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

Objectives

The Cancer Drugs Fund (CDF) guidance for England for 2012-13 aims to maximise NHS patient access to cancer medicines while placing clinicians and cancer specialists at the centre of individual funding decisions.[1]It updates the 2011-12 arrangements and is intended to bridge the transition to value-based pricing for branded medicines anticipated from 2014, following the end of the Pharmaceutical Price Regulation Scheme in 2013.[1]

• Improve access to cancer treatments, including radiopharmaceuticals, where an oncologist recommends a medicine that is unavailable through usual commissioning routes.[2]
• Fund treatments that the National Institute for Health and Care Excellence (NICE) has found not cost-effective, has not yet appraised, or has recommended for narrower use than is clinically appropriate for an individual patient.[2]
• Apply support to adults and people under 18, and permit consideration of precancerous conditions where clinically appropriate.[2]
• Prioritise clinical effectiveness and anticipated measurable outcomes, including overall survival, progression-free survival and quality of life, when deciding access.[2][3]
• Use cost-effectiveness evidence where it is robust, particularly where treatments have similar clinical effectiveness, in order to treat the greatest possible number of patients within available resources.[2][3]
• Promote equitable, transparent and population-based decisions for defined patient groups while recognising that evidence may be limited for rare cancers and paediatric indications.[3]
• Clarify the relationship between local commissioning policies, Individual Funding Requests, exceptional funding arrangements and the CDF, so that the Fund complements rather than replaces ordinary NHS funding routes.[4][5]
• Improve informed patient choice by providing balanced information on treatment benefits, toxicities, palliative care and end-of-life care, and by securing informed consent.[6]

The Fund is intended for medicines that are not routinely commissioned locally or through a positive NICE recommendation for the relevant indication.[3][5]Where NICE recommends a treatment or a Primary Care Trust has adopted a policy to fund it, responsibility should transfer to the relevant Primary Care Trust and the treatment should be provided through normal NHS arrangements rather than the CDF.[3][4]

Implementation

Delivery is based on regional, clinically led decision-making panels, with Strategic Health Authorities retaining accountability and specialised commissioning teams able to undertake operational functions through Service Level Agreements.[1][7]The guidance is principally directed to Strategic Health Authorities, specialised commissioning teams and clinical panels, while also being relevant to wider NHS and finance leaders.[8][1]

• Allocate £200 million to the CDF in 2012-13, distribute Strategic Health Authority shares through the national weighted capitation formula, and require transparent local allocation processes.[7]
• Finance £140 million through Primary Care Trust allocations that are clawed back for Strategic Health Authority-level budgets, and retain £60 million centrally for in-year allocation by the Department of Health according to demand.[7]
• Restrict the total funding to CDF purposes, manage the fixed allocation flexibly as treatment availability and patient numbers change, and permit up to 1% for audit and management costs within existing administration limits.[7][2][3]
• Require clinicians to apply on behalf of patients and require panels to use expert clinical judgement, specialist advice where needed, and the guidance when making resource decisions.[7][3]
• Maintain dynamic priority or cohort lists of routinely supported medicines, review them at least quarterly, consider further applications between reviews, and allow local clinicians to make representations.[3]
• Design decisions around the 31-day cancer treatment standard, encourage more demanding local timescales, give reasons for refusals, permit reconsideration where evidence or relevant information changes, and provide a timely appeals process.[7]
• Include a lay perspective in decision-making and publish accessible information on local policies, application procedures and routinely funded medicines, including support for people unable to obtain information independently.[7][6]
• Use the Fund principally to purchase medicines, require Primary Care Trusts to meet associated service costs, and permit funding of necessary molecular diagnostic testing.[2]

Strategic Health Authorities are expected to monitor and audit CDF use to support effective allocation, assure adherence to regional arrangements and strengthen evidence on real-world treatment performance.[9]Clinical audit data include the NHS number, diagnosis, medicine, regimen, treatment dates and date of death, subject to data-protection requirements.[9]The National Cancer Action Team coordinates national audit, while the Oxford Cancer Intelligence Unit develops and manages the national database; prospective data are expected from April 2012 and retrospective data back to April 2011.[9]

Financial accountability includes monthly basic financial monitoring returns to the Department of Health and publication of CDF activity and expenditure information.[9]The guidance took effect on 23 April 2012, does not apply retrospectively, and was to remain under review during 2012-13; post-April 2013 arrangements were to be discussed by the Department of Health and the NHS Commissioning Board Authority.[1]

Monitoring & Evaluation

Monitoring combines regional and national clinical audit, financial oversight, published information and review of treatment priorities, with Strategic Health Authorities retaining accountability for adherence to Cancer Drugs Fund arrangements.[9]

• Require Strategic Health Authorities to audit and monitor Fund use, support effective resource allocation, assure compliance with regional arrangements and strengthen evidence on real-world drug performance.[9]
• Collect clinical audit data on NHS number, diagnosis, medicine, regimen, treatment dates and date of death, in compliance with data-protection requirements.[9]
• Coordinate the national audit through the National Cancer Action Team, with the Oxford Cancer Intelligence Unit developing and managing the national database.[9]
• Submit prospective data from April 2012 and retrospective data back to April 2011.[9]
• Provide monthly basic financial monitoring information to the Department of Health, publish activity and expenditure data, update activity regularly and report expenditure periodically.[9]
• Assess medicines against clinical effectiveness and anticipated measurable outcomes, including overall survival, progression-free survival and quality of life.[3]
• Review dynamic priority or cohort lists at least quarterly, considering new National Institute for Health and Care Excellence recommendations, emerging evidence, treatment availability, patient numbers and local priorities.[3]
• Keep panel decisions open to reconsideration when relevant new evidence or developments emerge.[3]
• Document reasons for refusals, permit reconsideration where information was missed or evidence changes, and maintain timely appeals processes.[7]
• Ensure local and exceptional funding decisions are rational, evidence-based and transparent, consistent with the NHS Constitution and relevant Department of Health and National Prescribing Centre guidance.[4]

The guidance identifies monitoring, audit and information provision as covered areas and was to remain under review during 2012-13, but it does not set out a broader quantitative indicator framework, detailed surveillance methodology or formal evaluation timetable.[10][1]

Costing & Financing

The Cancer Drugs Fund has a fixed annual allocation of £200 million, intended primarily to purchase eligible medicines and managed flexibly as treatment availability and patient numbers change.[7][3][2]

• Make £200 million available to the NHS for the Fund in 2012-13 and distribute Strategic Health Authority shares through the national weighted capitation formula, reflecting population age distribution and additional need.[7]
• Include £140 million in Primary Care Trust allocations before clawing it back for Strategic Health Authority-level budgets.[7]
• Hold £60 million centrally within the Department of Health for in-year allocation, adjusting allocations between Strategic Health Authorities after assessment of demand where appropriate.[7]
• Restrict the full £200 million allocation to Cancer Drugs Fund purposes in 2012-13.[7]
• Maintain annual funding of £200 million throughout the life of the Fund.[3]
• Permit Strategic Health Authorities to use up to 1% of Fund resources for audit and management costs, within existing administration-cost limits.[2]
• Fund necessary molecular diagnostic testing through the Fund where required, while requiring Primary Care Trusts to meet associated service costs.[2]
• Transfer responsibility and associated funding to the relevant Primary Care Trust when the National Institute for Health and Care Excellence positively recommends a medicine for the relevant indication.[3]
• Provide treatments funded under Primary Care Trust policy through normal NHS arrangements rather than the Fund.[4]
• Use cost-effectiveness evidence where robust evidence exists, particularly when clinical effectiveness is similar, to maximise the number of patients treated from available funding.[3]

No additional funding sources, quantified funding gap, unit-cost schedule, resource-mobilisation plan or wider economic assumptions are specified.[7][2]