A Shortcut to Medical Device Reimbursement in the UKJanuary 5, 2023
1. The Problem
You developed a new and innovative medical device that provides substantial clinical benefits in a cost effective manner.
You know the UK has one of the largest medical device markets in the world, positioned alongside France as the second largest in Europe behind Germany.
You plan on getting your product approved in Europe and complete the CE mark process relatively quickly and you already signed agreements with local UK distributors.
The only problem – will your device be reimbursed, or in other words, will the UK National Health Service (NHS) pay for it?
Since your device is new, there are probably no existing reimbursement mechanisms (codes, coverage and payment rates) into which it could fit. On the other hand, in order to apply for the development of new reimbursement mechanisms, your device should first be in wide use by UK physicians for the local patient population. But since your device doesn’t currently fit into any reimbursement mechanisms, physicians are reluctant to use it, and therefore it will never reach a wide user base to justify the creation of new reimbursement mechanisms…
Sounds like a Catch-22, right?
Luckily, the NHS operates an Innovation Procurement Plan NHS Medical Keyboards designed to encourage the quick uptake of innovative new technologies. Similar to the USA Centers for Medicare & Medicaid services (CMS) “Health Care Innovation Awards” program, the UK’s NHS understands that “innovation must be central to the NHS”, indicating that innovation will be driven regionally by strategic health authorities (SHAs) with a legal duty to promote innovation; and that front-line innovation will be supported through the creation of substantial new innovation funds held by SHAs.
In this article, we will try to describe the requirements, the relevant decision makers and the overall process that may help you leverage this plan to expedite the commercialization of your product in the UK market.
But first, we provide a short description of the NHS below.
2. The UK Healthcare System
* The United Kingdom of Great Britain and Northern Ireland (commonly known as the UK) consists of England and the devolved administrations of Northern Ireland, Scotland and Wales, each with varying powers.
* Population: 62 million.
* Type of Healthcare System: Single Payer / national health service (NHS).
Public health system: England provides public healthcare to all of its permanent residents. Public healthcare is free at the point of need. The responsibility for providing NHS healthcare services in England is divided between 10 Strategic Health Authorities.
SHAs issue guidelines for healthcare in their region, verify appropriate distribution of funds and carry out regional plans and projects to improve public healthcare. In addition, each SHA is responsible for the Primary Care Trusts (PCTs) in its region.
PCTs examine local needs and negotiate with healthcare providers to provide health care services to the local population. PCTs have their own budgets and set their own priorities, within the overriding priorities and budgets set by the relevant SHA and ultimately the national Department of Health (DH).
PCTs provide a range of community health services, including: funding for general practitioners, medical prescriptions, and commissioning of hospital and mental health services, as such they are considered key stakeholders in healthcare decision making.