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Replies to post #183295 on Anavex Life Sciences Corp (AVXL)
Medicines Access Programs
MAPs can go by a number of different names such as compassionate use, expanded access, product
familiarisation, cost-share, early access programs but all have the same principle that patients can get
access to a medicine that is subsidised by the sponsor.
These programs provide patients with access to medicines that may not yet be registered in Australia or
may be registered with the TGA but not yet subsidised under the PBS. MAPs allow patients to access
the medicine before registration or subsidy and differ from the Special Access Scheme (SAS).
Medicines Australia
The Medicines Australia Code of Conduct2 makes the following points with regards to Product
Familiarisation Programs (PFPs):
? Companies must ensure that all Product Familiarisation Programs (PFP) have the aim of allowing the
medical profession to evaluate and become familiar with a product.
? A company will make available on request the rationale for a PFP without delay, but in any event in
no longer than 10 working days from the date of the request.
? Companies must not offer any monetary or any other type of reward to healthcare professionals, their
families and/or employees for taking part in PFPs.
? PFPs must involve patients being treated for approved indications of the product.
? The company must provide a patient information document to be given to the patient by the
healthcare professional which explains that the product will be provided under a PFP for a fixed
period, after which it may only be available on a private prescription if it is not reimbursed under the
PBS at that time.
? PFPs may be initiated at any time following the approval of the product for registration; or the
approval of new indications. Only one PFP may be conducted for a particular indication.
Australia | “Special Access Scheme”
In Australia, the Therapeutic Goods Administration (TGA) manages compassionate use under the Special Access Scheme (SAS). SAS classifies patients under two categories:
CATEGORY A: Patient is “seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.”
Doctors can provide special access (compassionate use) of unauthorized drugs to Category A patients without approval of the TGA. The doctor must notify the TGA of the treatment. The doctor must also send an Authority to Supply form to the drug company to provide the drug company legal authority to supply the drug. However, the drug company is under no obligation to supply the drug. The drug company must determine if will agree to provide compassionate use of the drug.
CATEGORY B: All other patients
For Category B patients, the TGA approves special access (compassionate use) to unauthorized drugs on a patient-by-patient basis. The doctor must submit an application to the TGA. If the TGA approves the request, the drug company must then determine if it is willing to provide compassionate use of the experimental drug.
For more information, visit the SAS website.
