Chilean consensus by expert panel using the Delphi technique for primary and secondary prevention of gastric cancer. / Estrategias para la prevención primaria y secundaria del cáncer gástrico: consenso chileno de panel de expertos con técnica Delfi.

INTRODUCTION: Gastric cancer (GC) is the first cause of cancer-related death in Chile and 6th in Latin America and the Caribbean (LAC). Helicobacter pylori (H. pylori) is the main gastric carcinogen, and its treatment reduces GC incidence and mortality. Esophageal-gastro-duodenoscopy (EGD) allows for the detection of premalignant conditions and early-stage GC. Mass screening programs for H. pylori infection and screening for premalignant conditions and early-stage GC are not currently implemented in LAC. The aim of this study is to establish recommendations for primary and secondary prevention of GC in asymptomatic standard-risk populations in Chile. METHODS: Two on-line synchronous workshops and a seminar were conducted with Chilean experts. A Delphi panel consensus was conducted over 2 rounds to achieve>80% agreement on proposed primary and secondary prevention strategies for the population stratified by age groups. RESULTS: 10, 12, and 12 experts participated in two workshops and a seminar, respectively. In the Delphi panel, 25 out of 37 experts (77.14%) and 28 out of 52 experts (53.85%) responded. For the population aged 16-34, there was no consensus on non-invasive testing and treatment for H. pylori, and the use of EGD was excluded. For the 35-44 age group, non-invasive testing and treatment for H. pylori is recommended, followed by subsequent test-of-cure using non-invasive tests (stool antigen test or urea breath test). In the ≥45 age group, a combined strategy is recommended, involving H. pylori testing and treatment plus non-invasive biomarkers (H. pylori IgG serology and serum pepsinogens I and II); subsequently, a selected group of subjects will undergo EGD with gastric biopsies (Sydney Protocol), which will be used to stratify surveillance according to the classification Operative Link for Gastritis Assessment (OLGA); every 3 years for OLGA III-IV and every 5 years for OLGA I-II. CONCLUSION: A "test-and-treat" strategy for H. pylori infection based on non-invasive studies (primary prevention) is proposed in the 35-44 age group, and a combined strategy (serology and EGD) is recommended for the ≥45 age group (primary and secondary prevention). These strategies are potentially applicable to other countries in LAC.

Influence of SARS-CoV-2 mRNA Vaccine Booster among Cancer Patients on Active Treatment Previously Immunized with Inactivated versus mRNA Vaccines: A Prospective Cohort Study.

Cancer patients on chemotherapy have a lower immune response to SARS-CoV-2 vaccines. Therefore, through a prospective cohort study of patients with solid tumors receiving chemotherapy, we aimed to determine the immunogenicity of an mRNA vaccine booster (BNT162b2) among patients previously immunized with an inactivated (CoronaVac) or homologous (BNT162b2) SARS-CoV-2 vaccine. The primary outcome was the proportion of patients with anti-SARS-CoV-2 neutralizing antibody (NAb) seropositivity at 8-12 weeks post-booster. The secondary end points included IgG antibody (TAb) seropositivity and specific T-cell responses. A total of 109 patients were included. Eighty-four (77%) had heterologous vaccine schedules (two doses of CoronaVac followed by the BNT162b2 booster) and twenty-five had (23%) homologous vaccine schedules (three doses of BNT162b2). IgG antibody positivity for the homologous and heterologous regimen were 100% and 96% (p = 0.338), whereas NAb positivity reached 100% and 92% (p = 0.13), respectively. Absolute NAb positivity and Tab levels were associated with the homologous schedule (with a beta coefficient of 0.26 with p = 0.027 and a geometric mean ratio 1.41 with p = 0.044, respectively). Both the homologous and heterologous vaccine regimens elicited a strong humoral and cellular response after the BNT162b2 booster. The homologous regimen was associated with higher NAb positivity and Tab levels after adjusting for relevant covariates.

Health State Utility Values of Type 2 Diabetes Mellitus and Related Complications: A Systematic Review and Meta-Analysis.

OBJECTIVES: This study aims to synthesize health state utility values (HSUVs) of type 2 diabetes mellitus (T2DM) and its related complications published in the literature, conducting a meta-analysis of the data when possible. METHODS: We conducted a systematic search in MEDLINE and School of Health and Related Research Health Utilities Database repository. Studies focused on T2DM and its complications reporting utility values elicited using direct and indirect methods were selected. We categorized the results according to the instrument to describe health and meta-analyzed them accordingly. Data included in the analysis were pooled in a fixed-effect model by the inverse of variance mean and random-effects DerSimonian-Laird method. Two approaches on sensitivity analysis were performed: leave-one-out method and including data of HSUVs obtained by foreign population value sets. RESULTS: We identified 70 studies for the meta-analysis from a total of 467 studies. Sufficient data to pool T2DM HSUVs from EQ-5D instrument, hypoglycemia, and stroke were obtained. HSUVs varied from 0.7 to 0.92 in direct valuations, and the pooled mean of 3-level version of EQ-5D studies was 0.772 (95% confidence interval 0.763-0.78) and of 5-level version of EQ-5D 0.815 (95% confidence interval 0.808-0.823). HSUVs of complications varied from 0.739 to 0.843, or reductions of HSUVs between -0.014 and -0.094. In general, HSUVs obtained from 3-level version of EQ-5D and Health Utility Index 3 instruments were lower than those directly elicited. A considerable amount of heterogeneity was observed. Some complications remained unable to be pooled due to scarce of original articles. CONCLUSIONS: T2DM and its complications have a considerable impact on health-related quality of life. 5-level version of EQ-5D estimates seems comparable with direct elicited HSUVs.

Health in Chile's Recent Constitutional Process: A Qualitative Thematic Analysis of Civil Proposals.

(1) Background: In response to the recent political crisis in Chile, the "Agreement for Social Peace and the New Constitution'' was approved. We aimed to analyze the health-related civil proposals uploaded to the official website for popular participation in the new constitution in Chile. (2) Methods: We carried out a qualitative thematic analysis of 126 health-related valid proposals. Moreover, we analyzed their link to the Health Goals 2030, established by the Ministry of Health of Chile and to the Sustainable Development Goals (SDGs). (3) Results: Sixteen main categories were reached. In all, they were organized into four main areas: (i) the right to health and the establishment of a universal health system; (ii) effective access to selected healthcare services; (iii) improving health outcomes for all and for the relevant subgroups; and (iv) the social determinants of health, health in all the policies, and community health. We found that these four areas were strongly linked to the Health Goals 2030 for Chile and to the SDGs. (4) Conclusions: Despite the fact that the new constitutional proposal was rejected in September 2022, the civil health-related proposals and the areas of health and healthcare were of interest to the citizens as the request showed a strong demand from the population for participation in matters of health, healthcare, and public health.

El costo esperado de cáncer en Chile / The expected cost of cancer in Chile

BACKGROUND: Cancer is a public health priority in Chile. AIM: To estimate the expected annual cost of cancer in Chile, due to direct costs of health services, working allowances and indirect costs for productivity losses. MATERIAL AND METHODS: We undertook an ascendent costing methodology to calculate direct costs. We built diagnostic, treatment and follow-up cost baskets for each cancer type. Further, we estimated the expenditure due to sick leave subsidies. Both estimates were performed either for the public or private sector. Costs related to productivity loss were estimated using the human capital approach, incorporating disease related absenteeism premature deaths. The time frame for all estimates was one year. RESULTS: The annual expected costs attributed to cancer was $1,557 billion of Chilean pesos. The health services expected annual costs were $1,436 billion, 67% of which are spent on five cancer groups (digestive, hematologic, respiratory, breast and urinary tract). The expected costs of sick leave subsidies and productivity loss were $48 and $71 billion, respectively. CONCLUSIONS: Cancer generates costs to the health system, which obliges health planners to allocate a significant proportion of the health budget to this disease. The expected costs estimated in this study are equivalent to 8.9% of all health expenditures and 0.69% of the Gross Domestic Product. This study provides an updated reference for future research, such as those aimed at evaluating the current health policies in cancer.

Cost analysis of chronic pain due to musculoskeletal disorders in Chile.

The magnitude of the cost of chronic pain has been a matter of concern in many countries worldwide. The high prevalence, the cost it implies for the health system, productivity, and absenteeism need to be addressed urgently. Studies have begun describing this problem in Chile, but there is still a debt in highlighting its importance and urgency on contributing to chronic pain financial coverage. This study objective is to estimate the expected cost of chronic pain and its related musculoskeletal diseases in the Chilean adult population. We conducted a mathematical decision model exercise, Markov Model, to estimate costs and consequences. Patients were classified into severe, moderate, and mild pain groups, restricted to five diseases: knee osteoarthritis, hip osteoarthritis, lower back pain, shoulder pain, and fibromyalgia. Data analysis considered a set of transition probabilities to estimate the total cost, sick leave payment, and productivity losses. Results show that the total annual cost for chronic pain in Chile is USD 943,413,490, corresponding an 80% to the five diseases studied. The highest costs are related to therapeutic management, followed by productivity losses and sick leave days. Low back pain and fibromyalgia are both the costlier chronic pain-related musculoskeletal diseases. We can conclude that the magnitude of the cost in our country's approach to chronic pain is related to increased productivity losses and sick leave payments. Incorporating actions to ensure access and financial coverage and new care strategies that reorganize care delivery to more integrated and comprehensive care could potentially impact costs in both patients and the health system. Finally, the impact of the COVID-19 pandemic will probably deepen even more this problem.

SARS-CoV-2 vaccine booster in solid organ transplant recipients previously immunised with inactivated versus mRNA vaccines: A prospective cohort study.

Background: Solid-organ transplant (SOT) recipients have worse COVID-19 outcomes than general population and effective immunisation in these patients is essential but more difficult to reach. We aimed to determine the immunogenicity of an mRNA SARS-CoV-2 vaccine booster in SOT recipients previously immunised with either inactivated or homologous SARS-CoV-2 mRNA vaccine. Methods: Prospective cohort study of SOT recipients under medical care at Red de Salud UC-CHRISTUS, Chile, previously vaccinated with either CoronaVac or BNT162b2. All participants received a BNT162b2 vaccine booster. The primary study end point was anti-SARS-CoV-2 total IgG antibodies (TAb) seropositivity at 8-12 weeks (56-84 days) post booster. Secondary end points included neutralising antibodies (NAb) and specific T-cell responses. Findings: A total of 140 (50% kidney, 38% liver, 6% heart) SOT recipients (mean age 54 [13.6] years; 64 [46%] women) were included. Of them, 62 had homologous (three doses of BNT162b2) and 78 heterologous vaccine schedules (two doses of CoronaVac followed by BNT162b2 booster). Boosters were received at a median of 21.3 weeks after primary vaccination. The proportion achieving TAb seropositivity (82.3% vs 65.4%, P = 0.035) and NAb positivity (77.4% vs 55.1%, P = 0.007) were higher for the homologous versus the heterologous group. On the other hand, the number of IFN-γ and IL-2 secreting SARS-CoV-2-specific T-cells did not differ significantly between groups. Interpretation: This cohort study shows that homologous mRNA vaccine priming plus boosting in SOT recipients, reaches a significantly higher humoral immune response than inactivated SARS-CoV-2 vaccine priming followed by heterologous mRNA booster. Funding: School of Medicine, UC-Chile and ANID.ClinicalTrials.gov ID: NCT05124509.

Cost-effectiveness analysis: fluticasone furoate/umeclidinium/vilanterol for the treatment of moderate to severe chronic obstructive pulmonary disease from the perspective of the Chilean public health system.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is an inflammatory lung disease characterized by long-term breathing problems and airflow limitations. International guidelines recommend using bronchodilators like long-acting beta- and muscarinic antagonists, and inhalational corticosteroids. OBJECTIVES: The cost-effectiveness of single-inhaler triple therapy containing fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) was compared to the treatments Fluticasone Furoate/Vilanterol (FF/VI), Umeclidinio/Vilanterol (UMEC/VI) and Fluticasone Propionate 250 mcg/Salmeterol 25mcg + Tiotropio 18 mcg (FP/SAL/TIO) for patients with COPD from the Chilean public health system perspective. METHODS: A cost-effectiveness analysis was performed, including a deterministic and probabilistic sensitivity analysis over a 25-year time horizon. Two scenarios were assessed to study the effect of a 3%-discount for costs and outcomes on FF/UMEC/VI. RESULTS: The incremental cost-effectiveness (ICER) of FF/UMEC/VI versus FF/VI was $10,076/QALY, being a cost-effective alternative to a threshold of one Gross Domestic Product per capita (GDPpc), while versus FP/SAL/TIO the ICER increased to $50,288/QALY, showing to be a non-cost effective alternative to 1 GDPpc, but at a threshold of 3 GDPpc. CONCLUSION: FF/UMEC/VI appears to be a cost-effective intervention for treating COPD compared to FF/VI. However, FF/UMEC/VI compared to FP/SAL/TIO showed an ICER above the threshold of 1 GDPpc, but, in comparison with lower price, the ICER was below 3 GDPpc.

Estándares Consolidados de Reporte de Evaluaciones Económicas Sanitarias: adaptación al español de la lista de comprobación CHEERS 2022.

OBJECTIVES: Health economic evaluations (HEEs) are comparative analyses of courses of action in terms of both costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) original version and its adaptation to Spanish were published in 2013. Its objectives were to promote that the HEEs are identifiable, interpretable, and useful for decision making and serve as a reporting guide. The new CHEERS 2022 replaces the previous one and tries to be more easily applied to any HEE and incorporates recent methodological advances and the importance of stakeholder involvement including patients and the general public. METHODS: For the present adaptation, the following stages were followed: (1) independent translations of the original list into Spanish, (2) blind back-translations, (3) evaluation of their quality, (4) preparation of a new version in Spanish, (5) review and improvement by the author team, (6) preparation of a new version in Spanish, (7) distribution of the preliminary Spanish version and the original one to the American HTA Network (Red de las Américas de Evaluación de Tecnologías Sanitarias) and Spanish-speaking experts for evaluation and feedback, (8) monitoring of changes to the original list under peer review at BritishMedicalJournal, and (9) consolidation of the final adaptation of the Spanish CHEERS 2022 checklist. RESULTS: In this article, we detail the process and the Spanish adaptation of the 28-item CHEERS 2022 checklist and its recommendations. CONCLUSIONS: This list is intended for researchers reporting HEE in peer-reviewed journals and reviewers, editors, and, among others, health technology assessment bodies.

[The expected cost of cancer in Chile]. / El costo esperado de cáncer en Chile.

BACKGROUND: Cancer is a public health priority in Chile. AIM: To estimate the expected annual cost of cancer in Chile, due to direct costs of health services, working allowances and indirect costs for productivity losses. MATERIAL AND METHODS: We undertook an ascendent costing methodology to calculate direct costs. We built diagnostic, treatment and follow-up cost baskets for each cancer type. Further, we estimated the expenditure due to sick leave subsidies. Both estimates were performed either for the public or private sector. Costs related to productivity loss were estimated using the human capital approach, incorporating disease related absenteeism premature deaths. The time frame for all estimates was one year. RESULTS: The annual expected costs attributed to cancer was $1,557 billion of Chilean pesos. The health services expected annual costs were $1,436 billion, 67% of which are spent on five cancer groups (digestive, hematologic, respiratory, breast and urinary tract). The expected costs of sick leave subsidies and productivity loss were $48 and $71 billion, respectively. CONCLUSIONS: Cancer generates costs to the health system, which obliges health planners to allocate a significant proportion of the health budget to this disease. The expected costs estimated in this study are equivalent to 8.9% of all health expenditures and 0.69% of the Gross Domestic Product. This study provides an updated reference for future research, such as those aimed at evaluating the current health policies in cancer.

The impact of hypoglycemia on healthcare costs: a modeling study from Chile.

BACKGROUND: This study aimed to estimate the expected cost of hypoglycemia in Diabetes Mellitus type-2 patients receiving hypoglycemic treatment in Chile and to explore the effect of the potential reduction of hypoglycemia over the total cost incurred by its public health system. RESEARCH DESIGN AND METHODS: A cost analysis was carried out based on a state transition mathematical model. The model used microsimulation with data from the National Health Survey 2016-2017 in Chile. Costs included follow-up, in-hospital and ambulatory care. Separate analysis was conducted for patients treated with insulin, or sulfonylurea. RESULTS: The annual expected total cost of hypoglycemia estimated for the Chilean public system was USD 288,922,523 (USD 273 per patient). The subgroup treated with insulin reached USD 353 per patient whereas the sulfonylurea subgroup was USD 217 per patient. The analysis revealed that for every 1% reduction of the incidence rate of severe hypoglycemia the cost is reduced 0.79% in total, 0.59% for the insulin subgroup, and 0.95% for the sulfonylurea subgroup. CONCLUSIONS: The cost of hypoglycemia represents a high proportion of the public health budget in Chile, being similar to those resources allocated to provide coverage of diabetic treatments through its universal health benefit plan. ABBREVIATIONS: DM2: type 2 diabetes mellitus; RR: relative risk; ENS: national health survey in Chile.

Different Alternatives to Assess the Burden of Disease Using Attributable Fraction on a Disability Variable: The Case of Pain and Chronic Musculoskeletal Disorders in Chile.

OBJECTIVES: To estimate the burden of disease through 4 complementary procedures to years lived with disability (YLDs) using the concept of attributable fraction and including analysis of subdomains of disability. METHODS: We explored the burden on disability for 7 common musculoskeletal disorders (CMD) using the 2009 to 2010 Chilean National Health Survey, which included the Community Oriented Programme for the Control of Rheumatic Disease Core Questionnaire to identify cases with CMD, and an 8-domain questionnaire for health state descriptions. We calculated the proportion of disability attributable to pain in the general population and people with CMD. We also estimated the burden of CMD expressed as YLD and as the proportion of the disability in the general population attributable to people with CMD, with a particular focus in the pain domain of disability. Second order of uncertainty around point estimations was also characterized. RESULTS: Pain domain of disability accounted for 23.4% of the total disability in the general population, and between 20% (fibromyalgia) to 27.1% (osteoarthritis of the hip) in people with some of the selected CMD. People with chronic musculoskeletal pain accounted for 21.2% of total disability from general population, which generated 1.2 million of YLD (6679 YLD/100 000 inhabitants). Chronic low back pain and osteoarthritis of the knee were in the top position of specific CMDs, explaining the highest national burden. CONCLUSION: Pain is an essential component of disability in people with CMD and also in the general population. The approach used can be easily applied to other health conditions and other domains of disability.

Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial.

BACKGROUND: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. METHODS AND FINDINGS: The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32-2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19-2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion. CONCLUSIONS: In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration. TRIAL REGISTRATION: NCT04375098.

Real-World Evidence in Healthcare Decision Making: Global Trends and Case Studies From Latin America.

BACKGROUND: Real-world evidence (RWE) is increasingly used to inform health technology assessments for resource allocation, which are valuable tools for emerging economies such as in America. Nevertheless, the characteristics and uses in South America are unknown. OBJECTIVES: To identify sources, characteristics, and uses of RWE in Argentina, Brazil, Colombia, and Chile, and evaluate the context-specific challenges. The implications for future regulation and responsible management of RWE in the region are also considered. METHODS: A systematic literature review, database mapping, and targeted gray literature search were conducted to identify the sources and characteristics of RWE. Findings were validated by key opinion leaders attending workshops in 4 South American countries. RESULTS: A database mapping exercise revealed 407 unique databases. Geographic scope, database type, population, and outcomes captured were reported. Characteristics of national health information systems show efforts to collect interoperable data from service providers, insurers, and government agencies, but that initiatives are hampered by fragmentation, lack of stewardship, and resources. In South America, RWE is mainly used for pharmacovigilance and as pure academic research, but less so for health technology assessment decision making or pricing negotiations and not at all to inform early access schemes. CONCLUSIONS: The quality of real-world data in the case study countries vary and RWE is not consistently used in healthcare decision making. Authors recommend that future studies monitor the impact of digitalization and the potential effects of access to RWE on the quality of patient care.

The Value of Further Research: The Added Value of Individual-Participant Level Data.

Judgements based on average cost-effectiveness estimates may disguise significant heterogeneity in net health outcomes. Decisions about coverage of new interventions are often more efficient when they consider between-patient heterogeneity, which is usually operationalized as different selections for different subgroups. While most model-based cost-effectiveness studies are populated with aggregated-level sub-group estimates, individual-level data are recognized as the best source of evidence to produce unbiased and efficient estimates to explore this heterogeneity. This paper extends a previously published framework to assesses the added value of having access to individual-level data, compared to using aggregate-level data only, in the absence/presence of mutually exclusive population subgroups. Supported by a case study on the cost-effectiveness of interventions to increase uptake of smoke-alarms, the extended framework provided a quantification of the benefits foregone of not using individual-level data, pointed to the optimal number of subgroups and where further research should be undertaken. Although not indicating changes in reimbursement decisions, results showed that irrespective of using aggregate or individual-level data, no substantial additional gains are obtained if more than two subgroups are taken into account. However, depending on the evidence type used, different subgroups are revealed as warranting larger research funds. The use of individual-level data, rather than aggregate, may however influence not only the extent to which an appropriate understanding of existing heterogeneity is attained, but, more importantly, it may shape approval decisions for particular population subgroups and judgements of future research.

Cost Effectiveness of Daclatasvir/Asunaprevir Versus Peginterferon/Ribavirin and Protease Inhibitors for the Treatment of Hepatitis c Genotype 1b Naïve Patients in Chile.

INTRODUCTION: Daclatasvir and Asunaprevir (DCV/ASV) have recently been approved for the treatment of chronic hepatitis C virus infection. In association, they are more effective and safer than previous available treatments, but more expensive. It is unclear if paying for the additional costs is an efficient strategy considering limited resources. METHODS: A Markov model was built to estimate the expected costs in Chilean pesos (CL$) and converted to US dollars (US$) and benefits in quality adjusted life years (QALYs) in a hypothetic cohort of naive patients receiving DCV/ASV compared to protease inhibitors (PIs) and Peginterferon plus Ribavirin (PR). Efficacy was obtained from a mixed-treatment comparison study and costs were estimated from local sources. Utilities were obtained applying the EQ-5D survey to local patients and then valued with the Chilean tariff. A time horizon of 46 years and a discount rate of 3% for costs and outcomes was considered. The ICERs were estimated for a range of DCV/ASV prices. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: PIs were extendedly dominated by DCV/ASV. The ICER of DCV/ASV compared to PR was US$ 16,635/QALY at a total treatment price of US$ 77,419; US$11,581 /QALY at a price of US$ 58,065; US$ 6,375/QALY at a price of US$ 38,710; and US$ 1,364 /QALY at a price of US$ 19,355. The probability of cost-effectiveness at a price of US$ 38,710 was 91.6% while there is a 21.43% probability that DCV/ASV dominates PR if the total treatment price was US$ 19,355. Although the results are sensitive to certain parameters, the ICER did not increase above the suggested threshold of 1 GDP per capita. CONCLUSIONS: DCV/ASV can be considered cost-effective at any price of the range studied. These results provide decision makers useful information about the value of incorporating these drugs into the public Chilean healthcare system.

Impacto de una Política de Equivalencia Terapéutica en el Precio de Medicamentos en Chile.

Bioequivalence has become a standard request for drug commercialization in most high income countries, and significant efforts have been made to implement it in many low and middle income countries. In Chile, the requirement of bioequivalency has been gradually implemented since 2008, associated to a communicational campaign to inform the general population about its scope and importance. The objective of this study is to estimate the effect of the implementation of bioequivalence on the prices of products that have been affected by this policy. We conducted a difference in difference study in a set of 30 chronic use drugs, selected from the eighty clinical guidelines published by the Chilean Ministry of Health. The effect was assessed according to the date when the corresponding ministerial decree was published. A control drugs was selected for each analyzed medication in order to estimate the effect of implementation independently of other factors of the market. We identified three groups of drugs: (i) those which experimented a significant increment of price due to bioequivalence; (ii) those where prices decreased; and (iii) those where prices did not (significantly changed) decrease. A sensitivity analysis complemented the study results and identified the significant effect of the date when the bioequivalence was implemented. It is concluded that the implementation of bioequivalence in Chile had a significant effect on prices of some medications. However, the magnitude and direction of such effect depends on the characteristics of the particular market defined by each drug.