Therapeutic value and price of the new pharmaceuticals commercialized in Argentina: Are they worth what they cost?

被引：9

作者：

Canas, Martin ^{[1
]}

Omar Buschiazzo, Hector ^{[2
]}

Alejandro Urtasun, Martin ^{[3
]}

机构：

[1] Univ Nacl La Plata, Federac Mod Prov Buenos Aires FEMEBA, Fac Ciencias Med, Inst Ciencias Salud,Univ Nacl Arturo Jauretche,Ar, Buenos Aires, DF, Argentina

[2] Univ Nacl La Plata, Fac Ciencias Med, Area Pharmacol, Federat Med Prov Buenos Aires FEMEBA, Buenos Aires, DF, Argentina

[3] Univ Nacl Arturo Jauretche, Inst Ciencias Salud, Area Pharmacol, Federac Med Prov Buenos Aires FEMEBA, Buenos Aires, DF, Argentina

来源：

SALUD COLECTIVA | 2019年 / 15卷

关键词：

Drug Approval; Drug Evaluation; Drug Costs; Argentina; CHRONIC HEPATITIS-C; ACCELERATED APPROVAL; DRUGS; MORTALITY; ASSOCIATION; PREDICTORS; SURVIVAL; DISEASE;

D O I：

10.18294/sc.2019.1962

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

In Argentina, new drugs can be authorized by presenting the drug's certificate of approval in at least one of 15 countries considered to have rigorous health surveillance, without needing to carry out a local evaluation of the efficacy, safety or added therapeutic value of the new product. In this article, we evaluate the new drugs commercialized in Argentina in 2016 using different approaches: their approval by other regulatory agencies, the demonstration of their efficacy in randomized clinical trials, types of outcomes studied, rating of their added therapeutic value using two widely recognized scales, and their sale price to the public. It is concluded that, as a reflection of what occurs in developed countries, new drugs enter the market at exorbitant prices, but the majority do not represent a significant therapeutic advancements. The result is increased risks to patients and an overburdening of the public and private funding systems.

引用

页数：17

共 37 条

[21] Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs [J].