Cost-of-care discussions for individuals with advanced non-small cell lung cancer and melanoma: Findings from a large, population-based pilot study.

BACKGROUND: Costs of cancer care can result in patient financial hardship; many professional organizations recommend provider discussions about treatment costs as part of high-quality care. In this pilot study, the authors examined patient-provider cost discussions documented in the medical records of individuals who were diagnosed with advanced non-small cell lung cancer (NSCLC) and melanoma-cancers with recently approved, high-cost treatment options. METHODS: Individuals who were newly diagnosed in 2017-2018 with stage III/IV NSCLC (n = 1767) and in 2018 with stage III/IV melanoma (n = 689) from 12 Surveillance, Epidemiology, and End Results regions were randomly selected for the National Cancer Institute Patterns of Care Study. Documentation of cost discussions was abstracted from the medical record. The authors examined patient, treatment, and hospital factors associated with cost discussions in multivariable logistic regression analyses. RESULTS: Cost discussions were documented in the medical records of 20.3% of patients with NSCLC and in 24.0% of those with melanoma. In adjusted analyses, privately insured (vs. publicly insured) patients were less likely to have documented cost discussions (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.37-0.80). Patients who did not receive systemic therapy or did not receive any cancer-directed treatment were less likely to have documented cost discussions than those who did receive systemic therapy (OR, 0.39 [95% CI, 0.19-0.81] and 0.46 [95% CI, 0.30-0.70], respectively), as were patients who were treated at hospitals without residency programs (OR, 0.64; 95% CI, 0.42-0.98). CONCLUSIONS: Cost discussions were infrequently documented in the medical records of patients who were diagnosed with advanced NSCLC and melanoma, which may hinder identifying patient needs and tracking outcomes of associated referrals. Efforts to increase cost-of-care discussions and relevant referrals, as well as their documentation, are warranted.

Trends in the availability and prices of quality-assured tuberculosis drugs: a systematic analysis of Global Drug Facility Product Catalogs from 2001 to 2024.

BACKGROUND: The Global Drug Facility (GDF) of the Stop TB Partnership was launched in 2001 with the goal of increasing access to quality-assured tuberculosis (TB) drugs and products. We aimed to describe the TB drugs and prices available from the GDF over time and to assess trends. METHODS: We searched the internet, including an internet archive, for past and recent GDF Product Catalogs and extracted the listed TB drugs and prices. We calculated the lowest price for the most common drug formulations assuming drugs with similar active pharmaceutical ingredients (APIs) are substitutes for each other. We assessed time trends in the TB drugs and prices offered by the GDF in univariable regressions over the longest possible period. RESULTS: We identified 43 different GDF Product Catalogs published between November 2001 and May 2024. These product catalogs included 122 single medicines (31 APIs), 28 fixed-dose combinations (9 API combinations), and 8 patient kits (8 API regimens and other materials). The number of TB drugs listed in the GDF Product Catalog increased from 9 (8 APIs) to 55 (32 APIs). The price decreased for 17, increased for 19, and showed no trend for 12 APIs. The price of 15 (53.6%) of 28 APIs used against drug-resistant TB decreased, including the price of drugs used in new treatment regimens. The decreasing price trend was strongest for linezolid (-16.60 [95% CI: -26.35 to -6.85] percentage points [pp] per year), bedaquiline (-12.61 [95% CI: -18.00 to -7.22] pp per year), cycloserine (-11.20 [95% CI: -17.40 to -4.99] pp per year), pretomanid (-10.47 [95% CI: -15.06 to -5.89] pp per year), and rifapentine (-10.46 [95% CI: -12.86 to -8.06] pp per year). The prices of 16 (61.5%) of 23 APIs for standard drug-susceptible TB treatment increased, including rifampicin (23.70 [95% CI: 18.48 to 28.92] pp per year), isoniazid (20.95 [95% CI: 18.96 to 22.95] pp per year), ethambutol (9.85 [95% CI: 8.83 to 10.88] pp per year), and fixed-dose combinations thereof. CONCLUSIONS: The number of TB drugs available from the GDF has substantially increased during its first 23 years of operation. The prices of most APIs for new TB treatments decreased or remained stable. The prices of most APIs for standard drug-sensitive TB treatment increased.

Impact of government-issued financial incentive to medical facilities on management of secondary dysmenorrhea.

AIM: In April 2020, the Japanese government introduced a Specific Medical Fee for managing secondary dysmenorrhea (SD). This initiative provided financial incentives to medical facilities that provide appropriate management of SD with hormonal therapies. We aimed to assess how this policy affects the management processes and outcomes of patients with SD. METHODS: Using a large Japanese administrative claims database, we identified outpatient visits of patients diagnosed with SD from April 2018 to March 2022. We used an interrupted time-series analysis and defined before April 2020 as the pre-introduction period and after April 2020 as the post-introduction period. Outcomes were the monthly proportions of outpatient visits due to SD and hormonal therapy among women in the database and the proportions of outpatient visits for hormonal therapy and continuous outpatient visits among patients with SD. RESULTS: We identified 815 477 outpatient visits of patients diagnosed with SD during the pre-introduction period and 920 183 outpatient visits during the post-introduction period. There were significant upward slope changes after the introduction of financial incentives in the outpatient visits due to SD (+0.29% yearly; 95% confidence interval, +0.20% to +0.38%) and hormonal therapies (+0.038% yearly; 95% confidence interval, +0.030% to +0.045%) among the women in the database. Similarly, a significant level change was observed after the introduction of continuous outpatient visits among patients with SD (+2.68% monthly; 95% confidence interval, +0.87% to +4.49%). CONCLUSIONS: Government-issued financial incentives were associated with an increase in the number of patients diagnosed with SD, hormonal therapies, and continuous outpatient visits.

[High-cost medicines: the difficult balance between individual and collective rightsMedicamentos de alto custo: o difícil equilíbrio entre direitos individuais e coletivos]. / Medicamentos de alto costo: el difícil equilibrio entre los derechos individuales y los derechos colectivos.

Medicines are special goods that cover the health needs of the population. In recent decades, the pharmaceutical industry has changed its research and development strategy, shifting its focus from the exploration of medicines for chronic diseases affecting a large part of the population to the search for drugs for rare diseases that affect a small number of people.This lack of a mass consumer base is reflected in a selective offer of a few very high-cost products aimed at certain diseases, which hinders both patient access and financial coverage.This article reviews the issue of high-cost medicines, including its cultural, legal, political, economic, and health aspects. It emphasizes the differences between various medicines in terms of their efficacy in changing the natural course of diseases, their market price, the consequences of their cost for healthcare funders, and the cost-opportunity ratio of having to pay for them at the expense of other essential resources.Finally, the article reflects on the legitimate rights of each individual to claim access to high-cost medicines when they are considered essential to recover a person's health, and on how guaranteeing such coverage can affect the collective rights of the population. Concrete examples that illustrate this situation are provided.

Medicamentos são bens especiais que atendem às necessidades de saúde da população. Nas últimas décadas, a indústria farmacêutica mudou sua estratégia de pesquisa e desenvolvimento, deixando de explorar medicamentos para doenças crônicas que afetam grande parte da população e passando a buscar medicamentos para poucas pessoas com doenças raras.Esse número limitado de consumidores se reflete em uma oferta seletiva de poucos produtos de preço elevado para determinadas doenças, dificultando o acesso dos pacientes e a obtenção de cobertura dos agentes financiadores da saúde.Neste artigo, analisa-se a questão dos medicamentos de alto custo e incorpora-se ao debate o contexto sanitário, cultural, jurídico, político e econômico. São enfatizados os seguintes aspectos: diferenças entre os diferentes medicamentos em termos da eficácia em mudar o curso natural das doenças para as quais são indicados; determinação do preço pelo qual esses medicamentos são vendidos no mercado; consequências desse preço para os agentes financiadores da saúde; e a relação custo-oportunidade de ter de pagar por esses medicamentos em detrimento de outros recursos considerados essenciais.Por fim, reflete-se sobre os direitos legítimos de cada indivíduo de reivindicar acesso a medicamentos de alto custo, por considerá-los essenciais para recuperar a própria saúde, e como a garantia dessa cobertura pode afetar os direitos coletivos da população; também são fornecidos exemplos concretos que ilustram essa situação.

Estimating Tiotropium Wasted Doses After Adding Revefenacin to an Inpatient Formulary: A Single-Center Cross-Sectional Study.

Introduction: Revefenacin is a once-daily nebulized long-acting muscarinic antagonist (LAMA). Revefenacin is supplied as single-use nebulized vials, which may be preferable and less costly for hospital and health-system pharmacies to dispense versus multidose tiotropium inhalers. Estimates of LAMA multidose inhaler wasted doses remains unknown. Methods: This was a single-center descriptive cross-sectional study conducted between January 1 2021 and December 31 2021. Adult patients 18 years and older admitted to a 500-bed academic medical center in the southern United States and were ordered multidose tiotropium packages or single-use revefenacin vials during the study period were included. Results: Among 602 inpatients, there were 705 LAMA orders: 541 tiotropium (76.7%) and 164 revefenacin (23.3%). Four hundred ninety-five tiotropium orders (91.5%) wasted between 20% and 90% of multidose packages. Approximately $24,000 tiotropium doses were wasted versus single-use revefenacin vials. Conclusion: Multidose inhalers of tiotropium dispensed to hospitalized patients contributed to wasted doses compared to nebulized single-use revefenacin vials. Opportunities exist to minimize wasted doses of multidose long-acting inhalers dispensed to hospitalized patients.

Extended duration of treatment using reduced-frequency dosing of anti-PD-1 therapy in patients with advanced melanoma and Merkel cell carcinoma.

BACKGROUND: Optimal duration of treatment (DoT) with immune checkpoint inhibitors (ICI) in metastatic cancers remains unclear. Many patients, especially those without radiologic complete remission, develop progressive disease after ICI discontinuation. Extending DoT with ICI may potentially improve efficacy outcomes but presents major logistical and cost challenges with standard frequency dosing (SFD). Receptor occupancy data supports reduced frequency dosing (RFD) of anti-PD-1 antibodies, which may represent a more practical and economically viable option to extend DoT. METHODS: We conducted a retrospective study of patients with metastatic melanoma and Merkel cell carcinoma (MCC), who received ICI at RFD administered every 3 months, after initial disease control at SFD. We evaluated efficacy, safety, and cost-savings of the RFD approach in this cohort. RESULTS: Between 2014 and 2021, 23 patients with advanced melanoma (N = 18) or MCC (N = 5) received anti-PD-1 therapy at RFD. Median DoT was 1.1 years at SFD and 1.2 years at RFD. The 3 year PFS after start of RFD was 73% in melanoma and 100% in MCC patients, which compare favorably to historical control rates. In the subset of 15 patients who received at least 2 years of therapy, total savings amounted to $1.1 million in drug costs and 384 h saved despite the extended DoT (median 3.4 years), as compared to the calculated cost of 2 years at SFD. CONCLUSIONS: ICI administration at RFD can allow extension of treatment duration, while preserving efficacy and reducing logistical and financial burden. RFD approach deserves further exploration in prospective clinical trials.

Medication Cost Concerns and Disparities in Patient-Reported Outcomes Among a Multiethnic Cohort of Patients With Systemic Lupus Erythematosus.

OBJECTIVE: Concerns about the affordability of medications are common in systemic lupus erythematosus (SLE), but the relationship between medication cost concerns and health outcomes is poorly understood. We assessed the association of self-reported medication cost concerns and patient-reported outcomes (PROs) in a multiethnic SLE cohort. METHODS: The California Lupus Epidemiology Study is a cohort of individuals with physician-confirmed SLE. Medication cost concerns were defined as having difficulties affording SLE medications, skipping doses, delaying refills, requesting lower-cost alternatives, purchasing medications outside the United States, or applying for patient assistance programs. Linear regression and mixed effects models assessed the cross-sectional and longitudinal association of medication cost concerns and PROs, respectively, adjusting for age, sex, race and ethnicity, income, principal insurance, immunomodulatory medications, and organ damage. RESULTS: Of 334 participants, medication cost concerns were reported by 91 (27%). Medication cost concerns were associated with worse Systemic Lupus Activity Questionnaire (SLAQ; beta coefficient [ß] 5.9, 95% CI 4.3-7.6; P < 0.001), 8-item Patient Health Questionnaire depression scale (PHQ-8; ß 2.7, 95% CI 1.4-4.0; P < 0.001), and Patient-Reported Outcomes Measurement Information System (PROMIS; ß for physical function -4.6, 95% CI -6.7 to -2.4; P < 0.001) scores after adjusting for covariates. Medication cost concerns were not associated with significant changes in PROs over 2-year follow-up. CONCLUSION: More than a quarter of participants reported at least 1 medication cost concern, which was associated with worse PROs. Our results reveal a potentially modifiable risk factor for poor outcomes rooted in the unaffordability of SLE care.

Are high-cost drug funding mechanisms fit for purpose? A retrospective study of individual funding requests in an NHS tertiary hospital.

AIMS: To report on a retrospective study of individual funding request (IFR) submissions from a large tertiary hospital and describe gaps in current mechanisms for funding of high-cost medicines in England. METHODS: Data on the number and outcome of IFR submissions submitted to commissioners between 2014/15 and 2018/19 was extracted from the electronic patient health record and a local high-cost drug database. RESULTS: In total, 230 IFRs were submitted: 112 to NHS England and 118 to a Clinical Commissioning Group (CCG). The decline rate for IFRs was 71% for NHS England and 34% for CCGs. Lack of exceptionality was the primary reason cited for declining IFRs submitted between 2016-18 (n = 42/45; 93%). Half of the patients whose IFR was declined received treatment funded through other routes, the majority (13/23; 57%) from internal hospital budget. This was governed via a local high-cost drug panel. Positive clinical outcomes were observed in 50% (4/8) of patients who received NHS England IFR-funded treatment, 54% (19/35) who received CCG IFR-funded treatment and 91% (21/23) who were funded via other routes. CONCLUSION: The high rate of IFR decline signals inefficient use of resource expended in the IFR process. Gaps in access to high-cost medicines remain for patients with rare and refractory disease requiring urgent treatment, largely due to the demand for exceptionality from NHS commissioners. Local mechanisms address this unmet need but have limitations. An outcomes-based evaluation approach to commissioning and greater transparency of previous funding decisions by commissioners may improve efficiency and equity in the IFR system.

Physicians' assessment of the Bavarian drug-expenditure control system: a qualitative study.

BACKGROUND: In 2014 a new system for drug expenditures, the Wirkstoffvereinbarung (WSV, English: Active substance agreement) was implemented in Bavaria. In pre-defined indication groups, economic prescription of medications shall be enabled based on the selection, quantity, and proportion of an individual drug. Ambulatory care physicians receive quarterly trend reports on their prescribing behavior. This study examines physicians' perceptions of the WSV. METHODS: Qualitative interviews (n = 20) and seven focus groups (n = 36) were conducted with ambulatory care physicians (e.g. general practitioners, cardiologists, pulmonologists). The methodology followed Qualitative Content Analysis. RESULTS: Physicians generally accepted the necessity of prescribing economically. The majority of them rated the WSV positively and better than the previous system. As an improvement, they especially named timely feedback in form of easily understandable trend reports, encouraging self-reflection as well as allowing early control options. Problems perceived were drug discount contracts that were strongly criticized as leading to patients mixing up medications. Some perceived constraints of therapeutic freedom. CONCLUSIONS: The implementation of the WSV is mostly viewed positively by physicians. The restrictions of therapeutic freedom partially perceived might be met by improved information on the reasons why some drugs are rated as less economical than others. TRIAL REGISTRATION NUMBER: Main ID: DRKS00019820 (German Register of Clinical Studies and World Health Organization).

Evergreening of Psychiatric Medications: A Systemic Literature Review of Strategies, Case Examples, and the Implications of Cost.

Evergreening consists of multiple ways that pharmaceutical companies extend patent protection and prolong profitability of brand name drugs past patent expiration. In psychotropic medications, these strategies do not necessarily make more effective drugs, and often increase drug prices, which can result in lower access and utilization. There has not been a systematic literature review of evergreening strategies for psychiatric medications. Based on such a review, 11 strategies were identified and relevant examples were provided. Four case examples of commonly used psychiatric medications indicated evergreen prices 3 to 211 times the cost of the original medication, and the evergreen costs ranging from $132.00 to $10,125.24 higher than the original cost on an annual basis. The higher cost of evergreening medications can create inefficiencies and waste in healthcare resulting in lower-quality patient care. Healthcare providers, patient advocates, health insurance companies, and policy-makers should be aware of these practices to improve healthcare systems.

Survival, cost and added therapeutic benefit of drugs granted early access through the French temporary authorization for use program in solid tumors from 2009 to 2019.

Decisions on market authorization (MA) and reimbursement have different durations across countries because of health technology assessment (HTA) procedures and negotiations between manufacturers and national authorities. To overcome this delay, France has implemented a Temporary Authorization for Use (ATU) program that allows early access to drugs before MA, in order to treat patients with unmet medical needs. The objectives of our study were to establish the added therapeutic benefit (ATB) of ATUs for solid tumors and to investigate the correlations between three tools evaluating ATB and survival outcomes and drug costs. Data on ATUs granted from January 2009 to December 2019 to treat solid tumors were analyzed. An assessment of their ATB was conducted using the American Society of Clinical Oncology-Value Framework (ASCO-VF), the European Society for Medical Oncology-Magnitude Clinical Benefit Scale (ESMO-MCBS) and the French HTA criterion, clinical added value (CAV). The latter score determines reimbursement and national market access. Thirty-five drugs in 39 indications were granted ATUs. All of them obtained MA and derived a clinical benefit to be reimbursed by the Social Security. Twenty-eight (71.8%) had CAV compared to preexisting therapies. 24/38 (63.2%) had a 4-5 ESMO-MCBS score and 19/33 (57.6%) had an ASCO-VF score over 45. No correlations were found between cost, PFS, OS, CAV and ASCO-VF score, while high ESMO-MCBS scores were correlated to OS. In conclusion, many patients were treated with innovations before MA thanks to ATU, although there are discrepancies between ATB scales, hence the importance of international collaboration in the evaluation of innovative therapies.

Public procurement of antineoplastic agents used for treating breast cancer in Brazil between 2013 and 2019.

BACKGROUND: Breast cancer is the most common cancer among women in Brazil and the country's public health care system is the main care provider. Timely treatment can increase the chance of cure, prevent metastasis and improve quality of life. Effective public procurement of antineoplastic agents can therefore improve access to drug therapy. This study investigates patterns in the procurement of selected antineoplastic agents used for treating breast cancer by public bodies and avoidable expenditure on these drugs between January 2013 and December 2019. METHODS: We selected antineoplastic agents used for adjuvant or preoperative chemotherapy listed in the 2018 Breast Cancer Diagnosis and Treatment Guidelines and included in category L of the WHO Anatomical Therapeutic Chemical classification system. We analyzed regular purchases of antineoplastic agents registered in the Integrated General Services Administration System (SIASG), considering purchased quantity, unit price, date of purchase and procuring entity. Prices were inflation-adjusted to July 2019 based on the National Consumer Price Index. RESULTS: A total of 10 antineoplastic agents were selected. Trastuzumab and tamoxifen accounted for the largest share of total spending and largest volume of purchases, respectively. The Ministry of Education was the largest purchaser in volume terms of all the drugs studied, except trastuzumab 440 mg, where the category "Other Institutions" accounted for most purchases, and vinorelbine 20 mg, where the Ministry of Health made most purchases. The category "Other Institutions" accounted for the largest share of total spending. Total avoidable expenditure was R$99,130,645. Prices paid for medicines and avoidable expenditure were highest in the Ministry of Defense. CONCLUSIONS: The differences observed in the performance of different categories of buyers as to amounts purchased and prices practiced for antineoplastic agents could be reduced by employing strategies to expand the centralization of purchases, resulting in expanded access to breast cancer medicines in the public sector.

Compulsory Licensing of Pharmaceuticals in High-Income Countries: A Comparative Analysis.

Policy Points Pharmaceutical trade organizations and media outlets in the United States regularly point to compulsory licensing-or even its threat-as the mechanism that peer countries use to control the price of prescription drugs. Our comparative analysis shows that compulsory licensing is not frequently employed in high-income countries outside the United States as a direct response to drug prices. When its use is threatened, a license is rarely issued and even less often does it lead to a price discount. Accordingly, compulsory licensing is unlikely to contribute to price discrepancies between the United States and other developed nations. In fact, of the 21 compulsory licensing petitions we identified outside the United States, over one-third were made by pharmaceutical companies themselves and only three were threatened by a government authority. CONTEXT: Compulsory licensing is a practice whereby national authorities can license a third party to produce a patented product, such as a pharmaceutical drug, effectively enabling the production of a generic before the original patent expires. The policy was designed-and has historically been used-to improve access to essential medicines in low-income countries and during public health crises. Although it was not intended to impact drug prices directly, the threat of compulsory licensing may indeed contribute to lower drug prices in high-income countries outside the United States. Our study sought to determine the plausibility of this claim. METHODS: We compiled a comprehensive database of compulsory licensing episodes in the United States and 17 comparator nations over the 20 years following the 2001 Doha Declaration, and we recorded the motivation and outcome of each instance. Our search began with publicly available reports compiled by organizations specializing in pharmaceutical intellectual property, expanded to a query of legal proceedings in Westlaw, and concluded with a comprehensive literature review on PubMed. FINDINGS: This strategy yielded 45 unique episodes of compulsory licensing, 24 in the United States and 21 outside. A minority (24%) of petitions outside the United States were motivated by high prices, and in all countries, only three cases were clearly associated with a price discount. CONCLUSIONS: We found no evidence to suggest that compulsory licensing is either frequently threatened or successfully implemented by countries outside the United States to secure price discounts for the most expensive pharmaceuticals, those that are newly patented and just entering the market.

Use and Costs of Nonprescription Medications Among People With Spinal Cord Injury.

OBJECTIVES: The study objectives were to assess the prevalence of, and factors associated with the use and costs of nonprescription medications among people with spinal cord injury. DESIGN: Observational design; a cross-sectional online survey. SETTING: Community in Canada. PARTICIPANTS: Individuals with spinal cord injury (N=160). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: A total of 160 individuals participated in this study. Of all study participants, 83% reported that they used at least 1 nonprescription medication over the last 12 months. On average, participants spent $52 per month on nonprescription medications. The average use and monthly expenditure did not differ significantly by age, sex, or injury parameters. Vitamins and minerals were most commonly used and constituted 62% of all nonprescription medications listed by the participants. Musculoskeletal issues were the most common health problems for which nonprescription medications were used. CONCLUSION: Nonprescription medications are a common part of therapeutic drug regimens for people with spinal cord injuries and are purchased as an out-of-pocket expense. These products may or may not have established benefits. Knowledge about the use of nonprescription medications may help prescribers to improve drug safety, medication affordability, and quality of pharmacotherapy for patients with spinal cord injury.

Cost Efficiency Analysis for Spasticity Management Based on Physician Botulinum Toxin Prescribing Habits.

OBJECTIVE: To estimate differences in botulinum toxin type A (BoNT-A) treatment costs per patient for spasticity-injecting physicians, with a focus on physicians' use of alternative BoNT-A agents other than onabotulinumtoxinA. DESIGN: Retrospective cohort study. SETTING: National Medicare data for fee-for-service beneficiaries in 2017. PARTICIPANTS: A total of 116 physicians, 6829 BoNT-A procedures, and 3051 patients were included in this analysis. Most physicians were physiatrists (84%) and used only onabotulinumtoxinA (82%). INTERVENTIONS: Type of BoNT-A selected by physicians was the independent variable of interest. Included physicians were separated into 2 groups: (1) onabotulinumtoxinA only injectors and (2) abobotulinumtoxinA and/or incobotulinumtoxinA injectors (may still use onabotulinumtoxinA). MAIN OUTCOME MEASURE: Average cost per patient per year. RESULTS: The total average BoNT-A cost per patient per year was significantly less for physicians who used abobotulinumtoxinA and/or incobotulinumtoxinA vs those who used only onabotulinumtoxinA ($3684 vs $4739; P=.01). Patients' average annual out-of-pocket costs also reflected a similar difference ($855 vs $1082; P=.02) between the groups. Doses used and numbers of injections per patient per year were not significantly different between groups. CONCLUSIONS: The present analysis demonstrated lower cost per patient for both the payer and patient when physicians used types of BoNT-A other than onabotulinumtoxinA for spasticity. Nevertheless, most physicians in this spasticity-focused study used exclusively onabotulinumtoxinA, the most expensive BoNT-A available. Reasons for this are complex and include history on the market and approved indications beyond those associated with spasticity. However, future research should continue to identify such issues with a goal of finding solutions to improve cost inefficiencies.

Profile of judicialization in access to antineoplastic drugs and their costs: a cross-sectional, descriptive study based on a set of all lawsuits filed between 2016 and 2018 in a state in the Northeast Region of Brazil.

BACKGROUND: The judicialization of the acquisition of medication for healthcare is not restricted to Brazil but can also be found in other Latin American countries, despite the existence of a universal health system in the case of Brazil, the Unified Health System (known as the SUS). Right-to-medicines litigation has existed ever since the emergence of a high demand for treatment of Acquired Immuno-deficiency Syndrome (AIDS) but the current focus is on cancer. Pharmaceutical Assistance (PA) is the area within the SUS that is responsible for ensuring access to medication and the aim of this article is thus to draw up a profile of litigation related to PA in one economically significant state in the Northeast Region of Brazil, in terms of the following characteristics of lawsuits: the plaintiff filing the lawsuit; medical and health information; the cost of acquiring the requested medications; and the proportion accounted for by spending on antineoplastic drugs. METHODS: A cross-sectional, descriptive study was conducted of lawsuits filed between 2016 and 2018 at the Litigation Center of the State of Pernambuco Department of Health. RESULTS: A total of 2,947 lawsuits containing at least one requested medication were analyzed. The majority of the plaintiffs were male (51.7%); 49.8% of the requests originated in the Unified Health System (SUS), and plaintiffs were primarily patients in the Metropolitan region of the State capital, Recife. The most frequent cancers involved were those classified by the ICD as C61, C71 and C50. The median general expense on medications for the actions was U$1,734.94. Considering antineoplastic drugs alone, the cost exceeded U$7,500 per lawsuit over the three years, given that the median unit price for antineoplastic drugs is approximately US$65 compared to US$4 for non-antineoplastic drugs. CONCLUSION: The present study is of relevance to the field of public health and examines how a profile of such healthcare litigation can be used as a tool for managing and improving decision-making in times of economic austerity.

Relationship between vigorous physical activity and health care costs among adolescents: ABCD Growth Study.

BACKGROUND: The relationship between physical activity and health care costs among adolescents is not yet clear in the literature. OBJECTIVE: To analyze the relationship between physical activity and annual health care costs among adolescents. METHODS: The present sample was composed of 85 adolescents of both sexes with ages ranging from 11 to 18 years (mean age 15.6 ± 2.1). Health care costs were self-reported every month for 12 months, and information on health care values was verified with local pharmacies, private health care plans, and the National Health Service. The time spent in different physical activity intensities was objectively measured by accelerometers. Confounding variables were: sex, age, somatic maturation, body fatness, blood pressure, and components of dyslipidemia and insulin resistance. Multivariate models were generated using generalized linear models with gamma distribution and a log-link function. RESULTS: The overall annual health care cost was US$ 733.60/ R$ 2,342.38 (medication: US$ 400.46 / R$ 1,278.66; primary and secondary care: US$ 333.14 / R$ 1,063.70). The time spent in vigorous physical activity (minutes/day) was negatively related to health care costs (r = -0.342 [95% CI: -0.537,-0.139]; ß = -0.06 cents (95% CI: -0.089, -0.031). CONCLUSION: Vigorous physical activity seems to be associated with lower health care costs among adolescents.

Cost Implications of Using Carbetocin Injection to Prevent Postpartum Hemorrhage in a Canadian Urban Hospital.

OBJECTIVE: Recent World Health Organization (WHO) recommendations regarding uterotonics for the prevention of postpartum hemorrhage (PPH) state that carbetocin should be considered a first-line prophylactic agent for all births where its cost is comparable to other effective uterotonics. This study evaluated whether a room temperature stable formulation of carbetocin met this recommendation in a Canadian urban hospital setting. METHODS: A decision tree model was developed to assess the financial implications of replacing oxytocin with carbetocin as a first-line prophylactic agent for PPH prevention in a Greater Toronto Area (GTA) hospital. The analysis accounted for the mode of delivery, efficacies of carbetocin and oxytocin in PPH prevention, occurrence of PPH-related health outcomes, and health care resource costs for PPH interventions. RESULTS: This study found that a GTA hospital, with 3242 deliveries per year, could save over CAD $349 000 annually by switching to room temperature stable carbetocin for PPH prevention. Carbetocin was able to lower institution costs by reducing the use of health care resources for PPH management in low-risk and high-risk PPH patients. The cost-saving potential of carbetocin relative to oxytocin was largely attributed to its greater efficacy in preventing the consequences of PPH. CONCLUSION: The use of room temperature stable carbetocin as a first-line prophylactic agent for PPH prevention meets WHO recommendations regarding uterotonics for PPH in a GTA hospital. The model from this study can be used to determine the financial impact of switching from oxytocin to carbetocin in other jurisdictions while diversifying a hospital's pool of PPH prophylactic agents.

Value-Based Insurance Design: Clinically Nuanced Consumer Cost Sharing to Increase the Use of High-Value Medications.

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 multistakeholder 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.

Pursuing Value-Based Prices for Drugs: A Comprehensive Comparison of State Prescription Drug-Pricing Boards.

Policy Points In the absence of federal action on rising prescription drug costs, we reviewed the details of five states that have enacted prescription drug-pricing boards seeking to lower drug prices based on products' value. Within these states, six such boards are currently authorized; they have similarities but vary in terms of structure, authority, scope, and leverage. As of June 2021, only one of the boards in our sample has conducted pricing reviews; legislators in other states can learn from the successes and challenges of existing boards. Prescription drug-pricing boards represent a novel and promising way to curb state spending and pay for value in prescription drugs but face legal and political barriers in implementation. CONTEXT: Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with a variety of policies to contain spending and achieve value in prescription drugs. As part of this series of reforms, some state legislatures have recently authorized prescription drug-pricing boards to address the high prices of brand-name prescription drugs and assess the value of those drugs. METHODS: We identified state prescription drug-pricing boards in the United States, defined as any agency authorized by a state legislature to review specific drugs and pursue value-based drug prices. To describe the characteristics of the boards, we obtained public records of authorizing legislation, guidance documents, and board meeting minutes. We compared the boards' powers and responsibilities and analyzed completed pricing reviews. FINDINGS: Six state drug-pricing boards in five states met our definition; their design varied substantially. Two of the boards (New York Medicaid and Massachusetts) have authority over drug rebates paid by state Medicaid programs, one (New York Drug Accountability Board) has jurisdiction over state-regulated commercial insurance, and another three (Maine, Maryland, and New Hampshire) oversee non-Medicaid, state-funded insurance. Three boards are authorized to require manufacturers to confidentially submit information related to the pricing and clinical effectiveness of reviewed drugs to inform value determinations. Only one board (New York Medicaid) had completed pricing reviews as of June 3, 2021. CONCLUSIONS: Boards' structure, scope, and statutory leverages to compel manufacturers to negotiate lower net costs are key factors that influence whether and to what extent boards can achieve cost savings for states. Though legal constraints may limit the effective reach of prescription drug-pricing boards, these agencies can enable states to address rising prescription drug costs, in part by virtue of their very existence. To overcome practical limitations, states seeking to implement similar policies can build on the experiences and designs of current boards.