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Increased discount leads NICE to reverse positon on Clovis cancer drug

Ovarian cancer drug Rubraca now recommended for use within the Cancer Drugs Fund


The National Institute for Health and Care Excellence (NICE) has recommended Clovis Oncology’s ovarian cancer drug Rubraca for use within the Cancer Drugs Fund (CDF).

NICE’s final appraisal document overturns the position it reached originally. In draft guidance shared for consultation earlier this year, NICE found Rubraca ‘does not have the plausible potential to be cost-effective’ and as such failed to meet the criteria needed for inclusion in CDF.

Months later, NICE has concluded that Rubraca ‘has the potential to be cost-effective if further data confirms the estimated overall-survival benefit’. The need for confirmatory data means Rubraca is not recommended for routine use but is permitted for inclusion in the CDF.

NICE’s U-turn follows Clovis’ decision to provide Rubraca to the NHS at ‘a higher discount’. The extent of the discount to the list price of £3,562 per 60-tablet pack is confidential but NICE has shared details of how the quality-adjusted life year (QALY) calculations changed after Clovis’ offer.

QALY figures quoted in the draft appraisal ranged from £36,387 to £42,175. Following the discount, the QALY figures came in between £29,138 and £32,455, putting Rubraca around the upper limit of what NICE considers a cost-effective use of NHS resources.

The change led NICE to recommend the inclusion of Rubraca in the CDF as an option for maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that responded to platinum-based chemotherapy.

Clovis won European approval for Rubraca in that indication at the start of the year, making the drug the first PARP inhibitor cleared for use in ovarian cancer patients as a treatment and maintenance therapy in the region. Rubraca was also the first PARP inhibitor authorised to treat ovarian cancer in Europe.

Despite that first mover advantage, Clovis has struggled to turn Rubraca into a big product in the face of competition from AstraZeneca and Merck’s Lynparza. Over the first half of 2019, Lynparza sales were $520m (£418m), as compared to $66m for Rubraca.

The NICE decision gives Clovis another avenue for sales growth, although the size of the CDF, which spreads a £340m budget across tens of drugs, means it is unlikely to have a major near-term impact. In the longer term, the decision could unlock more sales of Rubraca by leading to the data needed to support routine use of the therapy.

Article by
Nick Taylor

14th October 2019

From: Research



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