The UK has launched a pilot of its "Innovation Pass" process, which will provide £25 million in funding for medicines that treat very rare diseases but are not evaluated at launch by the National Institute for health and Clinical Excellence (NICE).
Innovation passes were first proposed in the UK's office for life sciences' Life Sciences Blueprint, issued last year. The government has run a public consultation on the proposals since then.
There’s a maximum spending cap of only £8 million per year for each individual product – and uncertainty over long-term funding. The pilot is to run for three years, but government funding of £25 million has only been arranged for the first year.
Products included in the pilot Innovation Pass scheme will automatically be appraised by NICE after the end of three years, raising the suspicions that they could be rejected for use in the UK national health service (NHS) at that stage.
NICE giveth and NICE taketh away since it will set up and run an advisory committee that will select products based on defined criteria. These criteria include the medicine being a significant medical innovation (acting at a new target receptor, for example), it should satisfy an unmet clinical need, and is expected to have a substantial impact. Additional studies to gain further clinical data should be planned.
The government will pay an amount to the pharmaceutical company for supplying the medicine based on a price-volume agreement (the number of patients multiplied by the price), rather than paying for each dose of drug dispensed. This is to ensure a financial return for the company. Products would normally be submitted for consideration at around the same time as they are filed for marketing approval.
BUT … the sum asked for by the company will be judged to be reasonable or not by a governmental/NHS panel that will look at the cost of therapeutically similar medicines, the actual cost of the medicine in other European countries, and the cost of its research and manufacture.
This judgment on whether the cost is reasonable or not will then be passed to NICE's advisory committee, which will produce a list of drugs for funding, which will be approved by government ministers.
Sounds familiar.
NICE work … if you can get it.
Head 'em off at the (innovation) pass
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
