A shortcut to reimbursement of medical devices in the UK

1. The problem

You have developed a new and innovative medical device that provides significant clinical benefits in a cost-effective way.

You know that the UK has one of the largest medical device markets in the world, ranked alongside France as the second largest in Europe behind Germany.

You are planning to get your product approved in Europe and complete the CE marking process relatively quickly and you have already signed agreements with local UK distributors.

The only problem – will your unit 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) that it could fit in. On the other hand, to apply for the development of new reimbursement mechanisms, your equipment must first be widely used by UK doctors to the local patient population. However, as your device does not currently fit into any reimbursement mechanisms, physicians are reluctant to use it and therefore it will never reach a broad user base to justify the creation of new reimbursement mechanisms …

Sounds like a Catch-22, right?

Fortunately, the NHS runs an innovation process plan designed to encourage the rapid application of innovative new technologies. Similar to the US 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) is) with a legal duty to promote innovation; and that front-line innovation will be supported through the creation of significant 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 can help you leverage this plan to accelerate the commercialization of your product in the UK market.

But first, we give a brief description of the NHS below.

2. The UK Health Care System

* The United Kingdom of Great Britain and Northern Ireland (commonly known as the United Kingdom) consists of England and the decentralized administrations of Northern Ireland, Scotland and Wales, each with different powers.

* Population: 62 million.

* Type of healthcare: Single-payer / National Health Service (NHS).

Public health system: England provides public health services to all its permanent residents. Public health care is free when needed. Responsibility for providing NHS healthcare in England is shared between 10 strategic health authorities.

SHAs issue health care guidelines in their region, verify appropriate allocation of funds, and implement regional plans and projects to improve public health care. In addition, each SHA is responsible for primary care trusts (PCTs) in its region.

PCTs investigate local needs and negotiate with health care providers to provide health services to the local population. PCTs have their own budgets and set their own priorities within the overall priorities and budgets set by the relevant SHA and ultimately the National Ministry of Health (DH).

PCTs provide a range of community health services including: funding for GPs, medical prescriptions and commissioning of hospitals and mental health services, as such they are considered the main stakeholders in healthcare decision making.

In total, there are 151 PCTs in England.

3. The national innovation procurement plan

As mentioned above, the NHS is interested in encouraging the spread of innovation in healthcare and has launched a package of proposals to promote this. One of them is the National Innovation Process Plan, which seeks to create clarity and coherence by organizing the adoption of technology-led innovation at the regional level. In support of this legal duty, an innovation fund worth £ 220m has been set up over five years. This fund supports faster innovation and more universal dissemination of best practices – innovation will be encouraged, recognized and rewarded.

a. process

1) Medical device companies, which are usually partnered with local healthcare providers, can submit details of specific medical technologies that may contribute to the NHS by downloading a submission form from the DH website and submitting details of innovative technologies using the e-mail service. email address that appears there.

2) NICE (National Institute for Health and Clinical Excellence)[1]- analyzes and prioritizes submitted technologies according to their potential to increase the quality of care provided to patients while reducing overall NHS care costs. NICE Implementation Collaborative (NIC) supports implementation of NICE guidance within each SHA.

The priority list is then shared to inform the technology selection process by:

3) NTAC (NHS Technology Adoption Center) – formed in 2007 following recommendations from the Healthcare Industries Task Force that recognized that despite the potential of innovative healthcare technologies to improve health outcomes and productivity, the NHS is slow to use healthcare technology compared to health systems in others. developed countries. NTAC was commissioned by DH to support NHS regional innovation leaders to facilitate the selection of high impact technologies for wide adoption in their regions. NTAC helps individual NHS organizations work with key regional influencers to implement the selected technologies

4) Regional Innovation Leaders – Each SHA has a legal duty to foster innovation, raise the innovation profile and encourage faster adoption of innovation throughout the healthcare system. ‘Innovation Leaders’ are used in each SHA to deliver this requirement.

5) Commercial Support Units (CSUs) are set up in each region and as part of their role, they will support their innovation management by providing a key interface between industry and the NHS.

b. application

All companies presenting within the framework will be offered a first meeting with the iTAPP team (now, NICE). This meeting will be used to clarify any queries regarding the submission and to:

* Gain a deeper understanding of the potential benefits for patients and taxpayers.

* Explain how the program works.

* Agree all next steps.

Technology registrations consist of three sections:

* Management Case: To demonstrate the overall benefits and challenges of using the proposed technology.

* Clinical Case: To demonstrate the clinical benefits offered by the adoption of the proposed technology.

* Financial Case: To demonstrate the costs and savings applicable to the adoption of the proposed technology.

c. prioritization

The process does not provide a pass / fail approach for including technologies in the list. Instead, all technologies remain on the list, allowing them to be categorized and re-prioritized in response to changing circumstances. Technologies are categorized in the list as follows:

* Level 3: In the market with sufficient evidence of wide adoption

* Level 2: In the market without sufficient documentation for wide adoption

* Level 1: Not on the market yet

* Level 0: Out of reach (ie not a medical technology)

* Level -1: Pending categorization

* Level -2: Withdrawn by the manufacturer

Levels 1, 2 and 3 represent a pipeline of innovative medical technologies. The overall goal of iTAPP (now, NICE) to realize the benefits of technology adoption sooner than would otherwise be the case, supports high impact technologies to move faster through the pipeline.

Within each category, technologies based on an impact assessment calculation are prioritized as follows:

low:

* Utilizing population: Less than 250 kg

* Net financial savings: Less than £ 250k

* Timetable for implementation: 3 years

Medium:

* Utilizing population: 250 kg – 2.5 m

* Net financial savings: £ 250m – £ 2.5m

* Timetable for implementation: 2 years

high:

* Utilizing population: More than 2.5 m

* Net financial savings: More than £ 2.5m

* Schedule for implementation: 1 year

In both cases, scores 3, medium 2 and low scores 1. To calculate the total score, the scores are multiplied together. This gives a maximum score of 27 and a minimum score of 1. Advice is sought from national clinical directors at the Department of Health to enable a clinical perspective for each technology.

The list of all technologies indicating their level and primary benefit can be downloaded from the DH website.

As can be noted, the unit’s score is not affected by the number of UK doctors currently using the unit for the local population.

4. The strategy

Each of the SHAs publishes calls for applications for its Regional Innovation Fund. Before submitting an application, we recommend taking the following steps.

Step 1 – Landscape Reimbursement Report

The purpose of this step is to understand the current reimbursement landscape for the business entity. It includes:

* Identification of relevant code systems, available coverage policies, restrictions and guidelines, relevant payment mechanisms and rates outside the National Innovation Process Plan.

* Identification of existing reimbursement mechanisms that can be used or compared with the corporate entity, regardless of the national innovation process plan. Recommendation on whether new mechanisms should be developed and, if so, what mechanisms.

* Identification of key decision makers and their specific incentives and a description of the typical path towards obtaining third-party reimbursement, including milestones and typical schedules.

b. Step 2 – Plan of Evidence

At the end of Step 1, the company should clarify what ‘evidence’ needs to be developed to receive high priority according to the above criteria for: (1) Population benefiting; (2) Net financial savings; and (3) implementation schedule. This step includes:

1) Developing a value story that specifies specific assertions explaining how the use of the new entity promotes the above criteria in comparison to current alternatives.

2) Developing an economic model, quantifying economic benefits and enabling sensitivity analysis.

3) Verification of available clinical data supporting the clinical and financial claims of the above Value Story and economic model. If necessary, add reimbursement-related aspects to any scheduled clinical trial protocols.

4) Presentation of the above value history, economic model and existing / planned clinical data to relevant stakeholders within the NHS. It is important to verify in advance that these stakeholders understand the benefits and would agree to provide funding for the new equipment if the generated data supports the requirements of value history and economic model.

In the case of negative feedback, consider changing Value Story, financial model, clinical data or product. Repeat this step until you receive positive feedback from the relevant stakeholders.

c. Step 3 – Generate evidence

Perform clinical studies to substantiate the claims in the History value or verify that existing clinical data supports them. Compile the value history, financial model and clinical data into a dossier.

d. Step 4 – Establish support / demand

Use the developed file to:

1) Convince the relevant healthcare providers of the clinical and financial benefits of using the new equipment.

2) Convince the local leaders with important opinions on giving lectures, writing articles and issuing supportive letters highlighting the benefits of using the new device.

3) Similarly, the relevant medical companies and organizations convince to submit attitudinal statements.

Add these documents to the dossier.

e. Step 5 – Implementation

Use the developed file as a sales tool and apply for funding from the Innovation Fund.

5. Conclusion

According to an assessment by PwC, the UK, with its largely single-payer, government-controlled system, ranks third in easy reimbursement and significantly above European countries such as Germany and France. The NHS focus on innovation may make it even easier for smaller companies to introduce their first product to the market.

It should be noted that in order to prepare a winning application, a great deal of preparatory reimbursement-related work should be done in advance. This preparatory work should result in the development of evidence and support the required criteria for high priority in the list of new entities that are candidates for funding from the Innovation Fund.

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[1] Initially, this assignment was assigned to the Investment and Commercial Department (PICD) of the Department, which was later renamed the Innovation Technology Adoption Procurement Program (iTAPP). In 2012, according to the “Innovation Health and Prosperity” document, NICE replaced iTAPP and took responsibility for these applications.