Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes.

BACKGROUND: In 2014, the US Food and Drug Administration approved the first glucagon-like peptide-1 (GLP-1) receptor agonist product, liraglutide injection, for obesity treatment. Many GLP-1 obesity treatment clinical trials report significant weight loss and medication adherence at more than 85%. Little is known about the real-world GLP-1 obesity treatment adherence, persistence, and switch rates. OBJECTIVE: To measure GLP-1 therapy persistence, adherence, and switch rates in a real-world cohort of members without diabetes using these drugs for obesity treatment. METHODS: Integrated pharmacy and medical claims data from 16.5 million average monthly commercially insured membership were used to identify obese members without diabetes newly initiating GLP-1 therapy between January 1, 2021, and December 31, 2021. Members were required to be continuously enrolled 1-year before and after the GLP-1 therapy start date and aged 19 years of age or older. Persistence was measured as no greater than or equal to 60-day gap with allowance for GLP-1 switching. Adherence was measured as the proportion of days covered (PDC) and members with a PDC greater than or equal to 80% were considered adherent. GLP-1 product switching was also assessed descriptively. RESULTS: 4,066 commercially insured obese members without diabetes that newly initiated GLP-1 therapy met all study criteria. The mean age was 46 years, and 81% were female. Overall, GLP-1 persistence was 46.3% at 180 days and 32.3% at 1 year. The highest and lowest persistence rates at 1 year were observed for semaglutide (Ozempic) at 47.1% and liraglutide (Saxenda) 19.2%, respectively. Average PDC during the 1-year assessment was 51.0% with 27.2% adherent to therapy and 11.1% switched GLP-1 drugs. CONCLUSIONS: This GLP-1 weight loss treatment real-world analysis, among obese individuals without diabetes, found poor 1-year persistence and adherence and low rates of switching between products. These findings will aid in assessing products cost-effectiveness, understanding obesity care management program needs, forecasting future GLP-1 use and cost trends, and negotiating GLP-1 pharmaceutical manufacturer value-based purchasing agreements.

Descriptive, real-world treatment patterns, resource use, and total cost of care among eculizumab- and ravulizumab-treated members with paroxysmal nocturnal hemoglobinuria.

BACKGROUND: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, genetic, chronic, and life-threatening blood disease with an estimated prevalence of 13 per 1,000,000 persons reported in the United States. Available at analysis, PNH treatment included the use of C5 inhibitors (C5is), which prevent formation of membrane attack complex and consequently intravascular hemolysis. Limited real-world evidence suggests some individuals with PNH continue to experience anemia and breakthrough hemolysis (BTH) after C5i treatment, indicating unmet needs. OBJECTIVE: To describe real-world treatment patterns and outcomes among individuals treated with C5is, eculizumab (ECU), and ravulizumab (RAV), focusing on affordability challenges and therapy unmet needs from a US payer perspective. METHODS: This retrospective cohort study was conducted using deidentified data from Prime Therapeutics' approximately 15 million commercially insured US members with integrated medical and pharmacy claims data. Members were identified between January 1, 2018, and December 31, 2020. Inclusion criteria for cohort identification were adults aged 18 years or older at ECU or RAV index date requiring 2 or more claims for ECU or 1 or more claims for RAV. ECU and RAV users were excluded if they had a claim indicating treatment for a US Food and Drug Administration (FDA)-approved non-PNH indication. Members were required to be continuously enrolled 6 months before and 12 months after their index ECU or RAV claim. Real-world C5i claims-based treatment dosage and frequency patterns were compared with FDA-labeled dosing. Clinical outcomes, including transfusions and BTH events, were identified in the pre-index and post-index periods. Health care resource use and costs were calculated after network discounts, including member share. RESULTS: A total of 86 commercial members met analysis criteria: 34 in the ECU cohort and 52 in the RAV cohort. The mean age was 42.6 years, and 54.6% were female. Estimated higher-than-label PNH-recommended dosage occurred in 38.2% of ECU and 9.6% of RAV members. In total, 29.4% of ECU and 17.3% of RAV members had 4 or more transfusions in the post-index period. Additionally, 29.4% of ECU and 13.5% of RAV members had 1 or more BTH episodes. Post-index period mean per member total health care costs were $711,785 among ECU members and $624,911 among RAV members, and C5i costs accounted for 79.7% and 85.6% of total health care costs, respectively. CONCLUSIONS: Although all members received at minimum FDA-approved dosages, transfusions and BTH events continue to occur for some members. These findings indicate potentially inadequate therapy responses in a substantial subset of C5i users, adding additional therapy costs to an already extremely expensive therapy. DISCLOSURES: This study was funded by Apellis Pharmaceuticals. Drs Broderick and Fishman report employment by Apellis Pharmaceuticals and own stock options. Dr Burke reports employment by Prime Therapeutics, LLC, which has received research funding from Apellis Pharmaceuticals. Dr Gleason reports employment by Prime Therapeutics, LLC, which has received research funding from Apellis Pharmaceuticals; serves on the advisory committee at the Institute for Clinical and Economic Review; and has served on the Board of Directors at the Academy of Managed Care Pharmacy.

Real-world outcomes and direct care cost before and after elexacaftor/tezacaftor/ivacaftor initiation in commercially insured members with cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is a chronic, progressive genetic disease caused by mutations in the CF transmembrane conductance regulator (CFTR) gene resulting in a dysfunctional CFTR protein. Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a triple combination oral drug therapy with an annual cost greater than $300,000 and available to nearly 90% of the CF population based on age and genotype. Limited real-world direct medical cost offset data are available for ELX/TEZ/IVA among commercially insured individuals. OBJECTIVE: To describe and compare total cost of care and health care resource utilization (HRU) 180 days before and 180 days after first ELX/TEZ/IVA drug claim among CFTR modulator treatment-naive, commercially insured members. METHODS: This study was a retrospective analysis of integrated pharmacy and medical claims data from 17.9 million commercially insured members. A 180-day prestudy and 180-day poststudy design was used to compare outcomes prior to and following ELX/TEZ/IVA initiation. Study inclusion was limited to members with first ELX/TEZ/IVA claim (index date) between October 21, 2019, and December 31, 2021, continuously enrolled 180 days before and 180 days after index date, and no CFTR-modulator drug claim 180 days prior to index date. Total paid amounts from medical and pharmacy claims after network discounts (defined as total cost of care), HRU, and pulmonary exacerbation events were summarized using descriptive statistics and compared using Wilcoxon signed rank test. RESULTS: 494 members newly initiating ELX/TEZ/IVA met inclusion criteria. Prestudy to poststudy mean member total cost of care increased from $58,180 to $198,815 (difference: $140,635; P < 0.001). Mean member medical benefit costs decreased from $28,764 to $12,484 (difference: -$16,280; P < 0.001), whereas mean member pharmacy benefit costs increased from $29,416 to $186,331 (difference: $156,915; P < 0.001). Mean member inpatient hospitalizations (62% absolute reduction; P < 0.001), emergency department visits (43% absolute reduction; P < 0.01), and pulmonary exacerbation events (44% absolute reduction; P < 0.001) were significantly lower in the postperiod compared with the preperiod. CONCLUSIONS: Among members with CF newly initiating CFTR modulator with ELX/TEZ/IVA, mean member total cost of care increased 3-fold despite significant and meaningful reductions in pulmonary exacerbation events, HRU, and medical benefit spend. Pharmacy benefit spend outpaced medical benefit spend at a rate of $9.64 to $1 in the 180 days following ELX/TEZ/IVA initiation. Real-world data should be used to objectively measure the clinical and economic benefits of costly medications, such as CFTR modulators, to align price with value. DISCLOSURES: Drs Marshall, Espinosa, Starner, and Gleason are employees of Prime Therapeutics. The study was funded by Prime Therapeutics.

Drug super spender tsunami: An integrated medical and pharmacy benefits assessment.

BACKGROUND: As new rare-disease drug therapy, gene therapies, and high-priced cancer drugs receive US Food and Drug Administration approval, there is an increasing potential for drug super spender individuals with more than $250,000 annual drug cost. OBJECTIVE: To categorize all members in a large, commercially insured population by their total annual combined drug costs from both medical and pharmacy benefits and to determine the trend in drug super spender prevalence. METHODS: Using a commercially insured population with integrated medical and pharmacy benefits, all unique members with any enrollment between January 2016 and December 2019 were identified. The sum of total cost for all pharmacy claims plus all medical benefit claim lines for drugs was determined for each member, for each calendar year. Cost was defined as the plan plus member liability at network-discounted price, with no further adjustment for any coupons or rebates. Descriptive statistics were used to describe the drug super spender growth. RESULTS: There was an average of 17.9 million members per year with at least 1 month of eligibility through the 4-year study period. In 2016, a total of 2,994 members with more than $250,000 drug cost per member accounted for $1,324 million drug spend. In 2019, there were 5,894 super spender members (97% increase), accounting for $2,579 million drug cost (95% increase), which was 9.6% of $26,618 million total drug spend. CONCLUSIONS: In this large, commercially insured population, a small (32 per 100,000) number of drug super spender members comprise a disproportionate portion of the total drug expenditures, at $1 of every $10 dollars of total drug expenditures. Health plans need to understand the drug super spender trend and develop strategies to maintain health care affordability. DISCLOSURES: This study was funded internally by Prime Therapeutics LLC. Drs Starner and Gleason are employees of Prime Therapeutics LLC, a pharmacy benefits management company. Dr Bowen is a former employee of Prime Therapeutics LLC.

Medical Costs and Health Care Utilization Among Self-Insured Members with Carve-In Versus Carve-Out Pharmacy Benefits.

BACKGROUND: Pharmacy benefit can be purchased as part of an integrated medical and pharmacy health package-a carve-in model-or purchased separately and administered by an external pharmacy benefit manager-a carve-out model. Limited peer-reviewed information is available assessing differences in use and medical costs among carve-in versus carve-out populations. OBJECTIVE: To compare total medical costs per member per year (PMPY) and utilization between commercially self-insured members receiving carve-in to those receiving carve-out pharmacy benefits overall and by 7 chronic condition subgroups. METHODS: This study used deidentified data of members continuously enrolled in Cambia Health Solutions self-insured Blue plans without benefit changes from 2017 through 2018. Cambia covers 1.6 million members in Oregon, Washington, Idaho, and Utah. The medical cost PMPY comparison was performed using multivariable general linear regression with gamma distribution adjusting for age, gender, state, insured group size, case or disease management enrollment, 7 chronic diseases, risk score (illness severity proxy), and plan paid to total paid ratio (benefit richness proxy). Medical event objectives were assessed using multivariable logistic regression comparing odds of hospitalization and emergency department (ED) visit adjusting for the same covariates. Sensitivity analyses repeated the medical cost PMPY comparison excluding high-cost members, greater than $250,000 annually. Chronic condition subgroup analyses were performed using the same methods separately for members having asthma, coronary artery disease, chronic obstructive pulmonary disease, heart failure, diabetes mellitus, depression, and rheumatoid arthritis. RESULTS: There were 205,835 carve-in and 125,555 carve-out members meeting study criteria. Average age (SD) was 34.2 years (18.6) and risk score (SD) 1.1 (2.3) for carve-in versus 35.2 years (19.3) and 1.1 (2.4), respectively, for carve-out. Members with carve-in benefits had lower medical costs after adjustment (4%, P < 0.001), translating into an average $148 lower medical cost PMPY ($3,749 carve-out vs. $3,601 carve-in annualized). After adjustment, the carve-in group had an estimated 15% (P < 0.001) lower hospitalization odds and 7% (P < 0.001) lower ED visit odds. Of 7 chronic conditions, significantly lower costs (12%-17% lower), odds of hospitalization (22%-36% lower), and odds of ED visit (16%-20% lower) were found among members with carve-in benefits for 5 conditions (all P < 0.05). CONCLUSIONS: These findings suggest that integrated, carve-in pharmacy and medical benefits are associated with lower medical costs, fewer hospitalizations, and fewer ED visits. This study focused on associations, and defining causation was not in scope. Possible reasons for these findings include plan access to both medical and pharmacy data and data-informed care management and coordination. Future research should include investigation of integrated data use and its effect across the spectrum of integrated health plan offerings, provider partnerships, and analytic strategies, as well as inclusion of analyzing pharmacy costs to encompass total cost of care. DISCLOSURES: This study received no external funding. The study was jointly conducted by employees of Cambia Health Solutions and Prime Therapeutics, a pharmacy benefit manager servicing Cambia Health Solutions. Smith, Lam, Lockwood, and Pegus are employees of Cambia Health Solutions. Qiu and Gleason are employees of Prime Therapeutics.

Spinal Muscular Atrophy Therapies: ICER Grounds the Price to Value Conversation in Facts.

DISCLOSURES: No funding supported the writing of this commentary. The authors are employed by Prime Therapeutics, a pharmacy benefits management company.

Association of a Controlled Substance Scoring Algorithm with Health Care Costs and Hospitalizations: A Cohort Study.

BACKGROUND: Patients often misuse a combination of prescription drugs including opioids; however, the relationship between a controlled substance (CS) score and health outcomes is unknown. OBJECTIVE: To examine the association between a CS scoring algorithm and health care use, specifically total cost of care, hospitalizations, and emergency room (ER) visits. METHODS: This analysis was a retrospective cohort study using administrative claims data from a large U.S. health insurer. Included in the analysis were 999,852 members with a minimum CS score of 2.5 in the fourth quarter (4Q) of 2012, who were continuously enrolled from January 1, 2012, to December 31, 2013, and who were aged 18 years or older. A CS score was calculated using 4Q 2012 (3 months) prescription claims data and divided into 3 components: (1) number of CS claims, (2) number of unique pharmacies and unique prescribers, and (3) evidence of increasing CS use. The primary outcomes were total cost of care (pharmacy and medical costs), all-cause hospitalizations, and ER visits in 2013. We also quantified what a 1-point change in CS score meant for the primary outcomes. RESULTS: 47% of members had a CS score of 2.5, indicating a single CS claim, and 51% of members had a score between 3 and less than 12. The remaining 2% (20,858 members) had a score of 12 or more. There was a statistically significant and consistently increasing association between the 4Q 2012 CS score and hospitalizations, ER visits, and total costs of care in 2013. A 1-point change in CS score was associated with a $1,488 change in total cost of care, 0.9% change in the hospitalization rate, and 1.5% change in the ER visit rate. CONCLUSIONS: There is a linear association between increasing CS score and negative health outcomes. Insurers should consider interventions to lower member CS scores. DISCLOSURES: This study was funded internally by Prime Therapeutics. Starner, Qiu, and Gleason are employees of Prime Therapeutics, a pharmacy benefits management company. Karaca-Mandic is an employee of the University of Minnesota and did not receive any compensation related to this work. The results of this study were presented as a poster at the Academy of Managed Care Pharmacy's 27th Annual Meeting and Expo; San Diego, California; April 7-10, 2015. Study concept and design were contributed by Starner, Gleason, and Qiu. Qiu took the lead in data collection, assisted by Starner and Gleason. Data interpretation was performed by all the authors. Starner primarily wrote and revised the manuscript, along with the other authors.

Impact of provider mailings on medication adherence by Medicare Part D members.

BACKGROUND: The Medicare 5-Star Rating System measures and provides incentive for improving Medicare Part D plans through a quality-based payment program. Adherence to medications for chronic conditions is key to the Star ratings. Our objective was to assess the impact of direct-to-provider letters on improving medication adherence. METHODS: Members of a large US pharmacy benefits manager (PBM) who did not adhere to prescription of oral diabetes (antidiabetics), cholesterol-reducing (statins), or hypertension (renin angiotensin system [RAS] antagonists) drug therapy were identified from the prescriptions claims data of>600,000 continuously enrolled Medicare members. Nonadherence was defined by the Star ratings definition of proportion of days covered (PDC)<80%. The PBM sent letters to prescribing physicians of nonadherent members, requesting that they discuss adherence barriers and potential solutions with their patients. A historical control cohort was constructed from the PBM satisfying the same eligibility criteria as the intervention cohort. Both binary (≥80%) and continuous PDC measures were assessed as outcomes through multivariate logistic regression and difference-in-difference models, respectively. RESULTS: Final sample sizes were 21,044; 106,829; and 73,560 patients for antidiabetic, statin, and RAS antagonist use, respectively, with approximately equal number of intervention and control subjects in each drug class. Physician mailing was associated with 11%, 16%, and 7% higher odds of being adherent by members in antidiabetic, statin, and RAS antagonist cohorts, respectively (all P<.001). CONCLUSIONS: Within limitations of historical controls, physician mailing was associated with improved medication adherence. IMPLICATIONS: Physician mailing can be an impactful tool for improving medication adherence. LEVEL OF EVIDENCE: II.

Sofosbuvir initial therapy abandonment and manufacturer coupons in a commercially insured population.

OBJECTIVES: To describe rates of sofosbuvir initial medication adherence as a function of the insurer-required member cost (ie, out-of-pocket cost) and to determine how manufacturer coupons affect insurer-required member cost. STUDY DESIGN: Observational cross-sectional analysis. METHODS: Administrative pharmacy claims data from 13 million commercially insured members were used to identify sofosbuvir new starts between January 2014 and September 2014. Members were categorized as either sofosbuvir initial adherence or as abandoning therapy. A multivariate logistic regression model adjusting for sociodemographic characteristics, severity of illness, and total drug costs (health insurer plus member amount) for non-sofosbuvir pharmacy claims in 2014 was used to evaluate the association between insurer-required member cost and initial medication adherence. In a sub-analysis, sofosbuvir index claims with coupon data available were analyzed to determine how coupon use impacted insurer-required member cost. RESULTS: A total of 67.3% of members had a pre-coupon member cost of < $250 for their index sofosbuvir claim. Just 201 (5.0%) members were exposed to a member cost of more than $10,000. The logistic regression model demonstrated an association between member cost and abandonment starting at $2500 to < $5000 (odds ratio: 1.9; 95% CI, 1.01-3.43; P = .0393). The average member sofosbuvir index claim cost was $1349 before coupon was applied, and $28 after. Overall, coupons offset the member amounts paid by 98%: $771,593 of the $787,860 member cost requested by the insurer. CONCLUSIONS: These findings indicate that a 30-day supply sofosbuvir member cost of > $2500 was associated with increased initial therapy abandonment, and that manufacturer coupons substantially reduced sofosbuvir insurer-required member cost. Insurers and policy makers should consider the impact of member cost on medication adherence and the impact coupons have on the actual member cost.

Specialty drug coupons lower out-of-pocket costs and may improve adherence at the risk of increasing premiums.

Expenditures for specialty drugs account for more than 25 percent of total US drug spending and have been increasing at more than 13 percent annually. We examined insurers' role in maintaining the affordability and accessibility of specialty drugs while maximizing their value. We conducted two analyses: one using an administrative claims database with information on more than ten million commercially insured patients and another using the same database combined with the drug prescription records from a specialty pharmacy. First, we examined the prevalence of specialty drug coupons and the degree to which these reduced patients' out-of-pocket costs, focusing on 264,801 prescriptions. Second, we quantified the association between the magnitude of out-of-pocket costs for specialty drugs and patients' abandonment of their new or restarted therapy, focusing on a group of nearly 16,000 patients. We found that drug coupons accounted for $21.2 million of patients' $35.3 million annual out-of-pocket costs. In the vast majority of cases, coupons reduced monthly cost sharing to less than $250, a point at which patients were far less likely to abandon therapy with biologic anti-inflammatory drugs or with drugs for multiple sclerosis. However, by reducing cost sharing, coupons may also circumvent efforts to encourage patients to use the most cost-effective drugs.

Impact of a drug utilization review program on high-risk use of prescription controlled substances.

BACKGROUND: Prescription drug abuse has prompted considerable concern. We evaluated a retrospective drug utilization review program to reduce controlled substance use among individuals with high-risk utilization. METHODS: We analyzed pharmacy claims from a large pharmaceutical benefits manager. For each eligible member, we calculated a controlled substance score based on the number and type of claims, prescribers and pharmacies, and utilization patterns over three months. Two state health plans sent controlled substance letters to prescribers of members meeting or exceeding a plan- and pre-specified controlled substance score. Two different state health plans did not send such letters. We used a difference-in-difference design and generalized estimating equations to quantify the impact of the program on the mean difference in reduction of the controlled substance score over six months. RESULTS: Eligible members in the intervention and comparison states had similar baseline mean controlled substance scores (19.0 vs. 18.6, p = 0.36). Adjusting for individuals' age, sex and pharmacy risk group score, reductions in the mean controlled substance score were greater in the intervention than comparison cohort (5.67 vs. 4.31, p = 0.01), corresponding with a 34.0% reduction in the intervention cohort compared to a 25.5% reduction in the comparison cohort. Changes were driven primarily by reductions in the number of controlled substance claims filled (30.5% vs. 23.1%, p = 0.01), as well as by a non-statistically significant trend towards reductions in the number of prescribers and pharmacies used (26.9% vs. 20.1%, p = 0.07). CONCLUSIONS: Retrospective drug utilization review programs may reduce controlled substance scores and claims among individuals with patterns suggesting high-risk utilization.

Health plan utilization and costs of specialty drugs within 4 chronic conditions.

BACKGROUND: Drugs are most typically defined as specialty because they are expensive; however, other criteria used to define a drug as specialty include biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network. Specialty drugs play an increasingly important role in the treatment of chronic conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD), yet little is known regarding the comprehensive medical and pharmacy benefit utilization and cost trends for these conditions. OBJECTIVE: To describe MS, RA, psoriasis, and IBD trends for condition prevalence, treatment with specialty drugs, specialty costs, nonspecialty costs, and total direct costs of care within the medical and pharmacy benefits. METHODS: This was a descriptive analysis of a commercially insured population made up of 1 million members, using integrated medical and pharmacy administrative claims data from 2008 to 2010. Analyses were limited to continuously enrolled commercially insured individuals less than 65 years of age. Condition-specific cohorts for MS, RA, psoriasis, and IBD were defined using standardized criteria. Trends in condition prevalence, specialty drug use for the conditions, and direct total cost of care were analyzed. The direct costs were subcategorized into the following: medical benefit specialty drug costs, medical benefit all other costs, pharmacy benefit specialty drug costs, and pharmacy benefit all other costs. Trends and compound annual growth rates were calculated for the total cost of care and subcategory costs from 2008 through 2010. RESULTS: Condition prevalence ranged from a low of 1,720 per million members for MS to a high of 4,489 per million members for RA. Psoriasis and MS condition prevalence rates were unchanged over the 3 years; however, IBD prevalence increased 7.0%, and RA prevalence increased 9.7%. The rate of specialty drug use was lowest for IBD (13.7%) and highest for MS (71.8%). The lowest total annual cost of care was for psoriasis ($14,815), and the highest total annual cost was for MS ($36,901). The most commonly used specialty drugs for each of the conditions were as follows: glatiramer (MS), etanercept (RA and psoriasis), and infliximab (IBD). The total annual costs were more than double for the specialty drug users for psoriasis compared with all the psoriasis members ($29,565 vs. $14,815). The total costs were only somewhat higher among MS members using specialty drugs ($41,760 vs. $36,901). Among specialty drug users for each of the cohorts, the annual costs of specialty drugs accounted for 50% or more of the total annual costs. The annual spending growth rate for specialty drugs ranged from 4.4% to 18.0%. CONCLUSIONS: Although specialty drug utilization varied widely across the 4 chronic conditions analyzed, when specialty drugs were used they accounted for the majority of the annual total direct cost of care. Because specialty drugs are accounting for a growing portion of chronic disease total cost of care, health insurers will need to become more vigilant regarding specialty drug use and focus on 4 cost saving management opportunities: drug distribution channel, utilization management, contracting activities, and care coordination.

Dalfampridine prior authorization program: a cohort study.

BACKGROUND: Dalfampridine (Ampyra) is indicated to improve walking in patients with multiple sclerosis (MS) and was found to be effective in 35%-43% of individuals with MS in clinical trials. Dalfampridine may increase seizure risk, particularly in patients with renal impairment. A U.S. managed care expert consensus panel agreed that patient access to dalfampridine is best managed by a prior authorization (PA) in accordance with the FDA-approved labeling. To ensure safe and appropriate dalfampridine use, a health plan developed and implemented a 2-phase point-of-sale PA program. OBJECTIVES: To evaluate dalfampridine PA review decisions, utilization, and pharmacy expenditures following the implementation of a dalfampridine safety and clinical PA program compared with a group of dalfampridine utilizers unexposed to a PA program. METHODS: The study utilized retrospective administrative pharmacy claims data from a commercial health plan averaging 1.3 million members per month. The plan implemented a 2-phase dalfampridine safety and effectiveness PA program on August 1, 2010. A comparison group that did not implement the dalfampridine PA program was identified from a commercially insured population with approximately 350,000 members per month. Members in both groups were required to be continuously enrolled from August 1, 2010, through January 31, 2011. A member's earliest paid or rejected claim found from August 1, 2010, through October 31, 2010, was defined as the index claim. Dalfampridine-weighted 30-day supply claims were summed and compared between groups from index date through January 31, 2011. A pharmacy cost avoidance estimate was calculated using the difference in average claims per member from index claim through January 31, 2011, multiplied by dalfampridine wholesale acquisition cost. Overall, dalfampridine utilization was evaluated between the intervention and comparison populations from August 2010 (implementation of PA in intervention group) through December 2011. Linear regression and Poisson models were used to test the trend differences. RESULTS: The 60 PA-exposed dalfampridine members' average follow-up was 157 days. Phase 1 approval was obtained by 32 (53.3%) members; 4 (6.7%) members received a denial because of renal impairment; 8 (13.3%) members received a denial due to inability to obtain walking time; 1 (1.7%) member with relapse-remitting MS was denied a PA due to no concomitant disease-modifying agent; and 15 (25.0%) members did not initiate the PA process. Phase 2 approval was obtained by 23 (38.3%) of the 60 members. The 60 PA members had a total of 126 claims and an average utilization of 2.1 (SD 1.8) claims per member. The 20 non-PA dalfampridine members' average follow-up was 157 days. The comparison group members had a total of 84 claims and an average utilization of 4.2 (SD 2.0) claims per member. The PA program resulted in an average of 2.1 (P less than 0.001) fewer claims per member in the PA group. The total dalfampridine cost avoidance estimate was $143,010 or $0.03 per member per month. The overall measure of a monthly claims utilization difference over time was statistically significantly different at P less than 0.001, using the linear regression slope trend test. The trend line slope was not statistically significantly different, P = 0.841, between the intervention and comparison populations. CONCLUSIONS: The study indicates that a dalfampridine PA program potentially improved safety and minimized dalfampridine costs. A PA program is effective in selecting appropriate utilizers for initial therapy. Addition of care management may further optimize use by encouraging adherence and tracking patient response.

Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

UNLABELLED:   BACKGROUND: In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. OBJECTIVE: To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. METHODS: This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing supply on July 1, 2006, was the index claim. Members with a Kmart pharmacy index claim were excluded, since the Kmart membership drug discount program began prior to July 1, 2006. Levothyroxine claims capture nonpersistency, defined as the occurrence of a claim supply end date prior to a 180-day gap, was the primary outcome variable and was assessed from July 1, 2006, through June 30, 2010 (follow-up period). The odds of levothyroxine claims capture nonpersistency by pharmacy group were assessed using a logistic regression analysis adjusted for the following covariates: age, gender, median income in the ZIP code of residence (binomial for ≤ $50,000 vs. greater than $50,000), switch to a brand levothyroxine product during the follow-up period, index levothyroxine claim supply of 90 days or more, and index levothyroxine claim member cost share per 30-day supply in tertiles (≤ $5.00, $5.01-$7.99, ≥ $8.00). RESULTS: Of 2,632,855 eligible members aged 18 years or older, 13,427 met all study eligibility criteria. The baseline pharmacy groups were membership with 3,595 (26.8%), nonmembership with 1,919 (14.3%), and all other pharmacies with 7,913 (58.9%) members. The rates of levothyroxine claims capture persistency throughout the 4-year follow-up period were 85.4% for nonmembership (P = 0.593 vs. all other pharmacies), 77.7% for the membership group (P less than 0.001 vs. all other pharmacies), and 85.9% for all other pharmacies. The Kaplan-Meier comparison of claims capture persistency found nearly identical claims capture loss for the nonmembership compared with all other pharmacies group, and when compared in a multivariate logistic regression model, there was no difference in the odds of levothyroxine claims capture over 4 years follow-up (OR = 1.01, 95% CI = 0.88-1.16, P = 0.900). The membership generic drug discount programs (Walgreens, CVS, Alberstons, and Savon pharmacies) had a statistically significant 61% higher odds (OR = 1.61, 95% CI = 1.45-1.79, P less than 0.001) of levothyroxine claims capture nonpersistency. The onset of the difference between the membership group and the all other pharmacies group was temporally associated with the launch of the membership programs. In comparison to index levothyroxine member cost of ≤ $5.00 per 30-day supply, higher cost shares were associated with higher levothyroxine claims capture nonpersistency ($5.01 to $7.99 OR 1.34, 95% CI 1.19-1.52 and ≥ $8.00 OR 1.60, 95% CI 1.40-1.82). CONCLUSIONS: Among levothyroxine utilizers in 2006 (prior to the advent of drug discount programs), those with claims from a pharmacy that subsequently implemented a nonmembership generic drug discount program did not appear to have a different rate of levothyroxine claims capture than members from the reference group when followed through June 2010. Utilizers with claims from a pharmacy that subsequently implemented a membership program had a significantly lower levothyroxine claims capture rate. Increasing index levothyroxine member cost was associated with higher levothyroxine claims capture loss. Because the analysis could not directly measure claims capture loss associated with members who switched to a new pharmacy group without presenting their insurance information (e.g., membership discount programs), further research is needed to confirm these findings.

Rosiglitazone prior authorization safety policy: a cohort study.

BACKGROUND: Prior authorizations (PA) are intended to promote safe and cost-effective medication use. Unwanted outcomes may occur, however, such as a patient forgoing drug therapy after a PA. The label for rosiglitazone was revised in November 2007 to include the warning of contraindicated use with nitrates or insulin, creating an opportunity for a PA directed at safe use. OBJECTIVE: To evaluate antidiabetic drug utilization after the implementation of an electronic PA that denied a claim for rosiglitazone if the patient had a history of either insulin or nitrate supply in the previous 60 days. METHODS: This quasi-experimental study used pharmacy claims for 1.4 million commercially insured members who were exposed to a rosiglitazone PA beginning on January 1, 2009, compared with a group of approximately 2 million commercially insured members who did not have this safety PA intervention. Continuously enrolled members were identified who had a rejected (intervention group) or paid (comparison group) claim for rosiglitazone during the period from January 1, 2009, through June 30, 2009. Pharmacy claims were assessed for the presence of nitrates, insulin, rosiglitazone, other antidiabetic therapy, or no antidiabetic therapy supply on days 30, 60, 90, and 180 after the rejected/paid claim. A time-series analysis using rosiglitazone claims for all health plan members from January 2008 through December 2009 was used to evaluate the impact of the PA on rosiglitazone utilization overall. RESULTS: At 30 days, there were 134 patients (60.4% of 222) in the comparison group with concurrent supply of rosiglitazone with insulin and/or nitrates versus 4 patients (2.4% of 168, P less than 0.001) in the PA intervention group, and the utilization rate remained significantly higher at 180 days in the comparison group (37.8%, n = 84) versus the PA group (2.4%, n = 4, P less than 0.001). Beginning at 60 days, there was no significant difference in the percentage of members with no antidiabetic therapy in the comparison and PA intervention groups (9.9% vs. 15.5%, respectively, P = 0.133), and the rates remained similar through 180 days (15.3% vs. 13.7%, respectively, P = 0.760). The PA was associated with an absolute decrease of 5.1 average monthly rosiglitazone claims per day per million members (P less than 0.001). CONCLUSIONS: This PA, intended to reduce known cardiovascular event risks among health plan members with type 2 diabetes, was associated with a significant reduction in concurrent use of rosiglitazone with nitrates or insulin.

Formulary review of 2 new biologic agents: tocilizumab for rheumatoid arthritis and ustekinumab for plaque psoriasis.

BACKGROUND: Two autoimmune biologics were recently approved by the FDA: ustekinumab in September 2009 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy and tocilizumab in January 2010 for adult patients with moderate to severe rheumatoid arthritis (RA) who have not responded adequately to 1 or more tumor necrosis factor (TNF) antagonist therapies. Both agents use new mechanisms of action and add to the growing group of autoimmune biologics. OBJECTIVE: To critically review the phase 3 trials for ustekinumab and tocilizumab and provide managed care considerations in the context of the 9 other biologic agents on the market in the United States that are used to treat moderate to severe RA or psoriasis. METHODS: A MEDLINE review was performed for articles published and available through January 2010 using keywords "ustekinumab" and "tocilizumab" with an emphasis on phase 3 trials. The literature search was limited to articles in English, clinical trials, randomized controlled trials, and research conducted in humans. Search results for ustekinumab included 8 articles of which 4 were excluded for not being psoriasis or psoriatic arthritis trials. Search results for tocilizumab included 16 articles of which 8 were excluded for not being RA trials or using biomarkers as primary endpoints. Additional information was obtained from the FDA website. RESULTS: Three phase 3 trials are available for ustekinumab. Ustekinumab demonstrated superior efficacy to placebo in 2 trials for the treatment of psoriasis. In a 12-week trial, ustekinumab 45 milligrams (mg) and 90 mg demonstrated significantly higher rates of 75% improvement in the psoriasis area and severity index (PASI 75) (67.5% and 73.8%, respectively) compared with etanercept (56.8%) in the first phase 3 comparative psoriasis trial between autoimmune biologics (P < 0.05 for both comparisons). In a phase 3 trial of RA patients who had failed prior TNF antagonist therapy, a 20% improvement in signs or symptoms according to the American College of Rheumatology criteria (ACR 20) at week 24 was achieved by significantly more study participants in the tocilizumab 8 mg per kilogram (kg) (50.0%) and 4 mg per kg (30.4%) groups than the placebo group (10.1%, P < 0.001 for both tocilizumab groups compared with placebo). Safety data for ustekinumab are limited to use for less than 2 years, and the prescribing information contains warnings regarding infection and malignancy. Tocilizumab is associated with neutropenia, thrombocytopenia, and elevations in lipids and liver function tests. Tocilizumab has unique adverse events when compared with other autoimmune biologics and requires laboratory testing and careful monitoring. CONCLUSIONS: Ustekinumab and tocilizumab are new additions to the treatment of autoinflammatory disease. The majority of safety data for both agents are from trials lasting 3 to 6 months. Published long-term safety data for tocilizumab are limited to less than 143 patients treated longer than 5 years, and safety data for ustekinumab are scant beyond 2 years of use; therefore, clinicians should exercise caution prior to widespread adoption. The comparative efficacy and safety trial of etanercept and ustekinumab brings important clinical information to decision makers. Tocilizumab is indicated after failure or intolerance to a TNF antagonist and has unique safety concerns. Managed care plans will consider the experience and long-term data of these agents along with efficacy data and cost when establishing management programs such as prior authorization or step therapy.

Pharmacy students' views of managed care pharmacy and PBMS: should there be more exposure to managed care in the pharmacy curriculum?

BACKGROUND: New accreditation standards implemented in 2007 have required schools of pharmacy to evaluate their existing curricula. An issue frequently encountered is the limited amount of content in the pharmacy curriculum specific to managed care and the role and function of pharmacy benefit management companies (PBMs). OBJECTIVE: To determine pharmacy student knowledge and opinions about managed care pharmacy, including the function of PBMs in the delivery of health care, in a college of pharmacy, and to explore tendencies in communication between pharmacy interns and patients in the community setting. METHODS: Students from all 4 PharmD years (n = 663) in 1 college of pharmacy were invited to complete an online survey consisting of 19 questions on demographics, students' views and understanding of PBMs, and interest in working at a PBM in their career. Follow-up in-person and online focus group sessions with representatives from each pharmacy class year were conducted to collect information from students regarding views and understanding of managed care pharmacy. Focus group data were analyzed using a constant comparative method by 2 independent researchers. RESULTS: Of 374 respondents, 332 (88.8%) answered all of the survey questions and were included in the analysis. Most students (72.0%) indicated that they understand little or nothing about the functions of PBMs; 84.3% rated the amount that they had been taught about PBMs in pharmacy school as "inadequate" or "very inadequate;" and 45.2% indicated little or no interest in a PBM career. Yet, 34.7% (99 of 285) of students with past or current community pharmacy work experience rated the percentage of time that PBMs directly affected their practice worksite during a shift at 50% or greater. Focus group emerging themes confirmed survey data findings that students feel uninformed about managed care but regularly communicate with patients about managed care issues. Focus group findings also suggest that students may perceive managed care to be a "masculine," "uncaring" field. CONCLUSIONS: In an exploratory survey conducted at 1 pharmacy school, students perceived themselves as generally uninformed about managed care issues, yet more than one-third believed that dealing with PBMs constituted a significant portion of their work day as community-based pharmacy interns. Managed care understanding is necessary for all pharmacy students because most graduates will practice in community settings. Patients are exposed to managed care and their pharmacy benefit primarily at the point of medication procurement and medication counseling. As a result, pharmacists provide many patients with managed care and pharmacy benefit education. Schools of pharmacy may wish to evaluate and consider increasing the amount of curriculum content specific to managed care and PBMs.