NICE Recommends Once-a-day Oral Niraparib for Routine Use in the NHS

Pavankumar Kamat

February 25, 2022

The National Institute for Health and Care Excellence (NICE) has approved the routine use of once-a-day oral niraparib (Zejula; GSK) for the treatment of certain types of advanced high-grade epithelial ovarian, fallopian tube, and primary peritoneal cancers, a move that is likely to benefit over 400 patients.

In the draft guidance published on Thursday, oral niraparib has been recommended for the treatment of cancer patients harbouring the BRCA mutation and who have had two courses of platinum-based chemotherapy earlier. It is also recommended for patients without BRCA mutations but who have had two or more courses of platinum-based chemotherapy.

Niraparib was initially approved by the NICE to be available through the Cancer Drugs Fund (CDF) in January 2021. The drug will now advance from the CDF to routine commissioning, making it the 20th drug to do so. The decision is only applicable to niraparib as a second-line therapy, while it continues to be recommended within the CDF as a first-line maintenance treatment option for patients responding to initial platinum-based chemotherapy.

The recommendation for routine commissioning was made based on additional clinical evidence which showed that for people without a BRCA mutation, the median time to progression was more than 9 months with niraparib vs nearly 4 months with placebo. In individuals with a BRCA mutation, the time to progression was 20 months and 6 months with niraparib and placebo, respectively.

A Welcome Decision

Expressing delight at the recommendation, drugmaker GSK said in an official tweet: "We are pleased that today NICE has made a positive final appraisal determination. This news underlines our commitment to provide early access to innovations to address unmet patient need in oncology."

Jenniffer Prescott, programme director in the centre for health technology evaluation at NICE, said: "People with these forms of Fallopian, peritoneal and ovarian cancer have a poor prognosis and limited treatment options available to them, particularly if they do not have the BRCA mutation. Today’s recommendation provides hope that they can have a longer and an improved quality of life."

Prof Steve Powis, national medical director of the NHS, added: "This treatment is life-changing for women with advanced ovarian cancer, helping them to live longer and better lives by preventing or delaying the return of tumours after chemotherapy, and is just another example of how the NHS is delivering on our Long Term Plan commitment to provide patients with cutting-edge treatments for cancer."

Annwen Jones OBE, chief executive of Target Ovarian Cancer, UK’s leading ovarian cancer charity, commented: "This news will bring clarity and reassurance to many."

The NHS will purchase the drug under a commercial agreement with the manufacturer GSK. The list price is £4500 for a 58-capsule pack of 100 mg and £6750 for an 84-capsule pack of 100 mg.

The final guidance is expected to be published in March 2022.


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