Nearly 8,000 Packets of Orkambi Destroyed as the U.K. and Vertex Hash out Pricing Concerns

protesters gathered in England over the price of Orkambi

London, UK. - March 7, 2019: Protestors gathered in Parliament Square to campaign to have access to the life-saving drug Orkambi for people suffering with cystic fibrosis. Credit: Kevin J. Frost / Shutterstock.com

Cystic fibrosis drugmaker Vertex Pharmaceuticals was forced to destroy nearly 8,000 packs of its drug Orkambi after the medication had expired before they could be shipped to the United Kingdom due to a contentious pricing fight.

Boston-based Vertex and the National Health Service in England have been at odds over the £100,000 per year price the company is seeking to charge for Orkambi. The NHS believes the price is too high and the medication has gone unused, The Guardian reported Wednesday. The 7,880 packets of medication that were destroyed amounted to a 600 years’ supply for England. Each of the packets of Orkambi provides 28 days’ worth of treatment for a cystic fibrosis patient. In its report, The Guardian noted that the amount of medication destroyed could have provided treatment for about 100 cystic fibrosis patients for up to six years.

There are approximately 10,000 cystic fibrosis patients in the United Kingdom and about 40 percent of them are expected to benefit from Orkambi. A combination of Kalydeco and lumacaftor, Orkambi, was approved by the U.S. Food and Drug Administration in the summer of 2015 and was also approved for use in Europe and the U.K. that same year.

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In a letter sent to the NHS from Vertex, the company said it maintains a stockpile of the medication in an England facility. That medication is then distributed across Europe. Since 2015, Simon Lem, who heads Vertex’s Northern Europe Region, said the company has distributed more than 80,000 packets of Orkambi throughout Europe. Additionally, Lem noted that more than 11,000 packets of the medication had been provided free of charge through the company’s Vertex Managed Access Program.

“We have provided our medicines free of charge under this program to approximately 600 patients in England, all of whom qualified under certain criteria,” Lem said in the letter.

Regarding the nearly 8,000 packets that were destroyed, Lem said those had been manufactured in 2015 and 2016 for the purpose of supplying patients in 13 different countries, including the U.K. However, they exceeded their expiration date and had to be destroyed.

“We manage our medicinal stocks over a four-year timeframe because the final packaging and labeling of the medicines typically takes place up to two years from ordering of raw materials, and the finished product had a shelf life of two years under controlled room temperature conditions,” Lem said.

Despite the destruction of those packets of medication, Lem said Vertex holds “significant inventory reserves of Orkambi” in order to meet its obligations to patients across Europe and the U.K. He added that when Vertex and the NHS can resolve its pricing differences, the supply Vertex has on hand will meet its commitment to “supply medicines to every patient in England within four weeks of a successful resolution to our negotiations.”

While Lem noted that there are packets of Orkambi awaiting cystic fibrosis patients in the U.K., there is no word on when Vertex and the NHA will come to an agreement. The U.K. health secretary Matt Hancock said discussions are ongoing, The Guardian reported.

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