Lowering Out of Pocket Drug Costs for Consumers

Prohibiting gag clauses could help lower consumer out-of-pocket pharmacy costs - if Pharmacy Benefits Managers don\u27t raise prices to make-up the difference. Mylissa Price closes our blog series on President Trump\u27s Blueprint to Lower Drug Costs in this final entry

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

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

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

An evaluation of the effectiveness of HCV genotype 1 treatment with Harvoni® (ledipasvir/sofosbuvir) as measured by a sustained virological response (SVR) of 12 weeks in the MassHealth fee-for-service and Primary Care Clinician plan population. The analysis concluded that treatment was associated with a a high rate of SVR12, which means that Hepatitis C is not detected in the blood after 12 weeks

Impact of Ivacaftor on Medication Use, Hospital and Outpatient Provider Visits and Associated Costs in a Medicaid Population

BACKGROUND: Ivacaftor is the first Food and Drug Administration-approved medication to treat an underlying genetic defect in patients with cystic fibrosis (CF). With an approximate annual cost of $300,000 per patient, ivacaftor may have a profound financial impact on health systems, even when utilized by a small population. Clinical data has demonstrated that treatment with ivacaftor may reduce pulmonary exacerbations (PE) and associated hospitalizations. As a result, patients receiving ivacaftor may need less outpatient care and fewer medications to treat CF complications. Evaluating the impact of ivacaftor therapy on medication utilization, PEs and hospital/outpatient visits can aid formulary decision makers in its effective management. OBJECTIVES: The primary objective is to examine the effects of ivacaftor on patients’ overall medication regimen and associated costs within a Medicaid population. The secondary objective is to examine its effect on the rates of PEs and hospital/outpatient visits. METHODS: Pharmacy and medical claims data for Medicaid members ≥ six years of age was collected for six months before and after the first reported pharmacy claim of ivacaftor. Data included: total number of unique claims, days supply, dose, and total cost for each medication, number of short-term antibiotic and/or steroid courses, outpatient provider visits, hospitalizations, ER visits and corresponding diagnosis codes. Diagnosis codes and short-term antibiotic and/or steroid courses were reviewed to determine if a PE may have occurred. RESULTS: Ivacaftor treatment did not decrease the utilization of medications used to treat patients with CF and resulted in increased pharmacy expenditures for other medications. However, a 65% reduction in PEs as well as a reduction in hospitalizations/ER visits was observed in members receiving ivacaftor. CONCLUSIONS: This study found that while ivacaftor treatment may not decrease total medication utilization or associated costs, it may decrease the number of PEs and associated hospitalizations in patients with CF

Overview of Comprehensive Hepatitis C Virus Medication Management in a State Medicaid Program

BACKGROUND: Breakthrough direct-acting antivirals set a new standard in the management of hepatitis C virus (HCV) with regard to cure rates and improved tolerability; however, the health care system is challenged by the cost of these medications. OBJECTIVE: To describe the effect of a comprehensive HCV medication management program on optimized regimen use, prior authorization (PA) modifications, and medication cost avoidance in a state Medicaid program. METHODS: This program consists of a 2-tiered prescriber outreach: (1) regimen outreach to promote optimized regimen selection and (2) refill outreach to support medication adherence. PA criteria were developed to identify optimized regimens, taking into account member- and virus-specific factors as well as cost. Prescriber outreach was conducted to recommend the use of an optimized regimen as applicable. Successful regimen outreach was defined as the number of members for whom a recommendation was accepted. A refill report identified members without a subsequent paid HCV medication claim within 25 days of the previous claim and outreach to the prescriber\u27s office was performed. The outcome measure for refill outreach was the number and type of PA modifications made secondary to outreach (closure or extension). Cost avoidance was calculated for members who completed treatment with an optimized regimen. Return on investment (ROI) was calculated for the program. RESULTS: Between December 18, 2013, and January 31, 2015, 911 members had PA requests approved for simeprevir, sofosbuvir, or ledipasvir/ sofosbuvir. Of these members, 223 (24.5%) met the criteria for regimen outreach. Pharmacist interventions to treat with an optimized regimen were accepted for 135 members (60.5%). Following implementation of prescriber outreach to promote refills, between March 10, 2014, and January 31, 2015, offices were informed of an upcoming refill for 515 members. As a result of outreach, 19.6% of members had a subsequent PA modification. Sixty-nine approved PAs (for 68 members) were closed after correspondence with the prescriber, and 33 approved PAs (for 33 members) were extended. The total projected cost avoidance was $3,770,097. The comprehensive HCV medication management program demonstrated an ROI of$10.28 for every $1 spent. CONCLUSIONS: A comprehensive HCV medication management program can help contain costs while ensuring that members have access to most clinically appropriate regimens

A Comparison of the Costs Associated with the Administration of Select High-cost Infused Medications in Three Sites of Care for a State Medicaid Population

This poster evaluates the financial impact of high-cost infused medications across three site of care programs. Site of care programs help payers save money on specialty drug spend by shifting utilization on high costs infused medications to less costly sites of administration. The objective of this project was to evaluate the costs associated with the administration of select high-cost infused medications in site of care programs in Massachusetts Medicaid populations. Research was done through retrospective analysis that included pharmacy and medical claims data for select high cost infused medications between April 1, 2017 - September 20, 2017. This presentation was given at the 2018 Managed Care & Specialty Pharmacy Annual Meeting and received the AMCP Foundation Best Poster Award in the Resident and Fellows category

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

OBJECTIVES: 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. METHODS: This retrospective cohort study used medical claims, pharmacy claims, and prior authorization (PA) request data for MassHealth members who had a PA submitted for progesterone between January 1, 2011, and March 31, 2015. Members were excluded due to breaks in coverage, progesterone was not indicated for prevention of PTB, and if current gestational week or date of delivery was unavailable. MAIN RESULTS: A total of 418 members were screened for inclusion of whom 190 met criteria and 169 filled progesterone. Mean age was 29.2 years (SD = 5.23), and clinical comorbidities were identified in 90.5% of members. Consistent with clinical trials on progesterone effectiveness, 62.1% of members had a term delivery (37 wks of gestation). Among members with prior gestational age at delivery available, the average difference in gestational age between pregnancies was 8.25 weeks (SD = 6.11). In addition, 66.3% of members were adherent to progesterone based on proportion of days covered (PDC) of 0.8 or higher. The overall mean PDC was 0.79 (SD = 0.26). CONCLUSION: Despite similar birth outcomes in clinical trials and national trends, medication adherence is low in this state Medicaid program. Therefore, members may benefit from adherence support

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

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 \u3c 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 \u3c 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 \u3c 0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P \u3c 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 Pharmacy\u27s 2016 Annual Meeting in San Francisco, California, April 2016