Market access for drugs is a relatively well-established pathway, however, market access for devices, diagnostics, digital technologies is much more opaque. There are no clearly defined pathways, beyond the regulatory requirements, which can be as limited as self-certification. On top of that, there is asymmetry of information for many developers, who do not recognise the need for a market access strategy because they are not familiar with health technology assessment (HTA).
One of the first issues that is commonly raised is about the level of evidence required for market access – how much is enough? There are several factors: the type of technology, the value proposition and the countries for which market access is intended. This blog focuses on the UK, although similar principles apply in many markets.
Medical technologies often require a lower level of evidence to be given regulatory approval than drugs. This is both a benefit and a drawback in terms of market access – while it can mean exposure to a market is gained more quickly, that exposure may not come with the same level of confidence in its benefits for a healthcare system. Payers may be reluctant to invest in technologies that cannot demonstrate benefit within their healthcare system, which makes it more difficult to gather the evidence that would be convincing to payers. There are some strategies available to mitigate this risk, including provision within specific centres for free as part of either a randomised trial or a registrational study, or the use of data from other systems to support adoption.
At the moment, in the UK, medtech may be placed on the market with regulatory approval, without formal HTA evaluation. This can mean that there is a very wide range of evidence available for a medtech device and it can often come as a shock to a developer that the same evidence package that was acceptable for regulation is not convincing to payers. There is no single, straightforward path for medtech market access and UK developers are often left in a difficult situation, where they may need to generate more evidence post-regulation to get their product to market, delaying access for patients and posing a risk to their business. There are several ways to mitigate these risks – early engagement with stakeholders in the UK can be achieved through the HealthTech Connect platform, evidence requirements can be discussed using the Medtech Early Technical Assessment (META) tool, or more direct discussion with Academic Health Science Networks (AHSNs), Catapults and key opinion leaders (KOLs).
In the UK, several positive developments are close to fruition. The first is the idea of a funding mandate for medtech, with positive National Institute for Health and Care Excellence (NICE) guidance. There is an ongoing pilot testing four technologies supported by the Innovation Technology Payment, which may mean that, in the future, technologies fulfilling the following criteria may have a funding mandate associated with them. These are technologies which:
are effective: demonstrated through positive NICE guidance
deliver material savings to the NHS: the benefits of the innovation are over £1 million over five years for the population of England
are cost-saving in-year: NICE modelling demonstrates a net saving in the first 12 months of implementing the technology
are affordable to the NHS: the budget impact should not exceed £20 million in any of the first three years.
Another initiative, part of the NICE Methods and Process updates, is to treat all technologies according to their value proposition, as opposed to the type of technology. This would permit medtech with a value proposition of increased cost and increased benefit to be assessed using a full cost-utility analysis, which is currently extremely rare at NICE.
None of these initiatives are panaceas for the fundamental issue associated with non-drug technologies, that the evidence requirements for regulation often do not match those of payers. However, the numerous sources of support that are available can help developers to understand the ‘unknown unknowns’, develop the relevant evidence and accelerate market access so that, ultimately, NHS patients are able to benefit from the most advanced innovations available.
MAP BioPharma have published a guidance note with N-Site with more details on this topic. To view the full guidance note, visit the N-Site website and create a subscription account to view resources free of charge.
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