Acute myeloid leukemia (AML) is a high-cost category with an increasing number of therapies that treat different subtypes of the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for AML, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Oncology Index: Acute Myeloid Leukemia combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading oncology brands.
Commercial and Medicare payers covering almost one-third of lives said that managing branded treatments for AML is a high priority. Commercial payers with more than half of beneficiaries said they are somewhat aggressive in their management of branded therapies for the condition, while Medicare payers with more than two-fifths of lives said they were not aggressive in their management of the agents.
Most payers and oncologists expressed an average level of satisfaction with the current AML treatment options. Almost three-fourths of payers and more than four-fifths of oncologists said that there is moderate to high unmet need in treating the disease.
Approximately two-thirds of payers said they had not adopted a clinical treatment pathway for AML. Among those that had a pathway in place, those with almost all lives said that it reduced costs to their organization. Payers that had not implemented a pathway varied in their reasoning around that, with the top reasons being they preferred to let physicians/medical staff determine the best treatment and that many provider practices already have their own pathways. More than one-third of oncologists said they follow a clinical treatment pathway, and they said the top benefit was well-monitored AML protocols, followed by increased quality of care for AML patients. However, more than half of oncologists said that pathways do not account for individuality among people with the disease.
The FDA approved Gamida Cell Ltd.’s Omisirge (omidubicel-onlv) in April 2023 for use in people at least 12 years old with hematologic malignancies, including AML, planned for umbilical cord blood transplantation following myeloablative conditioning to quicken the recovery of neutrophils and reduce the incidence of infection. Among the almost three-quarters of payers that had not held a P&T review of the agent, those with one-third of commercial lives said they expect the drug’s availability to have a moderate impact on their management of other AML drugs, while those with almost two-thirds of Medicare beneficiaries expect it will have no impact. However, among those payers that had conducted a P&T review, those with the majority of commercial and Medicare lives expect it will have some impact.
Social Determinants of Health
The top social determinants of health initiatives that both commercial and Medicare payers have implemented are offering greater access to telehealth and providing services to support health and medicine literacy. In addition, commercial payers with more than half of lives said they offer services to assist in health/medicine language barriers, and payers with more than half of Medicare beneficiaries said they provide transportation to and from medical appointments. Oncologists said that socioeconomic status is the top non-medical factor that impacts their AML patients’ access to health care services, followed closely by occupation and job security and then familial/other support.
Message: “Quizartinib is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive. 25% of newly diagnosed AML cases have the FLT3-ITD mutation, which is associated with shorter survival. In clinical trials, quizartinib was studied with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy. There was some QT prolongation in clinical trials, which will require ECG [electrocardiogram] monitoring for patients taking this drug.”
Payer Thoughts: “There are other FLT3 inhibitors in the market, such as Xospata or Cabometyx. While this quizartinib is expected to have less side effects as it has a more targeted approach, a head-to-head trial or some real-world evidence would help with the assessment. Understanding the limitation of oncology studies and having placebo or active treatment arms, even an indirect treatment comparison, would be helpful.”
FDA Approves Vanflyta
On July 20, 2023, the FDA approved Daiichi Sankyo, Inc.’s Vanflyta (quizartinib), in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. The same day, the agency gave another indication to Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay to include the selection of people with FLT3-ITD positive AML who may be eligible for treatment with Vanflyta. The drug’s application was given priority review, as well as fast track and orphan drug designations; the review used the Assessment Aid. Dosing for the tablet is 35.4 mg once daily on days one through 21 of induction for up to two cycles, then 35.4 mg on days six through 19 of consolidation for up to four cycles and then during maintenance, 26.5 mg once daily on days one to 14 and then 53 mg once daily thereafter for up to 36 28-day cycles. The drug’s price per tablet for both the 17.7 mg and 26.5 mg is $546, for an annual price of $199,290.
FDA Approves Omisirge
On April 17, 2023, the FDA approved Gamida Cell Ltd.’s Omisirge (omidubicel-onlv) for use in people at least 12 years old with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to quicken the recovery of neutrophils and reduce the incidence of infection. The agency gave the allogeneic cell therapy priority review, as well as breakthrough therapy and orphan drug designations. Administration is a single dose via intravenous infusion and must be done at a transplant center. The drug’s annual price is $338,000.