AbbVie's ovarian cancer drug Elahere gets NHS green light

AbbVie's antibody-drug conjugate (ADC) Elahere has become the first new NHS therapy in more than 20 years for resistant ovarian cancer, with hundreds of women every year expected to be eligible for treatment.

Final draft guidance from reimbursement authority NICE recommends Elahere (mirvetuximab soravtansine) for treating platinum-resistant ovarian cancer that expresses folate receptor-alpha (FRα) after one to three lines of systemic treatment.

That is a patient population that would usually be treated with other forms of chemotherapy, mainly pegylated liposomal doxorubicin and paclitaxel, which require frequent hospital visits and are associated with debilitating side effects, including extreme fatigue, hair loss, nausea and long-term nerve damage.

Elahere was approved by the US drugs regulator, the MHRA, last July, after the MIRASOL clinical trial showed that women treated with the ADC lived an average of 16.9 months, compared to 13 months with chemotherapy, and delayed cancer progression by six months, versus four in the control group.

As part of its evaluation process, NICE heard from women who described chemotherapy as putting their lives on hold, leading to isolation, inability to work, and heavy reliance on others for support.

One UK Elahere patient said the treatment helped "add life to years," enabling her to get on with life "rather than spending it in bed recovering from the side effects of chemotherapy."

NICE said it expects around 270 patients to be eligible for treatment with Elahere in the first year, rising to an estimated 420 in year three, as access to the FRα diagnostic test needed to confirm eligibility becomes more widely available.

"This is a hugely important moment for women with platinum-resistant ovarian cancer and their families, who have faced limited effective treatment options for far too long. Today's announcement offers real hope of improved quality of life," said Rachel Downing, head of policy and external affairs at Target Ovarian Cancer.

"This long-awaited breakthrough also shows how vital the patient voice is in decision-making," she added. "Target Ovarian Cancer worked closely with NICE throughout the process, presenting patients' stories and evidencing the real, first-hand impact that access to this treatment will have on those living with ovarian cancer now and in the future."

Ovarian cancer is one of the leading causes of death from gynaecological cancer worldwide, and approximately 35% to 40% of platinum-resistant ovarian cancers express FRα. In the UK, there are around 7,500 new diagnoses of ovarian cancer each year.

Last year, AbbVie said it may not be able to launch Elahere in the UK for use by NHS patients if negotiations with reimbursement authority NICE did not result in a reasonable price for the drug.

Since then, NICE has revised its appraisal criteria for new medicines, which include raising the standard cost-effectiveness threshold from £20,000-£30,000 to between £25,000-£35,000 per quality adjusted life year (QALY).

Elahere costs £4,950 per 100-mg vial ex VAT at list prices, but AbbVie has offered a confidential discount to the NHS in England.