Egrifta
Patient Support Information
January
21, 2011 -- EMD Serono, Inc. is proud to announce the full
commercial availability of Egrifta (tesamorelin for injection).
We are pleased to provide the full Prescribing Information
for Egrifta including Patient Information and Patient Instructions
for Use. The Prescribing Information has key information
about Egrifta, including its full indication and limitations,
clinical data and safety information.
EMD
Serono is committed to ensuring that appropriate patients
have access to Egrifta. To make this commitment a reality,
the following programs and services are now available to
support patients in gaining access to and staying on Egrifta.
The
AXIS Center
The
AXIS Center offers dedicated reimbursement, teaching and
adherence support for patients on Egrifta. With a team of
dedicated Reimbursement Case Managers, the AXIS Center assists
patients throughout the process of getting access to and
staying on Egrifta.
The
AXIS Center offers in-home or in-office injection training
to every new patient through a national network of Injection
Trainers. Every new patient also receives an Education Kit
that provides video and print administration guides along
with other useful tools. Support continues throughout treatment
with product support specialists available 24 hours-a-day/7
days-a-week to answer patients' questions about mixing and
injecting Egrifta.
To
start the process, licensed healthcare providers must fax
a Statement of Medical Necessity (SMN) (i.e., prescription),
signed by the healthcare provider, and Patient Authorization,
signed by the patient, to the AXIS Center at 866-823-9554.
SMNs will be provided by the EMD Serono sales team or can
be requested by calling the AXIS Center at 877-714-AXIS
(2947).
Co-pay
Assistance Program
For
commercially insured patients with a prescription drug benefit
that covers Egrifta, the Co-pay Assistance Program covers
up to $2,400 of patients' out of pocket cost over a 12-month
period. Patients must use the card for the first time in
2011 and can off-set up to $200 of their co-pay or coinsurance
for up to 12 uses prior to 12/31/12, not more than once
every 21 days. Patients may not use the Co-pay Assistance
Program if they receive drug benefits from state or federal
health care initiatives (including Medicare or Medicaid).
This program is not valid in the Commonwealth of Massachusetts.
Patient
Assistance Program (PAP)
The
PAP program provides free Egrifta for eligible patients
who are uninsured or under-insured. Patients must meet other
eligibility requirements, including a household income that
does not exceed 600% of the Federal Poverty Level (FPL).
Patients must also have a diagnosis of the indicated condition
and be a resident of the United States. The Egrifta PAP
program provides free drug for one year and patients will
need to reapply if they seek to continue receiving Egrifta.
The Egrifta PAP program is coordinated by the AXIS Center
at 877-714-AXIS (2947).
We
are excited to be launching Egrifta with a comprehensive
set of patient support programs. Our aim is to offer the
most relevant programs for patients, so, as always, please
provide us with any feedback that you may have.
The
U.S. Food and Drug Administration (FDA) approved 
