New AOTM ordinance allows pharma companies to comment on its assessments

2010-03-03

A new ordinance of the director of the Health Technology Assessment Agency (AOTM) has come into force that regulates the procedure whereby applicant pharmaceutical companies operating in Poland may submit official commentaries on the Agency’s assessments of drug evaluation reports that they prepare for the AOTM as part of the drug reimbursement application procedure, before the Consultation Panel meets to take the final decision.
Under the procedure, the applicant company may declare an intention to submit its commentary by means of a special declaration form, received from the Agency shortly upon filing its report. Then, and not later than a week before the Agency’s Consultation Panel is due to meet to take a final decision on its application, the company receives an official request from the AOTM to provide its opinion, along with the final version of the Agency’s assessment (containing a full list of sources but without appendices; and with certain sensitive information, such as names of analysts or financial or market data gleaned from other sources, blacked out). The company then has three working days to file its commentary by e-mail or fax.
The commentary may not be longer than two A4 pages (1,800 characters per page, including spacing). At the end of the document, the company must give its consent for the publication of it (or its part) on the Agency’s website, in case its contents are quoted in the official minutes of the Panel’s meeting.
The commentary, which may not be supported with data other than those included in the drug evaluation report, is presented as a separate reference at the meeting and may be considered by the Panel in its proceedings.