With more than 300 active clinical trials for combination therapies in cancer currently in progress in the UK alone, we can expect that the prevalence of combination treatments will continue to increase over time, and, with that, so will our understanding of their efficacy and impact on long-term patient outcomes.
This is an incredibly exciting time for the clinical and patient community. There is increasing evidence to show that combination therapies can extend disease-free or progression-free survival for those living with certain cancers, as well as reduce the risk of tumours developing resistance to treatment. However, multiple unresolved issues around the value, assessment, pricing and funding of treatments used in combination remain.
In my role as head of market access at Sanofi UK and Ireland, I strive to address challenges around matching treatment value to patient access, and I am passionate about delivering evidence to ensure patients can receive the most appropriate treatments for their condition. But the issue around pricing and reimbursement of combination therapies within the current healthcare system isn’t something I – or the pharmaceutical industry – can resolve in isolation.
In light of this, innovative new treatment options must be explored, and the complex therapeutic challenges presented by oncology patients must be addressed with more effective solutions.
The need for therapies involving multiple mechanisms of action is clear, as are the positive implications of new combination medicines for the cancer community. But it’s no use having effective new treatments if patients aren’t able to access them and innovation, too, will be halted if not met with fair and balanced long-term solutions.
The Life Science’s Vision outlines the UK Government’s ambition to become the best place in the world for the discovery, development and launch of new treatments, however access challenges could stand in the way of additional investment and scientific advancements. This, in turn, will be of detriment to patients or could act to delay, or even stop, availability. It’s vital that we address these challenges to keep pace with future needs, solidify the UK’s position as a global leader in life sciences and support patient access.
Evidence from clinical trials regularly demonstrates how life changing combination therapies can be for those living with cancer. It can however be difficult to demonstrate the cost-effectiveness of such treatments to Health Technology Assessment (HTA) bodies due to restrictions associated with combination pricing.
Almost one third (15) of the 48 potential combination therapies that were submitted to the National Institute for Health and Care Excellence (NICE) between 2016 and 2020 were either not recommended, or were withdrawn so had their appraisal terminated. A major factor contributing to this low success rate of medicines under appraisal comes from the pressure placed on manufacturers under the current system to provide vastly discounted prices that are unsustainable in the long-term.
Further to this, combination therapies are currently evaluated as single technologies, even though they usually include treatments that are priced independently and are owned by different manufacturers. In fact, the current cost-effectiveness threshold that NICE is willing to approve medicines for use on the NHS means that, in some cases, the manufacturer of the new “add-on” therapy would have to offer the medicine at £0 to meet it.
This issue is further heightened by the effectiveness of combination therapies, meaning that patients are living longer, and therefore, the cost of the episode of care for each patient is extended. As such, it’s clear that the current system for assessing an individual medicine within a combination therapy does not allow truly value-based pricing for each component of the combination therapy.
Although it may seem this could be addressed by the pharmaceutical industry practicing greater collaboration and agreeing to lower the prices of medicines within the combination, competition law currently prohibits companies from discussing commercially sensitive information.
However, it’s time to realise that such conversations are necessary before therapies are submitted to NICE, in order to help provide the NHS with value for money and, ultimately, allow patients to access effective combination treatments. Intra-industry collaboration can only take us so far in achieving value for money for all: the challenges around combination policy are multi-faceted and will require a broader range of stakeholders to work together before the issue is fully resolved.
This will only work if we approach the challenge together: we need to enable cross-sector conversations between a number of key stakeholders, including payers, pharmaceutical companies and policymakers. Together, we can support positive, fair and efficient pricing and reimbursement frameworks that have the patient need at the centre.
To help the oncology community move forwards, we need to reform pricing and reimbursement systems to promote increased flexibility and recognise the total value brought by combination therapies. With combination medicines at the heart of our pipeline, it’s our ambition to advance oncology treatment to create more effective therapies for a wide range of diseases, including genetically defined and hormone-dependent cancers.
To ensure these treatment combinations are able to benefit the lives of patients, we need to make sure each product in a combination is valued fairly, while promoting patient access, sustainable health system expenditure and rewarding innovation.
Conversations are already taking place in an attempt to initiate these changes. The pharmaceutical industry made a commitment in the 2019 Voluntary Scheme to investigate an industry side solution to enable companies to engage with one another, ahead of submitting therapies to NICE. Sanofi, along with other companies, has supported the Association of the British Pharmaceutical Industry’s work to deliver this, which could mark a significant step towards a long-term solution.
For many people living with cancer, access to combination therapy options could mean better chances of survival and improved quality of life. As an industry, together with regulatory bodies and payers, we must have a united mission to provide access to appropriate treatments and put patient needs at the centre of these efforts.
As science and research continues to advance, our frameworks must adapt and shift to allow for progress and growth, to the benefit of industry, payers and, vitally, patients. We remain open to discussion on this important topic and look forward to working together with all stakeholders to make the solutions to combination policy a reality.