NICE, Vertex continue to spar over drug prices

Aug 13, 2018

The U.K.'s National Institute for Health and Care Excellence (NICE) has suspended its review of Vertex's Symkevi for treating cystic fibrosis patients who are homozygous for the F508del mutation, after the biotech did not provide evidence for the agency's appraisal.

In response, Vertex commented 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.” Vertex has not submitted data on the forthcoming drug to NICE.

Vertex and U.K. health officials have been going back and forth for years to reach a deal for Orkambi, which secured European approval in 2015. In late July, Vertex announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for Symkevi  (tezacaftor/ivacaftor) in a combination regimen with ivacaftor (KALYDECO) for the treatment of people with cystic fibrosis.

Symkevi, marketed as Symdeko, has been available in the U.S. since February.

Read the NICE document