England’s NICE, NHS mull changes that could speed up drug, device appraisal process


NICE and NHS England have put forward changes to NICE’s process of assessing and funding drugs and devices in a bid to get treatments to patients more quickly.

NICE and the NHS have kicked off a 12-week consultation on these changes, through which they hope to bring drugs and devices to patients in the most timely manner--but in a way that optimizes the financial stability of the NHS, they said in a statement. The public may read the consultation document and email comments and queries to NICE by Jan. 13.

The proposed changes include the introduction of a “fast track” for new technologies and a new “budget impact threshold” of £20 million per year to better manage the launch of treatments that are judged to be cost-effective, but are still very expensive. Another proposal is the automatic funding of treatments for very rare conditions.

“NICE and NHS England believe these proposals represent a fair approach to the significant challenge of providing faster access to innovative, cost-effective treatments alongside the need to safeguard future financial sustainability,” said Sir Andrew Dillon, NICE chief executive, in the statement.

The fast-track process is intended to speed up the appraisal for new technologies that have an exceptional value for money, the NHS said in the statement. This means that devices that have a cost per quality adjusted life year of up to £10,000 would be evaluated more quickly by NICE and would also be funded more quickly by the NHS--within 30 days rather than the current 90-day period, according to the statement.

Meanwhile, the “budget impact threshold” will be a launchpad therefor discussions about commercial agreements between NHS England and pharmaceutical companies and devicemakers, according to the statement. Currently, approximately 80% of NICE-recommended treatments fall below the £20 million threshold. When the threshold is met or surpassed, the NHS may ask NICE to consider a time scale other than the standard 90-day period for NHS bodies to secure funding for NICE-recommended treatments.

“Our proposals also provide clarity, for the first time, that the NHS is prepared to pay far more for effective highly specialized treatments appraised by NICE,” said Dr. Jonathan Fielden, NHS England’s director of specialized commissioning and deputy national medical director, in the statement. “These treatments, for patients with very rare conditions, will now qualify for automatic funding at a level that is five times higher than NICE’s current limit. On top of this, there will also be the added flexibility to negotiate with drug companies on those technologies which are cost effective but have a heftier price tag.”