MMIT Reality Check on Acute Lymphoblastic Leukemia (July 2022)

Payer Coverage:

A review of market access for acute lymphoblastic leukemia treatments shows that under the pharmacy benefit, about 37% of the lives under commercial formularies are covered with utilization management restrictions. Around 42% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Under the medical benefit, about 56% of the lives under commercial policies are covered with utilization management restrictions. Almost 70% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

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For about 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 38% of the lives require multiple steps. Around 67% of payer-controlled pharmacy benefit covered lives require prior authorization, with 4% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

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Trends:

FDA Approves Nelarabine

In November 2021, the FDA approved Zydus Cadila’s nelarabine 250 mg/50 mL (5 mg/mL) for the treatment of people with T-cell acute lymphoblastic leukemia and people at least 1 year old with T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is the first approved applicant for the generic of Novartis Pharmaceuticals Corp.’s Arranon and has 180 days of market exclusivity. Dosing for adults is 1,500 mg/m2 via a two-hour intravenous infusion on days one, three and five repeated every 21 days. Pediatric dosing is 650 mg/m2 through a one-hour intravenous infusion for five consecutive days repeated every 21 days. Website Drugs.com lists the price of a 5 mg/mL vial as more than $777.

FDA Gives Tecartus Additional Indication

In October 2021, the FDA gave another indication to Gilead Sciences, Inc. division Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel) for the treatment of people at least 18 years old with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The chimeric antigen receptor T-cell (CAR-T) initially was approved July 24, 2020. One-time dosing for the newest use is 1 x 106 CAR-positive viable T cells per kg of body weight with a maximum of 1 x 108 CAR-positive viable T cells. The therapy’s price is $373,000.

New Tecartus FDA Approval for Adults With ALL Offers Welcome Therapeutic Option

On Oct. 1, 2021, the FDA gave another indication to Gilead Sciences, Inc. division Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel) for the treatment of people 18 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). According to a Zitter Insights survey, oncologists said they are likely to prescribe the drug over certain therapies for that indication. Industry experts tell AIS Health, a division of MMIT, that the agent may be a game changer for certain patients, as it fills a treatment gap.

Key Findings:

Market Events Drive Changes

In November 2021, the FDA approved Zydus Cadila’s nelarabine 250 mg/50 mL (5 mg/mL) for the treatment of people with T-cell acute lymphoblastic leukemia (ALL) and people at least 1 year old with T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It was the first generic of Novartis Pharmaceuticals Corp.’s Arranon. In October 2021, the agency gave another indication to Gilead Sciences, Inc. division Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel) for the treatment of people at least 18 years old with relapsed or refractory B-cell precursor ALL.

Competitive Market Landscape

Novartis Pharmaceuticals Corp.’s Kymriah (tisagenlecleucel) was the first FDA-approved CAR-T cell therapy indicated for patients up to 25 years of age with relapsed or refractory B-cell ALL, while Tecartus was the first CAR-T approved for adults with ALL. There is no current cure for ALL except an allogeneic hematopoietic stem cell transplant (HSCT), which has a high cure rate.

Pharmacy, Medical Benefit Implications

The first-line treatment for many of the variants of ALL is to enroll eligible patients into clinical trials. If this is not done, most medications require prior authorization. Most drugs are covered under either the pharmacy or medical benefit, and coverage is dependent upon the route of administration. Kymriah and Tecartus are covered under the medical benefit.

Key Players in Market:

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AIS Health Staff

AIS Health Staff

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