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Table 70: Progesterone Agents


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Drug Category: Endocrine/Metabolic Agents

Medication Class/Individual Agents: Progesterone agents

I. Prior-Authorization Requirements

 Progesterone Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

hydroxyprogesterone caproate injection - Delalutin PA  
progesterone gel Crinone PA  
progesterone vaginal insert Endometrin 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.

  • On April 6, 2023 the Food and Drug Administration (FDA) announced a final decision to withdraw the approval of Makena (hydroxyprogesterone caproate, HPC, 17-OHPC) and effective immediately Makena and its generics are no longer approved.1
  • The American Academy of Obstetricians and Gynecologists has updated the Clinical Guidance for the Use of Progesterone Supplementation for the Prevention of Recurrent Preterm Birth noting that hydroxyprogesterone caproate is not recommended for the primary prevention of preterm birth in patients with a history of spontaneous preterm birth.2
  • 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.3
  • Hydroxyprogesterone caproate injection is ONLY 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.4 


1FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena [press release on the Internet]. Rockville (MD): Food and Drug Administration (US); 2023 April 6 [cited 2023 Apr 6]. Available from: https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena.

2American College of Obstetricians and Gynecologists. Updated Clinical Guidance for the Use of Progesterone Supplementation for the Prevention of Recurrent Preterm Birth. 2023 [Practice Advisory on the internet] [cited 2023 Apr 12]. Available from: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/04/updated-guidance-use-of-progesterone-supplementation-for-prevention-of-recurrent-preterm-birth.

3Preterm labor and premature birth [webpage on the Internet]. March of Dimes; 2016 Mar 1 [cited 2021 Oct 16]. Available from: http://www.marchofdimes.org/complications/preterm-labor-and-premature-birth.aspx

4Hydroxyprogesterone caproate [package insert on the Internet]. Morgantown (WV): Mylan Institutional LLC; 2021 Nov [cited 2023 April 13]. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0919b927-c57c-40ae-88a8-39e9efe4f677

 
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

Non-FDA-approved, for example:

  • Maintenance of pregnancy/placental support through gestational week 12 after positive pregnancy test
  • Prevention of miscarriage with history of recurrent miscarriages through gestational week 12
  • Prevention of spontaneous preterm birth
  • Short cervix

 

Note: The above lists may not include all FDA-approved and non-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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

Crinone

  • Documentation of all the following is required for requests for Crinone 4% or 8% gel for progestin challenge for the diagnosis of secondary amenorrhea: 
    • appropriate diagnosis; and
    • inadequate response or adverse drug reaction to one or contraindication to all of the following: medroxyprogesterone, norethindrone, oral progesterone (micronized); and
    • requested dose is ≤ six doses; and
    • for the 8% gel, inadequate response or adverse reaction to the 4% gel.
  • Documentation of all the following is required for requests for Crinone 8% gel for all other diagnoses:
    • indication of one of the following:
      • prevention of spontaneous preterm birth with one of the following:
        • both of the following:
          • history of spontaneous singleton delivery and/or premature rupture of membranes; and
          • gestational age ≥ 18 weeks to < 23 weeks; and
        • both of the following: diagnosis of short cervix and gestational age ≥ 18 weeks to < 23 weeks; or
      • maintenance of pregnancy/placental support through gestational week 12 after positive pregnancy test; or
      • prevention of miscarriage with history of recurrent miscarriages through gestational week 12; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: compounded progesterone suppository, intramuscular progesterone, oral progesterone capsule, Endometrin (progesterone vaginal insert); and
    • appropriate dosing and treatment duration.

 

Endometrin

  • Documentation of all the following is required for the diagnosis of prevention of spontaneous preterm birth:
    • appropriate diagnosis; and
    • gestational age ≥ 18 weeks to < 23 weeks; and
    • one of the following:
      • member has a history of spontaneous singleton delivery and/or premature rupture of membranes; or
      • short cervix.

 

hydroxyprogesterone caproate injection (generic Delalutin)

  • Documentation of all the following is required: 
    • indication of one of the following:
      • treatment of advanced adenocarcinoma of the uterine corpus (stage III or IV); or
      • management of amenorrhea (primary and secondary); or
      • member requires a test for endogenous estrogen production; or
      • production of secretory endometrium and desquamation; and
    • appropriate dosing.

 

Please note: The MassHealth agency does not pay for any drug when used to promote 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: 03/2024


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Last updated 05/16/24

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