Background

The injectable risperidone products mentioned in this policy (Rykindo, Risperdal Consta) are approved by the Food and Drug Administration for the treatment of schizophrenia and bipolar I disorder. These products are covered at parity status. The lack of mention of a particular risperidone product does not insinuate that there is no coverage for that product.

Policy

Rykindo (Risperidone) ER injectable suspension may be approved as medically necessary if the following criteria are met:

1. Diagnosis of one of the following:
   1. Bipolar disorder: As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.
   2. Schizophrenia
2. Prescribed by or in consultation with a psychiatrist
3. Trial and failure of one oral generic therapy (aripiprazole, asenapine, lurasidone, olanzapine, quetiapine, risperidone, ziprasidone)
4. Age ≥ 18 years
5. Request dose does not exceed 50 mg every two weeks

References

1. Rykindo [package insert]. Shandong Luye Pharmaceutical Co., Ltd. Yantai, Shandong Province, China. Updated June 2023.
2. Risperdal Consta [package insert]. Janssen Pharmaceuticals, Inc. Titusville, NJ. Updated October 2024.
3. Medical Policy 501502. Blue Cross of Idaho. Meridian, ID. Updated December 2024.
4. Select Injectable risperidone Products. Blue Cross and Blue Shield of Louisiana. Updated January 2025.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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