One of the crowning achievements in healthcare over the past several decades is the gradual improvement in cancer outcomes for patients around the world.
Whereas in the past some cancer types had few or no treatment options, we now often see precision therapies as the standard of care. This is one of the reasons – along with changes in lifestyles and modern diagnostic tools — why the five-year survival rates for many types of cancer have increased significantly since the 1990.1
In 2024, we are still making huge advances in the battle against cancer. In some ways these advances are more significant than ever with the introduction of personalised treatments, sophisticated testing and diagnostic tools, and next-generation immuno-oncology treatments such as CAR-Ts.
Nevertheless, the arrival of new technologies often comes with novel patient access barriers, as health care systems that were designed to evaluate less complex treatments grapple with providing access to the latest innovations.
The rate of innovation coming in the form of novel/novel combinations is rising, with over 1,700 clinical trials currently registered in this setting, a number which is growing year on year.2
While combining these assets into a ‘single treatment’ is often proving efficacious in patients (and in some cases is already the standard of care3), it is causing significant challenges for health decision-makers due to a variety of complex access challenges. These challenges are exacerbated when the different components of the treatment are manufactured by two different companies, which have existing agreements with health care systems and payers for the provision of those drugs. It has also proven difficult to assess the value of each component of a combination using the same methodology used to assess a single treatment.
These challenges are manifesting in comparatively worse access for combination therapies than monotherapies. In Europe between 2015 and 2021, 68 per cent of new oncology products were reimbursed, compared with just 51 per cent of combination therapies.4 Thus, there is an urgent need to consider new, more flexible reimbursement models, which ensure timely access to the best care for people affected by cancer.
Thus, there is an urgent need to consider new, more flexible reimbursement models, which ensure a timely access to the best care to people affected by cancer.
The good news for patients is that health economists and policymakers are beginning to coalesce around practical and implementable solutions to ensure that these combination therapies can reach patients without further delay.
Astellas, working in partnership with industry partners, patient advocates and the clinical community have supported several efforts to define how these long-held barriers to access in combination therapies could be overcome.
The latest of these is an independent report by the Office for Health Economics (OHE) on the topic of “Value-Aligned Combination Pricing”5 – this would enable companies to work together with health authorities to have a bespoke access model for a medicine when it’s used in combination, versus when it’s used on its own. This would overcome some of the “reverse incentives” which exist in the current framework that have led to avoidable non submissions of combination therapies in many countries. At the same time, this model would limit the budgetary impact for the health care system by enabling differential access models between the same therapies when used in a monotherapy and combination, ensuring economic viability.
The OHE report builds on the existing literature but crucially provides a practical definition and access route for combination therapies. It proposed the creation of a new framework tailored to the specific needs of combination therapies, rather than applying the same methodology for a monotherapy.
This concept could line up with other novel flexibilities which have been deployed to overcome the inherent challenges of combination therapies. One of those is the recent flexibilities in competition law pioneered in the U.K. through the Competition and Markets Authority (CMA),6 which has enabled companies to appropriately collaborate on limited information exchange related to the combination therapy and deliver better value for the health care system. Another area is in Sweden,7 where a new approach to attributing value of the two components of the combination has enabled a new approach to value assessment.
The concepts put forward by OHE in its report on Value-Aligned Combination Pricing is the last piece of this complex puzzle, which should allow payers and health care systems to adopt a more cohesive solution to access.
The concepts put forward by OHE in their report on Value-Aligned Combination Pricing is the last piece of this complex puzzle, which should allow payers and healthcare systems to adopt a more cohesive solution to access.
If we continue to see impressive results from novel-novel combination trials, it will become more important for policymakers and payers to engage with the topic and adopt these solutions. If — as we expect — a significant chunk of the contribution toward improved cancer care outcomes over the coming decades will come in the form of combination therapies, it’s vital that we act now to ensure we have a reimbursement framework that can enable access to innovative therapies and move with the times as innovation shifts from singular to multiple treatments.
Forward-thinking payers can be the “first movers” in adopting this threefold solution of competition law-led innovation, value attribution and value-aligned combination pricing, and championing access to the most impactful cancer treatments.
We have the opportunity now to partner on smaller, regional trials together, exploring how these processes could improve access for patients, now and in the future.
Patients are waiting, and it’s up to us — collectively — to ensure that reimbursement frameworks meet the needs of tomorrow’s therapies, today.
To find out more about how Astellas and the Office of Health Economics are helping ensure patients can access innovation combination therapies in a timely way please read the full report at: https://www.ohe.org/publications/framework-for-value-aligned-pricing-of-combination-therapies/?utm_source=Politico&utm_medium=Sponsored+content
References
1. Max Roser and Hannah Ritchie (2015) – “Cancer” Published online at OurWorldInData.org. Retrieved from: ‘https://ourworldindata.org/cancer’ [Online Resource]
2. Yang et al, A target map of clinical combination therapies in oncology: an analysis of clinicaltrials.gov, Discov Oncol. 2023 Dec; 14: 151.
3. ESMO Clinical Practice Guideline interim update on first-line therapy in advanced urothelial carcinoma, 13 March 2024 – Annals of Oncology Powles T, Bellmunt J, Comperat E, et al., on behalf of the ESMO Guidelines Committee
4. Access to Oncology Therapies in Europe: Today’s Challenges and Solutions, EFPIA, 2023
5. Napier M., Sampson C., Cole A., Garau M., 2024. A framework for value-aligned pricing of combination therapies. OHE Contract Research Report, London: Office of Health Economics
6. Prioritisation statement on combination therapies, Competition and Markets Authority, Nov 2023
7. Lif. (2023, June 12). Collaboration to solve challenges around combination therapies. Retrieved from Lif: https://www.lif.se/fokusomraden/effektiva-lakemedel-och-en-modern-sjukvard/kombinationsbehandlingar
MAT-ABC-NON-2024-00187
Date of Preparation: May 2024
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