REFLECTIONS AND PERSPECTIVES ON BIOSIMILARS IN BRAZIL

Objective: Biological agents are among the medicines with the highest revenue in the world market. Biosimilars are copies of biological products introduced into the market to offer clinical efficacy like the originator or reference product at lower prices. This study aimed to verify the characteristics and price differences between biological medicines registered and marketed in Brazil until the end of 2019. Methods: All records were collected by November 2019 on the website of the National Health Surveillance Agency (Anvisa). The list of the Chamber of Regulation of the Medicines Market (CMED) consulted for the price analysis, has an economic classificatory criterion with eight ranges. Categorization, according to the date/period of authorization for marketing, was also made. Results: At Anvisa site, there are 144 drugs present in 277 products distributed in three regulatory categories: new, biological, and similar. Approximately 73% of drugs have been approved in the past five years. Three classes represent 77.9% of all drugs-antineoplastics and immunomodulatory agents (38.6%), blood and blood organ forming (20.7%), and alimentary tract and metabolism (18.6%). Of the 178 products listed in the CMED, 26 (14.6%) have prices above 10,000 reais. Conclusion: The prices of original products, for most of the inputs, are lower than those of biosimilars, reversing the international logic

Healthcare Rationing in Spain: Framework, Descriptive Analysis and Consequences

This paper describes the main healthcare rationing policies implemented in Spain over the last 2 decades, and analyses the consequences of these policies on the healthcare system, patients, healthcare practitioners, the pharmaceutical industry and policymakers. The primary explicit healthcare rationing policies utilised in Spain include a catalogue that defines the healthcare rights of citizens. However, the existing system may lead to inequity between regions, and is not structured to direct resources towards the most cost-effective options. Health technology assessment requires further work before it can be utilised widely for the development of rationing strategies. Selective reimbursement of drugs and drug co-payments provide only short-term results and appear to have little long-term impact on expenditure. Implicit rationing instruments, especially waiting lists, have had a significant effect on healthcare quality and the welfare of citizens, and have contributed to keeping the Spanish healthcare budget under control. Newer regulations should integrate some form of economic evaluation within the policy-making processes associated with healthcare. Further research is needed to identify those efficient and equitable rationing instruments that are most likely to improve health interventions for an aging society that is increasingly demanding of health services.Economic-implications, Health-policy

Dynamic Modelling of Infectious Diseases: An Application to the Economic Evaluation of Influenza Vaccination

Objective: To evaluate the economic efficiency of influenza vaccination using both dynamic and static modelling approaches. Setting: The Spanish National Health System. Design and methods: We modelled the progress of an influenza epidemic in Spain according to the epidemiological pattern of susceptible->infective->resistant, employing a non-linear system of ordinary differential equations that enables the measurement of epidemiological effects of an anti-influenza vaccination. We used a decision tree to represent the repercussion on healthcare resources use and on financial resources. The same analyses were conducted using a static approach, and the results were compared. Healthcare costs were valued in _, year 2005 values. Results: For the base case, the impact of the healthcare intervention (vaccination) was not efficient from the perspective of the healthcare payer when using a static approach (return rate 0.28 per _ invested in vaccination). Nevertheless, it was efficient when employing a dynamic approach (return rate 1.22 per _). Furthermore, a considerable freeing of healthcare resources would have been produced over the entire influenza season. Conclusions: The indirect effect of vaccination on the non-vaccinated individuals (the `herd immunity effect') can be greater than the direct effect on individuals vaccinated. This implies that the herd immunity effect needs to be taken into consideration in the economic evaluations of prophylactic measures employed against infectious diseases.Cost-analysis, Influenza-virus-infections, Influenza-virus-vaccine, Modelling