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3.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 717-723, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31826655

RESUMO

Objectives: Timely access to novel anticancer drugs is challenging and value frameworks such as the European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) could assist in drug prioritization. We assessed the overall time to access to novel anticancer drugs in Slovenia and its correlation with ESMO-MCBS scores.Methods: Anticancer drugs with European Medicines Agency marketing authorization (EMA MA), applying for national reimbursement approval (NRA) in the period 2008-2018 with assigned ESMO-MCBS score, were included. Publically available data from EMA and the Slovenian National Health Insurance Institute were used for time calculations.Results: Among 53 studied drugs; a majority (47) of them obtained reimbursement approval within the observed time. The median time to EMA MA was 397 (range 98-615) days with the NRA requiring additional 422 (range 154-892) days. Neither time to EMA MA nor NRA correlated with ESMO-MCBS substantial clinical benefit (p = 0.332 and p = 0.965, respectively).Conclusions: In Slovenia, time to access to novel anticancer drugs exceeds two years and, more importantly, is equally long for drugs with or without substantial clinical benefit. Integration of the ESMO-MCBS into reimbursement deliberations could improve access to drugs with substantial clinical benefit.


Assuntos
Antineoplásicos/provisão & distribução , Acesso aos Serviços de Saúde/estatística & dados numéricos , Mecanismo de Reembolso/economia , Antineoplásicos/economia , Acesso aos Serviços de Saúde/economia , Humanos , Neoplasias/tratamento farmacológico , Eslovênia , Sociedades Médicas , Fatores de Tempo
5.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 633-643, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31608715

RESUMO

Introduction: With the advent of targeted therapy, the U.S. Food and Drug Administration has recently approved several oral anticancer medications (OAMs) for breast cancer (BC). Despite the improved effectiveness of those OAMs, the high financial burden is an issue. Evidence from cost-effectiveness analysis (CEA) can provide valuable information for decision-makers when deciding whether to use these high-priced medications. Many CEAs on OAMs have been conducted using various analytical approaches and cost-effectiveness thresholds (CETs). However, there is no comprehensive systematic review of CEAs across all OAMs.Area covered: PubMed and Cochrane library were used to select for CEAs of OAM for BC in the U.S. published by May 2019. Among the 25 included studies, studies published between 1993 and 2011 analyzed either early BC (n = 11) or advanced/metastatic BC (n = 5), those between 2012-2019 analyzed advanced/metastatic BC (n = 9). Studies including targeted therapies were published after 2009. The CETs tended to increase over time and were higher in the studies for advanced/metastatic BC (median = $125,000) than those for early BC (median = $50,000).Expert commentary: The target population and medications of interest have changed and the methods of articles have evolved. The range of CETs tends to differ by study setting with an increase over time.


Assuntos
Antineoplásicos/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Administração Oral , Antineoplásicos/economia , Neoplasias da Mama/economia , Neoplasias da Mama/patologia , Análise Custo-Benefício , Feminino , Humanos , Terapia de Alvo Molecular/economia , Estados Unidos
7.
Anticancer Res ; 39(10): 5559-5564, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31570450

RESUMO

BACKGROUND/AIM: Tyrosine kinase inhibitors are important in the treatment of metastatic renal cell cancer (mRCC). The aim of the study was to evaluate the costs and effects of sunitinib in mRCC. PATIENTS AND METHODS: A total of 81 mRCC patients who received first-line sunitinib therapy between 2010 and 2014 were recruited. Drug doses, laboratory and imaging studies, outpatient visits and inpatient stays were recorded. Health-related quality of life (HRQoL) was measured (15D- and EQ-5D - 3L questionnaires). RESULTS: The cost of sunitinib (mean 22,268 €/patient range 274 € to 105,121 €) covered 73% of the total costs during the treatment period. The total treatment cost was 30,530 €/patient (range=1,661-111,516 €). The median overall survival was 17.9 months. HRQoL decreased during treatment. CONCLUSION: The main cost during sunitinib treatment of mRCC was the drug itself (73% of the total costs). Drug costs and HRQoL should be considered when choosing treatment for mRCC.


Assuntos
Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/economia , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/economia , Sunitinibe/economia , Sunitinibe/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Análise Custo-Benefício/métodos , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida
8.
Global Health ; 15(1): 57, 2019 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-31533850

RESUMO

In 2015, the World Health Organization (WHO) Expert Committee approved the addition of 16 cancer medicines to the WHO Model List of Essential Medicines (EML), bringing the total number of cancer medicines on the list to 46. This change represented the first major revision to the EML oncology section in recent history and reinforces international recognition of the need to ensure access and affordability for cancer treatments. Importantly, many low and middle-income countries rely on the EML, as well as the children's EML, as a guide to establish national formularies, and moreover use these lists as tools to negotiate medicine pricing. However, EML inclusion is only one component that impacts cancer treatment access. More specifically, factors such as intellectual property rights and international trade agreements can interact with EML inclusion, drug pricing, and accessibility. To better understand this dynamic, we conducted an interdisciplinary review of the patent status of EML cancer medicines compared to other EML noncommunicable disease medicines using the 17th, 18th, 19th, 20th, and 21st editions of the list. We also explored the interaction of intellectual property rights with the international trade regime and how trade agreements can and do impact cancer treatment access and affordability. Based on this analysis, we conclude that patent status is simply one factor in the complex international environment of health systems, IPR policies, and trade regimes and that aligning these oftentimes disparate interests will require shared global governance across the cancer care continuum.


Assuntos
Antineoplásicos , Comércio/organização & administração , Medicamentos Essenciais , Propriedade Intelectual , Cooperação Internacional , Políticas , Antineoplásicos/economia , Antineoplásicos/provisão & distribução , Custos e Análise de Custo , Medicamentos Essenciais/economia , Medicamentos Essenciais/provisão & distribução , Acesso aos Serviços de Saúde , Humanos , Neoplasias/tratamento farmacológico , Organização Mundial da Saúde
9.
Gan To Kagaku Ryoho ; 46(8): 1281-1286, 2019 Aug.
Artigo em Japonês | MEDLINE | ID: mdl-31501370

RESUMO

At Ogaki Municipal Hospital, we expanded the preparation of anticancer drugs using a closed system drug transfer device (CSTD)when revising medical fees in 2016. In this study, we investigated the number of regimens and number of preparations for outpatients in December 2017. Subsequently, the cost of all consumables related to the preparation of anticancer drugs was calculated. In total, 574 preparations of 68 regimens were conducted, with CSTD used in the preparation of 331 (57.7%)drugs. The cost associated with preparation of anticancer drugs was 1,608,163 yen/month, of which the CSTD cost was 1,135,315 yen/month(70.6%). Given the disproportionately high cost related to CSTD, we investigated for material cost reduction. Although CSTD has a mechanism for adjusting the differential pressure inside and outside the vial, the conditions were used to calculate medical fee; however, if we use what we do not have, we estimated that the facility burden would be reduced by 24.7%. CSTD can contribute not only to safety through exposure prevention but also to medical cost reduction through introduction of "Drug Vial Optimization." We believe it will continue to act as a medical evidence to reduce medical fee remuneration and ease the conditions of fee calculation.


Assuntos
Antineoplásicos/economia , Exposição Ocupacional , Equipamentos de Proteção
10.
J Pak Med Assoc ; 69(Suppl 2)(6): S34-S40, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31369532

RESUMO

Objective: Colorectal cancer (CRC) is the third most common, and the second deadliest, cancer documented in recent years, and numerous studies have addressed this issue. Nevertheless, little attention has been given to the CRC burden in Vietnam. Our study aims to analyze variations in cost for CRC treatments using the cost of illness (COI) method. Methods: Utilizing medical records spanning from 2014 to 2017 supplied by a primary healthcare facility in Ho Chi Minh City, a population of 9,126 patients, diagnosed with and treated for CRC, was analyzed in terms of demographic detail and individual treatment cost. Results: Among the 9,126 patients hospitalized with CRC, 3,699 patients were between the ages of 50 and 65. Colon cancer accounted for 56.4% and 60.4% of the total patients in Inpatient Department (IPD) and Outpatient Department (OPD). The total direct medical cost was calculated to be over ten million USD for IPD patients and over three million USD for OPD patients over a four year span of data. The per-patient cost was $2,741.00 (IPD) and $588.80 (OPD), with chemotherapy drugs being 53% (IPD) and 73% (OPD) of the overall treatment cost. Patients going through both treatment regimens incurred a mean cost of $4,271.20 (IPD) and $1,779.80 (OPD). Conclusions: There is a similarity in the costs of CRC treatment in developing countries in Asia. Despite many limitations, we are certain this study will be useful for future studies regarding the CRC burden in Asia in general, as well as in developing countries like Vietnam.


Assuntos
Assistência Ambulatorial/economia , Antineoplásicos/economia , Neoplasias Colorretais/economia , Efeitos Psicossociais da Doença , Procedimentos Cirúrgicos do Sistema Digestório/economia , Gastos em Saúde , Hospitalização/economia , Adulto , Idoso , Neoplasias Colorretais/terapia , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Vietnã
11.
Hist Philos Life Sci ; 41(3): 30, 2019 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-31363860

RESUMO

This paper looks at the commodification of interferon, marketed by Hoffmann La Roche (short: Roche) as Roferon A in 1986, as a case study that helps us understand the role of pharmaceutical industry in cancer research, the impact of molecular biology on cancer therapy, and the relationships between biotech start-ups and established pharmaceutical firms. Drawing extensively on materials from the Roche company archives, the paper traces interferon's trajectory from observed phenomenon (viral interference) to product (Roferon A). Roche embraced molecular biology in the late 1960s to prepare for the moment when the patents on some of its bestselling drugs were going to expire. The company funded two basic science institutes to gain direct access to talents and scientific leads. These investments, I argue, were crucial for Roche's success with recombinant interferon, along with more mundane, technical and regulatory know-how held at Roche's Nutley base. The paper analyses in some detail the development process following the initial success of cloning the interferon gene in collaboration with Genentech. It looks at the factors necessary to scale up the production sufficiently for clinical trials. Using Alfred Chandler's concept of 'organizational capabilities', I argue that the process is better described as 'mobilisation' than as 'translation'.


Assuntos
Antineoplásicos/história , Mercantilização , Desenvolvimento de Medicamentos/história , Indústria Farmacêutica/história , Interferon alfa-2/história , Antineoplásicos/economia , Ensaios Clínicos como Assunto/história , Indústria Farmacêutica/economia , História do Século XX , Humanos , Interferon alfa-2/economia , Interferência Viral
12.
BMC Public Health ; 19(1): 977, 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31331312

RESUMO

BACKGROUND: Decisions relating to the funding of new drugs are becoming increasingly challenging due to a combination of aging populations, rapidly increasing list prices, and greater numbers of drug-indication pairs being brought to market. This is especially true in cancer, where rapid list price inflation is coupled with steeply rising numbers of incident cancer cases. Within a publicly funded health care system, there is increasing recognition that resource allocation decisions should consider the reassessment of, and potential disinvestment from, currently funded interventions alongside new investments. Public input into the decision-making process can help legitimize the outcomes and ensure priority-setting processes are aligned with public priorities. METHODS: In September 2014, a public deliberation event was held in Vancouver, Canada, to obtain public input on the topic of cancer drug funding. Twenty-four members of the general public were tasked with making collective recommendations for policy-makers about the principles that should guide funding decisions for cancer drugs in the province of British Columbia. Deliberative questions and decision aids were used to elicit individuals' willingness to make trade-offs between expenditures and health outcomes. RESULTS: Participants discussed the implications of disinvestment decisions from cancer drugs in terms of its impact on patient choice, fairness and quality of life. Their discussions indicate that in order for a decision to disinvest from currently-funded cancer drugs to be acceptable, it must align with three main principles: the decision must be accompanied by significant gains, described both in terms of cost savings and opportunities to re-invest elsewhere in the health care system; those who are currently prescribed a cancer drug should be allowed to continue their course of treatment (referred to as a continuance clause, or "grandfathering" approach); and it must consider how access to care for specialized populations is impacted. CONCLUSIONS: The results from this deliberation event provide insight into what is acceptable to British Columbians with respect to disinvestment decisions for cancer drugs. These recommendations can be considered within wider health system decision-making frameworks for funding decisions relating to all drugs, as well as for cancer drugs.


Assuntos
Antineoplásicos/economia , Financiamento Governamental , Opinião Pública , Adolescente , Adulto , Idoso , Colúmbia Britânica , Participação da Comunidade , Tomada de Decisões , Feminino , Alocação de Recursos para a Atenção à Saúde/organização & administração , Humanos , Masculino , Pessoa de Meia-Idade , Formulação de Políticas , Adulto Jovem
13.
Value Health ; 22(7): 762-767, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31277821

RESUMO

OBJECTIVES: To evaluate the relationship between cancer history and cost-related medication nonadherence (CRN) as well as cost-coping strategies, by health insurance coverage. METHODS: We used the 2013 to 2016 National Health Interview Survey to identify adults aged 18 to 64 years with (n = 3599) and without (n = 56 909) a cancer history. Cost-related changes in medication use included (1) CRN, measured as skipping, taking less, or delaying medication because of cost, and (2) cost-coping strategies, measured as requesting lower cost medication or using alternative therapies to save money. Separate multivariable logistic regressions were used to calculate the adjusted odds ratios (AORs) of CRN and cost-coping strategies associated with cancer history, stratified by insurance. RESULTS: Cancer survivors were more likely than adults without a cancer history to report CRN (AOR 1.26; 95% confidence interval [CI] 1.10-1.43) and cost-coping strategies (AOR 1.10; 95% CI 0.99-1.19). Among the privately insured, the difference in CRN by cancer history was the greatest among those enrolled in high-deductible health plans (HDHPs) without health savings accounts (HSAs) (AOR 1.78; 95% CI 1.30-2.44). Among adults with HDHP and HSA, cancer survivors were less likely to report cost-coping strategies (AOR 0.62; 95% CI 0.42-0.90). Regardless of cancer history, CRN and cost-coping strategies were the highest for those uninsured, enrolled in HDHP without HSA, and without prescription drug coverage under their health plan (all P<.001). CONCLUSIONS: Cancer survivors are prone to CRN and more likely to use cost-coping strategies. Expanding options for health insurance coverage, use of HSAs for those with HDHP, and enhanced prescription drug coverage may effectively address CRN.


Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Sobreviventes de Câncer/psicologia , Gastos em Saúde , Cobertura do Seguro/economia , Seguro Saúde/economia , Adesão à Medicação , Neoplasias/tratamento farmacológico , Neoplasias/economia , Adolescente , Adulto , Redução de Custos , Dedutíveis e Cosseguros/economia , Substituição de Medicamentos/economia , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Feminino , Pesquisas sobre Serviços de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Poupança para Cobertura de Despesas Médicas , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Neoplasias/psicologia , Fatores de Tempo , Estados Unidos/epidemiologia , Adulto Jovem
14.
S Afr Med J ; 109(6): 387-391, 2019 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-31266556

RESUMO

South Africa (SA) is in the process of amending its patent laws. Since its 2011 inception, Fix the Patent Laws, a coalition of 40 patient groups, has advocated for reform of SA's patent laws to improve affordability of medicines in the country. Building on two draft policies (2013, 2017) and a consultative framework (2016) for reform of SA's patent laws, Cabinet approved phase 1 of the Intellectual Property Policy of the Republic of South Africa on 23 May 2018. Fix the Patent Laws welcomed the policy, but highlighted concerns regarding the absence of important technical details, as well as the urgent need for government to develop bills, regulations and guidelines to provide technical detail and to codify and implement patent law reform in the country. In this article, we explore how reforms proposed in SA's new intellectual property policy could improve access to medicine through four medicine case studies.


Assuntos
Custos de Medicamentos , Acesso aos Serviços de Saúde , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Antineoplásicos/economia , Antivirais/economia , Custos e Análise de Custo , Indústria Farmacêutica , Cloridrato de Erlotinib/economia , Guanina/análogos & derivados , Guanina/economia , Humanos , Fatores Imunológicos/economia , Lenalidomida/economia , Sorafenibe/economia , África do Sul
17.
J Manag Care Spec Pharm ; 25(7): 765-769, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31232209

RESUMO

BACKGROUND: Patients with cancer often face financial toxicity. They may face financial distress because of high out-of-pocket costs that in turn can result in delays in treatment, treatment abandonment, and higher overall costs of care, all of which can have have a negative effect on patient care. A specialty pharmacy practice model can play a role in decreasing financial toxicity. OBJECTIVE: To evaluate the patient out-of-pocket costs after enrollment in manufacturer patient assistance programs, copay cards, and foundation grants by an oncology specialty pharmacy at University of Chicago Medicine (UCM). METHODS: For this quality improvement project, a retrospective analysis of prescription claims from January 2017 to June 2017 was performed. The primary outcomes included the number of patients enrolled in manufacturer patient assistance programs, copay cards, and foundation grants, along with the total dollars applied to pharmacy claims. The secondary outcome was the average days to approval of a foundation grant. Inclusion criteria for this quality improvement project included prescriptions filled at UCM Specialty Pharmacy in the 6-month time frame for an oncology indication. Exclusion criteria were prescriptions that were not filled at UCM Specialty Pharmacy due to out-of-network insurance and prescriptions that were part of a patient assistance program where the medication was directly shipped from the manufacturer. RESULTS: In the 6-month time frame, 75 patients received financial assistance, with a total cost savings of $314,857. Financial assistance was most frequently applied to the following medications: peg-filgrastim, dasatinib, abiraterone, filgrastim and filgrastim-sndz, palbociclib, venetoclax, and ruxolitinib. The cost savings of these interventions ranged between $5 and $13,138 per prescription claim. The average days from date of insurance approval to date of financial grant approval was 1.2 days. CONCLUSIONS: This project demonstrates the importance of an oncology specialty pharmacy team in ensuring timely approval of a foundation grant and reducing financial toxicity, which can play a major role in access to therapy. DISCLOSURES: No outside funding supported this project. The authors have no conflicts of interest to report. This project was presented at the Vizient University Health System Consortium Pharmacy Network Resident Poster Session; December 1, 2017; Orlando, FL.


Assuntos
Antineoplásicos/economia , Gastos em Saúde/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Serviço de Farmácia Hospitalar/economia , Centros Médicos Acadêmicos , Redução de Custos , Custos de Medicamentos , Indústria Farmacêutica/economia , Acesso aos Serviços de Saúde/economia , Humanos , Oncologia , Neoplasias/economia , Serviço de Farmácia Hospitalar/organização & administração , Melhoria de Qualidade , Estudos Retrospectivos , Fatores de Tempo
19.
Indian J Cancer ; 56(2): 146-150, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31062734

RESUMO

PURPOSE: Drug wastage is a major concern in oncology where costs of antineoplastic drugs are exorbitant, and the disposal of toxic drugs increases the chances of occupational hazards to healthcare and sanitary workers and environmental pollution at the site of disposal. The principal objective of this study was to ascertain the extent of drug wastage and calculate its financial costs. MATERIALS AND METHODS: This was a prospective pilot study conducted to ascertain the quantity of drug wastage in a tertiary care hospital. This pilot study was conducted in day care and inpatient facilities in February 2016. The prescription of cytotoxic drugs, recommended dose, the quantity used, and remainder (waste) left were recorded from the nurses and pharmacy files of the hospital. Cost evaluation of the actual use and the waste was undertaken and an audit was conducted to understand in which anticancer drug the maximum wastage was generated. RESULTS: The results of this study indicated that 6.1% of the total amount of reconstituted drugs was wasted. The highest drug wastage was observed in trastuzumab (29.55%), followed by etoposide (20.4%), dacarbazine (17.14%), daunorubicin (16.67%), and carboplatin (11.29%). Cost analysis showed that the total cost of the drug issued during the study period was Rs. 1,294,975 and the cost of drug wastage amounted to Rs. 143,820 (11.1%). CONCLUSION: To the best of authors' knowledge, this is the first study from India and the results indicate that the financial impact of anticancer drug wastage was substantial. Attempts should be directed at minimizing the wastage and cost savings without risking patients' treatment regimen and administering effective dose schedule.


Assuntos
Antineoplásicos/economia , Caquexia/tratamento farmacológico , Análise Custo-Benefício , Centros de Atenção Terciária/economia , Antineoplásicos/uso terapêutico , Caquexia/economia , Caquexia/patologia , Carboplatina/economia , Carboplatina/uso terapêutico , Dacarbazina/economia , Dacarbazina/uso terapêutico , Daunorrubicina/economia , Daunorrubicina/uso terapêutico , Etoposídeo/economia , Etoposídeo/uso terapêutico , Feminino , Auditoria Financeira , Humanos , Índia/epidemiologia , Masculino , Projetos Piloto , Estudos Prospectivos , Trastuzumab/economia , Trastuzumab/uso terapêutico
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