Subject: Inqovi 4002-A SGM P2022

Drug

INQOVI  (decitabine and cedazuridine)

Policy:

       I.  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 Indications
            Inqovi is indicated for treatment of adult patients with
            myelodysplastic syndromes (MDS), including previously treated
            and untreated, de novo and secondary MDS with the following
            French-American-British subtypes (refractory anemia,
            refractory anemia with ringed sideroblasts, refractory anemia
            with excess blasts, and chronic myelomonocytic leukemia
            [CMML]) and intermediate-1, intermediate-2, and high-risk
            International Prognostic Scoring System groups.

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

 
     II.  CRITERIA FOR INITIAL APPROVAL

           Myelodysplastic syndromes (MDS)/Chronic
           myelomonocytic leukemia (CMML)
           Authorization of 12 months may be granted for the treatment of
           myelodysplastic syndromes (MDS), including chronic
           myelomonocytic leukemia (CMML).

 
    IV.  CONTINUATION OF THERAPY

           Authorization of 12 months may be granted for continued
           treatment in members requesting reauthorization for an
           indication listed in Section II when there is no evidence of
           unacceptable toxicity or disease progression while on the
           current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Inqovi [package insert]. Japan: Otsuka Pharmaceutical Co, Ltd; July 2020.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 26, 2022