CurrentAvMedPolicy N/A

Vyvgart Hytrulo - Generalized Myasthenia Gravis (gMG) (Pharmacy)

Pharmacy prior authorization and step-edit policy defining clinical criteria, documentation requirements, initial and reauthorization criteria, exclusions, dosing/quantity limits, and specialty pharmacy dispensing for Vyvgart Hytrulo for adults with gMG.

Policy Summary

PayerAvMed

PolicyVyvgart Hytrulo - Generalized Myasthenia Gravis (gMG) (Pharmacy)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed pharmacy prior authorization form signed by the prescribing neurologist with documentation (IgG, AchR antibody, baseline and follow-up MG-ADL and QMG scores, chart notes) and fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

11Clinical criteria lines (approx.)

6 monthsInitial Authorization Duration

4 syringes/28 daysQuantity Limit

Coverage Summary

Medical Necessity Criteria

Initial Authorization (6 months)

All criteria must be met for approval. To support each line checked, documentation (lab results, diagnostics, chart notes) must be provided.

ALL of the following

Prescribing physician must be a neurologist
Documentation must be provided
Member must be 18 years of age or older
Documentation must be provided
Member must have Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV disease and have a positive serologic test for anti-acetylcholine receptor (AchR) antibodies
Lab test for AchR antibodies must be submitted
Physician has assessed objective signs of neurological weakness and fatigability on a baseline neurological examination (e.g., including but not limited to the Quantitative Myasthenia Gravis (QMG) score)
Baseline neurologic exam/chart notes must be submitted
Member has a baseline MG-Activities of Daily Living (MG-ADL) total score ≥ 5MG-ADL total score >= 5
Results must be submitted
Member has a baseline immunoglobulin G (IgG) level of at least 6 g/L (600 mg)IgG >= 6 g/L (600 mg)
Results must be submitted
ONE of the following (prior therapies)
- Member has tried and had an inadequate response to pyridostigmine
  Documentation required (chart notes or claims)
- Member has an intolerance, hypersensitivity or contraindication to pyridostigmine
  Documentation required (chart notes or claims)
ONE of the following (immunosuppressive / rescue therapy history)
- Member failed over 1 year of therapy with at least 2 immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate)
  Documentation required
- Member failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, plasma exchange (PE) or intravenous immunoglobulin (IVIG)
  Documentation required
Member will avoid or use with caution medications known to worsen or exacerbate symptoms of MG (e.g., aminoglycosides, fluoroquinolones, beta-blockers, botulinum toxins, hydroxychloroquine)
Documentation required
Member does NOT have an active infection, including clinically important localized infections
Documentation required
Requested medication will NOT be administered with live-attenuated or live vaccines during treatment
Documentation required
Medication will NOT be used in combination with other immunomodulatory biologic therapies (examples listed in policy)
Documentation required

Reauthorization (6 months)

All criteria must be met for approval. Documentation including labs, diagnostics, chart notes must be provided.

ALL of the following

Member continues to meet all initial authorization criteria
Documentation required
Member has NOT experienced unacceptable toxicity from the drug (e.g., infections, severe hypersensitivity reactions, infusion reactions)
Documentation required
ONE of the following (clinical response)
- Member has demonstrated an improvement of at least 2 points in the MG-ADL total score from baseline sustained for at least 4 weeksMG-ADL improvement >= 2 points sustained >= 4 weeks
  Results must be submitted to document improvement

Exclusions / Not eligible

Therapy will NOT be approved if the member has any of the following at treatment initiation:

ANY of the following

MGFA Class I at initiation of treatment
Exclusion at treatment initiation
Myasthenic crisis at initiation of treatment (MGFA Class V)
Exclusion at treatment initiation
Use of rituximab within 6 months prior to treatment
Exclusion at treatment initiation
Use of IVIG or plasma exchange (PE) within 4 weeks prior to treatment
Exclusion at treatment initiation

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Submit completed pharmacy prior authorization form signed by the prescribing neurologist and include supporting documentation (labs: IgG, AchR antibody; baseline and follow-up MG-ADL and QMG scores; chart notes verifying prior therapies and objective neurologic exam). Fax the completed and signed form to 1-305-671-0200. Prescriber signature must be an actual signature (preprinted stamps not valid).

Fax: 1-305-671-0200
Prescribing neurologist signature required (preprinted stamps not valid)

Documentation Required

Baseline and ongoing clinical documentation

Provide baseline and ongoing clinical documentation to support initial authorization and reauthorization. Submit baseline MG-ADL total score, baseline QMG score, baseline IgG level, anti-acetylcholine receptor (AchR) antibody results, and chart notes documenting prior therapies and objective neurologic examination findings. These results and notes must be submitted for both initial requests and reauthorization to demonstrate eligibility and response.

Baseline MG-ADL total score (≥ 5) and follow-up MG-ADL results
Quantitative Myasthenia Gravis (QMG) score (baseline and follow-up)
Immunoglobulin G (IgG) level
Anti-acetylcholine receptor (AchR) antibody results
Chart notes verifying prior therapies and objective neurologic exam findings

Billing Rule

Quantity limit

Quantity limit applies per dosing guidance.

Quantity limit: 4 syringes per 28 days.

Documentation Required

Specialty pharmacy dispensing

Medication is dispensed by the Specialty Pharmacy - Proprium Rx. Note that use of samples to initiate therapy does not meet preauthorization/step-edit criteria and will not satisfy authorization requirements.

Definitions & Background

This is a form-based pharmacy prior authorization for efgartigimod alfa/hyaluronidase (Vyvgart Hytrulo) for the treatment of generalized myasthenia gravis (gMG). The form requires prescriber signature and completion of member and drug information, documentation of diagnosis and applicable ICD code, and submission of supporting clinical documentation. Recommended dosing: SUBQ: 1,000 mg efgartigimod alfa/10,000 units hyaluronidase once weekly for 4 weeks per cycle, with subsequent cycles based on clinical evaluation; quantity limit is 4 syringes per 28 days.

MG-ADL: MG—Activities of Daily Living score is a patient-reported outcome used to assess symptom burden in myasthenia gravis; baseline total score of ≥ 5 is required for initial authorization and an improvement of ≥ 2 points sustained for ≥ 4 weeks is one reauthorization criterion.

QMG: Quantitative Myasthenia Gravis (QMG) is an objective physician-assessed measure of muscle strength and fatigability; an improvement of ≥ 3 points from baseline sustained for ≥ 4 weeks is an alternative reauthorization criterion.

MGFA: Myasthenia Gravis Foundation of America (MGFA) Clinical Classification is used to define disease class; therapy is intended for patients with MGFA Class II–IV and is excluded for patients with MGFA Class I or myasthenic crisis (MGFA Class V) at treatment initiation.

OpenPayer

Vyvgart Hytrulo - Generalized Myasthenia Gravis (gMG) (Pharmacy)

Coverage Summary

Medical Necessity Criteria

Provider Actions & Requirements

Coding

Definitions & Background

Revision History