Contact us

LEO Pharma Policy on Access to Medicinal Products through Managed Access Programs

Managed Access Programs

At LEO Pharma, we are focused on advancing medical dermatology through well-designed and rigorous clinical trials and obtaining approval from regulatory authorities. Prior to such regulatory approval, participation in one of LEO Pharma’s clinical trials provides an option for patients to gain access to medicines not yet authorized. When a clinical trial is not an option, either because a patient is not able to participate or is ineligible, LEO Pharma’s Managed Access Program (MAP) may address the needs for patients who have exhausted all other available treatment options.

There are a variety of local regulations and mechanisms to provide medicinal products before regulatory approval or commercial availability. Different terms exist locally for these access provisions, including “Compassionate Use”, “Expanded Access”, and “Named Patient Supply”. LEO Pharma’s MAPs refer to these local mechanisms where access is provided to medicinal products outside of clinical trials and in some cases, before regulatory approval or commercial availability. These programs must comply with the specific regulatory and legal requirements of each country, which may vary based on different indications and formulations available and may evolve over time.

LEO Pharma’s Policy

LEO Pharma is dedicated to exploring viable ways to provide patients access via MAPs to our medicinal products outside of a clinical trial and in some cases, before regulatory approval or commercial availability, in compliance with applicable local regulations and approvals, if the following criteria are met:

  • Only an appropriately licensed and qualified physician may initiate a request on behalf of a patient.
  • The patient to be treated has a serious or life-threatening disease or condition and there is no satisfactory alternative therapy.
  • The patient is not eligible or is unable to participate in any ongoing clinical trial including lack of access due to geographical limitations.
  • There is an adequate supply of the medicinal product to support the clinical trials and the MAP request.
  • Providing the medicinal product should not interfere with, delay or compromise the timely completion of clinical trials that are intended to support approval by regulatory authorities.
  • The patient meets the MAP approval criteria per medicinal product defined by LEO Pharma.
  • Sufficient data is available to reasonably expect a potential benefit of treatment which outweighs the potential risk(s) in the context of the disease or condition to be treated.
  • The medicinal product is under active development (a dose and regimen has been defined, and the medicinal product is in Phase 2 development or beyond) and has not been placed on regulatory or other hold.

LEO Pharma commits to a transparent, careful, and fair evaluation of each request.

All initial requests received through the below MAP platform will be acknowledged within one business day. Requests will thereafter be reviewed using LEO Pharma’s processes and standards.

LEO Pharma commits to evaluate requests and provide prompt response, provided the documentation required from a physician to evaluate the request is complete and no additional clarifications or authorizations are needed. 

At LEO Pharma, a MAP is available; however, availability of the program does not guarantee access to a medicinal product. Regulatory pathways for providing medicinal products differ across jurisdictions, and as a result, country specific variations can occur outside of a clinical trial and in some cases, before regulatory approval or commercial availability. Other criteria set forth above and legal restrictions may apply and can limit availability. Approval of any request is at LEO Pharma’s sole discretion and may only be granted under limited circumstances; consequently, LEO Pharma may be unable to accommodate all requests. If LEO Pharma approval is granted, the physician requesting the medicinal product must enter into a documented agreement with LEO Pharma.

LEO Pharma rigorously follows local country regulations and compliant procedures. In some countries the physician may need to obtain regulatory agency and/or local ethics committee approval. Such approvals remain the responsibility of the requesting physician. LEO Pharma strives to ensure the provision of medicinal products in a timely manner once all required local health authority and import/distribution licenses are received by us. However, timelines for provision may vary based on local regulatory requirements, product availability and logistical challenges.

This Policy does not apply to the continued supply of a LEO Pharma medicinal product to patients who participated in a LEO Pharma clinical trial.

Once a medicinal product is approved and commercially available for the indication in question in the country of the request, a MAP will no longer be available as a mechanism to provide access. 

Further information and contact:

For Spesolimab MAP requests, please send an email to spesolimab@earlyaccesscare.com

For more information on LEO Pharma’s MAPs, please contact us on Managed_Access_LEO_Pharma@leo-pharma.com