NICE changes stance on Genmab's cervical cancer drug

Two months after saying it couldn't recommend Genmab's cervical cancer therapy Tivdak for use by the NHS, reimbursement authority NICE has had a change of heart.

In final draft guidance (PDF), NICE has backed the commissioning of Tivdak (tisotumab vedotin) as a monotherapy for adults with recurrent or metastatic cervical cancer whose disease has progressed despite earlier systemic therapy.

Tivdak was approved by the MHRA in December as an alternative to chemotherapy in these patients, who have few treatment options, but NICE said in March it had concerns about the economic model Genmab put forward to make the case for the drug and was unable to decide whether it would be a cost-effective use of NHS resources.

Now, those concerns have been largely laid to rest thanks to changes to the economic model, drawing on the findings of the innovaTV 301 trial that supported Tvdak's approval, as well as real-world evidence collected from a group of patients who were followed up for five years, and updated cost data for alternative therapies.

"Despite real progress in prevention and early detection, women with metastatic or recurrent cervical cancer still face poor outcomes and limited options beyond chemotherapy. While early-stage care has improved, there remains an urgent need for women whose cancer returns or spreads," said Prof Susana Banerjee of The Royal Marsden NHS Foundation Trust, who was the UK lead for innovaTV 301.

She added that Tivdak, a tissue factor-targeting antibody-drug conjugate, "may offer clinically meaningful improvement in survival outcomes for some patients in this hard-to-treat setting."

In innovaTV 301, median overall survival (OS) was 11.5 months with Tivdak compared with 9.5 months in a chemotherapy control arm, equivalent to an approximately 30% reduction in the risk for death.

It is estimated that 3,300 women are diagnosed with cervical cancer in the UK every year, with approximately 900 women dying from the disease. Among those who respond to initial treatment, recurrence occurs in up to 30% of cases.

The Cancer Drugs Fund (CDF) will provide initial coverage of Tivdak ahead of routine NHS commissioning, and Genmab UK's general manager, Matt Kiely, said: "We look forward to working with the NHS, clinicians and patient groups to support timely access and smooth implementation."

Tivdak is an important product for Genmab because it is the first launched by the company independently of commercial partners, although sales in the US are handled by Pfizer and in China by Zai Lab.

Genmab takes the lead commercially in all other markets and reported revenues of $39 million from the product in the first quarter of the year, ahead of a broad rollout in Europe. Analysts have previously suggested it could eventually bring in $600 million in peak global sales.

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