Zitter Pulse Check: Multiple Myeloma (December 2023)

Coverage

Multiple myeloma is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for multiple myeloma, 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: Multiple Myeloma combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading oncology brands.

Payer Management

Payers with more than two-fifths of commercial and Medicare lives said that managing branded treatments for multiple myeloma is a high priority. Payers with more than half of Medicare covered lives and less than half of commercial beneficiaries said they are somewhat aggressive in their management of the condition, meaning that all products are covered, but some may be preferred over others through tiering, step edits and/or prior authorization.

Payers with almost all lives expressed average satisfaction with available multiple myeloma agents, while almost half of oncologists responded similarly. More than two-thirds of all payers and oncologists said that moderate-to-high unmet need exists in treating the condition. Almost three-fifths of payers said that multiple myeloma has a high impact on people’s daily activities.

Key Findings

Elrexfio

On Aug. 14, 2023, the FDA gave accelerated approval to Pfizer Inc.’s Elrexfio (elranatamab-bcmm) 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. Payers covering more than two-fifths of commercial lives and those with almost half of Medicare lives said they were moderately aware of the drug, compared with one-fifth of oncologists. Almost half of all payers said they expect the new medication to have some impact on other multiple myeloma agents, meaning that they may implement some modification in utilization management criteria. More than one-third of oncologists said they anticipate that the therapy will have a moderate impact on their treatment approach, expecting it to change for a considerable amount of patients.

Talvey

On Aug. 9, 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. While payers with two-fifths of commercial lives were moderately aware of the drug, Medicare payers with two-thirds of beneficiaries said the same. More than two-thirds of payers had conducted a P&T review of the agent. Among those respondents, those with 47% of commercial beneficiaries said they expected it to have a moderate impact on other available products to treat multiple myeloma, meaning that some products are likely to see a change in tiering and/or utilization management criteria.

Manufacturer Ratings

Payers, oncologists and practice managers were asked to rate manufacturers of multiple myeloma medications on six different metrics: overall commitment to the disease, account representative support, patient/family support resources, patient copay assistance, physician education/support and hub services. Payers rated Johnson & Johnson Innovative Medicine — formerly known as Janssen — as the top company across all six metrics, tying with Takeda Pharmaceutical Company Limited in account representative support and patient/family support resources and tying with Bristol Myers Squibb in hub services. Oncologists also ranked Johnson & Johnson Innovative Medicine as the No. 1 multiple myeloma manufacturer in all categories. Practice managers rated the company first in account representative support, patient copay assistance and hub services and named Bristol Myers Squibb the top manufacturer in the other three metrics.

Trends

Tecvayli

Message: “Tecvayli is a bispecific T cell engaging antibody that binds to CD3 receptor expressed on the surface of T cells. In clinical trials, the ORR [overall response rate] was 52.5% in patients with prior BCMA targeted treatment. Responses occurred early and were durable, as median time to first and best response was 1.25 months and at data cutoff (14 months), 71.4% responders maintained response.”

Payer Thoughts: “This is a very interesting product. The clinical efficacy is hard to compare to the CAR-T therapies due to trial limitations, but this is a cheaper product that is administered SQ (albeit by health care professional) versus the long process to receive CAR-T therapies via IV. I think it will be interesting to see how NCCN guidelines view this product, as I imagine it is probably much easier for patients to receive, compared to CAR-T. Clinical trials did allow for previous CAR-T therapy users to use this drug, so I’m curious to see if payers try to step members thru Tecvayli first, before trying CAR-T therapy, as it is a much cheaper product.”

FDA Gives Accelerated Approval to Elrexfio

On Aug. 14, 2023, the FDA gave accelerated approval to Pfizer Inc.’s Elrexfio (elranatamab-bcmm) 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 agent is a B-cell maturation antigen-CD3-directed bispecific antibody immunotherapy and is the first off-the-shelf fixed-dose subcutaneous BCMA-directed therapy in the U.S. with the option for every-other-week long-term dosing after 24 weeks of weekly treatment. It had orphan drug and breakthrough therapy designations. The FDA conducted its review via Project Orbis in collaboration with Switzerland, Brazil, Canada, Australia and Singapore. Dosing is done by a qualified health care professional and starts with 12 mg via subcutaneous injection on day one, 32 mg on day four, 76 mg on day eight and then one week later and weekly through week 24. People who have received at least 24 weeks of treatment and have achieved at least a partial response and maintained that response for at least two months can transition to a biweekly schedule of 76 mg. The drug’s monthly list price is $41,500, and, based on the duration of treatment in a clinical trial, a treatment course could be around $330,000.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

FDA Gives Talvey Accelerated Approval

On Aug. 9, 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.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

0

0

0 Comments

0

0

• Pulse Checks