Marketing authorisations under exceptional circumstances for oncology drugs: an analysis of approval and reimbursement decisions of four drugs

Van der Vossen AC, Nachtnebel A, Wild C
Record ID 32013000255
English
Authors' objectives: This report aims to provide insight into the authorisation under exceptional circumstances of oncology drugs.
Authors' recommendations: To successfully develop drugs for very rare conditions, it is important that industry, EMA and reimbursement agencies intensify the collaboration. On introduction these drugs cannot always prove their cost-effectiveness, therefore conditional coverage with evidence development, preferably on an international level, should be encouraged and facilitated.
Details
Project Status: Completed
Year Published: 2013
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Austria
MeSH Terms
  • Drug Approval
  • Antineoplastic Agents
Contact
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
Contact Name: tarquin.mittermayr@aihta.at
Contact Email: office@aihta.at
Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.