Rx -to- OTC switch increased access and lowered cost of topical adapalene.

Topical adapalene gel is an effective and well tolerated acne treatment that transitioned from prescription to over-the-counter (OTC) availability in 2016. Historically, prescription to OTC transitions have lowered costs to patients and payers and increased access to medications. This study used sales and prescriber data to assess access to topical retinoid therapies and their costs in the pre- and post- Rx-to-OTC transition. We demonstrate that the prescription to OTC transition of adapalene gel increased access to this medication, while lowering costs to patients and payers, including Medicare patients. These results provide a necessary call to action for future OTC shifts with other high safety profile, well-tolerated medications in ultimate efforts and hopes of cost savings for patients, insurers, and Medicare within our healthcare industry.

A primer on brand-name prescription drug contracting.

Prescription drug contracting in the United States has evolved over decades from discounts provided to members of early health maintenance organization plans to rebate contracts to more complex value-based purchasing arrangements. This primer describes the history of contracting between pharmaceutical manufacturers and managed care pharmacy organizations and details the various contracting methods used today.

Out-of-pocket prescription drug costs for adults with cardiovascular risk factors under Amazon's direct-to-consumer pharmacy service.

BACKGROUND: US adults often overpay for generic prescription medications, which can lead to medication nonadherence that negatively impacts cardiovascular outcomes. As a result, new direct-to-consumer online medication services are growing in popularity nationwide. Amazon recently launched a $5/month direct-to-consumer medication subscription service (Amazon RxPass), but it is unclear how many US adults could save on out-of-pocket drug costs by using this new service. OBJECTIVES: To estimate out-of-pocket savings on generic prescription medications achievable through Amazon's new direct-to-consumer subscription medication service for adults with cardiovascular risk factors and/or conditions. METHODS: Cross-sectional study of adults 18-64 years in the 2019 Medical Expenditure Panel Survey. RESULTS: Of the 25,280,517 (SE ± 934,809) adults aged 18-64 years with cardiovascular risk factors or conditions who were prescribed at least 1 medication available in the Amazon RxPass formulary, only 6.4% (1,624,587 [SE ± 68,571]) would achieve savings. Among those achieving savings, the estimated average out-of-pocket savings would be $140 (SE ± $15.8) per person per year, amounting to a total savings of $228,093,570 (SE ± $26,117,241). In multivariable regression models, lack of insurance coverage (adjusted odds ratio [OR] 3.5, 95%CI 1.9-6.5) and being prescribed a greater number of RxPass-eligible medications (2-3 medications versus 1 medication: OR 5.6, 95%CI 3.0-10.3; 4+ medications: OR 21.8, 95%CI 10.7-44.3) were each associated with a higher likelihood of achieving out-of-pocket savings from RxPass. CONCLUSIONS: Changes to the pricing structure of Amazon's direct-to-consumer medication service are needed to expand out-of-pocket savings on generic medications to a larger segment of the working-age adults with cardiovascular risk factors and/or diseases.

Prescription drug coverage and effective coverage of three chronic conditions of high prevalence in Chile: Hypertension, diabetes and dyslipidemia.

BACKGROUND: Access to medicines is a serious problem globally and in Chile. Despite the creation of coverage policies, part of the population with chronic conditions of high prevalence, still does not have access to the medicines it requires and disease control continues to be low. The objective of the study was to estimate the medication use and effective coverage for diabetes, dyslipidemia and hypertension in Chile, analyzing them according to sociodemographic variables and social determinants of health. METHODS: Cross-sectional analytical study with information from the 2016-2017 National Health Survey (sample = 6,233 people aged 15 years or older, expanded = 14,518,969). Descriptive analyses of medication use and effective coverage for hypertension, diabetes and dyslipidemia were carried out, and multivariate logistic regression models were developed to analyze possible associations with variables of interest. RESULTS: 60% of people with hypertension or diabetes use medications and only 27.7% in dyslipidemia. While 54.2% of those with diabetes have their glycemia controlled, in hypertension and dyslipidemia the effective coverage drops to 33.3% and 6.6%, respectively. There are no differences in use by health system, but there are differences in the control of hypertension and diabetes, favoring beneficiaries of the private subsystem. Effective coverage of dyslipidemia and hypertension also increases in those using medications. The drugs coincide with the established protocols, although beneficiaries of the private sector report greater use of innovative drugs. CONCLUSION: A significant proportion of Chileans with hypertension, diabetes or dyslipidemia still do not use the required medications and do not control their conditions.

Spending on Dual Over-the-Counter and Prescription Drugs in the Medicare Part D Program.

This study compares Medicare and patient spending for dual over-the-counter and prescription drugs with their over-the-counter cash prices.

Reimbursement to Pharmacies for Generic Drugs by Medicare Part D Sponsors.

This study evaluates whether organizations that offer Medicare Part D plans (referred to as Part D sponsors) overpay pharmacies for generic drugs.

Medicare's Historic Prescription Drug Price Negotiations.

This Viewpoint evaluates the legal claims and policy implications of historic drug price negotiations possible with the Inflation Reduction Act of 2022.

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.

Characteristics of Adults Aged 18-64 Who Did Not Take Medication as Prescribed to Reduce Costs: United States, 2021.

About 60% of adults aged 18 and over reported taking at least one prescription medication in 2021, with 36% reporting taking three or more (1). Out-ofpocket costs on retail drugs rose 4.8% to $63 billion in 2021 (2). High costs may limit individuals' access to medications and lead to people not taking medication as prescribed (3,4); this may result in more serious illness and require additional treatment (5). This report examines the characteristics of adults aged 18-64 who took prescription medication in the past 12 months and did not take medication as prescribed due to cost. Cost-saving measures included skipping doses, taking less medication than prescribed, or delaying filling a prescription.

Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation.

This study evaluates sales revenue earned in the first 5 years for newly marketed brand-name drugs with and without an initial orphan drug designation.

Added Therapeutic Benefit of Top-Selling Brand-name Drugs in Medicare.

Importance: The Inflation Reduction Act of 2022 authorizes Medicare to negotiate prices of top-selling drugs based on several factors, including therapeutic benefit compared with existing treatment options. Objective: To determine the added therapeutic benefit of the 50 top-selling brand-name drugs in Medicare in 2020, as assessed by health technology assessment (HTA) organizations in Canada, France, and Germany. Design, Setting, and Participants: In this cross-sectional study, publicly available therapeutic benefit ratings, US Food and Drug Administration documents, and the Medicare Part B and Part D prescription drug spending dashboards were used to determine the 50 top-selling single-source drugs used in Medicare in 2020 and to assess their added therapeutic benefit ratings through 2021. Main Outcomes and Measures: Ratings from HTA bodies in Canada, France, and Germany were categorized as high (moderate or greater) or low (minor or no) added benefit. Each drug was rated based on its most favorable rating across countries, indications, subpopulations, and dosage forms. We compared the use and prerebate and postrebate (ie, net) Medicare spending between drugs with high vs low added benefit. Results: Forty-nine drugs (98%) received an HTA rating by at least 1 country; 22 of 36 drugs (61%) received a low added benefit rating in Canada, 34 of 47 in France (72%), and 17 of 29 in Germany (59%). Across countries, 27 drugs (55%) had a low added therapeutic rating, accounting for $19.3 billion in annual estimated net spending, or 35% of Medicare net spending on the 50 top-selling single-source drugs and 11% of total Medicare net prescription drug spending in 2020. Compared with those with high added benefit, drugs with a low added therapeutic rating were used by more Medicare beneficiaries (median 387 149 vs 44 869) and had lower net spending per beneficiary (median $992 vs $32 287). Conclusions and Relevance: Many top-selling Medicare drugs received low added benefit ratings by the national HTA organizations of Canada, France, and Germany. When negotiating prices for these drugs, Medicare should ensure they are not priced higher than reasonable therapeutic alternatives.

Medical Expenditures Associated with Attention-Deficit/Hyperactivity Disorder Among Adults in the United States by Age, 2015-2019.

BACKGROUND: Attention-deficit hyperactivity disorder is a common disorder that affects both children and adults. However, for adults, little is known about ADHD-attributable medical expenditures. OBJECTIVE: To estimate the medical expenditures associated with ADHD, stratified by age, in the US adult population. DESIGN: Using a two-part model, we analyzed data from Medical Expenditure Panel Survey for 2015 to 2019. The first part of the model predicts the probability that individuals incurred any medical costs during the calendar year using a logit model. The second part of the model estimates the medical expenditures for individuals who incurred any medical expenses in the calendar year using a generalized linear model. Covariates included age, sex, race/ethnicity, geographic region, Charlson comorbidity index, insurance, asthma, anxiety, and mood disorders. PARTICIPANTS: Adults (18 +) who participated in the Medical Expenditure Panel Survey from 2015 to 2019 (N = 83,776). MAIN MEASURES: Overall and service specific direct ADHD-attributable medical expenditures. KEY RESULTS: A total of 1206 participants (1.44%) were classified as having ADHD. The estimated incremental costs of ADHD in adults were $2591.06 per person, amounting to $8.29 billion nationally. Significant adjusted incremental costs were prescription medication ($1347.06; 95% CI: $990.69-$1625.93), which accounted for the largest portion of total costs, and office-based visits ($724.86; 95% CI: $177.75-$1528.62). The adjusted incremental costs for outpatient visits, inpatient visits, emergency room visits, and home health visits were not significantly different. Among older adults (31 +), the incremental cost of ADHD was $2623.48, while in young adults (18-30), the incremental cost was $1856.66. CONCLUSIONS: The average medical expenditures for adults with ADHD in the US were substantially higher than those without ADHD and the incremental costs were higher in older adults (31 +) than younger adults (18-30). Future research is needed to understand the increasing trend in ADHD attributable cost.

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.