General market access

In late April, NHS Accelerated Access Collaborative introduced the Health Technology Navigation Pathway Tool to help innovators adopt new technologies into the NHS. The Tool breaks the innovation journey down into 25 steps, themed around the five key phases of the product lifecycle, from creation to commissioning and adoption. For each step, the schematic flowchart outlines key organizations to engage with, regulatory insights, best practice approaches, policies, guidelines, to-do lists, and required outputs.

In March 2023, a new ‘AI and Digital Regulations Service’ for developers and adopters of artificial intelligence (AI) and digital technologies was launched in England. Four organizations provide this multi-agency advisory service: NICE, Care Quality Commission, Medicines and Healthcare products Regulatory Agency, and Health Research Authority. The website is currently in public beta and focused on information for developers.

A new multi-agency advisory service (MAAS) is currently under development by the National Institute of Health and Care Excellence (NICE). This new cross-regulatory service will be a “one-stop-shop” for support, information, and guidance on the regulation and evaluation of AI technologies. The launch of the new service is scheduled for summer 2022.

On December 17, 2021, the Belgian Health Care Knowledge Center (KCE) published a health services research report “Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions”. In this report, KCE examined the lack of comparative evidence health technology assessment (HTA) agencies and payers face in evaluating new medicinal products and high-risk medical devices at market entry.

In November 2020, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched a theme survey for medical technology products in stroke, focusing on products for diagnostic/assessment in case of suspected stroke. The submissions in relation to this survey will be closed on December 16, 2020

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is currently performing a theme survey for medical technology products for ischemic heart disease and heart failure. The submissions in relation to this survey will be closed on August 21, 2020

HealthTech Connect, a new online resource provided by NICE to help identify and support new health technologies as they move from inception to adoption in the UK health and care system, was formally launched April 29th, 2019. The system, which is free to use, will help companies to understand what information is needed by decision makers in the UK health and care system, and clarify possible routes to market access.

Our analysis of creation of procedure codes for TAVI in 11 European markets shows different speed in creation of codes, but in general it was a quick process (1.8 years on average). However, in all markets, availability of procedure code did not automatically lead to reimbursement or appropriate reimbursement.