Coburn on PEPFAR2: Unworkable Formula Depressing Treatment Scale-Up

15 July 2008

Download fact sheet

As we near hopeful passage of a historic bill strengthening US commitments for global health, one very significant issue should not be lost in the crush of congressional negotiations.

In heated negotiations surrounding the efforts to pass this landmark bill on global AIDS, TB and malaria, Senator Coburn was able to remove an ambitious AIDS treatment target in exchange for a scheme that will very likely have negative implications for people with AIDS. In the urgent effort to pass PEPFAR through the Senate before the G8 Summit, and with a stated goal of increasing the numbers of people on antiretroviral treatment (ARVs), Senator Coburn inserted under some duress a new scheme where funding will drive program goals, rather than program goals driving funding. This transforms clear targets into confusion for implementing agencies and future Global AIDS Coordinators who must now revise plans and targets on an annual basis to attempt to meet shifting and unpredictable policy goals based on poorly defined criteria. Most importantly, by linking treatment goals to annual appropriations levels and to treatment costs, the Coburn proposal creates financial incentives to treat fewer people with AIDS worldwide and/or to promote the use of outmoded toxic therapies instead of moving towards powerful but more expensive new generations of anti-AIDS medicines.

Pre-Coburn Senate bill would have treated four million people
The pre-Coburn Senate bill language set a target of supporting treatment for three million people through bilateral programs plus additional people with HIV treated through multilateral programs such as the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM). The was a very significant improvement over the House bill (with respect to AIDS treatment), since the House language still allows the current practice of counting sometimes very large percentages (as much as 100%!) of the people treated by the GFATM towards the overall US targets. If the US continues to contribute at least 1/3rd of the funds for the GFATM, then the total number of people with AIDS receiving ARVs due to US action would have been at least four million individuals or more under the earlier Senate formulation. This number is what most activists have seen as the minimum U.S. fair share to roll back HIV and work towards universal access as pledged.

Coburn Scheme: undefined and unpredictable variables
The Coburn scheme now sets a floor of only two million on ARVs (the five-year PEPFAR I goal intended to be reached by the end of this year). Every additional person on treatment is determined by a complex and unpredictable annual calculation that depends on the percentage increase of global AIDS-specific (not TB or malaria) appropriations above FY08 levels, as well as the unit cost of treatment. What is and is not counted as “AIDS spending” is not defined. For example, will substantial health systems expenditures included in the legislation be measured as an increase in AIDS funding?

Coburn Scheme: problems for implementers
The goal stable goal of supporting treatment for two million people over the first five years of PEPFAR programming allowed OGAC and implementing agencies to collaborate with each other, country-partners and other donor agencies continuously towards meeting this target.

The near impossibility of implementers and OGAC to program towards an uncertain and shifting treatment goal will create incoherence at the country level, and reduce ambition on the part of program partners and applicants.

Coburn Scheme: a disincentive for treatment scale-up
Most importantly, the Coburn scheme reverses the annual appropriations equation by removing the signature policy target that was a hallmark of PEPFAR’s first five years. In place of a hard target which can be progress can be measured and costed on an annual basis, the new scheme is a disincentive to increase the numbers of people with HIV on treatment. Without a solid treatment target to meet, appropriators and budget Committee members will face very difficult challenges, especially for those who have been concerned about the growth of AIDS spending at a time of economic contraction when other worthy issues also need attention. This is doubly true considering the uncertain level of presidential backing in the next round of US global health initiatives.

Coburn Scheme: treatment costs must either go up, or the US promotes outmoded regimens
Another unpredictable but certain-to-be-unhelpful variable included in the Coburn scheme is an annual adjustment to potentially increase the treatment goal in an undefined manner based on decreases in unit costs of treatment. Although this appears to be responsive to decreases in costs resulting from increased generic competition, the reality over the next five years is that significant (if temporary) increases in treatment costs per patient are almost certain. The reason for this is that the developing world is moving gradually towards the very powerful new drug regimens that are rapidly transforming AIDS therapy in the United States. New medicines and improved standards of care over the last two years and in the very near future have finally made HIV/AIDS a chronic manageable illness in wealthier countries, making obsolete the less effective, less durable, and less tolerable therapies with high toxicity-profiles still common in impoverished countries.

It can take several years for generic producers to bring down the costs of new medicines, and in the mean time, higher per-patient costs must be expected. Nonetheless, the move towards dramatically improved new medicines must be an urgent priority, especially when measured against the health and diplomacy costs of continuing to use medicines (like D4T) that are being phased out in the United States.

The only way in which the Coburn drug pricing scheme could increase the numbers on treatment is if the US were to continue to promote increasingly obsolete drug regimens. This is not a tenable option.

Many in the AIDS community gasped when President Bush proposed in spring 2007 to reduce the ambitious rates of treatment scale-up from PEPFAR 1’s level of 33% of those in clinical need (as estimated in 2003), transforming a five year, two-million person program into a 10-year, 2.5 million person program -- a mere 15-17% of those in clinical need by 2013. Very different from Senator Coburn’s public statements, the scheme he inserted in the Senate bill seems poised to restore the unacceptably low percentages on treatment that advocates and members of Congress had worked so hard to set aside.

Proposal: Safeguard 3 million Treatment target as a minimum, with formula applied above that floor

Establish three million plus GFATM as a floor, with Coburn formula applying above that level. This will protect against the Coburn formulation reducing the numbers on treatment, preserve the ability of programmers to plan, and enable the formula’s stated intent to increase the numbers on treatment.

HOW: One way to safeguard treatment targets would be through House-Senate Conference negotiations. Another option is report language when/if a new report is filed to reflect the numerous changes incorporated since bill passed Senate Committee. Additional helpful measures could include report language and/or corrections included in relevant appropriations bills this session or in the first weeks of the coming year.

Draft fix:

Page 74, policy objectives of the United States to assist countries to, by 2013—

‘‘(ii) support—
‘‘(I) the increase in the number of individuals with HIV/AIDS receiving antiretroviral treatment above [at least 3,000,000 by 2013 or more, plus any additional pursuant to] the goal established under section 402(a)(3) and increased pursuant to paragraphs (1) through (3) of section 403(d); and

‘‘(II) additional treatment through coordinated multilateral efforts;

Page 134: 403(d)(1) ‘‘(1) the [bilateral] treatment goal under section 402(a)(3) shall be increased above 2,000,000 by at least [the greater of 3,000,000 or] the percentage increase in the amount appropriated for bilateral global HIV/AIDS assistance for such fiscal year compared with fiscal year 2008;

-end-

WWW www.healthgap.org

429 W. 127th St, 2nd Fl, New York, NY 10027

Tax ID Number 20-505-3765

Fax 212-937-5283

info@healthgap.org