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The state of Durango has long been a centre of Mexican heroin production and an important node in transnational drug trafficking networks. As early as 1944, it was the site of one of the biggest drug busts in Mexican history, when an opium poppy plantation the size of 325 football pitches, irrigated by a purpose-built aqueduct, was discovered in the state's northern mountains. By the mid 1970s, a combination of kinship ties and concrete connected these poppy fields directly with the US drug market hub of Chicago, Illinois, along a route known as the 'heroin highway', which helped Mexico become the supplier of 90 per cent of US heroin. But how did a poor, underpopulated and overwhelmingly rural state become a major player in the billion-dollar US–Mexican drug trade? This article shows that in Durango, the rise of heroin production and trafficking were integral aspects of local processes of social, political and economic modernization. Stimulated by the Mexican and US governments' promotion of infrastructural improvements and mass migration, and protected by representatives of Mexico's post-revolutionary political system, the drug trade in turn fuelled further 'licit' economic development, making it part of the very foundation of Mexico as we know it today. [ABSTRACT FROM AUTHOR]

This cross-sectional study included a nationally representative sample of U.S. adults aged ≥50 years with self-reported pain in the past 4 weeks from the 2018 Medical Expenditure Panel Survey. Adjusted linear regression analyses accounted for the complex survey design and assessed differences in several types of annual health care expenditures between individuals who reported frequent exercise (≥30 min of moderate–vigorous intensity physical activity ≥5 times per week) and those who did not. Approximately 23,940,144 of 56,979,267 older U.S. adults with pain reported frequent exercise. In adjusted analyses, individuals who reported frequent exercise had 15% lower annual prescription medication expenditures compared with those who did not report frequent exercise (p =.007). There were no statistical differences between frequent exercise status for other health care expenditure types (p >.05). In conclusion, adjusted annual prescription medication expenditures were 15% lower among older U.S. adults with pain who reported frequent exercise versus those who did not. [ABSTRACT FROM AUTHOR]

Objective: The personal importation scheme is a legislative mechanism that allows health consumers to import unapproved medicines under certain conditions. This article analyses the legal and policy basis for the scheme and considers how reforms to advertising laws for therapeutic goods may restrict communications about it. The article represents the first published analysis of the personal importation scheme's interaction with the communications of health professionals and buyer's clubs. It considers how these communications may be affected by legal amendments, particularly where unapproved medicines may be accessed through the scheme. Methods: An examination of Australian therapeutic goods law concerning the personal importation scheme was conducted, including both the historical law and recent regulatory reforms. Illustrative tables were prepared to identify scheme-related advertising that may contravene therapeutic goods law. Risk estimates were allocated to several new legal rules to indicate whether health professionals or buyer's clubs would contravene these laws when promoting the scheme to health consumers for unapproved medicines. Results: Representations made directly to the public by health practitioners or on buyer's clubs websites about accessing unapproved therapeutic goods through the personal importation scheme are likely to contravene one or more advertising laws. Conclusions: The Therapeutic Goods Administration has very strong powers to initiate compliance or enforcement action for advertising breaches in Australia for many promotional practices. Arguably, in the age of the internet and in the context of emerging expensive medicines, these powers should not be used to restrict health practitioners or buyer's clubs from sharing information about the lawful personal importation scheme to health consumers in need. Nevertheless, the study finds that health practitioners who promote or refer to the availability of unapproved medicines through the personal importation scheme outside of a consultation are likely to contravene the law and may be subject to disciplinary or enforcement action. What is known about the topic?. The personal importation scheme has not been studied extensively. This paper investigates whether recent updates to the advertising laws will affect the operation of the personal importation scheme and health practitioners' ability to refer to it in public. What does this paper add? This paper represents the first ever analysis of the way in which the personal importation scheme interacts with health practitioners' statements, buyer's clubs, and the internet. What are the implications for practitioners ? The study finds that health practitioners who promote the availability of unapproved medicines through the personal importation scheme outside professional consultations are likely to be liable to enforcement action from the Therapeutic Goods Administration. [ABSTRACT FROM AUTHOR]

Purpose: Medications that require prior authorization can complicate the discharge planning process. This study implemented and evaluated a process for identifying and completing prior authorizations during the inpatient setting prior to patient discharge. Methods: A patient identification tool was developed within the electronic health record to alert the patient care resource manager of inpatient orders for targeted medications that frequently require prior authorization with the potential to delay discharge. A workflow process using the identification tool and flowsheet documentation was developed to prompt the initiation of a prior authorization, if necessary. Following hospital-wide implementation, descriptive data for a 2-month period was collected. Results: The tool detected 1353 medications for 1096 patient encounters over the 2-month period. The most frequent medications identified included apixaban (28.1%), enoxaparin (14.4%), sacubitril/valsartan (6.4%), and darbepoetin (6.4%). For the medications identified, there were 93 medications documented in the flowsheet data for 91 unique patient encounters. Of the 93 medications documented, 30% did not require prior authorization, 29% had prior authorization started, 10% were for patients discharged to a facility, 3% were for home medications, 3% were medications discontinued at discharge, 1% had prior authorization denied, and 24% had missing data. The most frequent medications documented in the flowsheet included apixaban (12%), enoxaparin (10%), and rifaximin (20%). Of the 28 prior authorizations processed, 2 led to a referral to the Medication Assistance Program. Conclusion: The implementation of an identification tool and documentation process can help improve PA workflow and discharge care coordination. [ABSTRACT FROM AUTHOR]

The article enumerates the available treatments for Alzheimer's disease, including when they were approved by the U.S. Food and Drug Administration (FDA), their effects, and how much they cost to patients. These include the Aducanumab (Aduhelm) that received approval in June 2021, the monoclonal antibody Lecanemab which was approved under the FDA's accelerated pathway based on phase 2 trial data, and the Donepezil (Aricept) which was approved by the FDA in 1996.

Purpose Inadequate hospital antidote inventory is a widely documented international issue due to high medication costs, lack of emphasis on antidote importance, variable international standards, hospital size, and drug availability. A large health system underwent process and policy implementation for antidote stocking, availability tracking, and administration strategies to ensure appropriate inventory and improve patient safety. Summary Process and policy implementation occurred over a 12-month period across the health system's 11 acute care hospitals with emergency department services. Opportunities for optimization were identified following data capture surrounding institution-specific antidote inventory and usage across the health system. Specifically, minimum par levels at each institution were determined from 2018 expert recommendations for both the central pharmacy and automated dispensing machines within the emergency department. These quantities ensured the availability of an antidote within a specific timeframe contingent on the acquisition acuity for at least one 100-kg patient. Entries for order sets, order statements, and smart pump drug libraries were modified or formulated to facilitate standardized practices and minimize safety errors before a system-wide electronic health record transition. Conclusion It is prudent for all institutions, independent or within a health system, to identify areas of improvement for antidote inventory and management. Implementation of a similar process for antidote stocking, sharing, and delivery at other institutions is feasible and necessary to mitigate issues with drug acquisition and timely administration. [ABSTRACT FROM AUTHOR]

Purpose. To investigate the changes of the types and daily costs of topical antiglaucoma medications from 2006 to 2021 in China, providing evidence for optimizing treatment regimen and medical insurance policy. Methods. The types of topical antiglaucoma drugs except complementary and traditional medicines and associated price information were collected from the largest pharmaceutical database in China (YAOZH database). The daily costs of each drug, the average income level, and the daily cost of topical antiglaucoma medications relative with daily disposable income were calculated and compared between 2006 and 2021. Results. The options of topical antiglaucoma drugs increased remarkably to 32 types in 2021, of which prostaglandin analogs comprised the largest proportion (31.25%). There were 10 types of the same brand drugs available in 2006 and 2021, the mean daily cost of which decreased from $0.39 ± 0.30 to $0.28 ± 0.23 (p < 0.001). As the average daily disposable income of Chinese residents grew greatly, the proportion of the daily cost of topical antiglaucoma medications in daily disposable income in 2021 declined significantly from 32.52% to 5.78% (all the drugs, p < 0.001) and 3.94% (without unit dose package, p < 0.001) in rural areas and from 9.95% to 2.31% (all the drugs, p < 0.001) and 1.57% (without unit dose package, p < 0.001) in urban areas. Conclusions. Topical antiglaucoma medications available become much more abundant in China. With the increase of residents' disposable income and reduction of daily costs of topical antiglaucoma medications, the drug treatment for glaucoma becomes more affordable both in rural and urban areas. [ABSTRACT FROM AUTHOR]

Introduction: Lifestyle modification through incorporation of exercise training could improve metabolic syndrome (MetS) clinical components (hypertension, dyslipidemia, hyperglycemia, and visceral abdominal obesity). We aimed to assess if long-term exercise training could restrain the increased pharmacological cost of the clinical management of the MetS. Methods: Medicine cost during a 5-yr-long randomized controlled exercise intervention trial was analyzed. After a per-protocol analysis, a group of 64 individuals 53 ± 2 yr old, with overweight (body mass index, 33.4 ± 0.9 kg·m−2) and MetS (3.6 ± 0.2 factors) were randomized to a training (4 months·yr−1 for 5 yr; EXERCISE, n = 25) or to a control group (CONTROL, n = 26). Subjects were studied on three occasions during the 5-yr follow-up. Participants continued their routine medication managed by their general practitioner. The main outcome is the 5-yr evolution of medication cost to treat MetS (hyperglycemia, hypertension, and hyperlipidemia). A secondary outcome is the benefit–cost ratio of the exercise intervention. Results: In CONTROL, medicine cost increased 160% from baseline (P < 0.001), whereas in EXERCISE, it remained unchanged (33%; P = 0.25). After the 5-yr follow-up, medicine use was 60% and medicine cost 74% higher in CONTROL than EXERCISE (P < 0.05 in both cases). However, MetS z score was similarly reduced over time in both groups (P = 0.244 for group–time interaction). The number of prescribed medications increased after 5 yr in CONTROL (89%; P < 0.001), whereas it remained stable with yearly training (17%; P = 0.72 in EXERCISE). Ten-year atherosclerotic cardiovascular disease risk estimation increased only in CONTROL (15%; P = 0.05 for group–time interaction). The benefit in medicine savings (€153 per year and patient) triplicated the estimated cost (€50.8 per year and patient) of the exercise intervention. Conclusions: A 5-yr-long supervised exercise training program in middle-age individuals with MetS prevents the need for increasing medicine use. The savings in pharmacological therapy outweighs the estimated costs of implementing the exercise program. [ABSTRACT FROM AUTHOR]

This systematic study aims at analyzing the differences between the approach of the European healthcare systems to the pharmaceutical market and the American one. This paper highlights the opportunities and the limitations given by the application of managed entry agreements (MEAs) in European countries as opposed to the American market, which does not regulate pharmaceutical prices. Data were collected from the Organisation for Economic Co-operation and Development (OECD), the European Medicines Agency, and the national healthcare agencies of US and European countries. A literature review was undertaken in PubMed, Scopus, MEDLINE, and Google for a period ten years (2010–2019). The period 2020–2021 was considered to compare health expenditure before and after the SARS-CoV-2 pandemic. Scarce information from national agencies has been given in terms of MEAs related to the COVID-19 pandemic. The comparison between the United States approach and the European one shows the importance of a market access regulation to reduce the cost of therapies, increasing the efficiency of national healthcare systems and the advantages in terms of quality and accessibility to the final users: patients. Nevertheless, it seems that the golden age of MEAs for Europe was during the examined period. Except for Italy, countries will move to other forms of reimbursements to obtain higher benefits, reducing the costs of an inefficient implementation and outcomes in the medium term. [ABSTRACT FROM AUTHOR]

Background: In patients with pulmonary arterial hypertension (PAH), the use of disease-specific therapies (i.e., endothelin receptor antagonists, phosphodiesterase type-5 inhibitors, soluble guanylate cyclase stimulators, prostacyclins, and prostanoids) has been associated with disease improvement and decreased mortality risk. We aimed to quantify the adherence and discontinuation rates for patients prescribed PAH-specific therapies. Methods: We performed a systematic review via searching MEDLINE, EMBASE, and the Cochrane Library from their inception to 4 March 2022 for observational studies published in English that reported data on adherence to and persistence with PAH-targeted therapies. Random-effects meta-analysis was performed to explore average adherence and discontinuation rates. Results: In all, 14 studies involving 14,861 individuals prescribed PAH-targeted therapies were included. The overall pooled proportion of patients adherent to their PAH-targeted medications was 60.9% (95% confidence interval [CI] 52.3–69.1%). The pooled proportions of patients adherent in questionnaire-based studies and in studies using prescription/dispensing data were 52.9% (95% CI 48.9–56.9%) and 62.9% (95% CI 53.1–72.2%), respectively. The pooled proportion of patients who discontinued their PAH-targeted medications was 42.3% (95% CI 31.6–53.3). Factors reported to impact adherence included administration frequency, length of time on treatment, co-payment, and occurrence of adverse events. Conclusions: In the real world, a considerable proportion of patients prescribed PAH-specific therapies were non-adherent or discontinued. As diverse factors may influence treatment adherence, multifaceted interventions are needed to address this trend in order to improve patient outcomes. Registration: The systematic review protocol was registered in the PROSPERO database (CRD42022316638). [ABSTRACT FROM AUTHOR]

This study evaluated the early drug prescription patterns as predictors of final workers compensation claim costs and closure based on an updated analysis on a large cohort. The result would provide claim management with tools to estimate final claims outcomes in the first 3- or 6-months post-injury. Objective: The aim of the study is to determine the associations of workers' compensation claim costs and return to work with drugs prescribed for early symptom management. Methods: Claims filed from 1998 to 2007 were followed for 10 years from the injury date. Drugs analyzed included gabapentin, pregabalin, antipsychotics, antidepressants, sedatives, benzodiazepines, carisoprodol, and opioids, controlling for initial reserve, sex, age, physical therapy, attorney involvement, and surgery. Results: Gabapentin, antipsychotics, antidepressants, and sedatives used in the first 3 months after injury were significantly associated with higher claim cost (≥$100,000). All opioid morphine equivalent doses greater than or equal to 5 mg/d for the first 6 months was significantly associated with higher cost (≥$100,000) and not being released to work at end of third year after injury with dose-response relationships. Conclusions: Prescription patterns in the first 3 months or first 6 months of workers' compensation claim development may be used as predictors of claim outcomes. [ABSTRACT FROM AUTHOR]

Assessing opioid prescription patterns is key to understanding the opioid crisis. Some researchers have suggested that work and workplace issues are not adequately represented in efforts to reduce the opioid crisis. This paper addresses this concern by comparing opioid prescription patterns of occupational injury-caused conditions to other injury-caused conditions. Objectives: This study aimed to compare opioid prescription incidence, supply days, and cost associated with occupational injury and other injury-caused conditions. Methods: We used Medical Expenditure Panel Survey (MEPS) data for 2010–2019. The MEPS provides information on medical conditions and associated medical encounters, treatments, and treatment costs, as well as demographic, education, health, working status, income, and insurance coverage information. We used descriptive statistics and logistic and 2-part regressions. Results: Controlling for covariates and compared with other injury-caused conditions, occupational injury–caused conditions resulted in 33% higher odds of opioid prescribing, 32.8 more opioid prescription supply days, and $134 higher average cost. Conclusions: Occupational injuries were associated with higher opioid incidence and costs, and more opioid supply days. These findings point to the need to focus on making work safer and the role employers may play in supporting worker recovery from injury and opioid use disorders. [ABSTRACT FROM AUTHOR]

New research and a government investigation have shed light on an anticompetitive practice called "Product Hopping" and specifically how it was employed in the case of the multiple sclerosis treatment glatiramer acetate beginning in 2014, which cost payers billions of dollars. We examine this case as well as a separate, impending instance of product hopping. [ABSTRACT FROM AUTHOR]

Thailand's antimicrobial stewardship strategy has focussed on promoting 'rational drug use' in the public sector, to reduce the threat of drug resistance and control healthcare expenditure. The strategy's next ambition is to attend to the private sector, where antibiotics are widely available over the counter without prescription. Using ethnographic and survey data, this paper follows antibiotics through community pharmacies, to explore drug distribution and access, and identify potential challenges for stewardship. We extend the analytical frame beyond 'irrational' dispenser-customer transactions, to explore the logics of practice of a multiplicity of actors in the context of a highly competitive pharmaceutical market. Highlighting the role of the pharmaceutical industry in mystifying medicines, we show how antibiotics are collapsed into a category of 'strong medicines' and requested by customers using 'prescriptions by proxy'. We further examine how Thailand's drug regulation and classificatory systems, historically orientated around access to medicines, enable the proliferation of antibiotics in the context of contemporary efforts to control distribution. Recognising the negotiations involved in dispensing antibiotics in a pluralistic health system, we attempt to reconfigure allocations of responsibility, advocating for stewardship approaches that take into account local ecologies of care, as well as implications for access, equity, and accountability. [ABSTRACT FROM AUTHOR]

Consumer cost sharing is widely employed by payers in the United States in an effort to control spending. Most cost-sharing strategies set patient contributions on the basis of costs incurred by payers and often do not consider medical necessity as a coverage criterion. Available evidence suggests that increases in cost sharing worsen health disparities and adversely affect patient-centered outcomes, particularly among economically vulnerable individuals, people of color, and those with chronic conditions. A key question has been how to better engage consumers while balancing appropriate access to essential services with increasing fiscal pressures. Value-based insurance design (VBID) is a promising approach designed to improve desired clinical and financial outcomes, in which out-of-pocket costs are based on the potential for clinical benefit, taking into consideration the patient's clinical condition. For more than two decades, broad multi stakeholder support and multiple federal policy initiatives have led to the implementation of VBID programs that enhance access to vital preventive and chronic disease medications for millions of Americans. A robust evidence base shows that when financial barriers to essential medications are reduced, increased adherence results, leading to improved patient-centered outcomes, reduced health care disparities, and in some (but not most) instances, lower total medical expenditures. [ABSTRACT FROM AUTHOR]

The article addresses the debates over regulating the pharmaceutical industry and managing spending on drugs. Topics discussed include development of COVID-19 vaccines, the need for governments to invest in and negotiate prices for therapies that benefit the public, and problems relating to the cost of and access to prescription drugs.

International reference prices (IRP), also called external reference prices, are widely used across developed nations. IRP uses the prices paid in other countries to either inform negotiations with the pharmaceutical industry or as a cap on market prices. The authors review the application of IRP to cap the prices of negotiated outcomes in the context of US proposals for changing the way prescription drug prices are established for the Medicare program. They examine the economic, political, and administrative issues associated with the use of IRP, and they summarize the evidence on the impacts of IRP. [ABSTRACT FROM AUTHOR]

This article compares the pharmaceutical pricing policies employed by public and private insurers in the United States with seven price and spending control strategies employed in the United Kingdom, France, and Germany. Differences between American and European policies explain why American pharmaceutical prices and per capita spending are higher than in European nations. The article then analyzes two recent bills as examples of significant American reform ideas--H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (introduced in 2019) and the Build Back Better Act (BBBA, introduced in 2021)--and compares them with European cost control strategies. Key drug price provisions of the BBBA were incorporated into the recently enacted Inflation Reduction Act (IRA). H.R. 3 would have used an international (mostly European) price index to cap U.S. prices, the BBBA would cap Medicare prices at a discount from average U.S. market prices. Neither bill would employ the key cost control strategies that European nations do. Both bills would have significantly less impact on prices than legislation that employs European-style cost controls. This article proposes steps that Congress could take in line with European strategies to lower purchase prices and costs for patients. These measures would have to overcome political obstacles that currently stymie reform. [ABSTRACT FROM AUTHOR]

Context: To what extent does pharmaceutical revenue growth depend on new medicines versus increasing prices for existing medicines? Moreover. does using list prices, as is commonly done. instead of prices net of confidential rebates offered by manufacturers. which are harder to observe, change the relative importance of the sources of revenue growth? Methods: This study uses data from SSR Health LLC to address these research questions using decomposition methods that analyze list prices, prices net of rebates, and sales for branded pharmaceutical products sold primarily through retail pharmacies. Findings: From 2009 to 2019, retail pharmaceutical revenue growth was primarily driven by new products rather than by price increases on existing products. Failing to account for confidential rebates creates a more prominent role for price increases in explaining revenue growth, because list price inflation during this period was 10.9%, whereas net price inflation was 3.3%. Conclusions: Policies that restrict price growth on existing medicines likely need to be coupled with policies that reduce launch prices to have a meaningful long-term impact on pharmaceutical revenue growth. Using pharmaceutical list prices is often an inadequate approximation for net prices because the role of rebates has increased and varies by drug class. [ABSTRACT FROM AUTHOR]

Background: Branded drugs contribute disproportionately to high prescription drug spending. Pharmaceutical companies utilize patent extension "evergreening" techniques that contribute to high drug costs. Aims: This article describes various patent extension techniques and analyzes the tactic of combining generic drugs with branded drugs, using metformin combinations for diabetes treatment as a case study. It examines the argument that FDCs enhance adherence and compares the cost of several branded fixed‐dose combinations with the cost of their individual constituents. Materials & Methods: We reviewed literature on patent extension techniques in both medical and marketing literature, supplemented by our own extensive files. We performed a price analysis of several branded pharmaceuticals and generically available equivalents. Prescription drug prices were determined using GoodRx.com, and prices of over‐the‐counter products were established based on the prices of two chain wholesalers. Patent and formulation information was taken from the FDA Orange Book: Approved Drugs with Therapeutic Equivalence Evaluations database. Results: "Evergreening" patent extension tactics include the sequential release of different formulations, minor dosing changes, and fixed‐dose combinations (FDCs). A "new use" provides an opportunity for a company to re‐patent, rebrand, and remarket one drug for multiple indications. It is unclear whether or not FDCs enhance adherence. Branded fixed‐dose combinations generally cost far more than their individual constituents. FDCs that combine metformin with other drugs are an exception, often costing the same as the non‐metformin component. Discussion: Patent extension tactics increase drug costs while providing little additional benefit to patients. Minor alterations in formulations or dosing may provide no clinical benefits. Many FDCs are expensive and fail to provide cost‐justified improvements in clinical outcomes, compared to equivalent generic drugs that would save money while delivering an equal standard of care. Combining newer hypoglycemic drugs with metformin, a gold‐standard, generic, inexpensive drug, does not appear to cost more than individual constituents but offers no clinical advantage over metformin alone. Conclusion: Evergreening tactics should be reined in, as they represent significant cost to the healthcare system and to patients. Physicians and other prescribers should avoid prescribing FDCs, or slightly tweaked "new" drugs. Patented drug combinations generate profit without innovation. [ABSTRACT FROM AUTHOR]

The article proposes the legal standard of duty of care in Dutch law as an avenue for enforcing the human rights responsibilities and accountability of the pharmaceutical industry. Emphasis is given on the need to ensure access to essential medicines as part of the core obligations imposed on governments. It refers to global monitoring and evaluation of pharmaceutical companies' behavior as a first step toward accountability and stresses the need for legal accountability mechanisms.

How and why is implicit and explicit human rights language used by World Trade Organization (WTO) negotiators in debates about intellectual property, know-how, and technology needed to manufacture COVID-19 vaccines, and how do these findings compare with negotiators' human rights framing in 2001? Sampling 26 WTO members and two groups of members, this study uses document analysis and six key informant interviews with WTO negotiators, a representative of the WTO Secretariat, and a nonstate actor. In WTO debates about COVID-19 medicines, negotiators scarcely used human rights frames (e.g., "human rights" or "right to health"). Supporters used both human rights frames and implicit language (e.g., "equity," "affordability," and "solidarity") to garner support for the TRIPS waiver proposal, while opponents and WTO members with undetermined positions on the waiver used only implicit language to advocate for alternative proposals. WTO negotiators use human rights frames to appeal to previously agreed language about state obligations; for coherence between their domestic values and policy on one hand, and their global policy positions on the other; and to catalyze public support for the waiver proposal beyond the WTO. This mixed-methods design yields a rich contextual understanding of the modern role of human rights language in trade negotiations relevant for public health. [ABSTRACT FROM AUTHOR]

Introduction: Neglected tropical diseases (NTDs) are an important global health challenge, however, little is known about how to effectively finance NTD related services. Integrated management in particular, is put forward as an efficient and effective treatment modality. This is a background study to a broader health economic evaluation, seeking to document the costs of integrated case management of NTDs versus standard care in Liberia. In the current study, we document barriers and facilitators to NTD care from a health financing perspective. Methods: We carried out key informant interviews with 86 health professionals and 16 national health system policymakers. 46 participants were active in counties implementing integrated case management and 40 participants were active in counties implementing standard care. We also interviewed 16 patients and community members. All interviews were transcribed and analysed using the thematic framework approach. Findings: We found that decentralization for NTD financing is not yet achieved – financing and reporting for NTDs is still centralized and largely donor-driven as a vertical programme; government involvement in NTD financing is still minimal, focused mainly on staffing, but non-governmental organisations (NGOs) or international agencies are supporting supply and procurement of medications. Donor support and involvement in NTDs are largely coordinated around the integrated case management. Quantification for goods and budget estimations are specific challenges, given the high donor dependence, particularly for NTD related costs and the government's limited financial role at present. These challenges contribute to stockouts of medications and supplies at clinic level, while delays in payments of salaries from the government compromise staff attendance and retention. For patients, the main challenges are high transportation costs, with inflated charges due to fear and stigma amongst motorbike taxi riders, and out-of-pocket payments for medication during stockouts and food/toiletries (for in-patients). Conclusion: Our findings contribute to the limited work on financing of SSSD services in West African settings and provide insight on challenges and opportunities for financing and large costs in accessing care by households, which is also being exacerbated by stigma. [ABSTRACT FROM AUTHOR]

Background: This study was an ex-ante cost-utility analysis of deemed consent legislation for deceased organ donation in Nova Scotia, a province in Canada. The legislation became effective in January 2021. The study's objective was to assess the conditions necessary for the legislation change's cost-effectiveness compared to expressed consent, focusing on kidney transplantation (KT). Method: We performed a cost-utility analysis using a Markov model with a lifetime horizon. The study was from a Canadian payer perspective. The target population was patients with end-stage kidney disease (ESKD) in Atlantic Canada waitlisted for KT. The intervention was the deemed consent and accompanying health system transformations. Expressed consent (before the change) was the comparator. We simulated the minimum required increase in deceased donor KT per year for the cost-effectiveness of the deemed consent. We also evaluated how changes in dialysis and maintenance immunosuppressant drug costs and living donor KT per year impacted cost-effectiveness in sensitivity analyses. Results: The expected lifetime cost of an ESKD patient ranged from $177,663 to $553,897. In the deemed consent environment, the expected lifetime cost per patient depended on the percentage increases in the proportion of ESKD patients on the waitlist getting a KT in a year. The incremental cost-utility ratio (ICUR) increased with deceased donor KT per year. Cost-effectiveness of deemed consent compared to expressed consent required a minimum of a 1% increase in deceased donor KT per year. A 1% increase was associated with an ICUR of $32,629 per QALY (95% CI: − $64,279, $232,488) with a 81% probability of being cost-effective if the willingness-to-pay (WTP) was $61,466. Increases in dialysis and post-KT maintenance immunosuppressant drug costs above a threshold impacted value for money. The threshold for immunosuppressant drug costs also depended on the percent increases in deceased donor KT probability and the WTP threshold. Conclusions: The deemed consent legislation in NS for deceased organ donation and the accompanying health system transformations are cost-effective to the extent that they are anticipated to contribute to more deceased donor KTs than before, and even a small increase in the proportion of waitlist patients receiving a deceased donor KT than before the change represents value for money. [ABSTRACT FROM AUTHOR]

The objective of this empirical exercise was to examine how drug providers in states that implemented the Medicaid expansion in 2014 reacted to the expansion compared with providers in states where Medicare was not expanded. Medicaid beneficiaries have been susceptible to higher cost and lower quality of health care. The Affordable Care Act increased access to drugs for uninsured people. Numerous studies highlighted the effects of the Medicaid expansion on beneficiaries. However, there is a gap in the literature that looks at prescription behavior of physicians during the Medicaid expansion that compared expanded states versus nonexpanded states. A difference-in-differences regression was used to estimate the average treatment effect of implementing the Medicaid expansion on each of the 6 outcomes of interest: (1) total cost of prescribing drugs, (2) number of total drug claims for non-Medicaid beneficiaries, (3) number of drug claims for Medicaid beneficiaries, (4) number of beneficiaries, (5) number of beneficiaries who were 65 years old or older, and (6) ratio of brand-name drugs. To address potential estimation biases, a matching procedure was used to ensure that pre- and post-Medicaid period trends were parallel. Our results provide evidence that, on average, the Medicaid expansion led each provider in expanded states prescribed more drugs for beneficiaries with low-income subsidies, whereas prescribed less drugs for other beneficiaries including those over 65 years old. The authors also show the proportion of brand-name drugs prescribed by a provider in expanded states declined due to the implementation of the Medicaid expansion. These results suggests that the Medicaid expansion has contributed to increasing access to health care by low-income citizens who were in need of prescriptions. [ABSTRACT FROM AUTHOR]

On May 12, 2022, Senator Bernie Sanders held a hearing in the U.S. Senate Budget Committee on Medicare for All legislation. These were the first such hearings in the U.S. Senate. In testimony presented to the Budget Committee, I argued that the achievement of Medicare for All was a medical and moral imperative. I explored the problem of uninsurance, noting that 30 million Americans remain uninsured at a cost of more than 30,000 deaths annually. I contended that improving the quality of coverage was equally crucial, describing how some 41 million Americans remain underinsured at a grave cost to their health and financial wellbeing. Finally, I examined the economics of Medicare for All reform, and showed how the reduction of the enormous administrative waste in American healthcare could save hundreds of billions of dollars a year. Medicare for All, I concluded, is the one health reform that could expand and improve coverage for all while simultaneously controlling costs. [ABSTRACT FROM AUTHOR]

PURPOSE Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. METHODS We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. RESULTS Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids (P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered (P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% (P < .001). For the same four opioids, median OOP costs doubled to quadrupled (P < .001). CONCLUSION Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain. [ABSTRACT FROM AUTHOR]

Background and aims: Chronic migraine is a common neurovascular brain disorder with substantial economic costs. We performed a systematic review to identify economic evaluations of pharmacological treatments for adults with chronic migraine. Methods: We undertook systematic literature searches using terms for migraine/headache and prophylactic drug interventions, combined with economic/cost terms where appropriate. Using inclusion and exclusion criteria, two reviewers independently assessed the citations and abstracts, and full-text articles were retrieved. A review of study characteristics and methodological quality was assessed. Results: Sixteen citations met the inclusion criteria and were model-based cost-utility studies evaluating: Botox (n = 6); Erenumab (n = 8); Fremanezumab (n = 2); and Galcanezumab (n = 1) as the main treatment. They varied in their use of comparators, perspective, and model type. Botox was cost-effective compared to placebo with an incremental cost-effectiveness ratio (ICER) ranging between £15,028 (€17,720) and £16,598 (€19,572). Erenumab, Fremanezumab and Galcanezumab when compared to Botox, was associated with ICERs ranging between £59,712 ($81,080) and £182,128 (€218,870), with the ICERs above the most common willingness-to-pay thresholds (WTPs). But they were cost-effective within the commonly used WTPs among the population for whom the previous treatments including Botox were failed. Three studies compared the cost-effectiveness of Erenumab against the placebo and found that Erenumab was dominant. All studies performed sensitivity analyses to check the robustness of their results. None of the findings from the included articles were generalisable and none of the included studies fulfilled all the criteria mentioned in the CHEERS 2022 reporting checklist and Phillips's checklist for economic models. Conclusions: Evidence to support the cost-effectiveness of pharmacological treatments of chronic migraine in the adult population using Botox and Erenumab were identified. Our findings suggest that both Botox and Erenumab, are cost-effective compared to placebo; although Erenumab had more incremental economic benefits compared to Botox, the ICERs were above the most common willingness-to-pay thresholds. Hence, Erenumab might be an acceptable treatment for chronic migraine for patients whom other treatments such as Botox do not work. Further research is needed to help characterise the data to adequately structure and parameterise an economic model to support decision-making for chronic migraine therapies. [ABSTRACT FROM AUTHOR]

The article offers information on the development of a model for Medicaid Managed Care (MMC) enacted by Kentucky in 2021 designed to avoid a complete reversal of the Medicaid drug benefit from an MMC model to a purely Medicaid fee-for-service (FFS) model. Topics covered include how the pharmacy benefit manager (PBM) reform legislation disrupted the vertically aligned PBM industry, a summary of the PBM reform elements, and the goal of the model to preserve the intent of the 340B program.

Objectives: Louisiana extended Medicaid coverage on July 1, 2016, to previously ineligible populations. We aimed to estimate the effect of Louisiana's Medicaid expansion on self-reported affordability of health care. Methods: We used 2011-2019 data from the Behavioral Risk Factor Surveillance System (BRFSS). The BRFSS measured affordability of health care by asking respondents 2 questions: (1) whether they could not see a doctor due to cost in the previous 12 months and (2) whether they could not get a prescribed medication due to cost in the previous 12 months. We estimated difference-in-differences and difference-in-difference-in-differences analytical models using multivariable linear regression that compared trends in Louisiana with trends in states that did not expand Medicaid during the study period. Results: Compared with adults aged <65 with annual household income >138% of the federal poverty level (FPL) in nonexpansion states, Medicaid expansion in Louisiana decreased the percentage of adults aged <65 with annual household income ≤138% FPL who reported being unable to see a doctor due to cost by 5.1 percentage points (95% CI, −6.5 to −3.6; P <.001) and unable to afford prescribed medication by 7.9 percentage points (95% CI, −9.2 to −6.6; P <.001). We found similar estimates when we limited the comparison group to Southern nonexpansion states. Conclusions: Louisiana's Medicaid expansion lowered cost barriers to health care. Further research may find improvements in health care affordability in states that have not yet expanded Medicaid. [ABSTRACT FROM AUTHOR]

The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees' out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations for a condition treated by their drugs. To assess whether this law and its associated regulations prevent manufacturers from profiting from their donations, we analyzed drug spending of more than three million Medicare Advantage enrollees in 2010 and 2017, together with data on conditions and drugs covered by these charities. We found that donations by the leading manufacturer of drugs for each condition were often likely to be profitable, even if relatively few patients were induced to use the manufacturer's drugs as a result. This was particularly true among the ten costliest conditions, where the leading manufacturer accounted for 67 percent of sales in 2010 and 89 percent in 2017, on average, indicating that manufacturers could effectively assist in the purchase of their own medications by contributing to condition-specific charities. We conclude that the current regulations or enforcement permit donations that violate the spirit of Medicare's Anti-Kickback Statute. [ABSTRACT FROM AUTHOR]

Introduction: Due to their impact on healthcare systems, the sustainability and optimization of high-cost drugs is an issue of concern for several countries. Different strategies have been implemented such as centralized purchasing to optimize budgetary resources. However, there is still a need for a mechanism to optimize these drugs further. Methods: We conducted this prospective multicenter intervention study in five hospitals in the Andalusian Public Health System of Cádiz (Spain) between July 2019 and September 2021. We developed an online website (Farmastock) and implemented it to determine the availability of high-cost, low-use, and near-expiry medicines in each hospital. We used a simple analysis using operational variables to assess the project intervention's savings impact on managing these high-cost drugs. Results: The implementation of Farmastock in Cádiz resulted in savings of 675,757.52 € for the Andalusian Public Health System, with 238 medicines transferred out of the 373 available. Of these medicines offered, the most considerable percentage were medicines used for pathologies with high clinical instability and accounted for nearly 80% of the medicines optimized by the tool. Conclusions: Farmastock allowed the Andalusian Public Health System to make substantial financial savings by not making new purchases of high-cost drugs available in other centers of this health network that were not being used. Therefore, this tool is a very efficient measure to contribute to the sustainability of the APHS and could be implemented in more hospitals soon. [ABSTRACT FROM AUTHOR]

(1) Purpose: As the economy develops and lifestyles become more westernized, diabetes is on the rise in Korea. This study tried to measure the socio-economic cost of diabetes by estimating the direct medical expenses and indirect costs used in Korea during the year due to diabetes mellitus. (2) Methods: This study extracted the insurance claim records from the Korea National Health Insurance claim database to determine the healthcare services provided to patients with diabetes mellitus in 2017. The total diabetes mellitus-related cost was the sum of the direct medical care costs: the costs paid by insurers and patients, the non-covered care costs and the prescribed pharmaceuticals costs, and also the direct non-medical care costs: the transportation costs for visits in outpatients and inpatients and the guardian's cost for hospitalized patients, as well as the indirect cost: lost productivity. (3) Findings: The total socio-economic cost of diabetic patients in 2017 measured in this study was KRW 3.2 trillion, of which 48.3% was used for medical expenses, 10% was non-medical expenses, and 41.7% was estimated as indirect expenses. (4) Implications: Korea is considered to be aging significantly, and it is considered that more attention should be paid to reducing medical expenses through diabetes management. [ABSTRACT FROM AUTHOR]

Introduction: Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, including those related to research and development (R&D) and manufacturing. Such considerations could enter the decision process in collectively financed health care systems. This paper investigates whether manufacturers' costs in relation to drug prices, or profit margins, are explicitly mentioned and considered by health technology assessment (HTA) organisations. Method: An analysis of reimbursement reports for cancer drugs was performed. All relevant Dutch HTA-reports, published between 2017 and 2019, were selected and matched with HTA-reports from three other jurisdictions (England, Canada, Australia). Information was extracted. Additionally, reimbursement reports for three cases of expensive non-oncolytic orphan drugs prominent in pricing debates in the Netherlands were investigated in depth to examine consideration of profit margins. Results: A total of 66 HTA-reports concerning 15 cancer drugs were included. None of these reports contained information on manufacturer's costs or profit margins. Some reports contained general considerations of the HTA organisation which related prices to manufacturers' costs: six contained a statement on the lack of price setting transparency, one mentioned recouping R&D costs as a potential argument to justify a high price. For the case studies, 21 HTA-reports were selected. One contained a cost-based price justification provided by the manufacturer. None of the other reports contained information on manufacturer's costs or profit margins. Six reports contained a discussion about lack of transparency. Reports from two jurisdictions contained invitations to justify high prices by demonstrating high costs. Conclusion: Despite the attention given to manufacturers' costs in relation to price in public debates and in the literature, this issue does not seem to get explicit systematic consideration in the reimbursement reports of expensive drugs. [ABSTRACT FROM AUTHOR]

Introduction: Oral oncolytics are becoming a mainstay in oncology, representing first-line therapies for numerous different malignancies. In addition, the cost of oncology drugs has increased dramatically in recent years. Given the increasing number of oral oncolytics available, as well as the increase in medication costs in recent years, it is important to assess the trend in prescriptions and expenditures of these agents. Methods: A descriptive retrospective analysis of the Medicare Part D Provider Utilization and Payment Data Public Use File (PUF) was conducted for the years 2013 through 2017. Outcomes of interest included total aggregate prescriptions per year, total aggregate expenditures per year, mean expenditure per prescription per year, and mean expenditure per standardized 30-day prescription per year. Chi-square tests were conducted to assess statistical significance of differences in proportions of prescriptions as well as expenditures between 2013 and 2017. Results: The number of prescriptions for oral oncolytics dispensed to Medicare Part D beneficiaries increased from 7,017,902 in 2013 to 8,164,883 in 2017. Medicare Part D expenditures for oral oncolytics increased greater than 2.5-fold from $5,631,224,307 in 2013 to $14,422,681,331 in 2017 after adjusting for inflation. The mean expenditure per prescription for oral oncolytics increased from $802 in 2013 to $1,766 in 2017. Conclusions: This study found oral oncolytic utilization has been increasing in recent years with a slight, but statistically significant increase in the proportion of oncolytics for all Medicare prescriptions from 2013 through 2017. [ABSTRACT FROM AUTHOR]

PURPOSE The relationship between out-of-pocket spending and cost-related medication nonadherence among older rural- and urban-dwelling cancer survivors is not well understood. METHODS This retrospective cohort study used the Surveillance, Epidemiology, and End Results Program, Medicare claims, and the Consumer Assessment of Healthcare Providers and Systems survey linked data resource linked data (2007-2015) to investigate the relationship between cancer survivors' cost responsibility in the year before and after report of delaying or not filling a prescription medication because of cost in the past 6 months (cost-related medication nonadherence). Secondary exposures and outcomes included Medicare spending and utilization. Generalized linear models assessed bidirectional relationships between cost-related medication nonadherence, spending, and utilization. Effects of residence were assessed via interaction terms. RESULTS Of 6,591 older cancer survivors, 13% reported cost-related medication nonadherence. Survivors were a median 8 years (interquartile range, 4.5-12.5 years) from their cancer diagnosis, 15% were dually Medicare/Medicaid-eligible, and prostate (40%) and breast (32%) cancer survivors were most prevalent. With every $500 USD increase in patient cost responsibility, risk of cost-related medication nonadherence increased by 3% (risk ratio, 1.03; 95% CI, 1.02 to 1.04). After report of cost-related medication nonadherence, patient cost responsibility was 22% higher (95% CI, 1.11 to 1.32) compared with those not reporting nonadherence, amounting to $523 USD (95% CI, $430 USD to $630 USD). Medicare spending and utilization were also higher before and after report of cost-related nonadherence versus none. For survivors residing in rural (18%) and urban (82%) areas, residence did not modify adherence or cost outcomes. CONCLUSION A bidirectional relationship exists between patient cost responsibility and cost-related medication nonadherence. Interventions reducing urban- and rural-dwelling survivor health care costs and cost-related adherence barriers are needed. [ABSTRACT FROM AUTHOR]

Background: Commonly recognized childhood conduct problems often lead to costly problems in adulthood. This study aimed to evaluate the long‐term cumulative cost of childhood conduct problems until the age of 30. The costs included inpatient care, nervous system medicine purchases, and criminal offences. Methods: The study used population‐based nationwide 1981 birth cohort data. Families and teachers assessed the conduct problems of the eight‐year‐olds based on Rutter questionnaires. We grouped 5,011 children into low‐level of conduct problems (52%), intermediate‐level of conduct problems (37%), and high‐level of conduct problems (11%) groups, based on combined conduct symptoms scores. The analysis included the cohort data with the Care Register for Health Care, the Drug Prescription Register, and the Finnish Police Register. The cost valuation of service use applied national unit costs in 2016 prices. We used Wilcoxon rank‐sum test to test the differences between groups and gender. Results: During 1989–2011, average cumulative costs of the high‐level (€44,348, p <.001) and the intermediate‐level (€19,405, p <.001) of conduct problems groups were higher than the low‐level of conduct problems group's (€10,547) costs. In all three groups, the boys' costs were higher than girls' costs. Conclusions: The costs associated with conduct problems in childhood are substantial, showing a clear need for cost‐effective interventions. Implementation decisions of interventions benefit from long‐term cost‐effectiveness modelling studies. Costing studies, like this, provide cost and cost offset information for modelling studies. [ABSTRACT FROM AUTHOR]

BACKGROUND: The burden of prescription drug prices affects patients and health system, creating a need for pharmacists to use their medication expertise to recommend the most cost-effective treatment for patients. OBJECTIVE: The study aimed to analyze the cost avoidance for medication conversions related to GERD from an integrated medication therapy management call center. METHODS: A quasi-experimental study was conducted at a call center during a 12-month intervention. Adult patients aged ≥18 years who received highercost PPIs were included. The pharmacists provided MTM services to patients telephonically to review all aspects of the patients' medication regimen as well as conversion recommendation to lower-cost PPIs. The cost avoidance analysis and sensitivity analysis were conducted. RESULTS: Of 40 eligible patients, 9 patients accepted the medication conversion, resulting in a 22.5% acceptance rate. The total cost avoidance from medication conversions was $19,937.1 per year, which equated to $2,215.2 per patient. The adjusted cost avoidance of medication conversion was estimated by assuming the patients who accepted the conversion continued taking the medication for 365 days and resulted in a total savings of $40,370.7 per year, which equated to $4,485.6 per patient. There were no significant association between the acceptance of medication conversions and patient's age(P = 0.15), gender(P = 0.73), and insurance status(P = 0.96). CONCLUSION: The study results showed that the call-center MTM with medicationconversion interventions successfully demonstrated an economically advantageous impact from a budgetary perspective. Further studies should explore methods to increase acceptance of MTM services and promote awareness of the profound effect on public health and well-being. [ABSTRACT FROM AUTHOR]

Background: Pharmacists' compliance with a medication partial fill policy at a Veterans Affairs healthcare system has been underwhelming. Academic detailing, an educational outreach approach conducted by trained health care professionals to improve patient care, is an attractive method for improving pharmacists' compliance with the policy. Objective: To evaluate the impact of academic detailing on pharmacists' compliance with the partial fill policy. Methods: A pre-post analysis was performed to evaluate the impact of academic detailing outreach visits on pharmacists' compliance with the partial fill policy. Data collection included all partial fill medication orders verified during the study duration. Student's t-test was used to analyze the change in the day supply of partial fills following the academic detailing intervention. Total partial fill drug expense during the pre- and post-intervention phases was calculated as drug cost plus material cost for each partial fill. Results: A total of 36 (97.3%) pharmacists received an academic detailing outreach visit. Total percentage of partial fills limited to a 7-day supply was significantly increased following academic detailing outreach visits (49.2% pre-intervention vs. 84.2% post-intervention, p-value <0.001). Total partial fill drug expense decreased from $12,144.42 to $9,713.50. Percentage of partial fills limited to a 7-day supply remained significant during the 6-month follow-up period (p-value = 0.03). Conclusions: Academic detailing is an effective method for improving pharmacists' compliance with an outpatient pharmacy partial fill policy and decreasing total partial fill drug expense for the pharmacy department. [ABSTRACT FROM AUTHOR]

Recent studies have examined strategic behaviors in the pharmaceutical industry that extend patent and regulatory protection, known alternatively as "lifecycle management" or "evergreening." This literature highlights the extent to which the patent system is increasingly focused on granting new protections for minor modifications of existing innovations. The phenomenon raises questions regarding the value of the trend to society and its potential effects on innovation. Specifically, is there value in tinkering with existing medication, and does that value justify the extensive rewards available with a "golden" patent? Could aspects of the current system be distorting how companies choose to spend their precious innovation time and money? As a society, we may decide that certain parts of the system are valuable and that others require reform, but we cannot make any considered evaluation without understanding how the system works on the ground. [ABSTRACT FROM AUTHOR]

Policy PointsOnly a small minority of new drugs in "nonprotected" classes are widely covered by Part D plans nationwide in the year after US Food and Drug Administration (FDA) approval.Part D plans frequently apply utilization management restrictions such as prior authorizations to newly approved drugs in both protected and nonprotected classes.Drug price influences both formulary inclusion (in nonprotected classes) and coverage restrictions (in both protected and nonprotected classes), while other drug characteristics such as therapeutic benefits are not consistently associated with formulary design. Plans do not seem to favor the minority of drugs that are determined to offer added therapeutic benefit over existing alternatives. Context: Medicare Part D is an outpatient prescription drug benefit for older Americans covering more than 46 million beneficiaries. Except for mandatory coverage for essentially all drugs in six protected classes, plans have substantial flexibility in how they design their formularies: which drugs are covered, which drugs are subject to restrictions, and what factors determine formulary placement. Our objective in this paper was to document the extent to which Part D plans limit coverage of newly approved drugs. Methods: We examined the formulary design of 4,582 Part D plans from 2014 through 2018 and measured (1) the decision to cover newly approved drugs in nonprotected classes, (2) use of utilization management tools in protected and nonprotected classes, and (3) the association between plan design and drug‐level characteristics such as 30‐day cost, therapeutic benefit, and the US Food and Drug Administration (FDA) expedited regulatory pathway. Findings: The FDA approved 109 new drugs predominantly used in outpatient settings between 2013 and 2017. Of these, 75 fell outside of the six protected drug classes. One‐fifth of drugs in nonprotected classes (15 out of 75) were covered by more than half of plans during the first year after approval. Coverage was often conditional on utilization management strategies in both protected and nonprotected classes: only seven drugs (6%) were covered without prior authorization requirements in more than half of plans. Higher 30‐day drug costs were associated with more widespread coverage in nonprotected classes: drugs that cost less than $150 for a 30‐day course were covered by fewer than 20% of plans while those that cost more than $30,000 per 30 days were covered by more than 50% of plans. Plans were also more likely to implement utilization management tools on high‐cost drugs in both protected and nonprotected classes. A higher proportion of plans implemented utilization management strategies on covered drugs with first‐in‐class status than drugs that were not first in class. Other drug characteristics, including availability of added therapeutic benefit and inclusion in FDA expedited regulatory approval, were not consistently associated with plan coverage or formulary restrictions. Conclusions: Newly approved drugs are frequently subject to formulary exclusions and restrictions in Medicare Part D. Ensuring that formulary design in Part D is linked closely to the therapeutic value of newly approved drugs would improve patients' welfare. [ABSTRACT FROM AUTHOR]

Background: The price of medicine in India has always been a point of discussion in public domain. The price range of the same drug is very large with more than 100% difference between various brands available in different settings. Aims and Objectives: To assess the price of different drugs at Jan Aushasdhi (JA), AMRIT and Private Chemist and to compare the prices of these three outlets so that the issues. Material and Methods: This institution-based cross-sectional study was carried out from May 2019 to June 2019. A pretested proforma was prepared to compare the prices of 284 different medicines in Jan Aushadhi, AMRIT and private chemist shops. The collected data were entered in an Excel spreadsheet and presented in Proportions, percentages, and mean. Results: The price of 284 medicines were compared from JA (Median(IQR)- 15.18(18.75) INR) and Private chemist shop (Median(IQR)-88(111.5) INR) while 249 medicine from AMRIT (Median(IQR)-61.05(78.33) INR). Although the majority of the AMRIT drugs are cheaper than the chemist shop except for 31% of Antipsychotic drugs, 26.6% of antihypertensives, 25% of respiratory drugs, 25% of steroids, 21.9% of antibiotics. Conclusion: We concluded that JA is providing drugs cheaper than AMRIT and Private chemist. The prices of medicines offered at AMRIT are lower than market pricing but they are costlier when compared to JA prices. [ABSTRACT FROM AUTHOR]

High drug price is a hot topic in Malaysia. In this systematic review of drug price comparison studies, we report on international comparison of drug prices with Malaysia. We systematically searched PubMed, Cochrane Library, ScienceDirect and Scopus for peer-reviewed articles. Only studies that made comparison internationally were included. Cost-effectiveness studies, budget impact analysis or costing studies were excluded. A total of 10 studies were included. Nine studies compared the price with median international reference prices (IRPs). Only one study compared the price with another country. The drug price in Malaysia for both government and public sectors was higher than IRP. This review provides the information that the drug price in Malaysia is higher than the international standard. The number of published studies in the drug pricing area is still inadequate with only one study that compares Malaysia drug price with another country. More studies are needed to improve Malaysia's drug pricing system. [ABSTRACT FROM AUTHOR]

The article focuses on prior authorization (PA) rules in the medical community. Topics discussed include characteristics made by Dr. Gerald E. Harmon, immediate past president of the American Medical Association (AMA), on PA systems, origin of PAs, and rationale for these policies. The development of PA phenomenon is also mentioned.

Introduction: In the 2019/20 financial year, PCV was introduced as an audit to confirm the expenditure of CDF meets the standard set out in the CDF policy.1 In the 2021/22 financial year, PCV became mandatory as a condition of usage of CDF for all NHS providers. In September 2021 (M6), communication was sent from CDF to providers outlining the ongoing issues with data submission to the CDF. CDF warned if submission quality did not improve, reimbursement might be denied at the end of the year. DVH was one of the providers that experienced issues with data submission. A working group of pharmacy, income team and business intelligence were formed to tackle the issues. Objectives: The aim was to ensure CDF data submissions meet the standard set out for PCV. The main objectives are to: • Ensure reimbursement from CDF • Minimise PCV challenges Methods: At M6, the Trust had cumulated 261 challenges, and the amount in dispute was £575,000 for the financial year to date. Upon reviewing existing challenges, the following issues were identified in previous submissions: • Data formats did not meet CDF PCV report specification.2 • Drugs recharged to incorrect commissioners. • PAS prices unavailable for compounded drugs. • On-costs charged to CDF. An initial action to manage the increasing number of challenges was a manual response to all cumulated challenges for M8 (November 2021) to CDF, as the amount-in-dispute reached over £1,000,000. The working group decided to create a crystal report template for all future HCD submissions. Several features would be implemented in the new template that would mitigate the issues identified: • Data formats were programmed to follow CDF PCV report specification guidance.2 • An alert would arise if HCD might be funded by different commissioners. • PAS prices were programmed into the reports, including compounded drugs. • On-costs and drug costs were programmed to be separated automatically. Configuration of the new template was completed, and the first report was implemented for submission for M11 (February 2022). Another manual response to M10 (January 2022) PCV challenges was also submitted to resolve all remaining challenges to date. Results: Impact of manual responses and new reports were evaluated by number of PCV challenges from M6 2021/22 (September 2021) to M2 2022/23 (May 2022) (Figure 1). At M10, the amount-in-dispute from CDF PCV was £838,000. The comprehensive manual response successfully reduced the cumulative challenges for M1–10 from 296 to 39, and the amount-in-dispute to £114,000. The new HCD report for M11 resulted in 19 new challenges. All 58 challenges were due to manual errors. The number of cumulative challenges reduced significantly since the implementation of the new report. In the following 3 months, PCV returned 5, 2 and 0 challenges. All challenges from 2021/22 were resolved at the end of the financial year, and CDF agreed to reimburse the full amount to the trust. Discussion: The response atM10 successfully resolvedmost of the challenges. However, manual response to challenges was a time-consuming process and considered to be inefficient. The new HCD template provided an effective solution. Reports were generated with automation, complied with data submission standards and minimised PCV challenges. [ABSTRACT FROM AUTHOR]

Background: Comorbid heart failure with reduced ejection fraction (HFrEF) and type 2 diabetes mellitus (DM) is associated with a very high risk of HF events. Sacubitril–valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), and dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, improve HF outcomes in these patients, but their comparative value for money in this patient population has not yet been determined. Objective: We aimed to compare the cost needed to treat (CNT) to avoid an HF event with each drug. Methods: CNT was estimated by multiplying the annualized number needed to treat (NNT) to prevent one HF event by the annual cost of each therapy. HF events were defined as the first event of hospitalization for HF or cardiovascular mortality. Drug efficacy data were extracted from published secondary analyses of patients with DM in the DAPA-HF and PARADIGM-HF trials. Drug costs were estimated as 75% of the 2021 US National Average Drug Acquisition Cost listing. Sensitivity analysis was performed on parameters that may have affected the CNT. Results: The annualized NNT was 24 (95% confidence interval [CI] 16–54) for dapagliflozin and 57 (95% CI 31–433) for the ARNI. At an annual cost of $US4523 and 5099, respectively, the CNT was $US108,563 (95% CI 72,375–244,267) for dapagliflozin and $US290,671 (95% CI 158,084–2,208,079) for the ARNI. Conclusions: Dapagliflozin seems to offer greater value for money than the ARNI for patients with HFrEF and DM. Our results provide support for contemporary guidelines advocating the use of dapagliflozin in these patients. [ABSTRACT FROM AUTHOR]

Background: Since the turn of the century, the prevalence of diabetes mellitus in Australia has increased, primarily due to rising rates of Type 2 diabetes. Simultaneously, the landscape of diabetes medications has evolved significantly. The change in prescribing trends and public spending on diabetes medications within Australia during this period are not well defined. Aims: To establish the frequency and cost of dispensed diabetes medications in the Australian public healthcare system between 2003 and 2019. Methods: We performed a longitudinal nationwide observational study using data obtained from the Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule websites, which contain information on frequency and spending of diabetes medications dispensed in Australia. Results: The total number of PBS‐subsidised prescriptions dispensed for diabetes increased from 5 218 690 in 2003 to 12 188 568 in 2019, and spending increased from $117 241 031 to $598 904 983. Of the non‐insulin agents, metformin was consistently the most frequently dispensed agent, with a rapid growth in metformin combination tablets. Dispensation of sulphonylureas and thiazolidinediones have declined, with a simultaneous increase in dipeptidyl peptidase‐4 inhibitors, sodium‐glucose co‐transporter 2 inhibitors and glucagon‐like peptide‐1 receptor agonists. Conclusions: Our data show a large growth in the use of diabetes medications between 2003 and 2019. The rapid growth in dispensing of drugs with proven cardiovascular and renal benefits reflect the evolving approach of diabetes treatment, from a historical approach targeting glycaemic control alone, to a modern individualised approach targeting specific co‐morbidities. [ABSTRACT FROM AUTHOR]

Background Educational interventions can reduce potentially inappropriate medication (PIM) use in older people. Their effectiveness has been measured mainly as changes in PIM use. In this economic evaluation, we analyse the impact of an educational intervention in terms of costs and quality-adjusted life years (QALYs). Methods The educational intervention consisted of activating and interactive training sessions for nursing staff and consulting physicians, and was compared with treatment as usual (TAU). Participants (n  = 227) in a cluster randomised trial (cRCT) were residents living permanently in assisted living facilities (n  = 20 wards). For economic evaluation, participants' healthcare service use costs and costs for the intervention were estimated for a 12 month period. Incremental cost-effectiveness ratios (ICERs) were estimated for QALYs per participant. Cost-effectiveness analysis was conducted from a healthcare perspective. A bootstrapped cost-effectiveness plane and one-way sensitivity analysis were undertaken to analyse the uncertainty surrounding the estimates. Results The educational intervention was estimated to be less costly and less effective in terms of QALYs than TAU at the 12 month follow-up [incremental costs –€1,629, confidence interval (CI) –€5,489 to €2,240; incremental effect −0.02, CI –0.06 to 0.02]. The base case ICER was >€80,000/QALY. Conclusion The educational intervention was estimated to be less costly and less effective in terms of QALYs compared with TAU, but the results are subject to some uncertainties. Reduction in PIM use or benefits in quality of life did not seem to translate into improvements in QALYs. Our findings emphasise the need for better understanding of the impact of decreasing PIM use on health outcomes. [ABSTRACT FROM AUTHOR]

The purpose of this study was to examine the temporal trends and dynamics of financial hardship among older adults in the U.S. between 2006 and 2016 using the Health and Retirement Study. Sample included a total of 13,537 eligible person observations with a median age of 68 years. Financial hardship included measures of difficulty paying bills, food insecurity, taking less medication due to cost, and ongoing financial strain. Regression analyses were performed using a three-wave quadrennial model to estimate the prevalence of financial hardship over time, to explore temporal patterns and identify persistent hardship. Findings reveal that 51% of respondents who experienced food insecurity at one or more waves were transient. This pattern was similar to respondents who experienced ongoing financial strain (52% transient). Respondents who reported difficulty paying bills (68%) and reduced medications due to cost (62%) were also transient. Significant predictors across all four domains of financial hardship include age, years of education, marital status, self-rated health. Being African American was positively associated with reduced medication use and food insecurity. This study provides insight into the temporal dynamics of financial hardship in later life. It also highlights the contiguous, intermediate and transient nature of financial hardship among older adult populations. [ABSTRACT FROM AUTHOR]