Sanofi wins appeal in spat with NICE over Sarclisa

Sanofi has taken a small step towards potentially overturning a recent rejection by NICE for NHS use of Sarclisa as a treatment for relapsed and refractory multiple myeloma (RRMM).

The drugmaker has won an appeal against NICE's recent final draft guidance on Sarclisa (isatuximab) as a regimen alongside Bristol-Myers Squibb/Celgene's Imnovid (pomalidomide) and dexamethasone (Isa-Pd) for relapsed RRMM.

The decision created a disparity within the UK for the Isa-Pd regimen, making it unavailable for routine commissioning in England and Wales – although for now it can be accessed via the Cancer Drugs Fund – but covered via the NHS for patients in Scotland and Northern Ireland.

Sanofi launched an appeal against the decision shortly after the guidance was published, claiming that NICE would not have considered the drug cost-effective even if it provided it at no cost, claiming that the health technology assessment (HTA) agency "lacks a suitable pricing and reimbursement framework that is appropriate for assessing combination therapies."

The company has welcomed the outcome of its appeal, which means that a third committee meeting will now be held to discuss making the drug available in England and Wales via routine NHS commissioning.

In a statement, it said NICE's appeal committee upheld four points submitted by Sanofi, including that under HTA's standard methodology Isa-Pd cannot be deemed cost-effective, even if Sarclisa is provided at zero price.

The committee also recognised NICE's methods for evaluating medicines have changed in recent years, meaning Isa-Pd will be re-appraised for routine NHS commissioning against different criteria to which it entered the CDF in 2020, as an option for RRMM patients who have had at least three prior lines of treatment.

In a statement, the company said it 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 Isa-Pd.

News of the re-examination has also been applauded by patient organisation Myeloma UK, which has been supporting Sanofi in its appeal.

Director of research and advocacy, Shelagh McKinlay, said: "We have been fighting this decision for months and we are delighted to have won our appeal."

She added: "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."

Sarclisa was approved as part of the Isa-Pd regimen for RRMM on the back of the ICARIA-MM study, which found that it nearly doubled progression-free survival compared to Pd alone from 6.5 months to 12.4 months.

In its earlier guidance, NICE said the evidence for the PFS benefit is uncertain and cost-effectiveness estimates "are considerably higher than what NICE considers an acceptable use of NHS resources."