Takeda announces launch of Framework to help support patient access to life-extending combination treatments
pharmafile | February 25, 2025 | News story | Business Services | Cancer, HIV/AIDS, Immunology, NHS, NICE, Oncology, Takeda, VPAG, patient access
- The Conceptual Implementation Framework outlines critical points within the UK healthcare access ecosystem to help improve the introduction of combination treatments
- By identifying stakeholders and decision-makers at each stage, this Framework seeks to provide a roadmap and address the systemic barriers that prevent patient access to combination treatments due to cost-effective challenges.
24 February 2025 — London, UK — Takeda UK Ltd. today announced the launch of its Conceptual Implementation Framework:Making Solutions Transactable for Combination Treatments in a Not Cost-Effective at Zero Price Scenario to address the cost-effectiveness challenges posed by combination treatments.
The Framework is an evolution from the two Whitepapers Takeda developed in 2021, describing the Attribution of Value and Arbitration Frameworks which called for collaboration to improve patient access to combination treatments. These earlier Whitepapers and the current Framework were developed in partnership with experts from academia, clinical and patient communities, and with advice from experts from NICE and the NHS. They were produced following a full evaluation of the existing access ecosystem, to identify the critical points, the stakeholders, and the decision-makers that need to be involved in identifying and successfully implementing the proposed solutions for combination treatment cost-effectiveness challenges.
The Framework provides a starting point for NHS England (NHSE), NICE, and manufacturers to discuss and evolve existing processes and methodologies to ensure consistent patient access to combination treatments, now and in the future. It also provides recommendations on how clinical and patient organisations can have an active role in this process.
There has been much progress in recent years to help support access to combination treatments, such as the commitments made in the 2019 Voluntary Scheme For Branded Medicines Pricing and Access (VPAS), and by the Competition and Markets Authority (CMA). The CMA published a statement in 2023 on combination treatment, recognising that, in some cases, a treatment combination can only be cost-effective and commercially feasible if manufacturers collaborate.
Additionally, the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) includes clear support for implementing solutions for combination treatment cost-effectiveness challenges, including NHSE’s support for transacting a solution for combination treatments under specific circumstances. Planned consultations on the NHSE Commercial Framework in 2024 and 2025 will reflect on the CMA prioritisation statement on combination treatments and consider options for transacting such a solution.
“We already know from experience that combination treatments can offer improved outcomes for patients, for example, in cancer, there is broad consensus that combining different treatments, with different modes of action, may improve upon the efficacy of using a single treatment. Combination treatments have also been revolutionary in infectious diseases, such as HIV and Hepatitis C, where viruses can quickly adapt and become resistant to single treatments. We need to ensure that patients can gain access to the treatments that can offer improved outcomes.” said Shelagh McKinlay, Director of Research and Advocacy at Myeloma UK.
Şeyda Atadan Memiş, General Manager at Takeda UK & Ireland, noted that: “Takeda is committed to bringing stakeholders together in the combination treatment landscape and ultimately increasing critical access for patients. The progress that has been made in recent years is positive, but more must be done to implement workable solutions so patients can access and benefit from combination treatments.This drive aligns with the Government’s Life Sciences ambition to grow the sector and transform the NHS into a service that delivers world-class patient outcomes.”
Professor Martin Kaiser, Chair of Haematology at the Institute of Cancer Research, highlighted the importance of this initiative, commenting: “This Framework is significant as it highlights ways to improve treatment access for patients who need it by helping all stakeholders conduct a fair assessment – which current methods do not fully address. If clinicians are unable to give patients the latest treatments, it could leave patients unable to benefit, while also contributing to UK clinical practice becoming disconnected from global advancements.”
To read the Conceptual Implementation Framework: Making Solutions Transactable for Combination Treatments in a Not Cost-Effective at Zero Price Scenario or find out more, visit: https://www.takeda.com/en-gb/what-we-do/combination-treatments/
About combination treatments
Combination treatments combine two or more individual treatments; with many combining a “backbone” treatment, which is usually the current standard of care, with a new “add-on” treatment. They are becoming increasingly common as the understanding of complex diseases increases; particularly in areas such as cancer, HIV and, Hepatitis C. This is because using multiple treatments in combination can simultaneously target numerous pathways that drive a disease.
- In HIV, a combination of antiretroviral medicines is used because the virus can quickly adapt and become resistant to treatments
- In cancer, there is broad consensus that combining different treatments may improve on the efficacy of using a single treatment on its own
- In hepatitis C, using a combination of treatments that work in different ways can be more effective and prevent the development of disease resistance
The backbone and add-on treatments are often produced by different companies, so compliant collaboration is essential to ensure patients benefit from combination treatments.
About the combination treatment challenge
Combination treatments often face cost effectiveness barriers even if the new add-on treatment were to be given away at zero price. As combination treatments can potentially extend the lives of patients, the combination, including the backbone treatment is used for longer. Extension of the backbone treatment alone can increase the cost of the combination treatment to the healthcare system, even before the cost of the add-on treatment is considered. The burden of the additional backbone cost is currently borne by the manufacturer of the add-on treatment.
Multiple stakeholders in the life science industry have published on the combination treatment challenge including:
- Davis S. Assessing Technologies That Are Not Cost-Effective at a Zero Price. NICE Decision Support Unit Rep 2014; 1–36.
- Latimer N, Pollard D, Towse A, et al. Challenges in valuing and paying for combination regimens in oncology. Report of an international workshop convened by Bellberry, held on November 18- 20, in Sydney, Australia. 2020; 1–26.
- Towse A, Lothgren M, et al. Why we need a new outcomes-based value attribution framework for combination regimes in oncology. Office of Health Economics report. Jan 2021
About the Takeda Whitepapers
Voluntary arbitration framework for combination treatments. A proposed process by the Voluntary Arbitration Working group.
The Voluntary Arbitration Framework proposes a standard operating procedure to support compliant dialogue and agreement between pharmaceutical companies on the value attributed to each treatment within a combination. This proposed Framework takes into consideration competition law and the current process used by UK health technology appraisal bodies in making decisions on access to medicines. This Framework should be used in conjunction with the Attribution of Value Framework, which assigns a proportionate value to each treatment in a combination to be agreed during the arbitration process.
Attribution of value framework for combination treatments. Report by the Value Attribution Working Group.
The Attribution of Value Framework proposes an economic methodology that aims to define a fair division of value across the treatments in a combination.
It does this by assigning a relative value to each treatment based on its health benefit. This proposed Framework takes into consideration health-economic methods used by health technology appraisal bodies, including NICE, in making decisions about access to medicines. This Framework should be used in conjunction with the Voluntary Arbitration Framework, which proposes a standard operating procedure to support compliant dialogue between the pharmaceutical companies associated with a combination treatment.
The Whitepapers were developed by Takeda alongside multiple contributing authors from the legal, economic, academic, patient and clinical communities including Sheffield University’s School of Health and Related Research (ScHARR), The Royal Marsden NHS Foundation Trust, The Institute of Cancer Research London, University College London Hospitals, Incisive Health, Aldwych Partners, Delta Hat, Eric Low Consulting, London School of Hygiene and Tropical Medicine, and Avalon Health Economics. Expert input was also provided by representatives from NICE and NHS England. Takeda gratefully acknowledges the contributions of the many authors, advisory board members and consultants that were engaged in the development of this project.
To access the Whitepapers: https://www.takeda.com/en-gb/what-we-do/combination-treatments/
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit https://www.takeda.com/en-gb/
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