Oncologists Show Interest in Prescribing New CML STAMP Inhibitor Scemblix

The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). Oncologists showed much more interest in the agent than did payers when Zitter Insights surveyed both stakeholder groups.

On Oct. 29, the FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of CML in two indications: (1) adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors (TKIs), which was given accelerated approval, and (2) adults with PH+ CML-CP with the T315I mutation, which was granted full approval. It is the first FDA approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor.

The FDA gave the application priority review, as well as breakthrough therapy, fast track and orphan drug designations. Recommended dosing for the first indication of the tablet is 80 mg once daily or 40 mg twice daily; for the second, it’s 200 mg twice daily.

For the Managed Care Oncology Index: Q2 2021, between May 18, 2021, and July 19, 2021, Zitter Insights polled 41 commercial payers with 128.1 million covered lives and 108 oncologists. Payers covering 36% of lives said they were moderately or extremely aware of Scemblix, compared with 51% of oncologists with the same response. In addition, payers with 56% of lives said they had moderate interest in the therapy upon approval and launch, while 58% of oncologists said they had high or very high interest in it. Reasons for oncologists’ interest included the drug’s good efficacy, its new innovative mechanism of action and clinical trials demonstrating safety and effectiveness.

Zitter Insights and AIS Health are both MMIT companies.

Payers representing 82% of covered lives said they expected managing Scemblix to label within six months of its approval, while those with 10% of lives said they anticipated managing the drug more restrictively than its FDA-approved label based on its full body of clinical evidence and expert opinions, as well as clinical trial inclusion/exclusion criteria.

In addition, payers that cover almost 60% of lives said they expected to manage Scemblix at parity with Teva Pharmaceuticals’ Synribo (omacetaxine mepesuccinate), but the new agent is unlikely to be preferred over it (see chart). However, 64% of oncologists said they were likely to prescribe Scemblix over Synribo as a third-line treatment for people with CML who have failed at least two TKIs, and 70% said they were likely to prescribe Scemblix for this use.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jbrown@aishealth.com.

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