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EAPs are known by differing names depending on the regulatory jurisdiction. These include Expanded Access, Early Access, Compassionate Use and Named Patient Programs.
These solutions are all used when there’s significant unmet clinical need, when all other alternatives are exhausted, or when there’s no suitable treatment alternative.
Physicians want to do the best for their patients and often ask for access to innovative new therapies.
Individual Patient Programs
Physicians take responsibility for treating an individual patient with a medicine unlicensed in the treatment country. In some regulatory jurisdictions, this may require permission from the competent authority and, if so, this is granted for the individual patient.
Group or Cohort Programs
A central protocol is approved by the relevant competent authority for a defined group of patients. This may be patients with a specific diagnosis, disease state, or patient profile.
Who initiates
Entry criteria set by
Liability
Restricted to protocol use
Physician re-imbursement
Can therapies be charged for
Examples
Individual or Named Patient Programs
Physician
Physician/ Regulator
(company may choose to supply only for certain pts)
In many countries Regulator may give permission
Physician/ Institution
In some countries
nATU – France
Single patient IND – USA
Group or Cohort Programs
Pharma/ Biotech or Group of Physicians
Pharma/ Biotech or Group of Physicians
Physician/ Pharma/ Biotech
cATU – France EAMS – UK Treatment IND – USA
For a country-by-country analysis of which program is right for you, please get in contact.
Please take a look at how else we can help you in EAP.
