Improving Patient Access Through the UK IDAP Scheme

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On 19 Sept. 2023, the Innovative Devices Access Pathway (IDAP) pilot scheme was launched in the United Kingdom. IDAP aims to enable and improve patient access to innovative and transformative medical devices, including diagnostics and digital health solutions, and to provide manufacturers with an integrated and enhanced regulatory and access pathway. According to the UK government, the pilot phase aims to “test the main elements of the pathway and provide informative learning and feedback that helps to build the future IDAP” (1). The scheme stems from the policy paper Life Sciences Vision, published in July 2021, which set out the UK government’s intention to strengthen access and the uptake of innovation (2).

The IDAP comprises a network of partner organizations that include the Department of Health and Social Care (DHSC), Health Technology Wales (HTW), Medicines and Healthcare products Regulatory Agency (MHRA), National Health Service England (NHSE), National Institute for Health and Care Excellence (NICE), Office of Life Sciences (OLS), and the Scottish Health Technologies Group (SHTG) (3). The scheme is backed by £10 million (€11.7 million) of government funding and provides faster access to cutting-edge medical device innovations for patients through targeted support for innovators in exchange for allowing the NHS to have access to their technology.

The benefits of the IDAP pathway

The successful applicants will receive non-financial, multi-partner support and specialist scientific advice from a team of experts to develop a product-specific Target Development Profile (TDP) roadmap. The TDP roadmap will define regulatory and access touchpoints across the product development cycle and could include:

• a fast-tracked clinical investigation review
• dialogue to discuss potential reimbursement options
• exceptional use authorization granted by MHRA, provided that necessary safety standards are met system navigation advice
• joint scientific advice with partners
• quality management system support
• safe-harbour meetings with Health Technology Assessment (HTA) Authorities, the NHS, and other key system stakeholders to discuss product realization, NHS adoption, and commercial challenges (1).

This collaborative approach is also designed to ensure that intellectual property considerations are fully integrated into the regulatory process.

Eligibility criteria used in the IDAP pilot

To be eligible, applicants had to submit devices that did not have a CE mark, UK CA mark, or regulatory approval. In addition, proof of concept evidenced by data to a near-final prototype had to be demonstrated. At the same time, clinical input from at least one UK health organization or medical charity must already have been obtained by the developer (4). According to UK government stipulated guidelines, the following eligibility criteria had to be met:

• Applicants are expected to have identified clinical investigation sites and ideally have signed agreements in place.
• For early-stage health technologies, organizations must demonstrate a proof of concept evidenced by data from a near-final prototype.
• Organizations must have a recognized quality management system in place. Whilst certification is not mandatory, the system must satisfy the requirements of ISO 13485 or equivalent.
• The product must be a medical device.
• The applicant must intend to market the health product in the UK and intend to obtain regulatory authorization.
• The applicant must commit to working with the IDAP partners to create a TDP.
• The lead applicant must be a legal entity with the rights to market their health product in the UK (1).

The IDAP pilot scheme was open (from 19 Sept. to 29 Oct. 2023) to applications from commercial and non-commercial developers from the UK and international markets who have developed new medical devices. In its updated guidance, the UK government announced in February 2024 that eight innovative medical devices had been selected, which are summarized in Table I (1).

Table I. Applicants for the Innovative Devices Access Pathway (IDAP) pilot scheme.

However, according to government-mandated guidelines, those companies that were ineligible to apply to the programme included developers that produced drug medical device combination products (e.g. a medical device and a medicinal product that constituents parts, such as autoinjectors, inhalers, pre-filled nebulizers, pre-filled pens, pre-filled syringes, and transdermal patches); and legal entities headquartered or operating out of jurisdictions that are the subject of UK Government sanctions.

IDAP pilot criteria

The updated guidance document published by the UK government in February 2024, stipulates that several criteria must be met for inclusion in the pilot programme (Figure 1).

Figure 1: Criteria for inclusion in the pilot programme. [FIGURE COURTESY OF THE AUTHOR]

According to the UK government’s IDAP pilot application guidance document, “the IDAP pilot phase has been restricted to eight technologies/devices to ensure the selected products will derive maximum benefit from their inclusion on the pathway and to enable comprehensive insights and knowledge to be integrated into the future IDAP” (4). The overall ambition of developing an end-to-end innovative pathway for developing and adopting innovative technology into the NHS is a priority set out in the Medical Technology Strategy published in February 2023.

The next steps for the IDAP pilot

The establishment of the new IDAP, designed to provide faster access to innovative medical technologies, is a pioneering legislative proposal in the UK medical device space that has potentially significant implications for patients and businesses. This scheme is set to create opportunities for real-world data collection, which can enhance the value proposition of products and give businesses a competitive advantage by allowing innovators to rapidly penetrate the UK market and build a strong patient base (5).

The IDAP initiative also seeks to streamline the regulatory process by reducing delays and bureaucracy and thereby bringing medical technology solutions to patients more quickly. It forms part of a broader package of reforms to the UK’s medical devices regulatory framework that the government is planning to introduce in a phased approach. The second stage of IDAP implementation is expected to include legislative changes that will mirror the Innovative Licensing and Access Pathway initiative for medicines, established in March 2021, designed to give patients quicker access to cutting-edge treatments and therapies by offering a streamlined approach to licensing and regulatory processes (6). Through these changes, the UK could become a more attractive destination for medical technology adoption, thereby ushering in a new era of innovation and accessibility in the healthcare sector.

References

1. UK Gov. The Innovative Devices Access Pathway (IDAP)–Pilot Phase. GOV.UK Updated 29 Feb. 2024.
2. HM Government. Life Sciences Vision. Report, July 2021.
3. MTRC Consulting. The Pilot Phase of the Innovative Devices Access Pathway Launched in the UK. News Release, 25 Sept. 2023.
4. UK Gov. IDAP Pilot Application Guidance (now closed). GOV.UK 19 Sept. 2023.
5. HGF Intellectual Property News. The Innovative Devices Access Pathway (IDAP). News Release, October 2023.
6. Gemmell, E. IDAP Pilot: A Welcome Post-Brexit Move. Med Tech Innovation News, 7 Nov. 2023.

About the author

Bianca Piachaud-Moustakis is lead writer at PharmaVision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 36, No. 5
May 2024
Pages: 8–9

Citation

When referring to this article, please cite it as Piachaud-Moustakis, B. Improving Patient Access Through the UK IDAP Scheme. Pharmaceutical Technology Europe, 2024, 36 (5), 8–9.