Bispecific antibody access landscape for myeloma and lymphoma

Bispecific antibodies have become the fastest-growing drug class in hematologic oncology. In multiple myeloma, four bispecific T-cell engagers are now FDA-approved — three targeting BCMA and one targeting GPRC5D. In lymphoma, three CD3×CD20 bispecific antibodies have been approved for diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Together, these seven products represent a fundamental shift in how relapsed and refractory hematologic cancers are treated, and they raise new questions about sequencing relative to CAR-T therapy, payer coverage, and site-of-care logistics.

This landscape covers the access picture across all approved bispecific antibodies — including formulary positioning, payer PA criteria, administration setting, step-up dosing, HCPCS coding, and the CAR-T/bispecific sequencing debate.

Who this is for

Oncology market access teams, pharmacy directors, billing and coding staff, and cell therapy coordinators who need a source-cited overview of bispecific antibody coverage and access in 2026.

Approved products at a glance

Multiple myeloma bispecifics

Lymphoma bispecifics

Administration setting and step-up dosing

Bispecific antibodies are administered by either subcutaneous (SC) injection or intravenous (IV) infusion, and all require a step-up dosing schedule to mitigate cytokine release syndrome (CRS). Tecvayli, Elrexfio, Talvey, and Epkinly are administered subcutaneously. Columvi, Lunsumio, and Lynozyfic are administered intravenously. (Lunsumio VELO, a separate SC formulation of mosunetuzumab approved in December 2025, is not covered in this article.) This has direct access implications:

Step-up dosing for myeloma bispecifics

• Tecvayli: Step-up doses on days 1 and 3, then weekly maintenance dosing (1.5 mg/kg). After 6 months of response, may transition to every-2-week dosing.
• Elrexfio: Step-up doses on days 1 and 8, then weekly maintenance (76 mg). After 24 weeks of response, may transition to every-2-week dosing.
• Talvey: Step-up doses on days 1 and 4, then weekly (0.4 mg/kg) or every-2-week (0.8 mg/kg) maintenance.
• Lynozyfic: IV infusion. Step-up doses of 5 mg on day 1 and 25 mg on day 8, then weekly maintenance (200 mg on day 15 and weekly thereafter), transitioning to every-2-week after response.

Step-up dosing for lymphoma bispecifics

• Columvi: IV infusion. Step-up doses on days 1 and 8 of cycle 1, then fixed dosing every 21 days for up to 12 cycles.
• Epkinly: Step-up doses in cycle 1 (days 1, 8, 15), then every-28-day maintenance dosing.
• Lunsumio: IV infusion. Step-up doses on days 1, 8, and 15 of cycle 1, then every-21-day maintenance for up to 17 cycles. (Lunsumio VELO, the SC formulation approved December 2025, uses a 1-minute SC injection.)

Access implications

1. Inpatient vs. outpatient. Step-up doses carry the highest CRS risk and often require inpatient monitoring. Some centers admit patients for the first 48–72 hours of step-up dosing; others manage with extended observation in outpatient infusion centers.
2. Community oncology access. Subcutaneous bispecifics (Tecvayli, Elrexfio, Talvey, Epkinly) can be administered at community oncology practices with CRS monitoring capability — a major access advantage over CAR-T. IV-administered bispecifics (Columvi, Lunsumio, Lynozyfic) require infusion center capabilities but still avoid the manufacturing logistics of CAR-T.
3. REMS. All bispecific antibodies carry Boxed Warnings for CRS and neurologic toxicity (including ICANS). Tecvayli, Elrexfio, Talvey, and Lynozyfic are distributed under REMS programs that require prescriber certification and patient enrollment.

Payer coverage and prior authorization

Prior authorization requirements

Prior authorization for bispecific antibodies is standard across commercial, Medicare Advantage, and Medicaid payers. Common PA criteria include:

1. Diagnosis confirmation. Pathology-confirmed multiple myeloma (for BCMA/GPRC5D bispecifics) or DLBCL/FL (for CD20 bispecifics).
2. Prior therapy requirements. Most payers require documentation of at least 3–4 prior lines of therapy, including specific drug classes:
   • For myeloma: proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody.
   • For lymphoma: at least 2 prior lines including an anti-CD20 antibody and an anthracycline-containing regimen.
3. Disease status. Documented relapsed or refractory disease with evidence of progression.
4. Performance status. ECOG 0–2 is typical.
5. Biomarker status. For BCMA-targeting agents, some payers require documented BCMA expression by IHC or flow cytometry (though BCMA is universally expressed on plasma cells and this is not a standard FDA requirement).

Payer positioning and step therapy

UnitedHealthcare's Medicare Advantage step therapy program for 2026 includes BCMA-targeting bispecifics in its CAR-T/bispecific management framework:

• Bispecifics (Tecvayli, Elrexfio) are listed as preferred agents for multiple myeloma alongside or instead of CAR-T in certain clinical scenarios.
• Step therapy may require trying a bispecific before CAR-T, or documentation of why CAR-T was not appropriate.

Commercial payers generally cover all four myeloma bispecifics without product-specific step therapy, but may require documentation of prior therapy and disease status.

HCPCS coding

Bispecific antibodies are relatively new products, and coding has evolved over time:

For products without dedicated HCPCS codes, bill under J3590 (Unclassified biologics) and include the product name, NDC, and dosage on the claim. Contact the payer for specific billing guidance.

CAR-T vs bispecific: the sequencing debate

In multiple myeloma, the overlap between BCMA-targeting CAR-T products (Abecma, Carvykti) and BCMA-targeting bispecifics (Tecvayli, Elrexfio, Lynozyfic) has created a practical sequencing question that affects payer policy:

Arguments for CAR-T first

• Treatment-free interval. CAR-T can produce durable remissions without ongoing therapy, while bispecifics require continuous treatment until progression.
• BCMA antigen exposure. Prior BCMA-directed bispecific therapy may reduce the efficacy of subsequent BCMA-targeted CAR-T by modulating BCMA surface expression or inducing anti-drug antibodies.

Arguments for bispecific first

• Immediate availability. No manufacturing lead time (CAR-T requires 3–6 weeks for apheresis and cell processing).
• Community setting access. Bispecifics can be administered at community oncology practices, expanding access for patients who cannot travel to specialized CAR-T centers.
• Older or frail patients. Bispecifics may be more suitable for patients who cannot tolerate the lymphodepletion chemotherapy or ICU-level monitoring required for CAR-T.

Current clinical guidance

Expert panels and NCCN guidelines suggest that both CAR-T-first and bispecific-first approaches are acceptable in many patients, with the choice driven by disease characteristics, patient fitness, access logistics, and prior therapy history. For patients who have received a BCMA-directed bispecific, a longer interval before BCMA CAR-T or use of a non-BCMA alternative (such as talquetamab or conventional combination therapy) may mitigate the impact on CAR-T efficacy.

Healthcare utilization and cost-effectiveness data

Comparative data is emerging that may influence payer positioning:

• Healthcare contact days. A healthcare utilization model comparing glofitamab (Columvi) and epcoritamab (Epkinly) in DLBCL found that glofitamab was associated with 30.9 healthcare contact days in year 1, compared with 44.9 days for epcoritamab. Over 2 years, the difference grew to 14 additional contact days for epcoritamab, primarily driven by more frequent administration schedules.

• Cost-effectiveness. A Spanish cost-effectiveness analysis found elranatamab dominant (less costly, more effective) over teclistamab in triple-class exposed R/R myeloma, with cost savings of approximately €101,026 per patient over a lifetime horizon, driven by differences in dosing frequency and duration of treatment. While this analysis reflects the Spanish healthcare context, it signals the type of comparative data payers may consider when differentiating between BCMA bispecifics.

• Teclistamab + daratumumab. The MajesTEC-3 trial evaluated teclistamab in combination with daratumumab for patients with 1–3 prior lines of therapy, positioning this bispecific combination as a potential standard-of-care option earlier in the treatment sequence. If approved for earlier-line use, the access landscape will shift significantly.

What to monitor next

Sources

• FDA. Tecvayli (teclistamab-cqyv) Prescribing Information. Janssen Biotech, Inc. Available at: dailymed.nlm.nih.gov
• FDA. Elrexfio (elranatamab-bcmm) Prescribing Information. Pfizer Inc. Available at: dailymed.nlm.nih.gov
• FDA. Talvey (talquetamab-tgvs) Prescribing Information. Janssen Biotech, Inc. Available at: dailymed.nlm.nih.gov
• FDA. Columvi (glofitamab-gxbm) Prescribing Information. Genentech, Inc. Available at: dailymed.nlm.nih.gov
• FDA. Epkinly (epcoritamab-bysp) Prescribing Information. AbbVie Inc. Available at: dailymed.nlm.nih.gov
• FDA. Lunsumio (mosunetuzumab-axgb) Prescribing Information. Genentech, Inc. Available at: dailymed.nlm.nih.gov
• FDA. Lynozyfic (linvoseltamab-gcpt) Prescribing Information. Regeneron Pharmaceuticals, Inc. Available at: dailymed.nlm.nih.gov
• FDA. FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma. July 2, 2025. Available at: fda.gov
• Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505. Available at: pubmed.ncbi.nlm.nih.gov
• Lesokhin AM, Tomasson MH, Arnulf B, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023;29(9):2259-2267. Available at: pubmed.ncbi.nlm.nih.gov
• Chari A, Minnema MC, Berdeja JG, et al. Talquetamab, a T-cell-redirecting GPRC5D bispecific antibody for multiple myeloma. N Engl J Med. 2022;387(24):2232-2244. Available at: pubmed.ncbi.nlm.nih.gov
• Dickinson MJ, Carlo-Stella C, Morschhauser F, et al. Glofitamab for relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2022;387(24):2220-2231. Available at: pubmed.ncbi.nlm.nih.gov
• Budde LE, Sehn LH, Matasar M, et al. Mosunetuzumab in relapsed or refractory follicular lymphoma. Lancet Oncol. 2022;23(8):1055-1065. Available at: pubmed.ncbi.nlm.nih.gov
• Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab in relapsed or refractory large B-cell lymphoma. J Clin Oncol. 2023;41(12):2238-2247. Available at: pubmed.ncbi.nlm.nih.gov
• ClinicalTrials.gov. MajesTEC-1: A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. clinicaltrials.gov
• ClinicalTrials.gov. MagnetisMM-3: A Study of Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma. clinicaltrials.gov
• Binaytara. CAR-T or Bispecific Antibodies First? A Practical Sequencing Guide for Relapsed Multiple Myeloma in 2026.
• Pfizer. Elrexfio significantly improves progression-free survival for double-class exposed patients with R/R multiple myeloma. Press release, April 29, 2026.