Efgartigimod Alfa-fcab (Vyvgart) and Efgartigimod Alfa and Hyaluronidase-qvfc (Vyvgart Hytrulo) — CPB 1002 | AETNA Coverage Update

Aetna modified CPB 1002 for efgartigimod alfa (Vyvgart and Vyvgart Hytrulo), effective December 10, 2025. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its Vyvgart and Vyvgart Hytrulo coverage policy under CPB 1002 Aetna system, effective December 10, 2025. The policy governs HCPCS codes J9332 (efgartigimod alfa-fcab, 2 mg) and J9334 (efgartigimod alfa and hyaluronidase-qvfc, 2 mg) across two approved indications: generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). If your practice bills either code for commercial Aetna members, this policy sets the prior authorization requirements and medical necessity criteria you need to meet before December 10.

---

Quick Reference

Field	Detail
Payer	Aetna, a CVS Health company
Policy	Efgartigimod Alfa-fcab (Vyvgart) and Efgartigimod Alfa and Hyaluronidase-qvfc (Vyvgart Hytrulo)
Policy Code	CPB 1002
Change Type	Modified
Effective Date	December 10, 2025
Impact Level	High
Specialties Affected	Neurology, Infusion Therapy, Specialty Pharmacy, Neuromuscular Medicine
Key Action	Audit open authorizations for J9332 and J9334 against updated gMG and CIDP criteria before December 10, 2025

---

Aetna Vyvgart Coverage Criteria and Medical Necessity Requirements 2025

This is a multi-condition policy with separate medical necessity criteria for each indication. Get these wrong and your claim denial is predictable. Read the criteria carefully — they are not identical between gMG and CIDP, and the allowed formulations differ between the two.

Generalized Myasthenia Gravis (gMG)

Aetna covers either Vyvgart (J9332) or Vyvgart Hytrulo (J9334) for gMG, but only when all five of the following criteria are met:

The step therapy requirement for gMG has three paths. The member must meet one:

#	Covered Indication Copy
1	Inadequate response or intolerable adverse event to at least two immunosuppressive therapies (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, tacrolimus) over at least 12 months; or
2	Inadequate response or intolerable adverse event to at least one immunosuppressive therapy plus IVIG over at least 12 months; or
3	A documented clinical reason to avoid both immunosuppressive agents and IVIG.

The 12-month duration requirement on the first two paths is a hard gate. If your documentation shows less than 12 months of prior therapy, expect a denial. This isn't unusual — it mirrors how Aetna handles other specialty neurological agents — but it requires precise chart documentation before you submit.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

For CIDP, only Vyvgart Hytrulo (J9334) qualifies. The IV formulation (J9332, Vyvgart) is not covered for this indication. All of the following must be met:

#	Covered Indication Copy
1	Progressive or relapsing/remitting disease course for two months or longer.
2	Diagnosis confirmed by electrodiagnostic testing consistent with EFNS/PNS guidelines. This means nerve conduction studies (CPT 95907–95913) or needle EMG (CPT 95860–95872, 95885–95887) are part of the required documentation trail.
3	The member meets one of the following: inadequate response or intolerable adverse event to immunoglobulins, corticosteroids, or plasma exchange (CPT 36514); or a documented clinical reason to avoid those therapies.

The electrodiagnostic confirmation requirement is specific and documentable. When you pull records for prior authorization submission, confirm the EFNS/PNS-consistent workup is in the chart. If it isn't, the authorization won't go through.

Prior Authorization Requirements

Precertification is required for all Aetna participating providers and members on applicable plan designs — for both J9332 and J9334. Call (866) 752-7021 or fax (888) 267-3277. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification portal.

Don't skip the site-of-care step for CIDP. Aetna's Site of Care Utilization Management Policy applies to Vyvgart Hytrulo for the CIDP indication specifically. Before you book a site of service for J9334 CIDP infusions, verify the site-of-care rules separately. Filing at the wrong site is a billing risk that prior auth alone won't cover.

---

Aetna Vyvgart Exclusions and Non-Covered Indications

Aetna considers all indications outside gMG and CIDP experimental, investigational, or unproven. There are no other approved uses under this coverage policy.

The combination restriction for gMG is effectively an exclusion. If a member is already on Rystiggo, Soliris, Ultomiris, or Zilbrysq, Vyvgart and Vyvgart Hytrulo are not medically necessary under this policy. Verify the member's current specialty drug profile before submitting authorization — a concurrent FcRn blocker or complement inhibitor is an automatic denial trigger.

---

Coverage Indications at a Glance

---

Aetna Vyvgart Billing Guidelines and Action Items 2025

Copy Action Items

If your practice sees a high volume of neuromuscular or CIDP patients across multiple payer plans, talk to your compliance officer before the December 10 effective date. The site-of-care layer on top of prior authorization creates a two-gate approval process that's easy to mismanage.

---

CPT, HCPCS, and ICD-10 Codes for Vyvgart and Vyvgart Hytrulo Under CPB 1002

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J9332	HCPCS	Injection, efgartigimod alfa-fcab, 2 mg (Vyvgart — IV formulation)
J9334	HCPCS	Injection, efgartigimod alfa and hyaluronidase-qvfc, 2 mg (Vyvgart Hytrulo — subcutaneous formulation)

Reference HCPCS Codes (Concurrent/Prior Therapy Context)

The policy references these codes in the context of prior therapy, concurrent agent restrictions, or comparator treatments. They are not covered under CPB 1002 for Vyvgart billing, but they appear in the policy documentation and may be relevant to medical necessity documentation.

Note: The policy data includes 162 total HCPCS codes. The full code list includes additional immune globulin formulations (J1492 and above). For the complete list, see the full CPB 1002 policy at app.payerpolicy.org/p/aetna/1002.

Key ICD-10-CM Diagnosis Codes

The policy data does not list specific ICD-10-CM codes. Confirm appropriate diagnosis coding for gMG and CIDP with your coding team using current ICD-10-CM conventions.

---