During its first three months of operation, the government’s interim Cancer Drugs Fund (CDF) has shown a lack of regional consistency in access, transparency, timing of decisions, appeal mechanisms, clinical involvement and audit arrangements, Ministers have been told.

However, the CDF has improved access and consistency in decision-making in some areas, but it has the potential to worsen regional variations in access to innovative medicines unless the right mechanisms are put in place, says the Association of the British Pharmaceutical Industry (ABPI), in its response to the government consultation on the CDF which closed yesterday (January 19).

The ABPI says that the Department of Health must provide the NHS with detailed guidance to ensure nationwide consistency in the Fund’s implementation and minimise potential inequities and variability in access, and also establish a national framework with a set of clear inclusion criteria so that the medicines which should be paid for from the CDF can be quickly and easily identified.

The categories which the industry group believes should be eligible for CDF funding are: - cancer medicines and specific indications for sub-groups of patients which have not been reviewed by the National Institute for Health and Clinical Excellence (NICE) or which have received a negative recommendation by NICE; and - cancer medicines and specific indications which are going through the NICE appraisal system but where final guidance has not yet been issued.

The eligibility criteria must be tight, in order to avoid regional variations in local decision-making, says the ABPI, but the Association does not support a restricted national list of eligible drugs; this, it says, would prove inflexible and a barrier to innovation.

Patient group Myeloma UK says the eligibility criteria must also include off-label drug use. If the intention is to give doctors greater prescribing freedom and flexibility, the CDF needs to reflect that improving access to drugs is not just about accessing a new product rejected or not yet approved by NICE, it says in its response to the consultation.

“In many cases, it is about responding to the heterogeneity of a cancer through off-label use of drugs, being creative with combination therapies, reusing a previous regimen or using a drug in a different way to how it is approved by NICE,” Myeloma UK tells the government.

The group is also concerned at the “perverse situation” in which Ministers can endorse a recommendation by NICE that a drug is not cost-effective but also have a policy that encourages the drug to be funded anyway through the CDF. “This in itself gives a wrong message to the pharmaceutical industry and makes less likely for NICE recommendations to hold weight for decision-makers,” it warns.

Therefore, it recommends that regionally-based panels should be able to decide not to fund drugs in cases where the manufacturer has refused to supply relevant information to NICE, and that they must still consider requests for drugs and drug combinations that have not been subject to NICE appraisal for any other reason.

In a joint response, the Royal Pharmaceutical Society’s (RPS) English Pharmacy Board and British Oncology Pharmacy Association also see a need for national guidance to help minimize differences in drug accessibility, without restricting regional decision-making.

“This should include guidance on the definition of ‘rarer’ cancers and the provision of a single system for the evaluation and scoring for the evidence of treatments.  A consistent decision must also be made on whether unlicensed medicines or those where the manufacturer has failed to submit a clinical and cost-effectiveness case to NICE should be considered for inclusion in the Fund,” they say.

It is not yet clear how the transfer from the CDF to value-based pricing (VBP) will take place, the groups point out.  There is a widespread belief that, in the interim, many cancer drugs may end up being financed exclusively from the Fund because Primary Care Trusts (PCTs) will perceive there is less need for them to be funded from their budgets but, they emphasise, it is vital that NHS funding continues via normal commissioning routes and the CDF remains as a fallback for funding non-NICE approved drugs.

In its response, the Ethical Medicines Industry Group (EMIG) stresses that the Fund must not be seen as a forerunner or pilot for the development of VBP.  EMIG, which represents small to medium-sized pharmaceutical enterprises in the UK, also points out that the deficiencies in the current system for cancer patients also exist in other disease areas, and that funding allocated to the CDF must not be at the expense of, or lead to, a loss of focus on the need for access to life-changing therapies for other conditions.

• Meantime, Scottish Conservatives say they would create a national cancer drugs fund worth up to £10 million each year, to be financed out of the £37 million which they say would be saved annually from overturning the scrapping of prescription charges.

It is unacceptable that patients in England and Wales can access at least 18 cancer drugs which are not available in Scotland due to reasons of cost, says Murdo Fraser, deputy leader of the Scottish Conservatives. Under the party’s proposals, the Scottish Medicines Consortium (SMC) would continue to recommend NHS funding for drugs which are regarded as clinical and cost-effective, but the additional funding would help cancer patients “access the vital drugs their clinicians think they need,” he said.