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How to provide Antiretrovirals for the cost of the presidents jet2

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					                          The HIV Equity Plan
     How the national fiscus could provide Antiretrovirals
                       for R500m/year

One of the most notable features of South Africa’s response to the AIDS epidemic has been how
it has deepened rather than reduced divisions in our country. The often fractious nature of our
efforts are of critical significance if we consider that a united national response is a precondition
to a successful HIV policy. The divisions have applied to differences in the understanding of the
aetiology of the disease, aswell as approaches to prevention and caring. The latest manifestation
of this phenomenon has revolved around the desirability of antiretroviral treatments. Some have
suggested that the paradigms that the different protagonists inhabit are so different that no
dialogue is possible between them. This article will argue that not only is dialogue possible, but
that part of the problem with our response to the epidemic has been it has often been based on
ideology rather than evidence of the efficacy of various interventions. The case of antiretrovirals
will be used as an example of how we should use certain rational criteria rather than dogma to
guide public policy around HIV/AIDS interventions.



How should one choose interventions in the health sector?
To ensure that public policies are designed to promote the greatest public good and not to
appease the most politically powerful, the choice of interventions should be based on a set of
rational criteria. Arguably the most important of these is cost-effectiveness. This simply involves
choosing interventions which provide the greatest health impact for the amount of money they
cost. This is the basis for emphasising those interventions that give the most value for money,
and giving less priority to those that, much as they may help individuals, contribute little per rand
spent to the improvement of the population’s health (Musgrove 2000).

Crucially, the emergence of new diseases and new interventions necessitates the reapplication of
these criteria on a regular basis. What is the cost effectiveness of Antiretroviral (ARV) therapy
then? We know that ARVs are one of the most effective classes of drugs ever developed in terms
of their impact on the length and quality of life. They can change HIV infection from a fatal illness
to a manageable chronic illness. We also know they are very expensive. Apart from the now
overwhelming evidence as to the cost effectiveness of ARVs in the prevention of Mother to Child
Transmission of HIV, no cost effectiveness studies have been done in South Africa on triple ARV
         1
therapy for persons living with HIV/AIDS. Studies in the USA have however demonstrated that
ARV therapy is more cost effective than many therapies for non-HIV disease, such as radiation
                                                                                        2
therapy for early breast cancer, treatment of raised cholesterol, and kidney dialysis (Freedberg
2001). Whilst the costs of these different interventions will be different in South Africa, it is unlikely
that their relative positions will change much. In fact if anything ARVs should be relatively more
cost effective than the USA. Thus if we consider firstly, that the effectiveness of both the ARVs
and cholesterol lowering drugs is roughly the same in South Africa and the USA and secondly
that there is not much difference in the drug prices of the cholesterol lowering drugs between the
two countries whilst South Africa could use ARV drugs costing twenty times less than their


1
    Triple therapy is also known as HAART (Highly Active Antiretroviral Therapy)
2
    Triple therapy also had a similar cost effectiveness to HIV prevention activities in the USA


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American equivalents we could infer that ARV therapy as compared with cholesterol therapy is
likely to be considerably more cost effective in South Africa than in the USA.

Showing that ARV therapy is more cost effective than other (rather expensive) interventions is
however an insufficient basis to argue for the wide-scale introduction of this intervention. This
would be especially so if it was likely that this programme would absorb an increasing proportion
of resources at the expense of much more cost effective interventions. Our first priority must be to
get the basics right. When it comes to our health system this means things like improving our
vaccination cover (63% in 2000), our TB cure rate (currently only 60% for smear positive
Pulmonary TB). As far as HIV/AIDS is concerned, we know that interventions such as the
promotion of Voluntary Counseling and Testing, the syndromic management of Sexually
Transmitted Diseases, and simple treatments such as cotrimoxazole prophylaxis are more cost
effective than ARV therapy (Sweat 2000, Freedberg 2001). These must therefore be our priority.
We should be wary of any ARV plan, which disregards the primacy of these interventions or takes
place at their expense.

What this means in essence is that it would be irresponsible for the Department of Health to allow
the unchecked proliferation of an ARV programme. There are however very powerful reasons
why the Department of Health should introduce a limited ARV treatment programme, many of
which are hard to quantify in cost effectiveness terms.

As seen in Table 1 below, the full benefits of an ARV treatment plan extend way beyond the
saving of lives, to important positive effects on the economy, and the maintenance of the social
fabric of our society. Perhaps most significantly however is the impact it would have on
prevention efforts. When treatment is not available, less incentive exists for an individual to take
an HIV test, since HIV-positive status not only is associated with social stigmatization but also is
tantamount to a death sentence. It is only when HIV testing is coupled with treatment that people
have an incentive to be tested, thus enabling a rational response to AIDS: primary prevention for
those who are HIV uninfected, and ARV treatment for those who are HIV infected. Effective ARV
treatment of HIV-positive people also lowers the viral load within infected individuals, which in
turn has a major effect in reducing the likelihood that they will transmit HIV infection to others.
Ultimately, then, appropriate treatment of infected individuals may become a major tool in AIDS
prevention. In the case of Brazil the introduction of a universal ARV programme was one of the
key interventions that ensured that Brazil now has half the number of HIV infected persons to that
predicted it would have 5 years ago. South Africa’s HIV prevention efforts have thus far been a
dismal failure. An ARV treatment programme could, through demonstrating that HIV is real, that it
is not stigmatized by the powers-that-be and is treatable, be just the catalyst required to ensure
that our preventive efforts start yielding results.

Including these hard-to-quantify-benefits would make the overall impact of an ARV plan
considerable. The major obstacle is developing a plan which is affordable and augments rather
than undermines the key elements of our Primary Health Care oriented Health Care system. The
HIV Equity Plan described below is an initial attempt to fulfill these criteria by balancing the need
to provide ARVs to those in need with resource constraints.

The HIV Equity Plan
The HEP is designed as a means to counter the current inequitable situation where all we offer
the poor is behaviour change (although their vulnerable position often makes it very hard for them
to effect the changes prescribed), whilst only a small rich minority (who are not that affected HIV)
can afford ARVs. Under the HIV Equity Plan (HEP), this dispensation would be altered so that
ARVs would be made available according to need and capacity to benefit, and not wealth. It
would be set up in an incremental manner. Initially only one site per province would provide
ARVs. These sites would act as training sites for clinicians all over the province in the




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management of all aspects of HIV/AIDS. Only the training, research and human resource costs
would be borne by the conventional health budget. All other costs would be borne by the HEP
Fund, which would be constituted as follows:

The government’s annual contribution would be set at R500 million (this is equivalent to 1,5% of
national health spending) and adjusted annually for inflation. This would initially be matched by
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contributions from the International Fund (which currently has R10 000 million in it) . Two further
sources of income should be noted: Firstly, public-private partnerships could be set up to deliver
ARVs to employees from companies like Anglo, De Beers and Daimler Chrysler who have
already undertaken to provide these drugs - though at a significantly higher cost from the private
sector. Secondly, recipients of ARVs would pay for them according to their income. ARVs would
only be free to those who cannot afford them. Assuming these latter two sources contribute R400
million, this gives the HEP Fund an initial total of R1,4 billion. What number of persons could this
Fund provide with ARV therapy?


Diagram 1. How the HEP Fund would work

Contributors                                                                                Benefactors

International Fund                                                                        All patients
                                                                                         according to need
National Fiscus                                                                          and probability of
 National SA budget                                                                      benefiting
                                               R1 400
Private-Public
Partnerships acc.
 Patients pay                                  million                                   All employees of
                                                                                         participating
Patients acc. means                                                                      companies / NGO’s
                                                                                         etc.




Costing the HIV Equity Plan
There are a number of models of ARV provision that could be evaluated for cost effectiveness in
the South African context. The most expensive model would be a conventional ARV programme
as delivered in first world countries. This requires at least 9 antiretroviral drugs to be available
(many of these are especially expensive) and includes frequent expensive laboratory tests such
as viral loads and CD4 counts. South African clinicians have a proud history of developing
                                                                          5
innovative ways of bringing down costs of costly health interventions . It is clearly in our interests

3
  This programme should be accompanied by a research component in order to optimize
treatment strategies within our context and resource constraints. The budget for this research
strategy should however come out of existing research programmes.
4
  South Africa is ideally placed to benefit from this fund. Not only do we have the largest number
of people living with HIV/AIDS, but of all the African countries affected, we also have the type of
health infrastructure which is most likely to be able to deliver ARVs on a large scale. In future
years it is therefore likely that these international contributions could increase significantly.
5
  Two examples here should suffice:           1. South Africa developed a technique to reuse kidney dialysis
units.      2. One of the drugs given to reduce the rejection of transplanted organs is very costly. To reduce


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to eliminate the least cost effective aspects of the ARV programmes. Some of the options we
could investigate to lower costs are as follows:

   A price limit is placed on ARVs so that for example only triple regimens which cost less than
    say R6000 per year are used
   Only the cheapest ARVs are used. At the moment the cheapest triple therapy on offer is
                                                                                   6
    R2400 per year. If/when drug resistance occurs, ARV treatment is stopped . This would add
    3-5 years to a recipients life expectancy
   Pulsed therapy where patients are off therapy for a period of time
   Starting therapy later, and not giving ARV therapy to the terminally ill who are less likely to
    respond
   Limiting expensive tests to essential indications only. Clinical criteria would be used to
    evaluate treatment failure.

One way to investigate the optimal makeup of the most cost-effective treatment plan would be to
test different combinations of these features in different provinces. The ARV plan on which the
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following costing section is based involves a middle course as far as costs are concerned :
patients will have option to more than one set of triple therapy agents, and some expensive
laboratory tests, but these would be severely limited.

Drugs
                                8
The cheapest triple ARV therapy on the market costs R2400 per year. For most patients (70%)
we assume a price of R3000 per year, and for the remaining 30% we assume a more expensive
regimen is necessary R7200 (to deal with drug resistance as it arises). The probability weighted
drug costs are therefore R4260 per person per year.

Laboratory costs
The basic state package would avoid expensive tests such as CD4 counts and viral loads
wherever possible. It would instead follow the successful models in Uganda and Haiti where
clinical criteria and simple lab tests (like total lymphocyte counts) are used to evaluate treatment
success. Limiting expensive tests to only vital cases would bring annual lab costs to R600 per
person.

DOTS (Directly Observed Treatment Supporters)
Ensuring that the treatment is taken appropriately, greatly enhances treatment efficacy and
lowers the chances of drug resistance. For this reason, patients should have their drug taking
monitored. These DOTS supporters are in place in many places already to assist with TB control,
but each should receive a stipend of R400 per month. If each supporter supervises 20 patients
this translates into a cost of R240 per patient per year.


Total cost per patient: R4260 + R600 + R240 = R5100

the amounts necessary for patients, local clinicians pioneered a technique whereby a further (cheap) drug
was given to prolong the action of the costly drug. Costs were greatly reduced in both cases, with little or
no impact on efficacy.
6
  This is the cheapest option and it may be argued that it is unethical as more effective treatments exist.
Whilst this is true, this treatment would add 3-5 years to an average recipients life span. Some have
recently argued that we should not introduce ARVs as we could not afford to deliver them with the same
quality as in the first world. The disingenuity of this line of reasoning is exposed if we consider the
consequence it proposes – no ARVs rather than say an ARV programme which prolongs life by 5 years.
We should also shut down our National TB Programme, with its cure rate of 60%, if we took this argument
seriously. There is an obvious tradeoff between the number treated and the cost one can spend per patient.
7
  It is loosely based on the Harvard Consensus Statement on Antiretroviral Therapy for AIDS in poor
countries
8
  Triple ARV therapy is otherwise known as HAART (Highly Active Antiretroviral Therapy)


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A R1,4 billion budget would therefore be able to provide 275 000 patients this package per year.

How many would need this treatment?
Internationally there has been a tendency to start ARV therapy later in the course of the disease.
Naturally the later one starts treatment the less the ARV programme will cost. Trials in settings
similar to our own have shown good results when treatment is started when patients develop
AIDS, but before they are bedridden (a Karnovsky score of greater than 40%). If we started ARV
therapy at this point, it would mean there would be a maximum of 180 000 people who could start
treatment in 2001.

 The actual numbers volunteering for treatment would be significantly lower due to numerous
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factors: less than 10% of HIV+ South Africans know their status , of those who know their status,
many would either not volunteer for treatment, live too far away from the centres offering
                                                       10
treatment or would not meet the criteria for enrollment . These factors would bring the number
down to around 50 000.

The most significant initial rate-limiting factor would, however, be the number of trained clinicians
who would be able to deliver this treatment. Some provinces do not have any clinicians in the
public sector adequately trained to deliver triple ARV therapy. It is no coincidence that these are
also the provinces where few doctors and nurses are trained in the general management of
HIV/AIDS. An HIV clinic which dispenses ARVs could thus act as a node around which this kind
of general HIV/AIDS capacity can be built. Given this current situation, it is unlikely that the
average province would be able to start treating more than a couple of thousand patients. This
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number could then be scaled up according to need and capacity to do so .

By 2010 we will have an estimated 850 000 people living with AIDS and because of this, costs
could accelerate dramatically. The increase in AIDS numbers could however be offset by
continuing falls in ARV prices (the production of generic ARVs has brought the prices down by a
factor of 20 in the past 3 years), and increases in contributions from the Global Fund (which is
projected to increase in size by a factor of ten). In the eventuality that these factors are unable to
lower costs sufficiently, to ensure that this increase in AIDS numbers does not drain resources
from other vital sectors of the budget such as the Primary Health Care system, it is proposed that
the HIV Equity Plan would place an upper limit on the numbers of persons eligible for treatment
based on the funds in the HIV Equity Fund. This figure would then be revised annually according
to changes in financing.

 Understandably, limit setting leads to cries of horror such as: “ how can one provide a lifesaving
treatment to some and deny it to others?” The truth however is that this is exactly what happens
with any number of expensive interventions not only in South Africa, but in many other countries
around the world. All organ transplants, many forms of chemotherapy and expensive antibiotics
fall into this category. We need to be cognizant of the fact that we live in a country where the sum
of all the medical interventions available to improve the health of our population greatly exceed
our national let alone our health budget. Rationing is therefore a fact of life. The question is
simply how should we go about this rationing? Arguing that we should never introduce ARV
treatment because we cannot guarantee ARVs to everyone for the next twenty years is a peculiar
line of reasoning if we consider that it is possible that demand may never actually exceed supply,




10
   These criteria would include biological, clinical, social and adherence dimensions, such as those used in
the MSF ARV programme in Khayalitsha (MSF 2001).
11
   The administration of drugs could be managed by doctors in the public and private system, though as
with other complex regimes this should depend on their having attained the requisite competency.


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in which case no rationing would be necessary. If demand does exceed supply then we must
ration ARVs in the same way that we ration other expensive interventions: according to need and
ability to benefit. The current situation where our health sector refuses to provide ARVs, but
provides other less cost-effective interventions is a form of stigma/discrimination towards people
living with HIV/AIDS. If we add to this the fact that many HIV+ persons have been denied
treatment by our hospitals because of their HIV status, and we consider the crucial role that
discrimination/stigma plays in the spread of the disease, then it could be argued that our health
sector’s current stance actually contributes to the spread of HIV.

There will be two direct savings that should be deducted from the above costs: an effective ARV
                                             12
programme will reduce hospitalization costs (currently estimated at R15500 per year for people
with AIDS) as well as the R6000 per year the state will pay for disability grants for each HIV
patient from Stage 3 (the stage before AIDS develops). Brazils ARV programme has lead to a
50% reduction in AIDS related hospitalization.

It is high time that we all made an effort to reduce the polarization around HIV in our country. One
way to do this would be to ensure that our HIV strategy is based on evidence rather than
ideology. There is good evidence as to the efficacy of ARVs, but also good evidence that an
unchecked proliferation of a first world style ARV programme would not be affordable in the long
term in our national setting. We thus need to flesh out the details of an ARV treatment plan which
finds a meeting place for these two considerations. The HIV Equity Plan (HEP) presented here is
a first sketch of the outline of one possible meeting point. This Plan should be seen as a way of
strengthening our national/continental government’s Millennium Africa Plan (MAP) which seeks to
deal with the upstream determinants of HIV/AIDS and other poverty related diseases. There is
however an abundance of evidence that, particularly for countries at our stage of the epidemic,
treatment is a vital component of prevention. Furthermore many companies have cited the
inadequacy of our response to HIV/AIDS as a major reason for their not investing in South Africa.
An ARV treatment plan would, in this sense, be an indispensable ingredient of the MAP. If we
were to embark on a plan similar to the HEP we would stand to benefit from contributions from
the International Fund in the same way that other African countries are currently negotiating to do
so. We may disagree on the details of the ARV treatment plan: we may think R500million is too
much or too little, we may favour some ARV regimes over others. We should however agree that
the ARV cost-benefit equation has changed sufficiently to ensure that the key question around
ARV provision in South Africa is no longer one of “if?”, but “how to provide ARVs?” Even if one
regards the current prices of ARVs as being too high, then the inevitable continued fall of ARV
prices will deal with this line of reasoning at some future point. We therefore need to embark on a
democratic process of stakeholder consultation to plan how we will implement the provision of
ARVs in South Africa.




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Table 1: The costs and benefits of introducing ARVs
             Costs                          Benefits
Good         High Cost of drugs             Treatment will prolong the lives of millions
Reasons
                                            Treatment is a crucial adjunct to prevention efforts
                                            Treatment is necessary to save the children -and fabric - of
                                            societies. Without treatment, the number of adult deaths
                                            expected from AIDS is so great that by 2010 there will be 2
                                            million AIDS orphans in South Africa. Without family support,
                                            these children often can not attend school, suffer from poverty
                                            and malnutrition, and become victims of violent and sexual
                                            crimes-all of which places them at high risk for acquiring AIDS
                                            and which threatens to mire them in increasingly desperate
                                            conditions, with all the consequences this places on the rest of
                                            society.
                                            Treatment is necessary for continuing economic development.
                                            Without treatment, millions of adults in the prime of their
                                            working lives will die of AIDS and take with them the skills and
                                            knowledge base that are necessary for human and economic
                                            development. Furthermore, a treatment plan would allay the
                                            fears of many investors who have cited the inadequacy of the
                                            government’s response to HIV/AIDS as a significant reason for
                                            failing to invest here.
                                            A public ARV programme would bring down the price private
                                            individuals are paying for treatment by a factor of ten.
                                            Providing ARVs would reverse the current discriminatory
                                            situation whereby less cost effective interventions are being
                                            offered by our health service, but not ARVs.
                                            The DOTS programme would provide all the benefits of a
                                            Public Works programme
Borderline   Inadequate Infrastructure      An ARV programme would provide the much-needed impetus
             (we would need to retrain      to set up adequate training programmes for doctors and nurses
             staff, and this programme      around the country.
             would increase workload,
             but it seems likely that the
             50% reduction in
             hospitalization seen in
             Brazil would offset this)
Bad          Problems with resistance       An ARV programme should be introduced regardless of costs
Reasons      (according to this logic we    or secondary impacts on other aspects of health care.
             should not treat TB either.
             As with TB we get around
             problems of resistance by
             using multidrug regimens
             that are closely monitored)
             Drugs are dangerous (far
             from being dangerous,
             they have reduced AIDS
             mortality by 70% in
             Europe)




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References
1. Freedberg, K. A., Losina, E. (2001) The cost effectiveness of combination antiretroviral
   therapy for HIV disease NEJM 334, 11, 824- 31
2. Musgrove, P. et al. (2000) The World Health Report 2000, WHO
3. Sweat, M. et al. (2000) Cost effectiveness of VCT in reducing sexual transmission of HIV-1 in
   Kenya and Tanzania The Lancet 2000 356 113-121
4. MSF (2001) Affordable Antiretrovirals in South Africa. Protocol




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