Subject: Menopur 1991-A, 1992-A SGM P2024

Drug

MENOPUR  (menotropins for injection)

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 Indication
          Menopur is indicated for development of multiple follicles and pregnancy in ovulatory women
          as part of an assisted reproductive technology (ART) cycle.

          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. 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.


   III.  CRITERIA FOR INITIAL APPROVAL

          Follicle stimulation
          Authorization of 12 months may be granted for members undergoing ovulation induction or
          assisted reproductive technology (ART) who meet any of the following criteria:
          A.  Member has completed three or more previous cycles of clomiphene or letrozole.
          B.  Member has a risk factor for poor ovarian response to clomiphene or letrozole.
          C.  Member has a contraindication or exclusion to clomiphene or letrozole.
          D.  Member is 37 years of age or older.


   IV.  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. Menopur [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; December 2021.
2. Practice Committee of the American Society for Reproductive Medicine. Evidence-based treatments for couples with unexplained infertility: a guideline. Fertil & Steril. 2020; 113(2):305-322.

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.

October 30, 2024