The Cancer Drugs Fund: Guidance to Support Operation of the Cancer Drugs Fund in 2012-13

Objectives

The Cancer Drugs Fund (the Fund) provides an England-only mechanism for improving National Health Service access to cancer medicines, including radiopharmaceuticals, where a patient’s oncologist recommends treatment that is unavailable through usual commissioning routes. It updates and replaces the 2011-12 guidance, operating during 2012-13 as a bridge towards anticipated value-based pricing reforms for branded medicines in 2014.[1][2][3]

• Improve access to treatments not recommended by the National Institute for Health and Care Excellence on cost-effectiveness grounds, treatments with restricted recommendations, and medicines not yet appraised.[3]
• Prioritise clinical effectiveness and measurable patient outcomes, particularly overall survival, progression-free survival and quality of life. Consider cost effectiveness where robust evidence is available, especially where clinically similar treatments must be ranked within a limited budget.[3][4]
• Cover adults and people under 18, and permit a broad clinical interpretation of cancer that can include precancerous conditions where appropriate.[3]
• Recognise evidence limitations for rare cancers and paediatric indications, using specialist clinical advice where needed.[4]
• Promote transparent, equitable and population-based funding decisions that reduce administrative burden, enable forward planning and maximise the number of patients who can benefit from the fixed allocation.[4]
• Support access through the most appropriate route, including routine local commissioning, National Institute for Health and Care Excellence recommendations, local policies, regional specialised commissioning arrangements, exceptional funding processes and the Fund.[5][6]
• Improve patients’ ability to make informed treatment decisions by providing information on treatment benefits and toxicities, alongside tumour-specific information pathways and information prescriptions.[7]

Implementation

The Fund is delivered through regional, clinically led panels, with Strategic Health Authorities retaining accountability and specialised commissioning teams able to undertake operational functions under service-level agreements. Panels manage a fixed annual allocation, assess clinician-led applications, and make decisions using clinical evidence, expert opinion and published regional processes.[2][8][4]

• Require each Strategic Health Authority to maintain a transparent, published process for allocating Fund resources, including application procedures, local policies and prioritised treatments.[8][7]
• Enable clinicians to apply on behalf of individual patients after exploring reasonable National Health Service commissioning routes. Where no local commissioning policy exists, use an Individual Funding Request for exceptional cases; population-level requests should lead to policy development rather than repeated exceptional applications.[5][6]
• Check whether a patient falls within a cohort already covered by a regional Fund decision before seeking exceptional funding, and clarify the relationship between Fund arrangements and local drug-funding policies.[6]
• Maintain dynamic priority or cohort lists of medicines, review them at least quarterly, accept applications between scheduled reviews, and take account of National Institute for Health and Care Excellence recommendations, new evidence, new treatments, demand changes and local priorities.[4]
• Allow local clinicians to make representations on prioritisation decisions, enable panel collaboration and expertise-sharing, and retain decision-making responsibility with the relevant regional panel.[4]
• Provide timely decisions with regard to the 31-day cancer treatment standard, give reasons for refusals, permit reconsideration where evidence or relevant information changes, and operate an appeals process.[8]
• Consider including a lay perspective in decision-making to reinforce patient confidence, and assist patients who cannot independently access published information.[8][7]
• Fund medicines and, where necessary, molecular diagnostic testing through the Fund, while Primary Care Trusts meet associated service costs. Transfer responsibility for treatment to routine National Health Service commissioning when a positive National Institute for Health and Care Excellence recommendation or relevant local policy takes effect.[3][4]
• Continue Fund support for patients already receiving a treatment removed from priority lists because of new developments or evidence, where the treatment is not locally commissioned and clinicians agree when treatment should cease.[4]
• Make £200 million available for the Fund in 2012-13, allocated to Strategic Health Authorities using the national weighted capitation formula. Include £140 million in Primary Care Trust allocations before clawback to Strategic Health Authority budgets, and retain £60 million centrally for in-year allocation or redistribution according to demand.[8]
• Limit expenditure to Fund purposes, permit Strategic Health Authorities to use up to 1% of Fund resources for audit and management within their administration limits, and avoid retrospective funding obligations for treatment delivered before an individual funding decision.[8][3]
• Monitor use through regional and national clinical audit, including the National Cancer Drugs Fund Audit coordinated by the National Cancer Action Team and supported by a national database managed by the Oxford Cancer Intelligence Unit under a Memorandum of Understanding.[9]
• Collect and submit data on the NHS number, diagnosis, medicine, regimen, treatment dates and date of death, subject to the Data Protection Act 1998; prospective data collection was expected from April 2012, with retrospective data from April 2011.[9]
• Provide the Department of Health with monthly basic financial monitoring information, publish regularly updated activity data and periodic expenditure data, and consider contractual requirements for providers to submit audit information.[9][7]
• Document discussions with patients on treatment options, benefits, toxicities, palliative and end-of-life care, and record informed consent.[9]

Monitoring & Evaluation

Monitoring and accountability combine clinically led, outcome-based funding decisions with regional and national audit, routine data collection, financial reporting and public transparency. Strategic Health Authorities remain accountable for the Cancer Drugs Fund, while specialised commissioning teams may undertake operational responsibilities.[2][8]Applications are assessed primarily against clinical effectiveness and measurable outcomes, including overall survival, progression-free survival and quality of life; cost effectiveness may be considered where robust evidence exists, particularly to rank clinically similar treatments and maximise the number of patients treated.[3][4]

• Assess applications through clinically led panels using expert clinical opinion, evidence of anticipated outcomes and, where applicable, robust cost-effectiveness evidence.[8][3]
• Review dynamic priority or cohort lists at least quarterly, taking account of National Institute for Health and Care Excellence recommendations, emerging evidence, new treatments, changing patient numbers and local priorities.[4]
• Allow applications and reconsideration between scheduled reviews where relevant evidence is new or material information was missed, and provide an appeals process and reasons for refusals.[8][4]
• Operate decisions promptly with regard to the 31-day cancer treatment standard, while pursuing more challenging timescales where practicable.[8]
• Undertake regional and national clinical audit to support effective resource allocation, compliance with regional arrangements and evidence on medicine performance in routine practice.[3][9]
• Participate in the National Cancer Drugs Fund Audit, coordinated by the National Cancer Action Team, with the Oxford Cancer Intelligence Unit developing, implementing and managing the national database under a Memorandum of Understanding.[9]
• Collect prospective audit data from April 2012 and retrospective data back to April 2011, subject to the Data Protection Act 1998.[9]Audit fields include NHS number, primary diagnosis, drug, regimen, treatment start and stop dates, and date of death.[9]
• Establish robust data collection and submission arrangements, including possible provider contractual requirements for information supply.[9]
• Submit basic financial monitoring information to the Department of Health monthly and publish regularly updated activity information and periodic expenditure information, with monthly activity and quarterly expenditure identified as examples.[9][7]
• Publish local policies, application procedures and prioritised medicines online, alongside relevant activity and expenditure information, and support patients unable to access this information independently.[7]
• Document discussions of treatment options, benefits, toxicities, palliative care and end-of-life care, as well as informed consent.[9]

No formal comprehensive indicator set, fixed reporting template, surveillance methodology beyond the audit arrangements, or independent evaluation framework is specified in the supplied material.[10][8][3]

Costing & Financing

The Cancer Drugs Fund has a fixed annual allocation of £200 million for 2012-13, intended solely for Fund purposes and managed by clinically led panels within fixed annual regional allocations.[8][4]The funding supports access to cancer medicines, including radiopharmaceuticals, and may cover necessary molecular diagnostic testing; Primary Care Trusts are expected to fund associated service costs.[3]

• Allocate funding shares to Strategic Health Authorities through the national weighted capitation formula.[8]
• Include £140 million in Primary Care Trust allocations and claw this back to support Strategic Health Authority-level Cancer Drugs Fund budgets.[8]
• Hold £60 million centrally for in-year allocation and potential redistribution in response to demand.[8]
• Limit audit and management expenditure to up to 1% of Fund resources, within Strategic Health Authority administration limits.[3]
• Manage fixed allocations against changes in treatment availability and patient demand.[4]
• Transfer funding responsibility from the Fund to the relevant Primary Care Trust where the National Institute for Health and Care Excellence issues a positive recommendation or a local commissioning policy applies.[4]
• Avoid retrospective Fund payments for treatment provided before an individual funding decision.[3]
• Monitor finances monthly and publish periodic expenditure information to support management of the total available resource.[9][7]

The material situates the Fund within anticipated branded-drug pricing reforms following expiry of the Pharmaceutical Price Regulation Scheme at the end of 2013.[2]It does not specify wider financing sources, a quantified funding gap, multi-year resource mobilisation arrangements, unit costs, or detailed economic assumptions beyond the fixed allocation and distribution arrangements.[8][3][4][9]