|Former: Atención Farmacéutica|
|Journal edited by Rasgo Editorial since 1983|
Virginia Hernández Corredoira
EDITOR IN CHIEF
Manuela Velázquez Prieto
Jaime E. Poquet Jornet
Ramón Jódar Masanés
Lluís Campins Bernadas
Tomás Casasín Edo
Juan Carlos Juárez Giménez
Carles Quiñones Ribas
Volume 22 - Issue 1, January-March 2020
MARKET ACCES IN THE EU DO WE HAVE ENOUGH EVIDENCE?
GÓMEZ LLUCH MARÍA TERESA, FRAGA FUENTES MARÍA DOLORES, NOTARIO DONGIL CLARA, NIETO-SANDOVAL MARTÍN DE LA SIERRA PATRICIA, SÁNCHEZ SERRANO JOSÉ LUIS, VALENZUELA GÁMEZ JUAN CARLOS
Objectives: The appearance of new drugs needs to represent a necessary option, however involves a challenge for healthcare decision makers. EMA is responsible for the scientific evaluation based on many aspects, but later there can be discrepancies between European drug approval and subsequent use. Our objective was to review EMA marketing authorization of new active substance (NAS) and analyze the conditions and evidence of these. Also, we analyzed the opinion and reports of this NAS in The Spanish National Healthcare System.
Method: We analyzed NAS who had received a positive opinion by EMA recommending the granting of a marketing authorization from 1st January 2014 to 31st December 2017, according to the dates of authorization details reflected on the EMA’s website.
We compiled: therapeutic area, indication, type of approval, route normally used, designation obtained and pivotal trials of drugs, according to their design features design, their clinical phase and the comparator, in order to evaluate the evidence provided.
It was verified the existence of reports in the Spanish Drugs Agency and we analyzed its conclusions as well as the financing conditions.
Results: A total of 136 NAS were approved, mainly in the oncology area. From them, 22 (16.2%) were conditional or exceptional approval. Otherwise, 22 (16.2%) of them were carried out by accelerated route. Of these drugs, 50 (36.8%) were authorized under orphan designation and 51 of the approved indications included
at least a pivotal essay in phase I or II. Also, 54 trials included a placebo as a comparator and 27 are single-arm-essays.
The Spanish-Drugs-Agency elaborated 132 reports. Most of them concluded that drugs were similar to than alternatives, considering their use based on efficiency.Finally, 46 indications were not financed or financed under conditions.
Conclusions: Our study shows that when a new drug is authorized, the evidence is low. This leads to uncertainties of efficacy and safety. The evaluation of the value is fundamental in the health system, and strategies are needed to improve the final outcomes with the limited available resources.
DRUG DEVELOPMENT – EVIDENCE-BASED PHARMACY PRACTICE –
NEW DRUG APPROVALS