Redefining Access to Novel Cancer Therapies: Exploring Country-Specific Health Policy Changes
Access to cancer therapies is a part of every country’s health policy agenda; it, however, is not guaranteed to the entire clinically eligible population. In the last five years, the market access landscape for cancer therapies has changed significantly with the addition of more treatment options, mainly immunotherapies. High-priced immune checkpoint inhibitors, a new class of anticancer drugs, have shown remarkable promise in the treatment of different cancer types such as melanoma, liver and lung cancers among others. The innovators of immune checkpoint inhibitors have often been asked to share the risk with governments for providing these high-cost therapies. In Italy, for example, offering discounts of up to 50% for cancer drugs is a common practice; governments have had to make essential policy changes, affecting the reimbursement of cancer drugs, to address the financial pressure for funding novel cancer therapies.
This article aims to explore the impact of some of the most remarkable recent policy changes on access to cancer therapies in some of the major markets with the launch of several immune checkpoint inhibitors. Are the trends observed in the reimbursement status of cancer markets before the launch of immunotherapies in 2015 similar to those of today?
Note: In the UK and Scotland, only the drugs reimbursed through the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) were included for reimbursement. Any additional medicines reimbursed through the Cancer Drugs Fund (CDF) were not included due to the uncertainty of the continuation of this fund.
UK: The evolving role of the CDF
The CDF was relaunched in the UK 2016, making it the main payer for cancer drugs in England under NICE’s remit. A new framework for funding has been introduced via the CDF: this is the interim funding for novel therapies that the CDF committee had recognized as promising, but there was still significant uncertainty around their use. The CDF can provide interim funding for these drugs for the first two years of their launch, while further data are collected. Two years after a drug’s launch, NICE will make a final positive or negative recommendation. Patients in the UK, therefore, can have access to more cancer therapies that would have been rejected in the first instance before the launch of the new CDF.
US: Potential trends in risk-sharing and value-based contracting
The drug pricing system in the US has been inefficient in controlling excessive healthcare spending; a review of the current pricing framework is needed for competition to work better and control prices more effectively. Moreover, contracting agreements have not been very popular in this market due to the difficulties related to collecting real-world evidence to support these agreements. Interest in outcomes-based contracting, however, is now growing in the US. Novartis, in August 2017, announced that it has entered into an agreement with The Centers for Medicare and Medicaid Services, where the latter will cover Kymriah® (CAR-T therapy) only if patients respond within the first month after treatment. Innovative contracting will continue to facilitate strong access to novel treatments in the US but may significantly affect the payment model for such therapies.
Additional markets: Increasingly restrictive eligibility criteria
Finally, universal funding for all the clinically eligible population is not the case anymore and a reimbursement status now often comes with restrictions. In Canada, Italy, England and Scotland, several restrictions are imposed to limit the use to the population that would benefit the most from these new therapies. In these countries, access to specific cancer therapies is not realized from all cancer patients in the same way.
On a final note, it is important to understand that access to novel cancer therapies has been redefined with a vast number of new drugs and governments trying to identify a sustainable financing model. In the past, the cancer space was a field where access was perceived as universal coverage of the entire clinically eligible population through public funding; unrestricted reimbursement, however, is not the case anymore. Companies are no longer mere drug suppliers, but act as collaborators with governments, and together they are trying to identify new financing paths for cancer treatments. Strong negotiating skills and the collection of the most compelling real-world evidence to support cancer drugs’ value are critical to achieving successful access across almost all markets.
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