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2.
J Oncol Pharm Pract ; 26(1): 124-132, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31106664

RESUMO

INTRODUCTION: Biosimilar drugs have significantly shaken the global pharmaceutical market through a better access to the health care services. The aim of this study is to establish a state of play in Tunisia based on the knowledge and perceptions of doctors on biosimilars in order to identify the problems related to these drugs and to propose solutions for improvement. MATERIALS AND METHODS: In our study, we conducted a prospective, descriptive survey using a questionnaire, destinated to oncologists and hematologists with different grades, from both public and private sectors and from several regions. The questions focused on physicians' general knowledge of biosimilars and their comparison with reference on safety, quality, efficacy, and indication. Finally, we explored the proportion of physicians who are favorable to the policy encouraging biosimilar use. RESULTS: One hundred and seven doctors among 150 answered the questionnaire; 57% were oncologists and 43% were hematologists. About one over five physicians defines biosimilar as a chemical drug. About 29% do not differentiate between a biosimilar and a generic one. A percentage of 68 believe that a biosimilar can have all the indications of its reference following complementary clinical studies. On the other side, 68.2% support the policy encouraging these drugs. Last, only 3.7% of the practitioners believe that they are well informed about biosimilars. DISCUSSION: Our results are comparable to other surveys described in the literature. However, this is the first study that targets oncologists and hematologists specifically. CONCLUSION: Our study showed a lack of information from oncologists and hematologists about biosimilars in Tunisia. Thus, health authorities should carry out training programs on biosimilars and introduce clear and effective legislation in order to allow better access to health care services.


Assuntos
Atitude do Pessoal de Saúde , Medicamentos Biossimilares/uso terapêutico , Hematologia/normas , Oncologistas/normas , Inquéritos e Questionários , Medicamentos Genéricos/uso terapêutico , Humanos , Oncologistas/psicologia , Estudos Prospectivos , Tunísia/epidemiologia
3.
Rev Saude Publica ; 53: 94, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31644724

RESUMO

OBJECTIVE: To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS: This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS: Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS: Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.


Assuntos
Anti-Hipertensivos/uso terapêutico , Comércio/tendências , Serviços Comunitários de Farmácia/tendências , Medicamentos Genéricos/uso terapêutico , Hipoglicemiantes/uso terapêutico , Programas Nacionais de Saúde/tendências , Brasil , Comércio/estatística & dados numéricos , Serviços Comunitários de Farmácia/estatística & dados numéricos , Diabetes Mellitus/tratamento farmacológico , Política de Saúde , Humanos , Hipertensão/tratamento farmacológico , Análise de Séries Temporais Interrompida , Estudos Longitudinais , Programas Nacionais de Saúde/estatística & dados numéricos , Farmácias/estatística & dados numéricos , Farmácias/tendências , Avaliação de Programas e Projetos de Saúde , Valores de Referência , Estudos Retrospectivos , Fatores de Tempo
4.
BMJ ; 367: l5205, 2019 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-31578187

RESUMO

OBJECTIVES: To determine how clinicians vary in their response to new guidance on existing or new interventions, by measuring the timing and magnitude of change at healthcare institutions. DESIGN: Automated change detection in longitudinal prescribing data. SETTING: Prescribing data in English primary care. PARTICIPANTS: English general practices. MAIN OUTCOME MEASURES: In each practice the following were measured: the timing of the largest changes, steepness of the change slope (change in proportion per month), and magnitude of the change for two example time series (expiry of the Cerazette patent in 2012, leading to cheaper generic desogestrel alternatives becoming available; and a change in antibiotic prescribing guidelines after 2014, favouring nitrofurantoin over trimethoprim for uncomplicated urinary tract infection (UTI)). RESULTS: Substantial heterogeneity was found between institutions in both timing and steepness of change. The range of time delay before a change was implemented was large (interquartile range 2-14 months (median 8) for Cerazette, and 5-29 months (18) for UTI). Substantial heterogeneity was also seen in slope following a detected change (interquartile range 2-28% absolute reduction per month (median 9%) for Cerazette, and 1-8% (2%) for UTI). When changes were implemented, the magnitude of change showed substantially less heterogeneity (interquartile range 44-85% (median 66%) for Cerazette and 28-47% (38%) for UTI). CONCLUSIONS: Substantial variation was observed in the speed with which individual NHS general practices responded to warranted changes in clinical practice. Changes in prescribing behaviour were detected automatically and robustly. Detection of structural breaks using indicator saturation methods opens up new opportunities to improve patient care through audit and feedback by moving away from cross sectional analyses, and automatically identifying institutions that respond rapidly, or slowly, to warranted changes in clinical practice.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Indicadores de Qualidade em Assistência à Saúde/estatística & dados numéricos , Medicina Estatal/estatística & dados numéricos , Anti-Infecciosos/uso terapêutico , Conjuntos de Dados como Assunto , Substituição de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/uso terapêutico , Inglaterra , Medicina Geral/organização & administração , Medicina Geral/normas , Medicina Geral/estatística & dados numéricos , Humanos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Medicina Estatal/normas , Fatores de Tempo , Infecções Urinárias/tratamento farmacológico
5.
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
6.
Braz J Infect Dis ; 23(4): 237-245, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31344357

RESUMO

BACKGROUND: Recent studies suggest that sustained use of generic antibiotics may be associated with clinical failure and emergence of antibacterial resistance. The present study was designed to determine the clinical outcome between the use of generic meropenem (GM) and brand-name meropenem (BNM). Additionally, this study evaluated the economic impact of GM and BNM to determine if the former represents a cost-effective alternative to the latter. METHODS: Patients treated between January 2011 and May 2014 received GM while patients treated between June 2014 and March 2017 received BNM. Mortality was compared between groups. Total infection cost was defined by the cost of antimicrobial consumption, length of stay, and laboratory and imaging exams until infection resolution. FINDINGS: A total of 168 patients were included; survival rate for the 68 patients treated with GM was 38% compared to 59% in the patients treated with BNM. Multivariate analysis showed that the variables most strongly-associated with mortality were cardiovascular disease (OR 18.18, 95% CI 1.25-262.3, p = 0.033) and treatment with generic meropenem (OR 18.45, 95% CI 1.45-232.32, p = 0.024). On the other hand, total infection cost did not show a significant difference between groups (BNM $10,771 vs. GM $11,343; p = 0.91). INTERPRETATION: The present study suggests that patients treated with GM have a risk of death 18 times higher compared to those treated with BNM. Furthermore, economic analysis shows that GM is not more cost effective than BNM. SUMMARY: More studies measuring clinical outcomes are needed to confirm the clinical equivalence of brand-name versus generic antibiotics, not only for meropenem but also for other molecules.


Assuntos
Antibacterianos/economia , Antibacterianos/uso terapêutico , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Unidades de Terapia Intensiva/economia , Meropeném/economia , Meropeném/uso terapêutico , Adolescente , Adulto , Distribuição por Idade , Idoso , Colômbia , Análise Custo-Benefício , Feminino , Infecções por Bactérias Gram-Negativas/tratamento farmacológico , Infecções por Bactérias Gram-Negativas/mortalidade , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Fatores de Risco , Distribuição por Sexo , Análise de Sobrevida , Centros de Atenção Terciária/estatística & dados numéricos , Resultado do Tratamento , Adulto Jovem
7.
Prog Urol ; 29(6): 326-331, 2019.
Artigo em Francês | MEDLINE | ID: mdl-31151915

RESUMO

INTRODUCTION: Phosphodiesterase type 5 inhibitors (PDE5i) are the first-line treatment of erectile dyfunction (ED). Cost of PDE5i is not covered by health insurance company in France. Few studies have examined the potential impact of the introduction of generic products of PDE5i on price non-compliance. The aim of the study was to compare the non-compliance rate because of price among patients treated for DE with generics of PDE5i and those treated with brand-name medications. METHOD: A multi-centre, cross-sectional, study that analyzed the answers to a questionnaire distributed to consultations in four hospitals for a period of twenty-eight months. Patients were included if they had DE treated for at least 3 months. The proportions between the two groups were compared with a non-inferiority test Wilcoxon-Mann-Whitney. RESULTS: One hundred and seventy-seven questionnaires were analyzed. Patients treated with generic PDE5i were significantly (α<0.05) as non-compliant because of price as patients treated with treated with brand-name PDE5i, respectively 34% (28/82) and 38% (36/95). The main causes of non-compliance were: high treatment costs, a lower than expected effect, lack of opportunity or sexual desire. The proportion of patients splitting the PDE5i tablet to achieve savings was 19% (33/177). To find the lowest price, 57% (101/177) of patients had consulted several pharmacies. These patients consulted 2.4±1.5 pharmacies. In the study population, 44% (78/177) of patients compared prices on commercial websites on the Internet. CONCLUSION: Patients treated with generic PDE5i are as unobservant as those treated with brand-name PDE5i. LEVEL OF EVIDENCE: 3.


Assuntos
Comércio , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Inibidores da Fosfodiesterase 5/economia , Inibidores da Fosfodiesterase 5/uso terapêutico , Estudos Transversais , Humanos , Masculino , Pessoa de Meia-Idade
8.
Lancet Haematol ; 6(8): e398-e408, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31208943

RESUMO

BACKGROUND: Treatment-free remission in chronic myeloid leukaemia-ie, achievement of a sustained deep molecular response leading to discontinuation of BCR-ABL1 tyrosine kinase inhibitor (TKI) therapy-has become a potential aim of therapy. Highly priced second-generation TKIs might offer deep molecular response status more quickly and for more patients than imatinib; however, with the availability and lower cost of generic imatinib, the value of second-generation TKIs as frontline therapy for this particular treatment endpoint remains unknown. We aimed to assess the potential value of second-generation TKIs used as frontline therapy in patients with chronic myeloid leukaemia in chronic phase in relation to the probability of achieving sustained deep molecular responses compared with generic imatinib, and the associated cost of each modality. METHODS: We used a decision analytic model to consider the value of different TKI approaches from the payer's perspective. The proportion of patients achieving sustained deep molecular response after 5 years of treatment in chronic phase was estimated at 26% with imatinib and 44% with second-generation TKIs. We also modelled more favourable scenarios of the proportion of patients achieving such response with second-generation TKIs at 66%, 88%, and a near-perfect response of 99%. For each scenario, we examined the impact of the combination of health utilities for chronic-phase chronic myeloid leukaemia (base case 0·89, range 0-1) and the annual cost of second-generation TKIs (base case US$152 814 [ie, the price of nilotinib in the USA], range 0-240 000) on the cost-effectiveness of second-generation TKIs compared with generic imatinib. We used different price scenarios for generic imatinib in the USA (average price $35 000 per year; lowest price $4400 per year), Europe ($4000 per year), and developing countries ($2100 per year). We calculated incremental cost-effectiveness ratios (ICERs) and assessed cost-effectiveness by considering two societal willingness-to-pay thresholds: $50 000 per quality-adjusted life-year (QALY) in all markets and $200 000 per QALY in the USA. FINDINGS: In the base case, we obtained an ICER of $22 765 208, meaning that second-generation TKIs as frontline therapy to achieve sustained deep molecular response was not cost-effective under either of the societal willingness-to-pay thresholds. In our sensitivity analyses, none of the explored scenarios showed potential treatment value for use of second-generation TKIs at the current prices in the USA or at the price of $30 000-40 000 per year elsewhere. For example, considering a scenario in the USA using second-generation TKIs versus imatinib (annual price $4400 per year) with the potential benefit in favour of second-generation TKI (willingness to pay $200 000 per QALY, 66% of patients achieving sustained deep molecular response, and health utility of the chronic phase of 0·1), the cost of second-generation TKIs would need to be less than $25 000 per year to be a cost-effective option. Under the same conditions in developing nations, with a price of generic imatinib of $2100 per year and a willingness to pay of $50 000 per QALY, the annual price of second-generation TKIs should not exceed $10 000 per year of therapy. INTERPRETATION: Considering the current prices of second-generation TKIs and of generic imatinib under different pricing scenarios in the USA, Europe, and developing countries, second-generation TKIs at current prices do not offer good value as frontline therapy in chronic myeloid leukaemia in order to achieve sustained deep molecular response and treatment-free remission. FUNDING: National Cancer Institute.


Assuntos
Análise Custo-Benefício , Mesilato de Imatinib/economia , Leucemia Mielogênica Crônica BCR-ABL Positiva/economia , Inibidores de Proteínas Quinases/economia , Antineoplásicos/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Proteínas de Fusão bcr-abl/antagonistas & inibidores , Proteínas de Fusão bcr-abl/metabolismo , Humanos , Mesilato de Imatinib/uso terapêutico , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/patologia , Inibidores de Proteínas Quinases/uso terapêutico , Pirimidinas/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Indução de Remissão
9.
Drugs Aging ; 36(8): 759-768, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31073846

RESUMO

BACKGROUND: Clopidogrel has been widely used to prevent atherothrombotic events. Since 2011, pharmacists have offered their patients the opportunity to switch to generic clopidogrel, an economic alternative. Whether bioequivalence of generic cardiovascular drugs translates into clinical equivalence at a population level remains unclear and needs to be further documented. OBJECTIVE: We aimed to evaluate the impact of generic clopidogrel commercialization on adverse events (AEs): hospitalizations or emergency room (ER) consultations. METHODS: This is an interrupted time series analysis using the Quebec Integrated Chronic Disease Surveillance System. We included all patients ≥ 66 years old who were users of the brand-name clopidogrel or a generic version (n = 6) 24 months before and up to 12 months after generics commercialization. Rates of AEs were computed, and periods before and after generics commercialization were analyzed by segmented regression models along with exploratory analyses (generic vs. brand name). Sensitivity analyses were also performed using stratification of the time series by (1) sex, (2) the number of prevalent cardiovascular comorbidities, and (3) socioeconomic status. RESULTS: Time series were constituted of 89,525 clopidogrel users (mean age 78 years, 45% women, 71% ischemic heart disease, 34% stroke). For all users, there was a mean rate of 157 AEs per 1000 user-months, stable trend before (-0.1% [95% confidence interval -0.3 to 0.1] and after (0.0% [- 0.5 to 0.6]) generics commercialization. In exploratory analyses, once generic clopidogrel versions were commercialized, rates of AEs were 19.2% (95% CI 11.7-26.7) higher for generic versus brand-name users. This difference persisted up to 1 year. Sensitivity analyses yielded similar results. CONCLUSIONS: The population treated with clopidogrel had similar rates of hospitalizations or ER consultations before and after generics commercialization. However, differences in rates of hospitalizations or ER consultations between generic and brand-name clopidogrel users may represent a drug safety signal which remains to be validated. Using a different study design, permitting adjustment for potential confounders, could be useful in this regard.


Assuntos
Clopidogrel/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Serviço Hospitalar de Emergência/tendências , Hospitalização/tendências , Encaminhamento e Consulta/tendências , Adulto , Idoso , Clopidogrel/efeitos adversos , Clopidogrel/economia , Comorbidade , Custos de Medicamentos , Medicamentos Genéricos/efeitos adversos , Medicamentos Genéricos/economia , Medicamentos Genéricos/farmacologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Quebeque , Análise de Regressão , Equivalência Terapêutica , Resultado do Tratamento
10.
Mayo Clin Proc ; 94(7): 1190-1198, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31036352

RESUMO

OBJECTIVE: To determine whether levothyroxine (L-T4) preparation (generic vs brand) affected hospitalization for cardiovascular events. PATIENTS AND METHODS: We performed a retrospective analysis using a large administrative claims database, OptumLabs Data Warehouse, creating two 1-to-1 propensity score-matched cohorts initiating generic or brand L-T4. Patients were followed for a mean of 1.0±1.2 years (range, 0-9.3 years). We included 87,902 propensity score-matched patients (43,951 patients per cohort) initiating generic or brand L-T4. Variables included in matching were age, sex, race/ethnicity, residence region, selected comorbidities, and Charlson-Deyo comorbidity score. Patients with previous use of any thyroid preparation, amiodarone, or lithium were excluded. Primary outcomes were the event rates for hospitalizations for incident atrial fibrillation, myocardial infarction, congestive heart failure, or stroke. RESULTS: In the generic L-T4 cohort, 35,242 (80.2%) were women and 7327 (16.7%) were 65 years of age or older; in the brand L-T4 cohort, 34,633 (78.8%) were women and 8092 (18.4%) were 65 years of age or older. We found no differences in event rates (events per 1000 person-years) for 4 outcomes comparing generic and brand L-T4 therapy: (1) atrial fibrillation (1.82 vs 2.19; hazard ratio [HR], 1.22; 95% CI, 0.90-1.65; P=.19); (2) myocardial infarction (2.12 vs 1.83; HR, 0.86; 95% CI, 0.64-1.17; P=.35); (3) congestive heart failure (2.27 vs 2.00; HR, 0.88; 95% CI, 0.66-1.18; P=.41); and (4) stroke (3.10 vs 2.38; HR, 0.77; 95% CI, 0.59-1.00; P=.05). Stratification by age group revealed no differences. CONCLUSION: In patients with newly treated hypothyroidism, cardiovascular event rates were similar for generic and brand L-T4.


Assuntos
Medicamentos Genéricos , Hipotireoidismo/tratamento farmacológico , Tiroxina , Adulto , Idoso , Fibrilação Atrial/induzido quimicamente , Fibrilação Atrial/epidemiologia , Medicamentos Genéricos/efeitos adversos , Medicamentos Genéricos/uso terapêutico , Feminino , Humanos , Revisão da Utilização de Seguros/tendências , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/induzido quimicamente , Infarto do Miocárdio/epidemiologia , Estudos Retrospectivos , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/epidemiologia , Tiroxina/efeitos adversos , Tiroxina/uso terapêutico
11.
Postgrad Med ; 131(5): 335-341, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31081414

RESUMO

Non-medical switching of medication, whereby a patient's treatment regimen is changed for reasons other than efficacy, side effects, or adherence, is often related to drug formulary changes aimed at reducing drug costs. In the era of health care reform, while cost-cutting measures are important, there is considerable evidence that non-medical switching, particularly when applied to medication used to treat chronic conditions such as diabetes, may impact patient outcomes, medication-taking behavior, and use of health care services. Ultimately, overall costs may be increased, as savings by insurers are cancelled out by higher costs to the health care system as a whole, such as extra administration, treatment failure from new medicines, and increased adverse events. The emergence of biosimilar and follow-on biologic treatments raises further questions among patients receiving biologic treatments, with patient advocacy groups calling for clear legislation to ensure that patients with complex or chronic conditions continue to receive effective, evidence-based medications for their disease. This article will discuss non-medical switching in the US, taking into account the different parties involved, such as patients, health care providers, pharmacists, payers, and pharmacy benefit managers, with the aim of providing a detailed overview of this complex and evolving topic.


Assuntos
Substituição de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/organização & administração , Medicamentos sob Prescrição/uso terapêutico , Substituição de Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Medicamentos Genéricos/economia , Humanos , Seguro de Serviços Farmacêuticos/estatística & dados numéricos , Conduta do Tratamento Medicamentoso/economia , Medicamentos sob Prescrição/economia , Estados Unidos
12.
Rev Chilena Infectol ; 36(1): 32-40, 2019 Feb.
Artigo em Espanhol | MEDLINE | ID: mdl-31095202

RESUMO

BACKGROUND: Clinical studies aimed to evaluating the quality of generic drugs may be useful to strengthen policies of access to combined antiretroviral therapy (cART). AIM: To describe the effectiveness and safety of the generic schema lamivudine/tenofovir/efavirenz (3TC/TDF/EFV) in patients with HIV/AIDS naive, belonging to a comprehensive care program. METHODS: A nonrandomized, open-label, phase IV study, during 2012 to 2014 naive HIV-infected patients 18 years or older with indication to receive cART were recruited. Patients were treated with generic scheme 3TC/TDF/EFV and were followed-up during 12 months. Clinical, immunological and laboratory parameters were assessed at baseline, 3, 6 and 12 months of treatment. RESULTS: Of the 40 patients, 30 (75%) met the 12 months of treatment; of them, 80% achieved undetectable viral load (< 40 copies/mL) and 83.3% viral load < 50 copies/mL. Additionally, there was a significant increase (173 cells/mm3) in the median for CD4 T lymphocyte count. Moreover, the results of the whole blood count, creatinine and transaminases were preserved in normal ranges and did not generate changes in the cART. Potential side effects of antiretroviral drugs occurred in less than 10% of patients and had no serious implications. CONCLUSIONS: In this small group of patients, the generic scheme 3TC/TDF/EFV is effective and safe in the treatment of patients with HIV/AIDS naïve, and its effectiveness and safety profile is similar to show by innovator scheme 3TC/TDF/EFV in patients with similar clinical conditions. Registro Estudio: Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000134. Registered 20 July 2012.


Assuntos
Síndrome de Imunodeficiência Adquirida/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Benzoxazinas/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Lamivudina/uso terapêutico , Tenofovir/uso terapêutico , Adulto , Análise de Variância , Colômbia , Feminino , Humanos , Masculino , Estudos Prospectivos , Reprodutibilidade dos Testes , Estatísticas não Paramétricas , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
13.
Glob Health Action ; 12(1): 1586317, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30983547

RESUMO

BACKGROUND: Increased coverage with antiretroviral therapy for people living with HIV in low- and middle-income countries has increased their life expectancy associated with non-HIV comorbidities and the need for quality-assured and affordable non-communicable diseases drugs . Funders are leaving many middle-income countries that will have to pay and provide quality-assured and affordable HIV and non-HIV drugs, including for non-communicable diseases. OBJECTIVE: To estimate costs for originator and generic antiretroviral therapy as the number of people living with HIV are projected to increase between 2016 and 2026, and discuss country, regional and global factors associated with increased access to generic drugs. METHODS: Based on estimates of annual demand and prices, annual cost estimates were produced for generic and originator antiretroviral drug prices in low- and middle-income countries and projected for 2016-2026. RESULTS: Drug costs varied between US$1.5 billion and US$4.8 billion for generic drugs and US$ 8.2 billion and US$16.5 billion for originator drugs between 2016 and 2026. DISCUSSION: The global HIV response increased access to affordable generic drugs in low- and middle-income countries. Cheaper active pharmaceutical ingredients and market competition were responsible for reduced drug costs. The development and implementation of regulatory changes at country, regional and global levels, covering intellectual property rights and public health, and flexibilities in patent laws enabled prices to be reduced. These changes have not yet been applied in many low- and middle-income countries for HIV, nor for other infectious and non-communicable diseases, that lack the profile and political attention of HIV. Licensing backed up with Trade-Related Aspects of Intellectual Property Rights safeguards should become the norm to provide quality-assured and affordable drugs within competitive generic markets. CONCLUSION: Does the political will exist among policymakers and other stakeholders to develop and implement these country, regional and global frameworks for non-HIV drugs as they did for antiretroviral drugs?


Assuntos
Antirretrovirais/economia , Antirretrovirais/uso terapêutico , Países em Desenvolvimento , Custos de Medicamentos/estatística & dados numéricos , Infecções por HIV/tratamento farmacológico , Política , Antirretrovirais/provisão & distribução , Comércio , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Humanos , Renda , Patentes como Assunto , Saúde Pública , Qualidade da Assistência à Saúde
14.
PLoS Med ; 16(3): e1002763, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30865626

RESUMO

BACKGROUND: To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing brand-name and generic drugs are susceptible to bias favoring the brand-name drugs. We used authorized generic (AG) products, which are identical in composition and appearance to brand-name products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus brand medications. METHODS AND FINDINGS: For commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004-2013) and (2) Truven MarketScan (years: 2003-2015). For a total of 8 drug products, the following groups were compared using a cohort study design: (1) patients switching from brand-name products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied brand-name use, addressing negative perception bias, and (2) patients initiating generic versus brand-name products (bias-prone direct comparison) and patients initiating AG versus brand-name products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine brand-name: HR [95% CI] 0.92 [0.88-0.97]). The comparison between generic and brand-name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus brand-name products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84-0.99] and 0.84 [0.76-0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01-1.10] and 1.07 [1.01-1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to brand-name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98-1.13] and 1.11 [1.05-1.18], respectively), suggesting that the differences observed between brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from brand products to generics. CONCLUSIONS: In this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.


Assuntos
Bases de Dados Factuais/tendências , Uso de Medicamentos/tendências , Medicamentos Genéricos/uso terapêutico , Revisão da Utilização de Seguros/tendências , Seguro Saúde/tendências , Idoso , Citalopram/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores de Captação de Serotonina/uso terapêutico , Sertralina/uso terapêutico , Resultado do Tratamento , Estados Unidos/epidemiologia
15.
Clin Pharmacol Ther ; 105(4): 878-885, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30648739

RESUMO

Regulatory science is science and research intended to improve decision making in a regulatory framework. Improvements in decision making can be in both accuracy (making better decisions) and in efficiency (making faster decisions). Science and research supported by the Generic Drug User Fee Amendments of 2012 (GDUFA) have focused on two innovative methodologies that work together to enable new approaches to development and review of generic drugs: quantitative models and advanced in vitro product characterization. Quantitative models faithfully represent current scientific understanding. They are tools pharmaceutical scientists and clinical pharmacologists use for making better and faster product development decisions. Advances in the in vitro product comparisons provide the measurements of product differences that are the critical input into the models. This paper outlines four areas where science and research funded by GDUFA support synergistic use of models and characterization at critical decision points during generic drug product development and review.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Usuários de Drogas/legislação & jurisprudência , Medicamentos Genéricos/uso terapêutico , Tomada de Decisões , Humanos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência
17.
Int J Clin Pharm ; 41(1): 81-87, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30478491

RESUMO

Background In the South African private sector context, generically similar products are grouped together and the reimbursement rate is set at the average price of the generically equivalent products. Very little evidence exists in low and middle-income countries with regards to the impact of this policy over time. Objectives To determine the impact of the introduction of generics and generic reference pricing on candesartan and rosuvastatin in the South African private health care sector in terms of medicine utilisation, medicine price and medicine expenditure. Setting South African private health sector. Method Medicine claims for candesartan and rosuvastatin was obtained from a Pharmacy Benefit Manager in South Africa. The claims covered a 48-month period from January 2012 to December 2015 and provided a pre- and post-reference price period for analysis. Medicine utilisation was measured as the number of Defined Daily Doses dispensed per 100,000 beneficiaries. Medicine price and expenditure was calculated as the average per Defined Daily Dose. Main outcome measure Medicine utilisation, price and expenditure. Results Candesartan experienced an average 7.0% year-on-year decline in utilisation and rosuvastatin a 5.0% increase. Medicine expenditure reduced by an additional 34.6% and 20.9% for candesartan and rosuvastatin respectively. The total savings was 54.8% for candesartan and 31.9% for rosuvastatin. Conclusion The introduction of generics and generic reference pricing did not have an impact on medicine utilisation, but reduced the price and expenditure of both candesartan and rosuvastatin.


Assuntos
Benzimidazóis/economia , Custos de Medicamentos , Uso de Medicamentos/economia , Medicamentos Genéricos/economia , Gastos em Saúde , Rosuvastatina Cálcica/economia , Tetrazóis/economia , Anticolesterolemiantes/economia , Anticolesterolemiantes/uso terapêutico , Anti-Hipertensivos/economia , Anti-Hipertensivos/uso terapêutico , Benzimidazóis/uso terapêutico , Custos de Medicamentos/tendências , Uso de Medicamentos/tendências , Medicamentos Genéricos/uso terapêutico , Gastos em Saúde/tendências , Humanos , Rosuvastatina Cálcica/uso terapêutico , África do Sul/epidemiologia , Tetrazóis/uso terapêutico
18.
Med Care ; 57(1): 85-93, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30489546

RESUMO

BACKGROUND: We extend an interrupted time series study design to identify heterogenous treatment effects using group-based trajectory models (GBTMs) to identify groups before a new policy and then examine if the effects of the policy has consistent impacts across groups using propensity score weighting to balance individuals within trajectory groups who are and are not exposed to the policy change. We explore this by examining how adherence to endocrine therapy (ET) for women with breast cancer was impacted by reducing copayments for medications by the introduction of generic ETs among women who do not receive a subsidy (the "treatment" group) to those that do receive a subsidy and are not exposed to any changes in copayments (the "control" group). METHODS: We examined monthly adherence to ET using the proportion of days covered for women diagnosed with breast cancer between 2008 and 2009 using SEER-Medicare data. To account for baseline trends, we characterize adherence for 1 year before generic approval of ET using GBTMs, within each groups we generate inverse probability treatment weights of not receiving a subsidy. We compared adherence after generic entry within each GBTM using a modified Poisson model. RESULTS: GBTMs for adherence in the 1-year pregeneric identified 6 groups. When comparing patients who did and did not receive a subsidy we found no overall effect of generic introduction. However, 1 of the 6 identified adherence groups postgeneric adherence increased [the "consistently low" (risk ratio=1.91; 95% confidence interval=1.34-2.72)]. CONCLUSIONS: This study describes a new approach to identify heterogenous effects when using an interrupted time series research design.


Assuntos
Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Medicamentos Genéricos/uso terapêutico , Adesão à Medicação , Idoso , Medicamentos Genéricos/economia , Feminino , Gastos em Saúde , Humanos , Medicare Part D/economia , Pontuação de Propensão , Programa de SEER , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
19.
Urology ; 124: 223-228, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30359708

RESUMO

OBJECTIVE: To characterize geographic variability of generic benign prostatic hyperplasia (BPH) medications in order to improve drug price transparency and improve patient access to affordable medication sources. This is of interest because BPH is one of the most common chronic diseases in men and contributes to individual healthcare cost. Medical therapy is the main treatment modality for BPH, burdening patients with lifelong medication expenses which may impact adherence and subsequent outcomes. With an aging population, this is compounded by many older individuals requiring multiple daily medications. METHODS: All pharmacies within a 25-mile radius of our institution were identified and classified as chain, wholesale or independent. The out-of-pocket price for a 30-day supply of tamsulosin (0.4 mg), finasteride (5 mg), oxybutynin (5 mg TID), and oxybutynin 10 mg XL were obtained using a scripted telephone survey. Multivariable linear regression assessed the association between census-tract level demographic and socioeconomic factors and disparate generic out-of-pocket drug-pricing. RESULTS: The response rate was 93% with 255 pharmacies across 173 census tracts providing data. By pharmacy type, there was up to 5.5-fold variation in median out-of-pocket drug prices for the most common BPH medications. Demographic and socioeconomic factors were not significantly associated with generic BPH drug price variation. CONCLUSION: The out-of-pocket price of generic medications for BPH varies significantly between pharmacies in a geographically-confined area. This study highlights the need for quality improvement initiatives that empower patients to price-compare and improve drug price transparency.


Assuntos
Comércio/estatística & dados numéricos , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Hiperplasia Prostática/tratamento farmacológico , Humanos , Masculino , Pennsylvania
20.
Eur J Clin Pharmacol ; 75(2): 275-283, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30368571

RESUMO

PURPOSE: The prescription in International Nonproprietary Names (INN) is a legal obligation for all physicians in France since January 2015. The objective of this study was to analyze the frequency and main factors of INN drug prescribing in general practice. METHODS: Multicenter cross-sectional study conducted with 11 interns acting as observers of 23 GP trainers between November 2015 and January 2016. Two evaluators analyzed all GPs' drug prescriptions to identify INN or brand name prescriptions. RESULTS: The database included 4957 drugs prescribed during 1647 visits. Of these, 1462 (29.5% [95% CI 28.2-30.8%]) were prescribed only in INN. According to the multivariate analyses, the factors favoring INN prescribing were as follows: at the drug level, its initial prescribing (OR = 1.4), a nonspecific prescribing objective (OR = 1.6), its listing in the generic drug index with (OR = 7.7) or without (OR = 2.9) efficiency objective included in the payment for public health objectives (PPHO) program, and the oral route of administration (OR from 0.4 for the percutaneous route to 0.2 for the pulmonary route); at the patient level, the male gender (OR = 1.3), the age of 15 years or more (OR = 1.9), and the absence of a long-term condition (OR = 1.3); at the physician level, the reception of a public healthcare insurance representative (OR = 4.1), the nonreception of pharmaceutical sales representatives (OR = 3.0), and the urban practice environment (OR = 2.8). CONCLUSIONS: In 2015, less than one third of drugs were prescribed in INN only in general practice. The use of various incentives and regulatory measures is likely to favor the prescription of INNs by practitioners.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Medicina Geral/estatística & dados numéricos , Medicamentos sob Prescrição/uso terapêutico , Adolescente , Estudos Transversais , Medicamentos Genéricos/uso terapêutico , Feminino , França , Gastos em Saúde/estatística & dados numéricos , Humanos , Masculino , Análise Multivariada , Padrões de Prática Médica/estatística & dados numéricos
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