The impact of willingness-to-pay threshold on price reduction recommendations for oncology drugs: a review of assessments conducted by the Canadian Agency for Drugs and Technologies in Health.

Since late 2020, the Canadian Agency of Drugs and Technologies in Health (CADTH) has been using a threshold of $50,000 (CAD) per quality-adjusted life-year (QALY) for both oncology and non-oncology drugs. When used for oncology products, this threshold is hypothesized to have a higher impact on the time to access these drugs in Canada. We studied the impact of price reductions on time to engagement and negotiation with the pan-Canadian Pharmaceutical Alliance for oncology drugs reviewed by CADTH between January 2020 and December 2022. Overall, 103 assessments reported data on price reductions recommended by CADTH to meet the cost-effectiveness threshold for reimbursement. Of these assessments, 57% (59/103) recommendations included a price reduction of greater than 70% off the list price. Eight percent (8/103) were not cost-effective even at a 100% price reduction. Of the 47 assessments that had a clear benefit, in 21 (45%) CADTH recommended a price reduction of at least 70%. The median time to price negotiation (not including time to engagement) for assessments that received at least 70% vs >70% price reduction was 2.6 vs 4.8 months. This study showed that there is a divergence between drug sponsor's incremental cost-effectiveness ratio (ICER) and CADTH revised ICER leading to a price reduction to meet the $50,000/QALY threshold. For the submissions with clear clinical benefit the median length of engagement (2.5 vs 3.3 months) and median length of negotiation (3.1 vs 3.6 months) were slightly shorter compared with the submissions where uncertainties were noted in the clinical benefit according to CADTH. This study shows that using a $50,000 per QALY threshold for oncology products potentially impacts timely access to life saving medications.

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.

Diabetes tipo 2 en Andalucía: uso de recursos y coste económico / Type 2 diabetes in Andalusia: Resources use and economic cost

Antecedentes y objetivos Estudios previos que cuantifican el coste de la diabetes tipo 2 (DM2) muestran resultados muy dispares. Nos planteamos definir el perfil del paciente con DM2 en Andalucía, analizar el uso de recursos sanitarios y, cuantificar su coste económico en el año 2022. Pacientes y métodos Estudio multicéntrico, transversal y descriptivo; 385 pacientes con DM2 de toda Andalucía (IC 95%; error: 5%). Datos analizados: edad, sexo, asistencia a consultas de Atención Primaria (AP), de enfermería, de urgencias y de especialidades hospitalarias; consumo de fármacos en general y antidiabéticos en particular, tiras de glucemia, pruebas complementarias y días de ingreso hospitalario. Resultados Edad media: 70,7 ± 12,44 años; 53,6% hombres. Contactos asistenciales: médico de AP: 8,36 ± 4,69; enfermería: 7,17 ± 12; consultas hospitalarias: 2,31 ± 2,38; urgencias: 1,71 ± 2,89. Días de ingreso hospitalario: 2,26 ± 6,46. Analíticas: 3,79 ± 5,45 y 2,17 ± 3,47 Rx. Fármacos consumidos: 9,20 ± 3,94 (1,76 ± 0,90 antidiabéticos). Tiras glucemia: 184 ± 488. Coste anual: 5.171,05 €/paciente/año (2.228,36 € por ingresos hospitalarios, 1.702,87 € por fármacos y 1.239,82 € por asistencias y pruebas complementarias). Conclusiones El andaluz con DM2 tiene 71 años de edad, consume 10 fármacos diferentes y trata su DM2 con doble terapia. Tiene 20 asistencias/año (75% en AP), cuatro análisis, dos Rx y precisa dos días de ingreso hospitalario. Los costes sanitarios directos superan los 5.000 €/año. Lo que supone 41,66% del presupuesto de la Consejería de Salud y triplica el gasto medio por habitante (AU)

Background and objectives Previous studies that quantify the cost of type 2 diabetes (DM2) show very different results. We set out to define the profile of the patient with DM2 in Andalusia, analyze the use of health resources and quantify their economic cost during 2022. Patients and methods Multicenter, cross-sectional and descriptive study. Three hundred and eighty-five patients with DM2 from Andalusia (confidence level: 95%; error: 5%). Data analyzed: age, sex, attendance at primary care (PC), nursing, emergency and hospital specialty consultations; consumption of drugs in general and antidiabetics in particular, blood glucose strips, complementary tests and hospitalization days. Results Mean age: 70.7 ± 12.44 years; 53.6% men. Care contacts: PC physician: 8.36 ± 4.69; nursing: 7.17 ± 12; hospital visits: 2.31 ± 2.38; emergencies: 1.71 ± 2.89; hospitalization days: 2.26 ± 6.46. Laboratory tests: 3.79 ± 5.45 and 2.17 ± 3.47 Rx. Drugs consumed: 9.20 ± 3.94 (1.76 ± 0.90 antidiabetics). Blood glucose strips: 184 ± 488. Annual cost: 5171.05 €/patient/year (2228.36 € for hospital admissions, 1702.87 € for drugs and 1239.82 € for assistance and complementary tests). Conclusions The DM2 Andalusian is 71 years old, consumes 10 different drugs and treats DM2 with double therapy. He has been 20 attendances/year (75% in PC), 4 analyses, 2 X-rays and requires 2 days of hospitalization. Direct healthcare costs goes over 5000 €/year. This represents 41.66% of the budget of the Andalusian Ministry of Health and triples the average cost per habitant (AU)

The Problem of Limited-Supply Agreements for Medicare Price Negotiation.

This Viewpoint discusses how limited-supply agreements (introduction of generic products in reduced volumes) might thwart efforts to negotiate lower prices on prescription drugs in the US.

Changes in the Number of Continuation Patents on Drugs Approved by the FDA.

This study assesses the frequency of continuation patents on brand-name drugs approved by the US Food and Drug Administration from 2000 to 2015.

Política de medicamentos de alto costo en un hospital público pediátrico: Análisis de utilización y costos / High-cost medication policy at a public pediatric hospital: utilization and cost analysis

Objetivos. Analizar el circuito de utilización de los medicamentos de alto costo (MAC) y los resultados clínicos obtenidos en un hospital de pediatría público de alta complejidad de Argentina y presentar una estrategia de selección replicable para otras instituciones de similares características de la región. Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. Se evaluaron dos unidades de estudio, la unidad paciente y la unidad MAC. Resultados: Los MAC consumen 7.921.200 dólares estadounidenses (USD) anuales y representan el 41% del costo de los medicamentos del hospital de alta complejidad. El 50% del costo de los MAC estuvo representado por la gammaglobulina (medicamento utilizado en diferentes enfermedades). Los pacientes proceden de toda la Argentina y otros países y un 44% tiene cobertura de salud. Los diagnósticos para los que se prescribieron MAC con mayor frecuencia fueron los relacionados con patología oncológica (leucemia linfoide aguda, leucemia mieloblástica aguda). El 54% de los pacientes presentó mejoría atribuible directamente a la administración de los MAC, 39% no presentó cambios y el 7% empeoró. Conclusiones: La efectividad en los resultados clínicos y el análisis de los circuitos de aprobación indican que, además de la aprobación por las entidades nacional e internacionales, la evaluación responsable por parte de las instituciones efectoras, mediante la discusión interdisciplinaria basada en la mejor evidencia, contribuye a optimizar la utilización de los MAC y la seguridad de los pacientes (AU)

Objectives. To analyze the utilization circuit of high-cost medications (HCM) and the clinical results obtained in a tertiarycare public pediatric hospital in Argentina and to present a selection strategy that may be disseminated to other institutions of similar characteristics in the region. Methods: A prospective, descriptive, randomized study was conducted at Hospital de Pediatría Juan P. Garrahan in Buenos Aires between September 1, 2018 and March 31, 2019. Two study units were evaluated, the patient and the HCM. Results: HCMs account for 7,921,200 US dollars (USD) per year and represent 41% of the cost of drugs in this tertiary-care hospital. Gamma globulin (a drug used for different diseases) accounted for 50% of the cost of HCMs. Patients came from Argentina and other countries and 44% had a health insurance. Cancer (acute lymphoid leukemia, acute myeloblastic leukemia) was the diagnosis for which HCMs were most frequently prescribed. Fifty-four percent of patients showed improvement directly attributable to the administration of HCMs, 39% showed no change, and 7% worsened. Conclusions: The effectiveness in clinical outcomes and the analysis of approval circuits show that, in addition to approval by national and international entities, responsible evaluation by the effector institutions through interdisciplinary discussion based on the best evidence contributes to optimizing the use of HCMs and patient safety (AU)

Economic outcomes of antiobesity medication use among adults in the United States: A retrospective cohort study.

BACKGROUND: Obesity prevalence exceeds 40% in the US adult population, posing a substantial burden on the health care system. Antiobesity medication (AOM) is recommended for obesity management. However, little evidence exists estimating the economic impact of AOMs on health care costs over time. OBJECTIVE: To estimate the impact of AOMs indicated for long-term therapy on shortterm direct medical costs, by obesity class, in a commercially insured population. METHODS: For this retrospective cohort study, we used the IBM MarketScan Commercial Claims and Encounters Database to capture health care utilization between January 1, 2015, and December 31, 2019. Adults aged 18-63 years with a body mass index greater than or equal to 30 kg/m2 were categorized into 2 cohorts based on new AOM usage at cohort entry. New AOM users were taking 1 of 4 AOMs currently approved by the US Food and Drug Administration for long-term therapy, with greater than 112 days supply of medicine within 12 months after treatment initiation. AOM nonusers were those not taking an AOM indicated for long-term therapy during the baseline or follow-up period. We used difference-in-differences estimation to calculate the change in average annual total health care costs and cost of medications (excluding AOMs) over a 2-year follow-up period using inverse probability of treatment-weighted estimates. RESULTS: The study population included 219,971 patients, 1,405 AOM users and 218,566 AOM nonusers. Over 2 years, patients on treatment were more than twice as likely to be classified into a lower obesity class than AOM nonusers. Although the average yearly direct cost of care increased for both treatment groups in the first year of follow-up, by year 2, costs for untreated patients continued to rise while costs for patients on therapy remained stable or declined. The difference-in-differences of medication cost (excluding AOMs) and total health care cost (excluding AOMs) across all 3 obesity classes in year 2 ranged from $1,321 to $1,952 and $1,323 to $2,766, respectively, indicating a cost savings. Total cost of care, inclusive of AOMs, followed a similar trend. CONCLUSIONS: Use of AOMs is associated with the odds of moving to a lower obesity class and a general stabilization or reduction in health care costs in year 2 of follow-up. When considering change in health care costs over time, use of AOMs may be an effective strategy to mitigate the rising health care costs associated with obesity. DISCLOSURES: Dr Toliver is an employee of Novo Nordisk, Inc. Dr Watkins, Dr Kim, and Ms Whitmire were employees of Novo Nordisk at the time the study was conducted. Dr Garvey has served as a volunteer consultant on advisory committees for Jazz Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Pfizer; in each instance, he received no financial compensation, nor was there a financial relationship. He also has served as site principal investigator for clinical trials sponsored by his university and funded by Eli Lilly, Novo Nordisk, Epitomee, and Pfizer. Novo Nordisk funded the study and had a role in the study design, data collection, analysis, and interpretation of data, as well as writing support of the manuscript.

Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology.

OBJECTIVE: To evaluate the association between pharmaceutical industry payments to rheumatologists and their prescribing behaviors. METHODS: A cross-sectional analysis was conducted of Medicare Part B Public Use File, Medicare Part D Public Use File, and Open Payments data for 2013 to 2015. Prescription drugs responsible for 80% of the total Medicare pharmaceutical expenditures in rheumatology were analyzed. We calculated the mean annual drug cost per beneficiary per year, the percentage of rheumatologists who received payments, and the median annual payment per physician per drug per year. Industry payments were categorized as food/beverage and consulting/compensation. Multivariable regression models were used to assess associations between industry payments and both prescribing patterns and prescription drug expenditures. RESULTS: Of 4822 rheumatologists in the Medicare prescribing databases, 3729 received any payment from a pharmaceutical company during this time frame. Food/beverage payments were associated with an increased proportion of prescriptions for the related drugs (range, 1.5% to 4.5%) and an increased proportion of annual Medicare spending for the related drugs (range, 3% to 23%). For every $100 in food/beverage payments, the probability of prescribing increased (range, 1.5% to 14% for most drugs) and Medicare reimbursements increased (range, 6% to 44% for most drugs). Consulting/compensation payments were associated with an increased proportion of prescriptions (range, 1.2% to 1.6%) and an increased proportion of annual Medicare spending (range, 1% to 2%). For every $1000 in consulting/compensation payments, both the probability of prescribing increased (5% or less for most drugs) and Medicare reimbursements increased (less than 10% for most drugs). CONCLUSION: Payments to rheumatologists by pharmaceutical companies are associated with increased probability of prescribing and Medicare spending.

Association of Beneficiary-Level Risk Factors and Hospital-Level Characteristics With Medicare Part B Drug Spending Differences Between 340B and Non-340B Hospitals.

Importance: Critics of the federal 340B Drug Pricing Program raised concerns that the program might provide financial incentives for participating hospitals to prescribe more and/or more expensive drugs because the revenue generated from Medicare reimbursement exceeds the purchase price by a substantial margin. Studies showing higher Medicare Part B drug spending at hospitals that are 340B hospitals, which can purchase outpatient drugs from manufacturers at discounted prices, compared with non-340B hospitals were used by the Centers for Medicare & Medicaid Services to justify their 340B payment policy that reduced Medicare payments for drugs in the 340B program in 2018 and thereafter. The Centers for Medicare & Medicaid Services attributed higher spending to the 340B benefit and believed that payment cuts would reduce the financial incentives associated with higher spending. However, the lack of sufficient risk adjustments is a significant concern of study validity. Objective: To examine whether per-beneficiary Medicare Part B drug spending is significantly different between 340B and non-340B hospitals while adequately controlling for patient-level and hospital-level risk factors. Design, Setting, and Participants: A cross-sectional study was conducted from October 1, 2020, to May 30, 2021, using 2017 administrative claims data from a random 5% sample of Medicare fee-for-service beneficiaries. Included beneficiaries had at least 1 separately payable non-pass-through drug claim in 2017, were fully enrolled in Part A and Part B through 2017, and did not die in 2017. Main Outcomes and Measures: The outcome was separately payable Part B drug spending. Results: The sample included 35 364 beneficiaries (21 825 women [61.7%]; 29 996 White patients [84.8%]; mean [SD] age, 70.6 [12.0] years) and 2446 hospitals. A total of 918 hospitals (37.5%) were in the 340B program and 938 hospitals (38.3%) were teaching hospitals. There was a higher percentage of teaching hospitals among 340B hospitals (517 of 918 [56.3%]) than non-340B hospitals (421 of 1528 [27.6%]), and beneficiaries who went to 340B hospitals were more likely to be non-White than those who went to non-340B hospitals (3360 of 19 139 [17.6%] vs 1583 of 13 710 [11.5%]). The Part B drug spending difference between 340B and non-340B hospitals was not statistically significant after controlling for beneficiary-level risk factors and hospital-level characteristics ($568; 95% CI, -$283 to $1419; P = .19). Conclusions and Relevance: The results show that the differences in patient population and hospital-level characteristics may explain drug spending differences between 340B and non-340B hospitals, which raises doubt about the financial incentive theory of the 340B program drug discount and the justification for the Centers for Medicare & Medicaid Services's 340B payment policy.

Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015.

Importance: Increasing prices of antidiabetic medications in the US have raised substantial concerns about the effects of drug affordability on diabetes care. There has been little rigorous evidence comparing the experiences of patients with diabetes across different types of insurance coverage. Objective: To compare the utilization patterns and costs of prescription drugs to treat diabetes among low-income adults with Medicaid vs those with Marketplace insurance in Colorado during 2014 and 2015. Design, Setting, and Participants: This cross-sectional study included diabetic patients enrolled in Colorado Medicaid and Marketplace plans who were aged 19 to 64 years and had incomes between 75% and 200% of the federal poverty level during 2014 and 2015. Data analysis was conducted from September 2020 to April 2021. Exposures: Health insurance through Colorado Medicaid or Colorado's state-based Marketplace. Main Outcomes and Measures: Primary outcomes were drug utilization (prescription drug fills) and drug costs (total costs and out-of-pocket costs). The secondary outcome was months with an active prescription for noninsulin antidiabetic medications. An all payer claims database was combined with income data, and linear models were used to adjust for clinical and demographic confounders. Results: Of 22 788 diabetic patients included in the study, 20 245 were enrolled in Medicaid and 2543 in a Marketplace plan. Marketplace-eligible individuals were older (mean [SD] age, 52.12 [10.60] vs 47.70 [11.33] years), and Medicaid-eligible individuals were more likely to be female (12 429 [61.4%] vs 1413 [55.6%]). Medicaid-eligible patients were significantly more likely than Marketplace-eligible patients to fill prescriptions for dipeptidyl peptidase 4 inhibitors (adjusted difference, -3.7%; 95% CI, -5.3 to -2.1; P < .001) and sulfonylureas (adjusted difference, -6.6%; 95% CI, -8.9 to -4.3; P < .001). Overall rates of insulin use were similar in the 2 groups (adjusted difference, -2.3%; -5.1 to 0.5; P = .11). Out-of-pocket costs for noninsulin medications were 84.4% to 95.2% lower and total costs were 9.4% to 54.2% lower in Medicaid than in Marketplace plans. Out-of-pocket costs for insulin were 76.7% to 94.7% lower in Medicaid than in Marketplace plans, whereas differences in total insulin costs were mixed. The percentage of months of apparent active medication coverage was similar between the 2 groups for 4 of 5 drug classes examined, with Marketplace-eligible patients having a greater percentage of months than Medicaid-eligible patients for sulfonylureas (adjusted difference, 5.3%; 95% CI, 0.3%-10.4%; P = .04). Conclusions and Relevance: In this cross-sectional study, drug utilization across multiple drug classes was higher and drug costs were significantly lower for adults with diabetes enrolled in Medicaid than for those with subsidized Marketplace plans. Patients with Marketplace coverage had a similar percentage of months with an active prescription as patients with Medicaid coverage.

Medication adherence among patients with advanced prostate cancer using oral therapies.

Aims: In light of the extended overall survival and improved quality of life provided by advanced prostate cancer (PC) oral therapies, this study aimed to describe treatment adherence to advanced PC oral therapies and evaluate associated patient characteristics and subsequent healthcare resource utilization (HRU). Patients & methods: Patients with advanced PC initiating apalutamide, enzalutamide or abiraterone acetate were identified from administrative data (October 1, 2014-September 30, 2019). Adherence and persistence at six months postinitiation were used to evaluate patient factors and HRU. Results: Aged ≥75 years, Black race, chemotherapy use and higher pharmacy paid amounts were associated with poor adherence/persistence, which translated to higher HRU. Conclusions: Strategies to increase adherence and persistence may improve patient outcomes and associated HRU.

Lay abstract This study included 27,262 patients with advanced prostate cancer who started taking one of three oral cancer medications (apalutamide, enzalutamide or abiraterone acetate) between October 2014 and September 2019. Patients who were black, aged 75 years or older, who had chemotherapy or who had higher prescription costs had the most difficulty following dosing guidelines or staying on treatment. Patients who did not follow dosing guidelines required more healthcare services. In light of the extended survival and improved quality of life that oral cancer medication for advanced prostate cancer provides, helping patients to take the correct medication dose, at the right time, and for the recommended length of time may improve their outcomes and reduce medical costs.

Daratumumab utilization and cost analysis among patients with multiple myeloma in a US community oncology setting.

Background: The introduction of daratumumab into the treatment of multiple myeloma has improved outcomes in patients; however, community oncologists often dose more frequently than the US FDA-approved label. Materials and methods: Integra analyzed its database to elucidate daratumumab treatment patterns and the impact of increased utilization on the cost of care for multiple myeloma. Results: Following week 24, 671 (65%) of 1037 patients remained on daratumumab-containing regimens, with 330 patients continuing more frequent treatments than the expected once-every-4-weeks dosing described in the standard dosing schedule. Patients received an average of 14% more daratumumab doses than the FDA-approved label indicates, increasing the 1-year daratumumab costs by an estimated US$31,353. Conclusion: Daratumumab is utilized more frequently than the FDA-recommended dosing, leading to higher multiple myeloma treatment costs.

Lay abstract Since its first approval in 2015, daratumumab has become the backbone of many multiple myeloma treatment regimens. While its approval has improved outcomes in many patients who undergo treatment, it is expensive and has largely contributed to the increasing costs of care in multiple myeloma. In its most common treatment schedule, patients should transition from weekly and biweekly dosing to treatment once every 4 weeks. However, many providers maintain their patients on a more frequent dosing schedule, which increases Medicare 1-year costs by an estimated US$31,353 and may have unforeseen impacts on adverse events and patient outcomes.

Five-year impact of Medicare Part D coverage gap reform on drug expenditures and utilization.

OBJECTIVE: To estimate the impact of the Medicare Part D coverage gap reform under the Affordable Care Act (ACA) on the utilization of and expenditures for prescription drugs within the first five years of the policy's implementation. DATA SOURCES: 2008-2015 Medicare Current Beneficiary Survey (MCBS). STUDY DESIGN: We used a difference-in-differences approach to estimate the year-by-year changes in prescription drug use and expenditures before (2006-2010) and after (2011-2015) the ACA's Part D coverage gap reform between Part D beneficiaries not receiving the Low-Income Subsidy (LIS) and those receiving the LIS. DATA COLLECTION: The study sample included Part D beneficiaries (a) aged 65 years or older; (b) not disabled or having end-stage renal disease; (c) continuously enrolled in a Part D plan (d) having at least one prescription fill in a given year. Survey-reported and administrative Part D events data in the MCBS were used for the analyses. PRINCIPAL FINDINGS: After the ACA reform, annual out-of-pocket drug spending significantly decreased by $88 (P < .01) among non-LIS beneficiaries compared to LIS beneficiaries, with growing decreases over time (average decreases of $41 in 2011, $49 in 2012, $105 in 2013, and $135 in 2015, P < .01 or <.05). Changes in out-of-pocket costs were largely driven by significant decreases among brand-name drugs (overall decrease of $106, P < .01). Despite significantly reduced out-of-pocket spending, there were no significant changes in the overall number of 30-day drug fills and total drug spending; however, changes in the use of brand-name and generic drugs were seen after the ACA (increase of 1.9 fills for brand-name drugs and decrease of 2.3 fills for generic drug in 2015, P < .05). CONCLUSIONS: The ACA coverage gap reform has helped to reduce the out-of-pocket drug cost burden for beneficiaries, although it had no noticeable impact on drug use or total drug spending.

Association of Multiple Hospital Affiliations With Clinician Service Use, Breadth of Procedures, and Costs.

Importance: Little is known about whether a clinician having multiple hospital affiliations (ie, 1 clinician working across multiple teams and organizations) is associated with clinician practice style and cost. The measurement of this association requires adjusting for selection into multihospital affiliations based on both observable and unobservable clinician characteristics. Objective: To evaluate the association of multiple hospital affiliations with clinician service use, breadth of procedures used, and costs. Design, Setting, and Participants: This cohort study used Medicare Part B data from 2016 through 2017 in a fixed-effects panel data design to compare service use, procedure breadth, and costs between clinicians with multiple affiliations (treatment group) and clinicians with a single affiliation (control group), with adjustment for volume, patients, and clinician characteristics. The study also controlled for unobserved (time-invariant) clinician characteristics using individual clinician fixed effects. Clinicians with Medicare claims, a reported National Provider Identifier, and affiliation data within Medicare Physician Compare were included for a total sample of 1 073 252 observations (633 552 unique clinicians) for medical services and 358 669 observations (210 260 unique clinicians) for drug prescribing. Statistical analyses were performed from February 1 to October 15, 2021. Main Outcomes and Measures: Service use is the total number of medical (or drug) services that clinicians render to their Medicare beneficiaries within a given year, procedure breadth is the total number of unique Healthcare Common Procedure Coding System codes that are associated with clinicians' medical (or drug) services within a given year, and costs represent the total standardized amount paid by Medicare for the medical (or drug) services. Additional measures were multiple-hospital affiliations, Accountable Care Organization affiliation, and controls across clinician and patient characteristics. Results: The medical service sample consisted of 633 552 clinicians (248 359 women [39.2%]; mean [SD] of 19.6 [12.5] years of experience), and the drug service sample consisted of 210 260 clinicians (74 875 women [35.6%]; mean [SD] of 21.6 [12.3] years of experience). For medical services, clinicians with multiple practice affiliations used a mean 8.2% (95% CI, 7.5%-8.9%; P < .001) more medical services per patient, drew on a mean 5.4% (95% CI, 5.1%-5.7%; P < .001) wider set of procedures within their medical care, and incurred a mean 8.6% (95% CI, 7.9%-9.2%; P < .001) more in medical costs. Pertaining to drug services, clinicians with multiple practice affiliations used a mean 2.9% (95% CI, 1.9%-3.9%; P < .001) more drug services per patient, drew on a mean 1.0% (95% CI, 0.5%-1.4%; P < .001) wider set of procedures within their medical care, and incurred a mean 2.7% (95% CI, 1.6%-3.7%; P < .001) more in drug costs. Significant results were also found across extensive and intensive margins of hospital affiliation, and supplemental analysis further indicated heterogenous treatment associations across clinician specialties. Conclusions and Relevance: This cohort study found that a clinician having multihospital affiliations was associated with greater service use, procedure breadth, and costs across both medical and drug services. These findings suggest that clinician affiliations ought to be considered as part of health care delivery design and potential cost-containment strategies.

Projected impact of biosimilar substitution policies on drug use and costs in Ontario, Canada: a cross-sectional time series analysis.

BACKGROUND: Several Canadian provinces have introduced reimbursement policies mandating substitution of innovator biologics with lower-cost biosimilars. We estimated the number of patients affected and cost implications if such policy changes were to be implemented in Ontario, Canada. METHODS: We conducted a cross-sectional time series analysis of Ontarians dispensed publicly funded biologics indicated for inflammatory diseases (rheumatic conditions, inflammatory bowel disease: infliximab, etanercept, adalimumab) between January 2018 and December 2019, and forecasted trends to Dec. 31, 2020. The primary source of data was pharmacy claims data for all biologics reimbursed by the public drug program. We modelled the number of patients affected and government expenditures (in nominal Canadian dollars) of several biosimilar policy options, including mandatory nonmedical biosimilar substitution, substitution in new users, introduction of a biosimilar for adalimumab, and price negotiations. In a secondary analysis, we included insulin glargine. RESULTS: In 2018, 14 089 individuals were prescribed a publicly funded biologic for inflammatory diseases. A mandatory nonmedical biosimilar substitution would potentially have affected 7209 patients and saved $238.6 million from 2018 to 2020. A new-user substitution would have affected 757 patients and saved $34.2 million. If an adalimumab biosimilar were to become available, 12 928 patients would be affected by a mandatory nonmedical substitution and the 3-year savings would increase to $645.9 million (all biosimilars priced at 25% of innovator biologics). Finally, an expanded nonmedical substitution policy including insulin glargine would affect 115 895 patients and save $288.7 million (not including adalimumab). INTERPRETATION: Policies designed to curb rising costs of biologics can have substantially different effects on patients and government expenditures. Such analyses warrant careful consideration of the balance between cost savings and effects on patients.

Accessibility of Pharmacist-Prescribed Contraceptives in Utah.

OBJECTIVE: To assess pharmacy participation in and accessibility of pharmacist-prescribed contraception after legislation effective in the state of Utah in 2019. METHODS: A secret-shopper telephone survey was used to assess participation in pharmacist-prescribed contraception. Geospatial analysis was used to map the distribution of participating pharmacies by population characteristics. RESULTS: Of all operating Class A retail pharmacies in Utah, 127 (27%) were providing pharmacist-prescribed contraception 1 year after implementation of the Utah standing order. Oral contraceptive pills were widely accessible (100%); however, other allowed methods were not (vaginal ring 14%; contraceptive patch 2%). Consultation fees and medication costs varied widely. Participating pharmacies were mainly concentrated in population centers. Assuming access to a personal vehicle, urban areas with a high percentage of Hispanic people (Utah's largest minority race or ethnicity group) have access to a participating pharmacy within a 20-minute driving distance. However, access in rural areas with a high percentage Hispanic or other minority were limited. We identified 235 (40%) census tracts with a high proportion of Utah's residents living below the poverty line or of minority race or ethnicity who also had low access to pharmacist-prescribed contraception. CONCLUSIONS: Although the pharmacy-based model is intended to increase access to contraception, practical availability 1 year after the authorization of pharmacist-prescribed contraception in Utah suggests that this service does not adequately serve rural areas, particularly rural areas with a high proportion of minorities and those living below the federal poverty line.

Association of Generic Competition With Price Decreases in Physician-Administered Drugs and Estimated Price Decreases for Biosimilar Competition.

Importance: Price decreases of biologic and biosimilar products in Medicare Part B have been minimal, even with biosimilar competition. Medicare reimburses clinicians for biologics and biosimilars differently than for brand-name and generic drugs, which has generated greater price reductions. Objective: To characterize the nature of price competition among brand-name and generic drugs under Medicare Part B and to estimate the cost savings to the program of subjecting biologic and biosimilar therapies to a similar price competition. Design, Setting, and Participants: This cohort study analyzed all brand-name drugs and their approved generic versions as well as biologics and biosimilars that were reimbursed under Medicare Part B from quarter 1 of 2005 to quarter 2 of 2021. Two separate data sets were created: brand-name and generic drugs as well as biologics and biosimilars data sets. Brand-name products with generic versions that were introduced before 2005 were excluded, and so were vaccines. Exposures: Number of generic and biosimilar competitors over time. Main Outcomes and Measures: Price change as a percentage of the brand-name drug or biologic price in the quarter before generic or biosimilar competition. Price change was modeled using a linear, fixed-effects time series regression, with the number of generic or biosimilar competitors as the main covariate. Time was expressed as the number of quarters since the first generic or biosimilar competitor entered the market. Savings were estimated by projecting the regression model of brand-name and generic drug competition to observed biologic and biosimilar competition and by applying the estimated price reduction to actual Medicare spending for those products from 2015 to 2019. Results: Of the 988 Healthcare Common Procedure Coding System codes identified, 50 (5.0%) met the inclusion criteria for the brand-name and generic drug data set and 28 (2.8%) met the criteria for the biologic and biosimilar data set. The first generic competitor was associated with reduced drug prices by 17.0%, the second competitor with a 39.5% decrease, the third competitor with a 52.5% decrease, and the fourth and more competitors with a 70.2% decrease (price decline was measured from brand-name drug price before the first generic competitor rather than from price established with fewer competitors). If biologics and biosimilars were subject to the same Medicare reimbursement framework as brand-name and generic drugs, Medicare spending on these products was estimated to have been 26.6% lower ($1.6 billion) from 2015 to 2019. Conclusions and Relevance: This study found minimal uptake of biosimilars and limited price reductions for biologics and biosimilars under the current Medicare Part B reimbursement policy. Adopting the bundled biosimilar reimbursement structure for biologic and biosimilar therapies may be associated with substantial savings and encourage greater biosimilar market entry.

Trends in Use and Expenditures for Brand-name Statins After Introduction of Generic Statins in the US, 2002-2018.

Importance: The high and increasing expenditures for prescription medications in the US is a national problem. Objective: To explore the association of generic statin competition on relevant use and cost savings and to provide use and expenditure trends for all available statins for private and public payers and for out-of-pocket spending. Design, Setting, and Participants: This survey study evaluated data from the January 1, 2002, to December 31, 2018, Medical Expenditure Panel Survey by using a difference-in-differences analysis. Participants included noninstitutionalized individual statin users. Data were analyzed from November 1, 2020, to March 30, 2021. Exposures: The market entry of 5 generic statin medications (atorvastatin, rosuvastatin, simvastatin, lovastatin, and pravastatin). Main Outcomes and Measures: National- and individual-level reductions in the annual number of statin purchases and total expenditures across private insurance, public insurance (Medicaid and Medicare), and out-of-pocket spending (presented in 2018 US dollars). Results: Between January 1, 2002, and December 31, 2018, an average of 21.35 million statins (95% CI, 16.7-25.5 million) were purchased annually, with an average total annual cost of $24.5 billion (95% CI, $18.2-$28.8 billion). The number of brand-name statin purchases decreased by 90.9% (95% CI, 56%-98%) nationally and 27.4% (95% CI, 13%-40%) individually after the end of market exclusivity. Among major payers, the end of market exclusivity was associated with individual cost savings of $370.00 (95% CI, $430.70-$309.20) for private insurers, $281.00 (95% CI, $346.80-$215.30) for Medicare, $72.34 (95% CI, $95.22-$49.46) for Medicaid, and $211.90 (95% CI, $231.20-$192.50) for out-of-pocket spending. Combining all payers, the decrease translates to $925.60 (95% CI, $1005.00-$846.40) of annual savings per individual and $11.9 billion (95% CI, $10.9-$13.0 billion) for the US. Conclusions and Relevance: Results of this survey study suggest that full generic competition of statins was associated with significant cost savings across all major payers within the US health care system.