Amid a tough budget situation in England, the pharma industry is challenging a new clampdown for meds projected to cost the country’s health system more than £20 million per year.
The Association of the British Pharmaceutical Industry—which represents companies such as GlaxoSmithKline, AstraZeneca, Pfizer, Roche and others—is fiercely opposed to the approach and has applied for a Judicial Review of the system “after many months” of trying to work toward a solution, ABPI chief executive Mike Thompson said in a statement.
Back in April, NHS England and NICE implemented a £20 million threshold for new drugs that triggers an additional “commercial discussion” for launch options between health authorities and drugmakers.
If the sides can’t agree to an amicable rollout, the new system allows NHS England to 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.
The new threshold adds another potential barrier to access, something critics blasted when details of the plan first surfaced earlier this year. One critic said patients could die while waiting for treatment.
“These new arrangements will delay access to cost-effective medicines and deny treatments to patients suffering from rare diseases,” Thompson said in a statement on Monday.
The industry is also challenging a new rare disease assessment method that tests drugs on a sliding scale against the level of additional quality-adjusted life years (QALY) they offer. The system requires drugs to meet a £100,000 per QALY level to start, advancing all the way to £300,000 per QALY.
ABPI called the system “inappropriate and unworkable” in its Monday statement.
The changes are part of a price-fighting initiative as growing costs have forced England’s health authorities to get creative. About 1 in 5 new drugs will be impacted by the new £20 million threshold.
The approach could impact drugs that treat few patients at a high price, and those that treat many patients at a relatively lower price. Earlier this year, ABPI said Johnson & Johnson's prostate cancer med Zytiga could have been affected by the regulation, as well as Merck's cholesterol med Zetia. J&J's med treats thousands of patients in the country, while Merck's drug treats hundreds of thousands of patients.