Patients in Scotland granted earlier access to oral treatment for multiple myeloma, an incurable form of blood cancer

Advice published by the Scottish Medicines Consortium (SMC) today recommends lenalidomide, in combination with dexamethasone, for restricted use within NHS Scotland for the treatment of multiple myeloma in adult patients who have received one prior therapy.

Although the SMC had previously accepted lenalidomide for use in patients who had received at least two prior lines of therapy¹, the new guidance extends the use of the treatment to patients at first relapse who have received bortezomib as their one prior therapy in whom thalidomide has not been tolerated or is contraindicated.

The update brings the advice in line with the Marketing Authorisation from the European Medicines Agency² and means that this group of patients now have earlier access to a medicine that already represents a significant advance in the treatment of myeloma, an incurable form of blood cancer³.

Referring to the recommendation, Dr Paul Micallef-Eynaud, Consultant Haematologist at NHS Ayrshire and Arran, said “Even though there is currently no cure for multiple myeloma, treatment can be very effective at controlling symptoms and preventing the progression of the disease for several years.  However, while remission is generally achieved for an extended period of time during and after treatment, the cancer returns in the majority of cases and further treatment is required.  Consequently, it is important that effective treatment options continue to be made available at all stages of the disease so that clinicians can help patients maintain ongoing control of their condition.”

Multiple myeloma is the second most common type of blood cancer⁴ and there are approximately 380 new cases per year in Scotland, equating to a crude incidence rate of 7.3 per 100,000⁵.

The disease causes plasma cells in the blood to replicate uncontrollably and accumulate in the bone marrow, which disrupts the normal production of blood cells.  Myeloma can affect multiple locations in the body where bone marrow is present and often causes bone pain, bone fractures, fatigue, anaemia, infection, hypercalcaemia and kidney damage^6.

“Being told that your myeloma has stopped responding to treatment or has relapsed can be very disappointing and distressing for myeloma patients and their families” said Eric Low, Chief Executive of the charity Myeloma UK. 

“We therefore welcome today’s decision from the SMC as it will provide access to another effective treatment for myeloma patients in Scotland who have failed or relapsed from their initial treatment.”

The SMC’s advice was based on the results of two phase III studies (MM-009 and MM-010) involving a total of 704 patients with relapsed and refractory multiple myeloma, in which lenalidomide or placebo were administered in combination with dexamethasone.  

The primary measure of effectiveness was how long it took until the disease progressed (assessed as median time to progression [TTP]) with a median follow-up duration of 130.7 weeks.

The results of the pooled studies showed that lenalidomide taken with dexamethasone was more effective than placebo/dexamethasone at extending the TTP (median TTP 60.1 weeks vs. 20.1 weeks respectively, p<1.001).

In England, the National Institute for Health and Care Excellence (NICE) is currently reviewing lenalidomide in adult patients with multiple myeloma at first relapse who have received bortezomib as their one prior therapy.

Celgene is working closely with NICE and is optimistic that positive guidance will be issued in the near future.

At this time, lenalidomide is available to patients in this setting in England through the Cancer Drugs Fund⁷. 

References

1.      Scottish Medicines Consortium. Revlimid® (lenalidomide) advice. Available here

2.      Revlimid Summary of Product Characteristics. Available here

3.      Myeloma UK. Revlimid and myeloma Infoguide. Available here

4.      EMedicineHealth. Myeloma Overview. Available here

5.      Cancer Research UK. Myeloma incidence statistics. Available here

6.      Myeloma UK. Myeloma – an introduction. Available here

7.     NHS England. National Cancer Drugs Fund List (updated 13 February 2014). Available here

Source: Scottish Medicines Consortium