AIDS Drug Assistance Protocol Fund - Report Date: October 26, 2004
Gordon Nary, Executive Director, AIDS Drug Assistance Protocol Fund

"To let oneself be bound by a duty from the moment you see it approaching is part of the integrity that alone justifies responsibility." - Dag Hammarskjöld

The AIDS Drug Assistance Protocol Fund commends the Health Resources and Services Administration (HRSA) for their interest in addressing the ethical challenges in the prioritization of people on state AIDS Drug Assistance Program (ADAP) waiting lists. The report "Allocating Scare Resources in AIDS Drug Assistance Programs: Ethical Considerations" is a valuable resource and will be of great value to state AIDS Drug Assistance Programs.

The AIDS Drug Assistance Protocol Fund has also undertaken the challenge of developing guidelines for the prioritization of people on state ADAP waiting lists. The AIDS Drug Assistance Protocol Fund Guidelines for State AIDS Drug Assistance Program Waiting Lists are in the process of development and are anticipated to be completed on or about February 1, 2005. This interim report was prepared to provide HRSA with an overview of our project and some of the challenges that we are addressing.

A. Project Organization

There are several steps in the development of the AIDS Drug Assistance Protocol Fund's guidelines for prioritization of people on state ADAP waiting lists:

1. Development of Medical Criteria

The AIDS Drug Assistance Protocol Fund Medical Advisory Committee (Attachment A) is charged with the development of the medical criteria for the guidelines. A draft of these criteria developed by the Committee is attached (Attachment B). The AIDS Drug Assistance Protocol Fund recommends that HIV specialists develop the medical criteria for the triage of people on state ADAP waiting lists.

2. Development of Ethics Criteria

The AIDS Drug Assistance Protocol Fund Ethics Advisory Committee (Attachment C) is charged with the development of ethics criteria for the prioritization guidelines. These criteria are currently in the process of being developed. In addition to commenting on the recommendation by the AIDS Drug Assistance Protocol Fund Medical Advisory Committee to give top priority to pregnant women, the Ethics Advisory Committee is also addressing the prioritization of children and other groups including post-partum women and the equity of prioritization/rationing of AIDS drugs via ADAP waiting lists. It is also the intent of the AIDS Drug Assistance Protocol Fund to publish a final report addressing these complex ethical challenges and the reasons for each recommendation.

3. Guidelines Input from People on State ADAP Waiting Lists Advisory Committee

People that are relegated to state ADAP waiting lists that are not based on the queue (first come/first served) model should have input into a model that may affect their access to HIV drugs. The creation of a prioritization model for drug access should be perceived as fair and equitable by those relegated to waiting lists. After a draft of the coordinated medical and ethics guidelines has been completed, the AIDS Drug Assistance Protocol Fund will organize a People on State ADAP Waiting Lists Advisory Committee to provide comments on the proposed guidelines and develop education materials to help those on state ADAP waiting lists understand the ethical and medical principles on which prioritization guidelines are based.

4. Coordination of Medical and Ethical Criteria

The AIDS Drug Assistance Protocol Fund State ADAP Waiting List Prioritization Guidelines Committee (Attachment D) is charged with responsibility for coordination of the medical, ethical, and patient criteria into guidelines that will be recommended for consideration by state ADAPs. A draft of the proposed guidelines will then be sent to each state and territorial ADAP director for comments. These comments will be reviewed by the AIDS Drug Assistance Protocol Fund State ADAP Waiting List Prioritization Guidelines Committee and any final changes based on these recommendations will be incorporated into the final recommended AIDS Drug Assistance Protocol Fund State ADAP Waiting List Prioritization Guidelines

B. Medical and Ethical Issues

One of the principal challenges in developing guidelines for the prioritization of people on state ADAP waiting lists is to prevent and reduce harm to those relegated to these waiting lists.

1. Pregnant Women

The report "Allocating Scare Resources in AIDS Drug Assistance Programs; Ethical Considerations" has recommended that pregnant women be prioritized after people who have been on antiretroviral therapy. The AIDS Drug Assistance Protocol Fund Medical Advisory Committee has recommended that pregnant women be given first priority on waiting lists; however, this issue is also being addressed by the AIDS Drug Assistance Protocol Fund Ethics Advisory Committee.

There are several reasons cited for recommending that pregnant women be given first priority:

• The prevention of harm to the fetus/neonate takes precedence over reduction of harm due to lack of access to AIDS drugs by others on waiting lists.

• The cost of the short-term drug regimens for pregnant women to prevent mother-to-child HIV transmission are low in comparison with the lifetime costs of AIDS drugs for those with HIV disease.

• Since many people on state waiting lists may have to wait several months or longer for AIDS drug access, pregnant women who do not have first priority may not be able to access the appropriate drug regimen to maximize the protection of the fetus/neonate from HIV infection

2. Post-Partum Women

One of the ethical challenges to be addressed by the AIDS Drug Assistance Protocol Fund Medical Advisory Committee is access to antiretrovirals by post-partum women who may choose to breastfeed and.thereby put their children at increased risk of HIV infection.

3. Medical Criteria

There are two recommendations in the use of medical criteria for prioritization:

• The AIDS Drug Assistance Protocol Fund Medical Advisory Committee has made recommendations for prioritization based on clinical markers of HIV disease progression so that those who have the greatest life--threatening risks of advanced HIV disease be prioritized for drug access. However, such markers are not always an accurate indication of disease progression. There is often a disconnect between CD4 and HIV RNA markers and disease progression. If medical criteria are used for the prioritization of patients, one might argue that there must also be a review process to allow for the reclassification of patients to a higher prioritization category based on the review of any supplemental medical data from the patient's physician that may justify reclassification. Changing from the queue (first come/first served) model to a medical prioritization model should provide an option for possible reclassification of a patient to a higher priority to maximize the fairness of such a model.

• States that develop medical criteria for prioritization are encouraged to establish a medical advisory committee to review requests for reprioritization based on submission of a patient's medical data. If a state medical advisory committee is not established to review requests for a higher prioritization, the AIDS Drug Assistance Protocol Fund Medical Advisory Committee has agreed to provide such a review process for those states who adopt the AIDS Drug Assistance Protocol Fund State ADAP Waiting List Prioritization Guidelines.

4. Restructuring State ADAP Funds

Assuming that a primary ethical consideration is the prevention and reduction of harm to people relegated to ADAP waiting lists, the AIDS Drug Assistance Protocol Fund recommends that this harm prevention and reduction be considered as an undergirding principle in the structuring of state ADAP funds. For example, consideration should be given to the structuring of state ADAP funds with set-aside subfunds for pregnant women and those currently on antiretroviral therapy. Such set-aside subfunds could reduce the risk of HIV infection to a fetus/neonate if a pregnant woman would otherwise be placed on a waiting list, and prevent the harmful antiretroviral resistance that would result from the interruption of antiretroviral therapy from those on antiretroviral therapy who placed on a waiting list.

Although it is difficult to accurately predict who many people would need to be protected by such a set-aside fund and when they would enter a state ADAP program, a conservative estimate could be made that would benefit at least some of those who otherwise would have their antiretroviral therapy interrupted or risk infecting their fetus/neonate.

5. Studies of People on State ADAP Waiting Lists

The AIDS Drug Assistance Protocol Fund recommends that HRSA consider funding scientific studies that assess the harm imposed on those who have been relegated to ADAP waiting lists to better understand how to better prioritize those whose lives depend on access to timely and appropriate healthcare.

6. Alternate Funding Strategies

After completion of our Guidelines for State AIDS Drug Assistance Program Waiting Lists, the AIDS Drug Assistance Protocol Fund is committed to the development of private sector resources to help prevent and reduce harm to those relegated to ADAP waiting lists. The AIDS Drug Assistance Protocol Fund is committed to developing a special fund for pregnant women and children who might otherwise have to wait to access AIDS drugs through state ADAPs, and to provide assistance to state ADAPs to develop local private sector financial support for state health departments to supplement their state ADAP funds.

7. Other Challenges

Other challenges that may affect the equity of state ADAPs that have been raised by committee members of the AIDS Drug Assistance Protocol Fund that have not been resolved include:

• Differences in funding and access among states,

• Expansion/contraction of ADAP formularies,

• Sealed bids from suppliers of similar medications to achieve cost savings,

• Use of centralized pharmacies,

• Uncertain funding commitments for continued provision of medications,

• Treatment adherence levels that should be required for continued access to ADAP support.

The AIDS Drug Assistance Protocol Fund recommends that HRSA consider sponsoring or cosponsoring a conference/colloquium of HRSA officials, state and territorial ADAP officials, HIV specialists, ethicists, and people affected by state ADAP waiting lists to develop policy recommendations to address these and other issues affecting people on state ADAP waiting lists.

Attachments:

A: Medical Advisory Committee (See above link)

B: Medical Advisory Committee Recommended Guidelines for the Prioritization of People on State ADAP Wafting Lists (See below)

C: Ethics Advisory Committee (See above link)

D: State ADAP Waiting List Prioritization Guidelines Committee (See above link)

Additional information on the AIDS Drug Assistance Protocol; Fund can be accessed on www.adapfund.org.

Exhibit B
DRAFT

Proposed CD4 Criteria Guidelines for State ADAP Waiting List Guidelines
(Revised September 20, 2004)

Group I: States with only applicant CD4 data

Prioritization Category A (first priority))
Pregnant Women

Prioritization Category B (second priority)
Persons who are or were recently on ARV therapy (whose therapy has been interrupted by administrative obstacles in continuing access to ARV drugs in transferring to a state ADAP program).

Prioritization Category C (third priority)
Persons (including post-partum women*) with a CD4 count below 200.

Prioritization Category D (fourth priority)
Persons (including post-partum women*) with CD4 cells 200-349.

Group II: States with applicant CD4 and HIV RNA data**

Prioritization Category A (first priority)
Pregnant Women

Prioritization Category B (second priority)
Persons who are or were recently on ARV therapy (whose therapy has been interrupted by administrative obstacles in continuing access to ARV drugs in transferring to a state ADAP program).

Prioritization Category C (third priority)
Persons (including post-partum women*) with a CD4 count below 200.

Prioritization Category D (fourth priority)
Persons (including post-partum women*) with CD4 cells 200-349 and HIV RNA levels. >55,000.

Prioritization Category E (fifth priority)
Persons (including post-partum women*) with CD4 cells 200-349 and HIV RNA levels. <55,000.

*Presumably all of these women will have access to formula feeding, and therefore the risk of transmission to their infants is non-existent. The decision about post-partum ART should be guided by the choice of the individual woman, and whether she meets the CD4 criteria. 041026
AF041001

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