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The National Institute for Health and Care Excellence (NICE) recommended the drug, lenalidomide (Revlimid), be offered in combination with the steroid dexamethasone. But only for those who cannot take the current thalidomide-based standard of care or are not able to have a stem cell transplant.
They say the decision will benefit approximately 2,100 patients a year.
Rose Gray, Cancer Research UK’s policy manager, said: “This decision is fantastic news for the myeloma patients who will be able to access this new treatment, and their families.”
Gray said this was an important step forward as it provides a new treatment option for patients who aren’t well enough to have some existing treatments on offer.
Thalidomide is the standard treatment for adult patients with multiple myeloma on the NHS, but it can produce serious side-effects, like breathlessness and bruising, so isn’t appropriate for everyone. This includes people with certain pre-existing conditions such as neuropathy.
The current alternative treatment for those who can’t take thalidomide is a drug called bortezomib (Velcade). But once bortezomib treatment stops working, patients usually have to receive chemotherapy before they become eligible for newer therapy options.
Because of this, NICE concluded there was an unmet need for alternative treatments for these patients, which would allow bortezomib to be used later in a patient’s treatment and delay or avoid the need for chemotherapy.
The decision came after studies suggested that taking lenalidomide with dexamethasone substantially improved how long patients live without their disease getting worse as well as their overall survival, compared with bortezomib therapy.
Patients in the trial were randomly split into 3 groups:
It was found that the taking lenalidomide and dexamethasone until a patient’s disease progressed was the best option for controlling the spread of the cancer. On average in this group patient’s disease did not worsen for 25.5 months, compared with 21.2 months for those taking thalidomide.
Compared with the thalidomide group, those taking lenalidomide–dexamethasone until their disease progressed had a similar level of side effects.
But despite promising trial data, NICE said the precise benefit of taking lenalidomide was uncertain because the trial compared lenalidomide to thalidomide, instead of bortezomib. But the evidence was enough for NICE to recommend lenalidomide as cost effective for patients who cannot take thalidomide. Additionally, clinical experts told NICE that they expected lenalidomide to produce less side effects than the alternatives.
Rose Gray added, “This treatment can significantly improve survival for these patients compared to the best existing alternative and can also cause fewer side effects, so we’re glad to see this approved.”
NICE concluded that lenalidomide plus dexamethasone did not offer the NHS value for money compared to thalidomide treatment. Therefore, lenalidomide is not recommended for patients who are able to take thalidomide therapy.
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