Combination treatments: Takeda’s Implementation Framework and the broader landscape
pharmafile | September 23, 2025 | Feature | Research and Development | HIV/AIDS, Hepatology, NHS, NICE, Oncology, Takeda, combination therapy, oncology
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment landscape and the impact of Takeda’s implementation framework, while advocating for needed change.
Pharmafile: How do combination treatments improve patient outcomes compared to monotherapies?
Emma Roffe (ER): Combination treatments combine two or more individual medicines to treat a disease, compared to monotherapies, which are a treatment strategy that involves using a single drug to manage a particular condition.
By using multiple drugs with different mechanisms of action, combination treatments can have enhanced efficacy and target various aspects of a disease.
We know from experience in complex diseases, such as cancer, HIV, rheumatoid arthritis and hepatitis C, that combination treatments have the potential to deliver significant clinical benefits to patients:
- In cancer, there is broad consensus that combining different treatments may improve the efficacy of using a single treatment on its own 1
- In HIV, a combination of antiretroviral medicines is used because the virus can quickly adapt and become resistant to treatments 2
- In hepatitis C, using a combination of treatments that work in different ways can be more effective and prevent the development of disease resistance. 3
Pharmafile: How has the clinical application of combination treatments evolved over the past decade?
ER: It has evolved significantly, particularly in oncology, infectious diseases, autoimmune disorders and chronic illnesses.
It is amazing to see how advancements like genomic and molecular profiling have enabled more tailored therapies, particularly in oncology, where treatments can be aligned with specific genetic mutations and biomarkers.
We have seen the use of multimodal approaches, combining traditional drugs with immunotherapy or targeted therapies, to enhance effectiveness and improve outcomes. Additionally, a deeper understanding of disease mechanisms has led to the development of targeted therapies that concurrently address multiple pathways, which is a great step forward.
Pharmafile: What are the primary barriers limiting patients’ access to combination treatments?
ER: Unfortunately, patients may miss out on the benefits of combination treatments if submissions for reimbursement are delayed or withdrawn and, as a result, the treatment is not made available on the NHS.
We know combination treatments have the potential to deliver significant clinical benefits to patients, but many have been held back from NHS access over recent years due to cost-effectiveness concerns.
Since 2017, half of all cancer combination treatments involving branded components submitted for assessment to the National Institute for Health and Care Excellence (NICE) have withdrawn from the process or were assessed as not being cost-effective. 4 These cost-effectiveness issues cause delays and prevent patients from accessing clinically effective treatments.
As we see rapid advancements in medical innovation – especially in fields like oncology and rare diseases – it’s essential that the UK keeps pace by supporting not just trials for new therapies, but also for combination treatments. These combinations are becoming the gold standard for achieving long-term control in complex diseases across the globe. However, the UK’s current infrastructure including the regulatory and reimbursement environment often isn’t evolving quickly enough, which risks making the UK a less attractive destination for global clinical research. Without a proactive approach – including more flexible regulation, sustained funding and better use of real-world data – we could see the UK fall off the radar for sponsors looking to run cutting-edge trials. That would be a major missed opportunity for UK patients who would miss out on early access to new treatments.
Pharmafile: What progress has been made in recent years to address these access challenges?
ER: Progress has been made in addressing the challenges around access to combination treatments, even though many stakeholders consider it a difficult issue to resolve, but more still needs to be done.
In 2024, we saw the Voluntary Scheme for Branded Medicines Pricing Access and Growth (VPAG) commit to increased commercial flexibility, including two consultations on updates to the NHS Commercial framework for new medicines. The first phase of the consultation has brought promising developments, with the framework now confirming NHS England (NHSE) and NICE’s support for the Competition and Markets Authority’s (CMA) position statement and inclusion of publicly available data on the number of active commercial access arrangements.
NHSE, NICE and industry need to continue working together to implement the CMA position statement. It is also imperative that we apply the flexibilities that NHSE is seeking to enable within the updated commercial framework to find a complete solution for combination therapies.
I recognise the transformative potential of combination treatments in delivering life-extending outcomes for cancer patients across the UK. With the Conceptual Implementation Framework: Making Solutions Transactable for Combination Treatments in a Not Cost-Effective at Zero Price Scenario[1] I hope we can drive meaningful progress in improving patient access to these vital innovations.
In an increasingly competitive global medicines market, the UK has an opportunity to be a leader in how it approaches the combination treatment challenge. It is important that these opportunities are maximised to enable companies to bring more combination treatments to the UK, thereby helping to both improve patient outcomes and access to innovation and align with the government’s ambitions for growth in the sector.
Pharmafile: How could an implementation framework support the adoption of solutions for cost-effectiveness issues with combination treatments?
ER: This can be done in several ways, highlighting areas that need to be addressed by a multitude of stakeholders across the life cycle of the development of a treatment to ensure any solutions are implementable, clear and workable for all stakeholders.
Following a full evaluation of the existing access ecosystem, Takeda created the Conceptual Implementation Framework: Making Solutions Transactable for Combination Treatments in a Not Cost-Effective at Zero Price Scenario[2] 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 issues. The Framework was developed in consultation and offers practical solutions by incorporating feedback from clinical, patient and access stakeholders, ensuring its relevance and applicability.
To better implement solutions so patients can benefit from effective combination treatments, it is important for us to align with the government’s vision of growing the life sciences sector and transforming the NHS to deliver world-class outcomes. By addressing these challenges, we not only enhance patient care but also stimulate innovation. Despite recent progress in improving access, some issues remain unaddressed, potentially slowing down future advancements.
Moving forward, collaboration is key. Stakeholders need to be willing to adopt and trial these solutions, supported by systems for regular evaluation and feedback.
We’ve made significant strides and by continuing to collaborate, we’ve mapped out how different groups can positively impact the future. The Conceptual Framework provides a comprehensive overview of implementing solutions, highlighting opportunities and policy levers across the continuum. By using this as a guide and maintaining dialogue, we can further progress in unlocking patient access to life-changing treatments.
EXA/GB/CORP/0416 Date of Prep: Aug2025
References
1 Irvine, L and Bunn, S., Advances in Cancer Treatment. POSTnote. 2019; 598. https://post.parliament.uk/research-briefings/post-pn-0598/ (2019, accessed June 2025).
2 NHS., Treatment: HIV and AIDS. https://www.nhs.uk/conditions/hiv-and-aids/treatment/. (2021, accessed June 2025).
3 Highleyman, L. Hepatitis C treatment for people with HIV. https://www.aidsmap.com/about-hiv/hepatitis-c-treatment-people-hiv. (2017, accessed: June 2025)
4 Competition and Markets Authority. CMA removes barrier to availability of vital treatments on the NHS, https://www.gov.uk/government/news/cma-removes-barrier-to-availability-of-vital-treatments-on-the-nhs (2023, accessed June 2025).
Author
Dr Emma Roffe is Oncology Country Head (UK & Ireland). She was appointed Oncology Country Head for Takeda UK and Ireland in 2018, joining the company’s Senior Leadership Team. Her appointment followed a 15-year career at Takeda, working across a number of its portfolios, having joined in 2003 as a Scientific Adviser.
This article featured in: October 2025 – The Pharmafile Brief
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