NICE to consider illness burden, societal impact under plans for value-based assessment of drugs

The National Institute for Health and Care Excellence opened a consultation Thursday on its proposed scheme for "value-based assessment" of new medicines, which is expected to be introduced later this year. The agency's chief executive Andrew Dillon said the changes "will add further clarity to our recommendations and enable our independent advisory committees to explore more fully the potential these treatments have to improve outcomes for patients."

Under the new plans, the agency said it will take the concept of "burden of illness" into account more explicitly and systematically, replacing the current approach for end-of-life treatments, while also considering the "wider societal impact" of a disease. NICE is also planning more flexibility on the use of its quality adjusted life years (QALYs) measure, which currently has a cut-off of between 20 000 pounds ($33 260) and 30 000 pounds ($49 890), rising to 50 000 pounds ($83 150) for some end-of-life medicines. The new scheme proposes a ceiling ranging from 20 000 pounds to 50 000 pounds, with the higher limit no longer restricted to drugs for patients who are close to death.

Dillon noted that "no patients will miss out on effective and cost effective treatments due to these changes." He indicated that the proposals have "the potential for increasing the number of positive appraisals," although he cautioned that this will only happen "if companies offer the very best price to the NHS," which he added "is under huge pressure." The consultation period ends on June 20, with the changes being introduced in the autumn.

In response, Paul Catchpole, director of value and access at the Association of the British Pharmaceutical Industry, said "we have a particular concern about the potential impact of incorporating NICE’s existing 'end-of-life criteria’ into the new system." Catchpole added "we need to ensure that this does not lead to fewer medicines for patients at the end of their life being approved."

In November last year, the UK Department of Health unveiled details of the new voluntary Pharmaceutical Price Regulation Scheme, with drugmakers agreeing to keep NHS expenditure on branded medicines flat for two years.

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