Ovarian Cancer Drug Niraparib (Zejula) Approved for CDF

Peter Russell

June 01, 2018

The drug niraparib (Zejula, Tesaro) has been approved for England's Cancer Drugs Fund (CDF) and for routine NHS use in Wales for women with a type of recurrent ovarian cancer

Niraparib is an innovative once-a-day maintenance treatment for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who respond well to platinum-based chemotherapy.

Final draft guidance by the National Institute for Health and Care Excellence (NICE) is that women in England should be eligible to receive the drug via the CDF if they have already had two or more courses of platinum-based chemotherapy.

Following the announcement, NHS Wales said that Welsh patients with ovarian cancer would be able to benefit from the treatment.

Ovarian cancer is one of the most common types of cancer in women. In 2015, 6198 women were diagnosed with the disease in England.

NICE said it had been informed by the manufacturer that 850 women in England and Wales could benefit from the treatment.

Patient Access Scheme

Meindert Boysen, director of the centre for health technology evaluation at NICE, said: "Clinical trial results showed that niraparib delayed cancer growth by around 6 to 15.5 months more than placebo, depending on a woman's genetic profile. However, the final results on overall survival were not available. Therefore, it was not clear whether niraparib increases the length of time people live."

The full ex-VAT cost for niraparib is £4500 for a 58-capsule pack of 100mg capsules or £6750 for an 84-capsule pack of 100mg capsules.

Long-term survival for women with ovarian cancer who take niraparib will be assessed while the manufacturer supplies the drug under a patient access scheme at a confidential discounted price.

If niraparib is found to increase the length of time people live, it may have the potential to be cost effective in two groups:

  • Patients with a germline BRCA mutation who have had 2 courses of platinum-based chemotherapy, or

  • People who do not have a germline BRCA mutation and have had 2 or more courses of platinum-based chemotherapy

The NICE decision was influenced by a patient expert who explained that relapsed ovarian, fallopian tube, or peritoneal cancer were devastating conditions with a poor prognosis requiring innovative treatments to extend and improve quality of life.

Niraparib is a PARP inhibitor that works by inhibiting two proteins involved in DNA repair in order to prevent cancer cells from repairing themselves.

A 'Game Changer': Cancer Charity

The decision has been welcomed by the charity Target Ovarian Cancer as a "game changer". Director of Public Affairs and Services, Rebecca Rennison, said: "While we have seen some new treatments in recent years, these have been for highly restricted groups. With niraparib, we're taking the fight to ovarian cancer. 

"We know that with the right investment in new treatments, more women can and will survive this disease. Today is a critical first step in making that a reality."

Welsh New Treatment Fund

The decision to approve niraparib for NHS use in Wales has been attributed to the new treatment fund which was set up in July 2017 to provide £16 million, or £80 million over the lifetime of the present government, to help health boards in Wales speed up access to medicines recommended by NICE and the All Wales Medicines Strategy Group (AWMSG).

The Welsh Health Secretary, Vaughan Gething, said: "This is another example of a new medicine becoming available to patients in Wales much more quickly, thanks to our £80m investment in the new treatment fund. Since its introduction more than 100 new medicines have been made available on the NHS Wales much more quickly than before."

A decision on niraparib is expected in Scotland later this year. If niraparib receives full NICE approval after spending time on the CDF, it will then be available to women in Northern Ireland.

Editor's note: This article was updated after publication to include the Welsh Government's decision.

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