Department of Health and Social Care
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Patients to Benefit from Innovative new Drugs
A pilot to help patients get innovative new drugs not currently available on the NHS is being launched for consultation today by Health Minister Mike O’Brien and Science and Innovation Minister Lord Drayson.
The Office for Life Sciences (OLS) Blueprint published in July, detailed the Government’s commitment to create an ‘Innovation Pass’ pilot to allow patients with rarer diseases access to highly innovative new drugs which are not yet appraised by NICE (National Institute for Health and Clinical Excellence), and where there is limited data on their effectiveness.
As the number of patients using these drugs is small, the lack of current evidence available means that NICE are not able to conduct a full assessment for their use on the NHS. During the three year pilot, the Innovation Pass will allow valuable data to be collected on the impact of these new drugs on patients and their cost effectiveness, helping contribute towards a future NICE appraisal.
The Innovation Pass pilot is being run in partnership with NICE and has involved significant input from a range of stakeholders including the NHS and the Life Sciences industry and will be funded from a ring-fenced £25m budget in 2010/11, set aside exclusively for the innovation pass. Funding for future years is discussed in the consultation.
Drugs included on the scheme will be licensed and NICE will play a key role in developing and applying the drug eligibility criteria for the Innovation Pass. All drugs included on the pilot will be submitted for NICE appraisal at the end of the three years.
Health Minister Mike O’Brien said:
“I am extremely pleased to launch this consultation that will help patients with the greatest need to benefit from and get access to exciting new innovative drugs.
“The Innovation Pass pilot will help collect the essential data needed to demonstrate that such drugs, which would not otherwise be available to patients, are making a big difference to their lives.
“I value NICE’s involvement in the pilot from the outset. NICE are recognised as a world leader in the assessment of health technologies and their involvement in the innovation pass process will ensure that the best information is available when assessing which drugs should qualify for the pass.”
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 Chief Executive Andrew Dillon said:
“We recognise that for a small number of very promising new treatments, the evidence available may not reveal their full potential benefits for patients. Where there is a high risk that a NICE appraisal of a new treatment at the point ofits first use in the NHS might underestimate its benefits, providing the opportunity to gather more evidence and making the treatment available before undertaking an appraisal is the right thing to do.
“We’re happy to play our part in making this new arrangement work well, and that it works in the interests of patients and the NHS.”
BIA (BioIndustry Association) Chairman Clive Dix said:
"The introduction of an Innovation Pass will allow
patients with unmet medical needs to gain early access to the
innovative technologies being developed by life sciences
companies. It also signals to the investment community that the
government understand and supports the innovative life science
sector in the UK.”
Director-General of the Association of the British Pharmaceutical Industry (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 Innovation Pass pilot consultation will run for 10 weeks, closing on 8th February 2010. Input and comments are welcome from all groups including stakeholders, industry, the NHS and patient groups.
Notes to Editors
1. The Innovation Pass pilot consultation can be found at: http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_109236
2. The Office for Life Sciences (OLS) Blueprint, published in July 2009, announcing a package of measures to help maintain a competitive life science sector in the UK. One of these recommendations - point 2.5 – was for the creation of an “Innovation Pass”. The Blueprint can be found at: http://www.dius.gov.uk/innovation/business_support/ols
3. For more information about how the NICE appraisal process works, please visit: http://www.nice.org.uk/aboutnice/howwework/how_we_work.jsp
4. For more information please contact the Department of Health press office on: 0207 210 5221 or the Department of Business, Innovation and Skills press office on: 0207 215 5938.
Department of Health
Phone: 020 7210 5221