The National Institute for Health and Care Excellence (NICE) in England has recommended treatment with Revlimid (lenalidomide) and dexamethasone for multiple myeloma patients not eligible for a stem cell transplant or thalidomide therapy.
NICE’s decision is expected to benefit around 2,100 people with myeloma. But it comes a full four years after Revlimid’s approval in Europe, due to disagreements about the patient access scheme (PAS) — the discount program applied to the therapy.
Without the PAS discount, Revlimid’s list price in England is up to £52,400 (US$66,360) a year per patient.
National Health Service (NHS) England had called for NICE’s appraisal to be halted to seek a better deal, since this PAS was both complex and did not return savings made by hospitals to its central budget. This resulted in a new confidential discount scheme, agreed to by Celgene and NHS England, that addressed these concerns.
Thalidomide is the standard therapy for adults with multiple myeloma on the NHS in England. But it can lead to serious side effects — including breathlessness and bruising — making it not appropriate for people with certain preexisting conditions, including neuropathy, or nerve damage.
Velcade (bortezomib, by Takeda Oncology) has been used in such cases. But once it becomes ineffective, patients usually have to receive chemotherapy before they become eligible for other therapies. The decision by NICE makes Celgene’s Revlimid an earlier option in multiple myeloma treatment.
“We are pleased to recommend lenalidomide (Revlimid) for these patients. Not only will this drug improve the length of time people live, but it will also have fewer side effects compared with current treatments,” Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said in a PMLiVE news release by Andrew McConaghie. “The new decision by NICE now means that those patients have an effective alternative.”
Maintenance treatment with Revlimid enabled both longer overall survival, and progression-free survival — the period without cancer progression — compared with Velcade, with or without thalidomide, according to a 2018 study.
A later Phase 3 trial named FIRST (NCT00689936) — with 1,623 patients; median age 73 years — showed that continuous treatment with Revlimid and low-dose dexamethasone led to 25.5 months without cancer progression, compared with 21.2 months for patients on thalidomide. Taking Revlimid also was associated with lengthened overall survival by 10 months or more compared with thalidomide, in continuous or fixed Revlimid regimens.
Other benefits included a higher proportion of patients responding to treatment (81% vs. 67%), and a longer time without needing a second-line myeloma therapy. The safety findings in each treatment were in line with those reported in previous studies.
The European Commission recently approved Revlimid, and Celgene’s other myeloma therapy Imnovid (pomalidomide, sold as Pomalyst in the U.S.), in triple combinations with Velcade and dexamethasone for some adult patients with multiple myeloma.