For medicines with different valued indications (uses), multi-indication pricing implies charging different prices for different uses. In this article, we assess how multi-indication pricing could help achieve overall strategic objectives of pricing controls, summarise its advantages and disadvantages (vs. uniform pricing) and estimate the hypothetical impact on prices of moving towards multi-indication pricing for specific oncologic medicines in Spain. International experience shows that multi-indication pricing can be implemented in real practice, and indeed a few initiatives are currently in use, albeit mostly applied indirectly through confidential pricing agreements that offer a way to discriminate prices across countries without altering list prices. However, some more sophisticated systems are in place in Italy, and more recently in Spain, where the objective is to monitor usage per patient/indication, and ultimately pay for outcomes. Based on the existing experience, we also outline six conditions required for multi-indication pricing. Multi-indication pricing is a useful tool to determine the relative prices of a drug for multiple (different-valued) indications, but by itself will not offer the 'solution' to what the absolute price should be. That will be driven, among other things, by cost-effectiveness thresholds, if they exist. Overall, we argue multi-indication pricing is nice in theory and it could work in practice, although changes in the manner in which medicines are priced, procured and monitored in clinical practice need to be applied.

Background and ObjectiveMulti-criteria decision analysis (MCDA) is a tool that systematically considers multiple factors relevant to health decision-making. The aim of this study was to use an MCDA to assess the value of dupilumab for severe atopic dermatitis compared with secukinumab for moderate to severe plaque psoriasis in Spain.MethodFollowing the EVIDEM (Evidence and Value: Impact on DEcision Making) methodology, the estimated value of both interventions was obtained by means of an additive linear model that combined the individual weighting (between 1 and 5) of each criterion with the individual scoring of each intervention in each criterion. Dupilumab was evaluated against placebo, while secukinumab was evaluated against placebo, etanercept and ustekinumab. A retest was performed to assess the reproducibility of weights, scores and value estimates.ResultsThe overall MCDA value estimate for dupilumab versus placebo was 0.51 ± 0.14. This value was higher than those obtained for secukinumab: 0.48 ± 0.15 versus placebo, 0.45 ± 0.15 versus etanercept and 0.39 ± 0.18 versus ustekinumab. The highest-value contribution was reported by the patients’ group, followed by the clinical professionals and the decision makers. A fundamental element that explained the difference in the scoring between pathologies was the availability of therapeutic alternatives. The retest confirmed the consistency and replicability of the analysis.ConclusionsUnder this methodology, and assuming similar economic costs per patient for both treatments, the results indicated that the overall value estimated of dupilumab for severe atopic dermatitis was similar to, or slightly higher than, that of secukinumab for moderate to severe plaque psoriasis.Electronic supplementary materialThe online version of this article (10.1007/s40259-018-0284-3) contains supplementary material, which is available to authorized users.

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It is well known that pharmaceutical innovation has improved the health and quality of life of patients. It is however sometimes forgotten that new drugs also have the potential of improving the efficiency and the sustainability of the healthcare system. The objective of this review is to shed light on the magnitude of the offset effect that drugs may have in the realm of the healthcare system and for society as a whole. A narrative literature review was carried out. This review demonstrated that a growing body of literature has tried to measure the magnitude of the offset effect associated with pharmaceutical innovation, both at the aggregate level and for different diseases. There is evidence that the aggregate use of new drugs can generate net savings to the healthcare system and to society, as they may release both healthcare and non-healthcare resources for alternative uses. A high degree of heterogeneity in the magnitude of the effect has been found across different pathologies and different types of drugs.

PI implies a complex scientific and technological process associated with long research periods and high financial investment. It is estimated that developing a new molecule may cost up to USD 2700 million and take up to 15 years of research. 2 Nevertheless, despite the cost that PI may represent to healthcare systems, an offset effect is often produced on other costs, which may lead to significant global savings in the total costs associated with the new drug's introduction to the market.Hence, beyond their clinical impact, drugs often have additional benefits on the healthcare system and society in general. Indeed, by preventing or treating more effectively different illnesses, PI, as many healthcare interventions, may reduce several direct and indirect costs associated with the disease and therefore become a very useful tool for optimal resource utilization. 3 In the health economics literature, direct costs refer to both direct healthcare costs (DHC) and direct nonhealthcare costs (DNHC). The former refers to the use of resources that is strictly related to illness management,

DT nº 01/2017 »»» Tabla 1. Comparación de definiciones de biosimilares en el mundo Nomenclatura Regulador Definición Similar biological medicinal products UE / EMA (2006) Medicamentos biológico que se desarrolla para que sea similar a un medicamento biológico exixtente. Cuando se aprueba, se ha demostrado que su variabilidad y las duiferencias entre este y su medicamento de referencia no afectan la seguridad o eficiencia. Similar biotherapeutic products WHO (2009) Producto bioterapéutico que es similar en términos de calidad, seguridad y eficacia a un producto bioterapéutico de referencia autorizado previamente. Biothechnological drug products Japón / PMDA (2009) Producto farmacológico biotecnológico, desarrollado por una empresa difeente, que es comparable a un producto derivado de la biotecnología de una empresa innovadora (producto de referencia). Subsequent entry products Health Canada (2010) Es un fármaco biológico que entra en el mercado después de una versión previamente autorizada en Canada y con similaridad demostrada a un fármaco biológico de referencia. Follow-on products EEUU /FDA (2012) Producto biológico qye es muy similar a un produzcto biológico de referencia con autorización de EE.UU., independientemente de las diferencias menores entre el producto biológico y el producto de referencia en términos de seguridad, pureza y concentración del producto. Biosimilar medicines Australia / TGA (2013) Un medicamento biosimilar es una versión de una medicina biológica y aregistrada (el medicamento de referencia). Tanto el biosimilar como su medicamento de referencia tendrán las siguientes características similares (demostradas mediante estudios de comparabilidad completos): Físicoquímicas, biológicas, inmunológicas, eficacia y seguridad.

Medicamentos con múltiples indicaciones: Un nuevo modelo de precio multi-anual multi-indicación El comité estuvo formado por los siguientes siete expertos con amplia experiencia demostrada en el ámbito clínico, técnico y/o de gestión (Tabla 2).