BlueCross BlueShield of Tennessee Medical Policy Manual

Crovalimab-akkz (Piasky®)

MPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

1. INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indication

Piasky is in indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.

All other indications are considered experimental/investigational and not medically necessary.

2. DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

1. For initial requests: Flow cytometry used to show results of glycosylphosphatidylinositol-anchored proteins (GPI-APs) deficiency.
2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.

3. CRITERIA FOR INITIAL APPROVAL

Paroxysmal nocturnal hemoglobinuria

Authorization of 6 months may be granted for treatment of paroxysmal nocturnal hemoglobinuria (PNH) when all of the following criteria are met:

1. Member is 13 years of age or older
2. Member has a body weight of at least 40 kg
3. The diagnosis of PNH was confirmed by detecting a deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs) (e.g., at least 5% PNH cells, at least 51% of GPI-AP deficient poly-morphonuclear cells)
4. Flow cytometry is used to demonstrate GPI-APs deficiency
5. Member has and exhibits clinical manifestations of disease (e.g., LDH > 1.5 ULN, thrombosis, renal dysfunction, pulmonary hypertension, dysphagia)
6. The requested medication will not be used in combination with another complement inhibitor (e.g., Empaveli, Fabhalta, Soliris, Ultomiris) for the treatment of PNH.

4. CONTINUATION OF THERAPY  

Paroxysmal nocturnal hemoglobinuria

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when all of the following criteria are met:

1. There is no evidence of unacceptable toxicity or disease progression while on the current regimen.
2. The member demonstrates a positive response to therapy (e.g., improvement in hemoglobin levels, normalization of lactate dehydrogenase [LDH] levels).
3. The requested medication will not be used in combination with another complement inhibitor (e.g., Empaveli, Fabhalta Soliris, Ultomiris) for the treatment of PNH.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION  

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Piasky [package insert]. South San Francisco, CA: Genentech, Inc.; June 2024.
2. Parker CJ. Management of paroxysmal nocturnal hemoglobinuria in the era of complement inhibitory therapy. Hematology. 2011; 21-29.
3. Borowitz MJ, Craig F, DiGiuseppe JA, et al. Guidelines for the Diagnosis and Monitoring of Paroxysmal Nocturnal Hemoglobinuria and Related Disorders by Flow Cytometry. Cytometry B Clin Cytom. 2010: 78: 211-230.
4. Preis M, Lowrey CH. Laboratory tests for paroxysmal nocturnal hemoglobinuria (PNH). Am J Hematol. 2014;89(3):339-341.
5. Parker CJ. Update on the diagnosis and management of paroxysmal nocturnal hemoglobinuria. Hematology Am Soc Hematol Educ Program. 2016;2016(1):208-216.
6. Dezern AE, Borowitz MJ. ICCS/ESCCA consensus guidelines to detect GPI-deficient cells in paroxysmal nocturnal hemoglobinuria (PNH) and related disorders part 1 - clinical utility. Cytometry B Clin Cytom. 2018 Jan;94(1):16-22.

ORIGINAL EFFECTIVE DATE: 3/4/2025

MOST RECENT REVIEW DATE: 3/4/2025

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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