Last week saw the publication of the new approach to the appraisal and funding of cancer drugs in England, which included the new-look Cancer Drugs Fund (CDF). Back at its inception in April 2011, the intention of the CDF was to act as a bridge to the proposed Value-Based Pricing concept; however, this was never realised and so the CDF remained, and will continue to do so due to its inclusion in the Government manifestos.
The new CDF sees a major overhaul in the way that cancer drugs are funded in England, with all cancer drugs now being subject to NICE appraisal, clear entry and exit criteria, new interim funding arrangements and an expenditure control mechanism to name but a few key features of the new system. The new fund is being hailed as good news for patients, tax payers and industry, but what does it mean for cancer services and how can Pharma ensure funding for cancer therapies?
The focus for the five-year cancer plan in 2016 is around early detection and diagnosis. The National Diagnostics Capacity Fund will be testing initiatives to increase diagnostic capacity and productivity. In addition, the Faster Diagnosis Standard is in place, with five pilot sites identified to help develop the 28-day pathway. It is recognised that one size will not fit all, and sites will be expected to share best practice and collaborate to ensure that when the system goes live by October, any major kinks will have been ironed out in preparation for a national roll out in summer 2017.
In addition to earlier diagnosis, the new CDF brings a mechanism for earlier funding for promising drugs and a fast-track NICE appraisal process. Interim funding is also available while further evidence is collected for drugs that have the potential to satisfy the criteria for routine commissioning. However, the Fund is finite, with a fixed budget of £340 million. In order to receive interim funding companies need to agree to an expenditure control mechanism whereby a proportional rebate will be applied to all Pharma companies receiving funding from the CDF budget in the event of any overspend.
The increasing incidence of cancer, an ageing population, and a push on diagnosis and early detection coupled with earlier funding for therapies, creates the perfect storm for the already overstretched services that are struggling to implement new technologies due to capacity challenges. With the cost pressure continually growing due to a higher patient throughput, the CDF will face an increasing demand and the challenge to keep within budget will become ever more difficult.
So what does this mean for the Pharmaceutical industry? The burden of proof is on the manufacturer. Existing cancer therapies will have to prove their value in appraisal or reassessment to access funding. Audits on outcomes, patient experience, and measurement of the impact on the whole system will become key, and the effective communication of evidence-based value will be critical. For the ‘maybe’ drugs, the identification of appropriate patient cohorts with robust, evidenced benefit will be vital to ensure access to funding.
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