Aetna modified CPB 1021 for mirvetuximab soravtansine-gynx (Elahere), effective January 29, 2026. Here's what billing teams need to know.
Aetna, a CVS Health company, updated its Elahere coverage policy under CPB 1021 Aetna system to add a second covered indication — platinum-sensitive recurrent disease — alongside the existing platinum-resistant pathway. The primary billing code is J9063 (injection, mirvetuximab soravtansine-gynx, 1 mg), administered via CPT codes 96413–96417 for chemotherapy infusion. If your oncology or gynecologic oncology practice bills Elahere for Aetna commercial members, this update changes what qualifies for reimbursement and adds a tighter biomarker threshold you must document before claims go out.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Mirvetuximab Soravtansine-gynx (Elahere) |
| Policy Code | CPB 1021 |
| Change Type | Modified |
| Effective Date | January 29, 2026 |
| Impact Level | High |
| Specialties Affected | Gynecologic Oncology, Medical Oncology, Hematology/Oncology |
| Key Action | Confirm folate receptor-alpha expression testing is documented before submitting precertification for either covered pathway |
Aetna Elahere Coverage Criteria and Medical Necessity Requirements 2026
CPB 1021 covers mirvetuximab soravtansine-gynx (Elahere) for two distinct clinical scenarios. Both require folate receptor-alpha (FRα) positive epithelial ovarian, fallopian tube, or primary peritoneal cancer. The pathways diverge by platinum status — and the documentation requirements differ significantly between them.
Pathway 1: Platinum-Resistant Disease
Aetna considers Elahere medically necessary when the member has platinum-resistant disease, has received at least one prior systemic therapy, and will use Elahere as a single agent or in combination with bevacizumab (J9035 or C9257). There is no minimum FRα expression threshold stated for this pathway — coverage policy just requires FRα positivity. The bevacizumab combination option is specific to this pathway. Do not assume it extends to platinum-sensitive patients.
Pathway 2: Platinum-Sensitive Recurrent Disease
This is the new addition in the January 2026 update, and it has a harder bar. The member must have recurrent platinum-sensitive disease, must have received two prior lines of platinum-based therapy (not just one), must use Elahere as a single agent only, and the tumor must be at least 75% positive for folate receptor-alpha expression. That 75% threshold is a claim denial waiting to happen if your documentation doesn't explicitly state it. Pull the pathology report. Confirm the percentage. Include it in the prior authorization request.
Prior Authorization Is Mandatory
Precertification is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277. Statement of Medical Necessity (SMN) forms are available through Aetna's Specialty Pharmacy Precertification portal. Do not bill J9063 without confirmed prior auth in hand — claim denial is the predictable outcome.
Continuation of Therapy
Reauthorization requires that the member shows no evidence of unacceptable toxicity or disease progression on the current regimen. Document clinical response at each reauthorization cycle. If your notes don't address toxicity and progression status, expect delays.
Aetna Elahere Exclusions and Non-Covered Indications
Aetna's coverage policy is direct on this: all other indications for mirvetuximab soravtansine-gynx are considered experimental, investigational, or unproven. That's not a soft hedge. Any use outside the two pathways above — different tumor types, different line-of-therapy sequences, combination use in platinum-sensitive patients — will not pass medical necessity review.
The platinum-sensitive pathway's single-agent-only restriction matters here. A provider who requests Elahere plus bevacizumab for a platinum-sensitive member is asking for something the policy explicitly doesn't cover. Make sure your oncology team understands that the combination pathway only applies to platinum-resistant disease.
If a member's FRα expression is below 75% and they have platinum-sensitive disease, there is no workaround in this policy. The threshold is a hard criterion.
Coverage Indications at a Glance
| Indication | Status | Key Codes | Notes |
|---|---|---|---|
| Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (FRα positive), ≥1 prior systemic therapy, single agent or + bevacizumab | Covered | J9063, J9035, C9257, CPT 96413–96417 | Prior auth required; no minimum FRα % threshold stated |
| Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (FRα positive, ≥75%), ≥2 prior platinum-based lines, single agent only | Covered | J9063, CPT 96413–96417 | Prior auth required; 75% FRα expression threshold must be documented; no bevacizumab combination |
| Continuation of therapy (either pathway) | Covered | J9063 | Reauthorization requires no disease progression and no unacceptable toxicity |
| All other indications | Not Covered | — | Considered experimental, investigational, or unproven |
Aetna Elahere Billing Guidelines and Action Items 2026
The January 29, 2026 effective date is already in effect. If your team hasn't updated workflows for the new platinum-sensitive pathway, do it now.
| # | Action Item |
|---|---|
| 1 | Update your precertification templates immediately. Add a field for FRα expression percentage. For platinum-sensitive cases, the 75% threshold must appear explicitly in the authorization request. A generic "FRα positive" notation won't be enough. |
| 2 | Separate your platinum-resistant and platinum-sensitive prior auth workflows. The criteria differ in three ways: prior therapy line count, combination eligibility, and FRα threshold. Using one template for both is how documentation errors happen. |
| 3 | Bill J9063 per milligram and verify your dose. Elahere mirvetuximab soravtansine-gynx billing under J9063 is per 1 mg. Confirm the ordered dose against the authorized units before submitting. Dose-to-billed-units mismatches are a common denial trigger for ADC (antibody-drug conjugate) drugs. |
| 4 | Pair J9063 with the correct administration codes. Use CPT 96413 for the initial chemotherapy infusion hour and CPT 96415 for each additional hour. If Elahere is given with bevacizumab on platinum-resistant claims, add J9035 or C9257 for bevacizumab and bill concurrent infusion administration under CPT 96417. Match your charge capture to the actual administration sequence. |
| 5 | Document platinum status explicitly in clinical notes. "Platinum-resistant" or "platinum-sensitive" must appear in the medical record — not just implied by line-of-therapy sequence. Aetna reviewers will look for it during precertification and audits. |
| 6 | Flag platinum-sensitive cases for compliance review. This is a new pathway with a biomarker threshold. If you're not certain how to document or code the 75% FRα criterion for your patient mix, talk to your compliance officer before submitting claims under this pathway. |
| 7 | Set a reauthorization trigger in your workflow. Continuation of therapy requires a separate authorization showing no progression and no unacceptable toxicity. Build a reminder into your infusion scheduling system so reauthorization requests don't lag behind treatment cycles. |
| 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 Mirvetuximab Soravtansine-gynx Under CPB 1021
HCPCS Codes — Covered When Selection Criteria Are Met
| Code | Type | Description |
|---|---|---|
| J9063 | HCPCS | Injection, mirvetuximab soravtansine-gynx, 1 mg |
HCPCS Codes — Related to CPB 1021 (Supporting/Combination Agents)
| Code | Type | Description |
|---|---|---|
| C9257 | HCPCS | Injection, bevacizumab, 0.25 mg |
| J9035 | HCPCS | Injection, bevacizumab, 10 mg |
| J9045 | HCPCS | Injection, carboplatin, 50 mg |
| J9060 | HCPCS | Injection, cisplatin, powder or solution, 10 mg |
| J9263 | HCPCS | Injection, oxaliplatin, 0.5 mg |
CPT Codes — Intravenous Infusion Administration
| Code | Type | Description |
|---|---|---|
| 96365 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour |
| 96366 | CPT | Intravenous infusion, each additional hour |
| 96367 | CPT | Intravenous infusion, additional sequential infusion |
| 96368 | CPT | Intravenous infusion, concurrent infusion |
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique; initiation of prolonged chemotherapy infusion (more than 8 hours) |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique; each additional hour |
| 96416 | CPT | Chemotherapy administration, intravenous infusion technique; initiation of prolonged chemotherapy infusion requiring use of a portable or implantable pump |
| 96417 | CPT | Chemotherapy administration, intravenous infusion technique; each additional sequential infusion |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C56.1 | Malignant neoplasm of right ovary |
| C56.2 | Malignant neoplasm of left ovary |
| C56.3 | Malignant neoplasm of bilateral ovaries |
| C56.4 | Malignant neoplasm of ovary, bilateral involvement (use with caution — confirm version-specific mapping) |
| C56.5–C56.9 | Malignant neoplasm of ovary, additional specificity codes |
| C57.0 | Malignant neoplasm of fallopian tube, right |
| C57.1 | Malignant neoplasm of fallopian tube, left |
| C57.2 | Malignant neoplasm of fallopian tube, bilateral |
| C48.0–C48.8 | Malignant neoplasm of retroperitoneum and peritoneum (primary peritoneal cancer) |
Use the most specific laterality code available. For primary peritoneal cancer, C48.x codes are the relevant ICD-10 range under this policy. Confirm your ICD-10 version mapping — some C56 subcodes have shifted in recent fiscal year updates.
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