MMIT Reality Check on Multiple Myeloma (4Q2023)

Payer Coverage:

A review of market access for multiple myeloma treatments shows that under the pharmacy benefit, about 45% 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.

Under the medical benefit, about 70% of the lives under commercial policies are covered with utilization management restrictions. Almost 58% 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 13% of the lives require multiple steps. Around 73% of payer-controlled pharmacy benefit covered lives require prior authorization, with 8% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Gives Talvey Accelerated Approval

In August 2023, the FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab-tgvs) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The review was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration and Switzerland’s Swissmedic; it used the Assessment Aid. The agent, a G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is a first-in-class bispecific antibody. Dosing of the subcutaneous injection, which is administered by a qualified health care professional, can be done weekly or biweekly. For weekly dosing, a step-up schedule consists of 0.01 mg/kg on day one, then 0.06 mg/kg on day four, then 0.4 mg/kg on day seven and then 0.4 mg/kg one week later and weekly thereafter. For biweekly dosing, administration starts at 0.01 mg/kg on day one, 0.06 mg/kg on day four, 0.4 mg/kg on day seven, then 0.8 mg/kg on day 10 and then 0.8 mg/kg two weeks later and every two weeks thereafter. The drug’s list price is $45,000 per month, and the company estimates a pricing range of $270,000 to $360,000 for an average treatment duration of six to eight months.

FDA Accepted Application for Sanofi’s Biosimilar Denosumab

In February 2023, the FDA accepted its first application for a biosimilar denosumab, Sandoz disclosed on Feb. 6. The Amgen Inc. reference drug is available as both Prolia and Xgeva. According to AmerisourceBergen’s Feb. 6 U.S. Biosimilar Report, nine companies have denosumab biosimilars in clinicals trials, with five of those in Phase III trials. Prolia and Xgeva are approved for multiple conditions, including for the treatment of postmenopausal women with osteoporosis at high risk for fracture and for the prevention of skeletal-related events in people with multiple myeloma and in people with bone metastases from solid tumors. Sandoz’s application is for all of the drugs’ indications. Prolia’s list price is $1,564.31 per injection every six months, and the per-dose price for Xgeva — which is dosed every four weeks — is $2,877.36.

FDA Requests Withdrawal of Pepaxto Marketing Authorization

The FDA has requested that Oncopeptides AB withdraw the U.S. marketing authorization for Pepaxto (melphalan flufenamide), the company revealed on Dec. 7, 2022. “We respect FDA’s accelerated approval regulations,” said CEO Jakob Lindberg in a statement. The FDA initially gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. But then on Oct. 22, 2021, the company requested voluntary withdrawal of the peptide-drug conjugate’s New Drug Application (NDA). That was followed early in 2022 by Oncopeptides’ rescinding the letter requesting the NDA’s withdrawal based on “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials.” On Sept. 22, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a meeting to assess the drug’s risk/benefit profile; it voted 14-2 that the drug is not favorable for adults with relapsed or refractory multiple myeloma. Oncopeptides is commercializing the therapy in Europe, where it is known as Pepaxti, following its full approval on Aug. 18, 2022.

Key Findings:

Market Events Drive Changes

In August 2023, the FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab-tgvs) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. In October 2022, the agency gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Tecvayli (teclistamab-cqyv) for the same indication. In June 2022, the FDA granted another indication to Amgen Inc. subsidiary Onyx Pharmaceuticals, Inc.’s Kyprolis (carfilzomib) in combination with Sanofi’s Sarclisa (isatuximab-irfc) and dexamethasone (Isa-Kd) for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

Competitive Market Landscape

Many different drugs to treat multiple myeloma are available. The choice and dose of drug therapy depend on many factors, including the stage of the cancer, the age of the patient, kidney function of the patient and if a stem cell transplant is planned. A variety of novel drugs are being studied for the treatment of relapsed myeloma and relapsed/refractory myeloma.

Pharmacy, Medical Benefit Implications

Drugs for this class receive excellent coverage by payers, and it is under both the pharmacy and medical benefit. Most myeloma cells will eventually become resistant to standard chemotherapy, a condition called multidrug resistance. New drugs and combinations of approved drugs are being researched to provide more options for patients with myeloma. Most payers will include these FDA-approved and off-label combination therapies in their payment policies.

Key Players in Market:

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