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Create the complete Product Overview for tendering and price negotiations
European Statement
Selection, Procurement and Distribution
Author(s)
Liselotte Kamper
Why was it done?
To ensure optimal price negotiations and tenders based on an up-to-date product overview including both pharmaceutical, therapeutic, and commercial knowledge.
What was done?
Team Horizon Scanning (HS) in Amgros has developed a comprehensive report covering all important information for a new medicine about to be marketed within the EU – an Extended Product Overview (EPO).
How was it done?
Following every meeting in the Committee for Medicines for Human Use (CHMP) at the European Medicines Agency (EMA), information on applications for marketing authorisation on new medicines is identified in the agenda and minutes. The following information is compiled:
• Name of the active substance
• (Commercial) name of medicine
• EMA procedure number
• Date of application
• Type of application (Orphan/Accelerated review/PRIME)
• Name of the marketing-authorisation applicant
• Therapeutic indication
The information is supplemented with:
• ATC-code
• Mechanism of action
• Incidence/Prevalence
• Potential impact for the patients and the health care system
• Already approved medicines to treat the same disease
The information is presented and discussed at an internal meeting in Amgros between the HS team and representatives from health economics, tendering and negotiations. At the meeting it is decided for which medicines it is relevant to produce an EPO. The EPO contains the above-mentioned information as well as the following information:
• A description of the disease
• A status of the current standard treatment of the disease
• Information from the clinical studies supporting the indication/application
• Other medicines in pipeline for the same indication, with a status on the timeline for applying for marketing authorization
• Analysis of the market into which the medicine will be launched
The final document is confidential.
What has been achieved?
The EPO-document ensures that Amgros is prepared in the best way in negotiations to agree on a price level that gives a reasonable match between the effect of the medicine and its costs compared with the current standard treatment. Thereby more cost-effective health solutions and possibility to achieve more health for money in the Danish hospital setting can be secured.
What next?
The HS team wish to expand the EPOs to also cover specific therapeutic areas of interest e.g., multiple myeloma and other complexed therapeutic indications.