Managed Access AgreementManaged Access Agreement • December 12th, 2023
Primary source(s) of data collection: Ongoing clinical studies FIREFISH and SUNFISH; SMA REACH; patient and carer quality of life data collection
Managed Access AgreementManaged Access Agreement • August 12th, 2021
NICE Agreement Manager Brad Groves – Associate Director, Managed Access NHS England and NHS Improvement Agreement Manager Sharon Hodgson – National Programme of Care Manager Novartis Agreement Manager Heather Moses – Country Medical Director National Haemoglobinopathy Registry Agreement Manager Sally Cavanagh – Clinical Information Manager, NHSE&IFarrukh Shah – Chair, National Haemoglobinopathy Registry Steering Group
Managed Access AgreementManaged Access Agreement • April 27th, 2023
NICE Agreement Manager Thomas Strong, Associate Director, Managed Access NHSE Agreement Manager Prof Peter Clark, CDF Clinical Lead MSD Agreement Manager Claire Grant, Head of HTA & OR, MSD
Managed Access AgreementManaged Access Agreement • January 4th, 2022
Secondary source of data collection: NHS Digital routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Managed Access AgreementManaged Access Agreement • January 8th, 2020
Secondary source of data collection: Public Health England routine population- wide cancer data sets, including Systemic Anti-Cancer Therapy (SACT) dataset, and NHS England’s Blueteq data
Managed Access AgreementManaged Access Agreement • March 14th, 2022
Secondary source of data collection: NHS Digital routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Managed Access AgreementManaged Access Agreement • December 12th, 2018
NICE Agreement Manager Linda Landells (Associate Director) NHS England Agreement Manager Peter Clark (CDF Clinical Lead) Novartis Pharmaceuticals Ltd Agreement Manager Deb Lancaster
Managed Access AgreementManaged Access Agreement • September 16th, 2023
Primary source of data collection: ZUMA-7 clinical trial and NHS England routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set and Blueteq
Managed Access AgreementManaged Access Agreement • February 2nd, 2023
Secondary source of data collection: Systemic Anti-Cancer Therapy (SACT) dataset during managed access agreement; NHS England & Improvement’s Blueteq data
Managed Access AgreementManaged Access Agreement • December 10th, 2021
Secondary source of data collection: NHS Digital routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCEManaged Access Agreement • March 5th, 2018
Date of Agreement NHS England ……………………………………… Dr Jonathan Fielden - Director of Specialised CommissioningDeputy National Medical Director NHS England PTC Therapeutics International ………………………………………Mr Adrian Haigh - Director Clinical Lead ……………………………………… Professor Francesco Muntoni/Dr Adnan Manzur, ICH and GOSH, London Patient Organisation(s) ………………………………………Mr Robert Meadowcroft, CEO MDUK …………………………………………..Ms Diana Ribeiro, CEO Action Duchenne NICE ……………………………………… Professor Carole Longson / Sir Andrew Dillon
Managed Access AgreementManaged Access Agreement • June 28th, 2021
Secondary source of data collection: Routinely collected clinical data in England, including patient baseline characteristics.
Managed Access AgreementManaged Access Agreement • June 23rd, 2023
Secondary source of data collection: NHS England routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set, and Blueteq
Managed Access AgreementManaged Access Agreement • February 17th, 2021
Company name: Gilead Sciences Ltd (the legal entity in the UK for Kite, a Gilead company) and referred to as Kite in this Agreement
Managed Access AgreementManaged Access Agreement • October 7th, 2024
Primary sources of data collection: Ongoing trial of belzutifan in VHL-associated tumours LITESPARK-004 (MK-6482-004); NHS England routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Managed Access AgreementManaged Access Agreement • March 22nd, 2022
Secondary source of data collection: NHS Digital routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Managed Access AgreementManaged Access Agreement • January 16th, 2019
Company name: Gilead Sciences Ltd (the legal entity in the UK for Kite, a Gilead company) and referred to as Kite in this Agreement
Cancer Drugs Fund Managed Access AgreementManaged Access Agreement • August 16th, 2017 • England
This Managed Access Agreement (MAA) combines the agreed terms of the Data Collection Arrangement (DCA) and a confidential Commercial Access Agreement (CAA). It allows the entry to the Cancer Drugs Fund (CDF) of ibrutinib for treating Waldenström’s macroglobulinaemia (WM).
Managed Access AgreementManaged Access Agreement • May 19th, 2021
Secondary source of data collection: DESTINY-Breast01 (NCT03248492; ongoing Phase II clinical trial); Systemic Anti-Cancer Therapy (SACT) dataset during managed access agreement; NHS England and NHS Improvement’s Blueteq data
Contract Variation Agreement No. 1 to Managed Access Agreement for Ataluren (Translarna™) for treating nonsense mutation Duchenne muscular dystrophyManaged Access Agreement • August 11th, 2021
Contract/Variation Reference: On 4 July 2016, NHS England and NHSE Improvement (NHSE&I), PTC Therapeutics International Limited (PTC), NICE together with two other parties (collectively the “Parties” and each a “Party”) entered into the “Managed Access Agreement for ataluren relating to the supply of ataluren (Translarna™) for treating nonsense mutation Duchenne muscular dystrophy (the “MAA”).
Nusinersen Managed Access Agreement: interim arrangements for ambulation stopping criteria as explained on NICE website 29.10.2020Managed Access Agreement • October 28th, 2020
These interim arrangements apply only to Type 3 paediatric Spinal Muscular Atrophy (SMA) patients who lost ambulation in the 12 months prior to 28th July 2019 and who have been initiated on nusinersen.
Contract Variation Agreement No. 1 to the Managed Access Agreement for Asfotase alfa (Strensiq®) for treating paediatric-onset hypophosphatasiaManaged Access Agreement • September 8th, 2021
Contract/Variation Reference: On 02 August 2017, NHS England and NHS Improvement (NHSE&I), Alexion Pharma UK Ltd., NICE together with two other parties (collectively the “Parties” and each a “Party”) entered into the “Managed Access Agreement for Asfotase alfa (Strensiq®) for treating paediatric-onset hypophatasia (the “MAA”).
Managed Access AgreementManaged Access Agreement • October 1st, 2020
Secondary source of data collection: Public Health England routine population- wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Managed Access AgreementManaged Access Agreement • February 14th, 2019
Tisagenlecleucel for treating relapsed or refractory diffuse large B- cell lymphoma after 2 or more systemic therapies [ID1166]
Managed Access AgreementManaged Access Agreement • October 3rd, 2019
Secondary source of data collection: Public Health England routine population- wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Regarding: NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE, Managed Access Agreement - DRAFT Nusinersen (SPINRAZA®) for the treatment of 5q spinal muscular atrophyManaged Access Agreement • June 14th, 2019
We are writing in response to the draft consultation document that NICE has published, in which the community was asked to provide feedback by the 17th of June 2019.
Managed Access AgreementManaged Access Agreement • September 26th, 2022
Secondary source of data collection: NHS Digital routine population-wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Managed Access AgreementManaged Access Agreement • July 18th, 2019
Secondary source of data collection: Public Health England routine population- wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Nusinersen Managed Access AgreementManaged Access Agreement • June 3rd, 2021
Authors: Laura Knight, Cedar Senior ResearcherSusan O’Connell, Cedar Senior Researcher Rhys Morris, Cedar Director Date: 7th April 2021 Version: 3.1
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCEManaged Access Agreement • May 8th, 2019
NICE Agreement Manager Carla Deakin NHS England Agreement Manager Peter Clark Public Health England Agreement Manager Rebecca Smittenaar Bristol-Myers Squibb Agreement Manager Agreement Manager Veronique Walsh
Managed Access AgreementManaged Access Agreement • February 20th, 2024
NICE Agreement Manager , Associate Director,Managed Access NHSE Agreement Manager , National Cancer Drugs Fund Clinical Lead NHSE Agreement Manager , Head of Data Projects GSK Agreement Manager
Managed Access AgreementManaged Access Agreement • November 7th, 2018
Secondary source of data collection: Public Health England routine population- wide cancer data sets, including Systemic Anti-Cancer Therapy data set
Managed Access AgreementManaged Access Agreement • July 15th, 2019
Date of Agreement NHS England ………………………………………NHS England Biogen ……………………………………… Clinical Lead ……………………………………… …………………………….. ……………………………………… Patient Organisation(s) SMAUK ……………………………………… TreatSMA ………………………………………….. Muscular Dystrophy UK ………………………………………….. NICE ………………………………………
Managed Access AgreementManaged Access Agreement • June 17th, 2024
NICEAgreement Manager , Associate Director, Managed Access NHSEAgreement Manager , NHSE Clinical Advisor (Non-oncology) CSL Behring UK Ltd Agreement Manager
ContractManaged Access Agreement • June 9th, 2020
The Managed Access Agreement (MAA) for nusinersen includes a Data Collection Agreement that outlines the types of data that will be collected from people on nusinersen treatment during the managed access period. This patient data is intended to answer uncertainties and knowledge gaps that were identified by the NICE appraisal committee during the original review of nusinersen.
