Letter of Intent EUnetHTA REA

Updated: April 2018

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Letter of Intent EUnetHTA REA

International Nonproprietary Name

Brand Name

Description of the medicine and mechanism of action

Method of administration and dosage

Marketing authorisation status

<Please state the current EU regulatory status, with relevant dates (date of application and expected date of approval from the EMA/CHMP), and type of regulatory procedure [new (initial) marketing authorisation application or post-authorisation procedure]. Please do note that the coordination team should be immediately notified if any change is foreseen.>

EU indication

<Please state the proposed (submitted to the EMA) and the anticipated indication(s) in the EU. Please do note that the coordination team should be immediately notified if any change is foreseen.>

Companion diagnostic

<Please state if a companion diagnostic is required. If yes, please provide us with a brief description.>

Description of the disease

<Please provide us with a brief description of the disease/condition for which the medicine is proposed and anticipated to be indicated.>

Specification of the population covered by the indication

<Please provide us with a brief description of the population that falls under the submitted and anticipated indication.>

EU clinical practice and comparators

<Please provide us with a brief summary of the current clinical pathway of the disease/condition for which the medicine is proposed and anticipated to be indicated, highlighting the anticipated comparators in the EU.>

Estimated population size

<Please provide us with the estimated European population size.>

Suggested PICO for the joint assessment

PICO 1	<Please provide us with your PICO suggestion(s) of for the joint assessment. If you consider more than one PICO relevant (e. g. different subpopulations require different comparators) please state them by adding more lines (e.g. PICO 1, PICO 2…).>
Population
Intervention
Comparator
Outcomes

PICO 2 (optional)	<Please provide more than one PICO if necessary. Please expand the table as required.>
Population
Intervention
Comparator
Outcomes

Summary table of the studies with the medicine described in paragraph number 3 in the EU indication(s) described in paragraph number 6

Study <Please provide a list of all the studies with the medicine described in paragraph number 3 in the EU indication(s) described in paragraph number 6. Please use the table below and add lines as required.>	Included in the regulatory submission dossier (yes / no)	Sponsored study (yes / no)	Status (completed / discontinued / ongoing)	Study duration	Treatment arms	Available documents CSR (yes / no) Study register entry (yes <include link> / no) Study results register entry (yes <include link> / no) Journal publication (yes <include link and bibliographic reference> / no) Abstract publication (yes <include link and bibliographic reference> / no)

Contact Details

Primary contact
Name:	<Please provide the name of the primary contact for the EUnetHTA Joint Assessment.>
Email:	<Please provide the email of the primary contact for the EUnetHTA Joint Assessment.>
Tel:	<Please provide the telephone number of the primary contact for the EUnetHTA Joint Assessment.>

Secondary contact
Name:	<Please provide the name of the secondary contact for the EUnetHTA Joint Assessment.>
Email:	<Please provide the email of the secondary contact for the EUnetHTA Joint Assessment.>
Tel:	<Please provide the telephone number of the secondary contact for the EUnetHTA Joint Assessment.>

Declaration

I confirm that all data relevant to the Letter of Intent have been disclosed to EUnetHTA WP4.

Signature	<Please insert a scanned signature or send a copy of this completed page as an attachment. Please note that a Word version of the completed Letter of Intent is required.>
Name
Position
Date