NICE will charge industry to speed up drug approvals
The Office for Market Access has been set up by the National Institute for Health and Care Excellence to help guide companies through the evaluation process.
The National Institute for Health and Care Excellence (NICE), which decides which drugs and devices should be made available on the NHS, has set up a paid-for service to help companies achieve quicker approval for their products.
The Office for Market Access (OMA), launched on 13 October 2015, comprises a team of experts who will advise companies on the most appropriate NICE evaluation process for their products.
NICE confirmed that organisations will be entitled to one free meeting with the OMA to discuss their needs.
“All stakeholders who make an enquiry with the OMA team will be offered an initial meeting, free of charge, to discuss their needs,” says a NICE spokesperson. “Following these discussions, stakeholders are able to access a range of fee-based services, designed to help tackle common challenges in getting access on the NHS.”
Commercial stakeholders are already able to engage with NICE for scientific advice related to their product development plans and this advice will be part of a suite of services that commercial stakeholders can access. “The OMA builds on this offering by allowing stakeholders to engage more closely on a broader range of issues relating to the development and adoption of health technologies,” the spokesperson explains.
The OMA team will only help companies identify the most appropriate journey for their products within NICE, says the spokesperson, and, if required, redirect companies to the other parts of the system.
“[The OMA] will speed up the adoption of innovative and cost-effective health technologies by helping companies to get the right evidence, develop a better business case and engage with the right people,” says Carole Longson, director of NICE’s health technology evaluation centre.
She adds that it will also help the government’s ‘Accelerated access review’ — an initiative set up with the sole purpose of finding ways to speed up NHS patient access to innovative drugs, devices and diagnostics.
The launch of the OMA was welcomed by the Association of the British Pharmaceutical Industry (ABPI). “Any initiative that strengthens relationships and delivers earlier, more frequent and meaningful dialogue between the life sciences industry, regulators, NICE and the NHS can only help speed up and improve the adoption and use of innovative medicines for NHS patients,” says Paul Catchpole, ABPI’s director of value and access.
“The ABPI looks forward to supporting the OMA and to helping shape and develop its portfolio of offerings and services, which will bring real added value to stakeholders, enabling NHS patients across the country to get more timely and consistent access to clinically and cost effective innovative new medicines.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20069534
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