CurrentMass General Brigham Health PlanPolicy N/A

Empaveli (pegcetacoplan) prior authorization and coverage

Defines prior authorization, coverage criteria, quantity limits, and renewal rules for Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH) under the plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyEmpaveli (pegcetacoplan) prior authorization and coverage

Policy CodePolicy N/A

Change TypeStep-therapy requirementquantity limitapproval duration clarified

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of PNH, specialist involvement, and inadequate response/adverse reaction or contraindication to Soliris or Ultomiris.

SourceLink

POLICY UPDATE CHANGES

Criteria updated to require step-through with Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz) and include a specified quantity limit.

Initial approval durations updated to 12 months.

12 monthsApproval duration

>=18Minimum age

<160 mL/30dQty limit

Coverage and Authorization Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial authorization criteria: Member is 18 years of age or older.

Documentation required to verify age and eligibility.

Initial authorization criteria: Member has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH).

Provide clinical documentation confirming PNH diagnosis (e.g., flow cytometry or specialist notes).

Initial authorization criteria: Prescriber is a hematologist or consult notes from a specialist are provided.

Include specialist attestation or consult notes with the request if prescriber is not a hematologist.

Initial authorization criteria: Inadequate response or adverse reaction to one, or contraindication to all, of the following agents: Piasky, Soliris (eculizumab), Ultomiris (ravulizumab).

Document prior therapies, response, adverse reactions, or contraindications.

Initial authorization criteria: Requested quantity is less than 160 mL per 30 days.< 160 mL/30 days

Provide dosing and quantity calculations to demonstrate requested amount is within limit.

Continuation of Therapy / Reauthorization

Reauthorization requirements:

Reauthorization criteria: Reauthorization by physician will infer a positive response to therapy.

Physician attestation of clinical benefit is required for renewal.

Reauthorization criteria: Initial approvals and reauthorizations will be granted for 12 months.

Specify next renewal date and provide documentation of ongoing benefit at reauthorization time.

The therapy is not appropriate for patients who are under 18 years of age, for diagnoses other than paroxysmal nocturnal hemoglobinuria (PNH), or when the prescribing clinician is not a hematologist and no specialist consult notes are provided. Authorization also requires documentation of an inadequate response, adverse reaction, or contraindication to listed prior biologic agents (Piasky, Soliris, Ultomiris). Requests lacking these elements do not meet the stated coverage criteria.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for medical benefit. Empaveli may also be available through the pharmacy benefit; check the MassHealth Drug List for pharmacy coverage and criteria.

Medical benefit prior authorization required
Pharmacy benefit availability — see MassHealth Drug List

Step Therapy

Step Therapy / Prior Biologic Required

Step therapy required: member must have inadequate response or adverse reaction to, or a contraindication to, Piasky and either Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz) before Empaveli will be authorized.

Step-through agents: Piasky; Soliris (eculizumab); Ultomiris (ravulizumab-cwvz)
Exception allowed for inadequate response, adverse reaction, or documented contraindication to all listed agents

Documentation Required

Documentation for Members New to Plan

For members new to the plan, provide documentation of current treatment, diagnostics, and specialist care. Authorization may be reviewed for members new to the plan who are currently receiving Empaveli (excluding samples or manufacturer patient assistance program supplies).

Document current treatment with Empaveli if member is new to the plan
Provide diagnostic documentation supporting PNH diagnosis
Include specialist documentation or consult notes

Denial Risk

Denial Risk Conditions

Denial risk if criteria not met. Possible denial when patient is under 18 years, has no diagnosis of paroxysmal nocturnal hemoglobinuria (PNH), or when the prescriber is not a hematologist and no specialist consult notes are provided. Ensure requested quantity is < 160 mL/30 days and all required documentation is submitted.

Patient < 18 years — not eligible
No PNH diagnosis — not eligible
Prescriber not a hematologist — provide specialist consult notes
Requested quantity must be < 160 mL/30 days

Key Definitions

Paroxysmal nocturnal hemoglobinuria (PNH) — definition & monitoring guidance

Definition of PNHParoxysmal nocturnal hemoglobinuria (PNH) is a hematologic disorder treated with complement inhibition; Empaveli is indicated for adults with PNH.

Diagnostic guidanceDiagnosis and monitoring references include flow cytometry and hematology guidelines (see Borowitz et al. and Parker CJ).

Monitoring referencesKey references: Empaveli package insert (Jan 2025); Parker CJ reviews on PNH diagnosis/management; Borowitz MJ et al. flow cytometry guidelines.

Age groupPolicy applies to adults (>= 18 years) with a diagnosis of PNH when prescribing Empaveli.