Industry Insight

Indication-based agreements – A key enabler of UK access to combination therapies in oncology

Jonathan Bowen from Sanofi UK and Ireland explains how indication-based agreements can remove barriers to patient access to combination cancer therapies
Combination therapies can provide important clinical benefits, yet NHS reimbursement remains a challenge and cancer patients are missing out on access to some of these treatments.1,2 Indication-based agreements have the potential to remove one of the barriers to patient access to combination therapies in cancer. At Sanofi, we would welcome the opportunity to work with the Department of Health and Social Care, NHS England, the National Institute for Health and Care Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG), the Scottish Medicines Consortium (SMC), patient groups, the pharmaceutical industry and other interested stakeholders to develop a framework for combination therapies, which reflects the need for new combinations or treatment options to be assessed fairly.
Combination therapies represent the future of cancer care
Around one in two people will develop some form of cancer during their lifetime. 3Despite considerable progress in prevention, diagnosis and treatment, the burden of cancer is continuing to increase.Every two minutes, someone in the UK is told “you have cancer”, and between now and 2040, UK cancer cases are projected to increase by 2%.In 2020, more than one in four UK deaths were attributed to cancer, which is the equivalent to a life lost to cancer every four minutes.5
These figures make it clear why cancer is a national priority, with the NHS providing cancer care to millions of people around the clock. The NHS Long Term Plan has set a goal that by 2028, an additional 55,000 people per year will survive their cancer for at least five years after diagnosis.6
Combination therapies are becoming increasingly central to cancer treatment, with many life sciences companies focusing research and development efforts on investigating different options.Bringing together two or more medicines that work in different ways can enhance the effectiveness of treatments compared to each medicine alone.1,8,9 The use of combination therapies will be key to improving patient outcomes in the future and achieving the NHS’s long-term ambitions in cancer.
Combination therapies often bring significant clinical benefit to patients and even now represent a cornerstone of cancer care
Combination therapies are unable to fit within the UK’s pricing and reimbursement framework
While positive efforts have been made to support access to innovative medicines on the NHS, the evolution of the UK’s pricing and reimbursement framework has not always kept pace with scientific advances.
A key challenge is that when two or more medicines – one of which has likely been assessed by NICE in the indication already – are brought together, it is only possible to negotiate the price of the new component. This makes it difficult, and sometimes impossible, for a combination to be considered cost-effective so it can be routinely prescribed to UK patients. As a result, the UK is falling behind in access to innovative combination therapies compared to similar countries across Europe.10
In the UK, a medicine can only have a single net price across all its indications, which is challenging for combination therapies
As drug development has evolved, more therapies are being used to treat multiple cancers at different stages of disease and in combinations that may not always be the same, depending on the indication.
NHS policy states that once the price of a medicine has been agreed, it must be applied to all its uses, both retrospectively (to previously agreed indications) and prospectively (to all future indications), whether the indication is for combination oncology or used on its own in any other disease area. Flexibility can be considered in exceptional circumstances under NHS England’s Commercial Framework. However, the criteria for pricing flexibility are challenging to meet, particularly for cancer combinations, since treatments must fall significantly below the standard NICE threshold of cost-effectiveness to qualify.
Demonstrating cost-effectiveness within the current NICE framework can be challenging for cancer combinations. The extended survival often provided means patients are treated for longer and receive both (or more) medicines for a greater amount of time. The costs of the new component(s) are therefore added to the increased costs of the existing component. The inability to price each component within the combination to appropriately reflect its value under the current framework may mean that these medicines won’t ever reach patients. In some instances, for example, where the existing component is already reimbursed in the indication at the upper limit of the cost-effectiveness threshold, even if the new component was given away at zero price, the combination still wouldn’t be cost-effective.11
While the Association of the British Pharmaceutical Industry (ABPI) and the pharmaceutical industry are engaging to find a solution that allows manufacturers of the different components of a combination to enter into pricing dialogue in a way that is compliant with competition law, these efforts will fail if the current system continues to prevent the agreement of a combination-specific price.
Rigid pricing arrangements do not incentivise companies to invest in combinations, if they know NHS reimbursement is not possible. The outcome of this is that the UK is prevented from realising the full value of innovations and patients are losing out on promising new treatments. In fact, since 2016, around half of terminated NICE appraisals for cancer treatments have been combinations.2
Indication-based agreements are a key part of the solution to increasing patient access to cancer combination therapies
Indication-based agreements refer to a mechanism whereby the price of a medicine is agreed based on its clinical benefits when it is used in different ways.12 This pricing arrangement provides greater flexibility, enabling the NHS to recognise the varying value of a medicine in each indication. Indication-based agreements will allow the true potential of innovative new therapies to be realised and will restore the UK as a destination where cancer patients can access the latest treatments.
Indication-based agreements are expected to improve access to combination therapies because they will help companies set a combination-specific price for their medicine, reflective of its value when used with another treatment. The ability to do so will increase the likelihood of the combination being considered cost-effective, in turn providing cancer patients with more options they might not previously have had.12
At the same time, investment into research and development will likely be encouraged to explore more niche indications, with smaller patient populations, since the prospect of a combination-specific price might mean these indications have a better probability of obtaining reimbursement.
A policy and infrastructure shift are required, but it is possible and much needed
Combination therapies often bring significant clinical benefit to patients and even now represent a cornerstone of cancer care.1,8,9 Introducing indication-based agreements would mean any changes in price required to demonstrate cost-effectiveness for the component medicines in the combination do not affect their price in other indications, and have the potential to be a key enabler in bringing many combination therapies to cancer patients. Given the move towards improved use of data across the NHS, we have a great opportunity to implement new targeted systems that can track the patient’s disease at the point of care. Doing so would facilitate access to value-based and personalised interventions such as cancer combination therapies.
Author bio
Dr Jonathan Bowen trained at UCL Medical School before transitioning to a career within
Medical Affairs in the pharmaceutical industry. He currently works as the medical lead for Haemato-Oncology at Sanofi for the UK and Ireland affiliate.