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 payers covering a little more than half of lives and Medicaid payers representing a little less than half said that managing branded treatments for AML is an average priority. Payers with about one-quarter of covered lives said it was a high priority. Both commercial and Medicare payers with approximately half of lives said they are somewhat aggressive in managing AML agents.
Payers covering more than half of commercial lives said there is moderate unmet need in treating AML. Commercial payers with more than half of lives assessed the disease burden for people with AML as high or very high. Payers with almost half of Medicare lives agreed, as did more than one-third of oncologists.
Among nine agents with FDA approval to treat AML, physician prescribing is fairly even, led by Vyxeos (daunorubicin and cytarabine) from Jazz Pharmaceuticals plc and Venclexta (venetoclax) from AbbVie Inc. and Genentech USA, Inc., a Roche Group member. Bristol Myers Squibb’s Onureg (azacitidine) has the greatest number of high-prescribing oncologists — those who prescribe a product to at least half of their patients — and the second highest amount of low-prescribing oncologists, which are those who prescribe a product to 10% or less patients. Pfizer Inc.’s Daurismo (glasdegib) has the greatest number of low-prescribing oncologists.
On Aug. 1, 2022, Gamida Cell Ltd. said that the FDA had accepted its Biologics License Application (BLA) for omidubicel for the treatment of patients with blood cancers, including AML, in need of an allogenic hematopoietic stem cell transplant. The agent is a first-in-class, advanced nicotinamide (NAM)-enabled stem cell therapy candidate with breakthrough therapy and orphan drug designations. The FDA has granted priority review to the treatment and is expected to make a decision on the BLA by Jan. 30, 2023. Even with the product’s availability, payers covering more than one-third of commercial lives said there is still high unmet need for the treatment of AML, and those covering almost one-fifth of Medicare lives perceive very high unmet need.
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, cited by respondents with approximately two-thirds of lives. Oncologists said that socioeconomic status is the top non-medical factor that impacts their AML patients’ access to health care services, followed closely by familial/other support, education and health literacy, and housing and transportation resources.
Message: “Xospata was approved for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 genetic mutation identified by an FDA-approved genetic test. Between 20 and 30 percent of people with AML have the FLT3 gene mutation. The FLT3 gene codes for a protein called FLT3 that helps white blood cells grow. A mutation in this gene encourages the growth of too many abnormal leukemia cells. As part of precision medicine advances, Xospata was one of the first drugs approved to treat AML with the FLT3 mutation. FDA approval of Xospata was based on the positive results of a Phase III open-label, multi-site, randomized clinical trial called ADMIRAL where overall survival, complete and partial remission indicators were significant. Side effects were minimal and included muscle pain, fatigue, diarrhea.”
Payer Thoughts: “The results of the ADMIRAL trial indicate that Xospata significantly improves the quality of life and survival of AML patients with the FLT3 mutation. This is a necessary therapy for this patient population.”
FDA Gives Additional Approval to Tibsovo
On May 25, 2022, the FDA expanded the label of Servier Pharmaceuticals LLC’s Tibsovo (ivosidenib) to include the treatment, in combination with azacitidine, of newly diagnosed isocitrate dehyrogenase-1 (IDH-1) mutated acute myeloid leukemia in people at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. The agency initially approved the tablet on July 20, 2018. The new use received priority review, which was conducted under the FDA’s Real-Time Oncology Review pilot program.
FDA Expands Vyxeos Label
On March 30, 2021, the FDA expanded the label for Jazz Pharmaceuticals plc’s Vyxeos (daunorubicin and cytarabine) to treat newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes in people at least 1 year old. The agency initially approved the drug Aug. 3, 2017.