Hydroxyprogesterone caproate (Makena)

hydroxyprogesterone caproate (Makena®)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

Makena SC auto-injector 275 MG/1.1 ML; Makena IM oil 250 MG/ML vials; hydroxyprogesterone caproate IM oil 250 MG/ML vials:

• Reduction of risk for preterm birth - Makena is a progestin 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 less than 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.

hydroxyprogesterone caproate IM solution 1.25 GM/5 ML vials:

• Amenorrhea - Indicated in non-pregnant women for the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
• Production of secretory endometrium and desquamation - Indicated in non-pregnant women for the production of secretory endometrium and desquamation.
• Adenocarcinoma of uterine corpus - Indicated in non-pregnant women for the treatment of advanced (Stage III or IV) adenocarcinoma of the uterine corpus.
• Test for endogenous estrogen production - Indicated as a test for endogenous estrogen production in nonpregnant women.

 Coverage Criteria:

For the reduction of risk for preterm birth:

• Request is for Makena SC auto-injector 275 MG/1.1 ML, Makena IM oil 250 MG/ML vial, or hydroxyprogesterone caproate IM oil 250 MG/ML vial; AND
• Dose does not exceed 275 mg weekly; AND
• Prescribed by or in consultation with a gynecologist or obstetrician; AND
• Patient had a previous singleton (single offspring) spontaneous preterm birth (less than 37 weeks of gestation); AND
• Patient is having a singleton pregnancy; AND
• Therapy will be started between 16 weeks, 0 days and 20 weeks, 6 days of gestation; AND
• Therapy will be continued up to week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

For diagnosis of amenorrhea or abnormal uterine bleeding:

• Request is for hydroxyprogesterone caproate IM solution 1.25 GM/5 ML vial; AND
• Dose does not exceed 375 mg IM as a one-time dosage or 250 mg IM every 4 weeks for 4 cycles; AND
• Patient is not pregnant; AND
• Amenorrhea or abnormal uterine bleeding is due to hormonal imbalance in the absence of organic pathology (e.g., submucous fibroids or uterine cancer).

For the production of secretory endometrium and desquamation:

• Request is for hydroxyprogesterone caproate IM solution 1.25 GM/5 ML vial; AND
• Dose does not exceed 375 mg IM as a one-time dosage or 250 mg IM every 4 weeks; AND
• Patient is not pregnant; AND
• Used for production of secretory endometrium and desquamation.

For diagnosis of adenocarcinoma of uterine corpus:

• Request is for hydroxyprogesterone caproate IM solution 1.25 GM/5 ML vial; AND
• Dose does not exceed 7 GM every week; AND
• Patient has advanced or metastatic (stage III or IV) adenocarcinoma of uterine corpus (also known as endometrial cancer); AND
• Prescribed by or in consultation with an oncologist; AND
• Patient is not pregnant.

Used to test for endogenous estrogen production:

• Request is for hydroxyprogesterone caproate IM solution 1.25 GM/5 ML vial; AND
• Dose does not exceed 250 mg IM once for estrogen testing with a repeat dose given 4 weeks after the first injection for confirmation; AND
• Patient is not pregnant.

Reauthorization Criteria:

For diagnosis of adenocarcinoma of uterine corpus:

• Request is for hydroxyprogesterone caproate IM solution 1.25 GM/5 ML vial; AND
• Dose does not exceed 7 GM every week; AND
• Patient does not show evidence of progressive disease while on therapy; AND
• Patient is not pregnant.

Coverage Duration:

• Reduce risk of preterm birth: up to 20 weeks.
• Amenorrhea: 4 months
• Production of secretory endometrium and desquamation: 1 year
• Adenocarcinoma of uterine corpus: 1 year
• Test for endogenous estrogen production: 2 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:

• 08/17/2021 – Changed formulary status to office administration (OA) in accordance to labeling. Added coverage criteria for hydroxyprogesterone caproate IM solution 1.25 GM/5 ML vial (non-Makena formulation).

References:

• Makena Prescribing Information. AMAG Pharmaceuticals, Inc. Waltham, MA. February 2018.
• Hydroxyprogesterone Caproate intramuscular injection, hydroxyprogesterone caproate intramuscular injection. ANI Pharmaceuticals Inc (per manufacturer), Baudette, MN, 2016.
• ACOG Committee Opinion number. Use of progesterone to reduce preterm birth. Obstet Gynecol. 2008 Oct;112(4):963-5.
• Per clinical consult with women's health specialist. May 9, 2011.
• How HY, Barton JR, Istwan NB, et al. Prophylaxis with 17 alpha-hydroxyprogesterone caproate for prevention of recurrent preterm delivery: does gestational age at initiation of treatment matter? Am J Obstet Gynecol. 2007;197(3):260.e1-4.
• González-Quintero VH, Istwan NB, Rhea DJ, et al. Gestational age at initiation of 17-hydroxyprogesterone caproate (17P) and recurrent preterm delivery. J Matern Fetal Neonatal Med. 2007;20(3):249-52.
• The choice of progestogen for the prevention of preterm birth in women with singleton pregnancy and prior preterm birth. Am J Obstet Gynecol. 2017;216(3):B11-B13. doi:10.1016/j.ajog.2017.01.022
• Hydroxyprogesterone caproate injection Prescribing Information. AuroMedics Pharma LLC. Windsor, NJ. June 2019.