NICE suspends review of Vertex's Symkevi
- The U.K.'s National Institute for Health and Care Excellence has suspended its review of Vertex's Symkevi (marketed as Symdeko in the U.S.) for treating cystic fibrosis patients who are homozygous for the F508del mutation, after the biotech did not provide evidence for NICE's appraisal.
- NICE, a governmental agency tasked with assessing the cost-effectiveness of new drugs, has therefore decided against reviewing Symkevi at a committee meeting scheduled for Nov. 8. The agency said it will provide updates on the drug's appraisal "as soon as possible."
- Symkevi received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in July.
U.K. regulators and Vertex have been sparring over the price of the company's cystic fibrosis drugs. In the latest twist, NICE stated in an update on its review of Symkevi (tezacaftor and ivacaftor) that Vertex "has not provided an evidence submission for this appraisal. Therefore, we are suspending the appraisal whilst we consider the next steps."
Vertex hasn't confirmed whether it failed to provide the evidence submission, but the biotech has placed the blame firmly back onto NICE and its technology appraisal process.
"We support the need for robust and fair medicines appraisal in England, but believe that NICE's single technology appraisal has not kept pace with changes in medicine and has significant limitations in how it captures and values the full benefits of precision medicines such as tezacaftor/ivacaftor," a Vertex spokesperson wrote in an email to BioPharma Dive.
"We would be happy to re-engage with NICE in the context of an appropriate appraisal process, which takes into account the benefits our cystic fibrosis medicines provide to people with this devastating disease," the spokesperson added.
Vertex also told BioPharma Dive that company CEO Jeffrey Leiden reached out to the head of the U.K.'s National Health Service, Simon Stevens, and the Secretary of State for Health and Social Care, Matt Hancock "weeks ago," but has heard nothing back.
The review suspension indicates Vertex's spat with the U.K. government is far from resolved. Since NICE decided not to recommend Vertex's Orkambi (lumacaftor and ivacaftor) in July 2016, the company has been in discussion with NHS officials to work out a pricing scheme for Orkambi, Symkevi and Kalydeco (ivacaftor).
Yet, following a lack of agreement between the NHS and Vertex and combative statements from both sides, Leiden contacted May directly in July 2018 to request her urgent intervention.
A NICE spokesperson said the agency is "ready to work with Vertex on both a review of our guidance on Orkambi, when the company is able to offer a price that reflects its value to patients and the NHS, and to start the evaluation of Symkevi."
- BioPharma Dive Vertex spars with UK's May over Orkambi pricing
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