NICE website. 2.8 2.9 The company must inform NICE and NHS England (NHSE) in writing of any anticipated changes to the estimated dates for data collection at the earliest opportunity. 2.9 2.10 Any changes to the terms or duration of any part of the data collection arrangement must be approved by NICE and NHS EnglandNHSE. 2.10 2.11 If data collection is anticipated to conclude earlier than the estimated dates for data collection, for example due to earlier than anticipated reporting of an ongoing clinical trial, the company should note: • Where capacity allows, NICE will explore options to reschedule the Cancer Drugs Fund guidance review update date to align with the earlier reporting timelines. • It may be necessary to amend the content of the final SACT or real- world data report (for example if planned outputs will no longer provide meaningful data). 2.11 2.12 If data collection is anticipated to conclude later than the estimated dates for data collection, the company should note: • The company must submit a written request to NICE and NHS EnglandNHSE, with details of the extension requested, including an explanation of the factors contributing to the request. • It may be necessary for the company to mitigate the impact of any delay, and reduce any risks of further delays. • In the event of an extension, it may not be possible to amend the date of the final SACT or real-world data report, although NICE will explore options with Public Health England NHSE to provide data over the extended period. 2.12 If 2.13 Xxx Xxxxx and Company Limited acknowledge their responsibility to provide an evidence submission for this technology to NICE under all circumstances following a primary source period of data is delayed or no longer reports outcome data managed access. 2.14 In the event that could resolve Xxx Xxxxx and Company Limited do not make a submission to NICE for the uncertainties identified purpose of updating the guidance, NICE and NHSE will require the company to agree to submit the clinical evidence collected during the managed access period, and to participate in an engagement meeting convened by NICE with attendance from NHSE, patient and professional group stakeholders, with the technology appraisal committee, company presenting the clinical evidence collected during the managed access period and an explanation of the decision to proceed with withdrawal of the guidance. 2.15 NICE and NHSE may consider the data collection agreement no longer valid, and withdraw the technology from the Cancer Drugs FundFund for the following, non-exhaustive, grounds: • The primary sources of data are delayed, without reasonable justification. • The primary sources of data are unlikely to report outcome data that could resolve the uncertainties identified by the technology appraisal committee. • Amendments are made to the marketing authorisation.