Judicial Review of NICE Policy That Could Restrict Drug Access

The Association of the British Pharmaceutical Industry (ABPI) announced this week that it has applied for judicial review of a new budget impact test implemented by the National Institute for Health and Care Excellence (NICE).

In April 2017, NICE introduced the budget impact test for treatments already approved for routine use that will cost more than £20 million ($26.15 million) in the first 3 years of use. When drugs exceed that cost limitation, the National Health Service (NHS) will initiate negotiations with the drug’s manufacturer in order to bring the product’s cost under £20 million. If the NHS is unable to reach an agreement with the pharmaceutical company, patient access to new drugs could be delayed by up to 3 years.

Previously, NICE had employed a per-patient threshold for spending, requiring price negotiation only for drugs that exceeded the cost-effectiveness margin of £20,000 to £30,000 ($26,160 to $39,250) per patient per extra year of quality-adjusted life (QALY).

ABPI’s application for judicial review of the new policy comes after the pharma group raised concerns about NICE’s change in approach and offered to work with the cost-control agency on alternative proposals to the plan that is expected to affect 1 out of every 5 new medicines. ABPI’s chief executive, Mike Thompson, said, “We believe this to be the right course of action due to the potential damage these changes will cause to NHS care and on our ability to research, develop and use new medicines here in the UK. We hope that the Government will reverse the changes and work with us to find a solution that works for everyone."

Some other industry groups had a tepid response to ABPI’s legal move; the UK BioIndustry Association (BIA)’s chief executive, Steve Bates, said that “there are several other complex issues the full life sciences sector is currently engaging with the government on. Namely, how we can make Brexit a success for the life sciences sector. This legal move must not impact or delay broader industry engagement with the UK government at a time of significant external change.”

For their part, patient advocacy groups are closely watching the outcome of the review. Baroness Delyth Morgan, chief executive of Breast Cancer Now, said that the group hopes the legal action will provide clarity on the issue of patient access, and that Breast Cancer Now is “ready and willing to work with all involved to look at how this critical issue can be resolved.”

The legal challenge comes just weeks after the NHS struck price deals with drug manufacturer Roche for the routine use of trastuzumab emtansine (Kadcyla) in patients with HER2-positive metastatic breast cancer in patients for whom trastuzumab treatment has failed. NICE had previously deemed the treatment to be cost ineffective, but the NHS reached a confidential agreement with Roche to make the drug available to approximately 1200 patients per year in England. Chief executive of NHS England, Simon Stevens, said of the deal, “for companies who are willing to work with us, there are concrete gains for them, for the NHS, and most importantly, for patients.”