CurrentMass General Brigham Health PlanPolicy N/A

Ultomiris (ravulizumab-cwvz) — MassHealth UPPL medical benefit coverage criteria

Defines prior authorization requirements, covered indications, prescriber qualifications, dosing appropriateness, and duration limits for Ultomiris under the MassHealth UPPL medical benefit. Applies to members of Mass General Brigham Health Plan covered under the MassHealth UPPL program.

Policy Summary

PayerMass General Brigham Health Plan

PolicyUltomiris (ravulizumab-cwvz) — MassHealth UPPL medical benefit coverage criteria

Policy CodePolicy N/A

Change TypeCriteria additions and step requirement refinements

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and supply diagnosis documentation, specialist consult notes, dosing details, and for gMG document positive response for continuation.

SourceLink

POLICY UPDATE CHANGES

Step-through with Imaavy, Rystiggo, Vyvgart, or Vyvgart Hytrulo was added in the generalized myasthenia gravis indication.

Criteria for myasthenia gravis now includes severity of disease and trial with IVIG or plasmapheresis with glucocorticoids.

Initial approval durations were updated (PNH/aHUS/NMOSD: 1 year; MG: 6 months).

4Indications listed

MassHealth UPPLPlan/program applicability

Prior AuthProgram type required

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PNH/aHUS/NMOSD: 1 yr; MG: 6 mo

Initial approval durations

Coverage and Medical Necessity Criteria

Atypical Hemolytic Uremic Syndrome (aHUS)

Authorization may be granted when ALL of the following are met:

aHUS criteria: 1. Diagnosis of atypical hemolytic uremic syndrome (aHUS); 2. Prescriber is a hematologist or nephrologist or consult notes from specialist are provided; 3. Appropriate dosing

Generalized Myasthenia Gravis (gMG)

Authorization may be granted when ALL of the following are met:

gMG initial criteria: 1. Diagnosis of generalized myasthenia gravis (MG); 2. Member is ≥ 18 years of age; 3. Member is AchR antibody positive; 4. Prescriber is a neurologist or consult notes from a neurology office are provided; 5. Inadequate response, adverse reaction, or contraindication to pyridostigmine; 7. Appropriate dosing; 8. Inadequate response or adverse reaction to ONE or contraindication to ALL of the following: a. Imaavy; b. Rystiggo; c. Vyvgart; d. Vyvgart Hytrulo

Includes severity/rapid-onset pathway in node 6

gMG step 6

6a severe disease pathway: a. BOTH of the following: i. Member has severe disease requiring faster onset medication; ii. Inadequate response, adverse reaction or contraindication to IVIG or plasmapheresis with glucocorticoids.
6b immunosuppressant pathway: b. Inadequate response or adverse reaction to TWO of the following or contraindication to ALL of the following immunosuppressant trials: i. azathioprine; ii. cyclosporine; iii. glucocorticoids (e.g., prednisone); iv. mycophenolate; v. tacrolimus.

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Authorization may be granted when ALL of the following are met:

NMOSD criteria: 1. Diagnosis of neuromyelitis optica spectrum disorder (NMOSD); 2. Prescriber is a neurologist or consult notes from specialist are provided; 3. Positive serologic test for anti-aquaporin-4 (AQP4); 4. Member is ≥ 18 years of age; 5. Appropriate dosing

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Authorization may be granted when ALL of the following are met:

PNH criteria: 1. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); 2. Prescriber is a hematologist or consult notes from specialist are provided; 3. Appropriate dosing

Continuation of Therapy

For continuation of therapy:

Continuation for gMG: Prescriber must provide documentation of positive response to therapy for generalized myasthenia gravis.

Continuation for other indications: For all other indications, prescriber reauthorization will infer a positive response to therapy.

Additional agents in the same drug class are available through the pharmacy benefit; refer to the MassHealth Drug List for pharmacy coverage and criteria. This policy applies to the MassHealth UPPL medical benefit, and prior authorization is required for Ultomiris when billed under the MassHealth UPPL medical benefit. Providers should note the distinction between pharmacy and medical benefit coverage when requesting authorization.

The criteria for generalized myasthenia gravis require that the member be AchR antibody positive. Use of Ultomiris for AchR-negative gMG is not supported by the listed approval criteria and therefore does not meet the policy’s coverage requirements.

Prescriber Requirements, Documentation, and Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required for MassHealth UPPL medical benefit requests for this medication. Authorization may be reviewed on a case-by-case basis for members who are new to the plan currently receiving the requested medication (excluding when product is obtained as samples or via manufacturer patient assistance programs).

MassHealth UPPL medical benefit prior authorization
Case-by-case review allowed for new-to-plan members on therapy (samples or manufacturer PAP excluded)

Step Therapy

gMG Step Requirements and Trials

For generalized myasthenia gravis (gMG), step requirements include documented inadequate response, adverse reaction, or contraindication to pyridostigmine, and additional step-throughs for IVIG or plasmapheresis with glucocorticoids when faster onset therapy is required; alternatively, failure of two standard immunosuppressants (azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus) may be required. Also, prior inadequate response or contraindication to one or contraindication to all of the listed targeted therapies (Imaavy, Rystiggo, Vyvgart, Vyvgart Hytrulo) must be documented.

Billing and Applicable Codes

Covered/Applicable Billing CodesHCPCS

HCPCS

Not specified in document — medical benefit applies (provider must use applicable HCPCS for administerable Ultomiris)

Background and Clinical Summary

Ultomiris (ravulizumab-cwvz) is a monoclonal antibody that targets complement protein C5, preventing its cleavage and thereby inhibiting formation of the terminal complement complex. It is indicated in this policy for complement-mediated and related disorders including atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD), and paroxysmal nocturnal hemoglobinuria (PNH).

Drug Definition

inv-14: Ultomiris (ravulizumab-cwvz) — key drug definition and mechanism

Drug nameUltomiris (ravulizumab-cwvz)

Drug classMonoclonal antibody complement inhibitor (targets C5)

Mechanism of actionBinds complement protein C5 with high affinity, inhibiting its cleavage to C5a and C5b and preventing formation of the terminal complement complex

Primary indications (document)Atypical hemolytic uremic syndrome (aHUS); generalized myasthenia gravis (gMG); paroxysmal nocturnal hemoglobinuria (PNH)

Targeted pathwayTerminal complement cascade (prevents generation of terminal complement complex)

Policy Summary

PayerMass General Brigham Health Plan

PolicyUltomiris (ravulizumab-cwvz) — MassHealth UPPL medical benefit coverage criteria

Policy CodePolicy N/A

Change TypeCriteria additions and step requirement refinements

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and supply diagnosis documentation, specialist consult notes, dosing details, and for gMG document positive response for continuation.

SourceLink

On This Page

Required trial: pyridostigmine
For severe disease requiring faster onset: trial or contraindication to IVIG or plasmapheresis with glucocorticoids
Alternative: inadequate response to TWO of azathioprine, cyclosporine, glucocorticoids, mycophenolate, tacrolimus
Required documentation of inadequate response/contraindication to Imaavy, Rystiggo, Vyvgart, or Vyvgart Hytrulo

Documentation Required

Required Documentation — Diagnosis, Specialist, Dosing, and Continuation

Prescribers must supply diagnosis confirmation, specialist prescriber credentials or consult notes (hematologist, nephrologist, or neurologist as applicable), and documentation of appropriate dosing. For continuation requests, provide evidence of positive response to therapy for generalized myasthenia gravis; for other indications, prescriber reauthorization will infer positive response. Include specialist consultation notes when the prescriber is not a listed specialist.

Diagnosis (e.g., aHUS, gMG, NMOSD, PNH)
Specialist prescriber (hematology, nephrology, neurology) or consult notes
Appropriate dosing information
Continuation: for gMG, documentation of positive clinical response; for other indications, reauthorization by prescriber infers response

Denial Risk

New-to-Plan Treatment Documentation and Denial Risk

New-to-plan members currently receiving treatment with the requested medication should have sufficient documentation demonstrating ongoing therapy and clinical response; insufficient evidence may lead to denial. Exceptions: products obtained only as samples or through manufacturer patient assistance programs are not eligible for this case-by-case continuation review.

New-to-plan continuation requires documentation of current therapy and response
Samples or manufacturer patient assistance program supplies are excluded from continuation review and authorization