Pharma's legal challenge to U.K. cost clampdown gets shot down

Pharmaceutical companies, which have taken a hard stance against new cost-management strategies in England, have fallen short in an effort to block them with a legal challenge. 

The Association of the British Pharmaceutical Industry (ABPI) said on Wednesday that a court denied its application to review an NHS England and NICE strategy that limits spending on medicines that are projected to cost the country’s health system more than £20 million per year. The group, which sought the review in July, represents top drugmakers such as GlaxoSmithKline, AstraZeneca, Roche, Pfizer and others. 

"It’s now appropriate for us to take time to reflect on the judgement with our members and decide next steps," the industry group said in a statement. On Thursday, ABPI announced it wouldn't appeal the decision.

Implemented in April, the new strategy triggers a "commercial discussion" between drugmakers and health authorities when a medicine is expected to cost the system more than £20 million per year. At that threshold, health officials and industry are to work together on affordable launch options for expensive new drugs. If they can't agree to terms, NHS England can apply for a “phased introduction of the product to help manage the financial impact over a longer period than the standard 90 days,” according to the agency’s website.  

Historically, patients in England have had legal access to drugs recommended by cost watchdog NICE. Officials have said the overhaul could impact one in five new drug launches. 

Critics blasted the system as another barrier to patient access, arguing that patients could die while waiting for treatment. Industry tried to block the implementation with an application for a judicial review "after many months" of negotiating, ABPI head Mike Thompson said. 

Now, the industry's legal effort has fallen short. An NHS spokesperson told FiercePharma via email that the court "rejected ABPI's flawed legal manoeuvres which the judge said would 'produce an absurd result.'  

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

Industry and cost watchdogs in England have had a contentious history lately as officials have worked to crack down on spending amid a tough budget situation. The country recently overhauled its Cancer Drugs Fund and has sometimes turned away pharma's new launches on cost-effectiveness grounds, triggering an industry backlash.