CurrentMass General Brigham Health PlanPolicy N/A

PiaSky (crovalimab-akkz) — Prior authorization and coverage criteria for PNH

Prior authorization and coverage criteria for PiaSky (crovalimab-akkz) under Mass General Brigham Health Plan pharmacy benefit for patients with PNH age ≥13 years and ≥40 kg.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPiaSky (crovalimab-akkz) — Prior authorization and coverage criteria for PNH

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateJul 9, 2025

Key ActionObtain prior authorization and document trial and failure, intolerance, or contraindication to one C5 inhibitor (eculizumab or ravulizumab) before approval; reauthorization requires documentation of positive response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13+minimum patient age

≥40 kgminimum body weight

12 moauthorization duration

1 trialprior C5 inhibitor required

Coverage Criteria for PiaSky (crovalimab-akkz)

Initial Therapy

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

Main coverage criteria: Member has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) confirmed by flow cytometry

PNH confirmation by flow cytometry required.

Main coverage criteria: Member is 13 years of age or older>= 13 years

Minimum age for coverage.

Main coverage criteria: Member weighs at least 40 kilograms>= 40 kilograms

Minimum body weight for coverage.

Main coverage criteria

ONE of: Soliris (eculizumab)
ONE of: Ultomiris (ravulizumab)

Continuation of Therapy

Requests for reauthorization will be approved when the following criteria are met:

Continuation criteria: Documentation of a positive response to therapy (examples include normalization of lactate dehydrogenase [LDH] levels, hemoglobin stabilization, decreased number of red blood cell transfusions)

Reauthorizations and initial approvals are limited to 12 months.

Authorization does not cover members who were newly started on therapy using medication samples or through a manufacturer's patient assistance program. For members new to the plan within the last 90 days, authorization may be considered only if they are currently receiving the medication and are clinically stable; this exception explicitly excludes treatment begun via samples or patient assistance programs.

Provider Requirements and Administrative Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. New-to-plan members (enrolled within the last 90 days) who are currently receiving the medication and are clinically stable may be authorized; this does not apply if the product was obtained as samples or through a manufacturer's patient assistance program.

New-to-plan authorization allowed when member is currently receiving and clinically stable
Excludes medications obtained as samples or via manufacturer assistance

Step Therapy

Required prior C5 inhibitor trial

Member must have trial and failure, intolerance, or contraindication to ONE of the following C5 inhibitors prior to authorization: Soliris (eculizumab) or Ultomiris (ravulizumab).

Required prior trial of Soliris (eculizumab) or Ultomiris (ravulizumab) — document trial and reason for failure/intolerance/contraindication

Documentation Required

Reauthorization Documentation Required

For reauthorization, clinical documentation demonstrating a positive response to therapy is required. Examples of acceptable objective response measures include but are not limited to normalization or substantial reduction of lactate dehydrogenase (LDH) levels, stabilization or improvement in hemoglobin, and decreased requirement for red blood cell transfusions. Include relevant lab results, transfusion records, and clinical notes showing treatment benefit.

Examples of objective response: LDH normalization or marked reduction; hemoglobin stabilization/improvement; fewer RBC transfusions

Denial Risk

Triggers for Denial

Authorizations may be denied if the member is not clinically stable on therapy when new to the plan, or if documentation does not meet the coverage criteria (including lack of required prior C5 inhibitor trial or insufficient evidence of response on reauthorization).

Denial triggers: new-to-plan member not stable on therapy
Denial triggers: missing required prior trial documentation
Denial triggers: insufficient reauthorization evidence of clinical benefit

Policy Summary

PayerMass General Brigham Health Plan

PolicyPiaSky (crovalimab-akkz) — Prior authorization and coverage criteria for PNH

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateJul 9, 2025

SourceLink

On This Page

OpenPayer

PiaSky (crovalimab-akkz) — Prior authorization and coverage criteria for PNH

Coverage Criteria for PiaSky (crovalimab-akkz)

Provider Requirements and Administrative Actions

Key Coding and Patient Metrics

Definitions and Diagnostic Requirements

Background