Evaluación, Financiación y Regulación de los medicamentos innovadores en los paises desarrollados

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.

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Section: Discussionmentioning

confidence: 99%

The offset effect of pharmaceutical innovation: A review study

Zozaya

Alcalá

Galindo

2019

Global & Regional Health Technology Assessment

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“…Value-based approaches are increasingly being used in decision-making processes in many developed countries that are implementing reforms to promote efficiency and sustainability within their healthcare systems. 56 Value-based prices will depend not only on those health and quality-of-life outcomes attributable to the new drug but also on the savings it may generate, and on society's willingness to pay for the new drug's marginal increase in health compared to that of its comparator. 57 Indeed, countries such as Australia, England and Sweden take into account evidence related to drugs' offset effect in order to decide whether to allow a price premium or not when it comes to a new drug for a particular illness, including evidence on potential savings that may arise in non-healthcare services.…”

Section: Discussionmentioning

confidence: 99%

The offset effect of pharmaceutical innovation: A review study

Zozaya¹,

Alcalá²,

Galindo³

2019

Grhta

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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,

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“…Además, resulta difícil capturar el valor asociado a estas terapias en el momento de su lanzamiento, lo que se une a que, dado el elevado precio que suelen tener estas terapias, su financiación se recomendaría con menor probabilidad desde el punto de vista de la eficiencia. A menudo, las terapias dirigidas a EERR se aprueban aunque no cumplan los criterios de eficiencia marcados, en tanto que también se tienen en cuenta otro tipo de criterios 45 .…”

Section: Elementos Clave Para La Financiaciónunclassified

Reflexión estratégica sobre financiación y acceso a las terapias dirigidas a enfermedades raras en España

2022

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general: incentivos a nivel europeo 3.3. Condicionantes clínicos 3.4. Investigación 3.5. Prácticas internacionales 3.6. Criterios para la financiación de terapias dirigidas a EERR 3.7. Determinantes de la financiación y acceso en españa 3.8. El papel de los pacientes y las asociaciones de pacientes 3.9. Autorizaciones y tiempos de comercialización de MMHH 3.10. Orientaciones futuras 4. DIAGNÓSTICO DE LA SITUACIÓN ACTUAL 4.1. Condicionantes de la financiación y acceso 4.2. Evaluación y acceso 4.3. Financiación y seguimiento 4.4. Titulares de elementos destacados

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Evaluación, Financiación y Regulación de los medicamentos innovadores en los paises desarrollados

Cited by 8 publications

References 88 publications

The offset effect of pharmaceutical innovation: A review study

The offset effect of pharmaceutical innovation: A review study

The offset effect of pharmaceutical innovation: A review study

Reflexión estratégica sobre financiación y acceso a las terapias dirigidas a enfermedades raras en España

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