At Novo Nordisk, we are committed to discovering, developing and delivering innovative medicines and delivery systems to address the unmet medical needs of people living with serious chronic diseases.
To achieve this, we conduct rigorous clinical studies to assess the safety and efficacy of investigational treatments, generating critical data to secure regulatory approvals and reimbursement, which enable the broadest patient access to new therapies.
Therefore, we prioritize access to our treatments, which are not yet available by prescription, through participation in clinical studies. Visit our R&D Pipeline to search our actively recruiting clinical studies with references to NCT numbers for more detailed information.
However, we recognize that in some cases participating in a clinical trial is not possible; in other cases a patient completing a clinical trial may benefit from continued access to the treatment received in the clinical trial through their treating physician. The time between the completion of clinical trials, regulatory approval and reimbursement may result in delayed access for patients.
In this context, Novo Nordisk may evaluate unsolicited requests from physicians to access our treatments before they are available by prescription. We refer to this as Expanded Access.
If a route for Expanded Access for a specific treatment is established by Novo Nordisk, requests will be considered on a case-by-case basis, in a fair and impartial manner, and in accordance with all applicable laws and regulations. Requests under Right to Try laws in the United States are treated in the same manner as all other Expanded Access requests.
The provision of Expanded Access is at the discretion of the company and access to the treatment is not guaranteed, even if all criteria are met. Expanded Access can cease at any time where medically, ethically or legally appropriate as determined by Novo Nordisk.
Novo Nordisk may change our position on Expanded Access at any time.
When Expanded Access is provided by Novo Nordisk for a treatment, all requests will be assessed against the following criteria:
- Diagnosed with a serious or life-threatening disease or condition.
- Has exhausted, or there are no comparable or satisfactory alternative treatments available to treat the disease or condition.
- Not eligible for or otherwise unable to participate in an ongoing clinical study for an investigational treatment for their disease or condition.
- Meets all other medical criteria required to access the treatment, as established by Novo Nordisk.
- Part of an active development program.
- There is a clear biological rationale for treating the disease or condition, supported by sufficient evidence to assess that the potential benefits and associated risks are reasonable given the context of the disease or condition.
- Providing access will not impede or compromise the clinical development of the treatment, including the conduct of ongoing or planned clinical trials and potential regulatory approvals and reimbursement decisions.
- Adequate supply of the treatment is available to provide uninterrupted treatment in this setting, in addition to supply required to support necessary development activities.
- An appropriate and sustainable supply chain is available.
- Providing access adheres to local regulatory and legal requirements.
- Properly licensed and fully qualified to administer the treatment at a suitable medical establishment
- Must agree in writing to comply with:
- Any applicable country-specific legal and regulatory requirements related to providing the treatment
- Any requirements defined by Novo Nordisk related to patient confidentiality and data privacy, medical criteria, safety reporting, treatment monitoring, treatment supply handling and use, and protection of Novo Nordisk intellectual property
- Performing such duties on a continued basis while the patient is receiving the treatment.
- Physician submits request to Novo Nordisk for Expanded Access to treatment for a specific patient. No patient-identifiable information is to be included in the request.
- If the request is for a treatment where NN is offering Expanded Access, we aim to acknowledge receipt of requests within a reasonable timeframe.
- We will evaluate the request to ensure that all criteria are met. We will request from the physician any additional information that may be required to complete the evaluation.
- We will notify the physician of the decision as soon as is it determined by Novo Nordisk.
- If the request is approved, all documentation required to supply the treatment for Expanded Access will be collected, in accordance with country specific laws and regulations.
- We will prepare the treatment for dispatch to the pharmacy/institution specified by the physician, as soon as possible, in accordance with local laws and regulations.
- Resupply requests will be submitted and evaluated following the same process as above.