Aetna modified CPB 1042 for talquetamab-tgvs (Talvey), effective October 19, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its talquetamab-tgvs coverage policy under CPB 1042 to add a second approval pathway—combination therapy with teclistamab-cqyv (Tecvayli) for relapsed or refractory multiple myeloma. The primary billing code is J3055 (injection, talquetamab-tgvs, 0.25 mg), and administration bills under CPT 96401. If your oncology or hematology practice bills for late-line myeloma therapies, this change expands who qualifies—but it also adds prior authorization complexity you need to build into your workflow before claims go out.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Talquetamab-tgvs (Talvey) — CPB 1042 |
| Policy Code | CPB 1042 |
| Change Type | Modified |
| Effective Date | October 19, 2025 |
| Impact Level | High |
| Specialties Affected | Hematology, Medical Oncology, Infusion Centers |
| Key Action | Update precertification workflows to capture both the single-agent pathway (4 prior therapies) and the teclistamab combination pathway (3 prior therapies) before submitting J3055 claims |
Aetna Talquetamab-tgvs Coverage Criteria and Medical Necessity Requirements 2025
Aetna's talquetamab-tgvs coverage policy under CPB 1042 requires precertification for all participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to get prior authorization. SMN precertification forms are available through Aetna's Specialty Pharmacy Precertification portal.
There are now two distinct pathways to medical necessity approval for relapsed or refractory multiple myeloma (ICD-10 C90.00 and C90.02).
Pathway 1 — Single-agent talquetamab-tgvs: The member must have received at least four prior therapies. Those therapies must include at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib—billing codes J9041, J9046, J9047, J9048, J9049 for bortezomib variants; J9047 for carfilzomib), at least one immunomodulatory agent (lenalidomide, pomalidomide, or thalidomide—no specific HCPCS code assigned), and at least one anti-CD38 monoclonal antibody (daratumumab or isatuximab—billing codes J9144, J9145, or J9227).
Pathway 2 — Combination with teclistamab-cqyv (Tecvayli): This is the new addition in this policy update. The member only needs at least three prior therapies—one fewer than the single-agent pathway. Teclistamab bills under J9380. This combination pathway is what makes the October 19, 2025 effective date significant. Patients who previously didn't qualify under the four-therapy threshold may now qualify under this route.
Reimbursement for talquetamab-tgvs under J3055 depends entirely on clearing this prior authorization hurdle. A missing or incomplete prior auth is the fastest path to a claim denial on this drug. Document every prior therapy with dates, NDC or HCPCS codes, and clinical response in the precert submission.
Continuation of therapy requires reauthorization. Aetna approves continued therapy when there is no evidence of unacceptable toxicity or disease progression on the current regimen. Build that language into your reauthorization request templates now.
Aetna Talquetamab-tgvs Exclusions and Non-Covered Indications
Aetna considers all uses of talquetamab-tgvs outside of relapsed or refractory multiple myeloma to be experimental, investigational, or unproven. Full stop. There are no other approved indications in this coverage policy.
If a provider submits J3055 for any indication other than C90.00 or C90.02, expect a denial. Emerging research into talquetamab for other hematologic malignancies does not factor into this policy. Aetna's position is unambiguous here.
The same applies to combinations not listed in the criteria. Talquetamab paired with anything other than teclistamab-cqyv as a combination regimen isn't covered under this policy. If your practice participates in trials using novel combinations, those claims need to go through a separate channel—not routine precertification under CPB 1042.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Relapsed/refractory multiple myeloma — single-agent talquetamab (≥4 prior therapies, including proteasome inhibitor, IMiD, and anti-CD38) | Covered | J3055, CPT 96401, C90.00, C90.02 | Prior auth required; document all prior therapy lines |
| Relapsed/refractory multiple myeloma — talquetamab + teclistamab-cqyv (≥3 prior therapies) | Covered | J3055, J9380, CPT 96401, C90.00, C90.02 | New pathway added October 19, 2025; prior auth required |
| Continuation of therapy (reauthorization) | Covered | J3055, CPT 96401, C90.00, C90.02 | Requires no evidence of toxicity or disease progression |
| Any other indication (including other hematologic malignancies) | Experimental / Not Covered | J3055 | Aetna considers all other uses unproven |
| Talquetamab in combination with agents other than teclistamab | Not Addressed / Presumed Not Covered | J3055 | Policy only covers teclistamab as approved combination partner |
Aetna Talquetamab-tgvs Billing Guidelines and Action Items 2025
The effective date is October 19, 2025. If you haven't already audited your workflow against this updated policy, do it now.
| # | Action Item |
|---|---|
| 1 | Update your precertification intake forms immediately. Your team needs to capture which pathway the patient qualifies under—single-agent (four prior therapies) or combination with teclistamab (three prior therapies). These are different clinical thresholds. A form that doesn't distinguish between them will slow your auth process and risk denials. |
| 2 | Verify prior therapy documentation for every new talquetamab-tgvs request. For the single-agent pathway, you need documented evidence of a proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), an immunomodulatory agent, and an anti-CD38 antibody. For the combination pathway, you need three prior therapies but Aetna's criteria don't specify the class breakdown. Pull treatment histories before the precert call, not during it. |
| 3 | Add J9380 (teclistamab-cqyv, 0.5 mg) to your charge capture alongside J3055 for combination regimen patients. These two drugs bill together. If your charge capture template only includes J3055, you'll miss J9380 claims or create mismatches that trigger reviews. |
| 4 | Build a reauthorization trigger into your treatment tracking system. Continuation of therapy requires reauthorization when there is no evidence of unacceptable toxicity or disease progression. Set a flag in your EHR or billing system to prompt a reauth request before the current auth period expires. A lapsed auth on a drug at this price point is expensive. |
| 5 | Use CPT 96401 for administration billing on every talquetamab-tgvs infusion. This is the chemotherapy administration code for subcutaneous or intramuscular non-hormonal anti-neoplastic agents. Confirm your infusion center has 96401 linked to talquetamab orders in your charge capture workflow. |
| 6 | Confirm your ICD-10 coding matches the policy. Aetna's coverage policy lists C90.00 (multiple myeloma without mention of having achieved remission) and C90.02 (multiple myeloma in relapse). If your coders are using a different C90 subcode, that's a claim denial waiting to happen. Check your encounter documentation for specificity. |
| 7 | Talk to your compliance officer if you're billing for talquetamab as part of a clinical trial or in a combination not listed in CPB 1042. This coverage policy is narrow. Off-label use outside the two approved pathways puts reimbursement at risk. Your compliance officer needs to weigh in on how you document and submit those claims. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Talquetamab-tgvs Under CPB 1042
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J3055 | HCPCS | Injection, talquetamab-tgvs, 0.25 mg |
| J9380 | HCPCS | Teclistamab-cqyv, 0.5 mg (combination pathway only) |
Other CPT Codes Related to CPB 1042
| Code | Type | Description |
|---|---|---|
| 96401 | CPT | Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic |
Prior Therapy Evidence Codes (for Documentation of Treatment History)
These codes represent the prior therapies Aetna requires evidence of for medical necessity approval. You won't bill these on the talquetamab claim, but your precert documentation should reference them.
| Code | Type | Description |
|---|---|---|
| J9041 | HCPCS | Injection, bortezomib, 0.1 mg |
| J9046 | HCPCS | Injection, bortezomib (Dr. Reddy's), not therapeutically equivalent to J9041, 0.1 mg |
| J9047 | HCPCS | Injection, carfilzomib, 1 mg |
| J9048 | HCPCS | Injection, bortezomib (Fresenius Kabi), not therapeutically equivalent to J9041, 0.1 mg |
| J9049 | HCPCS | Injection, bortezomib (Hospira), not therapeutically equivalent to J9041, 0.1 mg |
| J9144 | HCPCS | Injection, daratumumab, 10 mg and hyaluronidase-fihj |
| J9145 | HCPCS | Injection, daratumumab, 10 mg |
| J9227 | HCPCS | Injection, isatuximab-irfc, 10 mg |
Note: Lenalidomide and pomalidomide (immunomodulatory agents required under the single-agent pathway) do not have specific HCPCS codes listed in this policy. Document prior use of these agents by drug name, dates of therapy, and clinical notes in your precert submission.
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C90.00 | Multiple myeloma without mention of having achieved remission |
| C90.02 | Multiple myeloma in relapse |
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