Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH

Ortega, Ana; Fuentes, M.D. Fraga; Latorre, F. Puigventós; Santos-Ramos, Bernardo; Estela, Ana Clopés; Boltó, M. Vilanova

doi:10.1016/j.farma.2011.11.005

Cited by 16 publications

(28 citation statements)

References 2 publications

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“…In this case, the efficacy source included in the model was an indirect-comparison meta-analysis because of the lack of direct comparisons between the alternatives evaluated. This methodology, when developed with transparency and rigour, is widely recognized and accepted by health technology assessment agencies, such as the UK National Institute for Health and Care Excellence [40], and other scientific associations, such as the GENESIS group, belonging to the Spanish Society of Hospital Pharmacists [41]. The pivotal trials on which authorizations were based (ARISTOTLE [8] and ENGAGE-AF [12]) were considered the most robust studies to use as the source of individual efficacies.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness Analysis of Apixaban Versus Edoxaban in Patients with Atrial Fibrillation for Stroke Prevention

Oyagüez

Suárez

López‐Sendón

et al. 2019

PharmacoEconomics Open

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Objective Our objective was to assess the cost effectiveness of apixaban versus edoxaban in the prevention of stroke and systemic embolism (SE) in patients with atrial fibrillation (AF) in Spain. Methods We customized a Markov model with ten health states to estimate the lifetime economic and clinical outcomes in 6-week cycles. The efficacy (clinical event rates per 100 patient-years) and safety data were derived from a pairwise indirect treatment comparison. The analysis was conducted from both the national health service (NHS) and societal perspectives, and included pharmaceutical costs (retail price plus value-added tax (VAT) and applicable national deductions) according to daily dosages (apixaban 10 mg (5 mg twice daily (bid)) and edoxaban 60 or 30 mg) and complications and diseasemanagement costs, obtained from national databases. Utilities for quality-adjusted life-year (QALY) calculations reflected EuroQoL 5-Dimension scores in patients with AF. An annual discount rate of 3% was applied for costs (€, year 2019 values) and outcomes. Results In a 1000-patient cohort, apixaban 5 mg bid versus edoxaban 60 mg could avoid five strokes, six major bleedings and 29 clinically relevant non-major bleedings (CRNMBs). Compared with edoxaban 30 mg, apixaban could avoid 21 strokes and two SEs. An increase in bleedings was observed with apixaban (seven haemorrhagic strokes, 48 major bleedings and 17 CRNMBs). Apixaban yielded 0.04 additional QALYs compared with edoxaban 60 mg or 30 mg. Incremental costs/QALY were €9639.33 and €354.22 for apixaban versus edoxaban 60 mg and edoxaban 30 mg, respectively, from the NHS perspective and €7756.62 for apixaban versus edoxaban 60 mg from the societal perspective. Apixaban was dominant versus edoxaban 30 mg from the societal perspective. Sensitivity analyses confirmed the robustness of the model. Conclusions This study suggests that apixaban 5 mg bid is a cost-effective alternative to edoxaban for stroke prevention in the AF population in Spain.

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Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness Analysis of Apixaban Versus Edoxaban in Patients with Atrial Fibrillation for Stroke Prevention

Oyagüez

Suárez

López‐Sendón

et al. 2019

PharmacoEconomics Open

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“…The calculation was conducted in a Microsoft Excel-based spreadsheet model. The model was constructed in compliance with methodology guidelines for economic evaluations and analyses previously developed in Spain [ 45 , 46 ].…”

Section: Methodsmentioning

confidence: 99%

Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

García-Goñi

Río-Álvarez²,

Carcedo³

et al. 2021

Pharmaceuticals

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Since the first biosimilar medicine, Omnitrope® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System (NHS) over the period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) and uptake data for both originator and biosimilar as actual units consumed by the NHS were the two variables considered. Two scenarios were compared: a scenario where no biosimilars are available and the biosimilar scenario where biosimilars are effectively marketed. All molecules exposed to biosimilar competition during this period were included in the analysis. The robustness of the model was tested by conducting multiple sensitivity analyses. From the payer perspective, it is estimated that the savings produced by the adoption of biosimilars would reach EUR 2306 million over 11 years corresponding to the cumulative savings from all biosimilars. Three molecules (infliximab, somatropin and epoetin) account for 60% of the savings. This study provides the first estimation of the financial impact of biosimilars in Spain, considering both the effect of discounts that manufacturers give to hospitals and the growing market share of biosimilars. We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions.

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“…A discount rate of 3% per year was applied to costs and benefits, as recommended by national pharmacoeconomic guidelines when the time horizon of the analysis is > 1 year. 7,8 The model is an adaptation of the model presented to NICE, 9 and adaptations of this model were also submitted to CADTH 10 and HAS. 11 NICE recommendations on the economic evaluation of midostaurin 9 and the opinion of a panel of Spanish clinical experts were taken into account when carrying out the analysis.…”

Section: Methodsmentioning

confidence: 99%

“…Discount rates for the costs and benefits of 0% and 5%, respectively, were applied according to the recommendations of the main national pharmacoeconomic guidelines. 7,8 Following the recommendations of clinical experts, the effect of substituting daunorubicin for idarubicin for first line therapy was also evaluated.…”

Section: Sensitivity Analysismentioning

confidence: 99%

<p>Cost-Effectiveness Of Midostaurin In The Treatment Of Acute Myeloid Leukemia With The FLT3 Mutation In Spain</p>

Arenaza

Díez

Esteve

et al. 2019

CEOR

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The addition of midostaurin to standard chemotherapy (cytarabine and daunorubicin) has shown significant improvements in the survival of patients with acute myeloid leukemia with the FLT3 mutation (FLT3-AML). The objective of this study was to determine whether this intervention would be cost-effective in Spain. Methods: A partitioned survival model with five health states was developed (diagnosis and induction, complete remission, no complete remission, transplantation and death). A lifetime time horizon and the Spanish National Health System perspective were adopted. During the first three years, permanence in the different health states was determined according to the results of the RATIFY study. In successive years, the death rates of the Spanish population adjusted by a factor to reflect long-term disease-related mortality were used. Utilities were obtained from the literature. Pharmacological costs (first and second line) and the costs of other health resources (hospitalizations, visits and tests) were included. The robustness of the model was evaluated by deterministic and probabilistic sensitivity analyses. Results: The addition of midostaurin resulted in 1.46 life years gained (LYG) and 1.23 quality-adjusted life years (QALY) gained and implied an additional cost of € 47,955, resulting in an incremental cost-effectiveness ratio (ICER) of € 32,854/LYG and an incremental cost-utility ratio of € 38,985/QALY. In the univariate sensitivity analysis, the threshold of € 50,000/QALY was not exceeded in any case; taking into consideration potential discounts of 20-40% in the PVL of midostaurin the ICER would be below € 30,000/QALY, a commonly accepted threshold in Spain. In the probabilistic analysis, when the threshold was € 50,000/QALY, midostaurin was cost-effective in 82.3% of simulations. Conclusion:According to our modeling, midostaurin, in combination with standard chemotherapy, could be an efficient alternative for the treatment of FLT3-AML in Spain.

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Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH

Abstract: Most evaluated drugs have an active comparator but studies comparing them directly are not as common. ICs could be included in more reports along with quality control criteria.

Cited by 16 publications

References 2 publications

Cost-Effectiveness Analysis of Apixaban Versus Edoxaban in Patients with Atrial Fibrillation for Stroke Prevention

Cost-Effectiveness Analysis of Apixaban Versus Edoxaban in Patients with Atrial Fibrillation for Stroke Prevention

Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

<p>Cost-Effectiveness Of Midostaurin In The Treatment Of Acute Myeloid Leukemia With The FLT3 Mutation In Spain</p>

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