Decision

February 2019: Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis and Vertex Promotional Activities

Updated 11 June 2019

A member of the public complained about the activities undertaken by Vextex with regard to their product Orkambi indicated for cystic fibrosis. The complainant was concerned that a website about their pricing negotiations promoted a prescription only medicine to the public. It was further alleged that press releases were being disseminated to stimulate patient pressure on the NHS.

MHRA did not uphold the complaint. Vertex provided assurances that all materials had been provided only in response to unsolicited requests. Although Vertex made available information about the progress of negotiations for reimbursement on a dedicated website, we did not receive any information on how this information had been actively disseminated by the company, other than to those who had asked to be kept informed.