UK pilots shorter NICE appraisal for new medicines
UK reimbursement authority NICE and NHS England have launched a pilot of a shorter initial assessment process for promising new medicines that aims to slash the time it takes for them to reach patients from around a year to six months.
The SMART (Streamlined Managed Access Route for Therapies) pilot is one of a series of schemes designed to speed up and improve the fairness of how new treatments reach patients – first announced in July – that were drawn up in a 10-week 'sprint' process, with input from patient organisations.
For a medicine to be considered eligible for SMART, it must have highly promising early data, be capable of being introduced into the NHS quickly, have clear, robust plans in place to generate real-world evidence thereafter, and represent good value for money for the health service.
"At the moment, medicines that enter managed access are assessed twice by NICE – once before patients can receive them and again after more evidence has been collected," said the health technology assessment (HTA) agency in a blog introducing the pilot written by Steve Williamson, associate director of NICE's managed access team.
"The SMART pilot will test whether some medicines can reach patients sooner by using a shorter assessment at the start, followed by a full NICE evaluation later when more evidence is available," it added.
There will be a managed access period, after the truncated assessment, to gauge how the new medicines are performing in clinical practice. Once enough evidence has been gathered, NICE will carry out its full evaluation to decide whether the medicine should continue to be routinely available on the NHS.
"Speeding up access does not mean lowering standards," according to Williamson. "Medicines accepted onto the pilot will still go through a full NICE evaluation before any decision is made on long-term NHS use," he added. "The pilot also includes financial safeguards to protect both the NHS and companies while additional evidence is being collected."
The pilot builds on changes to NICE's cost-effectiveness thresholds for new medicines used by the NHS in England and Wales, introduced alongside the US-UK trade deal to ensure tariff-free pharma trade between the countries.
The UK Department of Health and Social Care has said that these changes, and other pilot schemes, could lead to the approval of five additional medicines per year.
Other pilots include a new approach to account for the productivity benefits of new medicines, such as enabling people who receive treatment to return to work, allowing industry to co-invest in screening, testing, and the care of patients to speed up access to innovative therapies, and regional funding to ensure take-up of new therapies is not impacted by where a patient lives.
