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Drug Category: Endocrine/Metabolic Agent

Medication Class/Individual Agents: Progesterone agents

I. Prior-Authorization Requirements

 Progesterone Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

hydroxyprogesterone caproate injection PA  
hydroxyprogesterone caproate injection-Makena Makena PA  
progesterone gel Crinone PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • Preterm birth is a significant public health issue in the United States. According to the March of Dimes, preterm birth or the birth of a baby at less than 37 weeks of gestation affects one in ten babies born in the United States. Although the causes of spontaneous preterm birth are often unknown, a leading risk factor is history of prior preterm birth, pregnancy of multiples, and abnormalities associated with the uterus or cervix.1
  • Makena (hydroxyprogesterone caproate injection) represents the first drug approved by the Food and Drug Administration (FDA) that is indicated to reduce the risk of preterm birth in women carrying one baby and have spontaneously given birth prematurely to one baby. It is given once a week via intramuscular injection into the hip. Treatment begins at week 16 (no later than week 21 of pregnancy) and continues to the 37th week of pregnancy.2
  • The benefits of vaginal progesterone supplementation in women with asymptomatic midtrimester sonographic short cervix are best illustrated by a meta-analysis of individual patient data from five placebo-controlled randomized trials, in which treatment with vaginal progesterone was associated with significant reductions in preterm birth.3
  • Hydroxyprogesterone caproate injection is indicated in non-pregnant women for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV), in the management of amenorrhea (primary or secondary) and abnormal uterine bleeding, as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation. The formulation is identical to the drug product that was the subject of an approved full new drug application, Delalutin (hydroxyprogesterone caproate).4


1Preterm labor and premature birth [webpage on the Internet]. March of Dimes; 2016 Mar 1 [cited 2016 Sep 23]. Available from: http://www.marchofdimes.org/complications/preterm-labor-and-premature-birth.aspx

2Makena [package insert on the Internet]. AMAG Pharmaceuticals; 2016 Apr [cited 2016 Sep 20]. Available from: http://www.makena.com

3Romero R, Nicolaides KH, Conde-Agudelo A. Vaginal progesterone decreases preterm birth  ≤  34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study. Ultrasound Obstet Gynecol. 2016 Sep;48(3):308-17.

4Hydroxyprogesterone caproate [package insert on the Internet]. Baudette (MN): ANI Pharmaceuticals; 2016 Jun [cited 2016 Jul 19]. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cdfa01cc-6315-44d4-ba79-3705fafe7ebe

 
Table Footnotes

II. Therapeutic Uses

FDA-approved, for example:

  • Advanced adenocarcinoma of the uterine corpus
  • Management of amenorrhea (primary and secondary)
  • Production of secretory endometrium and desquamation
  • Progestin challenge for the diagnosis of secondary amenorrhea
  • Test for endogenous estrogen production
  • To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth and/or rupture of membranes

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

 

Crinone

  • Documentation of all the following is required for progestin challenge for the diagnosis of secondary amenorrhea: 
    • appropriate diagnosis; and
    • clinical rationale why oral progesterone (micronized), medroxyprogesterone, or norethindrone would not be clinically appropriate options; and
    • request is for ≤ 6 doses; and
    • if request is for 8% gel, a trial with 4% gel.

   

hydroxyprogesterone caproate injection

  • Documentation of all the following is required: 
    • appropriate diagnosis.

  

hydroxyprogesterone caproate injection (generic Makena)

  • Documentation of all the following is required: 
    • appropriate diagnosis; and
    • current gestational week; and
    • request is for ≤ 21 injections per year.

 

 

Please note: The MassHealth agency does not pay for any drug when used to promote male or female fertility as described in 130 CMR 406.413(B) “Limitations on Coverage of Drugs – Drug Exclusions” (see link below).

https://www.mass.gov/regulations/130-CMR-406000-pharmacy-services


Original Effective Date: 09/2013

Last Revised Date: 08/2019


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Last updated 11/25/19