Download Makena® (hydroxyprogesterone caproate)

DRUG POLICY
Makena® (hydroxyprogesterone caproate)
BENEFIT APPLICATION
Benefit determinations are based on the applicable contract language in effect at the time the services were
rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and
individual member benefits must be verified. Wellmark determines medical necessity only if the benefit
exists and no contract exclusions are applicable. This policy may not apply to FEP. Benefits are determined
by the Federal Employee Program.
DESCRIPTION
The intent of the Makena (hydroxyprogesterone caproate) drug policy is to ensure the safe, clinically
appropriate and cost-effective use of Makena while maintaining optimal therapeutic outcomes.
Makena is a commercially available synthetic progestin administered by IM injection. It is approved by the
Food and Drug Administration (FDA) to reduce the risk of preterm birth in women with a singleton pregnancy
who have a history of singleton spontaneous preterm birth. While there are many risk factors for preterm
birth, safety and efficacy of Makena has been demonstrated only in the 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.
POLICY
I.
Makena (hydroxyprogesterone caproate) may be considered medical necessary for the
prevention of preterm birth when ALL of the following criteria is met:

The current pregnancy is a singleton pregnancy

The patient had a previous spontaneous preterm birth of a singleton pregnancy

Makena will be initiated between 16 weeks, 0 days and 24 weeks, 6 days gestation

The patient has none of the following contraindications to therapy:
o
Current of history of thrombosis or thromboembolic disorder
o
Known or suspected breast cancer, other hormone-sensitive cancer, or history of these
conditions
o
Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
o
Cholestatic jaundice of pregnancy
o
Liver tumors, benign or malignant, or active liver disease
o
Uncontrolled hypertension
Approval will be for 21 weeks or until 36 weeks, 6 days of gestation, whichever is less
II. Makena (hydroxyprogesterone caproate) is considered not medically necessary for patients
who do not meet the criteria set forth above.
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III. Criteria above does not apply to non-FDA approved preparations of hydroxyprogesterone
caproate (i.e. bulk chemicals used for compounding)
Prior approval is required. Submit a prior approval/treatment request now.
Quantity limits apply: Makena 250mg/week (1 vial/5 weeks)
CLINICAL RATIONALE
A spontaneous preterm birth is an unintentional, unplanned labor before 37 completed weeks of gestation.4
Preterm birth affects approximately 12% of all US pregnancies. In 2005, the estimated annual societal
economic impact of preterm birth was $26.2 billion. Women who are at higher risk of preterm labor include
those with a prior preterm delivery, multiple gestation, short cervical length, weight less than 50 kg, AfricanAmerican race, bleeding, and sexually transmitted diseases. Infants born before 37 weeks gestation are
more likely to experience delivery complications, long-term impairment, and early death than those infants
born later in pregnancy.
One of the strongest clinical risk factors for preterm birth is a prior preterm birth.6 According to the American
College of Obstetrics and Gynecology, a woman with a singleton gestation and a prior spontaneous preterm
singleton birth should be offered progesterone supplementation starting at 16 to 24 weeks of gestation,
regardless of transvaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm
birth. Vaginal progesterone is recommended to reduce the risk of preterm birth in asymptomatic women
with a singleton gestation without a prior preterm birth with an incidentally identified very short cervical
length ≤ 20 mm before or at 24 weeks of gestation. Progesterone treatment does not reduce the risk of
preterm birth in women with twin or triplet gestations; therefore, progesterone is not recommended in
women with multiple gestations.
A randomized, placebo-controlled clinical trial evaluated the efficacy and safety of intramuscular (IM)
hydroxy-progesterone caproate in reducing the risk of preterm delivery in 463 pregnant women with a
documented history of spontaneous preterm delivery. The frequency of delivery at less than 37 weeks of
gestation was significantly lower in the hydroxyprogesterone group (36.3%) than in the placebo group
(54.9%, p < 0.001). There was a small, nonsignificant increase in the rate of miscarriages and stillbirths in
the hydroxyprogesterone group, but no overall neonatal survival difference was demonstrated. Makena is
a commercially available synthetic progestin administered by IM injection. The prescribing information
recommends that a dose of 250 mg be given once weekly, beginning between 16 weeks, 0 days to 20
weeks, 6 days of gestation. Administration should be continued until 36 weeks, 6 days gestation or delivery,
whichever occurs first.
Makena is contraindicated in patients with thrombosis or thromboembolic disorders and should be
discontinued in patients who experience an arterial or deep venous thrombotic or thromboembolic event.
Makena is contraindicated for use in patients with certain cancers, including breast cancer, hormonesensitive cancers, or benign or malignant liver tumors. Makena also should not be used in patients with
abnormal vaginal bleeding unrelated to pregnancy or in patients with uncontrolled hypertension. Makena
should be avoided in cholestatic jaundice of pregnancy and in active liver disease. Allergic reactions (eg,
urticaria, pruritus, angioedema) can occur in products containing castor oil, including Makena.
Diabetic and prediabetic women should be monitored for a reduction in glucose tolerance while on Makena
treatment. Fluid retention may occur with the use of Makena. Women with conditions that might be
influenced by fluid retention (eg, pre-eclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction)
should be carefully monitored. Women who have a history of clinical depression should be monitored for
recurrence of depression.
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PROCEDURES AND BILLING CODES
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes,
Revenue codes, and/or ICD Diagnostic Codes.

J1725, Injection, hydroxyprogesterone caproate, 1mg
REFERENCES





Makena [package insert]. Chesterfield, MO: Lumara Helath; April 2014.
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.
American College of Obstetricians and Gynecologists District II. Preventing preterm birth: the role of
17α hydroxyprogesterone caproate. http://mail.ny.acog.org/website/17PResourceGuide.pdf.
Accessed January 28, 2013.
ACOG Committee opinion number 419 October 2008 (replaces no. 291, November 2003). Use of
progesterone to reduce preterm birth. Obstet Gynecol. 2008;112(4):963-965.
Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alphahydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379-2385.
POLICY HISTORY
Policy #: 05.01.86
Policy Creation: November 2015
Reviewed:
Revised:
Current Effective Date: January 20, 2016
© 2015 Caremark. All rights reserved.
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