On 5 October 2016, the Academy of Medical Sciences and the Pharmacogenetics and Stratified Medicine Network held a FORUM workshop on ‘Health economics for stratified medicine’.
The workshop aimed to explore the ‘value’ of stratified medicines and diagnostics and the evidence base underlying new approaches to economic evaluation.
The discussions at the meeting broadly focused on three main challenges:
(a) consideration of new elements of value;
(b) a new reimbursement model which reflects this value and the needs across different stakeholders; and
(c) different standards of evidence.
Key points of discussion from the workshop included:
Building a broader definition of value for stratified medicines that incorporates aspects beyond direct health improvements such as reduced switching between treatments, patient ‘trust’ in clinical decisions and ability to work. There should be a drive to better accommodate different stakeholder needs and perceptions of value such as patient preferences.
Establishing a robust model for separating the value of a diagnostic and treatment.
Acceptability of alternative forms of evidence and methodologies used to generate such evidence as there are specific challenges in evidence collection for stratified medicines. It was agreed that there is an important role for academia in working with regulators and policy-makers to explore such methodologies. Better alignment is needed on evidence requirements from regulators, health technology assessment bodies, payers and other key stakeholders to drive patient access and provide clear signals for development programmes.
Limited evidence generation around diagnostics which complicates assessment of these technologies. It was agreed that alternative forms of evidence should be accepted where required and in general, evidence generation on diagnostics must be better encouraged and incentivised to ensure that there is a robust evidence base underlying their use.
Ensuring patient access through driving uptake and adoption of stratified innovations in the NHS and establishing flexible pricing and reimbursement models. These models must both reflect the value of an intervention, and the The Academy of Medical Sciences 5 potential evolution in value over time, as well as creating a mechanism by which innovations such as companion and complementary diagnostics, and combination products, can be appropriately evaluated.
The overarching need for a general culture change in the healthcare system, particularly amongst commissioners and clinicians, moving from a short-term focus on cost-savings to a longer-term view of the benefits of moving towards a stratified approach.
Achieving a balance between value to individuals and populations when assessing medicines, and the benefits of mechanisms such as shared decision-making in supporting choices at a personal level whilst enabling wider evaluation at a population level. It was agreed that to be feasibly incorporated into evaluation, personal utility and patient preferences must be considered at the population level, which will require societal evaluation similar to the quality-adjusted life year (QALY) measure.