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NICE Recommends Novartis' Piqray, Gilead's Trodelvy for Certain Breast Cancer Patients in England

NEW YORK – The National Institute for Health and Care Excellence (NICE) on Thursday said it has reached a pricing agreement with Novartis and Gilead, sponsors of Piqray (alpelisib) and Trodelvy (sacituzumab govitecan), respectively, which will allow the National Health Service to make these personalized breast cancer drugs available to patients in England.

In separate final draft guidances, NICE is recommending both drugs for biomarker-defined breast cancer populations. The institute is supporting the use of Piqray plus fulvestrant as a treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated locally advanced or metastatic breast cancer. Patients must have already progressed on hormonal therapy, an aromatase inhibitor, and a CDK4/6 inhibitor.

The group is also recommending Trodelvy for locally advanced or metastatic triple-negative breast cancer when it cannot be surgically resected. Patients must have had at least two prior lines of systemic treatment, one of them for metastatic disease.

"Both Piqray and Trodelvy are effective additional options that hold out the hope of a longer and a better quality of life for people with these types of advanced breast cancer," Helen Knight, interim director of medicines evaluation at NICE, said in a statement. "And both represent another step in delaying chemotherapy, allowing people to stay well for longer." NICE estimated that around 3,450 breast cancer patients will be eligible for these treatments through the NHS.

After reviewing the data for Piqray plus fulvestrant, NICE concluded that despite having less clinical evidence compared to other treatments available in this setting, such as Novartis' Afinitor (everolimus) plus exemestane, an independent appraisal committee concluded that the Piqray-fulvestrant regimen still met NICE's criteria as a life-extending treatment at the end of life and agreed to evaluate it against a higher cost-effectiveness threshold.

The list price of Piqray is £4,082.14 ($4,825.54) for a 56 pack of 150 mg tablets, bringing the average cost for a course with Piqray plus fulvestrant to £6,170.70 for the loading dose and £5,126.42 for the following cycles. However, Novartis is providing Piqray to NHS at an undisclosed discounted price.

The clinical evidence for Trodelvy, meanwhile, showed that compared to chemotherapy it extends the time before patients' disease progresses by three months and their life by five months. The list price for the drug is £793.00 for a 180 mg vial, but Gilead is also providing Trodelvy to NHS at a confidential discount.

With these two recommendations, NICE has issued positive decisions in all 15 of its appraisals of breast cancer medicines since March 2018, the institute highlighted.