New treatments for myeloma continue to come through the appraisal pipeline. In the last few months, there have been several new treatment approvals from both the National Institute for Healthcare Excellence (NICE) and the Scottish Medicines Consortium (SMC), which is excellent news for patients.
Hopefully, there will be more good news for patients throughout 2021 as the access pipeline shows no sign of slowing down.
Daratumumab (Darzalex®), bortezomib (Velcade®), thalidomide and dexamethasone induction treatment
The quadruplet combination of daratumumab, bortezomib, thalidomide and dexamethasone is currently being appraised by NICE as induction treatment for newly diagnosed myeloma patients who are eligible for high-dose therapy and stem cell transplantation (HDT-SCT).
Myeloma UK have been taking part in this appraisal as it proceeds through the NICE process and have submitted evidence on behalf of patients. The committee meeting will take place in May 2021 with a decision expected up to six weeks later.
This treatment was approved for use in Scotland by the SMC in January 2021. This is the first quadruplet combination treatment for myeloma patients approved anywhere in the UK.
Lenalidomide (Revlimid®) maintenance
Lenalidomide maintenance was approved for the treatment of newly diagnosed myeloma patients who are eligible for HDT-SCT by NICE in February 2021 and by the SMC in October 2020.
The eligibility criteria for the starting time of maintenance treatment post HDT-SCT is flexible. Please refer to the guidance issued by the UK Myeloma Forum (UKMF) for patients eligibility.
We are delighted that this has been made available to patients across the UK. This is the first maintenance treatment approved for myeloma and it delivers an exceptional clinical benefit for patients. This was a long journey, and you can read about Myeloma UK’s involvement in this appraisal in our blog.
Carfilzomib (Kryprolis®), lenalidomide (Revlimid®) and dexamethasone
The combination of carfilzomib, lenalidomide and dexamethasone has just been approved by NICE on Friday 19 March 2021 for patients at second line who have been previously treated with bortezomib.
This is the first triplet combination therapy approved for routine commissioning at the second line of treatment.
This follows a positive recommendation for use through NHS Scotland, made by the SMC in October 2020. This treatment is now available to patients across the UK.
Isatuximab (Sarclisa®), pomalidomide (Imnovid®) and dexamethasone.
The combination of isatuximab, pomalidomide and dexamethasone is for myeloma patients who have received at least three previous lines of treatment including lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib (Ninlaro®)).
This combination was approved by NICE in October 2020 through the Cancer Drugs Fund (CDF) for patients based in England and Wales.
The treatment is currently being considered by the SMC for patients based in Scotland. Myeloma UK have taken part in this HTA process and attended the SMC committee meeting in March 2021. We are expecting a decision on the SMC’s recommendation at the beginning of April 2021.
Ixazomib (Ninlaro®), lenalidomide (Revlimid®) and dexamethasone
The combination of ixazomib, lenalidomide and dexamethasone will be re-appraised in 2021.
The combination was recommended by NICE through the Cancer Drugs Fund (CDF) in 2018 for patients who had received two or three lines of treatment.
The CDF is a pot of money that enables NICE to conditionally approve promising treatments for up to two years while more data is collected about the treatment’s clinical effectiveness and value. At the end of this period, NICE reconsider the treatment and make a final decision on whether the treatment will be made routinely available through the NHS.
Myeloma UK are taking part in this re-appraisal and will submit evidence on behalf of patients in April 2021. The NICE committee meeting is scheduled for July 2021.
Ciltacabtagene autoleucel (Cilta-Cel) CAR-T Therapy
This CAR-T Therapy is currently being considered by NICE for patients who have received three or more lines of treatment or are double-refractory to an immunomodulatory drug and a proteasome inhibitor.
Myeloma UK will submit evidence for this appraisal in May 2021 with the NICE committee meeting scheduled to take place in November 2021. The final positioning for this treatment will be determined through the HTA process.
Melphalan flufenamide (Melflufen®) with dexamethasone
The combination of melphalan flufenanmide and dexamethasone is being considered by NICE for patients who have received two-four lines of treatment. The final positioning shall be determined through the HTA process.
Myeloma UK have submitted a scoping response and this appraisal will continue into 2022.
The active HTA schedule is a welcome sign of the continuing advances in treatment in myeloma. We will continue to work with patients, their families and carers, and with clinicians to make the case for the approval of effective new myeloma treatments. We will also continue to update patients and healthcare professionals on the progress of these HTAs.
More treatments are coming through the HTA pipeline which have still to be scheduled by NICE. Some of these treatments can be accessed through expanded access programmes run by the manufacturer.
If you would like more information on HTA processes, any of the new treatments, or expanded access programmes get in touch with the Patient Advocacy Team.