UK's NICE isn't convinced by Merck's Keytruda in head and neck cancer
There may be 33 new cases of head and neck cancer in the United Kingdom each day, but the region’s cost-effectiveness watchdog NICE is not convinced by the data supporting Merck’s flagship immunotherapy Keytruda in the patient population.
On Wednesday the agency said it was not recommending Keytruda for patients with untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), citing uncertainty that the trial evidence supporting the drug does not reflect the current treatment paradigm in England’s NHS.
The approval for Keytruda in HNSCC patients was based on data from the KEYNOTE-048 study, which showed the checkpoint inhibitor improved overall survival compared to cetuximab (Erbitux), platinum chemotherapy (cisplatin or carboplatin) and 5-Fluorouracil (5-FU). The hazard ratio was 0.78 (p=0.0171) for PD-L1 positive patients in the monotherapy group and 0.77 (p=0.0067) for the entire combo cohort.
In the comparator arm, patients were given cetuximab with platinum chemotherapy and 5-FU regardless of whether the cancer started inside or outside the mouth — this is not established clinical practice in the NHS in England, NICE said.
(If the cancer starts inside the mouth, NHS England treats with cetuximab, platinum chemotherapy and 5-FU — if it starts outside the mouth, the cancer is initially treated with platinum chemotherapy and 5-FU).
NICE was looking for evidence of Keytruda’s impact stratified by patients whose cancer began outside the mouth and said that information about the clinical and cost-effectiveness for the two different patient groups (cancer starting inside or outside the mouth) was incomplete.
The drug secured EU approval for head and neck cancer last November. There are around 11,900 new head and neck cancer cases in the UK every year, that’s 33 every day, according to estimates compiled by Cancer Research UK between 2014-2016.
Keytruda is however recommended for a range of other cancers by NICE, on the basis that Merck agreed to a confidential discount on the blockbuster’s list price of £2,630 per 100 mg vial.
Separately, NICE also did not endorse Astellas Pharma’s cancer drug, Xospata, in patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia (AML).
Although the evidence suggests that Xospata can increase life expectancy by more than three months versus existing treatments, there is uncertainty around long-term survival, NICE said, adding that its cost-effectiveness estimates are also above the range the NHS considers acceptable.
The list price for Xospata is £14,188 for a 28-day pack — but a confidential discount is in place for the NHS. The drug scored EU approval in this patient population last October.
In addition, NICE did back AstraZeneca’s Lynparza in adults who have relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer with a BRCA1 or BRCA2 mutation.