Utilization Management Trends in Medicare Part D Oncology Drugs, 2010-2020.

This study examines the exposure of Medicare Part D beneficiaries to utilization management, such as prior authorization, for oral oncology drugs.

Insulin Fills by Medicare Enrollees and Out-of-Pocket Caps Under the Inflation Reduction Act.

This study uses data from IQVIA's National Prescription Audit to assess the association of the Inflation Reduction Act's cap on cost sharing with insulin fills by Medicare beneficiaries.

Prescription Drug Spending in Fee-for-Service Medicare, 2008-2019.

Importance: Prescription drug spending is a topic of increased interest to the public and policymakers. However, prior assessments have been limited by focusing on retail spending (Part D-covered drugs), omitting clinician-administered (Part B-covered) drug spending, or focusing on all fee-for-service Medicare beneficiaries, regardless of their enrollment into prescription drug coverage. Objective: To estimate the proportion of health care spending contributed by prescription drugs and to assess spending for retail and clinician-administered prescriptions. Design, Setting, and Participants: Descriptive, serial, cross-sectional analysis of a 20% random sample of fee-for-service Medicare beneficiaries in the United States from 2008 to 2019 who were continuously enrolled in Parts A (hospital), B (medical), and D (prescription drug) benefits, and not in Medicare Advantage. Exposure: Calendar year. Main Outcomes and Measures: Net spending on retail (Part D-covered) and clinician-administered (Part B-covered) prescription drugs; prescription drug spending (spending on Part B-covered and Part D-covered drugs) as a percentage of total per-capita health care spending. Measures were adjusted for inflation and for postsale rebates (for Part D-covered drugs). Results: There were 3 201 284 beneficiaries enrolled in Parts A, B, and D in 2008 and 4 502 718 in 2019. In 2019, beneficiaries had a mean (SD) age of 71.7 (12.0) years, documented sex was female for 57.7%, and 69.5% had no low-income subsidies. Total per-capita spending was $16 345 in 2008 and $20 117 in 2019. Comparing 2008 with 2019, per-capita Part A spending was $7106 (95% CI, $7084-$7128) vs $7120 (95% CI, $7098-$7141), Part B drug spending was $720 (95% CI, $713-$728) vs $1641 (95% CI, $1629-$1653), Part B nondrug spending was $5113 (95% CI, $5105-$5122) vs $6702 (95% CI, $6692-$6712), and Part D net spending was $3122 (95% CI, $3117-$3127) vs $3477 (95% CI, $3466-$3489). The proportion of total annual spending attributed to prescription drugs increased from 24.0% in 2008 to 27.2% in 2019, net of estimated rebates and discounts. Conclusions and Relevance: In 2019, spending on prescription drugs represented approximately 27% of total spending among fee-for-service Medicare beneficiaries enrolled in Part D, even after accounting for postsale rebates.

Differential Effects by Mental Health Status of Filling the Medicare Part D Coverage Gap.

OBJECTIVE: The objective of this study was to study how changes in insurance benefit design affect medication use of older adults with mental disorders. DATA SOURCES: US Medicare claims data from 2007 to 2018. STUDY DESIGN: Exploiting the gradual elimination of the Medicare prescription drug coverage gap beginning in 2011, we examine the effects on medication use and out-of-pocket spending by drug type with a difference-in-differences approach. We identify subpopulations by mental disorder and compare the estimates across mental health groups and to the general Medicare population. PRINCIPAL FINDINGS: Closing the gap substantially reduced individuals' out-of-pocket spending, and the reduction was larger for those with more severe mental disorders. The policy led to a statistically significant increase in branded drugs used for the Medicare population (0.91; P<0.01; 12.12% increase), beneficiaries with severe mental disorders (2.71; P<0.01; 11.13% increase), and common mental disorders (2.63; P<0.01; 11.62% increase), whereas such effect for beneficiaries with Alzheimer disease and dementia (AD) is substantially smaller (0.44; P<0.01; 1.83% increase). In contrast, the policy decreased generic drugs used by about 3%-5% for all groups. Overall, beneficiaries without mental health illness have a statistically significant increase in total medication use (2.05%) following the coverage gap closure, while all 3 mental health groups have either no statistically significant changes or a small reduction in total mediation use (AD, -1.26%). CONCLUSIONS: Patients' responses to price changes vary across mental disorders and by drug type. The impact on branded drug utilization among those with AD is particularly small. Our findings suggest that lowering medication costs has differential impacts across diseases and may not be sufficient to improve adherence for all conditions, in particular those with severe mental health disorders such as AD.

Availability of Cost-effectiveness Studies for Drugs With High Medicare Part D Expenditures.

Importance: Prescription drug spending in the US requires policy intervention to control costs and improve the value obtained from pharmaceutical spending. One such intervention is to apply cost-effectiveness evidence to decisions regarding drug coverage and pricing, but this intervention depends on the existence of such evidence to guide decisions. Objective: To characterize the availability and quality of cost-effectiveness studies for prescription drugs with the greatest Medicare Part D spending. Design, Setting, and Participants: In this national cross-sectional analysis, publicly available 2016 Medicare drug spending records were merged with 2016 US Food & Drug Administration Orange Book data and the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. All studies published through 2015 that evaluated the cost-effectiveness of the 250 drugs for which Medicare Part D spending was the greatest in US-based adult patient populations were included. Data were analyzed from September 2018 to June 2020. Main Outcomes and Measures: The presence and quality of published cost-effectiveness analyses for the 250 drugs for which Medicare Part D spending was greatest in 2016 were assessed based on the inclusion of key cost-effectiveness analysis elements and global ratings by independent reviewers for the Tufts CEA Registry. Results: Medicare Part D spending on the 250 drugs in the sample totaled $122.8 billion in 2016 (84.1% of total spending). Of these 250 drugs, 91 (36.4%) had a generic equivalent and 159 (63.6%) retained some patent exclusivity. There were 280 unique cost-effectiveness analyses for these drugs, representing data on 135 (54.0%) of the 250 drugs included and 67.0% of Part D spending on the top 250 drugs. The 115 drugs (46.0%) without cost-effectiveness studies accounted for 33.0% of Part D spending on the top 250 drugs. Of the 280 available studies, 128 (45.7%) were industry sponsored. A large proportion of the studies (250 [89.3%]) did not meet the minimum quality requirements. Conclusions and Relevance: In this cross-sectional study, a substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses. The lack of quality analyses may present a challenge in efforts to develop policies addressing drug spending in terms of value.

Medicare beneficiary panel characteristics associated with high Part D biologic disease-modifying anti-rheumatic drug prescribing for older adults among rheumatologists.

ABSTRACT: The aim of this study was to investigate beneficiary panel characteristics associated with rheumatologists' prescribing of biologic DMARDs (bDMARDs) for older adults.In this retrospective observational study, we used Medicare Public Use Files (PUFs) to identify rheumatologists who met criteria for high-prescribing, defined as bDMARD prescription constituting ≥20% of their DMARD claims for beneficiaries ≥65 years of age. We first used descriptive analysis then multivariable regression model to test the association of high prescribing of bDMARDs with rheumatologists' panel size and beneficiary characteristics. In particular, we quantified the proportion of panel beneficiaries ≥75 years of age to assess how caring for an older panel correlate with prescribing of bDMARDs.We identified 3197 unique rheumatologists, of whom 405 (13%) met criteria for high prescribing of bDMARDs for Medicare beneficiaries ≥65 years of age. The high-prescribers provided care to 12% of study older adults, and yet accounted for 21% of bDMARD prescriptions for them. High prescribing of bDMARDs was associated with smaller panel size, and their beneficiaries were more likely to be non-black, ≥75 years of age, non-dual eligible, have diagnosis of CHF, however, less likely to have CKD.Rheumatologists differ in their prescribing of bDMARDs for older adults, and those caring for more beneficiaries ≥75 years of age are more likely to be high-prescribers. Older adults are more prone to the side-effects of bDMARDs and further investigation is warranted to understand drivers of differential prescribing behaviors to optimize use of these high-risk and high-cost medications.

Effectiveness of the Recombinant Zoster Vaccine for Herpes Zoster Ophthalmicus in the United States.

PURPOSE: To examine the effectiveness of the recombinant zoster vaccine (RZV) for preventing herpes zoster ophthalmicus (HZO) in the general United States population. DESIGN: Retrospective, observational cohort study. PARTICIPANTS: Individuals enrolled in the OptumLabs Data Warehouse (OLDW; OptumLabs, Cambridge, MA) who were age eligible for herpes zoster (HZ) vaccination (≥50 years of age) from 2018 through 2019. The OLDW is a longitudinal, de-identified administrative claims and electronic health record database of patients in the United States with commercial insurance, Medicare Part D, or Medicare Advantage METHODS: Patients were required to have 365 days or more of continuous enrollment to be eligible. Those with a diagnosis code of HZ or an immunocompromising condition within 1 year before study inclusion were excluded. Vaccination with the RZV was ascertained by Current Procedural Terminology codes, and HZO was ascertained by International Classification of Diseases, Tenth Revision, codes. Cox proportional hazards regression models were used to estimate the hazard ratio of HZO associated with RZV, and inverse-probability weighting was used to control for confounding. Vaccine effectiveness was calculated from hazard ratios. MAIN OUTCOME MEASURES: Incidence of HZO in vaccinated versus unvaccinated person-times and vaccine effectiveness were assessed. RESULTS: From January 1, 2018, through December 31, 2019, a total of 4 842 579 individuals were included in this study. One hundred seventy-seven thousand two hundred eighty-nine (3.7%) received 2 valid doses of RZV. The incidence rate of HZO was 25.5 cases (95% confidence interval [CI], 17.4-35.8 cases) per 100 000 person-years in the vaccinated group compared with 76.7 cases (95% CI, 74.7-78.7 cases) in the unvaccinated group. The overall adjusted effectiveness of RZV against HZO was 89.1% (95% CI, 82.9%-93.0%). CONCLUSIONS: The effectiveness of RZV against HZO in individuals 50 years of age and older is high in a clinical setting. However, the low vaccination rate in this study highlights the public health need to increase HZV use. Ophthalmologists can play an important role in recommending vaccination to eligible patients.

Prevalence of psychotropic and opioid prescribing among hospice beneficiaries in the United States, 2014-2016.

BACKGROUND/OBJECTIVES: Psychotropic and opioid medications are routinely prescribed for symptom management in hospice, but national estimates of prescribing are lacking. Changes in Medicare hospice payment in 2014 provide the first opportunity to examine psychotropic and opioid prescribing among hospice beneficiaries, and the factors associated with use of specific medication classes. DESIGN: Cross-sectional analysis of a 20% sample of traditional and managed Medicare with Part D enrolled in hospice, 2014-2016. SETTING: Beneficiaries enrolled in the Medicare hospice benefit. PARTICIPANTS: Medicare beneficiaries ≥65 newly enrolled in hospice between July 1, 2014 and December 31, 2016 (N = 554,022). MAIN OUTCOME: Prevalence of psychotropic and opioid medication prescribing by class and factors associated with prescribing. RESULTS: 70.3% of hospice beneficiaries were prescribed a psychotropic and 63.3% were prescribed an opioid. The most common psychotropic classes prescribed were: benzodiazepines (60.6%), antipsychotics (38.3%), antidepressants (18.4%), and antiepileptics (10.2%). Lorazepam (56.4%), morphine (52.8%), and haloperidol (28.6%) were received by the most beneficiaries. Prevalence of any psychotropic and opioid prescription was highest among beneficiaries who were female (76.7%), non-Hispanic white (76.6%), and those with cancer (78.9%). Compared to white beneficiaries, non-Hispanic black beneficiaries were less likely to receive nearly every class of medication, with significantly lower odds of receiving opioids (64.1% vs 57.9%; AOR 0.75, 95% CI 0.72-0.77) and benzodiazepines (61.6% vs 52.2%; AOR 0.66, 95% CI 0.64-0.68). Differences were seen across hospice diagnosis; those with cancer were more likely to receive opioids, benzodiazepines, and antipsychotics but less likely to receive antidepressants and antiepileptics. CONCLUSIONS: Psychotropic and opioid medications are frequently prescribed in hospice. Observed variations in prescribing across race and ethnicity may reflect disparities in prescribing as well as patient preferences for care. Further work is important to understand factors driving prescribing given limited studies surrounding medication prescribing in hospice.

Opioid use in older adults and Medicare Part D.

OBJECTIVE: To determine whether the introduction of prescription drug coverage under Medicare Part D increased opioid prescriptions, patient care-seeking for pain, and pain diagnoses among elderly Medicare-eligible adults. STUDY SETTING: Office visits by adults aged 18 years or older from the 2000-2016 National Ambulatory Medical Care Survey (12 375 207 253 office visits), and respondents from the 2000-2017 Medical Expenditure Panel Survey (4 023 418 681 individuals). STUDY DESIGN: We compared care-seeking for pain, provider-assigned pain diagnoses, and opioid prescriptions before and after the Medicare eligibility age of 65, and before and after Part D's implementation using a regression discontinuity, difference-in-differences design. Analyses were adjusted for age, sex, race, and year. PRINCIPAL FINDINGS: Patient care-seeking for pain increased by 11.4 office visits per 100 people (95% confidence interval 2.0-20.8), or 29%, in response to the implementation of Part D. Opioid prescriptions and diagnoses of pain-related conditions did not change significantly, but the financing of opioid prescriptions shifted from private to public payers at age 65. CONCLUSIONS: The introduction of Medicare Part D was not associated with increased opioid use among older adults. Rather, opioid use among the elderly has been driven by high levels of opioid use among commercially insured adults who subsequently age into Medicare. Our findings raise the question of whether more judicious prescribing to younger adults coupled with concerted efforts to deprescribe opioids when appropriate may prevent problematic opioid use among the elderly.

Promotional Payments Made to Urologists by the Pharmaceutical Industry and Prescribing Patterns for Targeted Therapies.

OBJECTIVE: To measure the association between market-level promotional payments to urologists by the manufacturers of abiraterone and enzalutamide and national prescribing patterns. METHODS: A 20% national sample of the 2015 Part D event file was used to identify patients filling their first prescription for abiraterone and enzalutamide and their prescribing physicians. The 2015 Open Payments data were used to characterize promotional payments made to physicians at the market level. Generalized linear models were then used to measure the relationship between market-level payments to urologists and the physician specialty prescribing abiraterone or enzalutamide for the first time RESULTS: In 2015, 2318 men filled a prescription for abiraterone or enzalutamide by a urologist or medical oncologist. Increasing market-level promotional payments to urologists for abiraterone or enzalutamide was strongly associated with a urologist prescribing either drug-24.3% versus 5.8% of those residing in the markets with highest and lowest level of promotional payments to urologists, respectively (P <.01). Neither the number of urologists residing in a market nor other promotional payment measures (ie, to medical oncologists for these drugs, or to all physicians for all other drugs) were associated with a urologist prescribing either drug. CONCLUSION: Promotional payments to urologists at the market level are strongly associated with the specialty of the physician prescribing abiraterone or enzalutamide for the first time. Future work should elucidate the effects of the shift in prescribing patterns on quality of care and financial hardship for men with advanced prostate cancer.

Trends in Utilization and Cost of Low-Density Lipoprotein Cholesterol-Lowering Therapies Among Medicare Beneficiaries: An Analysis From the Medicare Part D Database.

Importance: Low-density lipoprotein cholesterol (LDL-C)-lowering therapies are a cornerstone of prevention in atherosclerotic cardiovascular disease. With the introduction of generic formulations and the release of new therapies, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, contemporary Medicare utilization of these therapies remains unknown. Objective: To determine trends in utilization and spending on brand-name and generic LDL-C-lowering therapies and to estimate potential savings if all Medicare beneficiaries were switched to available therapeutically equivalent generic formulations. Design, Setting, and Participants: This cross-sectional study analyzed prescription drug utilization and cost trend data from the Medicare Part D Prescription Drug Event data set from 2014 to 2018 for LDL-C-lowering therapies. A total of 11 LDL-C-lowering drugs with 25 formulations, including 16 brand-name and 9 generic formulations, were included. Data were collected and analyzed from October 2019 to June 2020. Main Outcomes and Measures: Number of Medicare Part D beneficiaries, annual spending, and spending per beneficiary for all formulations. Results: The total number of Medicare Part D beneficiaries ranged from 37 720 840 in 2014 to 44 249 461 in 2018. The number of Medicare beneficiaries taking LDL-C-lowering therapies increased by 23% (from 20.5 million in 2014 to 25.2 million in 2018), while the associated Medicare expenditure decreased by 46% (from $6.3 billion in 2014 to $3.3 billion in 2018). Lower expenditure was driven by greater uptake of generic statin and ezetimibe and a concurrent rapid decline in the use of their brand-name formulations. Medicare spent $9.6 billion on brand-name statins and ezetimibe and could have saved $2.1 billion and $0.4 billion, respectively, if brand-name formulations were switched to equivalent generic versions when available. The number of beneficiaries using PCSK9 inhibitors since their introduction in 2015 has been modest, although use has increased by 144% (from 25 569 in 2016 to 62 476 in 2018) and total spending has increased by 199% (from $164 million in 2016 to $491 million in 2018). Conclusions and Relevance: Between 2014 and 2018, LDL-C-lowering therapies were used by 4.8 million more Medicare beneficiaries annually, with an associated $3.0 billion decline in Medicare spending. This cost reduction was driven by the rapid transition from brand-name formulations to lower-cost generic formulations of statins and ezetimibe. Use of PCSK9 inhibitions, although low, increased over time and could have broad implications on future Medicare spending.

Cost-related Medication Nonadherence and Its Risk Factors Among Medicare Beneficiaries.

BACKGROUND: Unaffordability of medications is a barrier to effective treatment. Cost-related nonadherence (CRN) is a crucial, widely used measure of medications access. OBJECTIVES: Our study examines the current national prevalence of and risk factors for CRN (eg, not filling, skipping or reducing doses) and companion measures in the US Medicare population. RESEARCH DESIGN: Survey-weighted analyses included logistic regression and trends 2006-2016. SUBJECTS: Main analyses used the 2016 Medicare Current Beneficiary Survey. Our study sample of 12,625 represented 56 million community-dwelling beneficiaries. MEASURES: Additional outcome measures were spending less on other necessities in order to pay for medicines and use of drug cost reduction strategies such as requesting generics. RESULTS: In 2016, 34.5% of enrollees under 65 years with disability and 14.4% of those 65 years and older did not take their medications as prescribed due to high costs; 19.4% and 4.7%, respectively, experienced going without other essentials to pay for medicines. Near-poor older beneficiaries with incomes $15-25K had 50% higher odds of CRN (vs. >$50K), but beneficiaries with incomes <$15K, more likely to be eligible for the Part D Low-Income Subsidy, did not have significantly higher risk. Three indicators of worse health (general health status, functional limits, and count of conditions) were all independently associated with higher risk of CRN. CONCLUSIONS: Changes in the risk profile for CRN since Part D reflect the effectiveness of targeted policies. The persistent prevalence of CRN and associated risks for sicker people in Medicare demonstrate the consequences of high cost-sharing for prescription fills.

Validation of an oncology-specific opioid risk calculator in cancer survivors.

BACKGROUND: Clinical guidelines recommend that providers risk-stratify patients with cancer before prescribing opioids. Prior research has demonstrated that a simple cancer opioid risk score might help identify to patients with cancer at the time of diagnosis with a high likelihood of long-term posttreatment opioid use. This current project validates this cancer opioid risk score in a generalizable, population-based cohort of elderly cancer survivors. METHODS: This study identified 44,932 Medicare beneficiaries with cancer who had received local therapy. Longitudinal opioid use was ascertained from Medicare Part D data. A risk score was calculated for each patient, and patients were categorized into low-, moderate-, and high-risk groups on the basis of the predicted probability of persistent opioid use. Model discrimination was assessed with receiver operating characteristic curves. RESULTS: In the study cohort, 5.2% of the patients were chronic opioid users 1 to 2 years after the initiation of cancer treatment. The majority of the patients (64%) were at low risk and had a 1.2% probability of long-term opioid use. Moderate-risk patients (33% of the cohort) had a 5.6% probability of long-term opioid use. High-risk patients (3.5% of the cohort) had a 75% probability of long-term opioid use. The opioid risk score had an area under the receiver operating characteristic curve of 0.869. CONCLUSIONS: This study found that a cancer opioid risk score could accurately identify individuals with a high likelihood of long-term opioid use in a large, generalizable cohort of cancer survivors. Future research should focus on the implementation of these scores into clinical practice and how this could affect prescriber behavior and patient outcomes. LAY SUMMARY: A novel 5-question clinical decision tool allows physicians treating patients with cancer to accurately predict which patients will persistently be using opioid medications after completing therapy.

Understanding the Socioeconomic and Geographical Characteristics of Beneficiaries Receiving a Comprehensive Medication Review.

BACKGROUND: Medicare Part D sponsors are required to offer medication therapy management (MTM) programs to eligible beneficiaries. Recent studies have demonstrated that there have been racial/ethnic disparities in MTM eligibility criteria. For example, compared with non-Hispanic White beneficiaries, Hispanic and non-Hispanic Black beneficiaries are less likely to be eligible for MTM. However, there is limited evidence for socioeconomic and geographical characteristics of those who are eligible and receive MTM services. OBJECTIVE: To describe the demographic, socioeconomic, and geographic characteristics of Medicare beneficiaries who received MTM services. METHODS: As part of a previous study, a national survey evaluated a convenience sample of perspectives of Medicare beneficiaries on the MTM standardized format. The survey was distributed through Medicare Part D plans to beneficiaries receiving MTM services from 2017-2018. As part of the survey, respondents could provide their ZIP codes. Geographical variables, such as the National Center for Health Statistics (NCHS) urban-rural classification scheme and economic research service (ERS) county typology codes, were then applied to respondents' ZIP codes, allowing for the classification of counties or census tracts by urbanization and economic dependence measures. Descriptive statistics are reported for demographic, geographical, and socioeconomic information. RESULTS: Of the 300 (of 434) respondents who provided their ZIP codes, 51.3% were aged 65-74 years; 50% were male; and 66.7% had at least a college education. There were 82.7% who self-identified as White, while only 8% self-identified as Hispanic or Black/African American. The majority of respondents (58.4%) lived in large metropolitan areas as defined by the NCHS urban-rural classification scheme. Respondents' counties were characterized by economic dependence with 14.0% of respondents living in federal/state government-dependent counties and 12.7% living in recreation-dependent counties. CONCLUSIONS: The majority of respondents who provided their ZIP codes identified themselves as White and lived in large metropolitan areas. Respondents who identified themselves as Hispanic or Black/African American were not well represented. This study provides geographical and socioeconomic characteristics of Medicare beneficiaries who received MTM services and highlights racial/ethnic differences. Further work is needed to confirm geographical and socioeconomic disparities among beneficiaries who received MTM services. DISCLOSURES: No outside funding supported this study. Pellegrin is a member of the AMCP MTM Advisory Group. The other authors have nothing to disclose.

Current Procedural Terminology Codes for Medication Therapy Management in Administrative Data.

BACKGROUND: Three pharmacist-specific Current Procedural Terminology (CPT) codes exist to facilitate medication therapy management (MTM) reimbursement (codes 99605, 99606, and 99607). However, no studies have used CPT codes in administrative claims databases to identify subjects who have received MTM services. OBJECTIVE: To assess the prevalence of MTM services provided, using CPT codes identified in an administrative dataset. METHODS: A retrospective cohort study was conducted using a subset of Medicare Part D individuals from the IBM MarketScan Medicare Supplemental Research Databases (2009-2015). Researchers identified beneficiaries who received MTM services using CPT codes 99605, 99606, and 99607. RESULTS: Of the 16,483,709 individuals in the dataset, only 3,291 had CPT codes indicating that they received MTM services, representing an overall prevalence of 0.020%. CONCLUSIONS: The use of CPT codes as an indicator of MTM service provision resulted in far lower MTM utilization rates than in published literature. Reliance on CPT codes to identify MTM services in administrative claims is not recommended, given that it limited the researchers' ability to properly identify patient receipt of such services. More accurate methodologies are warranted for identifying MTM use and its effects on patient outcomes. DISCLOSURES: This work was supported by Pharmacy Quality Alliance; Merck Sharp & Dohme, a subsidiary of Merck & Co. (Kenilworth, NJ); and SinfoniaRx. The funding sources had no role in study design, collection, analysis, and interpretation of data, writing the report, or decision to submit the article for publication. Tate, Chinthammit, and Campbell completed this work during their employment at the University of Arizona. Pickering was an employee of Pharmacy Quality Alliance at the time of this study. Black is employed by Merck. Axon reports grants from the Arizona Department of Health Services and the American Association of Colleges of Pharmacy; Campbell reports a grant from the Community Pharmacy Foundation; Chinthammit reports fees from Eli Lilly; Black has received a grant from Merck; Warholak reports grants from the Arizona Department of Health Services and Novartis, all unrelated to this study. Taylor reports grants from Tabula Rasa Op-Co, during the conduct of the study, and from the Arizona Department of Health Services, outside the conduct of this study. This research was accepted as a poster presentation at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting, May 16-20, 2020, in Orlando, FL, but was not presented due to the COVID-19 pandemic. An abstract was published in Value in Health, 2020;23(Suppl 1):S305.

Association Between the Percentage of US Drug Sales Subject to Inflation Penalties and the Extent of Drug Price Increases.

Importance: Policy makers have proposed levying penalties for drug price increases that are higher than the rate of inflation for drugs covered in the US Medicare program, but research is lacking regarding the ways in which manufacturers might respond to those penalties. An understanding of manufacturers' responses to existing inflation penalties could inform such policy discussions. Objective: To estimate the association of existing inflation penalties in the US 340B Drug Pricing Program with manufacturer pricing behavior in the Medicare Part D program and associated changes in Medicare pharmacy expenditures. Design, Setting, and Participants: This study included a pooled cross-sectional time-series analysis of price changes for Medicare Part D drugs used annually by more than 5000 beneficiaries between January 1, 2013, and December 31, 2017. The percentage of Medicare Part D sales subject to inflation penalties in the 340B program was used to perform a regression analysis to estimate the association of inflation penalties with annual drug price changes. The 340B program requires manufacturers to sell their drugs at a lower price to safety-net health care organizations; this lower price includes a base discount and an additional discount equal to the amount of any price increase that is higher than the rate of inflation. Sales to these 340B-eligible health care organizations represent the market share of a drug subject to inflation penalties. Health care organization-level claims data were obtained from the Medicare Provider Utilization and Payment Data-Part D Prescriber database, and organizations were matched to the Office of Pharmacy Affairs Information System of the Health Resources and Services Administration to identify those organizations that were eligible for the 340B program. Price change and drug use data were obtained from the Medicare Part D Drug Spending Dashboard. Name-brand drugs were included in the analysis if they did not have generic competition and were used by more than 5000 individuals with Medicare Part D in 1 calendar year. Data analysis was conducted from January 1 to February 28, 2020. Main Outcomes and Measure: Annual price change was the primary outcome measure; spending changes associated with lower price increases were also estimated. Sales percentage subject to inflation penalties was the primary independent variable, and formulary classification was a control variable. Results: Of 2148 brand-name drugs included in the database, 606 drugs were used by more than 5000 beneficiaries annually, with a mean sales percentage subject to inflation penalties of 12.1%. A higher sales percentage subject to inflation penalties was associated with lower annual price increases (between-effects coefficient, -0.114; 95% CI, -0.205 to -0.023; P = .01; fixed-effects coefficient, -0.380; 95% CI, -0.466 to -0.294; P < .001). Lower price increases owing to inflation penalties were estimated to be associated with a reduction in Medicare Part D pharmacy expenditures of $7.1 billion between 2013 and 2017. Conclusions and Relevance: In this cross-sectional study, increases in the percentage of drug sales subject to inflation penalties were associated with lower annual price increases. Broader application of inflation penalties may help to reduce drug price increases and decrease overall drug spending.