Takeda calls for collaboration to improve patient access to combination treatments

• Combination treatments are becoming more common as the understanding of complex diseases increases
• Despite potentially delivering significant clinical benefits to patients, combination treatments often face cost-effectiveness barriers even if the new add-on treatment were to be given away for free
• There is consensus within key stakeholder groups, nationally and internationally, that solutions for accessing combination treatments need to be found quickly for the benefit of patient outcomes, now and in the future.
• Takeda has developed two Whitepapers setting out a proposed solution for solving this challenge and improving patient access to combination treatments in the UK and beyond

LONDON, England, (November, 2021) – Takeda UK Ltd. has today launched a proposed solution for improving patient access to combination treatments which can otherwise struggle to gain reimbursement. The proposed solution will contribute to the discussion and debate within the healthcare community to find transactable and implementable solutions for the benefit of patient outcomes.    

Outlined in two Whitepapers[i]^,[ii], An Attribution of Value Framework and The Voluntary Arbitration Framework, Takeda’s proposed solution has been developed in partnership with experts from the legal, economic, academic, patient and clinical communities, with input from experts from the National Institute of Health and Care Excellence (NICE) and the National Health Service (NHS) on the key challenges.

Jon Neal, Managing Director at Takeda UK & Ireland said, “Solving the combination treatment access challenge has historically been put in the ‘too hard to solve’ box due to the complex nature of the issue. At Takeda, we have a history of collaborating with stakeholders to solve complex challenges, so it was a natural fit for us to tackle the problem. We’ve been working over the last few years on a potential solution to contribute to the options being explored by other stakeholders, including the ABPI, to ensure patients can benefit from the potential of combination treatments as quickly as possible.”

Combination treatments have the potential to deliver significant clinical benefits to people with complex diseases such as cancer, HIV, rheumatoid arthritis, and Hepatitis C. As the understanding of these types of diseases increases, combination treatments are becoming increasingly common and critical to improving patient outcomes. 

However, despite their potential clinical benefit, the availability of combination treatments remains a challenge. In 2019, only 56 percent of licensed combination treatments were routinely available to patients on the NHS in the UK.[iii] Recent data from the Association of the British Pharmaceutical Industry (ABPI) has also shown that almost a quarter of terminated NICE appraisals have been due to challenges with the cost-effectiveness of combination treatments.[iv] Similar access challenges are also seen in other countries.

Shelagh McKinlay, representative from the Blood Cancer Alliance* said, “Within the blood cancer community, we are acutely aware of this issue and have seen first-hand effective and tolerable combination treatments not getting to patients. There is an urgent need to solve this issue so patients can access treatments that offer the potential of improved quality and length of life.” Dr Graham Collins, Consultant Haematologist, Oxford University Hospitals added, “If we are unable to treat our patients with the latest combination treatments in the UK, our clinical practice is at risk of becoming disconnected from global treatment standards. Not only could this impact patient outcomes, but it could also impact our ability to contribute to international clinical trials if trial eligibility cannot be met.”

Combination treatments often face several barriers; they can struggle to demonstrate cost-effectiveness even if the new add-on treatment were to be given away for free. This is because combination treatments extend disease free periods for patients, meaning the combination, including the backbone treatment, is used for longer. Extension of the backbone treatment alone can increase the cost of the combination to the healthcare system, even before the cost of the add-on treatment is considered. This is made even more challenging due to strict competition law, which prohibits and restricts discussions between pharmaceutical companies on commercially sensitive topics such as pricing and reimbursement.

Takeda’s proposed solution therefore aims to address the cost-effectiveness barrier by proposing an economic methodology that assigns a relative value to each treatment in a combination – The Attribution of Value Framework. The solution also aims to address how companies can interact in a compliant manner by proposing a standard operating procedure to support dialogue between companies – The Voluntary Arbitration Framework. The solution is treatment and disease agnostic and has been designed to align with current NICE appraisal processes and NHS England commercial methods; however, the principles could also be applied to other countries.

Professor Andrew H. Briggs, Professor of Health Economics, London School of Hygiene and Tropical Medicine, UK, and lead author of the Value Attribution Whitepaper, continued, “There is consensus within the health economic community that a solution for accessing combination treatments needs to be found, and quickly. Our solution is an important step in solving the challenge and although it might not be a perfect solution yet, we hope with some debate, intellectual vigour, and tenacity, we can solve this problem as a community.”

Takeda encourages further discussion on the challenge of combination treatments and welcomes feedback, critique, and debate of the two Whitepapers so that a solution, that represents perspectives from all stakeholders, can be found for the benefit of patients. Takeda also proposes that any solutions implemented to address the combination treatment challenge, become embedded into the next ‘Voluntary Scheme for branded medicines’ to encourage universal participation of the pharmaceutical industry, the NHS, and the wider healthcare community.

To read the Whitepapers or find out more, visit https://www.takeda.com/en-gb/what-we-do/combination-treatments/.

*Shelagh McKinlay is also Head of Patient Advocacy at Myeloma UK

[i] White Paper: An attribution of value framework for combination therapies. Report by the Value Attribution. Working Group. January 2021. Last accessed 30 August 2021. https://www.takeda.com/49a844/siteassets/en-gb/home/what-we-do/combination-treatments/a-value-attribution-framework-for-combination-therapies-takeda-whitepaper.pdf

[ii] White Paper: Voluntary arbitration framework for combination therapies. A proposed process by the Voluntary Arbitration Working group. https://www.takeda.com/4a81d5/siteassets/en-gb/home/what-we-do/combination-treatments/voluntaryarbitrationframeworkforcombinationtherapies_takedawhitepaper_september2021.pdf

[iii] 1 EFPIA and IQVIA., EFPIA Patients W.A.I.T. Indicator 2019 Survey. EFPIA. 2020. Pg. 46 https://www.efpia.eu/media/554526/patients-wait-indicator-2019.pdf Last accessed October 2021.

[iv] ABPI website. ABPI Member Survey: Reasons for NICE ‘Optimised’ Recommendations and Terminated Appraisals. ABPI. August 2021. Pg. 4 https://www.abpi.org.uk/media/8632/abpi-member-survey_nice-optimised-and-terminated-appraisals.pdf Last Accessed October 2021.