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NICE seeks more data on Merck & Co.'s Keytruda; Astellas' cancer drug rejected

U.K.'s drug pricing watchdog released draft guidance on two cancer medicines, neither of which were recommended — one due to lack of data and the other because of cost-effectiveness.

The U.K.'s National Institute for Health and Care Excellence did not recommend Merck & Co. Inc.'s Keytruda as a treatment for head and neck cancer, asking that the company provide additional clinical and cost-effectiveness data.

Keytruda, or pembrolizumab, was approved in the EU in November 2019 as a standalone initial treatment for patients with head and neck squamous cell carcinoma, or HNSCC, whose cancer has spread to other parts and whose tumors express the PD-L1 protein. In addition, Keytruda was also approved to be used in combination with a chemotherapy regimen of platinum and fluorouracil in HNSCC patients regardless of PD-L1 expression. The current standard of care has been a combination of cetuximab — marketed by Eli Lilly and Co. as Erbitux — and chemotherapy.

The drug pricing watchdog said data shared by Merck did not reflect the current practice in the National Health Service, or NHS, under which treatment is determined based on where the cancer originates — either inside the mouth or outside.

NICE said that because Merck's data did not differentiate between the origin of cancer, it could not recommend Keytruda in the indication at this stage. NICE has asked Merck to provide data for people whose cancer started outside the mouth, among other things.

Meanwhile, NICE said it would not recommend Astellas Pharma Inc.'s blood cancer medicine Xospata because it was uncertain it could help patients survive over the long term.

So far, evidence suggests that the therapy helps adult patients live three months longer than existing treatments when used to treat acute myeloid leukemia with the FLT3 mutation which has either returned or is unresponsive to other medicines.

Because Xospata, or gilteritinib, is an oral medicine, it could improve patients' quality of life by enabling them to avoid chemotherapy, but its cost-effectiveness estimates were above what NICE considers acceptable, the agency said.

Xospata was approved in the EU in October 2019 to treat the aggressive form of blood cancer.

NICE said its draft guidance on Xospata was open for public consultation until Feb. 5.