Sanofi wins appeal against negative Final Draft Guidance for its standard-of-care multiple myeloma combination therapy opening the door for a third NICE Committee Meeting

• Sanofi welcomes the decision as recognition from the National Institute for Health and Care Excellence (NICE) that there are challenges with the current framework for assessing and funding innovative combination therapies and there is a need for greater flexibility in certain situations
• As part of this extended evaluation process, Sanofi are calling for increased flexibility so that eligible new patients do not lose an important combination treatment for their relapsed and refractory multiple myeloma (RRMM) in the future
• Sanofi is committed to engaging further with NICE, NHS England, healthcare professionals, patients groups and other involved stakeholders to explore all options for ensuring the continued availability of isatuximab (SARCLISA ) plus pomalidomide and dexamethasone (Isa-Pd)
• Isa-Pd will continue to be available to newly eligible and existing patients in England and Wales through the Cancer Drugs Fund (CDF) whilst the appraisal process is still ongoing and until NICE publishes its Final Guidance

Reading, UK – 12 November 2024. Sanofi announced today that NICE has confirmed a third Committee Meeting to re-assess Isa-Pd at fourth-line, a subgroup of the population within the marketing authorisation, for treating RRMM in adults who have had lenalidomide and a proteasome inhibitor, and whose disease has progressed on their last treatment. NICE’s decision follows a successful appeal of the negative Final Draft Guidance published in June this year. The appeal committee upheld four points submitted by Sanofi, including the fact that under NICE’s standard methodology Isa-Pd cannot be deemed cost effective even if isatuximab is provided to the NHS at zero price (£0).1 The committee also recognised NICE’s methods for evaluating medicines have changed in recent years, meaning Isa-Pd is being re-appraised for routine NHS commissioning against different criteria to which it entered the CDF.

Isa-Pd will continue to be available to eligible new patients who might benefit in England and Wales through the CDF, as well as those currently on this therapy whilst NICE’s evaluation is still ongoing and until Final Guidance is published. The combination is available to all eligible patients in Scotland. 

Isa-Pd has become a standard-of-care for eligible patients in England and Wales through its availability on the CDF, with over 1,700 patients registered to have started Isa-Pd treatment in England. As a relapsing cancer, access to multiple lines of treatment is vital to delay progression for as long as possible.

Anju Bhalla

Head of Oncology and Haematology, Sanofi UK and Ireland

"We are encouraged by NICE’s decision to uphold our appeal, which will be welcomed by clinicians, patient groups and patients for whom the potential loss of a multiple myeloma treatment will be devastating. We are committed to maintaining access to Isa-Pd as an important fourth line option for RRMM patients who have limited alternatives at this later stage of their cancer and will work collaboratively with all involved stakeholders to find a solution. This appraisal has been protracted and complex for several reasons, but we remain hopeful of a positive outcome at the third time of sitting around the table together.”

Discussions haven’t reached a conclusion for Isa-Pd to date, highlighting the challenges with the current NICE framework for assessing and funding innovative combination therapies, which is struggling to potentially keep up with the pace of innovation. The consequence is negative recommendations that may not recognise the full value and benefits of combination therapies for patients. 

Shelagh McKinlay

Director of Research and Advocacy, Myeloma UK

“We have been fighting this decision for months and we are delighted to have won our appeal. The appeal panel felt, as do we, that the reimbursement of Isa-Pd requires further consideration and that NICE should have considered showing more flexibility in light of what were unique and unprecedented circumstances. We’re urging them to reconsider their decision and make this treatment available on the NHS as soon as possible. In practice, the new system has made it much harder to get treatments to patients who are nearing the end of their life. We will continue to make the case for Isa-Pd to be made available to those who need it. Every day counts when you’re living with myeloma because only one thing is certain: myeloma will always come back. This means patients need effective treatments now.”

England has fallen below comparable European countries when it comes to accessing cancer medicines and cancer survival rates in the UK are lagging as much as 25 years behind other parts of Europe. In terms of access to licensed and effective combination therapies, cancer patients in England and Wales are missing out compared to their European counterparts.

Sanofi is grateful for the strong support from the clinical and patient community throughout this process and remains hopeful a way forward can be found.