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Information on this page is intended for access and donation programs managed by Axios International. For questions about the GARDASIL® Access Program, managed by AHD, please click here to go directly to the program website.

General FAQs

 


FAQs per 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 Axios?

Axios acts as the coordinator of GIPAP programs in countries where Novartis has no Country Pharma Organizations (CPOs). Axios is responsible for identifying and qualifying leading medical centers in the targeted countries.

What is the role of TMF?

•The Max Foundation administers and coordinates the acceptance and review of applications for inclusion of patients in GIPAP.

How to apply for GIPAP™?

Physicians must be registered as GIPAP Qualified physicians in each country where GIPAP operates. The qualified physicians must first recommend and submit an application on behalf of the patient. The physicians must be involved in all stages of the treatment (diagnosis, prescription and follow-through).

Who is eligible for GIPAP™?

•GIPAP provides Glivec® at no cost to patients who are: Properly diagnosed; Not insured; Not reimbursed; Have no other financial recourse (cannot pay for it privately).

Gardasil® Access Program

Who can apply for the program?

Organisations and institutions in eligible low income countries are invited to apply for participation in the GARDASIL® Access Program. Are there any prerequisites for participation in the program?A letter of approval from the Ministry of Health is a prerequisite for participation in the GARDASIL® Access Program.

How do I apply for the program?

•

Organisations and institutions in eligible low income countries who meet the GARDASIL® Access Program eligibility criteria are invited to submit a vaccination program application. The application form can be downloaded from this website or requested by fax or email from the address below. The application will be reviewed by a team of experienced independent reviewers and the GARDASIL® Access Program Advisory Board.

The GARDASIL® Access Program Advisory Board meets twice a year to review applications.

The Max Foundation administers and coordinates the acceptance and review of applications for inclusion of patients in GIPAP.

What is the next application deadline?

The next proposal submission deadline is March 1, 2009. Applicants who miss the deadline for proposal submission may wait for the next call, which will be announced on this website. Proposals received after the deadline will be kept until the next submission date.

How long does the review process take?

•

As soon as the application is received by Axios International, a screening will be performed to ensure that the information provided is complete. Applicants will be contacted within five days of receipt of their application. Additional information may be requested at this stage. If the application is complete, independent experts, commissioned by AHD, will review the application and give their recommendations to the Advisory Board. The Advisory Board will make a final review of the application/proposal at their bi-annual board meeting and give a recommendation to AHD. Thereafter, AHD notifies the institution of its inclusion in the GARDASIL® Access Program or requests additional information or clarification to consider the institution for participation in the program.

How will I know if I receive the donation?

The applicant will receive an official letter to confirm that AHD has approved the organisation or institution for inclusion in the GARDASIL® Access Program. Details concerning the quantity of GARDASIL®, timescale, shipping schedules and shipping procedures will be defined in the approval note. The applicant will be notified of shipment schedule as soon as the information is received from the shipper.

Are there any logistic requirements for the import of GARDASIL® into my country?
The administration and use of GARDASIL® requires the donation product to be approved for use in the country. If the vaccine is not approved for use, the applying institution must have a special import license and/or a waiver letter from the government to import this donation.

Who should I contact if I have any questions?

•

The GARDASIL® Access Program manager is available for any questions you may have about the GARDASIL® Access Program. Please see below for contact details.

GARDASIL® Access Program
Axios International
7, Boulevard de la Madeleine
75001 Paris
France
Phone:   +33 144 860 760       ; Fax:   +33 144 860 122
Email:   GARDASILAccess@AccessToTreatment.org

 

  
           
 
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