England's cost-effectiveness watchdog, typically a fierce critic of pharma's launch prices, says it’s revamping the way it reviews new drugs, devices, diagnostics and more in a push to provide greater access, sooner.
The National Institute for Health and Care Excellence, or NICE, rolled out its planned remodel on Thursday aimed at providing “faster, fairer” access to the drugs and devices it reviews for National Health Service (NHS) patients.
NICE is an independent organization that makes rulings over which drugs should be made available to NHS patients, taking their price tag and benefits into consideration. For years, the watchdog has faced scrutiny from pharma companies and patient groups alike for restricting access to new and promising treatments while calling for steep discounts.
NICE’s revamp is the “culmination of the most wide-ranging and comprehensive review” it’s ever carried out, incorporating health system partners as well as industry, healthcare professionals, academia and patients, according to the organization. The group also acknowledged that products like cell therapies and precision medicines are becoming more complicated to evaluate.
As part of its plan, NICE says it will simplify and streamline its assessment processes to allow for more flexible decision making, especially for medicines that treat rare diseases or affect children. The group will also work with drug regulators to “provide patients with earlier access to innovative technologies.”
Further, NICE will grant drugs for more severe diseases, such as epilepsy and multiple sclerosis, “extra weight” in its decision-making process. Those medicines can also treat the disease at any stage, not just at the end of a patient’s life, NICE said. As for rare diseases, NICE plans to remove the criteria “that the condition being treated should be chronic and severely disabling.”
The watchdog will also expand its use of agreements that allow companies with “promising but clinically uncertain” medicines to offer their treatments at a reduced cost while more evidence is gathered.
NICE said it will accept feedback on its proposed changes until Oct. 13 and plans to initiate its remodel by January 2022.
Changes to the way the institute reviews new drugs has been a long time coming. In 2014, NICE said it would delay any further changes to its methodology after the group and its board couldn’t agree on adjustments aimed at expanding market access, Pharmafile reported at the time.
The calls for NICE to revamp its review methods rang loud again in 2016 when the group took over the beleaguered Cancer Drugs Fund, which sometimes would pick up the costs for NICE-excluded treatments.
In the interim, NICE has handed out some high-profile rejections, notably for Merck’s blockbuster cancer drug Keytruda in 2017 as a first-line treatment for non-small cell lung cancer, as well as for Bristol Myers Squibb’s Opdivo for previously treated lung cancer patients in 2016. On the flip side, though, the organization blessed Novartis' pricey spinal muscular atrophy gene therapy Zolgensma with an approval.
The Association of the British Pharmaceutical Industry said NICE’s update marked a “major milestone” and added that the group’s members will work with the organization to ensure its changes “deliver meaningful change for patients, their families, and the NHS.”