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 combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading oncology brands.
Since April 2017, the FDA has approved eight new AML therapies that target a variety of mutations
and patient populations. To help ensure that patients are getting the appropriate therapy, two-thirds of commercial payers maintain a clinical treatment pathway for physicians to follow (see chart). Among the payers providing a decision matrix with specific drugs, most suggest use that is in line with their FDA-approved label.
In addition, payers with two-thirds of covered lives will require testing for all of the AML biomarkers. Payers with almost half of those covered lives say they will require testing for all patients. Payers with approximately one-quarter of covered lives will require biomarker testing for only newly diagnosed patients, excluding retesting coverage for relapsed or refractory AML.
Among payers seeking contracts for AML drugs, portfolio contracting is the most popular. Other arrangements include value-based, risk-based and outcomes-based contracts. Payers seeking value-based deals use the criteria of progression-free survival, overall survival and adverse events related to the treatment. The focus of risk-based contracts is on the risk/benefit ratio, while outcomes-based arrangements are based on the percentage of patients in remission, as well as quality-adjusted life year, or QALY.
Site of Care
Commercial and Medicare payers with almost all covered lives will cover administration of the AML therapies in the outpatient setting. Among the reasons payers say they prefer administration in the inpatient setting are that it decreases patients’ cost-sharing burden and that the location provides better side-effect management. The least likely agents that oncologists will administer in an outpatient setting are Vyxeos (daunorubicin and cytarabine) from Jazz Pharmaceuticals plc and Mylotarg (gemtuzumab ozogamicin) from Pfizer Inc.
Almost all oncologists check to make sure their patients’ insurance covers an AML therapy in the outpatient setting before they administer it. If a drug is not covered, almost two-thirds of oncologists will not administer that therapy and instead administer a product that the insurance covers (see chart). A handful will take another approach, including trying to find another source of funding, appealing for payer coverage and admitting the patient for inpatient treatment. But almost one-third will administer the drug and then appeal for payer coverage of it afterward.
Message: “Xospata has documented interactions with many other medications, so a comprehensive medication review is vital to preventing adverse treatment outcomes. Patients most frequently experience myalgia/arthralgia, fatigue. diarrhea, rash, dyspnea, edema, stomatitis, cough and pneumonia as well as renal impairment, ab pain, insomnia, and elevated lab values. Patients must be closely monitored while taking Xospata but the benefits have been shown to significantly improve quality of life and extend life as indicated by an extended disease progression free interval.”
Payer Thoughts: “It is difficult to grasp whether the cost benefit and quality of life for patients in this category warrant treatment when the side effects are so serious. With close monitoring and dose adjustments though we feel that this medication can be of benefit to patients and their families. With the proper utilization management edits in place to ensure appropriateness of therapy, treatment can be beneficial in establishing improved future treatment parameters for future patients.”
AML Therapy Class Has Seen Boom
The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup.
FDA Issues CRL on Quizartinib NDA
In June 2019, Daiichi Sankyo Company, Ltd. said that the FDA had issued a complete response letter (CRL) for its new drug application (NDA) for quizartinib for the treatment of adults with R/R FLT3-internal tandem duplications acute myeloid leukemia. The company said it was evaluating the CRL and “will determine next steps in the U.S.”