Modelling the population-level benefits and cost-effectiveness of cell-based quadrivalent influenza vaccine for children and adolescents aged 6 months to 17 years in the US.

BACKGROUND: Cell-based quadrivalent influenza vaccines (QIVc) can increase effectiveness against seasonal influenza by avoiding mismatch from egg adaption of vaccine viruses. This study evaluates the population-level cost-effectiveness and impacts on health outcomes of QIVc versus an egg-based vaccine (QIVe) in children aged 6 months to 17 years in the US. RESEARCH DESIGN AND METHODS: A dynamic age-structured susceptible-exposed-infected-recovered model was used to simulate influenza transmission in low and high incidence seasons for two scenarios: 1. QIVe for 6 months-17 year-olds, QIVc for 18-64 year-olds, and adjuvanted QIV (aQIV) for ≥ 65 year-olds, and 2. QIVc for 6 months-64 year-olds, and aQIV for ≥ 65 year-olds. Probabilistic sensitivity analysis was performed to account for uncertainty in parameter estimates. Cost-effectiveness was evaluated as incremental cost-effectiveness ratios (ICERs). RESULTS: Extension of QIVc to children resulted in 3-4% reductions in cases (1,656,271), hospitalizations (16,688), and deaths (2,126) at a population level in a high incidence season, and 65% reductions (cases: 2,856,384; hospitalizations: 31667; deaths: 4,163) in a low incidence season. Use of QIVc would be cost-saving, with ICERs of -$16,427/QALY and -$8,100/QALY from a payer perspective and -$22,669/QALY and -$15,015/QALY from a societal perspective, for low and high incidence seasons respectively. Cost savings were estimated at approximately $468 million and $1.366 billion for high and low incidence seasons, respectively. CONCLUSION: Use of QIVc instead of QIVe in children > 6 months of age in the US would reduce the disease burden and be cost-saving from both a payer and societal perspective.

Cost-Effectiveness of Adjuvanted Quadrivalent Influenza Vaccine for Adults over 65 in France.

BACKGROUND: In France, influenza accounts for an average of over one million consultations with GPs, 20,000 hospitalizations, and 9000 deaths per year, particularly among the over-65s. This study evaluates the cost-effectiveness of the adjuvanted quadrivalent influenza vaccine (aQIV) compared to standard (SD-QIV) and high-dose (HD-QIV) quadrivalent influenza vaccines for individuals aged 65 and older in France. METHODS: The age-structured SEIR transmission model, calibrated to simulate a mean influenza season, incorporates a contact matrix to estimate intergroup contact rates. Epidemiological, economic, and utility outcomes are evaluated. Vaccine effectiveness and costs are derived from literature and national insurance data. Quality of life adjustments for influenza attack rates and hospitalizations are applied. Deterministic and probabilistic analyses are also conducted. RESULTS: Compared to SD-QIV, aQIV demonstrates substantial reductions in healthcare utilization and mortality, avoiding 89,485 GP consultations, 2144 hospitalizations, and preventing 1611 deaths. Despite an investment of EUR 110 million, aQIV yields a net saving of EUR 14 million in healthcare spending. Compared to HD-QIV, aQIV saves 62 million euros on vaccination costs. Cost-effectiveness analysis reveals an incremental cost-effectiveness ratio of EUR 7062 per QALY. CONCLUSIONS: This study highlights the cost-effectiveness of aQIV versus SD-QIV and HD-QIV, preventing influenza cases, hospitalizations, and deaths.

The economic rationale for cell-based influenza vaccines in children and adults: A review of cost-effectiveness analyses.

Seasonal influenza significantly affects both health and economic costs in children and adults. This narrative review summarizes published cost-effectiveness analyses (CEAs) of cell-based influenza vaccines in children and adults <65 years of age, critically assesses the assumptions and approaches used in these analyses, and considers the role of cell-based influenza vaccines for children and adults. CEAs from multiple countries demonstrated the cost-effectiveness of cell-based quadrivalent influenza vaccines (QIVc) compared with egg-based trivalent/quadrivalent influenza vaccines (TIVe/QIVe). CEA findings were consistent across models relying on different relative vaccine effectiveness (rVE) estimate inputs, with the rVE of QIVc versus QIVe ranging from 8.1% to 36.2% in favor of QIVc. Across multiple scenarios and types of analyses, QIVc was consistently cost-effective compared with QIVe, including in children and adults across different regions of the world.

Modelling the Relative Vaccine Efficacy of ARCT-154, a Self-Amplifying mRNA COVID-19 Vaccine, versus BNT162b2 Using Immunogenicity Data.

Background: Self-amplifying mRNA vaccines have the potential to increase the magnitude and duration of protection against COVID-19 by boosting neutralizing antibody titers and cellular responses. Methods: In this study, we used the immunogenicity data from a phase 3 randomized trial comparing the immunogenicity of ARCT-154, a self-amplifying mRNA COVID-19 vaccine, with BNT162b2 mRNA COVID-19 vaccine to estimate the relative vaccine efficacy (rVE) of the two vaccines over time in younger (<60 years) and older (≥60 years) adults. Results: By day 181 post-vaccination, the rVE against symptomatic and severe Wuhan-Hu-1 disease was 9.2-11.0% and 1.2-1.5%, respectively, across age groups whereas the rVE against symptomatic and severe Omicron BA.4/5 disease was 26.8-48.0% and 5.2-9.3%, respectively, across age groups. Sensitivity analysis showed that varying the threshold titer for 50% protection against severe disease up to 10% of convalescent sera revealed incremental benefits of ARCT-154 over BNT162b2, with an rVE of up to 28.0% against Omicron BA.4/5 in adults aged ≥60 year. Conclusions: Overall, the results of this study indicate that ARCT-154 elicits broader and more durable immunogenicity against SARS-CoV-2, translating to enhanced disease protection, particularly for older adults against Omicron BA.4/5.

Estimating the impact of influenza vaccination of low-risk 50-64-year-olds on acute and ICU hospital bed usage in an influenza season under endemic COVID-19 in the UK.

Co-circulation of influenza and SARS-CoV-2 has the potential to place considerable strain on health-care services. We estimate the cost-effectiveness and health-care resource utilization impacts of influenza vaccination of low-risk 50-64-y-olds in the United Kingdom (UK) against a background SARS-CoV-2 circulation. A dynamic susceptible-exposed-infected-recovered model was used to simulate influenza transmission, with varying rates of vaccine coverage in the low-risk 50-64 y age-group. Four scenarios were evaluated: no vaccination (baseline), 40%, 50%, and 60% coverage. For the 50% and 60% coverage, this rate was also applied to high-risk 50-64-y-olds, whereas 48.6% was used for the baseline and 40% coverage scenarios. Cost-effectiveness was estimated in terms of humanistic outcomes and incremental cost-effectiveness ratio (ICER), with discounting applied at 3%. Overall, influenza vaccination of 50-64-y-olds resulted in reductions in GP visits, hospitalizations, and deaths, with a reduction in influenza-related mortality of 34%, 41%, and 52% for 40%, 50%, and 60% coverage, respectively. All four scenarios resulted in acute and intensive care unit (ICU) bed occupancy levels above available capacity, although vaccination of low-risk 50-64-y-olds resulted in a 35-54% and 16-25% decrease in excess acute and ICU bed requirements, respectively. Vaccination of this group against influenza was highly cost-effective from the payer perspective, with ICERs of £2,200-£2,343/quality-adjusted life year across the coverage rates evaluated. In conclusion, in the UK, vaccination of low-risk 50-64-y-olds against influenza is cost-effective and can aid in alleviating bed shortages in a situation where influenza and SARS-CoV-2 are co-circulating.

Cost-Effectiveness of the Use of Adjuvanted Quadrivalent Seasonal Influenza Vaccine in Older Adults in Ireland.

BACKGROUND: Enhanced vaccines (e.g., containing adjuvants) have shown increased immunogenicity and effectiveness in older adults, who often respond sub-optimally to conventional influenza vaccines. In this study, we evaluated the cost-effectiveness of an inactivated, seasonal, MF59-adjuvanted quadrivalent influenza vaccine (aQIV) for use in adults ≥ 65 years in Ireland. METHODS: A published dynamic influenza model incorporating social contact, population immunity, and epidemiological data was used to assess the cost-effectiveness of aQIV in adults ≥ 65 years of age compared with a non-adjuvanted QIV. Sensitivity analysis was performed for influenza incidence, relative vaccine effectiveness, excess mortality, and the impact on bed occupancy from co-circulating influenza and COVID-19. RESULTS: The use of aQIV resulted in discounted incremental cost-effectiveness ratios (ICERs) of EUR 2420/quality-adjusted life years (QALYs) and EUR 12,970/QALY from societal and payer perspectives, respectively, both of which are below the cost-effectiveness threshold of EUR 45,000/QALY. Sensitivity analysis showed that aQIV was effective in most scenarios, except when relative vaccine effectiveness compared to QIV was below 3%, and resulted in a modest reduction in excess bed occupancy. CONCLUSION: The use of aQIV for adults ≥ 65 years old in Ireland was shown to be highly cost-effective from both payer and societal perspectives.

The Impact of Adjuvanted Influenza Vaccine on Disease Severity in the US: A Stochastic Model.

Influenza can exacerbate underlying medical conditions. In this study, we modelled the potential impact of an egg-based quadrivalent influenza vaccine (QIVe) or adjuvanted QIV (aQIV) on hospitalizations and mortality from influenza-related cardiovascular disease (CVD), respiratory, and other complications in adults ≥65 years of age in the US with underlying chronic conditions. We used a stochastic decision-tree model, with 1000 simulations varying input across predicted ranges. Due to the variable nature of influenza across seasons and differences in published estimates for input parameters, data are presented as 95% confidence intervals. Compared with no vaccination, use of aQIV would prevent 135,450-564,360 hospitalizations and 1612-29,226 deaths across outcomes evaluated. Overall, aQIV prevented 1071-18,388 more hospitalizations and 85-1944 more deaths than QIVe. By routine seasonal vaccination against influenza, a substantial number of severe influenza-associated complications and deaths, caused by direct influenza symptoms or by exacerbation of chronic conditions, can be prevented in high-risk adults ≥65 years of age in the US.

Vaccine Effectiveness of Cell-Based Quadrivalent Influenza Vaccine in Children: A Narrative Review.

Cell-based manufacturing of seasonal influenza vaccines eliminates the risk of egg-adaptation of candidate vaccine viruses, potentially increasing vaccine effectiveness (VE). We present an overview of published data reporting the VE and cost-effectiveness of a cell-based quadrivalent influenza vaccine (QIVc) in preventing influenza-related outcomes in the pediatric population. We identified 16 clinical studies that included data on the VE of a QIVc or the relative VE (rVE) of a QIVc versus an egg-based QIV (QIVe) in children and/or adolescents, 11 of which presented estimates specifically for the pediatric age group. Of these, two studies reported rVE against hospitalizations. Point estimates of rVE varied from 2.1% to 33.0%, with studies reporting significant benefits of using a QIVc against influenza-related, pneumonia, asthma, and all-cause hospitalization. Four studies reported rVE against influenza-related medical encounters, with point estimates against non-strain specific encounters ranging from 3.9% to 18.8% across seasons. One study evaluated rVE against any influenza, with variable results by strain. The other four studies presented VE data against laboratory-confirmed influenza. Three health economics studies focusing on a pediatric population also found the use of QIVc to be cost-effective or cost-saving. Overall, using a QIVc is effective in pediatric patients, with evidence of incremental benefits over using a QIVe in preventing hospitalizations and influenza-related medical encounters in nearly all published studies.

Estimating the Impact of Influenza Vaccination on Acute and ICU Hospital Bed Usage in an Influenza Season under Endemic COVID-19 in the US.

In 2021-2022, influenza vaccine coverage in the US dropped below pre-COVID-19 pandemic levels. Cocirculation of COVID-19 and influenza could place a substantial burden on hospital utilization in future seasons, particularly given the reduced exposure to influenza during the pandemic. We used a dynamic susceptible-exposed-infected-recovered model to simulate influenza transmission with varying influenza vaccine coverage against a background of COVID-19 circulation, in order to estimate acute and ICU hospital bed occupancy for both diseases. We evaluated two vaccine scenarios: egg-based quadrivalent influenza vaccine (QIVe) for all age groups or cell-based QIV (QIVc) for 0.5-64 year-olds with adjuvanted QIV (aQIV) for ≥65 year-olds. ICU bed availability was more limiting than general hospital bed availability, with a vaccine coverage of ≥70% required to avoid negatively impacting ICU bed availability in a high-incidence influenza season. The timing of disease peaks was a key factor together with vaccine coverage, with a difference of ≥50 days needed between peak influenza and COVID-19 bed usage together with 65% influenza vaccine coverage to avoid negative impacts. QIVc + aQIV resulted in lower bed occupancy which, while not substantial, may be critical in very high hospital resource usage situations. In a situation with co-circulating influenza and COVID-19, proactive vaccination planning could help to avert overwhelming healthcare systems in upcoming influenza seasons.

An Economic Comparison of Influenza Vaccines Recommended for Use in Eligible Adults under 65 Years in the United Kingdom.

Background: In the United Kingdom (UK), a cell-based quadrivalent influenza vaccine (QIVc) and a recombinant vaccine (QIVr) are recommended for eligible adults under 65 years. The objective of this analysis was to determine the potential cost-effectiveness of QIVc compared to QIVr for this age group using a range of assumptions about relative vaccine effectiveness (rVE). Methods: A dynamic transmission model, calibrated to match infection data from the UK, was used to estimate the clinical and economic impact of vaccination across 10 influenza seasons. The list price was £12.50 for QIVc and £22.00 for QIVr. The base case effectiveness of QIVc was 63.9%. As there are no data comparing the vaccines in the 18 to 64-year-old age group, rVE was varied. Results: For the base case, the rVE of QIVr compared with QIVc must be at least 25% in order for the cost per quality-adjusted life-year gained to be £20,000 or lower. Sensitivity analysis demonstrated that the rVE required for QIVr to be cost-effective was most dependent on the absolute effectiveness of QIVc. Conclusion: At list prices, our analysis predicts that the rVE for QIVr must be at least 25% compared to QIVc in order to be considered cost-effective.

The cost-effectiveness of an adjuvanted quadrivalent influenza vaccine in the United Kingdom.

In the United Kingdom (UK), both the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose QIV (QIV-HD) are preferred for persons aged 65 years and older but only aQIV is reimbursed by the National Health Service (NHS). The objective was to determine the potential cost-effectiveness of vaccinating adults aged 65 years and above with aQIV compared with QIV-HD in the UK. A dynamic transmission model, calibrated to match infection data from the UK, was used to estimate the impact of vaccination in 10 influenza seasons. Vaccine effectiveness was based on a meta-analysis that concluded the vaccines were not significantly different. Vaccine coverage, physician visits, hospitalizations, deaths, utility losses and NHS costs were estimated using published UK sources. The list price of aQIV was £11.88 while a range of prices were tested for QIV-HD. The price of the trivalent high-dose vaccine (TIV-HD) is £20.00 but a list price for QIV-HD is not yet available. The projected differences between the vaccines in terms of clinical cases and influenza treatment costs are minimal. Our analysis demonstrates that in order to be cost-effective, the price of QIV-HD must be similar to that of aQIV and may range from £7.57 to £12.94 depending on the relative effectiveness of the vaccines. The results of the analysis were most sensitive to variation in vaccine effectiveness and the rate of hospitalization due to influenza. Given the evidence, aQIV is cost-saving unless QIV-HD is priced lower than the existing list price of TIV-HD.

The Cost-Effectiveness of Expanding Vaccination with a Cell-Based Influenza Vaccine to Low Risk Adults Aged 50 to 64 Years in the United Kingdom.

BACKGROUND: In response to COVID-19, the UK National Health Service (NHS) extended influenza vaccination in 50- to 64-year-olds from at-risk only to all in this age group for the 2020/21 season. The objective of this research is to determine the cost-effectiveness of continuing to vaccinate all with a quadrivalent cell-based vaccine (QIVc) compared to returning to an at-risk only policy after the pandemic resolves. METHODS: A dynamic transmission model, calibrated to match infection data from the UK, was used to estimate the clinical and economic impact of vaccination across 10 influenza seasons. The base case effectiveness of QIVc was 63.9% and the list price was GBP 9.94. RESULTS: Vaccinating 50% of all 50- to 64-year-olds with QIVc reduced the average annual number of clinical infections (-682,000), hospitalizations (-5800) and deaths (-740) in the UK. The base case incremental cost per quality-adjusted life-year gained (ICER) of all compared to at-risk only was GBP6000 (NHS perspective). When the cost of lost productivity was considered, vaccinating all 50- to 64-year-olds with QIVc became cost-saving. CONCLUSION: Vaccinating all 50- to 64-year-olds with QIVc is likely to be cost-effective. The NHS should consider continuing this policy in future seasons.

Direct costs associated with the appropriateness of hospital stay in elderly population.

BACKGROUND: Ageing of Mexican population implies greater demand of hospital services. Nevertheless, the available resources are used inadequately. In this study, the direct medical costs associated with the appropriateness of elderly populations hospital stay are estimated. METHODS: Appropriateness of hospital stay was evaluated with the Appropriateness Evaluation Protocol (AEP). Direct medical costs associated with hospital stay under the third-party payer's institutional perspective were estimated, using as information source the clinical files of 60 years of age and older patients, hospitalized during year 2004 in a Regional Hospital from the Mexican Social Security Institute (IMSS), in Mexico City. RESULTS: The sample consisted of 724 clinical files, with a mean of 5.3 days (95% CI = 4.9-5.8) of hospital stay, of which 12.4% (n = 90) were classified with at least one inappropriate patient day, with a mean of 2.2 days (95% CI = 1.6-2.7). The main cause of inappropriateness days was the inexistence of a diagnostic and/or treatment plan, 98.9% (n = 89). The mean cost for an appropriate hospitalization per patient resulted in US$1,497.2 (95% CI = US$323.2-US$4,931.4), while the corresponding mean cost for an inappropriate hospitalization per patient resulted in US$2,323.3 (95% CI = US$471.7-US$6,198.3), (p < 0.001). CONCLUSION: Elderly patients who were inappropriately hospitalized had a higher rate of inappropriate patient days. The average of inappropriate patient days cost is considerably higher than appropriate days. In this study, inappropriate hospital-stay causes could be attributable to physicians and current organizational management.

Cost-effectiveness analysis for joint pain treatment in patients with osteoarthritis treated at the Instituto Mexicano del Seguro Social (IMSS): Comparison of nonsteroidal anti-inflammatory drugs (NSAIDs) vs. cyclooxygenase-2 selective inhibitors.

BACKGROUND: Osteoarthritis (OA) is one of the main causes of disability worldwide, especially in persons >55 years of age. Currently, controversy remains about the best therapeutic alternative for this disease when evaluated from a cost-effectiveness viewpoint. For Social Security Institutions in developing countries, it is very important to assess what drugs may decrease the subsequent use of medical care resources, considering their adverse events that are known to have a significant increase in medical care costs of patients with OA. Three treatment alternatives were compared: celecoxib (200 mg twice daily), non-selective NSAIDs (naproxen, 500 mg twice daily; diclofenac, 100 mg twice daily; and piroxicam, 20 mg/day) and acetaminophen, 1000 mg twice daily. The aim of this study was to identify the most cost-effective first-choice pharmacological treatment for the control of joint pain secondary to OA in patients treated at the Instituto Mexicano del Seguro Social (IMSS). METHODS: A cost-effectiveness assessment was carried out. A systematic review of the literature was performed to obtain transition probabilities. In order to evaluate analysis robustness, one-way and probabilistic sensitivity analyses were conducted. Estimations were done for a 6-month period. RESULTS: Treatment demonstrating the best cost-effectiveness results [lowest cost-effectiveness ratio $17.5 pesos/patient ($1.75 USD)] was celecoxib. According to the one-way sensitivity analysis, celecoxib would need to markedly decrease its effectiveness in order for it to not be the optimal treatment option. In the probabilistic analysis, both in the construction of the acceptability curves and in the estimation of net economic benefits, the most cost-effective option was celecoxib. CONCLUSION: From a Mexican institutional perspective and probably in other Social Security Institutions in similar developing countries, the most cost-effective option for treatment of knee and/or hip OA would be celecoxib.

[Competitiveness in the health care sector: analysis of the Swedish reform (1992-1995)]. / Competencia en el sector salud: análisis de la reforma sueca (1992-1995).

The paper reviews the outcomes and failures of the Swedish health care reform, as well as the lessons learned for accomplishing better financial results and quality standards.

Cost-Effectiveness Analysis of Atorvastatin versus Rosuvastatin in Primary and Secondary Cardiovascular Prevention Populations in Brazil and Columbia.

BACKGROUND: Latin America has witnessed a marked increase in cardiovascular (CV) disease, the leading cause of death in many countries. The benefits of lipid-lowering therapy to reduce CV-related events are widely accepted. Clinical evidence suggests that rosuvastatin is associated with slightly greater reductions in low-density lipoprotein cholesterol levels than is atorvastatin at comparable doses. Rosuvastatin, however, is often priced at a premium. OBJECTIVE: Our objective was to examine the cost-effectiveness of using atorvastatin versus rosuvastatin in reducing CV events in Brazil and Colombia using real-world prices. METHODS: A global Markov cohort model of primary and secondary CV prevention was developed and adapted to Brazilian and Colombian settings. The risks and costs of major CV events and efficacy, adherence, and costs of statins were considered. Total gains in life-years, quality-adjusted life-years, major CV events avoided, and costs over the lifetime horizon were estimated. Several dose comparisons were considered. RESULTS: In the Colombian analyses, differences in drug costs between therapies were considerable while outcomes were similar. The incremental cost per quality-adjusted life-year gained for rosuvastatin versus atorvastatin was more than $700,000 and $200,000 in primary and secondary prevention, respectively. Brazilian analyses found lower incremental cost-effectiveness ratios for rosuvastatin at some dose comparisons due to similar pricing between statins. Sensitivity analyses revealed that changes in treatment efficacy and adherence had the largest impact on results. CONCLUSIONS: In primary and secondary CV prevention, the efficacy advantage of rosuvastatin was minimal, while its acquisition cost was higher, particularly in Colombia. The incremental cost-effectiveness ratios were, therefore, generally in favor of atorvastatin being the cost-effective option.

The burden of caring for dementia patients: caregiver reports from a cross-sectional hospital-based study in China.

The impact of dementia care on caregivers' professional, personal, emotional and social well-being was measured in a cohort of 1,387 caregivers in seven regions across mainland China, using a Chinese version of the Zarit Burden Interview (ZBI) and four supplementary questions. Caregivers also estimated costs of care and medical resource utilization. Caregiver burden was generally low to moderate. Dementia care had the greatest impact on caregivers' professional lives, with 25.5% reporting a reduced work schedule in the past month. Lost work time was greater for caregivers of patients with previously diagnosed dementia than for those with newly diagnosed dementia. Average monthly out-of-pocket costs of dementia care exceeded national average monthly incomes of rural and urban residents. These findings highlight the obstacles facing the country with the fastest-growing elderly population in the world.

Clinical Characterization and the Caregiver Burden of Dementia in China.

OBJECTIVES: The prevalence of dementia in China is among the highest in the world, but systematic estimates of the rate of dementia subtypes and characterization of associated deficits are lacking. The primary aim of this study was to determine the clinical presentation of dementia and describe the caregiver burden in mainland China. METHODS: A 3-month, open-enrollment, multicenter, cross-sectional study was conducted at 48 tier-3 hospitals. Caregivers who qualified for study entry (provided amount and duration of care information), had intimate knowledge of patient status, and accompanied enrolled patients to study sites were asked to participate in an interview about patient care and caregiver burden. Caregiver burden was assessed via the Chinese version of the validated Zarit Burden Interview. RESULTS: A total of 1425 caregivers completed the survey. Patients had mild to moderate dementia (mean Clinical Dementia Rating score of 1.67±0.79), and the most common dementia subtypes were Alzheimer disease (46.7%) and vascular dementia (28.7%). Among caregivers, 57% were females, 52% were patients' spouses, and 67.3% had been caring for patients for 1 year or more. Most patients required family help and lived at home or with a family member. Caregiver awareness of dementia was limited. The mean total caregiver Zarit Burden Interview score was 26.6. Observations were similar across age, gender, education, dementia type, Clinical Dementia Rating score, and duration of care. CONCLUSIONS: China faces multiple obstacles in preparing to care for its fast-growing dementia population. Better understanding of patients and caregivers may mitigate these challenges by improving awareness and education.

Cost-effectiveness analysis of pharmacologic treatment of fibromyalgia in Mexico.

OBJECTIVE: To identify, from the Mexican Public Health System perspective, which would be the most cost-effective treatment for patients with Fibromyalgia (FM). MATERIAL AND METHODS: A Markov model including three health states, divided by pain intensity (absence or presence of mild, moderate or severe pain) and considering three-month cycles; costs and effectiveness were estimated for amitriptyline (50mg/day), fluoxetine (80 mg/day), duloxetine (120 mg/day), gabapentin (900 mg/day), pregabalin (450 mg/day), tramadol/acetaminophen (150 mg/1300 mg/día) and amitriptyline/fluoxetine (50mg/80 mg/día) for the treatment of FM. The clinical outcome considered was the annual rate of pain control. Probabilities assigned to the model were collected from published literature. Direct medical costs for FM treatment were retrieved from the 2006 data of the Mexican Institute of Social Security (IMSS) databases and were expressed in 2010 Mexican Pesos. Probabilistic Sensitivity Analyses were conducted. RESULTS: The best pain control rate was obtained with pregabalin (44.8%), followed by gabapentin (38.1%) and duloxetine (34.2%). The lowest treatment costs was for amitriptyline ($ 9047.01), followed by fluoxetine ($ 10,183.89) and amitriptyline/fluoxetine ($ 10,866.01). By comparing pregabalin vs amitriptyline, additional annual cost per patient for pain control would be around $ 50.000 and $ 75.000 and would result cost-effective in 70% and 80% of all cases. CONCLUSIONS: Among all treatment options for FM, pregabalin achieved the highest pain control and was cost-effective in 80% of patients of the Mexican Public Health System.