The Department of Health has produced guidance to the NHS, on the operation of the Cancer Drugs Fund (the fund) for the period 2011 to 2012, intended primarily for strategic health authorities (SHAs) and their clinically-led panels: The Cancer Drugs Fund: Department of Health - publications.

The guidance builds on experience gleaned from the 2010-11 regional operating arrangements for the provision (via the interim £50m fund) of additional cancer drugs, and is issued on the back of feedback from the department’s consultation, which closed in January of this year.

The principal strands of the guidance are as follows:

  • £200m is being made available in each of the next three years of the fund, divided up amongst SHAs according to the national weighted capitation formula. Each SHA should put in place a transparent, published process for allocating their funding.
  • Applications for funding should be made by clinicians on behalf of their patients, and decisions on the appropriate use of resources should be taken by clinically-led panels.
  • Decisions should be made in a timely manner and preferably on a shorter timescale than the 31-day cancer treatment standard.
  • Panels must provide reasons for any refusals to fund, the opportunity for cases to be reconsidered in the light of new evidence or if relevant information was missed, and a clear and transparent appeal process.
  • SHAs should consider how best to secure a lay perspective, to inspire patient confidence in the decision-making process.
  • Funding should be available for pre-cancer or cancer drugs (including radiopharmaceuticals) not appraised by NICE, rejected by NICE on the grounds of cost effectiveness, or limited by NICE to a smaller group than the marketing authorisation specification.
  • Although PCTs are expected to meet the associated service costs related to the provision of medicines by the fund, the fund may be used for molecular diagnostic testing which helps optimally to target the use of drugs for patients most likely to benefit.
  • The fund must contribute to clinical audit both regionally and nationally. SHAs may use up to one per cent of the funding on audit and management costs.
  • Access to the fund should be based primarily on evidence of clinical effectiveness and anticipated delivery of measurable outcomes such as improved overall survival, progression-free survival or improved quality of life. Panels should consider cost effectiveness where the evidence is robust.
  • Panels should be aware of rarity and make appropriate allowances where there are limitations in the evidence base, obtaining expert input where appropriate.
  • SHAs may collaborate on evidence assessment and share expertise, provided that they remember that the responsibility for decision-making remains with the relevant panel.
  • Funding may not be carried over from year to year, so panels will need to manage funding in a way that can respond to potential fluctuations in the number of applicants for particular treatments (eg, when a drug becomes the subject of a NICE TAG).
  • Panels are encouraged to take a population-based approach to decision-making for defined patient groups. This approach generates “priority lists” of drugs which will routinely be made available through the fund. Such lists, for which local clinicians may make recommendations for inclusion, should be reviewed at least quarterly, to remain dynamic.
  • Where a drug is removed from a priority list and becomes available through routine NHS funding, PCTs are expected to assume responsibility for funding patients from the fund.
  • Panels will need to agree transitional arrangements for patients currently funded under the interim £50m fund.
  • The fund does not supersede and replace the PCT Individual funding request process.
  • SHAs may expect clinicians to provide basic clinical audit data on patients whose treatment is supported through the fund, in a format which is consistent with use of the National Systemic Anti-Cancer Therapy Dataset due to become mandatory in April 2012. This should be made clear to clinicians as part of the application process.
  • SHAs should audit and monitor their use of the fund and will be required to provide basic financial monitoring information to the department on a monthly basis. They are also recommended to make appropriate activity data, and expenditure against the fund, available on their websites.  

The guidance came into force on 1 April 2011 and will be updated throughout the year as required. Arrangements from 1 April 2012 onwards will be the subject of discussions between the department and the shadow NHS Commissioning Board.