11 December 2009
The Department of Health (DH) has launched a consultation on the Government’s proposals for an ‘Innovation Pass’ pilot. The aim of which is to make selected innovative medicines available on the NHS in England for a time-limited period, prior to a NICE appraisal. These technologies will be funded during that time-period from a ring-fenced budget. The consultation asks the NHS, industry and other stakeholders for their views on how the Innovation Pass will be run, how technologies will be selected, how data will be collected, the funding arrangements and the potential impact of the proposals on equality.
Stakeholders, including those from the NHS, are encouraged to respond to the consultation, which runs until 8th February 2010. The completed proforma can be e-mailed to email@example.com
What is the background to this?
The Office for Life Sciences Blueprint, which was launched in July 2009, announced a number of measures to help maintain a competitive environment for life science companies. One of the measures is the ‘Innovation Pass’, a three-year initiative for selected medicines for patients with the greatest need.
The proposals in the consultation have been developed in conjunction with NICE, DH, the NHS and the pharmaceutical industry. Selected innovative medicines will be made available on the NHS in England for a limited period, prior to appraisal by NICE. These medicines will be funded from a new ring-fenced budget which will comprise £25 million in 2010/11, with funding for future years to be determined in the light of the next spending review.
This proposed initiative aims to make available earlier those medicines for small patient populations which may deliver improved patient outcomes, but where data on cost-effectiveness are limited. It will promote future research into innovative products and help to collect data to support the subsequent NICE appraisal. NHS bodies will be strongly encouraged to take part in data collection exercises organised by manufacturers. Medicines covered by the Innovation Pass will have a NICE appraisal after a maximum of three years. At the application stage, sponsors will be asked for their strategy for managing patients in the event of a negative or restrictive NICE appraisal.
It is proposed that sponsor companies will apply for an Innovation Pass around the time of submitting a dossier for regulatory review. An application is voluntary and a team at NICE will check the application for completeness. The DH will comment on the acceptability of the price proposed. An advisory committee will then make recommendations to the DH which will inform allocation of funding. If granted, an Innovation Pass will last for a maximum of three years and cannot be renewed. Funding for these products will be applied once the product reaches the UK market.
Products which may be suitable for the Innovation Pass process are likely to address unmet clinical need, but are not expected to lead to substantial additional service and monitoring costs to the NHS. Sponsor companies can apply when clinical data are limited but additional studies must be planned.
The scope of the Pass may be extended in future to cover diagnostics and other medical technologies.
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