Last Review Date: 09/04/2025

Date of Origin: 08/01/2024

Dates Reviewed: 08/2024, 05/2025, 09/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided initially for 6 months.
• Renewal: Prior authorization validity may be renewed every 12 months thereafter.

2. Dosing Limits

    Max Units (per dose and over time) [HCPCS Unit]:

• Loading Dose: 170 billable units IV on day 1; 34 billable units SQ on days 2, 8, 15, & 22; and 102 billable units SQ on day 29
• Maintenance Dose: 102 billable units SQ every 4 weeks

3. Initial Approval Criteria

*Preferred Agents may be targeted in another Utilization Management program and require Prior Authorization

Target Agent(s) will be approved when ALL of the following are met:

• ONE of the following:

• The patient has a diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) as confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages (e.g., RBCs and WBCs) demonstrating that the patient’s peripheral blood cells are deficient in glycosylphosphatidylinositol (GPI)-linked proteins (lab tests required); OR
• The patient has another FDA labeled indication for the requested agent and route of administration; AND

• If the patient is a Commercial Member, then the patient has ONE of the following:

• Tried and had an inadequate response to TWO preferred agents; OR
• Tried and had an inadequate response to ONE preferred agent AND an intolerance or hypersensitivity to ONE preferred agent; OR
• An intolerance or hypersensitivity to TWO preferred agents; OR
  • An FDA labeled contraindication to ALL preferred agents; AND

• If the patient has an FDA labeled indication, then ONE of the following:

• The patient’s age is within FDA labeling for the requested indication for the requested agent; OR
• There is support for using the requested agent for the patient’s age for the requested indication; AND

• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
• The patient will NOT be using the requested agent in combination with Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Fabhalta (iptacopan), or Empaveli (pegcetacoplan); AND
• The patient does NOT have any FDA labeled contraindications to the requested agent; AND
• The requested quantity (dose) is within FDA labeled dosing for the requested indication

4. Renewal Criteria

Target Agent(s) will be approved when ALL of the following are met:

• The patient was previously approved for the requested agent through the plan’s Medical Drug Review process (Note: patients not previously approved for the requested agent will require initial evaluation review); AND
• The patient has had improvements or stabilization with the requested agent (e.g., decreased requirement of RBC transfusions, stabilization/improvement of hemoglobin, reduction of lactate dehydrogenase [LDH], stabilization/improvement of symptoms) (medical records required); AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
• The patient will NOT be using the requested agent in combination with Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Fabhalta (iptacopan), or Empaveli (pegcetacoplan); AND
• The patient does NOT have any FDA labeled contraindications to the requested agent; AND
• The requested quantity (dose) is within FDA labeled dosing for the requested indication

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code(s):

• J1307 – Injection, crovalimab-akkz, 10 mg; 1 billable unit = 10 mg

NDC:

• Piasky 340 mg/2 mL solution in single-dose vials for infusion: 50242-0115-xx       

7. References

1. Piasky prescribing information. Genentech, Inc. June 2024.
2. Sahin F, Akay OM, Ayer M, et al. Pesg PNH diagnosis, follow-up and treatment guidelines. PubMed Central (PMC). Published 2016. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4981648/.    
3. Cançado RD, Da Silva Araújo A, Sandes AF, et al. Consensus statement for diagnosis and treatment of paroxysmal nocturnal haemoglobinuria. Hematology, Transfusion and Cell Therapy. 2021;43(3):341-348. doi:10.1016/j.htct.2020.06.006.
4. Shah N, Bhatt H. Paroxysmal nocturnal hemoglobinuria. StatPearls - NCBI Bookshelf. Published July 31, 2023. https://www.ncbi.nlm.nih.gov/books/NBK562292/.   

Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A