- General FAQs
- FAQ's per Program
General FAQs
FAQs per Program
- Diflucan Partnership Program
- Glivec International Patient Assistance Program
General FAQs
What is the difference between a “donation”
and an “access” program?
The difference resides in the cost to the
applicant institution. In a “donation” program,
products are offered free of charge. In “access”
programs, products are made available at cost.
What if I cannot satisfactorily fill
in all of the questions on the application?
If the information provided in your application
form is not sufficient to give Axios a level of comfort
to recommend your program, you will be requested to implement
specific changes and revise it. Axios will be happy to assist
you or put you in contact with relevant international institutions
that can assist you.
Are there items I should not submit with my form?
Axios is not collecting, and you should not
submit, any information with respect to individual patients
or the practice of physicians. You are solely responsible
for ensuring that you do not submit any such information
or any other information that may be subject to confidentiality
restrictions or privacy rights. Axios and the pharmaceutical
companies shall assume that the information submitted by
you through this site, or on any application, is not subject
to third party confidentiality restrictions or the privacy
rights of any individual.
Who sees my information?
No one but Axios International and the pharmaceutical company from which you are requesting products can see your information. For more information, please see our privacy
policy.
What is the role of Axios?
Axios is responsible for receiving, reviewing,
and recommending applications,
as well as for coordinating shipment information. Once a request is recommended by Axios, participating
companies will ship products directly to qualifying programs.
Wherever needed, Axios will assist requesting programs to
most effectively utilize the products provided in the programs.
Axios has considerable experience in access and donation
programs.
What happens once I submit my form?
Axios will forward each request to independent
reviewers who will evaluate the eligibility of the proposed
program following a set of standard criteria. The objective
of the review process is to ensure access for any treatment
program that has the basic capacity to provide sustainable
quality patient care. If the request requires clarification
or revision, Axios will work with the treatment program
to obtain the additional information needed.
If my institution is applying for more
than one access or donation program, do I need to complete
a separate application form for every program?
Once information is entered onto the first
application form, it is stored in our database and will
be used on the other application forms automatically. However,
some sections are specific to the individual programs, and
these will have to be completed for subsequent applications.
For example, the section for estimated quarterly requirements
will differ from product to product.
Who will review my form?
Axios has created a panel of reviewers. These
are independent experts experienced in establishing treatment
programs in resource-challenged settings in developing countries.
Requests are reviewed by this panel.
How long will the review process take?
We are committed to expediting access to medical products.
Upon receipt of the completed application form, Axios will contact requesting institutions within five days to acknowledge receipt and request additional information, if required.
Once complete, the file will be sent for review to the independent panel of reviewers.
Within four weeks of the acceptance of the complete form, Axios will notify the requesting institution of the reviewer s’ comments with one of the following responses:
· the request
is satisfactory and is approved;
or
· the request
will require some clarifications/amendment before it can
be approved.
If your proposal requires clarification after
the technical review, Axios will work with you to amend
your proposal.
Does the importation of the products
under this program require approval of the destination country?
Availability of the products under the program is subject to regulatory approval in the destination country before importation. Some of the products under the programs may not yet be registered in some nations. In this case, applying institutions need to process special importation permits to allow the importation of unregistered products.
How will I know if my institution has been approved
to receive the donation?
Each participant will receive an official
letter from Axios to confirm that the pharmaceutical company
has approved the application.
Once I receive the product(s), what
else do I need to do?
At a minimum, an annual progress report should
be sent to Axios International. A standard template will
be provided to each site to facilitate the elaboration of
a report summarizing the progress of the project.
Entities that successfully apply and purchase products may be subject to monitoring by Axios International or its designate to ensure that the products are utilized only as described in the application.
Are there other terms for participating
in the donation and access programs?
As a minimum, an annual progress report should
be sent to Axios International. A standard template will
be provided to each site to facilitate the elaboration of
a report summarizing the progress of the project.
Entities that successfully apply and purchase products may be subject to monitoring by Axios International or its designate to ensure that the products are utilized only as described in the application.
Products purchased under this program are
solely intended for use in the program specified by the
application. Diversion of product outside the program or
a failure to adequately track product usage is grounds for
termination of access to these products.
Terms and conditions of this program are
subject to change as required and Axios will be responsible
for their implementation.
Do I have to complete the entire application form
if I want to request a repeat donation?
No. Once an institution has received the first
donation of one of the products, the request for re-supply
is straightforward. The institution will be asked to complete
a progress report form outlining the quantity of product
requested and the justification for the amount.
What are the costs involved in accessing donations?
The donation programs offer the products free
of charge and cover the shipping costs up to the point of
entry into the eligible
countries. The applicant will bear all other costs,
including costs of handling, taxes duties, and distribution
to the specific health facilities.
Are there other costs involved in accessing
products at the no profit prices?
Under the access programs, products are offered
on an FOB basis. Additional costs including freight, insurance,
customs handling, taxes and duties, and the cost of product
distribution to the health facilities may be incurred by
the applicants and will be passed on to the purchaser. These
additional costs are levied at the discretion of the national
authorities and other respective entities and are beyond
the control of the programs.
Diflucan Partnership
Program
Can anyone living
with HIV/AIDS use Diflucan®?
No. Only people who have been diagnosed with
cryptococcal meningitis or esophageal candidiasis by a healthcare
professional should be treated with Diflucan®.
Are there risks associated with the
use of Diflucan®?
There are risks associated with the use of
any medicine. However, it is important to understand that
the Diflucan Partnership Program is not a clinical trial.
Diflucan has been approved and has been used for over ten
years for the treatment of cryptococcal meningitis and esophageal
candidiasis, and other indications. Please refer to the
Diflucan® prescribing information.
Will Diflucan® be provided free
for vaginal candidiasis (thrush) for HIV infected people?
Pfizer's donation program is only for
the treatment of cryptococcal meningitis and esophageal
candidiasis.
Glivec International
Patient Assistance Program
What is the role of The Max Foundation?
The Max Foundation coordinates the acceptance
and review of applications for inclusion of patients in
GIPAP.
