Tuesday, July 16, 2024

Cost Concerns: NICE Would Reject Sarclisa Even at Zero Cost, Says Sanofi

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Cost concerns have driven Sanofi to strongly criticize National Institute for Health and Care Excellence’s (NICE) decision not to recommend the use of Sarclisa as part of a treatment regimen for relapsed and refractory multiple myeloma (RRMM) within the NHS. The pharmaceutical company claims that NICE would not consider the drug cost-effective “even if [it] had been offered at zero price.”

Today, NICE published its final draft guidance, which concluded that the combination of Sarclisa with Bristol-Myers Squibb/Celgene’s Imnovid (pomalidomide) and dexamethasone is not cost-effective for treating RRMM in adults who have previously been treated with lenalidomide and a proteasome inhibitor, and whose disease has progressed following their last treatment.

Cost Concerns Drive Sanofi to Appeal NICE Decision on Isa-Pd Regimen Access

Sanofi has announced its intention to appeal the decision, highlighting the disparity in access to the Isa-Pd regimen, which will continue to be available in Scotland and Northern Ireland. The company argues that NICE lacks a suitable pricing and reimbursement framework for assessing combination therapies.

Since 2020, Sarclisa has been available for this indication under the Cancer Drugs Fund (CDF) for patients who have undergone at least three prior lines of treatment. According to Sanofi, it has become the standard of care for eligible patients in England and Wales, with more than 1,700 patients in England alone treated with the drug since its availability.

The CDF allows temporary funding for drugs while further evidence of their efficacy and cost-effectiveness is gathered. Isa-Pd will continue to receive funding from the CDF while the appraisal process and any appeals are ongoing.

Shelagh McKinlay, director of research and advocacy at the patient organization Myeloma UK, expressed her disappointment, stating that the decision is “a huge blow” to patients, many of whom will feel “like the rug has been pulled from under their feet.” She also suggested that the decision sets a concerning precedent that could affect patients with multiple myeloma and other conditions.


Cost Implications Lead to Appeal as Myeloma UK Fights for Isa-Pd Approval Nationwide

“We simply should not be here; where a vital and effective treatment option, which has been a standard of care for years, cannot be approved,” McKinlay continued. “Myeloma UK has been involved in every committee meeting about Isa-Pd and we believe this decision is disappointing. We will be submitting an appeal, and we won’t rest until Isa-Pd is available to everyone who needs it, no matter where they live.”

Multiple myeloma is a progressive and incurable cancer of the blood plasma cells, affecting around 24,000 individuals in the UK at any one time, with approximately 5,900 new cases diagnosed each year.

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Sarclisa was approved for this indication based on the ICARIA-MM study, which demonstrated that Isa-Pd nearly doubled progression-free survival compared to Pd alone, increasing from 6.5 months to 12.4 months. However, in its guidance, NICE stated that the evidence for the progression-free survival benefit is uncertain and that the cost-effectiveness estimates “are considerably higher than what NICE considers an acceptable use of NHS resources.”

“In our view, cancer patients in the UK are being let down by the current reimbursement system, which fails to recognize the benefits and full value of combination therapies for patients, carers, and families affected,” said Anju Bhalla, head of oncology and hematology at Sanofi in the UK. “In such a rapidly evolving and complex treatment landscape, we are open to working with NICE, as we believe it is time for urgent change,” she added.

This situation underscores the challenges faced by pharmaceutical companies and healthcare systems in balancing cost, effectiveness, and access to innovative treatments, particularly in the rapidly evolving field of oncology. The outcome of Sanofi’s appeal and any subsequent actions by NICE will be closely watched by stakeholders across the healthcare sector.


Resource: PharmaPhorum, June 20, 2024

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