Plan to bypass NICE put out for consultation
pharmafile | December 1, 2009 | News story | Sales and Marketing | ABPI, Drayson, NICE
The UK government is seeking industry input on its proposed pilot scheme to improve patient access to innovative drugs for rarer diseases.
The radical plans would see the creation of a three-year ‘Innovation Pass’ for some drugs that have been granted marketing approval but have not yet been assessed by NICE.
This allows NICE to be sidestepped by the process, which has been explicitly put in place to provide additional incentives for companies investing in the research and development of innovative new products.
The move, first outlined in a July paper by the Office for Life Sciences, is in part aimed at aiding the competitiveness of the UK life sciences sector.
Director-General of pharma industry association the ABPI Dr Richard Barker said: “The Innovation Pass is a very positive step for patients, clinicians, the life science industry and the NHS, and is the result of our work together under the Office for Life Sciences.
“It means that innovative medicines for small patient populations, that come to market with limited information about cost-effectiveness, will be available to patients earlier than they would otherwise have been.”
The move was also welcomed by UK biotech association the BIA, whose chairman Clive Dix said it sends a signal to the investment community that the government understands and supports the UK’s innovative life science sector.
The scheme will be funded by a ring-fenced budget of £25 million in 2010-11, with future money up for discussion in the consultation.
Explaining the scheme science and innovation minister Lord Drayson said: “The Innovation Pass is about government working with industry to secure patient and economic benefit.
“This consultation is a critical milestone for delivering the Office for Life Sciences Blueprint. It makes it plain that Government values and supports innovation in this key sector for the UK economy.”
NICE, which is a partner in the scheme, will still “play a key role” in deciding which products are eligible for the scheme. Inevitably these will those that can only show, initially at least, only limited evidence of their effectiveness.
“Their involvement in the Innovation Pass process will ensure that the best information is available when assessing which drugs should qualify for the pass,” said Health Minister Mike O’Brien.
NICE will not be able to fully assess their use on the NHS until the Innovation Pass ends, but it can use the patient impact and cost effectiveness data collected during the pilot to appraise them at the end of the three years.
“We recognise that for a small number of very promising new treatments, the evidence available may not reveal their full potential benefits for patients,” said NICE chief executive Andrew Dillon.
“Providing the opportunity to gather more evidence and making the treatment available before undertaking an appraisal is the right thing to do.”
The Innovation Pass pilot consultation will run for 10 weeks, closing on 8 February 2010. Input and comments are welcome from all groups including stakeholders, industry, the NHS and patient groups.
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