Choose the best clinical strategy with the help of our seasoned clinical drug development experts.…
ICTA set up a department dedicated to the conduct of Early Access and Compassionate Use programmes 17 years ago, managed by qualified staff who use dedicated processes and tools.
Today, ICTA is leader in conducting these programmes with a long history of successful programmes.
17 YEARS OF EXPERIENCE IN THE MANAGEMENT OF
EARLY ACCESS AND COMPASSIONATE USE PROGRAMMES
In July 2021, a new French legislation came into force. Its aim was to simplify existing mechanisms, making early access and off-label use easier for all users, and to ensure the sustainability of these programmes for the public health insurance system. It streamlined the access pathways into two distinct routes:
Pre- or Post-marketing authorisation
The Early Access authorisation allows the use of an innovative medicinal product for which the manufacturer agrees to apply for a marketing authorisation or, if already authorised, to submit for inclusion in the reimbursement lists (post-MA)
- The pre-marketing authorisation replaces the cohort ATU (former ATUc)
- and the post-marketing authorisations (Post-MA) replaces the post-ATU scheme
Drugs are eligible for the authorisation of an Early Access provided they meet the five following criteria:
- The patient is affected by a serious, rare, or disabling disease
- There is no therapeutic alternative
- The treatment cannot be delayed
- The treatment is presumed to be innovative
- There is a strong presumption that the product is effective and safe based on the results of therapeutic trials.
Compassionate prescription schemes
There are two types of Compassionate Access schemes:
- The compassionate use authorisation (former ATUn), granted for a named patient, renewable, and open to medicines which do not have a MA in any indication
- and the compassionate prescription scheme (former RTU), granted for a period of three years, renewable, and open to medicines which have a MA in another indication.
They allow the use of a medicinal product which is not necessarily innovative or initially intended to obtain a marketing authorisation, but which meets a therapeutic need.
To be eligible, drugs must fulfil the following criteria:
- There is no clinical research underway for commercial purposes
- There is no appropriate treatment
- Drug efficacy and safety are presumed based on the available clinical data.
ICTA builds on 17 years of experience in the management of Early Access and Compassionate Use programmes across a broad range of therapeutic areas to offer:
AN INTEGRATED SUITE OF SERVICES
for the management of your early access and compassionate use programmes including:
Consulting regarding the implementation of the new regulation
Support in the preparation of the EAP/CUP dossier: writing of PUT-RD/PUT-SP, regulatory aspects
Dedicated unit with hotline for healthcare professionals
Management of compensation agreements with the sites
Development of a platform/e-PRO with project-specific features/workflows
Online data monitoring
Validation of treament access requests in EAPs
Management of treatment orders
Processing of data according to ICTA standard procedures
A solId expertise valued by our clients
- Integrated operational approach (specific processes, specialised skills, dedicated resources)
- Centralised management
- Quality focused data collection process with close monitoring of sites and immediate communication to collect missing data
- In-house data processing on a continuous basis, writing of periodic reports
- Assistance to healthcare professionnals
- IT platform for data collection compliant with new requirements (Pasrel/ATIH and multi-factor authentication)
- Secure data flows to guarantee data integrity
- Experience across a wide range of therapeutic areas
- Ability to bring methodological and technical insight in your projects requiring matching with SNDS data