ModifiedCentenePolicy CP PHAR.664

Crovalimab (PiaSky) for paroxysmal nocturnal hemoglobinuria

Policy governs medical necessity criteria, dosing, and authorization requirements for crovalimab (PiaSky) for patients with PNH age ≥13 years and weight ≥40 kg for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyCrovalimab (PiaSky) for paroxysmal nocturnal hemoglobinuria

Policy CodePolicy CP PHAR.664

Change TypeMaterial clinical and coding revisions (age/weight criteria, dosing timing, HCPCS updates)

Effective DateJun 20, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation of PNH diagnosis, age ≥13, current body weight ≥40 kg, flow cytometry showing ≥10% GPI-deficient clones, and prior C5 inhibitor trial when applicable.

SourceLink

POLICY UPDATE CHANGES

Modified criteria to require age ≥ 13 years and body weight ≥ 40 kg and added documentation of member's current body weight.

Added criterion that members switching therapy from another C5 inhibitor must administer crovalimab IV loading dose at time of next scheduled C5 inhibitor dose.

Clarified dose maximum to include only SC maintenance doses in the continued therapy section.

HCPCS code J1307 added and codes C9399 and J3590 removed.

≥13 yrsminimum age for coverage

≥40 kgminimum body weight for coverage

12 monthsapproval duration for continued therapy

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C9399, J3590HCPCS codes removed

Coverage Criteria for Crovalimab (PiaSky)

Initial Therapy — covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Approval for PNH: 1) Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); 2) Prescribed by or in consultation with a hematologist; 3) Age ≥ 13 years; 4) Body weight ≥ 40 kg; 5) Flow cytometry showing detectable glycosylphosphatidylinositol (GPI)-deficient hematopoietic clones ≥ 10% PNH cells; 6) Documentation of member's current body weight (in kg); 7) PiaSky (crovalimab) is not prescribed concurrently with another FDA-approved product for PNH; 8) Failure of a ≥ 3-month trial of Soliris (eculizumab) or Ultomiris (ravulizumab) up to maximally indicated doses unless contraindicated or the member is transitioning from another C5 inhibitor per specified timing; 9) Requested dose does not exceed the specified loading and maintenance dosing by weight;

See dosing section for exact loading and maintenance doses; prior authorization required.

Initial and switching therapy eligibility — covered when ALL of the following are met

Covered when ALL of the following are met

Eligibility: Member meets FDA-aligned age (≥ 13 years) and weight (≥ 40 kg) criteria; documentation of current body weight provided; if switching from another complement C5 inhibitor, administration of the IV loading dose should occur at the time of the next scheduled C5 inhibitor dose.age >=13; weight >=40 kg

Additional clinical criteria and diagnosis-specific requirements are in other sections of the policy.

Continuation Therapy — covered when ALL of the following are met

Covered when ALL of the following are met:

Continued therapy for members already receiving PiaSky: 1) Member is currently receiving medication via Centene benefit or has previously met initial approval criteria and continuity of care applies as appropriate; 2) Member is responding positively to therapy as evidenced by improvement in one or more clinical parameters such as normalization of LDH, reduced need for RBC transfusions, decreased fatigue, increased or stabilized hemoglobin, improved health-related quality of life, or fewer thrombotic events; 3) Documentation of current body weight (in kg); 4) PiaSky is not prescribed concurrently with another FDA-approved product for PNH; 5) If request is for a dose increase, the new dose does not exceed SC maintenance maximums by weight (see dosing); Approval duration: 12 months.

Examples of response and approval duration clarified; documentation required for renewal.

Continued therapy — covered when ALL of the following are met for continued therapy

Covered when ALL of the following are met for continued therapy

Continued therapy: Demonstrated clinical benefit with ongoing documentation supporting continued use for chronic PNH; adherence to subcutaneous (SC) maintenance dose maximums by weight; documentation of current body weight; approval duration up to 12 months.continued approval up to 12 months

SC maintenance dose maximums clarified to apply only to SC maintenance dosing in continued therapy.

Indication	Loading (IV Day 1)	SC loading (Days 2, 8, 15, 22)	SC maintenance (starting Day 29)
PNH; body weight 40–100 kg
1,000 mg IV on Day 1
340 mg SC on Days 2, 8, 15, and 22
680 mg SC every 4 weeks starting Day 29

Indication	Loading (IV Day 1)	SC loading (Days 2, 8, 15, 22)	SC maintenance (starting Day 29)
PNH; body weight ≥100 kg
1,500 mg IV on Day 1
340 mg SC on Days 2, 8, 15, and 22
1,020 mg SC every 4 weeks starting Day 29

Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of safety and efficacy and the use is supported by the applicable off‑label use policy referenced in this document (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for any state‑specific coverage rules that supersede this policy.

Crovalimab (PiaSky) must not be prescribed concurrently with another FDA‑approved product for PNH (for example, Bkemv, Soliris/eculizumab, Ultomiris/ravulizumab, Empaveli, Fabhalta, or Voydeya). Requests for concurrent use are not authorized under this policy.

Coding and Billing

HCPCS Codes referenced/updatedHCPCS

J1307

HCPCS code added (informational in policy)

HCPCS Codes removedHCPCS

C9399	Removed code
J3590	Removed code

HCPCS coding updatesHCPCS

J1307	HCPCS code added for crovalimab (description provided in coding table)
C9399	HCPCS code removed (previously used)
J3590	HCPCS code removed (previously used)

GPI-deficient clone percent requirement (flow cytometry)

GPI-deficient clone percent requirementFlow cytometry must show detectable glycosylphosphatidylinositol (GPI)-deficient hematopoietic clones ≥ 10% PNH cells.

Test modalityRequirement specified for flow cytometry detection of GPI-deficient hematopoietic clones.

DocumentationFlow cytometry results must be included in prior authorization documentation.

Minimum body weight (policy)

Minimum body weightMember must weigh ≥ 40 kg for initiation of therapy.

Weight for dosing bands

Prior Authorization, Documentation, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior Authorization Required — submit documentation proving diagnosis, age, weight, hematology consultation, flow cytometry, and treatment history. Provider must submit office chart notes, lab results, and other clinical information supporting that the member meets ALL approval criteria. Requests lacking required documentation may be denied.

Submit documentation of Paroxysmal Nocturnal Hemoglobinuria (PNH) diagnosis
Documented age ≥ 13 years and current body weight (kg) — weight must be ≥ 40 kg
Prescribed by or in consultation with a hematologist
Flow cytometry demonstrating GPI‑deficient hematopoietic clones ≥ 10% PNH cells
If switching from another C5 inhibitor (eculizumab/Soliris, ravulizumab/Ultomiris, etc.), IV loading dose should be administered at time of next scheduled C5 inhibitor dose
Trial and failure of a ≥ 3‑month course of Soliris or Ultomiris at maximally indicated doses is required prior to PiaSky (step therapy) unless contraindicated or clinically significant adverse effects occurred

Dosing Schedules and Regimens

Dose element	Schedule / amount
IV loading dose (Day 1)
1,000 mg on Day 1 (IV)
SC loading doses (Days 2, 8, 15, 22)
340 mg SC on Days 2, 8, 15, and 22
SC maintenance (starting Day 29)
680 mg SC every 4 weeks starting Day 29

Dose element	Schedule / amount
IV loading dose (Day 1)
1,500 mg on Day 1 (IV)
SC loading doses (Days 2, 8, 15, 22)
340 mg SC on Days 2, 8, 15, and 22
SC maintenance (starting Day 29)
1,020 mg SC every 4 weeks starting Day 29

SC maintenance dose maximum clarified to apply only to SC maintenance doses in continued therapy

Scope of clarificationThe clarified maximum applies only to subcutaneous (SC) maintenance doses in the continued therapy section.

Continued therapy dosing limitsSC maintenance maximums: 680 mg every 4 weeks for weight 40–100 kg; 1,020 mg every 4 weeks for weight ≥100 kg.

Applies during renewalDose-maximum clarification used when evaluating requests for dose increases at renewal (continued therapy approvals).

Definitions and Diagnostic Thresholds

GPI-deficient hematopoietic clones ≥10% required on flow cytometry

GPI-deficient clone thresholdPolicy requires GPI-deficient hematopoietic clones ≥ 10% PNH cells detected by flow cytometry.

Definition contextGPI: glycosylphosphatidylinositol as listed in policy appendices/abbreviations.

Role in eligibilityMeeting the ≥10% GPI-deficient clone criterion is a required element of initial approval for PNH.

Background

Crovalimab (PiaSky) is a complement C5 inhibitor indicated for the treatment of adults and pediatric patients 13 years of age and older with paroxysmal nocturnal hemoglobinuria (PNH) who meet weight criteria. PNH is a chronic hematologic disorder characterized by hemolysis, thrombosis risk, and marrow populations with glycosylphosphatidylinositol (GPI)‑deficient hematopoietic clones identified by flow cytometry. The policy aligns with FDA‑approved dosing: an IV loading dose followed by subcutaneous loading doses in the first month and ongoing SC maintenance dosing every 4 weeks, with weight‑based regimens (e.g., IV 1,000 mg Day 1 then SC 680 mg every 4 weeks for patients 40–100 kg; IV 1,500 mg Day 1 then SC 1,020 mg every 4 weeks for patients ≥100 kg).

Policy Summary

PayerCentene

PolicyCrovalimab (PiaSky) for paroxysmal nocturnal hemoglobinuria

Policy CodePolicy CP PHAR.664

Change TypeMaterial clinical and coding revisions (age/weight criteria, dosing timing, HCPCS updates)

Effective DateJun 20, 2024

Next Review Date

SourceLink

On This Page

Weight bands (≥40 to <100 kg and ≥100 kg) determine IV loading and SC maintenance doses.

DocumentationCurrent body weight (in kg) must be documented with the request.

Minimum age (policy)

Minimum ageMember must be age ≥ 13 years for coverage eligibility.

FDA-aligned updateAge criterion updated per FDA labeling to require ≥ 13 years.

DocumentationMember's age must be documented in prior authorization materials.

Minimum body weight (FDA-aligned criterion)

FDA-aligned minimum body weightPer updated FDA-aligned criteria, member must weigh ≥ 40 kg.

DocumentationCurrent body weight must be provided when aligning to FDA criteria, especially when switching from another C5 inhibitor.

Dosing implicationWeight ≥40 kg placed member into dosing bands used for IV loading and SC maintenance regimens.

Denial Risk

Insufficient Documentation — denial risk

Insufficient documentation will delay or may result in denial of the request. Ensure submitted records clearly show the required diagnostic tests, hematology consultation, current weight, age, prior therapies and response, and dosing plan.

Requests missing office notes, lab results (e.g., flow cytometry, LDH), or documentation of prior C5 inhibitor trial and duration may be denied
If request is for dose increase or continued therapy, include documentation of clinical response (e.g., reduced transfusion need, stabilized or increased hemoglobin, reduced LDH, fewer thrombotic events, improved quality of life) and current body weight

Documentation Required

Documentation and Administration Timing Requirements

Documentation and administration timing requirements — document current body weight and age on all requests; when switching from another C5 inhibitor follow timing rules for IV loading dose and include timing documentation.

Always include member's current body weight (kg) and age on the prior authorization request
When switching therapy from Soliris/Bkemv/Empaveli/Ultomiris or other C5 inhibitors, document planned IV loading dose administration at the time of the member's next scheduled C5 inhibitor dose
Include dosing calculations and proposed schedule (loading and maintenance) with weight-based dose thresholds

Documentation Required

Required Clinical Documentation

Required clinical documentation to support approval: office/consult notes, hematology consultation, flow cytometry results, weight/age, prior treatment history and response, and any reasons for bypassing step therapy.

Office or clinic notes and hematology consultation confirming PNH diagnosis
Flow cytometry report showing GPI‑deficient clone percentage (≥ 10%)
Laboratory data supporting hemolysis and response (e.g., LDH) and clinical response measures (transfusion history, hemoglobin trends, thrombotic events, symptoms)
Documentation of prior C5 inhibitor therapy including drug name, dose, dates, and duration (≥ 3 months) or clinical contraindication/adverse effects to prior agents

Step Therapy

State-Level Step Therapy Bypass

State-level step therapy bypass — Illinois (IL HB 5395) step therapy bypass applies as specified; for Illinois Health Insurance Marketplace (HIM) requests, the step therapy requirement does not apply effective 2026-01-01. Check state addenda for continuity of care or other jurisdictional exceptions.

Illinois (IL HB 5395): step therapy requirements do not apply for IL HIM requests as of 2026-01-01
Refer to state-specific addendums for continuity of care and other exceptions (e.g., continuity rules for members already receiving therapy)