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UK's NICE Does Not Recommend Verzenio for Advanced Breast Cancer in Draft Guidance

NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) issued a draft guidance on Friday stating that it does not recommend abemaciclib (Eli Lily's Verzenio) for patients with hormone receptor-positive, HER2-negative, advanced breast cancer.

Abemaciclib is currently available through the National Health Service's Cancer Drugs Fund (CDF) as an alternative to treatment with exemestane (Pfizer's Aromasin) plus chemotherapy. Drugs provided through the CDF are available for a period of time while the sponsors provide more evidence for NICE to appraise. Using that data, NICE issues a final decision as to whether a particular treatment should be made available through the NHS.

In May 2019, NICE issued a draft guidance allowing Eli Lilly to provide abemaciclib for HR-positive, HER2-negative advanced breast cancer patients through the CDF. The agency noted at the time that the cost-effectiveness estimates for the treatment were highly uncertain and that some clinical data were incomplete, including survival data. Abemaciclib was made available while Lilly collected the remaining data.

However, that additional data doesn't appear to have swayed NICE toward a positive recommendation. In an indirect comparison, NICE found that patients treated with abemaciclib plus chemo live longer without disease progression than those treated with exemestane and chemo. However, NICE also noted that patients may need higher dosages and longer treatment times to benefit from abemaciclib, which creates uncertainty about the cost-effectiveness of the treatment.

The estimated cost of treatment with abemaciclib is likely higher than its threshold for a cost-effective use of NHS resources, NICE said. The drug typically costs about $4,000 for a packet of 56 tablets (150mg), but Eli Lilly agreed to an undisclosed discount with the NHS.

NICE's draft guidance is open for public consultation until March 5. If the consultation does not change NICE's recommendation, abemaciclib will no longer be available through the CDF.

In 2018, the US Food and Drug Administration approved abemaciclib for this same indication based on data from the Phase III MONARCH 3 trial, which showed an improvement in progression-free survival for patients taking abemaciclib (28.2 months) compared to placebo (14.8 months).