Patient Eligibility. The clinical community and patient organisations feel it is appropriate and right that all patients diagnosed with Duchenne muscular dystrophy (DMD) resulting from a nonsense mutation who are aged 5 and over and who are ambulatory should have access to ataluren (TranslarnaTM) in England. Ataluren will be added to existing standard treatment, including use of corticosteroids. Patients must be made aware of the start and stop criteria for receiving ataluren treatment and are required to attend their clinics 2 times for assessment within a 14 month period. All patients will sign up to the ‘Managed Access Patient Agreement’.
Patient Eligibility. 4.1 Key patient eligibility criteria to start treatment within managed access include: • Patient meets one of the following criteria: o Clinical diagnosis of SMA type 1, 2, or 3. o Pre-symptomatic of SMA and has been confirmed to have SMA via genetic testing and has one to four SMN2 copies. • Risdiplam is used as a monotherapy. • Must not have had successful treatment with onasemnogene abeparvovec. Non- successful treatment is defined in appendix A. • No permanent ventilation (≥16 hours/day for 21 consecutive days in the absence of acute reversible infection)/ tracheostomy requirement at baseline. Patients who do not meet this criterion but otherwise meet the eligibility criteria should be discussed with the NHS England Clinical Panel. • Mandated data items have been collected prior to starting treatment within this MAA (see section 7, Outcome data). Patients who have started treatment for SMA prior to this MAA are not required to repeat an assessment if a previous assessment has captured all mandated data items (see table 2) within the last 6 months. • Patient/carer has signed the ‘Managed Access Patient Agreement’ and agreed to the associated monitoring, clinical assessments and sharing of data for the purpose of the MAA (see section 10, Patient consent). • Clinician confirms they: o will submit data to SMA REACH UK as set out in the DCA. o have made the patient/carer aware that there are other treatments for SMA, which may be more suitable for that patient. o confirm annually, via completion of an addition Blueteq form, that the patient continues to receive benefit from treatment. • Risdiplam will be otherwise used as set out in its Summary of Product Characteristics (SmPC).
4.2 If a patient meets any of the following stopping criteria the treating clinician should decide whether to terminate or continue treatment: • the patient is diagnosed with an additional progressive life-limiting condition where treatment would not provide long- term benefit such as terminal cancer or catastrophic brain injury. • the patient uses a different disease-modifying therapy to treat SMA. • the patient/family/carer withdraws their consent or is unwilling to comply to the associated monitoring, clinical assessments or sharing of data for the purpose of the MAA. • the patient is not receiving benefit from treatment, as confirmed either by the annual additional Blueteq form or by meeting any of the stopping criteria within Table 1, Endpoints, assessments and stopping rules. ...
Patient Eligibility. MANAGER shall: (a) obtain and maintain current eligibility lists from the Payors subject to this Agreement; (b) assist in determining eligibility of patients for coverage prior to the provision of medical or other services; and (c) reconcile retroactive denials of eligibility with the authorization processes established by IPA or the applicable Payor with the Payor Contract, and with applicable provisions of health plan benefit agreement(s) or other evidences of coverage.
Patient Eligibility a. Company and THPR will develop a system to verify patient eligibility. As used in the context of this Agreement, an individual is a "patient" of Company (with the exception of State-operated or funded AIDS drug purchasing assistance programs) only if:
1. Company has established a relationship with the individual, such that Company maintains records of the individual's health care; and
2. the individual receives health care services from a health care professional who is either employed by Company or provides
3. the individual receives a health care service or range of services from Company which is consistent with the service or range of services for which grant funding or Federally-qualified health center look-alike status has been provided to Company.
b. An individual is not a "patient" of Company for purposes of 340B if the only health care service received by the individual from Company is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting.
c. An individual registered in a State-operated or funded AIDS drug purchasing assistance program receiving financial assistance under title XXVI of the Public Health Services Act will be considered a "patient" of Company for purposes of this definition if so registered as eligible by the State program.
Patient Eligibility. 3.1 Key patient eligibility criteria for the use of onasemnogene abeparvovec for pre-symptomatic SMA during the period covered by the MAA include: • patient has a confirmed genetic diagnosis of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and up to 3 (three) copies of the SMN2 gene, • patient does not display any clinical manifestations that are strongly suggestive of SMA, • patient has not received any prior treatment with nusinersen or risdiplam, • patient has confirmed anti-adeno-associated virus 9 (anti-AAV9) antibody titres below 1:50, • onasemnogene abeparvovec will be otherwise used as set out in its Summary of Product Characteristics (SmPC).
3.2 The estimated patient numbers per year in England for this technology within the MAA period are: As estimated by the company • Current practice: Approximately 2 per year ( sibling identified) • Up to 4 per year (should a newborn screening pilot be implemented) • Up to approximately 48 per year if a national newborn screening programme is introduced As estimated by NICE Resource Impact Assessment team • Current practice: Approximately 2 per year (sibling identified) • Up to approximately 50 per year if a national newborn screening programme is introduced
Patient Eligibility. 3.1 Key patient eligibility criteria for the use of palbociclib in combination with fulvestrant in the Cancer Drugs Fund include: • The application for palbociclib in combination with fulvestrant is made by and the first cycle of palbociclib plus fulvestrant will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy • Patient has histologically or cytologically documented oestrogen receptor positive and HER-2 negative breast cancer • Patient has metastatic breast cancer or locally advanced breast cancer which is not amenable to curative treatment • Patient is male or is female and if female is either post-menopausal or if pre- or peri-menopausal has undergone ovarian ablation or suppression with LHRH agonist treatment • Patient has an ECOG performance status of 0 or 1 or 2 • Patient has received previous endocrine therapy according to one of the three populations as set out below as these are the groups on which the NICE Technology Appraisal for palbociclib plus fulvestrant focused. Please record which population the patient falls into: o Patient has progressive disease whilst still receiving adjuvant or neoadjuvant endocrine therapy for early breast cancer with no subsequent endocrine therapy received following disease progression or, o Patient has progressive disease within 12 or less months of completing adjuvant endocrine therapy for early breast cancer with no subsequent endocrine therapy received following disease progression or, o Patient has progressive disease on 1st line endocrine therapy for advanced/metastatic breast cancer with no subsequent endocrine therapy received following disease progression. • Patient has had no prior treatment with a CDK 4/6 inhibitor unless either abemaciclib (in combination with fulvestrant) or ribociclib (in combination with fulvestrant) has been stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or palbociclib has been received as part of an early access scheme for the combination of palbociclib plus fulvestrant and the patient meets all the other criteria set out in this form. • Patient has had no prior treatment with fulvestrant • Patient has had no prior treatment with everolimus • Palbociclib will only be given in combination with a fulvestrant • Treatment will continue until there is progressive disease or excessive toxicity or until the patient chooses to discon...
Patient Eligibility. All admissions are subject to prior authorization by County. The following individuals shall be considered acceptable for admission:
a. Individuals with a DSM-IV diagnosis in need of twenty-four (24) hour skilled nursing services, and
b. Individuals, who may have histories of and, without adequate treatment, are at risk of displaying behavioral symptoms (such as combativeness, elopement risk, suicide risk, and excessive verbal abusiveness), which preclude them from being admitted into a lower level care facility.
c. Frequency of these behaviors is a determining factor to be negotiated on an individual patient basis between County and Contractor. County may grant individual exceptions to these admission criteria. It is agreed by County and Contractor that individuals whose mental illness is deemed appropriate for acute care, as well as individuals suffering exclusively from developmental disability, mental retardation, or physical illnesses (without a psychiatric component), shall not be considered for admission.
Patient Eligibility. 3.1 Key patient eligibility criteria for the use of axicabtagene ciloleucel in the Cancer Drugs Fund include: The first part of the Blueteq form is for the approval of leucapheresis and manufacture of CAR-T cells. This includes the following eligibility criteria: • the application is being made by and that leucapheresis for and treatment with axicabtagene ciloleucel-modified CAR-T cells will be initiated by a consultant haematologist or medical oncologist specifically trained and accredited in the use of systemic anti-cancer therapy and working in an accredited CAR-T cell treatment centre and who is a member of the National CAR-T Clinical Panel for DLBCL and high-grade B-cell lymphoma (HGBCL) and a member of the treating Trust’s DLBCL and HGBCL CAR-T cell multidisciplinary team. • the patient is an adult (age 18 years or over) on the date of approval for axicabtagene ciloleucel by the National CAR-T Clinical Panel for DLBCL and HGBCL. • the patient has a confirmed histological diagnosis of DLBCL or HGBCL: o Diffuse large B-cell lymphoma (DLBCL) NOS (including ABC and GCB types) or o High grade B-cell lymphoma (HGBCL) with or without MYC and BCL2 (double hit) and BCL6 (triple hit) re-arrangements or o Transformed follicular lymphoma (TFL) to DLBCL or o T cell/histiocyte-rich large B-cell lymphoma or o Primary cutaneous DLBCL of leg type or o HHV8 positive DLBCL o DLBCL associated with chronic inflammation or o EB virus positive DLBCL Note: Patients with Burkitt lymphoma or primary mediastinal B cell lymphoma or primary CNS lymphoma or Xxxxxxx’x transformation to DLBCL are not eligible for treatment with axicabtagene ciloleucel in this indication. • the histological diagnosis of DLBCL or HGBCL or transformed lymphoma to DLBCL has been either made by or reviewed and confirmed by a designated lymphoma stem cell transplant centre. • prior to consideration of CAR-T cell therapy the patient’s disease has been re-biopsied unless either the patient had outright progressive disease on standard 1st line chemo-immunotherapy or a biopsy is unsafe in which case the patient must have progressive disease at previously known sites of active disease. In such situations the original diagnostic biopsy review is acceptable. o All patients with transformed follicular lymphoma to DLBCL who fulfil the criteria below must have a re-biopsy and have confirmation of DLBCL histology prior to consideration of CAR- T cell therapy, either: ▪ no biopsy necessary as the patient had outrigh...
Patient Eligibility. 3.1. A person may access the service if at its commencement they are a smoker or are within 4 weeks of the start of their quit attempt.
3.2. A person may access the service following a referral from a healthcare professional or another Help Me Quit (HMQ) provider, including transfer of care, or may refer himself or herself directly.
3.3. The service will be provided to people who live, or are registered with a GP, in Wales.
3.4. A person wishing to use the service must consent to the sharing of information about their quit attempt with the person with whom they are registered for the provision of General Medical Services and with NHS Wales for the purposes of post payment verification.
3.5. Subject to paragraphs 3.6 and 3.7 the service will be provided to any person aged 18 years or older.
3.6. The service may be provided to any person aged between 12 and 17 years provided that
3.6.1. The approved service provider undertakes an assessment of their competence and on completing that assessment considers them to be competent to consent to treatment; and
3.6.2. The approved service provider provides them with information regarding smoking cessation by children and young people.
3.7. The service may be provided to individuals with co-morbidities, or women who are breastfeeding, where they are provided with relevant information regarding smoking cessation for people with their condition. Where pharmacotherapy is provided as part of the service, the responsible pharmacist must consider that it is safe to do so and that such use is within the terms of its summary of product characteristics.
3.8. The service may be provided to women who are pregnant. In the first instance, they should be offered behavioural support only. If this fails, or it is reasonable to assume it will not be successful, they may be offered behavioural support with supply of Nicotine Replacement Therapy.
3.9. The service will only be provided to any person who has made an unsuccessful quit attempt in the previous six months in exceptional circumstances, which are at the discretion of the approved service provider.
Patient Eligibility. Upon receipt of a valid prescription and other documentation specified by Arbor pursuant to the Program, Pharmacy will: (i) confirm the Patient’s eligibility to receive Services, and (ii) dispense such prescription in accordance with this Services Agreement, Applicable Law, and professional standards.
