- The U.K.'s National Health Services (NHS) and Vertex Pharmaceuticals are still sparring over the price of Orkambi for the treatment of cystic fibrosis. The latest step is a letter from the government's Health and Social Committee, requesting documentation and evidence.
- The committee is carrying out an inquiry into "access for NHS patients to drugs where their pricing means they are not considered cost effective." That move comes on the heels of the U.K.'s National Institute for Health and Care Excellence (NICE) deciding not to recommend the drug on cost grounds, and the subsequent lack of progress in discussions over the past two years.
- Back in July, Vertex took the discussion as high as it could by requesting "urgent intervention" from the U.K. Prime Minister Theresa May. Vertex has turned up the heat, implying that the company's future in the U.K. could be in question. As of May, Orkambi's U.S. list price sat at almost $273,000.
Orkambi (lumacaftor/ivacaftor) was approved in Europe three years ago this month for the treatment of cystic fibrosis. Yet in July 2016, NICE determined the drug wasn't sufficiently cost-effective.
Since then, Vertex and the NHS have been in discussion over a pricing scheme that will cover Orkambi. It would also include Vertex's other two CF therapeutics, Kalydeco (ivacaftor), and Symdeko/Symkevi (tezacaftor/ivacaftor), as well as future medicines still in development.
In a July letter to British Prime Minister Theresa May, Vertex CEO Jeff Leiden claimed the company had "made the most innovative and best offer in the world to NHS England — covering all patients, for all of our medicines today and tomorrow — at a price that is reflective of the exceptionally high prevalence of CF in the UK."
The latest letter from the U.K. government's Health and Social Committee, authored by members of parliament and chair of the committee, asked for a number of pieces of information — beginning with a copy of Vertex's final submission to NICE for Orkambi, including the price given to NHS and the evidence supporting the drug's benefit.
The committee also asked for details of formal offers made to NICE and NHS England for price reductions and drug supply. The committee also wants evidence "in support of your public statement that you have offered the NHS in England the lowest price for your drugs of any country in the world."
Overall, U.K. regulators seem to be showing a touch of impatience, stating, "As previously indicated, the Committee would expect to publish any documents received, and it will use the formal powers granted to it by the House of Commons to require the provision of those documents if they are not provided in response to this request."
This could be tricky for Vertex, as it would be a significant disclosure of Vertex's pricing strategies.