The Cancer Drugs Fund of England: improving access to innovative drugs or bypassing HTA informed decision-making?

Abstract

In the UK, the number of new cancer cases grows strongly each year, and its performance on cancer survival is significantly lower than in comparable countries. Even though a considerable amount of new cancer drugs is being developed, many end up not being reimbursed by the National Health Service (NHS), as they are often determined not to be cost-effective, meaning that they do not demonstrate sufficient added benefit to the healthcare system in relation to the price that is set by the pharmaceutical industry. This has resulted in cancer patient groups in the UK to strongly criticize the methods of NICE, which is the agency that carries out these evaluations.

In 2011, the UK government established the Cancer Drugs Fund (CDF) in England to address these issues. With the former system of the CDF, all drugs that were not recommended by NICE for routine use in the NHS were eligible for funding, which was subject to a considerable amount of criticism; patients suffering from other diseases felt excluded, the fund overspent its budget, it did not collect data on the effectiveness of the funded treatments, and pharmaceutical companies were given an alternative way to market their expensive drugs that were determined not to be cost-effective. In 2016, the fund was reformed and introduced clearer entry and exit rules. In this renewed system, promising drugs that were associated with too weak clinical evidence to be recommended for reimbursement, were funded for a set period of time, while simultaneously the pharmaceutical company could submit supplementary evidence to proof its effectiveness. Additionally, a financial control mechanism was set up to prevent the fund from overspending its budget. Throughout its existence, the fund has helped over 168,000 patients to get access to a cancer treatment.

Some other countries in the UK and in Europe have employed similar policies to the CDF; England’s neighboring countries Wales and Northern Ireland, for example, have recently introduced policies that allow access to the same drugs that have an arrangement through the CDF, whereas Scotland established a fund that reimburses drugs for rare diseases on an individual basis. We advocate countries that wish to introduce a similar funding policy to: 1) focus on high unmet clinical need rather than a specific disease to prevent the prioritization of one therapeutic area; 2) not solely focus on reimbursing drugs, but also other health technologies (prevention, surgery, diagnostics, etc.); 3) make use of a financial control mechanism to prevent overspending; 4) collect data on the effectiveness of funded treatments in order to determine the impact of the policy; 5) integrate the policy in the existing evaluation process of cost effectiveness, while collaborating closely with all relevant stakeholders and make use of clear and transparent entry and exit criteria; 6) adhere to robust clinical evidence. In that way, access to innovative drugs will be improved, while simultaneously maximizing the added value for society.