It was a thumbs-down week for the U.K.’s drug price watchdog.
In draft guidance, the National Institute of Health and Care Excellence has rejected Gilead Sciences’ Trodelvy for use against triple negative breast cancer, saying it is too expensive for use by the National Health Service.
In a separate decision, the National Institute for Health and Care Excellence (NICE) has shot down three atopic dermatitis drugs—AbbVie’s Rinvoq, Pfizer’s Cibinqo and Leo Pharma’s Adtralza. That decision doesn't affect patients already using the treatments, NICE said, and is subject to an open comment period through May 4.
First, on Trodelvy, the guidance sets up a disparity in coverage with Scotland, which has signed off on the drug. Trodelvy has been shown to extend the lives of triple-negative breast cancer (TNBC) patients longer than chemotherapy.
A three-week public comment period follows the draft guidance. Meanwhile, NICE has put the onus on Gilead to cut Trodelvy’s price.
“Given the lack of treatment options for people with this type of breast cancer, we’re very disappointed that its price means we can’t recommend it for use in the NHS at this point,” Helen Knight, interim director of medicines evaluation at NICE, said in a release. “We hope that the company will consider what it can do to enable NICE to approve a treatment that has the potential to give people with advanced triple negative breast cancer more time with their loved ones.”
NICE estimates that 2,000 women in England have TNBC and that 650 of them would be eligible for Trodelvy upon clearance. NICE does recommend the use of Roche’s Tecentriq along with chemotherapy for TNBC.
Gilead said the decision was "extremely disappointing" and points out that Great Britain is the only Project ORBIS country not to provide reimbursement for the drug. Gilead said it would work with NICE to try to come to an agreement ahead of a May 10 meeting.
"Gilead will be working closely with NICE to address questions raised around cost-effectiveness estimates," the company said. "We believe we have put forward a strong, cost-effective case for the reimbursement of SG in England and are deeply concerned by the prospect of unnecessary delay, especially in a cancer where every day matters."
As for the atopic dermatitis drugs, NICE says there is uncertainty about their effectiveness when compared to other topical treatments that are sanctioned such as creams and corticosteroids.
Beyond those, immunosuppressants such as methotrexate and ciclosporin are also approved for use along with targeted therapies such as Sanofi’s Dupixent and Lilly’s Olumiant.
“The limitations in clinical evidence mean the results from the economic model are also highly uncertain,” NICE said. “As such, it is challenging to determine the cost-effectiveness of the drugs.”
NICE has requested more information to assess cost effectiveness and will meet next month for further evaluation.