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NICE approval of bortezomib
The National Institute for Health and Care Excellence (NICE) appraises drugs and health technologies and develops guidance on the use of new and existing medicines. It decides what treatments should be available to patients via the NHS in England and Wales.
NICE published a Final Appraisal Determination recommending bortezomib, marketed by Janssen as Velcade®, for the treatment of mantle cell lymphoma last month but the outcome was subject to appeal. The decision to make the blood cancer drug available to NHS patients in England and Wales has now been confirmed, which means that patients with previously untreated mantle cell lymphoma should soon have access to this effective drug.
Mantle cell lymphoma (MCL) is a rare form of non-Hodgkin lymphoma (NHL). It affects around 510 people in the UK each year, about 5% of all lymphoma patients. It is a rare, high grade form of NHL that develops quickly and, if not treated, grows quickly.
Following the appraisal, NICE specifically recommends bortezomib in “combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VR-CAP) in adult patients with previously untreated mantle cell lymphoma” and “for whom haematopoietic stem cell transplantation is unsuitable”. The decision follows a clinical study which showed that when treated with bortezomib (in combination with VR-CAP) progression-free survival improved for adults with previously untreated mantle cell lymphoma compared to its existing treatment options.
SMC approval of lenalidomide
The Scottish Medicines Consortium (SMC) is responsible for appraising technologies for use within NHS Scotland. The SMC reviews the value of each new medicine to determine its benefits and costs.
It has been announced this week that the SMC has approved the restricted use of lenalidomide for multiple myeloma for routine use by NHS Scotland. It recommends lenalidomide, marketed by Celgene as Revlimid®, in combination with dexamethasone to treat previously untreated multiple myeloma patients “who are not eligible for stem cell transplant and not suitable for treatment with thalidomide”.
Multiple myeloma is a cancer which affects the plasma cells (a type of white blood cell which is made in the bone marrow). Normally, new plasma cells are created which produce antibodies to help fight infection. In myeloma, the process gets out of control and abnormal amounts of plasma cells are produced releasing only one type of antibody – known as paraprotein – which has no useful function and can’t fight infection effectively. There are around 398 new cases of myeloma in Scotland each year.
According to the SMC, the drug appraisal process highlighted lenalidomide’s “potential to improve length of life and increase patients’ ability to do normal daily activities with their families”. Although the overall survival data is not yet mature, the phase III study indicates that there is a significant increase in survival for patients receiving lenalidomide in combination with dexamethasone compared to the existing comparator treatment option - melphalan, prednisolone plus thalidomide.
Zack Pemberton-Whiteley, Head of Campaigns and Advocacy at Leukaemia CARE, has commented:
“These recent decisions by The National Institute for Health and Care Excellence (NICE)and the Scottish Medicines Consortium (SMC) are excellent news in terms of improved access to blood cancer treatments for patients in the UK.
Bortezomib is currently already available in Scotland (as recommended by the SMC) and Wales (The All Wales Medicines Strategy Group (AWMSG) so it is positive to see that it will also be available to NHS patients in England soon. As a patient organisation, it is important to us that access to blood cancer treatment is not dependent on where in the UK you live.
The approval of lenalidomide by the SMC is welcome as there are few effective treatment options for patients who are unable to receive existing routine therapies. It is also hoped that lenalidomide will soon be appraised by NICE and the AWMSG so that patients in England and Wales are also able to access the drug in this setting.”
If you could be affected by any of these changes and would like to speak to somebody, please call our CARE line on 08088 010 444.