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GLOBAL ACCESS TO MEDICINES POLICY

Alexion is committed to patients having access to our medicines. We work with private healthcare organizations, policymakers and governments around the world so that patients with rare and devastating diseases have access to the therapies they need.

We recognize, however, that access to medicines can be challenging and are committed to supporting programs that enable eligible patients around the world to receive our therapies outside of clinical and commercial settings.

Alexion’s access programs aim to 1) provide access to our therapies in geographies where approved treatments may be unavailable, 2) cover temporary gaps in funded access to treatment, and 3) enable patients to access investigational therapies that are actively being explored by Alexion. These programs, including those which provide for compassionate use or expanded access, are designed to address the pressing unmet medical needs that patients with rare diseases face while working toward the development of long-term, sustainable access solutions.

Process and Eligibility Criteria

Requests for access to Alexion therapies must follow the below procedure:

  • All requests for access must be sent to GlobalAccess@alexion.com for consideration.
  • The patient’s diagnosis must be confirmed by a treating physician and supported with appropriate documentation.
  • The treating physician must complete the Global Access to Medicines Request Form, which will be provided by Alexion after initial contact.

Alexion will carefully consider every request for access that we receive. If eligibility criteria under one of our defined access pathways are met, Alexion will assess the patient for inclusion in the relevant access program. At minimum, requests must meet the following conditions:

  • The underlying disease or condition is life-threatening or seriously debilitating.
  • There are no satisfactory alternative therapies available to the patient.
  • The patient is not eligible for enrollment in other ongoing Alexion-sponsored studies for that particular product and indication.
  • The request is for an approved use of a product, with the exception of compassionate use requests, which provide access to therapies for investigational uses.
  • The treating physician reasonably expects that the patient will benefit from the treatment without undue safety risks.
  • The physician agrees in writing to comply with Alexion requirements in terms of medical criteria, safety reporting, drug supply/use, and protection of Alexion proprietary information and/or intellectual property.
  • The request is from a country that is neither on the U.S. Embargoed list nor politically unstable.

In addition to these criteria, Alexion will consider a number of factors in determining whether access can be provided, including available clinical data for the proposed use and any potential implications regarding clinical development and supply of the requested product.

Alexion is committed to assessing every access request with the highest degree of ethical responsibility. We will respond to every request within 3 business days, but cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.

Treating physicians seeking access to an approved or investigational Alexion medicine on behalf of a patient should email GlobalAccess@alexion.com to submit their requests. Additionally, the list of Alexion’s ongoing clinical trials for both approved and investigational therapies can be found at clinicaltrials.gov.