Back in the warm summer months of 2009, the Government unveiled its new Life Sciences Blueprint, including a package of measures aimed at transforming the United Kingdom as an environment for the life sciences industry. Most interesting to the healthcare sector were the promised measures to ensure the NHS leads the way in the uptake of ground-breaking and cost-effective medicines and technologies, and the creation of an “Innovation Pass” promising patients faster access to cutting-edge medicines, as we mentioned in the January 2010 health legal update.

The Pass, which will make selected innovative medicines available on the NHS for a time-limited period, prior to a NICE appraisal, will be piloted for twelve months from April of this year. The idea is that highly novel drugs treating very small numbers of patients - where a consequent dearth of clinical data (especially relating to cost-effectiveness) would make a regular NICE assessment impossible - will nonetheless reach patients, whilst simultaneously enabling data to be collected to inform the regular NICE appraisal process further down the line. At the end of the pilot year, the Government will evaluate the results before setting out the budget for the remaining two years of the initiative. Best estimates suggest that with a budget of a “mere” £25 million for 2010, the Pass programme is likely to see a maximum of a dozen drugs brought on stream in 2010.

The Department of Health’s consultation on proposals for the Pass pilot formally closes on 8 February, although late submissions may be accepted. The proposals will then be reviewed in light of the comments received from the NHS, industry and other stakeholders, and will be used to inform the first set of decisions for the pilot. If the Pass is successful, its scope could be extended to other medical technologies and diagnostics in the future.