A decade of increases in Medicare Part B pharmaceutical spending: what are the drivers?

BACKGROUND: Medicare Part B pharmaceutical spending has increased rapidly, more than doubling in 2006-2017. Yet, it is unclear whether this increase was driven by increased utilization or increased cost per claim. OBJECTIVE: To evaluate the relative impact of changes in drug utilization and cost per claim on changes in Medicare Part B pharmaceutical spending in 2008-2016 overall, by drug type (specialty and nonspecialty) and therapeutic category. METHODS: In this retrospective descriptive study, we extracted all claims in 2008-2016 for separately payable Part B drugs from a 5% random sample of Medicare beneficiaries. Our study included 3 outcomes calculated annually for all included drugs: (1) spending, defined as the sum of total payments; (2) utilization, defined as total number of claims; and (3) cost per claim, defined as spending divided by the number of claims. Estimates of spending and utilization were expressed per beneficiary-year. Spending and cost per claim were adjusted for inflation. For each outcome, we calculated relative changes in 2008-2016. We repeated analyses stratifying by drug type (specialty and nonspecialty) and therapeutic class. RESULTS: Pharmaceutical spending in Medicare Part B increased by 34% from 2008-2016, driven by a 53% increase in the cost per claim. Utilization decreased by 12%. Spending on specialty drugs increased by 56%, driven by a 48% increase in the cost per claim and a 6% utilization increase. Spending on nonspecialty drugs decreased by 32% driven by an 18% reduction in the cost per claim and a 17% reduction in utilization. Spending on ophthalmic preparations increased by 281%, driven by a 238% utilization increase and a 13% increase in the cost per claim. Spending on antiarthritic and immunologic agents increased by 159%, driven by a 117% increase in the cost per claim and a 19% utilization increase. CONCLUSIONS: Medicare Part B pharmaceutical spending grew in recent years, despite decreased utilization, driven by an overall increase in the cost per claim. This was a product of rising drug prices and increased utilization of more expensive specialty drugs. These findings support the development of policies that aim to spur competition and control price growth of provider-administered drugs. DISCLOSURES: The authors acknowledge funding from the Myers Family Foundation. Hernandez was funded by the National Heart, Lung and Blood Institute (grant number K01HL142847). Shrank is an employee of Humana. Good is an employee of the UPMC Health Plan Insurance Services Division. There are no other potential conflicts of interest to disclose.

Trends in list prices, net prices, and discounts of self-administered injectable tumor necrosis factor inhibitors.

BACKGROUND: List prices of tumor necrosis factor (TNF) inhibitors drastically increased during the last decade, but previous research has shown that half of these increases were offset by rising manufacturer discounts. It remains unclear to what extent manufacturers' discounts have offset increases in list prices of each self-administered injectable TNF inhibitor. Evaluating trends in net prices and discounts at the product level will be paramount in understanding the role of competition in the biologic market. OBJECTIVES: To (a) describe product-level changes in net prices of each self-administered injectable TNF inhibitor available in 2007-2019 and (b) quantify to what extent manufacturer discounts have offset increases in list prices. METHODS: We obtained 2007-2019 pricing data for etanercept, adalimumab, certolizumab, and golimumab from the investment firm SSR Health, which uses company-reported sales to estimate net prices and discounts for brand products manufactured by publicly traded companies. For each drug and year, we calculated annual costs of treatment for patients with rheumatoid arthritis based on list and net prices and discounts in Medicaid and other payers. RESULTS: From 2007-2019, list prices of etanercept and adalimumab increased by 293% and 295%, respectively; however, discounts offset 47% and 45% of these increases, leading to net price increases of 171% and 203%. List prices of golimumab and certolizumab increased by 183% and 182%, respectively, but with discounts offsetting 58% and 59% of these increases, net prices increased by 103% and 109%. Net prices of golimumab started to decrease after 2016, while net prices of adalimumab and certolizumab experienced their first drop in 2019. Across the study period, discounts in Medicaid and in other payers increased, respectively, from 21% to 85% and 6% to 32% for etanercept; from 26% to 88% and 19% to 35% for adalimumab; from 28% to 63% and 22% to 46% for golimumab; and from 29% to 83% and 27% to 47% for certolizumab. CONCLUSIONS: Despite growing manufacturer discounts, net prices of self-administered injectable TNF inhibitors still increased at a mean annual rate of 9.6% in 2007-2019. This led to net prices tripling for adalimumab and more than doubling for etanercept, golimumab, and certolizumab. DISCLOSURES: This study was funded by the Myers Family Foundation. Hernandez is funded by the National Heart, Lung and Blood Institute (grant number K01HL142847). Funding sources had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Hernandez has served on Pfizer's scientific advisory board. The other authors have nothing to disclose.

Changes in List Prices, Net Prices, and Discounts for Branded Drugs in the US, 2007-2018.

Importance: Most studies that have examined drug prices have focused on list prices, without accounting for manufacturer rebates and other discounts, which have substantially increased in the last decade. Objective: To describe changes in list prices, net prices, and discounts for branded pharmaceutical products for which US sales are reported by publicly traded companies, and to determine the extent to which list price increases were offset by increases in discounts. Design, Setting, and Participants: Retrospective descriptive study using 2007-2018 pricing data from the investment firm SSR Health for branded products available before January 2007 with US sales reported by publicly traded companies (n = 602 drugs). Net prices were estimated by compiling company-reported sales for each product and number of units sold in the US. Exposures: Calendar year. Main Outcomes and Measures: Outcomes included list and net prices and discounts in Medicaid and other payers. List prices represent manufacturers' price to wholesalers or direct purchasers but do not account for discounts. Net prices represent revenue per unit of the product after all manufacturer concessions are accounted for (including rebates, coupon cards, and any other discount). Means of outcomes were calculated each year for the overall sample and 6 therapeutic classes, weighting each product by utilization and adjusting for inflation. Results: From 2007 to 2018, list prices increased by 159% (95% CI, 137%-181%), or 9.1% per year, while net prices increased by 60% (95% CI, 36%-84%), or 4.5% per year, with stable net prices between 2015 and 2018. Discounts increased from 40% to 76% in Medicaid and from 23% to 51% for other payers. Increases in discounts offset 62% of list price increases. There was large variability across classes. Multiple sclerosis treatments (n = 4) had the greatest increases in list (439%) and net (157%) prices. List prices of lipid-lowering agents (n = 11) increased by 278% and net prices by 95%. List prices of tumor necrosis factor inhibitors (n = 3) increased by 166% and net prices by 73%. List prices of insulins (n = 7) increased by 262%, and net prices by 51%. List prices of noninsulin antidiabetic agents (n = 10) increased by 165%, and net prices decreased by 1%. List price increases were lowest (59%) for antineoplastic agents (n = 44), but discounts only offset 41% of list price increases, leading to 35% increase in net prices. Conclusions and Relevance: In this analysis of branded drugs in the US from 2007 to 2018, mean increases in list and net prices were substantial, although discounts offset an estimated 62% of list price increases with substantial variation across classes.

Impact of community pharmacist-led interventions in chronic disease management on clinical, utilization, and economic outcomes: An umbrella review.

BACKGROUND: Chronic disease represents a significant burden to the United States (US) health care system, with approximately 50% of all adults in the US having one or more chronic disease conditions. Pharmacist-led chronic disease management interventions are of special interest since 80% of medical treatments involve the use of prescription drugs. Moreover, community pharmacists are among the most accessible health care professionals to provide care for populations with chronic diseases. The impact of care provided by community pharmacists isn't well defined, with interventions taking on diverse forms with varied effects on outcomes. OBJECTIVE: The purpose of this review is to summarize evidence from secondary literature on community pharmacist-led chronic disease management interventions and the impact on clinical, utilization, and economic outcomes. METHODS: We conducted a systematic search of systematic reviews, meta-analyses, and narrative reviews using MEDLINE via PubMed, EMBASE.com and Cochrane Library databases published between January 1, 2007 and October 17, 2017. The following data were extracted: citation details, review type, number of primary studies included, disease state, description of the intervention, outcomes assessed, and results. RESULTS: Our search strategy retrieved 2296 titles and abstracts of which 15 references met our inclusion criteria. Selected articles covered 7 main diseases -diabetes, asthma, chronic obstructive pulmonary disease (COPD), hypertension, heart failure, hyperlipidemia, and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Community pharmacist-led interventions mostly consisted of patient consultations and education. In diabetes, interventions achieved significant reductions in hemoglobin A1c, total cholesterol, and low-density lipoprotein (LDL). Reviews also reported favorable reductions in blood pressure, improved medication adherence and reduced readmission rates in patients with heart failure, improved lung function in patients with respiratory conditions, and increased medication adherence in those with HIV/AIDs. Literature reporting economic and utilization outcomes were limited and mostly focused on pharmacy interventions in diabetes. In some cases, community pharmacy services demonstrated a decrease in medical and health care costs in patients with diabetes. CONCLUSION: We found that community pharmacists can improve clinical outcomes in a wide array of chronic diseases, including diabetes, hyperlipidemia, HIV/AIDS, cardiovascular and respiratory diseases. More robust studies are needed to further assess the impact of specific interventions on economic and utilization outcomes.

Oral contraceptives use and development of obesity in a Mediterranean cohort: the SUN (Seguimiento Universidad de Navarra) Project.

BACKGROUND: The use of oral contraceptives (OC) has been suggested to represent a potential risk factor for the development of obesity. However, the available literature assessing the relationship between OC use and the development of obesity is still scarce and characterised by controversial heterogeneity. We prospectively evaluated the association between the use of OC and the development of obesity in female participants of a middle-aged and free-living cohort. METHODS: The study population included 4920 female Spanish university graduates, initially nonobese women, with mean age (standard deviation) 28.2 (5.4) years. The study population was followed up for a mean of 8.6 (3.7) years. Self-reported use of OC and body mass index were assessed at baseline and biennially during follow-up. We used generalized estimating equation models to evaluate the association between exposure to OC and the development of obesity. RESULTS: After adjusting for potential confounders, baseline OC use was associated with higher odds of new-onset obesity during the full follow-up period (multivariable-adjusted odds ratio [OR] = 1.78; 95% Confidence Interval [CI]: 1.01-3.15). The continued use of OC for periods of time longer than 2 years was significantly associated with a higher risk of developing obesity (OR = 2.82, 95% CI: 1.17-6.82). CONCLUSIONS: According to our prospective cohort study, OC use is significantly associated with higher odds of obesity development, especially when the use of OC is steady and extends over periods of more than 2 years.

Impact of direct-to-consumer drug advertising during the Super Bowl on drug utilization.

BACKGROUND: Direct-to-consumer advertising (DTCA) of prescription drugs impacts patients' requests for medications, and clinician prescribing. However, the impact of DTCA during the Super Bowl has not been previously described. OBJECTIVE: Evaluate the impact of prescription drug DTCA during the Super Bowl on drug utilization using 2014-2016 Medicare data. METHODS: Efinaconazole was advertised during Super Bowls XLIX (02/01/2015) and L (02/07/2016). The number of prescriptions for efinaconazole and for a comparator drug, tavaborole, were calculated in 31-day intervals from July 2014-December 2016. Interrupted time-series analysis models were created to test changes in trends of prescriptions for efinaconazole and tavaborole. RESULTS: Following Super Bowl XLIX, the number of prescriptions per 100,000 Medicare beneficiaries increased by 91% for efinaconazole, and 275% for tavaborole. After Super Bowl L, the number of prescriptions increased significantly for efinaconazole (p-value<0.001), but not for tavaborole (p = 0.70). Interrupted time-series analyses estimated that, in the absence of DTCA during Super Bowl XLIX, prescriptions for efinaconazole would have increased by 40%, instead of the observed 91%. For tavaborole, prescriptions would have increased by 90% instead of 275%. CONCLUSIONS: DTCA during the Super Bowl resulted in sharp increases in utilization of the prescription drug advertised, which supports further regulation of DTCA.

Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications.

Importance: Drug safety communications released by the US Food and Drug Administration (FDA) are often based on limited evidence on safety signals after approval. Varenicline may serve as a relevant case study because it was the target of several FDA communications in 2008 and 2009; ultimately, the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) dismissed safety concerns on increased suicidal thoughts and aggressive and erratic behavior on December 16, 2016. Objective: To examine the association between FDA drug safety communications and the use of varenicline. Design, Setting, and Participants: Retrospective, longitudinal, cross-sectional study of Veterans Health Administration (VHA) outpatient data from October 1, 2001, through December 31, 2018, and Medicaid drug state use data from July 1, 2006, through September 30, 2018, on varenicline prescribing. Main Outcomes and Measures: Prescribing records for varenicline and nicotine replacement therapy (NRT) in the VHA were extracted, and the number of unique varenicline and NRT users in the VHA per quarter was measured. An interrupted time series analysis was performed to describe the association between FDA safety warnings and the use of varenicline and NRT. To test the generalizability of the findings, similar analyses were conducted using the number of prescriptions reimbursed for varenicline by Medicaid every quarter in 2006-2018. Results: After its addition to the VHA national drug formulary in January 2007, varenicline use presented a steady increase, reaching a peak of 32 581 quarterly unique users in the first quarter of 2008. Within 12 months of the February 1, 2008, public health advisory, quarterly varenicline use in VHA patients decreased by 68.7% (from 32 581 to 10 182 patients; P < .001 for slope change), and NRT use increased by 32.1% (from 55 728 to 73 629 patients; P < .001 for slope change). In Medicaid prescriptions, varenicline use decreased by 38.0% (from 109 308 to 67 761 prescriptions; P < .001 for slope change) within 12 months of the 2008 public health advisory. Twelve months after the publication of the EAGLES trial, which showed no significant increase in psychiatric/behavioral effects with varenicline relative to NRT, use of varenicline increased by 42.7% in VHA patients (from 9251 to 13 199 patients; P = .01 for slope change) and by 26.0% in Medicaid prescriptions (112 063 to 141 122; P = .26 for slope change ). Conclusions and Relevance: With use of varenicline as a case study, early communications from the FDA and VHA followed by a labeling change appeared to be associated with a considerable decrease in drug use, which may have been associated with negative public health consequences.

Optimizing the Role of Community Pharmacists in Managing the Health of Populations: Barriers, Facilitators, and Policy Recommendations.

The shift to a value-based health care system has incentivized providers to implement strategies that improve population health outcomes while minimizing downstream costs. Given their accessibility and expanded clinical care models, community pharmacists are well positioned to join interdisciplinary care teams to advance efforts in effectively managing the health of populations. In this Viewpoints article, we discuss the expanded role of community pharmacists and potential barriers limiting the uptake of these services. We then explore strategies to integrate, leverage, and sustain these services in a value-based economy. Although community pharmacists have great potential to improve population health outcomes because of their accessibility and clinical interventions that have demonstrated improved outcomes, pharmacists are not recognized as merit-based incentive eligible providers and, as a result, may be underutilized in this role. Additional barriers include lack of formal billing codes, which limits patient access to services such as hormonal contraception; fragmentation of Medicare, which prevents alignment of medical and pharmaceutical costs; and continued fee-for-service payment models, which do not incentivize quality. Despite these barriers, there are several opportunities for continued pharmacist involvement in new care models such as patient-centered medical homes (PCMH), accountable care organizations, and other value-based payment models. Community pharmacists integrated within PCMHs have demonstrated improved hemoglobin A1c, blood pressure control, and immunization rates. Likewise, other integrated, value-based models that used community pharmacists to provide medication therapy management services have reported a positive return on investment in overall health care costs. To uphold these efforts and effectively leverage community pharmacist services, we recommend the following: (a) recognition of pharmacists as providers to facilitate full participation in performance-based models, (b) increased integration of pharmacists in emerging delivery and payment models with rapid cycle testing to further clarify the role and value of pharmacists, and (c) enhanced collaborative relationships between pharmacists and other providers to improve interdisciplinary care. DISCLOSURES: This article was funded by the National Association of Chain Drug Stores. The authors have no potential conflicts of interest to report.

Trends in Prices, Market Share, and Spending on Self-administered Disease-Modifying Therapies for Multiple Sclerosis in Medicare Part D.

IMPORTANCE: Before 2009, only 4 self-administered disease-modifying therapies (DMTs) were approved for the treatment of multiple sclerosis (MS). Since then, 7 new agents have entered the market. OBJECTIVE: To assess trends in prices, market share, and spending on self-administered DMTs for MS in Medicare Part D from 2006 through 2016. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used claims data from 2006 through 2016 from a 5% random sample of Medicare beneficiaries (a mean of 2.8 million Medicare beneficiaries per year). All prescription claims for self-administered DMTs for MS (glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod hydrochloride, teriflunomide, dimethyl fumarate, and peginterferon beta-1a) were extracted throughout the study period. MAIN OUTCOMES AND MEASURES: The main outcomes were the annual cost of treatment with each medication, based on Medicare Part D prescription claims gross costs and US Food and Drug Administration-approved recommended dosing; market share of each medication, defined as the proportion of pharmaceutical spending accounted by every drug; and pharmaceutical spending per 1000 Medicare beneficiaries for all drugs. The relative contributions of Medicare Part D Plans' payments, Medicare catastrophic coverage payments, low-income cost-sharing subsidies, patients' out-of-pocket costs, manufacturers' coverage gap discounts, and other payments toward pharmaceutical spending were further quantified. RESULTS: Annual costs of treatment with self-administered DMTs for MS more than quadrupled from 2006 to 2016, from a mean (SD) of $18 660 ($1177) to $75 847 ($16 956) and at a mean rate of 12.8% every year. Brand-name glatiramers accounted for the largest market share across the study period, ranging between $25 552 of $79 411 per 1000 Medicare beneficiaries (32.2%) and $10 342 of $21 365 per 1000 Medicare beneficiaries (48.4%). Platform therapies experienced a substantial drop from 2006 to 2016 in favor of newer therapies, with decreases in the market shares of brand-name glatiramers (per 1000 Medicare beneficiaries: $2861 of $7794 [36.7%] to $25 552 of $79 411 [32.2%]), interferon beta-1a (30 µg; per 1000 Medicare beneficiaries: $2521 of $7794 [32.3%] to $11 298 of $79 411 [14.2%]), interferon beta-1b (Betaseron; per 1000 Medicare beneficiaries: $1460 of $7794 [18.7%] to $3588 of $79 411 [4.5%]), and interferon beta-1a (8.8/22/44 µg; per 1000 Medicare beneficiaries: $951 of $7794 [12.2%] to $6588 of $79 411 [8.3%]) and increases in fingolimod (to $6311 of $79 411 per 1000 Medicare beneficiaries [7.9%]), teriflunomide (to $7177 of $79 411 per 1000 Medicare beneficiaries [9.0%]), and dimethyl fumarate (to $15 262 of $79 411 per 1000 Medicare beneficiaries [19.2%]). Throughout the study period, pharmaceutical spending per 1000 beneficiaries increased 10.2-fold (from $7794 to $79 411), and out-of-pocket patient spending per 1000 beneficiaries increased 7.2-fold (from $372 to $2673). The relative contribution of federal payments toward pharmaceutical spending increased from $5335 of $7794 (68.5%) to $58 620 to $79 411 (73.8%). CONCLUSIONS AND RELEVANCE: Per this analysis, prices of self-administered DMTs for MS increased dramatically between 2006 and 2016. This resulted in a 7.2-fold increase in patient out-of-pocket costs.

Association of Antidementia Therapies With Time to Skilled Nursing Facility Admission and Cardiovascular Events Among Elderly Adults With Alzheimer Disease.

Importance: To date, no study has compared time to skilled nursing facility (SNF) admission and cardiovascular events across medications available to treat Alzheimer disease. Objective: To compare time to SNF admission and cardiovascular events between acetylcholinesterase inhibitor (AChEI) monotherapy, memantine hydrochloride monotherapy, and combination therapy with an AChEI and memantine in treating elderly adults with Alzheimer disease. Design, Setting, and Participants: This retrospective cohort study uses January 1, 2006, to December 31, 2014, claims data from a 5% random sample of Medicare beneficiaries who had received a new diagnosis of Alzheimer disease between January 1, 2007, and December 31, 2013, and who initiated AChEI monotherapy, memantine monotherapy, or combination therapy with an AChEI and memantine (N = 73 475). Patients were followed up until discontinuation of treatment, switch of treatment, death, or the end of the study period. Statistical analysis was conducted from February 15, 2018, to June 15, 2018. Exposures: Acetylcholinesterase inhibitor monotherapy (n = 44 424), memantine monotherapy (n = 11 809), and combination therapy with an AChEI and memantine (n = 17 242). Main Outcomes and Measures: Primary outcomes were time to SNF admission and the composite of the following cardiovascular events: acute myocardial infarction, bradycardia, syncope, atrioventricular block, QT interval prolongation, and ventricular tachycardia. Cox proportional hazards regression models were constructed to compare outcomes between each pair of treatment groups, controlling for a comprehensive list of patient characteristics. Results: The study population included 73 475 participants (53 068 women and 20 407 men; mean [SD] age, 81.8 [8.3] years); 25.5% of the participants initiating AChEI monotherapy, 25.6% of participants initiating memantine monotherapy, and 29.7% of participants initiating combination therapy with an AChEI and memantine were admitted to an SNF. Similarly, 22.2% of the participants initiating AChEI monotherapy, 20.0% of those initiating memantine monotherapy, and 24.5% of those initiating combination therapy experienced at least 1 cardiovascular event. No difference in time to SNF admission was found across the 3 treatment groups. The risk of the composite measure of any cardiovascular event did not differ between the combination therapy and AChEI monotherapy groups (adjusted hazard ratio [aHR], 0.99; 95% CI, 0.96-1.03); however, it was higher for both AChEI monotherapy (aHR, 1.07; 95% CI, 1.02-1.12) and combination therapy (aHR, 1.07; 95% CI, 1.01-1.12), relative to memantine monotherapy. This result was mainly driven by the lower risk of bradycardia and syncope observed for the memantine monotherapy group relative to both AChEI monotherapy (bradycardia: aHR, 0.88; 95% CI, 0.82-0.95; and syncope: aHR, 0.92; 95% CI, 0.86-0.97) and combination therapy (bradycardia: aHR, 0.89; 95% CI, 0.82-0.97; and syncope: aHR, 0.87; 95% CI, 0.83-0.94). Conclusions and Relevance: Time to SNF admission did not differ across treatment groups, but memantine monotherapy was associated with a lower risk of cardiovascular events compared with both AChEI monotherapy and combination therapy with an AChEI and memantine.

Impact of community pharmacist-provided preventive services on clinical, utilization, and economic outcomes: An umbrella review.

Preventable diseases and late diagnosis of disease impose great clinical and economic burden for health care systems, especially in the current juncture of rising medical expenditures. Under these circumstances, community pharmacies have been identified as accessible venues to receive preventive services. This umbrella review aims to examine existing evidence on the impact of community pharmacist-provided preventive services on clinical, utilization, and economic outcomes in the United States (US). We included systematic reviews, narrative reviews and meta-analyses published in English between January 2007 and October 2017. Of 2742 references identified by our search strategy, a total of 13 research syntheses met our inclusion criteria. Included reviews showed that community pharmacists are effective at increasing immunization rates, supporting smoking cessation, managing hormonal contraception therapies, and identifying patients at high risk for certain diseases. Moreover, evidence suggests that community pharmacies are especially well-positioned for the provision of preventive services due to their convenient location and extended hours of operation. There is general agreement on the positive impact of community pharmacists in increasing access to preventive health, particularly among patients who otherwise would not be reached by other healthcare providers. The provision of preventive services at US community pharmacies is feasible and effective, and has potential for improving patient outcomes and health system efficiency. However, high-quality evidence is still lacking. As the healthcare landscape shifts towards a value-based framework, it will be important to conduct robust studies that further evaluate the impact of community pharmacist-provided preventive services on utilization and economic outcomes.