Prescription digital therapeutics: Applying Medicaid experience to value assessment and formulary management.

Digital therapeutics (DTx) are a rapidly growing therapeutic category with more than 150 clinical trials evaluating US Food and Drug Administration-regulated DTx to develop additional evidence by the end of 2022. Investments in DTx development have doubled since 2019, reaching $14.7 billion in 2021. Prescription DTx are regulated by the US Food and Drug Administration and require demonstration of efficacy and safety prior to commercialization and reimbursement by payers. Drawing insights from the Massachusetts Medicaid program's early experience with prescription DTx, we provide an overview of this new category of therapeutics and suggest a roadmap for payers and policymakers to evaluate the value of prescription DTx for their member population. Finally, we propose solutions to potential challenges that may be encountered in the DTx coverage and reimbursement management.

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.

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.

Rurality and differences in pharmacy characteristics and community factors associated with provision of naloxone in the pharmacy.

BACKGROUND: Pharmacies are the most accessible healthcare settings across urban, suburban, and rural areas of the United States and, thus a key venue in the overdose risk environment. Pharmacy dispensing of naloxone is part of the public health response to the opioid overdose crisis, yet little is known about the pharmacy- and community-level characteristics with which naloxone provision is associated. METHODS: We conducted a longitudinal analysis of pharmacy-level quarterly naloxone dispensed from one large US community pharmacy chain from the 1st quarter of 2013 to the 2nd quarter of 2017, examining associations between naloxone provision and pharmacy-level characteristics and community factors in two US states, Rhode Island and Massachusetts. Rurality was defined using the rural urban commuting area (RUCA) scale scores, calculated based on US 2010 Census variables. Pharmacy-level characteristics (e.g., 24 h store, average daily volumes of total prescriptions, nonprescription syringe sales, buprenorphine prescriptions) derived from the pharmacy chain; community factors (e.g., RUCA score, ZIP-code level age, race distributions, and median household income) were obtained from the decennial census files. The linear mixed effects methods modeled dispensing history and the number of naloxone doses dispensed through binomial and negative binomial distributions respectively, accounting for trend and covariates. RESULTS: Adjusted analyses of dispensing data from 449 pharmacies in two states indicated that more rural pharmacies (i.e., stores in areas with higher RUCA scores), pharmacies with higher volumes of all prescriptions and of buprenorphine, that sell more nonprescription syringes, that have drive-throughs and longer weekend hours, and that are located in communities with younger age distributions were associated with increased likelihood of ever dispensing naloxone and a greater number of naloxone doses dispensed (all p<.05). CONCLUSION: Pharmacies are a key evolving element in the overdose risk environment, striving to develop reputations as sources of wellness, prevention, and harm reduction supplies, like naloxone. Pharmacy naloxone dispensing may be an especially effective strategy to alter the overdose risk environment in rural communities.

Effect of Lumacaftor/Ivacaftor on Pulmonary Exacerbation Rates in Members with Cystic Fibrosis in a Medicaid Population.

BACKGROUND: Lumacaftor/ivacaftor (LUM/IVA) is indicated for patients with cystic fibrosis (CF) homozygous for the F508del mutation in the CFTR gene. In clinical trials, LUM/IVA decreased pulmonary exacerbation rates. To our knowledge, there is no published data evaluating real-world outcomes for Medicaid patients receiving LUM/IVA. OBJECTIVE: To compare CF pulmonary exacerbation rates before and after initiation of LUM/IVA in 1 state's Medicaid program. METHODS: This pre-post claims analysis screened fee-for-service and managed Medicaid members who had ≥ 1 pharmacy claim for LUM/IVA between July 2, 2015, and September 30, 2016. Members were included if they were aged ≥ 6 years with a CF diagnosis and homozygous for the F508del mutation, consistent with the indication at study initiation. Exclusion criteria included Medicaid as a secondary payer or any break in coverage during the study. The index date was defined as the first claim for LUM/IVA. Demographics and outcomes were derived from pharmacy and medical claims. Outcomes included overall rate of pulmonary exacerbations (reported as the total events for the study population 6 months before and after the index date and average annualized rate). Pulmonary exacerbation was defined as any combination of medical claims for an emergency room (ER) visit or inpatient hospitalization with a CF pulmonary exacerbation or respiratory infection (ICD-9/10-CM codes) or pharmacy claims for an oral or intravenous antibiotic (excluding macrolides). A gap of > 7 days was considered a new pulmonary exacerbation. Paired t-test was used to test significance. RESULTS: 21 patients met inclusion criteria with an average age at treatment initiation of 20.1 years. Average proportion of days covered (SD) was 0.62 (0.29). The number of pulmonary exacerbations increased from 45 to 48 during the 6 months before and after the index date, respectively, and the annualized rate increased from 4.37 to 4.66 (P = 0.69). While the number of pulmonary exacerbations associated with antibiotics alone increased (23 to 33; P = 0.08), those associated with at least 1 ER visit or inpatient hospitalization decreased (22 to 15; P = 0.08). CONCLUSIONS: This analysis did not find a decrease in pulmonary exacerbation rate for Medicaid members receiving LUM/IVA; however, adherence was low. Further study of similar populations is needed to better understand the long-term effect of treatment. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. A poster of this project was presented at the Academy of Managed Care Pharmacy Managed Care & Specialty Pharmacy Annual Meeting 2018 in Boston, MA, on April 23-26, 2018.

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.

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.

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.

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.

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.

Implementation of an opioid management initiative by a state Medicaid program.

BACKGROUND: The utilization of prescription opioids has increased over the last 2 decades. Associated with this is the misuse of prescription opioids for nonmedical purposes. Medicaid programs have struggled with developing strategies that balance best practice models, appropriate utilization, and reduction in costs associated with the opioid medication class. OBJECTIVE: To examine the impact of a 2-year stepwise initiative to reduce utilization and therapy costs of long-acting opioid analgesics (LAOA) by addressing issues of high dose, daily dose, and preferred therapeutic alternatives. METHODS: Utilization data from the Massachusetts Medicaid pharmacy program for LAOAs were reviewed and compared for 2 time periods. The calendar year prior to the initiative, 2002, was used as a base year and represents a time period when there were no restrictions in place for members to obtain long-acting opioids. The calendar year 2005 was the comparison year representing a time period after the multiple steps of the initiative had been implemented. A retrospective claims-based analysis was performed to determine the impact of restrictions on LAOAs, defined as brand and generic versions of oxycodone ER, morphine ER, methadone, and fentanyl transdermal system. The primary measure was the percentage of change of unique utilizers, paid claims, and average daily dose for each LAOA following the implementation of the opioid management initiative. Secondary measures included a cost analysis. RESULTS: Compared with 2002, the overall number of LAOA unique utilizers declined 17.8% (P < 0.0001), and the overall number of claims declined by 4.1% (P < 0.0001), while Medicaid pharmacy benefit member enrollment remained relatively stable. Average daily dose declined in methadone and morphine ER and increased in oxycodone ER and fentanyl transdermal system. The 2005 overall cost of LAOAs decreased 8.0% compared with the overall cost in 2002. The per-member-per-month (PMPM) cost for opioid users in 2002 was $110.57 ($120.04 when adjusted to 2005 dollars) compared with $123.75 in 2005. In comparison, the overall PMPM for all members in 2002 was $3.52 ($3.82 when adjusted to 2005 dollars) compared with $3.59 in 2005. CONCLUSIONS: Our study successfully demonstrated that a state Medicaid program initiative can result in a significant overall decrease in opioid class utilization specifically for the targeted, more costly agents. This was achieved via the implementation of a Therapeutic Class Management multidisciplinary workgroup that established a prior authorization process implementing limits on dose, as well as identified preferred less costly agents. It further facilitated the direct opportunity for pharmacy-prescriber collaboration for LAOA medication management.