CurrentAvMedPolicy Pub. 100-2

PiaSky (crovalimab-akkz) IV/SQ for Paroxysmal Nocturnal Hemoglobinuria (PNH) — Coverage Criteria

Prior authorization and step-edit requirements for PiaSky (crovalimab-akkz) IV/SQ for treatment of PNH for AvMed members; outlines documentation, clinical eligibility, dosing, and administration/site options and applies to prescribers requesting coverage.

Policy Summary

PayerAvMed

PolicyPiaSky (crovalimab-akkz) IV/SQ for PNH — Coverage Criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and submit the prior authorization/step-edit request form with supporting documentation including flow cytometry reports, labs, vaccination records, and chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial approval

6 moreauthorization

≥13min age

≥10%PNH clone

≥2 wkvaccination timing

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Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Initial Authorization - Core Requirements: Prescribed by or in consultation with a hematologist or nephrologist; prescriber enrolled in the PiaSky Risk Evaluation and Mitigation Strategy (PIASKY REMS); member age >= 13 years; body weight >= 40 kg; diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) confirmed by detection of PNH clones >= 10% by flow cytometry; flow cytometry pathology report demonstrates >= 2 different GPI protein deficiencies in two different cell lines (e.g., CD55, CD59)

Submit flow cytometry labs and pathology report

Clinical indications (one of the following required): Member is transfusion dependent (defined as a transfusion within the last 12 months) AND one of: hemoglobin <= 7 g/dL; OR symptomatic anemia with hemoglobin <= 9 g/dL; OR high LDH defined as >= 1.5 x ULN with clinical symptoms; OR presence of a thrombotic event (e.g., DVT, PE); OR presence of organ damage secondary to chronic hemolysis; OR member is pregnant and potential benefit outweighs potential fetal risk

Must submit chart notes and labs to document indication

Vaccination requirement: Member must be vaccinated against encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type B) at least 2 weeks prior to initiation and revaccinated per current guidelines2 weeks

If vaccination not given, documentation that risks of delay outweigh infection risk may be submitted

Concurrent therapy exclusion: Medication will NOT be prescribed concurrently with another FDA‑approved product for PNH (examples: eculizumab, ravulizumab, Empaveli, etc.)

Provide documentation if switching from another C5 inhibitor per form instructions

Reauthorization — Reauthorization covered when ALL of the following are met:

Reauthorization covered when ALL of the following are met:

Continued eligibility: Member continues to meet all initial authorization criteria; provider attests absence of unacceptable toxicity from the drug (e.g., serious meningococcal infections, infusion reactions, serious infections)

Documentation including labs and chart notes required

Evidence of clinical benefit: At least one of: documentation of a recent (within 3 months) LDH level showing reduction from baseline; reduction in number of transfusions or units transfused from baseline; stabilized hemoglobin supported by either maintenance above 7 g/dL or maintenance above 9 g/dL if baseline was >7 and <9 g/dL; reduction in thrombotic events (e.g., DVT, PE)

Results must be submitted to support benefit

Therapy will not be approved for members with a history of unresolved meningococcal disease or with any systemic bacterial or significant infection that has not been treated with appropriate antibiotics. Documentation demonstrating that infections are resolved and appropriately treated must be provided with the authorization request.

Use of free samples to initiate PiaSky therapy does not meet step edit or prior authorization criteria. Prior therapy status will be verified through pharmacy paid-claims history or submitted chart notes, and initiation based solely on samples will not satisfy the requirement for previous therapy or step-edit exceptions.

Coding and Key Clinical Thresholds

Requested drug codeHCPCS

J3590

Unclassified biologics (used here for PiaSky IV) as listed on the form

inv-06: PNH clone size by flow cytometry — required threshold

Required thresholdPNH clone size ≥ 10% by flow cytometry (must submit labs)

Flow cytometry report requirementPathology report must demonstrate ≥2 different GPI protein deficiencies (e.g., CD55, CD59) in two different cell lines

Test modalityFlow cytometry testing of granulocytes, monocytes, or erythrocytes

inv-07: Minimum body weight for dosing — >= 40 kg

Minimum body weight>= 40 kg

Age contextApplies for members age ≥ 13 years per initial authorization criteria

DocumentationWeight and date weight obtained must be provided on the PA form

inv-08: Hemoglobin thresholds — <= 7 g/dL or <= 9 g/dL with symptoms

Severe anemia thresholdHemoglobin ≤ 7 g/dL

Symptomatic anemia thresholdHemoglobin ≤ 9 g/dL when the member has symptoms of anemia

Transfusion linkageThese hemoglobin thresholds are used in the context of transfusion-dependent members (transfusion within last 12 months)

Provider Requirements and Submission Instructions

Prior Authorization

Authorization required — Prior authorization and prescriber signature

Prior authorization is required for PiaSky (crovalimab-akkz) IV (J3590). The prescribing physician must sign and submit the medical prior authorization/step-edit request form with supporting documentation as directed on the form.

Drug requested: PiaSky (crovalimab-akkz) IV (J3590)
Prescribing physician must sign and clearly print name on the request form (preprinted stamps not valid)

Step Therapy

Step edit verification — samples and prior therapy proof

Use of samples to initiate therapy does not satisfy the step-edit/preauthorization requirement. Prior therapies will be verified through pharmacy paid claims or submitted chart notes to confirm step edit criteria.

Samples do not meet step edit/preauthorization criteria
Previous therapies verified via pharmacy paid claims or chart notes

Documentation Required

Required documentation — signed form, labs, chart notes, vaccinations

Submit the completed form signed by the prescribing physician and include supporting clinical documentation: flow cytometry pathology report with PNH clone percentage, relevant chart notes, and vaccination records to support each checked clinical criterion.

Flow cytometry report demonstrating PNH clones ≥ 10% and ≥2 different GPI protein deficiencies in two different cell lines
Chart notes supporting indicated clinical criteria (e.g., transfusion history, hemoglobin/LDH results)
Vaccination records for encapsulated bacteria

Billing Rule

Administrative details — identification, NPI, diagnosis, weight

Provide complete prescriber and member identifying information on the request form, including prescriber NPI, member identifiers, diagnosis and ICD code, and weight with date weight obtained.

Member name and AvMed ID
Prescriber name, signature, and NPI
Diagnosis and ICD code
Weight and date weight obtained

Denial Risk

Documentation completeness — risk of denial if incomplete

Authorization requests may be denied or delayed if required documentation—including lab results, diagnostics, or chart notes—is missing, incomplete, incorrect, or illegible; ensure all supporting materials are provided.

Incomplete, incorrect, or illegible information can delay or result in denial
All documentation supporting each checked clinical criterion must be provided

Denial Risk

Active or unresolved infections — exclusion for approval

Therapy will not be approved if the member has unresolved meningococcal disease or any systemic bacterial or significant infection that has not been treated with appropriate antibiotics.

Unresolved meningococcal disease is an exclusion
Any untreated systemic bacterial or significant infection disqualifies approval

Definitions and Clinical Terms

inv-16: Transfusion dependent — Defined as having a transfusion within the last 12 months (used in criteria)

DefinitionTransfusion dependent = having a transfusion within the last 12 months

Use in criteriaUsed as one of the clinical indications required for therapy (must submit chart notes and labs)

DocumentationChart notes supporting transfusion history must be submitted with the PA

inv-17: High LDH — Defined as LDH ≥ 1.5 times the upper limit of normal with clinical symptoms

DefinitionHigh LDH = lactate dehydrogenase (LDH) ≥ 1.5 × upper limit of normal with clinical symptoms

Clinical contextHigh LDH with symptoms is an acceptable indication for therapy when present in a transfusion-dependent member

DocumentationSubmit recent LDH results and chart notes to demonstrate symptoms as part of PA supporting evidence

OpenPayer

PiaSky (crovalimab-akkz) IV/SQ for Paroxysmal Nocturnal Hemoglobinuria (PNH) — Coverage Criteria

Coverage Criteria for PiaSky (crovalimab)

Coding and Key Clinical Thresholds

Provider Requirements and Submission Instructions

Background

Definitions and Clinical Terms