Paul L. Jeffrey

The Effect of a Federal Controlled Substance Act Schedule Change on Hydrocodone Combination Products Claims in a Medicaid Population

BACKGROUND In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone. In response to concerns for drug abuse and overdose, the Drug Enforcement Agency rescheduled HCPs to Schedule II in October 2014, with the intent of limiting overprescribing and increasing awareness of their abuse potential. However, it is unknown whether this has affected the overall claims for HCPs in a Medicaid population. OBJECTIVES To (a) compare the trend in HCP prescription claims with select non-HCP (opioid and nonopioid) analgesic claims before and after the HCP schedule change in the Massachusetts Medicaid fee-for-service/Primary Care Clinician plan population and (b) identify if there was a change in HCP new start member and claim characteristics before and after the HCP schedule change. METHODS This quasi-experimental, retrospective study used enrollment and pharmacy claims data to evaluate all members in the study population 1 year before and after the HCP schedule change. The number of claims for HCPs and select non-HCP analgesics was reported as the monthly rate per total population, and an interrupted time series analysis compared the change in the monthly rate of claims across groups. Members with 1 or more pharmacy claims for a new HCP prescription during a 5-month period before or after the HCP schedule change were analyzed to determine member demographics (age, gender, and number of claims) and claim characteristics (average daily dose, average quantity per claim, and days supply). RESULTS The rate of HCP claims increased before and decreased after the HCP schedule change. Controlling for the trend during the period before the HCP schedule change, the rate of HCP claims per 1,000 members per month decreased at a greater rate than non-HCP analgesics in the period after the HCP schedule change (P < 0.001). The percentage of HCP claims for new start members decreased after the HCP schedule change (44.9% vs. 34.1% of all HCP claims pre- to post-schedule change; P < 0.001). In the group of new starts, there was not a significant difference in the average daily dose (26.3 mg vs. 26.4 mg; P = 0.69), while there was a decrease in average number of tablets dispensed per claim (from 37.1 to 20.3 tablets; P < 0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P < 0.001). CONCLUSIONS The findings of this study suggest that the HCP schedule change may have contributed to the decrease in claims for HCPs in a Medicaid population. After the HCP schedule change, there was a trend towards decreased HCP use among new starts. DISCLOSURES No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by all authors except for Arnold and Clements. Tran, Arnold, and Clements took the lead in data collection, along with Peristere, and data interpretation was performed by all the authors, except Arnold. The manuscript was written primarily by Tran, along with Lavitas, Stevens, and Greenwood, and revised by all the authors except Arnold and Peristere. A poster of this research project was presented at the Academy of Managed Care Pharmacys 2016 Annual Meeting in San Francisco, California, April 2016.

Effectiveness of Ledipasvir/Sofosbuvir and Predictors of Treatment Failure in Members with Hepatitis C Genotype 1 Infection: A Retrospective Cohort Study in a Medicaid Population

BACKGROUND The primary goal of therapy for patients with chronic hepatitis C virus (HCV) infection is eradication of HCV ribonucleic acid, which is predicted by achievement of sustained virologic response at 12 weeks (SVR12). Ledipasvir/sofosbuvir was approved by the FDA in 2014 and 2015 as a once-daily regimen for the treatment of HCV genotype 1 and HCV genotypes 4, 5, and 6, respectively. Although its efficacy has been demonstrated in randomized controlled trials, there is an unmet need for real-world effectiveness data and studies that assess the association of rates of SVR12 with specific clinical and demographic factors in the Medicaid population. OBJECTIVES To (a) evaluate the effectiveness of HCV genotype 1 treatment with ledipasvir/sofosbuvir as measured by the rate of SVR12 overall and within the subgroups of 8-, 12-, and 24-week regimens and (b) identify predictors of treatment failure in the Massachusetts Medicaid (MassHealth) population. METHODS This retrospective cohort study evaluated the rate of SVR12 among 796 MassHealth Primary Care Clinician and fee-for-service plan members who completed treatment with at least one 8-, 12-, or 24-week treatment with ledipasvir/sofosbuvir for HCV genotype 1 infection between October 10, 2014, and November 1, 2016. The following variables were evaluated to identify predictors of treatment failure: sex, history of treatment failure, cirrhosis, substance use disorder, human immunodeficiency virus coinfection, and concomitant use of interacting medications. The proportion of members who achieved SVR12 was calculated for the entire study population and stratified by treatment regimen. Chi-square tests were used to compare the proportion of members who achieved SVR12, stratified by clinical and demographic variables. RESULTS SVR12 was achieved in 95% (756/796) of members. High proportions of members who received 8 weeks of treatment or 12 weeks of treatment without concomitant ribavirin achieved SVR12 (96.0% [285/297] and 95.7% [382/399], respectively). A slightly lower proportion of members who received 12 weeks of treatment with concomitant ribavirin or 24 weeks of treatment achieved SVR12 (89.9% [62/69] and 87.1% [27/31], respectively). The proportion of members who achieved SVR12 with each treatment regimen was consistent when stratified by clinical and demographic variables. None of the included variables were found to be associated with statistically significant differences in odds of treatment failure. CONCLUSIONS In the Medicaid population of 1 state, treatment of HCV genotype 1 infection with ledipasvir/sofosbuvir was associated with a high rate of SVR12. The outcomes of treatment of HCV genotype 1 infection with ledipasvir/sofosbuvir in the Medicaid population are comparable with outcomes observed in other patient populations. DISCLOSURES No outside funding supported this study. The authors have no financial disclosures. A poster of this manuscript was presented at the Academy of Managed Care Pharmacy 2017 Annual Meeting, March 27-30, 2017, in Denver, Colorado.

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.

State Medicaid Reimbursement for Medications for Chronic Hepatitis C Infection from 2012 through 2015

BACKGROUND New direct-acting antivirals (DAAs) can cure chronic hepatitis C virus (HCV) infection. High DAA prices combined with a large number of patients needing treatment may pose substantial economic burden on health systems. OBJECTIVES To examine Medicaid reimbursement for medications for HCV infection before and after the availability of new DAAs overall and by state and to also assess the impact of Medicaid expansion on reimbursement for DAAs. METHODS We calculated Medicaid reimbursements for medications for HCV infection between 2012 and 2015 in all 50 states and the District of Columbia. Outcomes included inflation-adjusted Medicaid reimbursement for medications for HCV infection, market share of individual DAAs, percentages of Medicaid outpatient pharmacy reimbursement for DAAs, and Medicaid reimbursement per Medicaid enrollee with HCV infection. RESULTS Medicaid reimbursement for medications for HCV infection increased from

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

723 million in 2012 to

Implementation of an Opioid Management Initiative by a State Medicaid Program

2.35 billion in 2015. We found variations in Medicaid reimbursement for DAAs between states in 2014 (up to 7.4 times HCV infection prevalence) that widened in 2015 (0.1-11.4 times HCV infection prevalence). Expansion states had significantly higher increases in reimbursement for DAAs per enrollee with HCV infection compared with non- or late-expansion states (

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

2178.60; 95% confidence interval

The Opiate Dilemma

1558.90-

Adherence Measurement and Incidence of Bleeding and Systemic Embolism with Dabigatran in a Medicaid Population

2798.40), controlling for pre-expansion reimbursement. CONCLUSIONS Medicaid reimbursement for DAAs differs across states after controlling for HCV infection prevalence. A third of states contributed more than 5% to 15% of pharmacy reimbursements to DAAs. Medications for HCV infection are only one class of highly priced specialty drugs. Innovative policy strategies are needed for health systems to manage coverage for an increasing number of expensive specialty medications indicated for an increasing number of patients.

Impact of a Pilot Outreach Program upon Provider Awareness and Prescribing of a Concerning Opioid Combination Regimen

Progesterone (hydroxyprogesterone caproate injection and vaginal progesterone) has been shown to reduce preterm birth (PTB) rates by a third among pregnant women at high risk. The purpose of this analysis is to report birth outcomes and medication adherence among Massachusetts Medicaid (MassHealth) members receiving progesterone, evaluate the association between member characteristics and birth outcomes and medication adherence, and compare cost of care with a prior preterm pregnancy.