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1.
Global Health ; 20(1): 51, 2024 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-38918859

RESUMO

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.


Assuntos
Antituberculosos , Humanos , Antituberculosos/uso terapêutico , Antituberculosos/economia , Custos de Medicamentos , Tuberculose/tratamento farmacológico , Saúde Global
2.
Cancer ; 2024 Jun 13.
Artigo em Inglês | MEDLINE | ID: mdl-38869706

RESUMO

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.

3.
Curr Oncol ; 31(5): 2453-2480, 2024 04 28.
Artigo em Inglês | MEDLINE | ID: mdl-38785465

RESUMO

Countries face challenges in paying for new drugs. High prices are driven in part by exploding drug development costs, which, in turn, are driven by essential but excessive regulation. Burdensome regulation also delays drug development, and this can translate into thousands of life-years lost. We need system-wide reform that will enable less expensive, faster drug development. The speed with which COVID-19 vaccines and AIDS therapies were developed indicates this is possible if governments prioritize it. Countries also differ in how they value drugs, and generally, those willing to pay more have better, faster access. Canada is used as an example to illustrate how "incremental cost-effectiveness ratios" (ICERs) based on measures such as gains in "quality-adjusted life-years" (QALYs) may be used to determine a drug's value but are often problematic, imprecise assessments. Generally, ICER/QALY estimates inadequately consider the impact of patient crossover or long post-progression survival, therapy benefits in distinct subpopulations, positive impacts of the therapy on other healthcare or societal costs, how much governments willingly might pay for other things, etc. Furthermore, a QALY value should be higher for a lethal or uncommon disease than for a common, nonlethal disease. Compared to international comparators, Canada is particularly ineffective in initiating public funding for essential new medications. Addressing these disparities demands urgent reform.


Assuntos
Antineoplásicos , Análise Custo-Benefício , Humanos , Antineoplásicos/uso terapêutico , Antineoplásicos/economia , Análise Custo-Benefício/métodos , Canadá , Anos de Vida Ajustados por Qualidade de Vida , Custos de Medicamentos , COVID-19 , Neoplasias/tratamento farmacológico , Neoplasias/economia , SARS-CoV-2
4.
Hosp Pharm ; 59(3): 353-358, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38764992

RESUMO

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.

5.
Artigo em Inglês | MEDLINE | ID: mdl-38597093

RESUMO

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.

6.
Artigo em Inglês | MEDLINE | ID: mdl-38557600

RESUMO

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: The 340B Drug Pricing Program is important to healthcare organizations that serve vulnerable communities. However, it is unknown whether healthcare providers in these organizations understand the 340B program and how it supports enhanced patient services. This study aims to characterize the knowledge, attitudes, and beliefs of healthcare providers toward the 340B program in a multisite federally qualified health center (FQHC). METHODS: This was a cross-sectional survey. A 27-item survey designed to assess prescriber knowledge and perspectives toward the 340B program was developed and administered. Closed-ended items were summarized using descriptive statistics, and open-ended items were analyzed with qualitative methods. RESULTS: A total of 198 healthcare providers with prescribing authority received the survey; of those, 65 (32.8%) participated. The majority of respondents (66.2%) were female; 41.5% were 35 years of age or younger, and 49.2% were physicians. The majority of respondents agreed that patients benefited from access to the organization's 340B pharmacies (95%) and that 340B pricing is important to consider when prescribing medications (78.3%). However, knowledge of the 340B program was limited, with only half of respondents (54%) able to correctly answer at least 4 of 7 knowledge-focused items. Reponses to a patient case suggested that some providers may be unfamiliar with which drugs are available at reduced prices. CONCLUSION: The findings suggest that providers believe the 340B program benefits patients and the organization but often lack a complete understanding of the program. Future research should focus on prescriber education as a strategy to help organizations optimize their 340B programs and facilitate patient access to medications.

7.
Cureus ; 16(3): e56103, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38618372

RESUMO

Introduction Type 2 diabetes mellitus (T2DM) poses a substantial burden globally and particularly in India, affecting health, finances, and overall quality of life. The management of this condition relies on lifestyle modifications and advanced pharmacological interventions, with emerging drugs showing promise in areas such as administration, side effects, efficacy, and cardiovascular benefits. However, their market penetration is hindered by high costs. Understanding the target population's expectations and willingness to pay (WTP) for these drugs is crucial. WTP, a key concept in behavioral science, reflects the maximum price consumers are willing to pay for a product, aiding in healthcare cost-effectiveness evaluations. Despite its relevance, only one WTP study has been conducted in the Indian context for diabetes. This study explores WTP for two novel drugs: oral semaglutide and icodec (weekly insulin). Material and methods This observational study, conducted in a diabetes specialty clinic and telemedicine facility in All India Institute of Medical Sciences, Bhopal, India, involved adults (18-80 years) diagnosed with T2DM. Data collection adhered to ethical guidelines, and participants provided written informed consent. Face-to-face interviews were employed to gather socio-economic, demographic, and medical details. Participants estimated their WTP for oral semaglutide and weekly insulin, considering reference ranges for existing antidiabetic treatments. Statistical analyses, including t-tests and analysis of variance, explored sociodemographic and clinical factors influencing WTP. Results Of 105 approached patients, 87 (74.3%) participated. The majority were males (55.2%) with an average age of 57.2 years. The average WTP for oral semaglutide was INR 9.35±5.66 per pill, significantly lower than its market price (INR 315). For weekly insulin (icodec), the WTP was INR 157.25±112.60 per dose. Subgroup analyses revealed no significant correlations based on sociodemographic or clinical parameters. Conclusion This study demonstrated the feasibility of WTP assessments in an Indian outpatient setting, revealing a substantial cost disparity between patients' WTP for oral semaglutide and its market price. The findings underscore the importance of considering WTP in introducing new diabetes medications in India, offering valuable insights for healthcare decision-makers and developers.

8.
Urol Pract ; 11(2): 276-282, 2024 03.
Artigo em Inglês | MEDLINE | ID: mdl-38377158

RESUMO

INTRODUCTION: Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022 with a goal to decrease prescription drug costs. Thus far, research has focused on possible savings if Medicare purchased its annual volume of drugs at MCCPDC prices. The aim of this study is to analyze if MCCPDC can offer savings directly to urologic patients compared with other mail-order pharmacies, local pharmacies, and with patients using health insurance. METHODS: Twelve drugs used to treat urological diseases available on MCCPDC were analyzed. Pricing data of 30-tab and 90-tab prescriptions from MCCPDC, other mail-order pharmacies, and local in-person pharmacies near our zip code 40508 (Lexington, Kentucky) were compiled. To compare if MCCPDC could offer savings to patients using health insurance to fill their prescriptions, out-of-pocket drug costs for patients from the 2020 and 2021 Medical Expenditure Panel Survey and the 2021 Medicare Part D spending data were extracted. RESULTS: Greater savings at MCCPDC were found at 90-tab prescriptions, but overall variability in prices existed. When comparing without health insurance, 9 of 12 drugs at MCCPDC were cheaper at 90 tabs with solifenacin and tadalafil saving $20 and $12 per prescription. When considering patients using insurance, abiraterone, sildenafil, and tadalafil offered savings on out-of-pocket costs at 30- and 90-tab prescriptions. CONCLUSIONS: MCCPDC may offer cheaper prices for patients filling urologic medications, especially at 90-tab prescriptions. This study is the first to show patients could save money using MCCPDC and has implications for physician counseling when prescribing common urologic drugs.


Assuntos
Medicare Part D , Medicamentos sob Prescrição , Idoso , Humanos , Estados Unidos , Custos de Medicamentos , Tadalafila , Seguro Saúde
9.
J Am Board Fam Med ; 36(6): 1065-1067, 2024 01 05.
Artigo em Inglês | MEDLINE | ID: mdl-38171579

RESUMO

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


Assuntos
Farmácia , Medicamentos sob Prescrição , Humanos , Estados Unidos , Seguro de Serviços Farmacêuticos , Custos de Medicamentos
10.
Ciênc. Saúde Colet. (Impr.) ; 29(1): e18142022, 2024. tab
Artigo em Português | LILACS-Express | LILACS | ID: biblio-1528328

RESUMO

Resumo No Sistema Único de Saúde os medicamentos do grupo 1 do Componente Especializado da Assistência Farmacêutica (CEAF) são financiados pela União e adquiridos de forma centralizada (grupo 1A) ou por cada Unidade Federativa (UF) (grupo 1B). Diferentemente de outros países onde se negocia um preço fixo a ser praticado no sistema público, no Brasil as aquisições são realizadas por licitação, o que pode levar a diferentes preços. Para permitir a comparação de preços, foi pactuada a obrigatoriedade de registro das aquisições públicas no Banco de Preços em Saúde (BPS). O estudo teve como objetivo analisar a variabilidade dos preços de medicamentos do grupo 1B adquiridos pelas UF do Brasil em 2021. Foram obtidas as aquisições de medicamentos do grupo 1B realizadas pelas Secretarias de Estado das 27 UF por consulta ao BPS excluindo-se os medicamentos sem preço de ressarcimento estabelecido em dezembro/2021. Foi obtido do Sistema de Informações Ambulatoriais o ressarcimento para cada UF. Verificou-se grande variabilidade dos preços de aquisição para cada medicamento entre as UF e dentro da mesma UF. O estudo demonstrou potencial iniquidade de acesso ao CEAF, privilegiando com menores preços UF mais favorecidas (maior população e riqueza).


Abstract In the Brazilian Health System (SUS), drugs covered by the Specialized Pharmaceutical Scheme (CEAF) receive federal funding and can be procured either centrally (Group 1A) or by individual states (Federal Units - UF) (Group 1B). Unlike other countries where national procurement prices are negotiated centrally by the government, public procurement in Brazil follows a public auction procedure, potentially resulting in varying purchase prices. To facilitate price comparisons, it is a legal requirement to register public acquisitions in the Health Prices Registry (BPS). This study aimed to assess the variability in the procurement prices for Group 1B drugs across the 27 Brazilian states during 2021. Data on the acquisitions of Group 1B drugs by the 27 Health Secretariats were obtained from the BPS. Drugs with no reported reimbursement prices as of December 2021 were excluded from the analysis. The total reimbursement amount for each state was sourced from the SUS Ambulatory Information System. The findings revealed significant variability in drug procurement prices both across and within states. The study underscored a potential disparity in CEAF access, favoring wealthier states (those with larger populations and higher economic status) by securing lower drug prices.

11.
Orphanet J Rare Dis ; 18(1): 342, 2023 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-37915031

RESUMO

BACKGROUND: The Orphan Regulation ((EC) No 141/2000) has successfully redirected private and public investment towards previously neglected areas through incentives, regulatory obligations and rewards. However, the growth in the number of licensed orphan medicinal products (OMPs) has led to concerns about increased costs. The aims were to investigate the trend in the costs of OMPs to the National Health Service in Wales, to attribute costs of medicines within and outside periods of marketing exclusivity, and estimate the contribution of individual medicines to the overall costs of OMPs. METHODS: Expenditure on OMPs in Wales was analysed between the 2014/15 and 2019/20 financial years using data on prescriptions dispensed in primary care, secondary care, and specialised commissioned services. OMP spend was calculated as a proportion of total medicines expenditure, whether it was incurred during, or outside the marketing exclusivity period (MEP), and by therapeutic area and medicine. RESULTS: Overall spend on OMPs and all medicines increased from £32 m to £82 m, and from £1,030 m to £1,198 m, respectively, with the proportion of spend on OMPs more than doubling from 3.1% to 6.9% per annum. Average year-on-year growth in the costs of OMPs was 21%, compared to 2% for other medicines. Costs following MEP expiry contributed significantly to overall OMP costs, increasing from £8 m to £30 m, corresponding to an increase from 24% to 37%. Treatments for 'malignant disease and immunosuppression', 'nutrition and blood' and the 'respiratory system' accounted for 90% of all OMP spend. Half of total OMP annual expenditure was on just 4 medicines in 2014/15, increasing to 8 in 2019/20. CONCLUSIONS: Both the number of OMPs and the amount spent on OMPs in Wales has increased over time, possibly as a consequence of favourable licensing conditions, permissive health technology assessment policies and dedicated funding.


Assuntos
Gastos em Saúde , Doenças Raras , Humanos , Doenças Raras/tratamento farmacológico , País de Gales , Medicina Estatal , Produção de Droga sem Interesse Comercial
13.
BMC Health Serv Res ; 23(1): 961, 2023 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-37679698

RESUMO

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).


Assuntos
Clínicos Gerais , Gastos em Saúde , Humanos , Pesquisa Qualitativa , Grupos Focais , Assistência Ambulatorial
15.
Cancer Immunol Immunother ; 72(11): 3839-3850, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37733060

RESUMO

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.


Assuntos
Carcinoma de Célula de Merkel , Inibidores de Checkpoint Imunológico , Melanoma , Neoplasias Cutâneas , Humanos , Carcinoma de Célula de Merkel/tratamento farmacológico , Duração da Terapia , Melanoma/tratamento farmacológico , Estudos Prospectivos , Estudos Retrospectivos , Neoplasias Cutâneas/tratamento farmacológico , Inibidores de Checkpoint Imunológico/uso terapêutico
16.
Front Pharmacol ; 14: 1215431, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37719853

RESUMO

The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases. However, the resulting increase of medicines being marketed with conditional authorizations and in exceptional circumstances has lead to higher clinical uncertainty about their efficacy and safety than when the standard authorizations are applied. This uncertainty has significant implications for clinical practice and the negotiation of pricing and reimbursement, particularly as high prices are based on assumptions of high value, supported by regulatory prioritization. The burden of clinical development is often shifted towards public healthcare systems, resulting in increased spending budgets and opportunity costs. Effective management of uncertainty, through appropriate testing and evaluation, and fair reflection of costs and risks in prices, is crucial. However, it is important not to sacrifice essential elements of evidence-based healthcare for the sake of access to new treatments. Balancing sensitive and rational access to new treatments, ensuring their safety, efficacy, and affordability to healthcare systems requires thoughtful decision-making. Ultimately, a responsible approach to timely access to innovative medicines that balances the needs of patients with healthcare systems' concerns is necessary. This approach emphasizes the importance of evidence-based decision-making and fair pricing and reimbursement.

17.
Urol Pract ; 10(5): 476-483, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37409930

RESUMO

INTRODUCTION: Combination systemic therapy for advanced prostate cancer has reduced mortality, but high out-of-pocket costs impose financial barriers for patients. The Inflation Reduction Act's $2,000 out-of-pocket spending cap for Medicare's prescription drug benefit (Part D) can potentially lower out-of-pocket spending for beneficiaries starting in 2025. This study aims to compare out-of-pocket spending for commonly prescribed regimens for advanced prostate cancer before and after implementation of the Inflation Reduction Act. METHODS: Medication regimens constructed to treat metastatic, hormone-sensitive prostate cancer consisted of baseline androgen deprivation therapy with traditional chemotherapy, androgen receptor inhibitors, and androgen biosynthesis inhibitors. Using 2023 Medicare Part B prices and the Medicare Part D plan finder, we estimated annual out-of-pocket costs under current law and under the Inflation Reduction Act's redesigned standard Part D benefit. RESULTS: Under current law, out-of-pocket costs for Part D drugs ranged from $464 to $11,336 per year. Under the Inflation Reduction Act, annual out-of-pocket costs for 2 regimens remained unchanged: androgen deprivation therapy with docetaxel and androgen deprivation therapy with abiraterone and prednisone. However, out-of-pocket costs for regimens using branded novel hormonal therapy were significantly lower under the 2025 law with potential savings estimated to be $9,336 (79.2%) for apalutamide, $9,036 (78.7%) for enzalutamide, and $8,480 (76.5%) for docetaxel and darolutamide. CONCLUSIONS: The $2,000 spending cap introduced by the Inflation Reduction Act may significantly decrease out-of-pocket costs and reduce financial toxicity associated with advanced prostate cancer treatment, impacting an estimated 25,000 Medicare beneficiaries.


Assuntos
Medicare Part B , Neoplasias da Próstata , Masculino , Humanos , Idoso , Estados Unidos/epidemiologia , Neoplasias da Próstata/tratamento farmacológico , Gastos em Saúde , Docetaxel , Antagonistas de Androgênios , Androgênios
18.
Explor Res Clin Soc Pharm ; 11: 100295, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37404594

RESUMO

Background: The federal 340B drug program was designed to stretch scarce federal resources to provide more comprehensive services for more eligible patients. To help satisfy community needs, 340B Prescription Assistance Programs (PAPs) allow eligible patients to access medications at significantly reduced costs. Objectives: To measure the impact of reduced-cost medications for chronic obstructive pulmonary disease (COPD) through a 340B PAP on all-cause hospitalizations and emergency department visits. Methods: This multi-site, retrospective, single-sample, pre-post cohort study involved patients with COPD who used a 340B PAP to fill prescriptions for an inhaler or nebulizer between April 1, 2018, and June 30, 2019. Data from included subjects were evaluated and compared in the year before and after each individual patient's respective prescription fill in the 340B PAP. The primary outcome evaluated the impact of 340B PAP on all-cause hospitalizations and emergency department visits. Secondary outcomes evaluated the financial impact associated with program use. Wilcoxon signed-rank test was utilized to assess changes in the outcome measures. Results: Data for 115 patients were included in the study. Use of the 340B PAP resulted in a significant reduction in the composite mean number of all-cause hospitalizations and emergency department visits (2.42 vs 1.66, Z = -3.12, p = 0.002). There was an estimated $1012.82 mean cost avoidance per patient due to reduction in healthcare utilization. Annual program-wide prescription cost savings for patients totaled $178,050.21. Conclusions: This study suggested that access to reduced-cost medications through the federal 340B Drug Pricing Program was associated with a significant reduction in hospitalizations and emergency department visits for patients with COPD, decreasing patients' utilization of healthcare resources.

19.
J Rheumatol ; 50(10): 1302-1309, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37321640

RESUMO

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.


Assuntos
Lúpus Eritematoso Sistêmico , Humanos , Estados Unidos , Estudos Transversais , Inquéritos e Questionários , Modelos Lineares , Lúpus Eritematoso Sistêmico/epidemiologia , Medidas de Resultados Relatados pelo Paciente
20.
Front Public Health ; 11: 1159119, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37228740

RESUMO

Background: In April 2009, the Chinese government launched Zero Markup Drug Policy (ZMDP) to adjust medical institutions' revenue and expenditure structures. Objective: This study evaluated the impact of implementing ZMDP (as an intervention) on the drug costs for managing Parkinson's disease (PD) and its complications from the healthcare providers' perspective. Methods: The drug costs for managing PD and its complications per outpatient visit or inpatient stay were estimated using electronic health data from a tertiary hospital in China from January 2016 to August 2018. An interrupted time series analysis was conducted to evaluate the immediate change following the intervention (step change, ß1) and the change in slope, comparing post-intervention with the pre-intervention period (trend change, ß2). Subgroup analyses were conducted in outpatients within the strata of age, patients with or without health insurance, and whether drugs were listed in the national Essential Medicine List (EML). Results: Overall, 18,158 outpatient visits and 366 inpatient stays were included. Outpatient (ß1 = -201.7, 95%CI: -285.4, -117.9) and inpatient (ß1 = -372.1, 95% CI: -643.6, -100.6) drug costs for managing PD significantly decreased when implementing ZMDP. However, for outpatients without health insurance, the trend change in drug costs for managing PD (ß2 = 16.8, 95% CI: 8.0, 25.6) or PD complications (ß2 = 12.6, 95% CI: 5.5, 19.7) significantly increased. Trend changes in outpatient drug costs for managing PD differed when stratifying drugs listed in EML (ß2 = -1.4, 95% CI: -2.6, -0.2) or not (ß2 = 6.3, 95%CI: 2.0, 10.7). Trend changes of outpatient drug costs for managing PD complications significantly increased in drugs listed in EML (ß2 = 14.7, 95% CI 9.2, 20.3), patients without health insurance (ß2 = 12.6, 95% CI 5.5, 19.7), and age under 65 (ß2 = 24.3, 95% CI 17.3, 31.4). Conclusions: Drug costs for managing PD and its complications significantly decreased when implementing ZMDP. However, the trend in drug costs increased significantly in several subgroups, which may offset the decrease at the implementation.


Assuntos
Medicamentos Essenciais , Doença de Parkinson , Humanos , Custos de Medicamentos , Análise de Séries Temporais Interrompida , Doença de Parkinson/tratamento farmacológico , Política de Saúde , Reforma dos Serviços de Saúde , China
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