NICE Draft Guidance Rejects Merck's Keytruda for Metastatic Triple-Negative Breast Cancer
MSD
Pharmaceutical R&D and Manufacturer
NICE
NICE is a non-departmental public body of the UK Department of Health, primarily responsible for: National Health Service, clinical practice of health technologies, guidelines for health promotion and disease prevention, and social care services. It serves the UK NHS.
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Recently, the National Institute for Health and Care Excellence (NICE) in the UK released a draft guideline rejecting the approval of MSD's anti-PD-1 therapy Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC).
In the draft guidelines, the agency said that while the Keytruda + chemotherapy combination is more effective than chemotherapy alone, its long-term benefits remain uncertain. Additionally, there is no comparative data available between the Keytruda + chemotherapy combination and Roche's anti-PD-L1 therapy Tecentriq (atezolizumab) + chemotherapy combination. The latter was recommended by NICE for use in the UK National Health Service (NHS) in May 2020 to treat patients with mTNBC.
NICE said that for Keytruda, "its cost-effectiveness estimate is higher than the standard generally considered acceptable for NHS resources." But unusually, the agency wants to see more information from MSD about the comparison between Keytruda + chemotherapy and Tecentriq + chemotherapy.
Previously, Roche's Tecentriq had also been rejected in the draft guidelines by NICE. However, after Roche agreed to offer a confidential discount on the pricing of Tecentriq, NICE eventually approved the drug for the treatment of mTNBC.
TNBC is an extremely aggressive breast cancer with a lack of effective therapeutic targets, leaving almost no other treatment options besides surgery, radiotherapy, and chemotherapy. TNBC tumors lack the expression of estrogen, progesterone, and HER2 receptors, making them unsuitable for treatment with drugs targeting these biomarkers.
MSD said in a statement that it was disappointed with the draft guidance from NICE, but the company will work with NICE to try to find a way for patients to access Keytruda. It is estimated that if approved, the Keytruda + chemotherapy regimen would provide a treatment option for approximately 600 patients with mTNBC in the UK.
Reference Source: NICE Says No to Keytruda in Triple-Negative Breast Cancer
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