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NICE sets out office for market access plans

Published on 28/05/15 at 09:40am
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The UK healthcare watchdog NICE is to set up a new office for market access to advise pharma companies on how to navigate the appraisal process and get their drugs to market.

The decision, outlined at a NICE board meeting in May, comes in part as a response to the “large volume and wide variety of market access related enquiries”, from pharma companies looking for support for their applications to the Early Access to Medicines Scheme (EAMS) and the EMA’s adaptive pathways pilot scheme.

The new Office for Market Access (OMA) is also an acknowledgement that NICE’s Centre for Health Technology Evaluation, which appraises new drugs and treatments, “is hampered by lack of visibility in engagement and outreach functions”.

In the board meeting papers, NICE says that setting up the OMA will “provide the mechanism for us to increase visibility, influence and impact on national endeavours designed to speed up the identification, development, evaluation and adoption of innovative, cost-effective health technologies”.

The document also outlines a situation where the OMA could be directly helpful to pharma and extend the current remit of NICE and its scientific advice office.

“Let’s take a pharmaceutical company that already has products on the market in England. Such a company may engage with NICE only during the technology appraisal stages in order to respond to technical queries related to their evidence base. If such a company wanted to discuss the opportunities for improving the chance of a positive NICE recommendation, a discussion at this stage would be much too late.

“OMA would be able to assist in a much earlier discussion around these issues, allowing the company to adjust their plans and the potential to secure access for patients. Through the development of these mechanisms, OMA will acquire a comprehensive understanding of, and ability to influence, life science market access policy.”

Some 30% of the £167,000 annual cost of running the OMA (£50,000) is expected to come from fees for its services, paid by pharma companies, with the rest coming from grants.

NICE anticipates its new arm will be self-funding through a combination of fee for services – including engagement meetings, exploratory and company portfolio discussions, a range of consultancy services and possibly also through a subscription service – within two years after its planned launch in October 2015.

NICE already has ‘strong support’ from the Department of health, NHS England and the ABPI, but the meetings notes suggest that NICE is wary of a backlash. It identifies that “the aims of OMA and even the name may attract criticism that NICE is too close to the life sciences industry”.

However, it mitigates this risk by planning to engage with pharma and others to “clearly articulate that OMA are all about helping the industry develop products that bring meaningful incremental therapeutic benefit at a price that is affordable to the NHS”.

The meeting notes suggest that despite its attempts more effort is required to meet market access needs. The technology appraisal programme reviewed 71% of its topics (12 of 17) within six months of a technology being first licensed in the UK – lower than its target of 90% – although it took on more review proposal projects in 2014-15 (28), more than the 19 planned at the start of the year.

Lilian Anekwe

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