Accelerated access

UK innovation drive will change licensing, reimbursement and trials

By Fiona BARRY

- Last updated on GMT

Accelerated access to medicines could help solve budget problems, says the review's chairman
Accelerated access to medicines could help solve budget problems, says the review's chairman

Related tags Medicine Clinical trial Clinical research

A UK government report on accelerated access to medicines proposes overhauling conditional licensing and reimbursement pathways to drive drug development.

The interim review,​ published by the Department for Business, Innovation & Skills and the Department of Health, and supported by the Wellcome Trust, says the UK is caught between the need for better drugs and budget pressures.

However, accelerated access to new products can be part of the “affordability solution, rather than the problem,​” said the review’s chair, Conservative UK Minister for Life Sciences George Freeman: “In an environment where the system is being asked to make significant efficiencies, we need innovation more than ever both to improve productivity and to generate wider benefits for UK growth.​”

‘Getting ahead of the curve’: flexible reimbursement

The report calls for the country to get “ahead of the curve​” and create sustainable ways to bring tech to patients, while “energis[ing] our health system so that it is receptive to innovation and […] uses new technologies​.”

We will lose ground if research budgets are threatened, if our leading academic hospitals cannot afford to support research or use the latest drugs and technologies to pioneer developments in the treatment of the most complex conditions, or if the wider system is paralysed by the cost pressures it is facing and fails to invest in […] change and innovation […],​” said the minister.

To give new drugs a better chance of succeeding and of earlier use, the report calls for a more transparent and systematic approach to deciding which products should be prioritised.

It also says the government should start working with life science companies at earlier stages in R&D to develop “bespoke packages for licensing, evaluation and reimbursement, and then at every stage of the innovation pathway, supporting them to deliver these products […] at the earliest possible opportunity.​”

This will involve a “conditional yes​” system which would allow patient access to drugs “as early as possible in the product cycle, when the evidence to determine its longer-term value has not been fully established.​” The scheme will allow “flexible​” reimbursement based, for instance on “price-volume agreements, multi-year agreements conditional on the achievement of certain outcomes, patient cost caps or free/discounted treatment initiation.​”

New trial methodologies

The report also encourages making the most of conditional licensing, building on existing initiatives like the Early Access to Medicines Scheme (EAMS), European Medicines Agency (EMA)’s Conditional Approval and the Adaptive Pathways Pilot.

It advocates “new trial methodologies​” to reduce the size, cost and time of clinical studies, particularly for precision medicine and devices.

The report authors also plan to set up a national Innovation Partnership with local chapters, intended to help small start-ups to receive development advice outside the established channels of the Catapult network,​ National Institute for Health Research (NIHR)’s Office for Clinical Research Infrastructure, MHRA and NICE’s advice services.

A final version of the report will be published in spring 2016.

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