The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies.
A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015.
When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determine how much the government will pay for the product.
In recent years, new regulatory pathways such as the UK's Early Access to Medicines Scheme (EAMS) and EMA's conditional marketing authorization and adaptive pathways pilot project, have allowed new products to get to market quicker. Each of these pathways allows medicines to be authorized using early (phase I and/or II) clinical studies, typically for life-threatening or serious diseases where there is high unmet need, and usually requires companies to provide follow-up data gathered from real world use.
Office of Market Access
While these programs are being lauded for speeding access to new medicines, they pose a challenge to NICE, whose responsibility is to assess products' cost-effectiveness based on clinical data.
Another issue, according to NICE, is a "lack of visibility in [its] engagement and outreach functions." Because NICE's current review mechanisms are tailored for traditionally authorized products, it is difficult for its reviewers to engage in early discussions with companies to "discuss the opportunities for improving the chance of a positive NICE recommendation either via a patient access scheme, or by exploring the potential for a recommendation with evidence development."
To address these issues, NICE is establishing the Office for Market Access (OMA), with the intention of "increas[ing] visibility, influence and impact on national endeavors designed to speed up the identification, development, evaluation and adoption of innovative, cost effective health technologies."
NICE says OMA's primary function will be to develop relationships with, and coordinate between, relevant government departments and the life science community. Additionally, OMA will work with companies to answer questions about market access and provide guidance on "how new and existing health technologies might be evaluated."
NICE expects the office to be operational by October 2015. NICE says it will fund about 30% of OMA using a portion of the fees gathered from the NICE scientific advice program, with about 70% of the funding coming from other grants. Eventually, NICE plans for OMA to be self-funded through fees or a subscription based service.
NICE Board Papers (20 May 2015, Item 5)