NICE Recommends Cancer Drug for Multiple Myeloma

Peter Russell

May 17, 2019

An immunomodulator drug to fight multiple myeloma should be available for more patients on the NHS in England and Wales, the National Institute for Health and Care Excellence (NICE) announced today.

Lenalidomide (Revlimid, Celgene) could soon be offered to patients with this form of plasma cell cancer as a first- and second-line drug, it said.

Multiple Myeloma

In final draft guidance, NICE recommended lenalidomide in combination with dexamethasone as an option for previously untreated multiple myeloma in adults who are not eligible for a stem cell transplant and cannot take thalidomide.

The committee explained that people with multiple myeloma are first treated with thalidomide-based therapy but, if a patient cannot have thalidomide, bortezomib-based therapy is an option.

For people who have had bortezomib (Velcade, Janssen-Cilag) as a first treatment, the second treatment would be with cytotoxic chemotherapy. However, clinical evidence shows that lenalidomide plus dexamethasone is more effective than cytotoxic chemotherapy.

NICE decided that as it already recommended lenalidomide as both a first and third treatment for multiple myeloma, it was appropriate to recommend lenalidomide for this small patient group as a second treatment.

In further final draft guidance, NICE also recommended lenalidomide as an option for treating multiple myeloma in adults if they have had only one previous therapy, which included bortezomib.

It said patients were currently offered chemotherapy as a second treatment after bortezomib. However, clinical evidence showed that lenalidomide with dexamethasone substantially improved the length of time people lived compared to bortezomib-based therapy. In one clinical study, patients taking lenalidomide lived on average 7 months longer, it said.

Since NICE already recommended lenalidomide as a third-line treatment, it considered it appropriate to also recommend it as a second-line option.

NICE estimated that the changes would benefit an estimated 320 people.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "We are pleased to recommend lenalidomide 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.

"Multiple myeloma is normally treated with a thalidomide-based therapy at first line; however, there is considerable need for new therapies for those who cannot take thalidomide. The new decision by NICE now means that those patients have an effective alternative."

The manufacturer has agreed to provide lenalidomide at a commercially confidential discount.

Shelagh McKinlay, head of patient advocacy at the charity Myeloma UK, commented: "This double approval from NICE is a significant step forward in building the best possible treatment pathway for patients in England and Wales.

"In their decision NICE confirm that unmet need was a key factor for them. This follows many years of work by Myeloma UK in raising awareness of the unmet need which exists for these patient groups.

"We have also long argued that individual treatment decisions must not be seen in isolation but as part of a treatment pathway that makes the best clinical sense for patients. In both decisions, particularly for patients at first relapse, NICE have taken the changing treatment pathway into account. We very much welcome the flexibility they have shown and their commitment to finding a solution that delivers for patients."

Kidney Cancer Drug Approval

Nivolumab (Opdivo, Bristol-Myers Squibb) with ipilimumab (Yervoy, Bristol-Myers Squibb) was recommended for use within England's Cancer Drugs Fund (CDF) as an option for adults with untreated advanced renal cell carcinoma that is intermediate- or poor-risk.

Appraisers said the CheckMate 214 clinical trial showed that nivolumab with ipilimumab was more effective than usual treatment with sunitinib (Sutent, Pfizer) in the short term, but that its long-term effects were uncertain.

Inclusion in the CDF would allow the manufacturer of nivolumab and ipilimumab to collect further data from longer-term follow-up of patients in the clinical trial to answer uncertainties about how long people lived, and how long they lived without their disease getting worse, NICE said in final guidance.

A commercial arrangement is in place to provide nivolumab and ipilimumab at a discount to the NHS.

Prostate Cancer Drug Rejection

Enzalutamide (Xtandi, Astellas) was rejected for routine NHS use for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults.

The drug was developed to treat patients whose cancer no longer responded to androgen deprivation therapy but had not yet spread beyond the prostate.

The list price of enzalutamide is £2,734.67 per 112 capsules with a 4 capsule daily dose costing £97.67. A commercial arrangement had been agreed in the event that the treatment was approved.

An appraisal committee accepted that clinical trial evidence showed that adding enzalutamide extended the time until the cancer started spreading to other parts of the body. However, it said there was no evidence that it increased how long people lived.

In final guidance, NICE said this clinical uncertainty, coupled with an analysis of costs versus benefits, meant it would not be a sensible use of NHS resources.


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