Patients with serious or life-threatening diseases or conditions sometimes seek medical products that are not yet approved or available in their country. Novartis “Managed Access” addresses this need by making certain investigational or unapproved treatments available to eligible patients. Below you’ll find additional details about these programs.
Product evaluation in clinical trials
Before a product can be placed on the market, it must undergo well-controlled clinical trials to prove that it is safe and effective, and its potential benefit to patients outweighs the possible risks. Clinical trial results and related product information are then submitted to the relevant health authorities for review. Clinical trials result in the generation of evidence that may lead to the approval of a product, which can make it more widely available to patients.
There are instances where a patient has a serious or life-threatening disease or condition, for which all currently available treatment options have been exhausted and enrollment into a clinical trial is not possible.
In these cases, the treating physician can request an investigational or pre-approval product prior to regulatory approval, provided it is allowed by the applicable local laws. Within Novartis, we refer to such provision of investigational or pre-approval products as “Managed Access.”
The Novartis “Managed Access” terminology covers all locally defined pre-approval access mechanisms and programs such as “Compassionate Use”, “Expanded Access”, “Named Patient Supply”, “Special Access Schemes/Programs”, “Autorisations temporaires d’utilisation (ATU)” and others.
Each request will be acknowledged immediately, and reviewed carefully and fairly by the appropriate Novartis medical experts with every effort made to provide a response promptly once we have all the necessary information.
Please note that your request will be assessed in consideration of applicable local laws and regulations.
In addition, since 2017 Novartis has collaborated with an external Independent Bioethics Advisory Committee (IBAC), which provides analysis and recommendations on Novartis guidelines and policies for the ethical conduct of clinical research, and on key ethical challenges which may arise in clinical trials, development programs and managed access programs. The IBAC is comprised of bioethicists, clinicians, healthcare practitioners, patient advocates and other domain knowledge experts appropriate to the problem at hand.
For Managed Access-related questions, please contact the medical team in your Novartis local country office.