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.

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 < 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 Pharmacy's 2016 Annual Meeting in San Francisco, California, April 2016.

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's 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. DISCLOSURES: No outside funding supported this study. Lavitas reports personal fees and nonfinancial support from University of Tennessee, Advanced Studies in Medicine and grant funding from Bristol-Myers Squibb, outside the submitted work. All other authors report no conflicts of interest. The poster "Overview of a Hepatitis C Medication Monitoring Program in a State Medicaid Program" was presented October 8, 2014, by Lavitas at the AMCP Nexus 2014 meeting in Boston, Massachusetts. A program update was presented at the 2015 American Drug Utilization Review Society Meeting on February 27, 2015. Study concept and design were contributed by Price, Lenz, and Jeffrey, with assistance from Lavitas, Tesell, and Hydery. Lavitas, Tesell, and Hydery collected the data, assisted by Price, Lenz, and Jeffrey, and data interpretation was performed by all authors. The manuscript was written by Greenwood, Lavitas, Tesell, and Hydery, with assistance from the other authors, and was revised by all authors.

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.