An analysis of medication adherence and birth outcomes among members receiving progesterone for the prevention of preterm birth in a state Medicaid program. Data is also used to evaluate the association between member characteristics and medication adherence and birth outcomes as well as whether there was a change in the cost of care

Greenwood, Bonnie C.

Hydery, Tasmina

Jeffrey, Paul L.

Kunte, Parag

Lenz, Kimberly J.

Mauro, Rose

Price, Mylissa K.

Takeshita, Mito

English

eScholarship@UMMS

University of Massachusetts Medical School eScholarship@UMMS Commonwealth Medicine Publications Commonwealth Medicine 2017-02-24 Evaluation of Progesterone Agent Utilization and Birth Outcomes in a State Medicaid Plan Tasmina Hydery University of Massachusetts Medical School Et al. Let us know how access to this document benefits you. Follow this and additional works at: https://escholarship.umassmed.edu/commed_pubs  Part of the Female Urogenital Diseases and Pregnancy Complications Commons, Health Economics Commons, Health Services Administration Commons, Health Services Research Commons, Maternal and Child Health Commons, Obstetrics and Gynecology Commons, and the Pharmacy and Pharmaceutical Sciences Commons Repository Citation Hydery T, Price MK, Greenwood BC, Takeshita M, Mauro R, Kunte P, Lenz KJ, Jeffrey PL. (2017). Evaluation of Progesterone Agent Utilization and Birth Outcomes in a State Medicaid Plan. Commonwealth Medicine Publications. https://doi.org/10.13028/gcxm-yr08. Retrieved from https://escholarship.umassmed.edu/commed_pubs/36 This material is brought to you by eScholarship@UMMS. It has been accepted for inclusion in Commonwealth Medicine Publications by an authorized administrator of eScholarship@UMMS. For more information, please contact Lisa.Palmer@umassmed.edu. • • DISCUSSION• Birth outcomes for members receiving progesterone for the prevention of PTB in the MassHealth PCC plan were consistent with clinical trial data.6 • Medication adherence among MassHealth PCC plan members was similar to or lower than findings from  other studies.7,8 • Bivariate and multivariate analyses did not identify member characteristics associated with either birth outcomes or medication adherence.• Differences in cost of care in a prior pregnancy and current pregnancy are driven by differences in the estimated cost of medical care between gestational ages of delivery.LIMITATIONS• A significant percentage of race data was reported as unknown. • Identification of delivery and clinical comorbidities were based upon ICD-9 and ICD-10 medical claims data. It was not feasible to investigate all potential risk factors that are not routinely recorded in medical claims. • The date of progesterone administration used for the  PDC calculation is assumed to be the date of the paid pharmacy claim. – Costs of progesterone therapy were based on wholesale acquisition cost and medical care costs were obtained from literature5 – The gestational age for prior pregnancy was obtained from the PA request and the gestational age of the study pregnancy was calculated based on date of delivery in claims data • Statistical Analysis: – Descriptive analyses were conducted to report study population characteristics. – Bivariate analyses were conducted to evaluate the associations between member characteristics and medication adherence and birth outcome. ° For the birth outcome analysis, the independent variables included demographic characteristics, clinical comorbidities, and medication adherence ° For the medication adherence analysis, the independent variables included demographic characteristics and clinical comorbidities – A multivariate logistic regression model was used to quantify the associations between birth outcome and the potential predictors, adjusting for age, race, number of clinical comorbidities and PDC – All analyses were completed using SAS 9.4.OBJECTIVEPrimary Objective:• To report medication adherence and birth outcomes among members receiving progesterone for the prevention of PTB in a state Medicaid program.Secondary Objectives:• To evaluate the association between member characteristics and medication adherence and birth outcomes. • To estimate the change in cost of care for study pregnancy compared to prior preterm pregnancy.STUDY DESIGN• This retrospective cohort study evaluated MassHealth Primary Care Clinician (PCC) plan members who had a PA request submitted for hydroxyprogesterone caproate injection or progesterone vaginal gel for the prevention of PTB between January 1, 2011 and March 31, 2015. • Data was obtained from medical claims, pharmacy claims, eligibility and enrollment records, and PA requests. • Members were excluded if MassHealth was the secondary payer, there were any breaks in MassHealth coverage, progesterone was not indicated for the prevention of PTB, the current gestational week was not provided on the PA form, or date of delivery was not available in claims data.METHODS• Outcomes collected included:  – Member (age, race) and prescriber (type, specialty) demographics  – Clinical comorbidities (nutritional disorders, anemia, depression, anxiety, bacteriuria, sexually transmitted disease, and substance use disorder), identified through ICD-9 and -10 codes – Medication adherence (defined as proportion of days covered [PDC] ≥0.8) – Birth outcomes (term vs. preterm)• For members who had information regarding their prior pregnancy on the PA request, a cost of care subanalysis comparing the prior pregnancy and study pregnancy was performed.   – Medical costs alone were used to calculate cost of prior pregnancy, and medical cost plus cost of progesterone therapy was used to calculate cost of study pregnancyRESULTSCONCLUSIONS• Timely availability and access to data are important  for monitoring risk factors and evaluating programs. • Medicaid members receiving progesterone for the prevention of PTB may benefit from additional care management services, including adherence programs.BACKGROUND• Preterm birth (PTB), or delivery before 37 weeks of gestation, is the leading cause of infant morbidity and mortality in the United States, affecting 9.6% of births.1 • History of PTB and cervical shortening during pregnancy are among the strongest risk factors for PTB. Progesterone has been shown to reduce PTB rates by one-third among women at high risk.2-4• The Massachusetts Medicaid Program (MassHealth) has required prior authorization (PA) for use of hydroxyprogesterone caproate injection (Makena®)  and progesterone vaginal gel (Crinone®) since 2011  and 2012, respectively.Evaluation of Progesterone Agent Utilization and Birth Outcomes  in a State Medicaid PlanClinical Pharmacy Services1 &  Center for Health Policy and Research2333 South Street, Shrewsbury, MA 01545508.856.6222  l  800.842.9375commed.umassmed.eduTasmina Hydery, PharmD, MBA, CGP1Mylissa Price, MPH, RPh1Bonnie C. Greenwood, PharmD, BCPS1Mito Takeshita, PharmD1Rose Mauro, MPH, CPhT1Parag S. Kunte, MPH2Kimberly Lenz, PharmD2Paul Jeffrey, PharmD2DISCLOSURES/ACKNOWLEDGMENTSThis research was funded by the University of Massachusetts Medical School’s Commonwealth Medicine Internal Grants Initiative, Shrewsbury, MA.Special thanks to Payal Kotadiya and Karen Clements  for their contributions to this project.REFERENCES1 Premature birth report card: March of Dimes; 2015 [cited 2016 Dec 6].  Available from: http://www.marchofdimes.org/mission/prematurity-reportcard.aspx.2 Auger N, Le TU, Park AL, Luo ZC. Association between maternal comorbidity and preterm birth by severity and clinical subtype: retrospective cohort study. BMC pregnancy and childbirth. 2011;11:67. 3 Practice bulletin no. 130: prediction and prevention of preterm birth. Obstetrics and gynecology. 2012;120(4):964-73. 4 Berghella V, Roman A, et al. Gestational age at cervical length measurement and incidence of preterm birth. Obstet Gynecol. 2007;110(2 Pt 1):311.5 Institute of Medicine Committee on Understanding Premature B, Assuring Healthy O. The National Academies Collection: Reports funded by National Institutes of Health. In: Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US) National Academy of Sciences.; 2007.6 Makena [package insert]. Waltham (MA): AMAG Pharmaceuticals, Inc.; 2016 Apr.7 Yee LM, Liu LY, Sakowicz A, Bolden JR, Miller ES. Racial and ethnic disparities in use of 17-alpha hydroxyprogesterone caproate for prevention of preterm birth. American journal of obstetrics and gynecology. 2016;214(3):374.e1-6. 8 Norman JE, Marlow N, Messow CM, Shennan A, Bennett PR, Thornton S, et al. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet (London, England). 2016;387(10033):2106-16. Characteristic Members who received progesterone for prevention of PTB N=169aAgeMean age, in years (SD) 29.2 (5.2)16-24 39 (23.1)25-34 107 (63.3)35-45 23 (13.6)RaceBlack 30 (17.8)Non-black 139 (82.2)White 59 (42.5)Other 28 (20.1)Unknown 52 (37.4)Prescriber typeMD 125 (74.0)DO 16 (9.4)NP 14 (8.3)CNM 14 (8.3)Prescriber specialty OB/GYN 98 (58.0)MLP 28 (16.6)OB/GYN, MFM specialty 26 (15.4)Family Medicine 17 (10.0)Term deliverybTerm 105 (62.1)Preterm 64 (37.9)Average difference in GA between pregnancies, in weeks (SD)c 8.25 (6.11)AdherenceMean PDC (SD) 0.79 (0.26)Number of adherent members 112 (66.3)Number of clinical comorbidities0 16 (9.4)1 64 (37.9)2 52 (30.8)≥ 3 37 (21.9)Type of clinical comorbidityNutritional disorder or anemia 139 (51.3)Depression or anxiety 57 (21.0)Bacteriuria 38 (14.0)STD or SUD 37 (13.7)a All numbers presented as n (%) unless otherwise noted, b Term = delivery at > 37 weeks gestational age,  Preterm = delivery at < 37 weeks gestational age, c n = 142 CI – confidence interval, GA – gestational age, GYN – gynecology, MFM – maternal family medicine, MLP – mid-level practitioner,  PA – prior authorization, PDC – proportion of days covered, OB – obstetrics, SD – standard deviation, STD – sexually transmitted disease, SUD – substance use disorderTABLE 1: Descriptive Characteristics and Birth and  Adherence OutcomesTerm Deliverya,b,cP-ValuedTerm N (%) Preterm N (%)RaceBlack 16 (53.3) 14 (46.7)0.2734Non-black 89 (64.0) 50 (36.0)PDC categories≥ 0.8 65 (58.0) 47 (42.0)0.1240< 0.8 40 (70.2) 17 (29.8)Number of clinical comorbidities0 c c0.87151 42 (65.6) 22 (34.4)2 31 (59.6) 21 (40.4)≥ 3 23 (62.2) 14 (37.8)Type of clinical comorbidityNutritional disorder or anemia 89 (64.0) 50 (36.0) 0.2734Depression or anxiety 34 (59.6) 23 (40.4) 0.6352Bacteriuria 24 (63.2) 14 (36.8) 0.8821STD or SUD 22 (59.5) 15 (40.5) 0.7047a Numbers presented as n (%), b Term = delivery at > 37 weeks gestational age, Preterm = delivery at < 37 weeks gestational age,  c Data for category not presented to protect member privacy due to low numbers, d Chi-square TestPDC – proportion of days covered, STD – sexually transmitted disease, SUD – substance use disorder  TABLE 2: Birth Outcome Bivariate Analysis  PDCa,bP-Valuec≥ 0.8 N (%) < 0.8 N (%)RaceBlack 16 (53.3) 14 (46.7)0.0984Non-black 96 (69.0) 43 (31.0)Number of clinical comorbidities0 b b0.92611 41 (64.1) 23 (35.9)2 34 (65.4) 18 (34.6)≥ 3 26 (70.3) 11 (29.7)Type of clinical comorbidityNutritional disorder or anemia 91 (65.5) 48 (34.5) 0.6339Depression or anxiety 36 (63.2) 21 (36.8) 0.5413Bacteriuria 24 (63.2) 14 (36.8) 0.6446STD or SUD 25 (67.6) 12 (32.4) 0.8504a Numbers presented as n (%), b Data for category not presented to protect member privacy due to low numbers, c Chi-square Test PDC – proportion of days covered, STD – sexually transmitted disease, SUD – substance use disorder TABLE 3: Medication Adherence Bivariate AnalysisGestational age of prior pregnancy (weeks)<28 (n=55) 28 to 31 (n=32) 32 to 36 (n=65) Total (n=152)Prior pregnancy Study pregnancy Prior pregnancy Study pregnancy Prior pregnancy Study pregnancy Prior pregnancy Study pregnancyCost of medical care $14,561,202.15 $1,913,519.87 $4,349,034.78 $504,008.44 $1,230,657.35 $1,191,092.39 $20,140,894.28 $3,608,620.70Cost of medication - $822,583.50 - $473,167.50 - $1,008,210.75 - $2,303,961.75Total cost of care $14,561,202.15 $2,736,103.37 $4,349,034.78 $977,175.94 $1,230,657.35 $2,199,303.14 $20,140,894.28 $5,912,582.45Difference in cost  between pregnancies ($11,825,098.78) ($3,371,858.84) $968,645.79 ($14,228,311.83)*Inflation rate of 1.39 for 2005 to 2015 dollars appliedTABLE 4: Cost Comparison Between Prior Pregnancy and Study Pregnancy by Gestational Age*FIGURE 1: Study EnrollmentMembers with PA request submitted for progesterone agentN=418Members eligible  for studyN=190Members who received progesterone for prevention of PTB enrolled in the studyN=169Members meeting exclusion criteria:MH was secondary payer  n=85Breaks in coverage  n=69Progesterone not indicated for prevention of PTB  n=22Current gestational week  not provided on PA form  n=25Date of delivery unavailable  n = 27Member did not have paid medical or pharmacy claim for approved progesterone agent or the PA  request was deniedn=21FIGURE 2: Proportion of Adherent MembersAdherentNon-Adherentn=112 (66.3%)n=57 (33.7%)Adherence is defined as proportion of days covered ≥ 0.8MH – MassHealth, PA – prior authorization, PTB – preterm birth © 2017 University of Massachusetts Medical School

Evaluation of Progesterone Agent Utilization and Birth Outcomes in a State Medicaid Plan

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Evaluation of Progesterone Agent Utilization and Birth Outcomes in a State Medicaid Plan

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