Subject: hydroxyprogesterone caproate-Makena 1780-A SGM P2021

Drug

MAKENA  (hydroxyprogesterone caproate)

hydroxyprogesterone caproate

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
          Makena is indicated to reduce the risk of preterm birth in women with a singleton pregnancy
          who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is
          based on improvement in the proportion of women who delivered < 37 weeks of gestation.
          There are no controlled trials demonstrating a direct clinical benefit, such as improvement in
          neonatal mortality and morbidity.

          Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of
          Makena has been demonstrated only in women with a prior spontaneous singleton preterm
          birth. It is not intended for use in women with multiple gestations or other risk
          factors for preterm birth.

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

 
    II.  EXCLUSIONS

         Coverage will not be provided for members with any of the following exclusions:
         A.  Current or history of thrombosis or thromboembolic disorders
         B.  Known or suspected breast cancer, other hormone-sensitive cancer, or a history of these
              conditions
         C.  Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
         D.  Cholestatic jaundice of pregnancy
         E.  Liver tumors, benign or malignant, or active liver disease
         F.  Uncontrolled hypertension 
 
 III.  CRITERIA FOR INITIAL APPROVAL

         Prevention of preterm birth
         Authorization of 21 weeks or through 36 weeks, 6 days of gestational age, whichever is less,
         may be granted for the prevention of preterm birth when all of the following criteria are met:
         A.  The current pregnancy is a singleton pregnancy (i.e., member is currently pregnant with
              only one baby).
         B.  The member has a history of singleton spontaneous preterm birth, defined as delivery at
              less than 37 weeks gestation following preterm labor, preterm rupture of membranes, and
              cervical insufficiency.
         C.  Makena will be initiated between 16 weeks, 0 days and 24 weeks, 6 days of gestation.³

 
   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:

V.  REFERENCES

 

1. Makena [package insert]. Waltham, MA: AMAG Pharmaceuticals; February 2018.
2. Hydroxyprogesterone caproate [package insert]. Shirley, NY. American Regent, Inc; July 2018.
3. American College of Obstetricians and Gynecologists Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964-973.

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 29, 2021