Patient advocacy news // 4th June 2020
Patient advocacy news // 4th June 2020
The National Institute for Health and Care Excellence (NICE) has issued a draft “no” on the triplet combination of isatuximab, pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory myeloma.
This draft decision means that, as it stands, NICE will not recommend that this triplet combination be made routinely available on the NHS in England and Wales. This decision is now out for consultation.
Sarah McDonald Myeloma UK Director of Research said, “This draft “no” from NICE is obviously disappointing for myeloma patients in England and Wales.
“NICE listened to and agreed with our evidence that more new treatment options are needed in myeloma. They also agreed that this triplet does have benefits compared to current standard treatments; but they felt that uncertainties remain about just how much benefit it delivers.”
“This meant that, at the price currently set by the company, NICE do not believe it would be a cost effective use of NHS resources.”
“There is still the possibility of a positive decision being reached, although there are significant challenges to be overcome.”
“It is vital that the company, NICE and NHS England now do everything possible to deliver a positive outcome. We will submit more evidence and do all that we can to secure a “yes” for myeloma patients and their families and carers.”
Isatuximab, which is marketed by the pharmaceutical company Sanofi, is being appraised by NICE in combination with pomalidomide and dexamethasone. Sanofi’s proposal would see the treatment being made available to patients at their fourth line of treatment (third relapse). (NICE have now asked the company to submit further data on the treatment as a third line option. Myeloma UK will review this evidence when it is made available.)
Isatuximab belongs to a group of drugs known as monoclonal antibodies, which work in an innovative way by harnessing the body’s own immune system You can read more about isatuximab in our Horizons Infosheet.
What happens now?
NICE have issued the draft decision in an Appraisal Consultation Document (ACD) and will now ask questions that could turn the draft “no” into a final approval.
Myeloma UK will continue to work with clinicians, the company and with NICE and will respond to the consultation, making the case for isatuximab to be approved. Once NICE has gathered views from all stakeholders (deadline 25 June), it will meet again to consider its decision. The date for this meeting has not yet been decided.
Why did NICE issue a draft ‘no’ on isatuximab, pomalidomide and dexamethasone?
NICE have recognised the benefits which have been demonstrated for isatuximab in clinical trials. However, they feel that uncertainties remain over the level of benefit it delivers. It considered the Cancer Drugs Fund as a funding route, but this is dependent on additional data being collected to learn more about the treatment being collected. NICE are concerned that it will not be possible to gather enough data to address the uncertainties that exist.
As well as its clinical effectiveness, the price charged for a treatment is also a key factor in whether NICE finds a treatment to be an effective use of NHS resources. At the current price the treatment is not cost effective.
During the consultation period the company, clinicians and Myeloma UK will be able to submit further evidence to address NICE’s concerns. The company is also able to come forward with a revised discount scheme which can make the treatment more cost effective.
What does it mean that the treatment is being considered for use at “fourth line”?
When NICE consider whether to approve a treatment this involves considering at what point in the treatment pathway it should be used. All approvals for myeloma treatments state which patients are eligible to receive the treatment. There are various reasons for this including what patient population the treatment is licensed to treat and where the company decides it is most clinically and cost effective.
If the treatment is approved under the company’s current proposal it would be available only to patients at fourth line.
Is isatuximab likely to be approved on the NHS?
At the moment we cannot be certain what the outcome will be. It is positive that NICE recognise the clinical benefits that this triplet combination can deliver, but there is still work to be done to resolve the concerns NICE have about its cost effectiveness. We will continue to work with clinicians and with the company to make a case for its approval
Who does this decision affect?
The decision affects myeloma patients living in England and Wales.
The Scottish Medicines Consortium (SMC) has not yet assessed, isatuximab, pomalidomide and dexamethasone. In Northern Ireland, the Department of Health, Social Services and Public Safety, usually decide on whether to fund a new treatment following publication of the final NICE decision.
If you have any questions or comments on please email email@example.com or call the Myeloma Infoline on 0800 980 3332 during office hours, Monday to Friday.