The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS).
Specifically, OMA will give commercial stakeholders access to a dedicated team at NICE that they can approach for inquiries relating to health technology evaluation, as NICE is responsible for measuring the cost-effectiveness and determining how much the government will pay for a product.
NICE has already created a website where industry and others and can ask confidential questions about particular drugs, biologics, advanced therapy medicinal products, nanomedicines, medical devices, diagnostics and other drug/device combo products.
The team at NICE under OMA will offer tailored support to industry, helping stakeholders identify the most appropriate pathway for their products and connect them with the right people in government, NHS and trade associations. OMA will also offer new insight into its processes and the principles of technology assessment.
"OMA will help to improve the rates at which drugs, devices and diagnostics get picked up and adopted by the NHS," Professor Carole Longson, NICE Health Technology Evaluation Centre director, said.
OMA was originally announced in a proposal and outline that was approved by NICE's Board of Directors on 20 May 2015.
Industry already seems pleased to work more closely with NICE. Dr. Paul Catchpole, the Association of the British Pharmaceutical Industry's director of Value and Access, said Tuesday: “The ABPI very much welcomes the new initiative announced today by NICE, and the real opportunity it represents for all key stakeholders that play a role in getting new medicines to patients, to engage and interact together more closely."
The office is intended to help NICE deal with issues, including a lack of visibility in its engagement and outreach functions. And because NICE's current review of products is meant for authorized products, it can be difficult for its reviewers to engage in early discussions with companies on opportunities for improving the chance of a positive NICE recommendation.
"OMA will help to deliver the outcomes of the government's Accelerated Access Review which is intended to clear a path through the regulatory landscape for technology developers to get effective and innovative technologies to patients faster," Longson said.
And 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.
NICE OMA Launch