In July 2016, NICE took over responsibility for the Cancer Drugs Fund (CDF) in England, with an annual budget of £340 million. The new process aims to be completely transparent and should enable faster patient access to oncology treatments that have the potential to be cost-effective.
Under the new CDF scheme, the intention is that NICE will evaluate all new cancer drugs and provide draft guidance prior to market authorisation. NICE will provide one of three recommendations:
- YES – Recommended. The drug is recommended for routine commissioning by NHS England.
- NO – Not recommended. NICE does not recommend the drug for use in NHS England. However, patients may still get access to the treatment through individual funding requests
- Recommended for use within the CDF. NICE consider there to be potential for the drug to be cost-effective, but there is clinical uncertainty which needs investigation, through data collection in the NHS or clinical studies. In these cases the CDF will fund the drug, for up to two years, whilst the additional data is being collected. NICE will then review the new evidence to determine if it should be recommended for routine commissioning by NHS England.
Those products with positive draft guidance will have interim CDF funding available at market authorisation. The interim funding will cover the time taken for NICE to publish its final guidance (90 days after marketing authorisation) and the time taken for baseline NHS funding to be made available (an additional 90 days).
Drugs receiving recommendation for use within the CDF are also eligible for this interim funding. This type of decision will be made for treatments that NICE consider to be genuinely promising, but do not yet have robust enough data to allow a final decision to be made. The company will sign a managed entry agreement at the time of NICE final approval with the price decided within the managed access agreement. This price is expected to reflect the uncertainty of the product. At the end of the managed access period (approximately 2 years) NICE will re-appraise the drug given the new evidence that has been generated and a final decision will be made as to whether to NHS England should permanently fund the product.
The NICE CDF assessment process is comparable to that of a single technology appraisal (STA), with the exception that the process will start prior to marketing authorisation and will last 21 weeks, as opposed to the 34 weeks for an STA. If NICE are to make a draft recommendation prior to marketing authorisation, this means that the pharmaceutical company must make their submission to NICE at least 12 weeks prior to the marketing authorisation.
At the time of reform, the existing CDF contained 25 drugs for treatment of 35 indications. In addition to evaluating all new oncology treatments, NICE are currently carrying out a rapid review assessment of the existing CDF drugs to determine their cost-effectiveness. Appraisal of all existing drugs on the CDF is expected to be complete by early 2018.
To date, NICE has evaluated nearly 50% of the drugs on the existing CDF and appears to have been quite positive, with 58% of drugs (14 of the 24) assessed by NICE being recommended for routine use in the NHS. However, for each of these drugs the pharmaceutical company has agreed to a patient access scheme or a restricted patient population in order for the drug to be considered cost-effective and accepted by NICE. It is also interesting to note that in 2015, 16 drugs for the treatment of 27 indications were removed from the CDF prior to NICE taking over responsibility for the CDF. Had these products been included in NICE’s rapid review – the NICE approval rate would be significantly lower!
Whilst the new NICE CDF approach offers a more transparent process and will enable faster access to cost-effective oncology treatments, the process there are a number of considerationspharmaceutical companies should take into account:
- Companies are likely to have to offer competitive patient access schemes to get their product to be considered cost-effective. This will have an impact on the net price.
- Companies must be pro-active and have in place a strategic and tactical real-world evidence plan if they believe the current evidence base is not sufficient for a positive NICE recommendation
- Companies will be required to submit their evidence dossiers to NICE before market authorisation. This will have implications from a company resource and data analytics perspective, it is likely that some of the data required for evaluation by NICE may not be available at time of the company submission to NICE
- Pharmaceutical companies bear all the financial risk of the CDF as all drugs funded by the CDF will be subject to an expenditure control mechanism whereby any overspend will have to be paid back.