Evaluation of the effects of a generic substitution policy implemented in Chile

Mansilla, Cristián; Cardenas, Jorge A.; Kaplan, Warren; Wirtz, Veronika J.; Kuhn-Barrientos, Lucy; Zárate, Matías Ortíz de; Tobar, Tatiana; Herrera, Cristian A

doi:10.1136/bmjgh-2018-000922

Cited by 6 publications

(4 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Clarification is also needed in cases in which the comparator API was different from the listed API requiring BE certification, as it was the case with isosorbide mononitrate listed as the referent for isosorbide dinitrate. [21]…”

Section: Discussionmentioning

confidence: 99%

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data

et al. 2019

Self Cite

View full text Add to dashboard Cite

Background Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability. Objective To study the implementation of the bioequivalence certification policy in Chile. Methods We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence. Results As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4–6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none. Conclusions Although the implementation of Chile’s bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

show abstract

Section: Discussionmentioning

confidence: 99%

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data

et al. 2019

Self Cite

View full text Add to dashboard Cite

show abstract

“…41 Chilean regulations mandate that generic drugs be bioequivalent to branded ones. 20 The drugs listed in the official protocols have been available for approximately 30 years, approved on average in 1988, suggesting a choice by policymakers to control public spending by favoring well-established, off-patent small-molecule drugs. Public health facilities and clinicians’ decisions are being influenced accordingly, because 71% of the total volume of on-protocol drugs are generic or branded generics.…”

Section: Discussionmentioning

confidence: 99%

Expanding Coverage of Oncology Drugs in an Aging, Upper-Middle-Income Country: Analyses of Public and Private Expenditures in Chile

Vargas

Leopold

Castillo-Riquelme

et al. 2019

JGO

View full text Add to dashboard Cite

PURPOSE The population of Chile has aged, and in 2017, cancer became the leading cause of death. Since 2005, a national health program has expanded coverage of drugs for 13 types of cancer and related palliative care. We describe the trends in public and private oncology drug expenditures in Chile and consider how increasing expenditures might be addressed. METHODS We analyzed total quarterly drug expenditures for 131 oncology drugs from quarter (Q)3 2012 until Q1 2017, including public and private insurance payments and patient out-of-pocket spending. The data were analyzed by drug-mix, sources of funding, growth, and intellectual property status. The Laspeyres Price Index was used to analyze expenditure growth. RESULTS We found 131 oncology drugs associated with 87,129 observations. Spending on drugs rose 120% from the first period, spanning from the first 3 quarters (Q3, Q4, Q1 2012-2013) to the last period (Q3, Q4, Q1 2016-2017), corresponding to an annualized rate of 19.2% and totaling US$398 million (in 2017 dollars). The public sector accounted for 84.2% of spending, which included 50 drugs in the official treatment protocols, whereas private insurance accounted for 7.3% in on-protocol drugs. The remaining 8.5% was paid out of pocket. In the public sector, more than 90% of growth resulted from increased use. Seven drugs, including 3 with nonexpired patents, accounted for 50% of total expenditures. CONCLUSION Increased use and access enabled by expanded public expenditures drove most of the growth in oncology drug expenditures. However, the rate of public expenditure growth may be fiscally unsustainable. Policies are urgently needed to promote the use of generic drugs, the appropriate mix of on-protocol versus off-protocol drugs, and the curbing of off-label prescribing.

show abstract

“…Our review and analysis of science articles which were devoted to a different generic drugs policies in high income countries [6,8], as well as low-middle income countries [14,15], gave general study description and generic authority market rules [7,11], substitution of original medicines to generic counterparts through implementation of international non-proprietary name prescribing [8,16], price control for generics and interaction between stakeholders [6,9]. The small part of this research focused on the issue of generic substitution efficacy [6], and actually, none has paid sufficient attention to the need to formulate evidence-based rules for this process.…”

Section: Introductionmentioning

confidence: 99%

Shaping of the evidence-based substitution conceptual framework of the original medicines to generic counterparts in Ukraine

Dobrova

Popov

Зупанец

et al. 2021

SR: PS

View full text Add to dashboard Cite

The aim. To develop conceptual framework of the strategy for a reasonable transition from original to generic medicines by complex implementation of proper bioequivalence studies and sufficient therapeutic drug monitoring management. Materials and methods. To conduct the study, we used the lists of medicines included in the state reimbursement program “Dostupny Liky” (Affordable Medicines), and materials of reports on medicines public procurement provided on the website of the Ministry of Health of Ukraine and the National Health Service of Ukraine, as well as information data on the results of studies of the quality and effectiveness of these drugs provided by the Rx-Index website. In the course of the study, the methods of logical analysis, SWOT analysis, and statistical evaluation of results, Kingdon’s Policy Streams Approach and the method of flowcharts construction were used. The concept of evidence-based medicine substitution formation in Ukraine was designed applying the Policy Streams Approach. Results. The analysis of public procurement programs for drugs for the period 2018–2020, as well as the analysis of drugs included in the new list under the “Dostupny Liky” (Affordable Medicines) program, carried out in the course of the study, showed that the level of evidence of data on assessing their effectiveness remains low. At the same time, more than 1.5 billion UAH (~ 50 mln USD) is spent annually on the purchase of such drugs and reimbursement of their cost, and the question of the optimal selection and monitoring of pharmacotherapy with these drugs remains open. A structural model has been developed, in which three basic levels are identified: provision of regulatory and financial components, executive and the level of implementation of the results. The SWOT-analysis of the strengths and weaknesses, as well as external opportunities and threats for the implementation of the conceptual framework made it possible to substantiate the advantages and reveal the possibilities of attracting clinical centers of universities and research institutions to the implementation of the concept. A framework for the interaction of a research center with health care institutions in the implementation of therapeutic drug monitoring was developed for low-income and low-middle income countries on the example of Ukraine. Distribution of responsibilities was proposed and the basic principles of interaction between performers of therapeutic drug monitoring were highlighted. Conclusions. Based on the results of the analysis of the evidence of the quality and effectiveness of drugs included in public procurement and in reimbursement programs, the key problems of organizing pharmaceutical provision of an appropriate level of quality for a number of chronic diseases requiring lifelong therapy were identified. The conceptual framework of evidence-based original medicines substitution to generic counterparts have been formed; and the ways of its implementation in the conditions of scarce financial resources on the example of Ukraine have been substantiated

show abstract

Evaluation of the effects of a generic substitution policy implemented in Chile

Cited by 6 publications

References 20 publications

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data

Expanding Coverage of Oncology Drugs in an Aging, Upper-Middle-Income Country: Analyses of Public and Private Expenditures in Chile

Shaping of the evidence-based substitution conceptual framework of the original medicines to generic counterparts in Ukraine

Contact Info

Product

Resources

About