Patients at second line to get 13 months’ remission thanks to first-of-its-kind treatment
A first-of-its-kind treatment that could give patients at second line remissions of over a year has been approved on the NHS in England and Wales.
A new type of treatment, SVD can stop myeloma in its tracks for 13 months on average.
It combines three drugs – selinexor (Nexpovio®), bortezomib (Velcade®), and dexamethasone – and is aimed at patients at second line, whose myeloma has become resistant to both daratumumab (Darzalex®) and lenalidomide (Revlimid®).
Based on the latest data from the BOSTON clinical trial, 76% of patients responded well to SVD and had an average remission of over 13 months.
This was around four months longer than patients on bortezomib and dexamethasone alone.
While the National Institute for Health and Care Excellence (NICE) approved the treatment at second line, its appraisal committee felt it could not accurately assess whether SVD would be cost-effective on the NHS at third line.
NICE is expected to review its decision on access at third line over the coming weeks, pending further data.
Shelagh McKinlay, Director of Research and Advocacy at Myeloma UK, said:
“This decision is not only welcome but a major step in the right direction for the myeloma community. We know that, over time, myeloma can become resistant to treatments so, until we have a cure, it is absolutely vital that all patients are given as many options to tackle their cancer as possible.
“While we’re delighted that NICE has recognised the clear benefits of SVD at second line, we can’t gloss over the fact that the patients who are at third line are being denied this option. Many people will no doubt feel ignored and unjustly left behind.
“But this is not a final no and we’re determined to work with NICE and the drug manufacturer behind SVD to make sure an agreement is reached, and that this pioneering treatment is available to all those who need it.
“Everyone affected by myeloma deserves to live a full life for as long as possible, no matter where they are on their treatment journey.”
Selinexor is a new type of drug known as a selective inhibitor of nuclear export (SINE). It tackles myeloma in a completely different way to currently approved drugs and provides an alternative for patients who have relapsed multiple times or do not respond to available treatments.
Selinexor stops a protein called Exportin 1 (XPO1) from working properly.
XPO1 is responsible for moving other proteins between different parts of the cell. Myeloma cells exploit XPO1 to get rid of proteins, called tumour suppressor proteins, which would stop them growing and multiplying.
By blocking XPO1, the tumour suppressor proteins build up within the myeloma cells, killing them.
Other important treatments for patients at third line and beyond will be making their way through NICE’s appraisal process over the coming months, including elranatamab and teclistamab.
Myeloma UK will work alongside the patient and clinical community to campaign and advocate for access to the next generation of myeloma drugs.
Does this decision affect patients based in Scotland and Northern Ireland?
In Scotland, the Scottish Medicines Consortium makes decisions about which treatments to fund through the NHS. It follows a similar decision process to NICE with the pharmaceutical company, clinical experts and patient experts submitting evidence. The evidence is then reviewed and assessed by the SMC committee. The SMC appraisal of SVD is expected to take place this year.
In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It can follow guidance issued by either NICE or the SMC but usually follows the guidance issued by NICE.
What happens next?
The recommendation from NICE is a draft decision based on the evidence the committee has received and heard during the appraisal so far.
After a draft decision is published, it is sent out for consultation and everyone involved in the appraisal, including Myeloma UK, has the chance to submit further evidence.
Myeloma UK will respond to the consultation and continue to work with clinicians, the pharmaceutical company and NICE to make the case for SVD to be approved at third line.
The committee will meet again to consider its decision and the additional evidence on 7 March.
Why was SVD approved at second line but not at third line?
The committee accepted that SVD is safe and effective for the treatment of myeloma patients who have had one or two previous treatments. It also agreed that the effectiveness and side effect profile for SVD was comparable to the treatments already used at second and third line.
However, for NICE to approve a treatment for use on the NHS it needs to be both clinically- and cost-effective. The pharmaceutical company needs to show that the price of treatment matches the benefit it delivers.
Based on the evidence presented SVD met the requirements for cost-effectiveness at second line but not third line. Therefore, the treatment could only be recommended for use at second line.
Why is there a difference in the cost-effectiveness at second and third line?
Cost-effectiveness is determined by comparing the cost and the effectiveness of the new treatment to the cost and effectiveness of standard treatment.
The cost of each treatment includes the cost of the drug and its administration. The treatments SVD is being compared to at second and third line are different and the cost of buying and delivering these treatments is different.
Effectiveness is calculated from clinical data based on how long people live after each treatment. The effectiveness of SVD at second and third line and the effectiveness of the comparator treatments are different.
These differences in the cost of standard treatments and the effectiveness of each treatment lead to a difference in cost-effectiveness.
When will SVD be available on the NHS?
When a treatment is recommended it should be made available to patients through the NHS within 90 days of the publication of the final decision.
The current recommendation issued by NICE is a draft decision, therefore the treatment will only become available when a final decision on the use at both second and third line has been made. The final decision will be issued after the second committee meeting in March.
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