Subject: Inlyta 2079-A SGM P2021

Drug

INLYTA  (axitinib)

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.

          A.  FDA-Approved Indications
               1.  First-Line Advanced Renal Cell Carcinoma
                    a.  Inlyta in combination with avelumab is indicated for the first-line treatment of
                         patients with advanced renal cell carcinoma (RCC).
                    b.  Inlyta in combination with pembrolizumab is indicated for the first-line treatment
                         of patients with advanced renal cell carcinoma.
               2.  Second-Line Advanced Renal Cell Carcinoma
                    Inlyta as a single agent is indicated for the treatment of advanced renal cell carcinoma
                    (RCC) after failure of one prior systemic therapy.

          B.  Compendial Uses
               1.  Relapsed or stage IV renal cell carcinoma
               2.  Papillary, Hürthle cell, or follicular thyroid carcinoma

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

 
    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Renal Cell Carcinoma
               Authorization of 12 months may be granted for treatment of advanced, relapsed, or stage
               IV renal cell carcinoma when any of the following criteria is met:
               1.  Inlyta will be used as a single agent 
               2.  Inlyta will be used in combination with pembrolizumab
               3.  Inlyta will be used as first-line treatment in combination with avelumab
 
          B.  Papillary, Hürthle cell, or Follicular Thyroid Carcinoma
               Authorization of 12 months may be granted for treatment of progressive and/or
               symptomatic papillary, Hürthle cell, or follicular thyroid carcinoma that is not amenable to
               radioactive iodine (RAI) therapy.

 
   III.  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:

IV. REFERENCES

 

1. Inlyta [package insert]. New York, NY: Pfizer Inc., June 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 3, 2021.

 

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.

September 28, 2021