Subject(s)
Antiviral Agents/therapeutic use , Biological Products/therapeutic use , Communicable Disease Control/organization & administration , Compassionate Use Trials/ethics , Drugs, Investigational/therapeutic use , Ethics, Medical , Hemorrhagic Fever, Ebola/drug therapy , Animals , Antiviral Agents/economics , Biological Products/economics , Canada , Compassionate Use Trials/economics , Drugs, Investigational/economics , Financing, Government/economics , Financing, Government/ethics , Hemorrhagic Fever, Ebola/epidemiology , Humans , Immune Sera , Liberia , Mice , United StatesABSTRACT
We are at the cusp of significant new alternatives for the treatment of chronic hepatitis C. Among more than 100 drugs in development, some are ready to be approved and in the market as soon as next year. The protease inhibitors telaprevir and boceprevir, will change the SOC treatment to triple therapy, (combined with peg IFN and RBV), with duration of treatment guided by rapid virological response. In this article we present the data supporting the approval of telaprevir and boceprevir, and information on polymerase inhibitors and IFN free proof of concept trials. Finally we discuss which patients should wait for DAA based therapies and which should be considered for peg IFN/RBV now. In the next 5 years our patients can expect higher response rates and truncated duration of therapy. They can expect drug cocktails or combos but for the next years these novel drugs will still require peg IFN and RBV. Also, a new era of resistance as a barrier to therapy will require sub typing and more viral monitoring. Overall, improved outcomes will come at the expense of more adverse events and increased costs of treatment.
Subject(s)
Antiviral Agents/therapeutic use , Drugs, Investigational/therapeutic use , Hepatitis C/drug therapy , Antiviral Agents/adverse effects , Antiviral Agents/economics , Clinical Trials as Topic , Drug Costs , Drug Therapy, Combination , Drugs, Investigational/adverse effects , Drugs, Investigational/economics , Evidence-Based Medicine , Hepatitis C/diagnosis , Hepatitis C/economics , Humans , Oligopeptides/therapeutic use , Patient Selection , Proline/analogs & derivatives , Proline/therapeutic use , Treatment Outcome , Viral LoadABSTRACT
Our paper is a first attempt to evaluate the long run impact of reference pricing on pharmaceutical innovation, health and expenditures. The model is based on a dynamic game involving three types of agents: pharmaceutical firms, consumers and a regulatory entity. Pharmaceutical firms choose the level of research investment and its innovative content, then negotiate introductory prices for new drugs with the regulator. Reference pricing affects negatively the intensity of research and it also modifies the types of innovations that are brought to the market, deterring small innovations. The model is calibrated with a small data on statins in France. Our results suggest that reference pricing typically generates a decline in health, whereas discounted expenditures may decrease or increase, depending on the degree of deterrence of cost reducing innovations.
Subject(s)
Drug Costs/legislation & jurisprudence , Drug Industry/legislation & jurisprudence , Biomedical Research/economics , Biomedical Research/statistics & numerical data , Drug Costs/statistics & numerical data , Drug Industry/economics , Drugs, Investigational/economics , Models, Economic , Models, TheoreticalABSTRACT
Este trabajo constituye una metodología teorico práctica para evaluar la conveniencia o no de proseguir desarrollando la investigación de un medicamento. El objetivo fundamental de estos estudios de factibilidad es disminuir el nivel de incertidumnbre (riesgo) que implica todo proceso investigativo y eliminar las pérdidas de recursos que afectan la economía nacional de los países subdesarrollados, si no se obtienen los beneficios que se esperan del resultado de la investigación (AU)
Subject(s)
Feasibility Studies , Drugs, Investigational/economics , EconomicsABSTRACT
Este trabajo constituye una metodologia teorico practica para evaluar la conveniencia o no de proseguir desarrollando la investigacion de un medicamento. El objetivo fundamental de estos estudios de factibilidad es disminuir el nivel de incertidumnbre (riesgo) que implica todo proceso investigativo y eliminar las perdidas de recursos que afectan la economia nacional de los paises subdesarrollados, si no se obtienen los beneficios que se esperan del resultado de la investigacion