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1 bmchp.org wellsense.org Pharmacy Policy Makena Policy Number: Version Number: 8.0 Version Effective Date: 09/15/2016 Product Applicability All Plan Products Well Sense Health Plan New Hampshire Medicaid NH Health Protection Program Boston Medical Center HealthNet Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options Note: Disclaimer and audit information is located at the end of this document. Policy Summary The Plan will authorize coverage of Makena TM when appropriate criteria are met. Description of Item or Service Makena TM (hydroxyprogesterone caproate injection) is a synthetic progestin FDA-approved to reduce the risk of preterm birth in women with a single offspring pregnancy who have a history of singleton spontaneous preterm birth. Safety and efficacy has not been demonstrated in women with multiple gestations or other risk factors for preterm birth. Makena TM has progestational activity, but the mechanism by which it reduces the risk of recurrent preterm birth has not been determined. Progesterone hormone helps maintain pregnancy by relaxation of smooth muscle in the uterus and inhibition of uterine contractility. There are many risk factors for preterm birth, with prior preterm birth being the strongest. Other risk factors for preterm birth include reproductive factors (i.e. history of abortion, short interpregnancy interval, assisted reproduction), multifetal gestation, vaginal bleeding, infection (i.e. asymptomatic bacteriuria, periodontal 1 of 5

2 disease, malaria, bacterial vaginosis, sexually transmitted disease), maternal genetic factors and chronic medical conditions (i.e. familial history of preterm birth, anemia, hypertension, renal insufficiency, diabetes), demographic characteristics, lifestyle issues (i.e. physical activity, coitus, nutrition, weight fluctuations, occupational and personal stress, smoking, substance abuse), cervical factors (i.e. short cervix, cervical surgery, uterine malformation), fetal factors (i.e. growth restriction, congenital anomalies, male fetal gender), and a previous infant that died of sudden infant death syndrome (SIDS). Some risk factors for preterm birth are likely to persist from pregnancy to pregnancy, however most women who have experienced preterm birth will go on to have pregnancies of normal duration. There was a statistically significant reduction in the rate of preterm delivery at < 37 weeks gestation in patients treated with Makena TM in comparison to placebo, 37.1% vs. 54.9%, respectively (CI: to -7.4%). In addition, the rates of preterm delivered at < 35 weeks gestation and < 32 weeks gestation were also lower and statistically significant in the Makena treatment arm compared to placebo, 21.3% vs. 30.7% (CI: to - 0.4%) and 11.9% vs. 19.6% (CI: to -0.3%), respectively, although the number of preterm births at less than 32 weeks was limited. Makena TM should be administered intramuscularly by a healthcare professional. Dosing is once weekly with treatment starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation for 17 to 21 weeks. Treatment should continue until week 37 of gestation or delivery, whichever occurs first. Makena TM is contraindicated in patients with a current diagnosis or history of thrombosis, thromboembolic disorders, breast cancer, other hormone-sensitive cancers, undiagnosed abnormal vaginal bleeding unrelated to pregnancy, cholestatic jaundice of pregnancy, benign or malignant liver tumors or active liver disease, and uncontrolled hypertension. Makena TM may increase the metabolism of drugs that are metabolized by cytochrome P450 enzymes CYP1A2, CYP2A6, and CYP2B6. As an alternative to Makena TM, compounded 17-hydroxyprogesterone caproate (17HP) has been available for several years through some hospital pharmacies and sterile compounding pharmacies. 17HP has a shelf life of six months and can be kept at room temperature with no refrigeration away from direct heat and sunlight. In a June 2012 update, the FDA stated that prescribers may give consideration to administering the compounded formulation of 17HP if it would provide a significant difference for the patient over the FDA-approved product. The American College of Obstetricians and Gynecologists (ACOG), along with the Society of Maternal and Fetal Medicine (SMFM) recommend progesterone supplementation for the prevention of recurrent preterm birth in women with a singleton pregnancy and a prior spontaneous preterm birth. The SMFM recommend 17-alphahydroxyprogesterone 250mg intramuscularly weekly starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation for 17 to 21 weeks and treatment should continue until week 37 of gestation or delivery, whichever occurs first. According to two Cochrane reviews of progesterone for the prevention of preterm birth, there is insufficient evidence to advocate progestational agents as tocolytic agents for women presenting with preterm labor. Policy The Plan may authorize coverage of Makena TM for members meeting the following clinical criteria 2 of 5

3 Prior Authorization (Duration of Approval Maximum of 21 weeks) A prior authorization request will be required for all prescriptions for Makena TM. These requests will be approved when the following criteria are met: Documentation of the following: 1. The member is pregnant with a single child and will begin treatment between 16 weeks 0 days and 20 weeks 6 days gestation (must document current gestation and expected date of delivery); AND 2. The member has a history of a spontaneous preterm birth of a single child at < 37 weeks gestation and treatable risk factors for preterm birth such as smoking or substance abuse have been discussed; AND 3. The member does NOT have any contraindications to, such as: current diagnosis or history of thrombosis, thromboembolic disorders, breast cancer, other hormone-sensitive cancers, undiagnosed abnormal vaginal bleeding unrelated to pregnancy, cholestatic jaundice of pregnancy, benign or malignant liver tumors or active liver disease, and uncontrolled hypertension. Quantity Limitations Apply See Appendix A Limitations The Plan will not approve coverage of in Makena TM the following instances: When the above criteria are not met. Clinical Background Information and References 1. Bernstein P, Berck D, Burgess T, et al. Prevention of preterm birth: the role of 17a-hydroxyprogesterone caproate. American College of Obstetricians and Gynecologists, District II in conjunction with the March of Dimes New York State Chapter. Compiled Jan Accessed June 30, Dodd JM, Flenady V, Cincotta R, Crowther CA. Prenatal administration of progesterone for preventing preterm birth. Cochrane Database Syst Rev Jan 25;(1):CD Farine D, Mundle WR, Dodd J, et al. The use of progesterone for prevention of preterm birth. J Obstet Gynaecol Can 2008;30(1): International Academy of Compounding Pharmacists (IACP) News Alert. FDA Issues Statement Regarding Makena and Pharmacists Ability to Compound 17P. iacpinfo@iacprx.org. Missouri City, TX March Accessed June 30, Makena (hydroxyprogesterone caproate) [prescribing information]. Waltham, MA: Lumara Health; December Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 hydroxyprogesterone caproate. Obstet & Gynecol.2007;110: Robinson JN, Norwitz ER. Risk factors for preterm labor and delivery. UpToDate. Updated April Accessed April Society for the Maternal Fetal Medicine Publications Committee. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol May;206(5): of 5

4 9. Su LL, Samuel M, Chong YS. Progestational agents for treating threatened or established preterm labour. Cochrane Database Syst Rev Jan 20;(1):CD Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena). June 15, Available at Committee on Practice Bulletins Obstetrics. American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4): Norwitz ER. Progesterone supplementation to reduce the risk of spontaneous preterm birth. UpToDate. Updated April Accessed April Appendix A Quantity Limitations for Makena Medication Name Maximum Quantity 1 ml single dose vial: 4 vials per 28 days 5 ml multidose vial: 1 vial per 30 days Original Approval Original Effective Date Date Policy Owner Approved by 07/14/ /14/2011 Pharmacy Services Pharmacy & Therapeutics (P&T) Committee Policy Revisions History Review Date Summary of Revisions Revision Effective Date Approved by 05/10/2012 P&T Annual Review, no changes required 09/01/2012 P&T Committee 08/22/2012 Policy applied to NH Medicaid 12/01/2013 P&T Committee 05/09/2013 P&T Annual Review, no changes required 09/01/2013 P&T Committee 12/13/2013 Policy applied to ConnectorCare/Qualified Health Plan (QHP) 04/01/2014 P&T Committee 05/08/2014 P&T Annual Review, modified criteria to reflect timing for initiating Makena treatment 05/14/2015 P&T Annual Review, minor rephrasing of criteria 09/10/2015 Policy Revision, minor rephrasing of criteria to address risk factors for preterm birth 09/01/2014 P&T Committee 09/01/2015 P&T Committee 10/01/2015 P&T Committee 4 of 5

5 Policy Revisions History 05/12/2016 P&T Annual Review, start of treatment range extended to 20 weeks and 6 days gestation and modified quantity limit to address new packaging 09/15/2016 P&T Committee Next Review Date 05/11/2017 Other Applicable Policies Mandatory Generic Substitution Policy Quantity Limitation Policy OCA 3.14 Medically Necessary Policy Reference to Applicable Laws and Regulations, If Any Disclaimer Information Medical Policies are the Plan s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member s benefit document, and when appropriate, coordinates with the Member s health care Providers to consider the individual Member s health care needs. Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan Provider agreement. 5 of 5