MMIT Reality Check on Acute Myeloid Leukemia

Payer Coverage:

A review of market access for treatments of adults with acute myeloid leukemia (AML) shows that under the pharmacy benefit, about 68% of the lives under commercial formularies are covered with utilization management restrictions. Around 7% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 62% of the lives under commercial policies are covered with utilization management restrictions. About 61% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 99% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 78% require multiple steps. Around 81% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

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.

FDA Gave Venclexta Full Approval

In October 2020, the FDA gave full approval to AbbVie Inc. and Roche Group unit Genentech USA, Inc.’s Venclexta (venetoclax) in combination with azacitidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia in people at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. The agency gave the companies accelerated approval for this indication on Nov. 21, 2018; the B-cell lymphoma-2 inhibitor’s initial approval was on April 11, 2016.

FDA Approves Onureg

In September 2020, the FDA approved Bristol-Myers Squibb Co. unit Celgene Corp.’s Onureg (azacitidine) for continued treatment of people with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. The agency gave the application priority review and orphan drug designation. The recommended dose of the tablet is 300 mg once daily on days one through 14 of each 28-day cycle.

Key Findings:

Market Events Drive Changes

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. In October 2020, the FDA gave full approval to AbbVie Inc. and Roche Group unit Genentech USA, Inc.’s Venclexta (venetoclax) in combination with azacitidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in people at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. In April 2022, Precigen, Inc. reported that the FDA had given fast track designation to PRGN-3006 UltraCAR-T for the treatment of people with relapsed or refractory AML. The agency previously granted the product orphan drug designation. If approved, it will be the first chimeric antigen receptor T-cell (CAR-T) therapy in AML.

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 CAR-T 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. Celgene Corp.’s Idhifa (enasidenib) and Onureg (azacitidine), Pfizer Inc.’s Daurismo (glasdegib), Agios Pharmaceuticals Inc.’s Tibsovo (ivosidenib), Astellas Pharma Inc.’s Xospata (gilteritinib), Novartis’ Rydapt (midostaurin) and Venclexta 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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