Subject: Cetrotide-Ganirelix 1912-A, 1913-A SGM P2021

Drug

CETROTIDE  (cetrorelix acetate)

ganirelix acetate

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
          Cetrotide and ganirelix are indicated for the inhibition of premature
          luteinizing hormone (LH) surges in women undergoing controlled
          ovarian stimulation.

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

 

    II.  MEDICAL BENEFIT ALIGNMENT

          Specialty Guideline Management coverage review will be bypassed for
          drug(s) being requested for a procedure that has been approved under a
          member’s medical benefit plan. Such members will be exempt from the
          requirements in Sections III and IV. A medical authorization number and
          confirmation of the approved procedure(s) will be required.

          NOTE: Some plans may opt-out of medical benefit alignment.
          Members receiving coverage under such plans must meet the
          requirements in Sections III and IV.

 

  III.  CRITERIA FOR INITIAL APPROVAL

          Inhibition of premature LH surges
          Authorization of 12 months may be granted for the inhibition of
          premature LH surges in members undergoing ovulation induction or
          assisted reproductive technology (ART).

 

     V. CONTINUATION OF THERAPY

         All members (including new members) requesting authorization for
         continuation of therapy must meet all initial authorization criteria.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cetrotide [package insert]. Rockland, MA: EMD Serono; May 2018.
2. Ganirelix [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; February 2019.
3. Bakas P, Konidaris S, Liapis A, et al. Role of gonadotropin-releasing hormone antagonist in the management of subfertile couples with intrauterine insemination and controlled ovarian stimulation. Fertil Steril. 2011;95:2024-2028.

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.

December 29, 2021