NICE gives draft approval to Thalidomide™ and Velcade™ as initial treatment options
Friday 4 June
The National Institute for Health and Clinical Excellence (NICE) has issued a draft approval for the use of Thalidomide Pharmion™ (thalidomide) and Velcade™ (bortezomib) combinations by newly-diagnosed myeloma patients.
After weighing up the evidence on benefits and costs, NICE has recommended that both Thalidomide and Velcade should be available as initial treatment options for myeloma patients for whom high-dose chemotherapy and stem cell transplantation is considered inappropriate.
The guidance recommends the use of either of these novel treatments in combination with an alkylating agent (a chemotherapy drug such as melphalan or cyclophosphamide) and a steroid (such as dexamethasone or prednisolone).
Many newly-diagnosed myeloma patients already commonly receive Thalidomide in this combination if they are not suitable for a stem cell transplant. Velcade has been less commonly used as an initial treatment in the UK to date, but doctors consider it offers an important alternative option to thalidomide for some patients.
The draft guidance is expected to be ratified within the next few months.
Eric Low, Myeloma Chief Executive, welcomed the decision:
"This is extremely good news for patients and their families. While Thalidomide combinations have been the standard of care in this setting for some time, it is very important that is this has now been endorsed by NICE.
In addition, having access to a Velcade combination in the initial treatment setting offers a very effective treatment option to those who are not suitable or are intolerant to thalidomide.
I applaud NICE for making these important recommendations which, when ratified, will make a significant contribution to improving both survival and quality of life for myeloma patients."
Q & A
What does the draft recommendation say?
The recommendation says that both Thalidomide and Velcade combinations should be available options for newly-diagnosed myeloma patients who are not considered suitable for high-dose chemotherapy and stem cell transplant.
The full text of the draft recommendation, including how NICE reached its decision, can be found here
What does a recommendation from NICE mean?
NICE makes recommendations on whether new treatments are good value for money for the NHS. It does this by considering the evidence from clinical studies, views from experts and the cost of the treatment compared to what treatments are already available on the NHS.
When NICE recommends a treatment NHS organisations must follow the guidance and make it available when the doctor wants to prescribe it. Without a recommendation from NICE, doctors must apply for funding for the treatment on a case by case basis.
What happens next?
These combinations are the subject of a NICE Multiple Technology Appraisal (MTA) which involves a fairly lengthy and indepth review of the treatments and the evidence for them. NICE has now completed its evidence review and made its draft recommendation, known as an Appraisal Consultation Document (ACD).
The ACD is now being consulted on and Myeloma UK has been invited to comment on the recommendations. After responses have been collected, there is a second stage at which point NICE will consider whether any changes are necessary. After this, a final recommendation, or Final Appraisal Document (FAD) will be produced. The MTA process should be completed within the next few months.
Does the recommendation from NICE affect all of the UK?
NICE is body that is responsible to the Department of Health in England. However, the recommendations from a Multiple Technology Appraisal (MTA) are usually applicable across the whole of the UK.
In Scotland, Thalidomide has already been reviewed and approved for use, in combination with the chemotherapy drug melphalan and the steroid prednisolone. An advisory body in Scotland will decide whether to accept the MTA recommendations on both Thalidomide and Velcade combinations for implementation in Scotland.
In Wales, Thalidomide was recently reviewed and approved as in Scotland. Velcade, in combination with melphalan and prednisolone was also recently approved for use on the NHS in Wales. The MTA will normally replace both of the previous recommendations produced in Wales.
Northern Ireland does not have its own treatment appraisal body. Instead, a local assessment will be undertaken to decide whether to apply the MTA in Northern Ireland.
Myeloma UK expects that the final recommendations of the MTA will be applied across the UK.
Where can I find out more?
You can find out more about Thalidomide and Velcade and how they work by downloading the Myeloma Infoguides here or ordering free copies from 0800 980 3332. For further information about the draft recommendation itself please contact Sarah Ritchie on 0131 557 3332 or sarahr@myeloma.org.uk
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