When patients are pleading for access to a drug and the company instead destroys thousands of months' worth of supply, it must be a pricing standoff—and it's one that doesn't look great on Vertex's part.
Off-and-on negotiations between Vertex and U.K. health officials over Orkambi pricing have lasted so long that the drugmaker had to trash almost 8,000 packs that expired last year. Vertex disclosed the info after its executives headed to U.K. Parliament this month to face questions over the pricing standoff. During the hearing, Member of Parliament Sarah Wallaston asked if the company has had to destroy any expired stock of the cystic fibrosis drug.
Responding to that inquiry, Vertex’s VP and general manager of the Northern Europe Region, Simon Lem, wrote to Wallaston that last year the company tossed 7,880 packs of Orkambi, each containing a 28-day supply. The packs were manufactured in 2015 and 2016 and expired last year, he wrote. Vertex intended them for use in 13 countries, including the United Kingdom.
It's not necessarily a supply problem, as “Vertex continues to hold significant inventory reserves of Orkambi to ensure that we can fulfill our obligations across the EU and also uphold our commitment to the Committee to supply medicines to every patient in England within four weeks of a successful resolution to our negotiations,” Lem wrote.
But it's a PR problem for the company, and it underscores just how long talks have dragged on without a resolution. For years, patients and advocates have pleaded with the company and officials, asking them to reach a deal to ensure quick access.
Vertex won European approval for the drug in 2015 but hasn’t launched because the company and British health officials can’t agree on a fair price. Last year, officials offered £500 million over five years and £1 billion over 10 years for access to all of Vertex’s CF drugs, but the company said that offer "does not take into account the vast time and resources invested” to develop the drugs. An executive added that it could hamper the company's ability to one day find a cure for the disease.
That back-and-forth development happened in July, and then the talks seemed to cool down. This month, the U.K. Parliament’s Health and Social Care Committee held a hearing, summoning Vertex CEO Jeffrey Leiden, M.D., Ph.D., and Chief Commercial Officer Stuart Arbuckle to answer questions. At that hearing, Leiden said he had a meeting planned for the following week with Britain's health secretary, Matt Hancock. Hancock recently told Britain’s House of Commons that the sides have been engaged in “constructive discussions,” The Guardian reports.
Lem wrote that Vertex has distributed more than 80,000 packs of Orkambi in Europe under commercial sales since 2015. The company has also supplied another 11,000 packs through an access program, including to about 600 patients in England who have qualified.