Often times, new drug launches are held up in England as cost-effectiveness watchdogs work through tough pricing negotiations with drugmakers. For a new collaboration with Novartis on cholesterol drug Leqvio, the U.K. government is going an entirely different route.
The U.K. government, NHS England and Swiss drug giant Novartis on Tuesday unveiled a "world-first" reimbursement deal that'll enable broad access to Leqvio for hundreds of thousands of high-risk cardiovascular patients. The news follows the January 2020 announcement of the deal parameters, and now the partners are ready to move into the "implementation phase" after the drug scored its European approval and passed muster at the National Institute for Health and Care Excellence.
Over the next three years, NHS England expects to treat about 300,000 patients with the drug, which won its European nod last year for adults with primary hypercholesterolemia or mixed dyslipidemia for use alongside statins or other lipid-lowering therapies.
After reviewing clinical data from three phase 3 trials, England's NICE endorsed the drug in patients who have a history of cardiovascular events—such as a heart attack—and whose LDL-C concentrations are persistently 2.6 mmol/l or higher despite treatment with lipid-lowering medicines.
Under the "landmark" collaboration, NHS England will identify high-risk patients, offer the treatment and monitor outcomes, Novartis’ global head of value & access and commercial development Haseeb Ahmad said in an interview. As a fast-acting medicine that’s administered twice per year, Leqvio is “ripe and ready” for a “population-health approach,” he added.
The drugmaker didn't unveil financial aspects of the deal, but a spokesperson said that NICE concluded it's a cost-effective use of resources when used as recommended.
Novartis plans to explore similar arrangements in other countries, Ahmad said.
The pharma giant picked up Leqvio, also known as inclisiran, when it acquired The Medicines Company back in November 2019 for $9.7 billion. Shortly after the deal, Novartis and NHS England unveiled their preliminary access agreement, which MedCo negotiated before Novartis bought it.
The drug then scored its European nod in late 2020. Across the pond, the U.S. FDA rejected the drug at about the same time.
The FDA turned away the drug “essentially due to COVID-19 travel restrictions (FDA couldn't inspect a third-party facility),” RBC Capital Markets analyst Luca Issi wrote to clients at the time.
Now, Novartis is hoping to get its med back on course in the U.S. with a recent FDA refiling. In its latest filing, Novartis sought to sidestep the FDA's concerns at a third-party manufacturing site and instead bring production in-house to a facility in Schaftenau, Austria.
The pandemic did not only disrupted Novartis' U.S. approval. The company also had to delay the readout for a key cardiovascular outcomes trial by two years to 2026, because the pandemic slowed patient enrollment in the U.K., Novartis' Chief Medical Officer John Tsai previously said.