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NICE Recommends Against Piqray Combo for PIK3CA-Mutated Metastatic Breast Cancer

NEW YORK – The UK's National Institute for Health and Care Excellence on Thursday advised the National Health Service in England to not provide Novartis' Piqray (alpelisib) with fulvestrant to post-menopausal women and men with a certain type of advanced breast cancer.

In the draft guidance, NICE reviewed data on the activity of Piqray with fulvestrant in hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated breast cancer after it has spread to other parts of the body while patients were on hormonal therapy. In its review documents, NICE said that it reviewed data from the SOLAR-1 and BYLieve trial, though only the latter was generalizable to the UK population. Based on data from the SOLAR-1 trial, meanwhile, the FDA approved this same indication for Piqray-fulvestrant in 2019.

Even though indirect comparisons suggested that Piqray-based treatment may be more effective than Novartis' Afinitor (everolimus) with exemestane, which is currently the only option for NHS patients at this stage, the committee said it saw no direct evidence in favor of the Piqray-based regimen when comparing it against this standard treatment.

"The limitations in the clinical evidence mean the cost-effectiveness of alpelisib is also very uncertain," NICE said in a statement, adding that compared to the cost-effectiveness of current treatments, costs for alpelisib-fulvestrant were higher than what NICE considers "a good use of NHS resources."

Novartis' list price is £4,082.14 ($5,365.18) per 56-pack of 150 mg Piqray tablets. The average cost of a course of Piqray-fulvestrant combination treatment has a list price is £6,170.70 for the loading dose and £5,126.42 for subsequent cycles.

Up to 40 percent of patients with estrogen receptor-positive, HER2-negative breast cancer harbor PIK3CA mutations. Approximately 600 people in England would currently be eligible for this treatment.

The public can comment on NICE's draft recommendation until April 21.