Disparities in Adverse Preconception Risk Factors Between Women with and Without Disabilities.

OBJECTIVE: The objective of this study was to compare the prevalence of select preconception health indicators among women with and without disabilities. METHODS: 2010 Behavioral Risk Factor Surveillance System data were used to estimate the prevalence of health behaviors, health status indicators, and preventive health care among non-pregnant women ages 18-44 years with (N = 8370) and without (N = 48,036) disabilities. Crude percentages were compared with Chi square statistics. Multivariable logistic regressions adjusted for socio-demographic factors. RESULTS: Women with disabilities were more likely than women without disabilities to currently smoke (30.5 vs. 14.5 %, p < 0.0001) and less likely to exercise in the past month (67.1 vs. 79.8 %, p < 0.0001). Heavy drinking was similar in the two groups (4.4 vs. 4.5 %, p = 0.9). Health status indicators were worse among women with disabilities, with 35.0 % reporting fair/poor health and 12.4 % reporting diabetes, compared with 6.7 and 5.6 %, respectively, among women with no disabilities (p < 0.0001 for both). Frequent mental distress, obesity, asthma, and lack of emotional support were also higher among women with disabilities compared with their non-disabled counterparts. Women with disabilities were more likely to receive some types of preventive care, (HIV), but less likely to receive others (recent dental cleaning, routine checkup). Disparities in health behaviors and health status indicators between the two groups remained after adjusting for socio-demographic factors. CONCLUSION: Women with disabilities at reproductive age are more vulnerable to risk factors associated with adverse pregnancy outcomes compared to their counterparts without disabilities. Our findings highlight the need for preconception health care for women with disabilities.

Maternal Characteristics, Pregnancy Complications, and Adverse Birth Outcomes Among Women With Disabilities.

OBJECTIVES: The objective of this study is to describe the maternal characteristics, pregnancy complications, and birth outcomes among a representative sample of Rhode Island women with disabilities who recently gave birth. METHODS: Data from the 2002-2011 Rhode Island Pregnancy Risk Assessment Monitoring System survey were analyzed. RESULTS: Approximately 7% of women in Rhode Island reported a disability. Women with disabilities reported significant disparities in their health care utilization, health behaviors, and health status before and during pregnancy and during the postpartum period. Compared with nondisabled women, they were significantly more likely to report stressful life events and medical complications during their most recent pregnancy, were less likely to receive prenatal care in the first trimester, and more likely to have preterm births (13.4%; 95% CI, 11.6-15.6 compared with 8.9%; 95% CI, 8.5-9.3 for women without disabilities) and low-birth-weight babies (10.3%; 95% CI, 9.4-11.2 compared with 6.8%; 95% CI, 6.8-6.9). There was no difference in the rates of cesarean section between women with and without disabilities. CONCLUSIONS: These findings support the need for clinicians providing care to pregnant women with disabilities to be aware of the increased risk for medical problems during pregnancy and factors that increase the risk for poor infant outcomes.

Cost-effectiveness analysis of antiepileptic drugs in the treatment of Lennox-Gastaut syndrome.

An economic model evaluated the costs and outcomes of adjunctive clobazam therapy for Lennox-Gastaut syndrome (LGS) compared with adjunctive lamotrigine, rufinamide, and topiramate. Clinical data were used to estimate baseline frequency and the percentage of drop-seizure reductions over 3 months (all comparators) and 2 years (rufinamide). Claims data from a large US health care plan were employed to estimate costs. After 3 months, 21.5% of those receiving clobazam were drop-seizure-free. Over a 3-month horizon, clobazam was more effective and less expensive than comparators, with the assumption that >0.77% of drop seizures required medical care. Below this threshold, topiramate was less costly than clobazam. With the base-case assumption that 2.3% of drop seizures were medically attended, costs for patients receiving clobazam totaled $30,147 versus $34,223-$35,378 for comparators. Clobazam was more efficacious and less costly than rufinamide over a 2-year horizon. The percentage of medically attended drop seizures was a driver of results. Clobazam treatment may be cost-saving.

Cost-benefit analysis of sacubitril/valsartan in a Medicaid population.

OBJECTIVE: To evaluate the cost-benefit of sacubitril/valsartan in adults with heart failure (HF) enrolled in a state Medicaid plan to prevent HF-related hospitalizations and emergency department (ED) visits. STUDY DESIGN: Retrospective, claims-based, cost-benefit study. METHODS: This exploratory cost-benefit study evaluated Massachusetts Medicaid (MassHealth) members with HF who had an initial pharmacy claim for sacubitril/valsartan between July 7, 2015, and August 31, 2018 (index date). Efficacy outcomes, HF-related hospitalizations and ED visits, and cost outcomes for HF-related medical and pharmacy claims were compared 1 year pre- and post index date. Benefit-cost ratio and net benefit were calculated for all members. A subgroup analysis evaluated the outcomes for members who were adherent to sacubitril/valsartan. RESULTS: A total of 22 members were identified for the study. There were fewer hospitalizations and ED visits post sacubitril/valsartan initiation in the overall population (post vs pre-: 23 vs 26) and among 12 members adherent to sacubitril/valsartan (10 vs 12). The median (IQR) cost for hospitalizations and ED visits was lower during the postindex period ($576 [$19,439] vs $132 [$11,692]) whereas the median (IQR) cost for HF pharmacotherapies was greater during the postindex period ($4578 [$3033] vs $270 [$255]). The benefit-cost ratio and net benefit were 0.91 and -$336, respectively, for all members and 1.43 and $2337, respectively, for members adherent to sacubitril/valsartan. CONCLUSIONS: The benefit as demonstrated by the cost avoidance of HF-related hospitalizations and ED visits did not outweigh the additional costs of sacubitril/valsartan, but cost-benefit was observed in members who were adherent to sacubitril/valsartan.

Uptake of hepatitis C virus treatment in a multi-state Medicaid population, 2013-2017.

OBJECTIVE: To examine trends in the direct acting antiviral (DAA) uptake in a multi-state Medicaid population with hepatitis C virus (HCV) prior to and after ledipasvir/sofosbuvir (LDV/SOF) approval and changes in prior authorization (PA) requirements. DATA SOURCES: Analyses utilized enrollment, medical, and pharmacy claims in four states, December 2013-December 2017. STUDY DESIGN: An interrupted time series examined trends in uptake (1+ claim for a DAA) before and after two events: LDV/SOV approval (October 2014) and lifting of PA requirements for 40% of members (July 2016). Analyses were also performed in subgroups defined by the number and dates of change in PA requirements in members' Medicaid plans. DATA COLLECTION/EXTRACTION METHODS: Members aged 18-64 years with an ICD code for HCV were included in the sample from diagnosis date until treatment initiation or Medicaid disenrollment. PRINCIPAL FINDINGS: The annual sample size ranged from 38,302 to 45,005 with approximately 30% ages 18-34 years and 40% female. In December 2013, 0.08% was treated, rising to 0.74% in December 2017 (p < 0.001). Uptake increased from 0.34%/month in October 2014 to 0.70%/month after LDV/SOF approval, (p < 0.001), and increased relative to the pre-LDV/SOV trend through June 2016 (p = 0.04). Uptake increased to 1.18%/month after PA change, (p < 0.001) and remained flat through 2017 (p = 0.64). Cumulatively, 20.1% were treated by December 2017. In plans with few/no requirements through 2017, uptake increased to 1.19%/month after LDV/SOF approval (p < 0.001) and remained flat through 2017 (p = 0.11), with 22.2% cumulatively treated. Among plans that lifted PA requirements from three to zero in mid-2016, uptake did not increase after LDV/SOF approval (p = 0.36) but did increase to 1.41%/month (p < 0.001) after PA change, with 18.1% cumulatively treated. CONCLUSIONS: HCV Treatment increased through 2017. LDV/SOF approval and lifting PA requirements led to an increase in uptake followed by flat monthly utilization. Cumulative uptake was higher in plans with few/no PA requirements relative to those with three requirements through mid-2016.

Cost-effectiveness of a recommendation of universal mass vaccination for seasonal influenza in the United States.

OBJECTIVES: We evaluated the cost-effectiveness of universal mass vaccination (UMV) against influenza compared with a targeted vaccine program (TVP) for selected age and risk groups in the United States. METHODS: We modeled costs and outcomes of seasonal influenza with UMV and TVP, taking a societal perspective. The US population was stratified to model age-specific (< 5, 5-17, 18-49, 50-64, and 65+ years) vaccine coverage and efficacy. Probability of influenza-related illness (ILI) and complications, health-care utilization, costs, and survival were estimated. For a season's intervention, ILI cases in that year, lifetime costs (2008 US$), and quality-adjusted life years (QALYs) lost (both discounted at 3% per annum) were calculated for each policy and used to derive incremental cost-effectiveness ratios. A range of sensitivity and alternative-scenario analyses were conducted. RESULTS: In base-case analyses, TVP resulted in 63 million ILI cases, 859,000 QALYs lost, and $114.5 billion in direct and indirect costs; corresponding estimates for UMV were 61 million cases, 825,000 QALYs lost, and $111.4 billion. UMV was therefore estimated to dominate TVP, saving $3.1 billion and 34,000 QALYs. In probabilistic sensitivity analyses, UMV was dominant in 82% and dominated in 0% of iterations. In alternative-scenario analyses, UMV dominated TVP when lower estimates of vaccine coverage were used. Lower estimates of ILI risk among unvaccinated, vaccine effectiveness, and risk of complications resulted in ICERs of $2800, $8100, and $15,900 per QALY gained, respectively, for UMV compared with TVP. CONCLUSIONS: UMV against seasonal influenza is cost saving in the United States under reasonable assumptions for coverage, cost, and efficacy.

Evaluating proactive outreach for prior authorization recertifications in Medicaid patients.

OBJECTIVES: To assess the effectiveness of a proactive provider intervention in prompting prior authorization (PA) submissions or provider response prior to PA expiration for medically complex Medicaid patients. STUDY DESIGN: Pre-post outreach study with data from pharmacy claims and provider outreach. METHODS: The intervention and historical comparison (control) groups included expired PAs from December 2019 to February 2020 and from December 2018 to February 2019, respectively. Provider outreach, including telephonic and fax attempts, was conducted over a 2-week period prior to PA expiration. Outcomes were classified as positive or negative based on provider conversation coupled with the result (eg, PA submission) for the intervention group and based solely on pharmacy claims for the control group. The primary end point was the percentage of positive outcomes between the groups, analyzed via χ2 test. The time from PA expiration to the new PA submission was evaluated via t test. RESULTS: A total of 342 outreach attempts were conducted for 270 PAs representing 193 unique patients. Outreach was more likely to result in positive outcomes in the intervention group vs no outreach in the control group (87% vs 25%; P < .00001). On average, PAs were submitted 3.5 days prior to expiration in the intervention group vs 13.0 days after expiration in the control group (t = -7.50; P < .00001). CONCLUSIONS: Proactive outreach resulted in a greater percentage of PA submissions and a significantly reduced time to PA submission. These findings provide important information for payers in guiding clinical programs to enhance continuity of care among at-risk populations.

Postpartum Health Care Among Women With Intellectual and Developmental Disabilities.

INTRODUCTION: Postpartum health care among women with intellectual and developmental disabilities has not been well studied. This study uses administrative claims to compare postpartum outpatient visits among women with and without intellectual and developmental disabilities. METHODS: Massachusetts All Payers Claims Database 2012-2015 was used to identify women with intellectual and developmental disabilities and a live birth during 2012-2014, matched by infant birth year to 3 women without intellectual and developmental disabilities. Women were followed up for 1 year after delivery. Analyses were conducted in 2019. Poisson regression compared guideline-concordant postpartum and other outpatient visits during the early (21-56 days after delivery) and late (57-365 days after delivery) periods. Types of nonpostpartum care visits were examined. RESULTS: Overall, 962 and 2,886 women with and without intellectual and developmental disabilities, respectively, comprised the sample. Among women with intellectual and developmental disabilities, 23.9% had a postpartum visit in the early and 33.3% in the late postpartum periods, compared with 25.2% and 32.1% of women without intellectual and developmental disabilities who had visits in the early and late postpartum periods, respectively (p=0.49, 0.59). Women with intellectual and developmental disabilities were more likely to have other outpatient visits than those without intellectual and developmental disabilities, both in the early (63.1% vs 40.3%, adjusted RR=1.42, 95% CI=1.28, 1.58, p<0.001) and late (94.2% vs 82.3%, RR=1.11, 95% CI=1.08, 1.14, p=0.008) postpartum periods. Ancillary services, home health services, and alcohol/drug-related visits were much more common among women with intellectual and developmental disabilities. CONCLUSIONS: Women with intellectual and developmental disabilities are equally likely to receive guideline-concordant postpartum visits and more likely to have other outpatient visits than other women. Further research is needed to evaluate visit quality and identify best practices to support mothers with intellectual and developmental disabilities during the postpartum period.

Emergency department utilization during the first year of life among infants born to women at risk of disability.

BACKGROUND: Women with disabilities are at risk for poor birth outcomes. Little is known about longer-term health and healthcare utilization of infants of women with disabilities. OBJECTIVES: We identified women at risk for disability and evaluated their infants' emergency department (ED) utilization during the first year of life. STUDY DESIGN: This population-based cohort study used Massachusetts 2007-2009 birth certificates linked to 2007-2010 hospital discharge data. Access Risk Classification System categorized ICD-9 CM/CPT codes into disability risk categories. Infant ED visits were evaluated overall and by severity (emergent/intermediate vs. non-emergent). Cox proportional hazards models provided adjusted estimates. Results were stratified by gestational age (preterm, < 37 weeks, term, 37 + weeks). RESULTS: Of 218,599 women, 6.7% were at risk of disability. Infants born to women at risk had a higher rate of ED visits in their first year than infants born to women not at risk: 0.85 visits/person-year (95% CI 0.84-0.87) vs. 0.55 (0.55-0.55) for term, 0.74 (0.70-0.77) vs. 0.55 (0.54-0.56) for preterm. Utilization varied by maternal diagnosis. Emergent/intermediate and non-emergent visits were both elevated among infants born to women at risk for disability. In adjusted analyses, term infants of women with musculoskeletal diagnoses (HR = 1.3, 95% CI 1.2-1.4) and preterm infants of women with circulatory diagnoses (HR = 1.2, 1.0-1.3) had the highest hazards of ED visit vs. infants of women not at risk of disability. CONCLUSION: Maternal disability risk is associated with postnatal infant ED utilization; utilization varies by maternal diagnosis. Interventions to improve health of infants born to women with disabilities are warranted.

Postpartum emergency department use among women with intellectual and developmental disabilities: a retrospective cohort study.

BACKGROUND: An emerging body of evidence underscores the often-intensive perinatal healthcare needs of women with intellectual and developmental disabilities (IDD). However, population-based research examining postpartum experiences of US women with IDD is sparse. We examined emergency department (ED) use in the postpartum period among Massachusetts mothers with IDD. METHODS: We analysed 2002-2010 Massachusetts Pregnancy to Early Life Longitudinal data to compare any and ≥2 ED visits between mothers with and without IDD: within 1-42 days post partum, 1-90 days post partum and 1-365 days post partum. We also determined whether or not such ED use was non-urgent or primary-care sensitive. RESULTS: We identified 776 births in women with IDD and 595 688 births in women without IDD. Across all three postpartum periods, women with IDD were vastly more likely to have any postpartum ED use, to have ≥2 ED visits and to have ED visits for mental health reasons. These findings persisted after controlling for numerous sociodemographic and clinical characteristics. Women with IDD were less likely to have non-urgent ED visits during the three postpartum periods and they were less likely to have primary-care sensitive ED visits during the postpartum period. CONCLUSION: These findings contribute to the emerging research on perinatal health and healthcare use among women with IDD. Further research examining potential mechanisms behind the observed ED visit use is warranted. High ED use for mental health reasons among women with IDD suggests that their mental health needs are not being adequately met.

Impact of Sequential Opioid Dose Reduction Interventions in a State Medicaid Program Between 2002 and 2017.

Policies that address opioid dose limits may help to decrease high-risk opioid prescribing. We evaluated 3 sequential and progressive decreases in high-dose (HD) opioid limits implemented by Massachusetts Medicaid over 15 years. The study population included members ages 18 to 64 years with ≥1 claim for a schedule II opioid between January 2002 and March 2017. The 3 interventions consisted of prior authorization requirements for prescriptions exceeding the morphine equivalent dose (MED) HD dose limits: >360 mg (intervention 1a and 1b), >240 mg (intervention 2), and >120 mg (intervention 3). A segmented regression evaluated the change in natural log of the average daily MED (AD_MED). The natural log of the AD_MED decreased during the 6 quarters after intervention 1a (P < .001), immediately after intervention 1b (P = .0002), and continued to decrease over the following 8 quarters (P = .023). The natural log of the AD_MED decreased immediately after intervention 2 (P = .002) and again after intervention 3 (P < .001). The percentage of users exceeding the HD limits of 360 mg, 240 mg, and 120 mg MED decreased by 87.3%, 79.8%, and 75.2% from baseline, respectively. The natural log of the AD_MED decreased among members after implementation of 3 sequential and progressive HD prior authorization limits, as did the percentage of members exceeding each of the HD limits. PERSPECTIVE: This study demonstrates the longitudinal impact of a prior authorization policy-based HD limit in a Medicaid population. This study contributes to options for policymakers and other Medicaid programs as a potential strategy to assist in addressing the opioid epidemic.

Antenatal Hospital Utilization Among Women at Risk for Disability.

BACKGROUND: Little is known about the effect of potentially disabling health conditions on healthcare utilization during pregnancy. Using hospital discharge data, we identified women at risk for disability and evaluated antenatal hospital utilization, including emergency department (ED), observational stay (OS), and inpatient (IP) visits, by underlying health condition. MATERIALS AND METHODS: Massachusetts Pregnancy to Early Life Longitudinal data system linked 2007-2009 birth certificates to 2006-2009 discharges. Access Risk Classification System categorized ICD-9-CM/Current Procedural Terminology codes recorded at delivery into disability risk groups (no/low vs. medium/high). Women were further categorized based on delivery diagnoses. Cox models evaluated the association between disability risk and utilization. Utilization by prenatal care and visit reason was examined. RESULTS: Of 221,867 women, 4.0% were at medium/high risk of disability. Mental illness (26.9%) and circulatory system (25.2%) diagnoses were most common. More than 2% had comorbid mental/physical conditions. Women at risk for disability were more likely than women not at risk to have an antenatal ED (37.1% vs. 25.0%), OS (19.1% vs. 13.1%), or nondelivery IP visit (11.5% vs. 4.0%) (p ≤ 0.001 for each). Utilization varied by diagnosis. In adjusted analyses, women with two or more physical conditions had highest rate of ED visit (hazard ratio [HR] = 2.3, 95% confidence interval 1.8-2.8) and OS/IP visit (HR = 2.9, 95% 2.3-3.6) compared with women not at risk. Inadequate prenatal care was associated with increased utilization across all disability risk groups. ED visits for mental illness were high across groups. CONCLUSIONS: Disability risk identified in discharge data is associated with elevated antenatal hospital utilization. Utilization varies by underlying diagnosis.

A systematic review of community-based interventions to improve oral chronic disease medication regimen adherence among individuals with substance use disorder.

BACKGROUND: Poor medication adherence has been shown to cause medical complications, death, and increased healthcare costs and may be of particular importance in patients with substance use disorder (SUD). Concerns regarding adherence in this population may influence a healthcare provider's decision to prescribe a medication requiring high adherence. Guidance defining best practices that promote adherence among individuals with SUD is lacking. METHODS: A review of English articles in Medline and PsycINFO databases, published between October 1, 1994 and October 31, 2017, was conducted in order to identify studies of interventions intended to improve adherence to oral chronic disease medication regimens among patients with SUD. Randomized controlled trials, quasi-experimental study designs, and case series were included. Article quality was assessed. RESULTS: A total of 854 abstracts were retrieved, of which 24 met inclusion criteria. Adherence interventions were categorized as those: 1) addressing the chronic disease state; 2) addressing SUD; or 3) both. Studies varied greatly with respect to intervention length, method of measuring adherence, and quality. Statistically significant improvement in adherence was observed in 12 of 24 studies (50%). Specific interventions that improved adherence included incentive-based interventions, directly observed therapy, and telephonic/home visits. Counseling-based interventions such motivational interviewing and cognitive behavioral therapy presented mixed results. CONCLUSIONS: While effective interventions were identified, heterogeneity of study designs and study quality preclude determination of optimal interventions to promote adherence in this population. Further evaluation with sound study design may inform the development of best practices for treating chronic disease in patients with SUD.

Antenatal Hospitalization Among U.S. Women With Intellectual and Developmental Disabilities: A Retrospective Cohort Study.

This population-based retrospective cohort study examines the prevalence of hospital utilization during pregnancy and the primary reason for antenatal hospital utilization among women with intellectual and developmental disabilities (IDD). Massachusetts residents with in-state deliveries that were ≥ 20 weeks gestational age were included via data from the 2002-2009 Massachusetts Pregnancy to Early Life Longitudinal Data System. Among women with IDD, 54.8% had at least one emergency department (ED) visit during pregnancy, compared to 23% of women without IDD. Women with IDD were more likely to have an antenatal ED visit, observational stays, and non-delivery hospital stays. This study highlights the need for further understanding of the health care needs of women with IDD during pregnancy.

An Evaluation of a Multidisciplinary Pediatric Behavioral Health Medication Initiative Workgroup's Interventions on Medication Prescribing in a Population of Medicaid Patients.

BACKGROUND: In response to concerns surrounding pediatric behavioral health medication prescribing, the Massachusetts Medicaid Pharmacy Program implemented a Pediatric Behavioral Health Medication Initiative (PBHMI), proactively requiring prior authorization for specific behavioral health medications and combination regimens. A multidisciplinary therapeutic class management (TCM) workgroup retrospectively reviews complex cases and conducts prescriber outreach to encourage evidence-based practices in Massachusetts. OBJECTIVE: To evaluate recommendation outcomes of telephonic peer-to-peer consultations conducted by the PBHMI TCM workgroup by assessing the percentage of accepted, modified accepted, or rejected recommendations, as well as prescriber satisfaction with consultation. METHODS: This retrospective evaluation reviewed PBHMI TCM workgroup cases with completed peer-to-peer consultations from September 1, 2015, to August 28, 2016. The proportion of medication interventions (e.g., medication changes, dose reductions, and elimination of polypharmacy within or across behavioral health medication classes) accepted, modified accepted, or rejected were assessed based on pharmacy claims data and prior authorization resubmission, following a peer-to-peer consultation. The medication class and prescriber type were categorized in relation to the acceptance, modified acceptance, or rejection outcomes. Satisfaction with the TCM workgroup process was evaluated with an anonymous survey offered to prescribers who participated in prescriber outreach. RESULTS: A total of 70 cases requiring a peer-to-peer consultation by a TCM workgroup child/adolescent psychiatrist had a completed outreach attempt during the evaluation period. Peer-to-peer consultations resulted in a recommendation acceptance rate of 31.4% (22/70), modified acceptance rate of 44.3% (31/70), and a rejection rate of 24.3% (17/70). Recommendations made during a peer-to-peer consultation were rejected by 30% (12/40) of child/adolescent psychiatrists compared with 16.7% (5/30) of nonchild/adolescent psychiatrists with completed peer-to-peer consultations (P = 0.43). Antipsychotics were most frequently recommended for regimen changes. All recommendations pertaining to a benzodiazepine were accepted by the prescriber. Results of an anonymous prescriber survey assessing satisfaction with the peer-to-peer consultation process exhibited variable responses among individual prescribers. CONCLUSIONS: The small sample size in this observational evaluation and lack of a defined control group prevented direct associations between the endpoints and outcomes. Further research is required to determine if prescriber specialty and medication class may be influencing factors on recommendation acceptance. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. A poster of this project was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2017; March 27-30, 2017; in Denver, CO.

Pregnancy Characteristics and Outcomes among Women at Risk for Disability from Health Conditions Identified in Medical Claims.

BACKGROUND: Women with disabilities are at risk for poor birth outcomes. Little is known about specific potentially disabling health conditions and their effects on pregnancies. Using hospital claims, we identified women at risk for disability and evaluated the relationship between disability risk and demographic characteristics, pregnancy risks, and infant and maternal outcomes. METHODS: The 2006 through 2009 Massachusetts Pregnancy to Early Life Longitudinal data system linked birth certificate and hospital claims one year pre-pregnancy through delivery. Access Risk Classification System categorized International Classification of Diseases, Ninth Revision, Clinical Modification/Current Procedural Terminology codes into disability risk groups (no/limited vs. medium/high). Generalized estimating equations evaluated the association between disability risk and infant and maternal outcomes. RESULTS: Of 221,867 women, 14,701 (6.6%) were at medium or high risk of disability. Health conditions were classified as circulatory (23%), musculoskeletal (10%), nervous system/sensory (13%), other physical (19%), two or more physical (5%), mental illness (24%), and comorbid mental/physical (6%). Women at risk of disability were more likely than others to have socioeconomic and pregnancy risks, and adverse infant and maternal outcomes. Socioeconomic and risk profile varied by health condition category. Adjusted risk ratios for preterm birth ranged from 1.2 (95% confidence interval [CI], 1.1-1.4) for women with nervous system/sensory diagnoses to 1.6 (95% CI, 1.4-1.9) for women with two or more physical diagnoses; risk ratios for maternal delivery hospitalization for more than 5 days ranged from 1.5 (95% CI, 1.2-1.9) for women with musculoskeletal diagnoses to 3.0 (95% CI, 2.5-3.6) for women with comorbid mental/physical diagnoses. CONCLUSIONS: Disability risk identified through claims is associated with poor infant and maternal outcomes. Risk profiles vary by underlying health condition.

Aflibercept vs. Ranibizumab: cost-effectiveness of treatment for wet age-related macular degeneration in Sweden.

PURPOSE: Monthly dosing with ranibizumab (RBZ) is needed to achieve maximal visual gains in patients with neovascular ('wet') age-related macular degeneration (wAMD). In Sweden, dosing is performed as needed (RBZ PRN), resulting in suboptimal efficacy. Intravitreal aflibercept (IVT-AFL) every 2 months after three initial monthly doses was clinically equivalent to RBZ monthly dosing (RBZ q4) in wAMD clinical trials. We assessed the cost-effectiveness of IVT-AFL versus RBZ q4 and RBZ PRN in Sweden. METHODS: A Markov model compared IVT-AFL to RBZ q4 or RBZ PRN over 2 years. Health states were based on visual acuity in better-seeing eye; a proportion discontinued treatment monthly or upon visual acuity <20/400. Parameters were estimated from trial data, published literature or expert opinion. Analyses were performed from a societal perspective with a lifetime horizon. The model calculated costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs), discounted 3% annually. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Lifetime cost of IVT-AFL was 578 400 SEK, compared with 565 700 SEK for RBZ PRN and 686 600 SEK for RBZ q4. Compared with RBZ PRN, the ICER of IVT-AFL was 27 000 SEK/QALY gained. RBZ q4 cost 20.4 million SEK/QALY gained versus IVT-AFL. Results were sensitive to IVT-AFL efficacy, but IVT-AFL had a 100% probability of being cost-effective versus both RBZ PRN and RBZ q4 at a willingness-to-pay threshold of 500 000 SEK. CONCLUSION: Results suggest, in Sweden, at parity price level, IVT-AFL is less costly than RBZ q4, while demonstrating similar efficacy; IVT-AFL is cost-effective versus RBZ PRN.

Access to New Medications for Hepatitis C for Medicaid Members: A Retrospective Cohort Study.

BACKGROUND: Sofosbuvir (SOF)- or simeprevir (SIM)-containing regimens are highly effective for treating chronic hepatitis C virus (HCV) infection. These regimens, however, are expensive. Most payers have implemented prior authorization (PA) requirements to ensure that patients who can benefit most have priority for these medications. While many Medicaid programs limit access to those with advanced disease or to members who do not have active substance use disorder (SUD), the Massachusetts Medicaid (MassHealth) Primary Care Clinician (PCC) plan does not limit access based on disease severity or presence of SUD. Evaluating PA requests for SOF and/or SIM among MassHealth members will offer a useful example of early uptake among Medicaid members and will identify patient groups who might face barriers to treatment at the provider or patient level. OBJECTIVES: To (a) evaluate the percentage of MassHealth PCC members with HCV who had a PA request, along with the percentage of requests approved, and (b) identify characteristics associated with PA requests for SOF or SIM among Massachusetts Medicaid (MassHealth) members with HCV. METHODS: This retrospective cohort study used enrollment, medical claims, and PA request data from MassHealth PCC members from December 6, 2012, to July 31, 2014. The sample included members with 1 or more claims with an ICD-9-CM code for HCV during this time who were continuously enrolled from December 6, 2013, to July 31, 2014. Enrollment and medical claims data for the cohort with HCV were linked to a database containing information collected from PA requests. The overall percentage of members with HCV and a PA request for SOF and/or SIM between December 6, 2013, and July 31, 2014, and the percentage of requests approved were calculated. Chi-square statistics were used to compare demographic and clinical characteristics among members with HCV who did and did not have a request. Logistic regression was used to estimate the strength of associations between patient characteristics and a PA treatment request, adjusting for clinical and demographic variables. RESULTS: Of 6,849 members identified with HCV, 346 (5.1%) had a PA request for SOF and/or SIM submitted to MassHealth. Compared with members with HCV who did not have a PA request for SOF or SIM, those with a PA request for these new treatments were more likely to be male (P = 0.01), older (P < 0.001), white race (P = 0.04), have standard MassHealth insurance (P = 0.01), and less likely to be homeless (P < 0.001). Members with a PA request were also more likely to have been treated for HCV in the past year and have advanced disease (hepatic decompensation, cirrhosis, or liver transplant) but less likely to have SUD (P < 0.001 for each). Ninety percent of requests for SOF or SIM were approved; few demographic or clinical characteristics were associated with approval. In adjusted analyses, predictors of PA request were aged 50-64 years (odds ratio (OR) = 2.0, 95% CI = 1.1-3.7 vs. aged < 30 years); hepatic decompensation (OR = 1.6, 95% CI = 1.2-2.3); cirrhosis (OR = 3.0, 95% CI = 2.2-4.1); liver transplant (OR = 3.0, 95% CI = 1.4-6.5); substance use (OR = 0.6, 95% CI = 0.5-0.8); recent HCV treatment (OR = 1.6, 95% CI = 1.0-2.6); comorbidity (OR = 0.95, 95% CI = 0.91-0.98) for 1-unit increase in Diagnostic Cost Group score; and care at a hospital outpatient department (OR = 2.0, 95% CI = 1.2-3.2 vs. group practice). CONCLUSIONS: Antiviral treatment with SOF and/or SIM was requested for a relatively small proportion of MassHealth members with HCV, with nearly all approved. Prescriber prioritization or patient barriers to care, rather than the PA process, determined access to treatment in this Medicaid population. Support may be needed to ensure patients with SUD benefit from advances in HCV treatment. DISCLOSURES: No outside funding supported this research. Internal funding was provided by the Commonwealth of Massachusetts. Lavitas has received compensation from University of Tennessee Advanced Studies in Medicine for development of CPE activity. Graham has consulted for the National Viral Hepatitis Roundtable and the Department of Health and Human Services, has received payment from Medscape for CME development, and is employed by Trek Therapeutics. Jeffrey has received payment for guest lectures at Boston University and Harvard University. Study concept and design were primarily contributed by Clark and Clements, along with Graham, Lenz, and Jeffrey. Kunte collected the data, which were interpreted by Graham, Lenz, and Jeffrey, with assistance from Lavitas, Clark, and Clements. The manuscript was written primarily by Clements, along with O'Connell and assisted by Graham, and revised by all the authors.