NEW YORK – The National Institute for Health and Care Excellence (NICE) on Friday recommended Eli Lilly's Verzenio (abemaciclib) be available to certain breast cancer patients in England following surgery.
In a final draft guidance, NICE recommended Verzenio combined with hormone therapy for patients with hormone receptor-positive, HER2-negative, node-positive early-stage breast cancer who are at a high risk of recurrence following surgical tumor resection.
The recommendation is based on results from cohort 1 of the Phase III monarchE clinical trial, in which Verzenio plus hormone therapy versus hormone therapy alone resulted in a 30 percent improvement in invasive disease-free survival rates.
Although overall survival results are not yet available from the ongoing trial, NICE recognized in its recommendation that overall survival readouts from adjuvant therapy trials for early-stage cancers can take nearly a decade, and that there are currently no other targeted treatment options for this high-risk patient population.
In the US, Verzenio plus hormone therapy has the US Food and Drug Administration's approval for early-stage breast cancer patients with node-positive disease who are at a high risk of recurrence based on a Ki-67 score of at least 20 percent.
Unlike the FDA, NICE's recommendation does not include Ki-67 — a marker for cellular proliferation signaling tumor aggressiveness — as a method of determining high-risk patients. This is because NHS patients aren't routinely tested for this biomarker. Accordingly, NICE recommended determining whether patients are at high recurrence risk using clinical and pathological factors such as the number of positive lymph nodes, large tumor size, or high cellular proliferation measured by tumor grade or other biomarkers.
NICE said Verzenio's cost falls within the range of what it considers an acceptable use of NHS resources. Verzenio costs £2,950 ($3,610) for a packet of 56 150 mg-tablets, but Eli Lilly has agreed to offer the drug to the NHS at an undisclosed discount.
NICE estimates that around 4,000 people will be eligible for this drug, which has provisional approval within NHS England.