A primer on quality measurement and reporting in pharmacy benefit plans.

Pharmacy benefit plans in the United States are evaluated on quality measures and other requirements of the government and accrediting organizations. This primer describes the roles of key organizations involved in measuring and reporting quality in pharmacy benefit plans and explains the methods that pharmacy benefit plans use to promote quality of medication use.

Pharmacy Benefit Managers in the Eye of the Storm: Growing Multipartite Scrutiny.

The high cost of prescription drugs in the U.S. remains an ongoing national challenge. A recurring focal point in discussions over this distressing steady state is the role(s) played by Pharmacy Benefit Managers (PBMs) who negotiate drug prices with pharmaceutical manufacturers, conduct drug utilization reviews, engage in disease management, and see to formulary creation. At their inception, the multiple newly established PBMs were arguably intent on constraining the rise of prescription drug prices. At the time of this writing, however, the lion share of a far less competitive PBM market is controlled by CVS Caremark, Express Scripts, and OptumRx. It is this evolving reality which could be interpreted to mean that the PBMs may have become part of the problem, rather than part of the solution. Expanded scrutiny of the PBMs by Federal and State authorities as well as by Professional Medical Associations must not be delayed with an eye toward affording the public with relief from the high cost of prescription drugs.

Pharmacy Benefit Managers: History, Business Practices, Economics, and Policy.

Importance: Pharmacy benefit managers (PBMs) play a major role in the provision of pharmacy services by acting as intermediaries between pharmacies, plan sponsors (insurance companies and employers), pharmaceutical manufacturers, and drug wholesalers. As their role and visibility have increased, PBMs have come under increased scrutiny from policymakers. However, no prior literature has systematically described the history, business practices, and policymaking of PBMs. Objective: To provide an overview of the PBM industry, including its history, the evolution of services provided by PBMs, an assessment of the current policy landscape, and analysis of how proposed policies could affect PBM practices and patient care. Evidence: This work reviews historical events; previous and current industry practices and publications; prior academic literature, existing statutes, regulations, and court cases; and recent legislative reforms and agency actions regarding PBMs. Findings: Pharmacy benefit managers evolved in parallel with the pharmaceutical manufacturing and health insurance industries. The evolution of the PBM industry has been characterized by horizontal and vertical integration and market concentration. The PBM provides 5 key functions: formulary design, utilization management, price negotiation, pharmacy network formation, and mail order pharmacy services. Criticism of the PBM industry centers around the lack of competition, pricing, agency problems, and lack of transparency. Legislation to address these concerns has been introduced at the state and federal levels, but the potential for these policies to address concerns about PBMs is unknown and may be eclipsed by private sector responses. Conclusions and Relevance: Pharmacy benefit managers are intermediaries in the pharmaceutical supply chain and perform multiple roles in the management and distribution of pharmaceuticals to patients. When regulating PBMs, it is important to adopt policies that address market failure problems by improving PBM competition as opposed to policies designed to serve the narrow financial interests of other market participants (eg, pharmacies, pharmaceutical manufacturers) without meeting the needs of consumers.

¿Recomendar la frecuencia de administración de medicamentos en la prescripción electrónica mejora su adecuación? Estudio antes-después / Does recommending the dosing frequency in the electronic prescription improve its adequacy? Before and after study

Objetivo: Analizar si informar la frecuencia de administración (FA) en el módulo de prescripción de la estación clínica de atención primaria (ECAP) del Institut Català de la Salut (ICS) mejora la adecuación de la FA de las prescripciones. Diseño: Estudio de adecuación antes-después con control no equivalente de prescripciones sin cambios en la FA. El periodo de estudio incluye desde el 1 de septiembre de 2019 hasta el 29 de febrero de 2020.Emplazamiento: Ámbito de atención primaria. Participantes: Se incluyen las prescripciones de los medicamentos con una única FA adecuada o mayoritariamente adecuada realizadas por los médicos de familia del ICS durante el periodo de estudio.IntervenciónRecomendar la FA adecuada en el módulo de prescripción. Mediciones principales: Adecuación definida como la coincidencia entre la FA prescrita y la FA adecuada. Resultados: Tras la intervención se produjo un aumento del 22,75% de prescripciones con FA adecuada. El mayor aumento se dio en los medicamentos del sistema genitourinario y hormonas sexuales. En términos absolutos, el grupo de antiinfecciosos es el que obtuvo más prescripciones con FA adecuada entre los dos periodos. Conclusiones: La intervención aumentó la adecuación en la FA de las prescripciones, lo que supone una mejora en la seguridad y en la eficacia de los tratamientos. Se evidencia que el diseño y la implantación de mejoras en los sistemas de prescripción electrónica contribuye a aumentar la calidad de la prescripción.(AU)

Objective: To assess whether reporting the dosing frequency into the prescription module of the Institut Català de la Salut (ICS) primary care electronic clinical workstation improves the dosing frequency's adequacy of the prescriptions. Design: Before and after study with non-equivalent control of prescriptions without any change in the dosing frequency. The study periods includes from September 1st, 2019 to February 29th, 2020.Location: Primary care setting. Participants: Prescriptions issued by ICS General Practitioner, during the study period of those medicines which indications have a single appropriate dosing frequency or mostly appropriate, are included.Intervention: Recommendation of the appropriate dosing frequency in the prescription module. Main measurements: Adequacy defined as the coincidence between the prescribed dosing frequency and the appropriate dosing frequency. Results: After the intervention there was a 22.75% increase in prescriptions with adequate dosing frequency. The largest increase occurred in the medicines for the genitourinary system and sex hormones. In absolute terms, the group of anti infective for systemic use is the one that obtained more prescriptions with an adequate dosing frequency between the two periods. Conclusions: The intervention increased the dosing frequency's adequacy leading to improvements in the safety and effectiveness of the treatments. It is evident that the design and implementation of improvements in electronic prescription systems contributes to increasing the quality of the prescription.(AU)

The impact of prescription drug insurance on cost related non-adherence to medications in Canada: A Heckman sample selection approach.

Unlike some other high-income counties, Canada does not provide universal prescription drug coverage. The various extent of coverage may left some Canadians vulnerable to cost-related non-adherence (CRNA) to medications. Using data from the 2015 national cycle of the Canadian Community Health Survey, we examine the impact of having private and public drug coverage on mitigating the risk of CRNA with a logit model and a Heckman selection model. CRNA was only observed in respondents who had prescriptions to fill, and respondents did not randomly make decisions on whether to get a prescription. This results in a classic sample selection problem. We found a higher estimated probability of reporting CRNA for uninsured respondents from the Heckman selection model than from the logit model. Respondents with government coverage only had a slightly higher probability of reporting CRNA relative to respondents with private coverage. These findings suggest that, without accounting for sample selection, the risk of not having drug insurance coverage is likely to be underestimated. Moreover, despite covering a less healthy cohort of respondents, the government insurance plans reduce risk of CRNA to a comparable level with private insurance.

Examining the case for direct contracting: A multistakeholder case study.

BACKGROUND: Employers and pharmacies are challenged by a complex system for prescription payment. Cost plus direct contracts for prescriptions and bundled services may yield benefits. OBJECTIVES: This study aimed to (1) explore direct contracting using multistakeholder interviews, (2) compare employer costs and employee copays for 6 months of prescription charges under their pharmacy benefit manager (PBM) with projected costs under a pharmacy direct contract, (3) project pharmacy revenue, costs, and net profit had these prescriptions been processed through the direct contract, and (4) assess employee satisfaction under the direct contract. METHODS: Semistructured stakeholder interviews were recorded transcribed and analyzed to identify different perspectives on direct contracting. Employer PBM invoices for 412 employee prescriptions over 6 months were analyzed to calculate employer and employee costs and reanalyzed for the invoice cost plus $12 professional fee direct contract. For the pharmacy financial analysis projection, invoice costs and a $9.82 cost of dispensing were subtracted from total revenue to yield an estimated profit had the parties been under the arrangement. A 34-item satisfaction survey was mailed using a 4-contact design with cash incentives to the 20 employees serviced by the direct contract that were analyzed descriptively. RESULTS: Eight stakeholder interviews described the benefits and potential challenges of such direct contracts. The financial analysis suggested the employer costs would be $5664 lower and employee copays would have been $1918 lower had all prescriptions been paid using the direct contract. The estimated profit for the pharmacy was projected at $899. Survey respondents were generally satisfied with the direct contract, but few used the bundled services. CONCLUSION: The direct contract may be financially beneficial for all parties. It also may offer more transparent pricing that may be desirable for the employer and pharmacy. Greater uptake of bundled services may increase the value to the employer.

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.

Universal cash transfers and prescription utilization: Evidence from the Alaska permanent fund dividend.

We investigate the impact of a large cash transfer on prescription utilization. Our identification strategy leverages the Alaksa Permanent Fund Dividend (PFD), which is distributed annually in October and comprises 6% of the average household's annual income. We study the impact of the PFD on the use of prescription medications using a within-Alaska comparison group and difference-in-differences design. Using the IBM MarketScan Commercial Claims and Encounters Prescription Drug Database, we observe prescriptions for 50,866 commercially-insured individuals who filled prescriptions between 2013 and 2019. We find no changes in prescription use overall and are able to rule out changes larger than 0.5% in the week of the PFD and 1.4% the week after. Subgroup analyses find no changes by patient characteristics, degree of cost sharing, or prescription type. We also conduct a synthetic control analysis using a non-Alaska comparison group and find no effects of the PFD on prescriptions. These findings are useful for understanding liquidity sensitivity for prescription medication and the effects of cash distributions among individuals with employer-based health insurance.

The impact of a mandatory universal drug insurance program on health behaviors and outcomes.

This paper investigates the effects of a mandatory, universal prescription drug insurance policy on health behaviors and outcomes within a public health care system providing physician and hospital services free of charge. Using Canadian longitudinal data, we show that the reform improved individuals' general health while reducing body mass index and smoking. However, the program also increased drinking and had no significant impact on mental health, physical activity, or preventive care. We also examine the mechanisms through which these effects can play a role, as well as the heterogeneous effects. Estimates suggest that the policy decreased SES-based disparities in health.

Patterns of Manufacturer Coupon Use for Prescription Drugs in the US, 2017-2019.

Importance: Although manufacturer-sponsored coupons are commonly used, little is known about how patients use them within a treatment episode. Objectives: To examine when and how frequently patients use manufacturer coupons during a treatment episode for a chronic condition, and to characterize factors associated with more frequent use. Design, Setting, and Participants: This is a retrospective cohort study of a 5% nationally representative sample of anonymized longitudinal retail pharmacy claims data from October 1, 2017, to September 30, 2019, obtained from IQVIA's Formulary Impact Analyzer. The data were analyzed from September to December 2022. Patients with new treatment episodes using at least 1 manufacturer coupon over a 12-month period were identified. This study focused on patients with 3 or more fills for a given drug and characterized the association of the outcomes of interest with patient, drug, and drug class characteristics. Main Outcomes and Measures: The primary outcomes were (1) the frequency of coupon use, measured as the proportion of prescription fills accompanied by manufacturer coupon within the treatment episode, and (2) the timing of first coupon use relative to the first prescription fill within the treatment episode. Results: A total of 36 951 treatment episodes accounted for 238 474 drug claims and 35 352 unique patients (mean [SD] age, 48.1 [18.2] years; 17 676 women [50.0%]). Among these episodes, nearly all instances (35 103 episodes [95.0%]) of first coupon use occurred within the first 4 prescription fills. Approximately two-thirds of treatment episodes (24 351 episodes [65.9%]) used a coupon for the incident fill. Coupons were used for a median (IQR) of 3 (2-6) fills. The median (IQR) proportion of fills with a coupon was 70.0% (33.3%-100.0%), and many patients discontinued the drug after the last coupon. After adjustment for covariates, there was no significant association between an individual's out-of-pocket costs or neighborhood-level income and the frequency of coupon use. The estimated proportion of fills with a coupon was greater for products in competitive (19.5% increase; 95% CI, 2.1%-36.9%) or oligopolistic (14.5% increase; 95% CI, 3.5%-25.6%) markets than monopoly markets when there is only 1 drug in the therapeutic class. Conclusions and Relevance: In this retrospective cohort analysis of individuals receiving pharmaceutical treatment for chronic diseases, the frequency of manufacturer-sponsored drug coupon use was associated with the degree of market competition, rather than patients' out-of-pocket costs.

The New Congress and Pharmacy Benefit Manager Reform: Will the Insurers Escape Again?

The Pharmacy Benefit Management industry is one which seems to attract bipartisan scorn, similar to the pharmaceutical manufacturers. Despite widespread criticism for many years, the manufacturers were finally presented with a big setback with the passage of the Inflation Reduction Act, which included a provision to require price negotiation in Medicare for prescription drugs. The provision does not go into effect until 2026, giving manufacturers time to escape-if they are able.

The Associations of Prescription Drug Insurance and Cost-Sharing With Drug Use, Health Services Use, and Health: A Systematic Review of Canadian Studies.

OBJECTIVES: In Canada, public insurance for physician and hospital services, without cost-sharing, is provided to all residents. Outpatient prescription drug coverage, however, is provided through a patchwork system of public and private plans, often with substantial cost-sharing, which leaves many underinsured or uninsured. METHODS: We conducted a systematic review to examine the association of drug insurance and cost-sharing with drug use, health services use, and health in Canada. We searched 4 electronic databases, 2 grey literature databases, 5 specialty journals, and 2 working paper repositories. At least 2 reviewers independently screened articles for inclusion, extracted characteristics, and assessed risk of bias. RESULTS: The expansion of drug insurance was associated with increases in drug use, individuals who reported drug insurance generally reported higher drug use, and increases in and higher levels of drug cost-sharing were associated with lower drug use. Although a number of studies found statistically significant associations between drug insurance or cost-sharing and health services use, the magnitudes of these associations were generally fairly small. Among 5 studies that examined the association of drug insurance and cost-sharing with health outcomes, 1 found a statistically significant and clinically meaningful association. We did not find that socioeconomic status or sex were effect modifiers; there was some evidence that health modified the association between drug insurance and cost-sharing and drug use. CONCLUSIONS: Increased cost-sharing is likely to reduce drug use. Universal pharmacare without cost-sharing may reduce inequities because it would likely increase drug use among lower-income populations relative to higher-income populations.