CurrentAmeriHealth Caritas VIP CarePolicy MA08.0178

Crovalimab-akkz (PiaSky) Coverage for Paroxysmal Nocturnal Hemoglobinuria

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Medical-benefit coverage and prior authorization for crovalimab-akkz (PiaSky) to treat paroxysmal nocturnal hemoglobinuria in adults and pediatric individuals age 13 years and older who weigh at least 40 kg, subject to clinical, safety, dosing, frequency, documentation, and benefit-contract requirements.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyCrovalimab-akkz (PiaSky) Coverage for Paroxysmal Nocturnal Hemoglobinuria

Policy CodePolicy MA08.0178

Change TypeAdministrative annual reviewno material clinical or coverage changes

Effective DateSeptember 16, 2025

Next Review DateNot specified

Key ActionPrescribers must enroll in the PiaSky REMS, counsel individuals about meningococcal infection risk, provide REMS educational materials, and ensure meningococcal vaccination.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PNHCovered indication

Age 13+; ≥40 kgEligible population

Every 4 weeksMaintenance frequency

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CurrentAmeriHealth Caritas VIP CarePolicy MA08.0178

Crovalimab-akkz (PiaSky) Coverage for Paroxysmal Nocturnal Hemoglobinuria

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyCrovalimab-akkz (PiaSky) Coverage for Paroxysmal Nocturnal Hemoglobinuria

Policy CodePolicy MA08.0178

Change TypeAdministrative annual reviewno material clinical or coverage changes

Effective DateSeptember 16, 2025

Next Review DateNot specified

Key ActionPrescribers must enroll in the PiaSky REMS, counsel individuals about meningococcal infection risk, provide REMS educational materials, and ensure meningococcal vaccination.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PNHCovered indication

Age 13+; ≥40 kgEligible population

Every 4 weeksMaintenance frequency

No unresolved N. meningitidis infection

Infection restriction

No other complement inhibitorConcomitant therapy restriction

Coverage Criteria

Initial Therapy Criteria

Covered when all initial criteria are met.

Initial therapy for PNH

Eligibility and disease findings
- The individual is an adult or pediatric individual age 13 years or older with PNH and weighs at least 40 kg.Age ≥13 years; weight ≥40 kg
- Flow-cytometry finding
  - Flow cytometry demonstrates at least 10% PNH type III red cells.≥10% PNH type III red cells
  - Flow cytometry demonstrates greater than 50% GPI-AP-deficient polymorphonuclear cells.>50% GPI-AP-deficient PM cells
- The individual exhibits clinical manifestations of PNH.Examples include LDH greater than 1.5 times the upper limit of normal, thrombosis, renal dysfunction, pulmonary hypertension, or dysphagia
- The individual is transfusion dependent due to PNH.
Safety and concomitant-therapy requirements
- The individual does not have an unresolved Neisseria meningitidis infection.
- The individual is vaccinated against N. meningitidis, unless the risk of delaying crovalimab-akkz (PiaSky) outweighs the risk of developing meningococcal infection.
  A risk-based exception must be documented when applicable.
- Crovalimab-akkz (PiaSky) will not be used in combination with another complement inhibitor for treatment of PNH.
  Examples include Empaveli, Fabhalta, Soliris, and Ultomiris.
Required dosing and frequency
- Applicable weight-based regimen
  - For body weight 40 kg to less than 100 kg: 1000 mg intravenously on Day 1, followed by 340 mg subcutaneously once weekly on Days 2, 8, 15, and 22; then 680 mg subcutaneously starting on Day 29 and every 4 weeks thereafter.40 kg to <100 kg
  - For body weight 100 kg or greater: 1500 mg intravenously on Day 1, followed by 340 mg subcutaneously once weekly on Days 2, 8, 15, and 22; then 1020 mg subcutaneously starting on Day 29 and every 4 weeks thereafter.≥100 kg

Continuation Therapy Criteria

Covered for continuation when documentation of a positive clinical response is provided.

Continuation therapy

Documentation demonstrates a positive clinical response to crovalimab-akkz (PiaSky).Reduction in hemolysis, manifested by stabilization of hemoglobin levels and reduction in transfusions from baseline at initiation

Crovalimab-akkz (PiaSky) must not be used in combination with another complement inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Treatment is restricted when the individual has an unresolved Neisseria meningitidis infection.

Coding and Clinical Thresholds

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10Covered

D59.5

Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli]

HCPCS Level II Code Number(s)HCPCSCovered

J1307

Injection, crovalimab-akkz, 10 mg

Revenue Code Number(s)Revenue

N/A

Minimum Body Weight

Minimum body weight40 kg or more

Eligible populationAdults and pediatric individuals age 13 years and older

Covered conditionParoxysmal nocturnal hemoglobinuria (PNH)

PNH Type III Red Cells

PNH type III red cellsAt least 10% by flow cytometry

Testing methodFlow cytometry

Provider Actions and Authorization Requirements

Prior Authorization

Initial PNH Authorization

Submit an initial prior authorization request for crovalimab-akkz (PiaSky) for PNH. Include records demonstrating that the individual meets the covered indication, clinical eligibility, safety, and dosing requirements.

Initial authorization applies to adults and pediatric individuals age 13 years and older.
PiaSky must not be used with another complement inhibitor for PNH.

Prior Authorization

Continuation Authorization

For continuation authorization, provide documentation of a positive clinical response to PiaSky. Continued coverage depends on evidence that treatment remains clinically beneficial.

Document reduction in hemolysis, such as stabilization of hemoglobin levels.
Document reduction in transfusions from baseline at treatment initiation.

Clinical Background

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare disorder in which abnormal red blood cells are susceptible to complement-mediated intravascular hemolysis. Complement activation can cause premature destruction of red blood cells, resulting in anemia and related manifestations such as fatigue, dark urine, pain, shortness of breath, renal complications, pulmonary hypertension, and thrombosis. Crovalimab-akkz is a recycled C5 complement inhibitor that prevents C5 cleavage and membrane attack complex formation, thereby inhibiting terminal complement-mediated hemolysis.

Definitions

Crovalimab-akkz

Drug classC5 complement inhibitor

MechanismBinds complement protein C5 and inhibits its cleavage into C5a and C5b

Treatment effectPrevents formation of the membrane attack complex and inhibits terminal complement-mediated intravascular hemolysis

Paroxysmal Nocturnal Hemoglobinuria (PNH)

ConditionA rare condition caused by a genetic mutation affecting red blood cells

Complement defectRed blood cells form without terminal complement inhibitors

Disease process

Initial Therapy Criteria

Initial therapy is covered for PNH when all eligibility, clinical, safety, concomitant-therapy, and dosing criteria are met.

Initial PNH treatment

Eligibility and disease findings
- The individual has PNH, is an adult or pediatric individual age 13 years or older, and weighs at least 40 kg.Age ≥13 years; weight ≥40 kg
- Required flow-cytometry finding
  - Flow cytometry demonstrates at least 10% PNH type III red cells.≥10% PNH type III red cells

Continuation Criteria

Continuation Therapy Criteria

Continuation therapy is covered when documentation shows a positive clinical response.

Positive clinical response

The individual demonstrates clinical benefit from crovalimab-akkz (PiaSky), with reduced hemolysis manifested by stabilization of hemoglobin levels and reduction in transfusions from baseline at initiation.Stabilized hemoglobin levels and reduced transfusions from baseline

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyCrovalimab-akkz (PiaSky) Coverage for Paroxysmal Nocturnal Hemoglobinuria

Policy CodePolicy MA08.0178

Change TypeAdministrative annual reviewno material clinical or coverage changes

Effective DateSeptember 16, 2025

Next Review DateNot specified

Key ActionPrescribers must enroll in the PiaSky REMS, counsel individuals about meningococcal infection risk, provide REMS educational materials, and ensure meningococcal vaccination.

SourceLink

On This Page

Alternative findingGreater than 50% GPI-AP-deficient polymorphonuclear cells

GPI-AP-Deficient Polymorphonuclear Cells

GPI-AP-deficient polymorphonuclear cellsGreater than 50% by flow cytometry

Testing methodFlow cytometry

Alternative findingAt least 10% PNH type III red cells

LDH Clinical Manifestation

LDH clinical manifestationGreater than 1.5 times the upper limit of normal (ULN)

Clinical contextA clinical manifestation of PNH

Other examplesThrombosis, renal dysfunction, pulmonary hypertension, or dysphagia

LDH Eligibility Threshold in COMMODORE 2

COMMODORE 2 eligibility thresholdLDH level at least 2 times the upper limit of normal (ULN)

Study populationIndividuals with PNH weighing at least 40 kg

Additional requirementAt least one PNH-related sign or symptom in the past three months

Body Weight Dosing Threshold

Weight category 140 kg to less than 100 kg

Weight category 2100 kg or greater

Maintenance frequencySubcutaneous maintenance dosing every 4 weeks beginning on Day 29

Prior Authorization

New Approval Required for Regimen Changes

A change in the member’s dose, frequency, or regimen requires submission to the Company for a new approval as part of utilization management.

Submit changes based on factors such as changes in member weight or incomplete therapeutic response.
Accurate member information is required to approve the requested dose and frequency.
The Company may conduct postpayment review and audit procedures for submitted claims.

Unsupported block type: documentation

Unsupported block type: prior_auth

Documentation Required

REMS Education and Meningococcal Vaccination

Complete the required meningococcal-risk education and vaccination actions under the PiaSky REMS before treatment whenever clinically appropriate.

Counsel the individual about the risk of meningococcal infection.
Provide the required REMS educational materials.
Ensure the individual is vaccinated against N. meningitidis.
An exception may apply when the risk of delaying PiaSky outweighs the risk of developing meningococcal infection.

Unsupported block type: denial_risk

The absence of complement inhibitors leads to premature complement-mediated destruction and loss of red blood cells (hemolysis)

PiaSky REMS

ProgramA risk-management program associated with PiaSky because of the risk of meningococcal infections

Prescriber actionEnroll in the program and counsel individuals about meningococcal infection risk

Required materials and preventionProvide REMS educational materials and ensure meningococcal vaccination

PNH

AbbreviationPNH means paroxysmal nocturnal hemoglobinuria

Disease contextA disease associated with complement-mediated hemolysis and related signs or symptoms

Study contextCOMMODORE 2 evaluated crovalimab-akkz in individuals with PNH

REMS

Full termRisk Evaluation and Mitigation Strategy

Regulatory requirementAn FDA-required program associated with crovalimab-akkz

Risk addressedMeningococcal infections

Flow cytometry demonstrates greater than 50% GPI-AP-deficient polymorphonuclear cells.>50% GPI-AP-deficient PM cells

The individual exhibits clinical manifestations of PNH.Examples include LDH greater than 1.5 times the upper limit of normal, thrombosis, renal dysfunction, pulmonary hypertension, or dysphagia

The individual is transfusion dependent due to PNH.

Safety and treatment restrictions

The individual does not have an unresolved Neisseria meningitidis infection.
The individual is vaccinated against N. meningitidis, unless the risk of delaying crovalimab-akkz (PiaSky) outweighs the risk of developing meningococcal infection.
A risk-based exception must be documented when applicable.
Crovalimab-akkz (PiaSky) will not be used in combination with another complement inhibitor for treatment of PNH.
Examples include Empaveli, Fabhalta, Soliris, and Ultomiris.

Required dosing and frequency

Applicable weight-based regimen
- For body weight 40 kg to less than 100 kg: loading dosage of 1000 mg intravenously on Day 1 followed by 340 mg subcutaneously once weekly on Days 2, 8, 15, and 22; maintenance dosage of 680 mg subcutaneously starting on Day 29 and every 4 weeks thereafter.40 kg to <100 kg
- For body weight 100 kg or greater: loading dosage of 1500 mg intravenously on Day 1 followed by 340 mg subcutaneously once weekly on Days 2, 8, 15, and 22; maintenance dosage of 1020 mg subcutaneously starting on Day 29 and every 4 weeks thereafter.≥100 kg