Neonatal Fc Receptor Blockers

POLICY NUMBER

L.5.01.616

Imaavy (nipocalimab-aahu)

Rystiggo (rozanolixizumab-noli)

Vyvgart (efgartigimod alfa-fcab)

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Rozanolixizumab, efgartigimod alfa, and nipocalimab are monoclonal antibodies that bind to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.

Rystiggo (rozanolixizumab-noli) is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Vyvgart (efgartigimod alfa-fcab) is indicated for the treatment of gMG in adult patients who are AChR antibody positive. Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with gMG who are AChR antibody positive and for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

Imaavy (nipocalimab-aahu) is indicated for the treatment of gMG in adult and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

Rystiggo (rozanolixizumab-noli) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 18 years of age or older;

2. The individual has a documented diagnosis of generalized Myasthenia Gravis (gMG) and ALL of the following:

   1. ONE of the following:

      1. The individual has a positive anti-AChR antibody; OR

      2. The individual has a positive anti-MuSK antibody;

   2. The individual has a Myasthenia Gravis Foundation of America (MFGA) clinical classification class of II-IV;

   3. The individual has a MG-Activities of Daily Living total score of greater than or equal to 6; AND

   4. ONE of the following:

      1. The individual has tried and had an inadequate response (see Policy Guidelines) to corticosteroids AND at least one immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate, mycophenolate, tacrolimus, cyclophosphamide) either in combination or as monotherapy;

      2. The individual has an FDA-labeled contraindication, intolerance, or hypersensitivity to ALL conventional agents used for the treatment of myasthenia gravis (i.e., e.g., corticosteroids, azathioprine, cyclosporine, methotrexate, mycophenolate, tacrolimus, cyclophosphamide); OR

      3. The individual has required chronic IVIG or plasmapheresis/plasma exchange (i.e., at least every 3 months over 12 months without symptom control);

3. The individual will NOT be using the requested agent in combination with a complement inhibitor [e.g. Soliris (eculizumab), Ultomiris (ravulizumab)] or another neonatal Fc receptor blocker;

4. The prescriber is a specialist in the area of the individual’s diagnosis (e.g., neurologist) or has consulted with a specialist in the area of the individual’s diagnosis;

5. The individual does not have any FDA-labeled contraindications to the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on the FDA approved labeled dosage.

Length of Approval:  6 months

Renewal Criteria

Rystiggo (rozanolixizumab-noli) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for the requested agent through the BCBSMS PA process;

2. The individual has documented clinical response/improvement (i.e., reductions in exacerbations of gMG, improvements in activities of daily living reflected by greater than or equal to 3-point improvement in the MG-ADL from baseline, etc.);

3. The prescriber is a specialist in the area of the individual’s diagnosis or has consulted with a specialist in the area of the individual’s diagnosis (e.g., neurologist); 

4. The requested agent is not used in combination with a complement inhibitor or another neonatal Fc receptor blocker;

5. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) are considered not medically necessary as other formulary alternatives are covered by the Plan for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).

Imaavy (nipocalimab-aahu) is considered not medically necessary as other formulary alternatives are covered by the Plan for the treatment of generalized myasthenia gravis (gMG). 

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for ≥3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

05/15/2025: Effective 07/15/2025 - New policy added. Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee.

11/01/2025: Policy title changed from "Neonatal Fc Receptor Blockers (Rystiggo, Vyvgart, and Vyvgart Hytrulo)" to "Neonatal Fc Receptor Blockers." Policy description updated regarding indications for Imaavy (nipocalimab-aahu). Added policy statement that Imaavy (nipocalimab-aahu) is considered not medically necessary as other formulary alternatives are covered by the Plan for the treatment of generalized myasthenia gravis (gMG). Sources updated. Code Reference section updated to add HCPCS code C9305 to the Not Medically Necessary Codes table.

01/01/2026: Code Reference section updated to add new HCPCS code J9256.

SOURCE(S)

1. Bird SJ. Chronic immunotherapy for myasthenia gravis. UpToDate, Connor RF (Ed), Wolters Kluwer.

   https://www.uptodate.com/contents/chronic-immunotherapy-for-myasthenia-gravis

2. Imaavy prescribing information. Janssen Biotech, Inc. May 2025. Last accessed October 2025.

3. Rystiggo prescribing information. UCB, Inc. June 2024. Last accessed February 2025.

4. Vu T, Wiendl H, Katsuno M, Reddel SW, Howard JF Jr. Ravulizumab in Myasthenia Gravis: A Review of the Current Evidence. Neuropsychiatr Dis Treat. 2023 Dec 1;19:2639-2655. doi: 10.2147/NDT.S374694. PMID: 38059203; PMCID: PMC10697093.

5. Vyvgart prescribing information. Argenx US. January 2025. Last accessed February 2025.

6. Vyvgart Hytrulo prescribing information. Argenx US. August 2024. Last accessed February 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes        

Not Medically Necessary Codes

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