Duración del proceso de financiación en España de los fármacos innovadores aprobados por la Agencia Europea del Medicamento: 2008-2013

Pinyol, Carme; Valmaseda, Aida; Gómez-Ulloa, David; Solozabal, Míriam; Restovic, G

doi:10.4321/s1135-57272015000200007

Cited by 6 publications

(4 citation statements)

References 2 publications

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“…Finally, several other country-based factors could play a role that we could not examine in the context of this study, for example, coverage decisions that consider cost-effectiveness, 28 , 29 , 30 , 31 , 32 acceptability of intermediate outcomes, P&R negotiations, 7 , 33 , 34 interdependencies in pricing among countries, the budget impact of introduction, 7 , 35 the capacity and complexity of the national reimbursement system 30 and the market size. 7 …”

Section: Discussionmentioning

confidence: 99%

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Post¹,

Schutte²,

Oijen³

et al. 2023

ESMO Open

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Section: Discussionmentioning

confidence: 99%

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Post¹,

Schutte²,

Oijen³

et al. 2023

ESMO Open

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“…43 Furthermore, during the years of economic crisis, many price negotiations for new pharmaceuticals were delayed, taking longer than the maximum 180 days required by the European Commission directive. 44 In other cases, the situation has been the opposite. Media pressure has acted as a catalyst to accelerate process times.…”

Section: Discussionmentioning

confidence: 99%

Economic Evaluation for Pricing and Reimbursement of New Drugs in Spain: Fable or Desideratum?

et al. 2020

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Background: The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. Objective: The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. Methods: Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. Results: Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. Conclusions: Poor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.

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“…Comisión Interministerial de Precios de los Medicamentos (CIPM) fija su precio, una decisión que será posteriormente ratificada por la Dirección General (Pinyol, Valmaseda, Gómez-Ulloa, Solozabal, & Restovic, 2015). La definición del precio se realiza por un acuerdo de sostenibilidad en el que se tiene en cuenta el riesgo compartido, techo máximo gasto, coste máximo paciente y el acuerdo precio volumen.…”

Section: )unclassified

“…Entre el 2008 y 2013 sólo 13 de 36 medicamentos clasificados como medicamentos huérfanos por la EMA recibieron fijación de precio y financiación en España, con precio más alto del promedio (Pinyol et al, 2015).…”

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Sofosbuvir in the Treatment of Chronic Hepatitis C: New Dog, New Tricks

Abraham

Spooner

2014

Clinical Infectious Diseases

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The existing standard of care for chronic hepatitis C virus (HCV) infection includes the use of pegylated interferon and ribavirin as primary components of treatment, with the addition of a direct-acting antiviral for genotype 1 infection. Sofosbuvir, an oral nucleotide inhibitor of the HCV nonstructural protein 5B RNA-dependent RNA polymerase enzyme, was recently approved for use in combination with ribavirin and/or pegylated interferon for chronic HCV infection, depending on the genotype. Sofosbuvir is orally administered, and peak plasma concentrations are not affected by food. The drug is renally eliminated and does not require adjustment in mild to moderate renal insufficiency or in any degree of hepatic impairment. Sofosbuvir is not metabolized by cytochrome P450 isoenzymes, nor does it induce or inhibit the metabolism of agents that are substrates of these enzymes. Sofosbuvir demonstrates a high barrier to resistance and was well tolerated by patients in clinical trials. Overall efficacy rates vary between 70% and 90%.

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Duración del proceso de financiación en España de los fármacos innovadores aprobados por la Agencia Europea del Medicamento: 2008-2013

Abstract: The median time from approval by the EMA of innovative drugs since the reimbursement in Spain in 2013 is double that of 2008. The main driver of delays in the process of P&R seems to be the budget impact of the drug instead of its unit price.

Cited by 6 publications

References 2 publications

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Economic Evaluation for Pricing and Reimbursement of New Drugs in Spain: Fable or Desideratum?

Sofosbuvir in the Treatment of Chronic Hepatitis C: New Dog, New Tricks

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