Final guidance from the National Institute for Health and Clinical Excellence (NICE) has recommended Celgene's Thalidomide, in combination with an alkylating agent and a corticosteroid, as an option for the first-line treatment of multiple myeloma.
The guidance recommends the use of thalidomide, marketed by the firm as Thalidomide Celgene, in people with multiple myeloma for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate.
The final guidance also recommends the use of Janssen's Velcade (bortezomib) under these circumstances if the patient is unable to tolerate thalidomide, or has contraindications to it.
Dr Carole Longson, director of NICE's health technology evaluation centre, said the Institute was "delighted" to be able to recommend these two new treatment options for people with multiple myeloma, a type of cancer that develops from cells in the bone marrow. Almost 4,000 cases are diagnosed every year in the UK and there is currently no cure, only treatments to stop the progress of the condition and help relieve symptoms, she said.
"Thalidomide and bortezomib regimens have been shown to be more effective at delaying disease progression and improving patients' life expectancy than the current treatment of an alkylating agent and corticosteroid alone," Dr Longson added.
The NICE appraisal committee had been told by clinical specialists that, although the choice of treatment would differ for each individual, a thalidomide regimen would be considered suitable for most patients. The Thalidomide and Velcade regimens were similar in terms of clinical effectiveness, but the former was more cost-effective.
The average cost of Velcade per treatment cycle is £3,000, with each 3.5mg vial costing £762.38. The average cost of Thalidomide per treatment cycle is £2,100, with a 28-capsule pack of 50mg capsules costing £298.48.
Velcade has been recommended as an option for people who are unable to take Thalidomide as it is considered an appropriate alternative treatment and is also cost-effective for this specific group of people, adds NICE.
These recommendations were originally made in draft guidance published by NICE last August, but Janssen subsequently launched an appeal, stating that its product was a clinically and cost-effective treatment option for this group of newly-diagnosed patients, and that adoption of the Institute's guidance as it stood would disadvantage patients in England and Wales compared to those in much of Europe, where Velcade has been "widely available in this setting for a number of years."
NICE's appeal panel subsequently met last November and upheld one of seven points made, stating that the Institute had made insufficient efforts to obtain permission to release an executable economic model to consultees. Following this decision, NICE worked with the owners of confidential data contained within the model and it was agreed to release this to consultees.
The Institute's appraisal committee met again to discuss comments received on the reliability of the model and to reconsider the draft recommendations. A second Final Appraisal Document (FAD) was published following this discussion, and no further appeals were received.