Clovis' Rubraca, trailing PARP rivals, nabs England coverage thanks to NICE U-turn

Rubraca AstraZeneca
Clovis Oncology's Rubraca has won NICE backing under the Cancer Drugs Fund. (Clovis Oncology)

Already behind in the PARP inhibitor race, Clovis Oncology’s Rubraca has won a boost with reserved backing from England’s drug cost watchdog that helps level the playground in the U.K. region.

Rubraca will now be covered under the Cancer Drugs Fund (CDF) as a maintenance treatment to keep tumors from returning in women with relapsed ovarian, fallopian tube or peritoneal cancer that has responded to at least two rounds of platinum-based chemotherapy, the National Institute for Health and Care Excellence (NICE) said Friday.

The support comes after recommendations for the other two PARP inhibitors marketed in ovarian cancer, GlaxoSmtihKline’s Zejula for the same patient group and for AstraZeneca and Merck & Co.’s Lynparza in the limited BRCA-mutated population that has received one line of chemo. Both NICE backings are also through the CDF, which allows patients to apply for coverage before more clinical evidence supports a drug’s routine use on the NHS.

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NICE originally rejected Rubraca due to cost-effectiveness concerns. In the Ariel3 trial, Rubraca stalled tumor progression for a median 10.8 months, significantly longer than the 5.4 months in the placebo arm. However, how much longer people live after taking the Clovis drug is not known—at the original data cut-off, 88% of patients were alive.

With that gold-standard survival data still not available, Clovis did what almost every company has done to win over NICE: offer up a discount.

After slashing Rubraca’s price from its list tag of £3,562.00 ($4,510) per 60-tablet pack, NICE now deems the drug worthy of CDF coverage while Clovis collects further data. “If this revised commercial arrangement is supported with long-term overall survival data, [Rubraca] has the potential to be a cost-effective use of NHS resources,” the agency said. It is estimated that around 1,350 patients in England could benefit from this new decision.

RELATED: GSK and AZ-Merck's PARP drugs scored at ESMO. But where does that leave Clovis' Rubraca?

Now, small Clovis will need to go up against GSK and AstraZeneca in their home countries—and things are not looking in its favor right now.

All three drugs are eyeing the much larger first-line maintenance market. Lynparza already has that approval, but only in those who carry BRCA mutations. But at the recent European Society for Medical Oncology annual meeting, a pairing of Lynparza and Roche’s Avastin showed it could cut the risk of disease progression by 41% for all patients compared with Avastin alone.

GSK, touting its own data, showed Zejula alone could cut the risk of disease progression or death by 38% over placebo in the broad all-comer ovarian cancer population who’d responded to one round of chemo.

As for Rubraca, it won’t have front-line maintenance results until the phase 3 Athena study reads out in 2021. Industry watchers expressed concerns that the new Zejula and Lynparza data could spell trouble for Rubraca, which already lags in sales.

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