MMIT Reality Check on Acute Myeloid Leukemia (2Q2023)

Payer Coverage:

A review of market access for treatments of adults with acute myeloid leukemia (AML) shows that under the pharmacy benefit, about 64% of the lives under commercial formularies are covered with utilization management restrictions. Around 18% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 60% of the lives under commercial policies are covered with utilization management restrictions. About 59% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 98% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 64% require multiple steps. Around 82% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

FDA Approves Rezlidhia

In December 2022, the FDA approved Rigel Pharmaceuticals, Inc.’s Rezlidhia (olutasidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Dosing of the capsule is 150 mg twice daily. Drugs.com lists the price of 30 150 mg capsules as more than $16,962. The same day, the agency gave another indication to the Abbott RealTime IDH1 to select people who may be candidates for treatment with Rezlidhia.

FDA Expands Tibsovo’s Label

In May 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 (IDH1) 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. Dosing is 500 mg once daily. Drugs.com lists the price of 60 250 mg tablets as more than $31,686.

FDA Expands Vyxeos’ Label

In March 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. Dosing via a 90-minute intravenous infusion varies depending on where in the treatment cycle a patient is. Drugs.com lists the price of a vial of 100 mg-44 mg intravenous powder as $8,850.76.

Key Findings:

Market Events Drive Changes

In December 2022, the FDA approved Rigel Pharmaceuticals, Inc.’s Rezlidhia (olutasidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. In May 2022, the agency expanded the label of Servier Pharmaceuticals LLC’s Tibsovo (ivosidenib) to include the treatment, in combination with azacitidine, of newly diagnosed IDH1 mutated AML in people at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. In March 2021, the FDA expanded the label for Jazz Pharmaceuticals plc’s Vyxeos (daunorubicin and cytarabine) to treat newly diagnosed therapy-related AML or AML with myelodysplasia-related changes in people at least 1 year old.

Competitive Market Landscape

An abundance of policies exists on the pharmacy side, particularly for the newer targeted therapies. Payers want to make sure these drugs are given to the appropriate patients at the appropriate point in therapy. Vyxeos is a combination of generics that are already on the market in a liposomal injection. It will likely have to step through the generic agents on the market before being considered for reimbursement. The first chimeric antigen receptor T-cell (CAR-T) therapy is in development for AML and was granted FDA fast track designation, which facilitates development and expedites the review process of drugs that address serious conditions and high unmet medical needs.

Pharmacy, Medical Benefit Implications

Coverage for drugs in this indication is good and processes through both the pharmacy and medical benefits. Rezlidhia, Tibsovo, Celgene Corp.’s Idhifa (enasidenib) and Onureg (azacitidine), Pfizer Inc.’s Daurismo (glasdegib), Astellas Pharma Inc.’s Xospata (gilteritinib), Novartis’ Rydapt (midostaurin), and Venclexta (venetoclax) from AbbVie Inc. and Genentech USA, Inc., a member of the Roche Group, are oral and will always process through the pharmacy benefit, while the injections Vyxeos and Pfizer’s Mylotarg (gemtuzumab ozogamicin) will be mainly through the medical benefit.

Key Players in Market:

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