National Centre for Pharmacoeconomics

Template for Rapid Review Assessment Submissions from Manufacturers

Version 1.4

Since September 2009, the NCPE in collaboration with the HSE Corporate Pharmaceutical Unit (HSE-CPU), consider the cost-effectiveness of all new medicines. In practice, all new medicines are subjected to a preliminary rapid review.

This template is intended to be completed by manufacturers and submitted at the time of pricing application. The completed document is intended to provide a summary of information to facilitate the rapid review process. A typical submission would be no longer than five pages long. Further information may be requested by the NCPE if necessary. Please send the completed form by email to .

Record of Updates

Version / Date / Description of changes
1.1 / 01.07.2010
1.2 / 27.10.2010 / Inclusion of drug name and date of submission on front page
1.3 / 17.05.2011 / Inclusion of the details of the price to the wholesaler for each product under the economic considerations section
1.4 / 16.08.2012 / Inclusion of EMA regulatory status of the product.

National Centre for Pharmacoeconomics Version 1.4 16.08.2012 2 of 3

Template for Rapid Review Assessment

Active ingredient
Brand Name
Company
Regulatory Status / The product should have at least CHMP positive opinion before submitting a rapid review.
Please indicate the stage of the regulatory process the technology is at:
Licensing status in Ireland
Proposed launch date
Licensing status in other jurisdictions
Orphan drug classification (Y or N)
Reimbursement settings/scheme / GMS/DP/HTDS
Hospital or primary care
The condition / Description
Epidemiology – incidence and prevalence (international and national), natural history
Current standard of care
The technology / Description – pharmacology
New class – Y or N
Presentation – formulation and administration
Dose
Place in therapy / treatment pathway
Proposed licensed indication
Target patient group / Class of disease
Population subgroup
Clinical evidence / Provide a summary of relevant trials and outcomes to include:
Type of study, study population, duration of trial, primary and secondary end-points, results (interim or final) {Note a tabular format will suffice}
Provide citations as a bibliography
Safety and tolerability / Provide summary details of adverse events encountered to date
Comparator(s) / Indicate the potential comparators for a cost-effectiveness assessment
Economic considerations / Details of the price to the wholesaler for each preparation – include details of the form, strength and pack size
Cost per patient per year
Preliminary budget impact analysis (if possible)
On-going clinical investigations / Other potential indications currently under investigation
On-going and completed assessments / Specify jurisdiction and agency (e.g. NICE, SMC)
Completed versus on-going
Reimbursement decisions to date
Additional information

Please Note: This document may be updated periodically, therefore please refer to the NCPE website to obtain the most recent version

National Centre for Pharmacoeconomics Version 1.4 16.08.2012 2 of 3