UK Court Denies Pharma's Application for Judicial Review of Drug Price Policy

UK trade group The Association of British Pharmaceutical Industry (ABPI) announced last week that the Administrative Court has denied its application for judicial review of a new National Health Service (NHS) drug pricing policy.

In July, ABPI applied for review of a new budget impact test implemented by the National Institute for Health and Care Excellence (NICE). Instituted in April 2017, the test applies to treatments that have already been approved for routine use under the NHS, but that would cost the system more than £20 million (approximately $26.3 million) in the first 3 years.

Therapies exceeding that cost threshold will now automatically become subject to negotiations between the drug’s manufacturer and the NHS in order to bring the cost below £20 million. If NHS is unable to reach an agreement with the drug maker, the therapies can be phased in over a period of 3 years. Drugs for rare diseases, however, will be evaluated on a sliding scale and allowed to have a higher cost threshold.

Prior to the introduction of the budget impact test, NICE had used a per-patient threshold for drug spending. Under the old system, drugs required price negotiation if they would cost more than £20,000 to £30,000 (approximately $26,300 to $39,500) per patient per extra year of quality-adjusted life that they provided.

On October 4, 2017, ABPI said that it will not appeal the court’s decision on the review. In its statement, the group said, "Our concern has always been that patients should not miss out on medicines which are proven to be both clinically beneficial and cost-effective. Throughout this action the ABPI has maintained positive and constructive dialogue with NICE, the NHS and Government and we are encouraged that the issues are now better understood. Working in partnership with industry, Government and the NHS we must now focus on finding real, workable solutions to help NHS patients get fast access to the medicines they need.”

A spokesperson for NHS England said that, “Rather than attempting to further frustrate NICE and the NHS' work to ensure patients and taxpayers get maximum value out of the £15 billion [$19.7 billion] being spent on drugs, it now makes sense to work together towards that shared goal.”

Following ABPI’s filing for review, critics alleged that overseas drug manufacturers, rather than UK pharmaceutical companies, were driving the group’s efforts as a means to maintain high profits.

However, questions remain as to whether the pricing policy will result in less patient access to high-cost therapies, including biologics. NICE has previously restricted the use of drugs such as trastuzumab emtansine (Kadcyla) to treat patients with HER2—positive metastatic breast cancer who had not responded adequately to trastuzumab alone, calling the treatment cost-ineffective. However, after receiving pressure from patient advocacy groups, the NHS struck a price deal with Roche that would allow the health system to make the drug available to approximately 1200 patients in England each year.