Risk Management in HIV/AIDS: Ethical and Economic Issues Concerning the Restriction of HAART Access Only to Adherent Patients as a Precautionary
Intervention
Richard Chawana, MD.School of Anatomical
SciencesTel: +27 11 717 2077Cell: +27 82 712 2118
I would like to thank the following for their unwavering support during this study and for
helping me put together this lecture:
Acknowledgements
Prof. D. K. van Bogaert(Co-author, Supervisor, Mentor)
Ms. Jillian Gardner (Postgraduate Coordinator)
Dr. Susan Nzenze(RMPRU)
Miss. Mandy Maredza (PRICELESS SA)
Health Economics and HIV/AIDS Research Division (HEARD) – UKZN for funding
• The success of HAART is without question.
• Clinical Success‐ CD4+ reconstitution‐ Decrease in morbidity & mortality rates
• Economical success‐ Inc. life expectancy of productive pple
‐ Restoration of tax base
Introduction & Background
Introduction & Background
Fraud stalks disability grant…AIDS patients default on treatment so they qualify for govt assistance
Social Grants, Welfare, and the Incentive to Trade-Off Healthfor Income among Individuals on HAART in South AfricaAtheendar S. VenkataramaniBrendan Maughan-Brown Nicoli Nattrass Jennifer Prah Ruger
AIDS Behav (2010) 14:1393–1400
Introduction & Background
Gauteng to probe smoking of ARV drug by patients
The Gauteng health department has launched an investigation into allegations that HIV-positive patients smoked an
antiretroviral (ARV) drug at Hammanskraal Clinic, spokesperson Zanele Mngadi said on Wednesday.
Life-saving drugs up in smoke Sep 1, 2009 6:01 PM | By NKOSANA LEKOTJOLO
Crooks, addicts steal Aids drugs Nov 28, 2010 12:00 AM | By SUBASHNI NAIDOO
The roll-out of the government's multibillion-rand anti-retroviral (ARV) programme is under threat from syndicates that are stealing the ingredients for a deadly new drug.
Introduction & Background
• Long term success of HAART is threatened by non‐adherence to therapy (HIVDR)
• Ability to scale up HAART access is also threatened
• Current coverage in SA is approx 28% (WHO 2008)
• Zero growth results in approx 1.2 million more deaths in SAby 2012 when compared to universal access
Introduction & Background
Source of Funds in 2007 PercentageDomestic public 77.3
InternationalBilaterals 4Multilaterals (Global Fund) 13Multilaterals (UN & allother Multilaterals)
3.2
All other internationals orsource not specified
2.6
Domestic and International AIDS Spending by service categoriesand financing sources for South Africa
Total reported Domestic Public and International Expenditure = US$ 622millionSource of data: UNAIDS 2008 Report on the Global AIDS Pandemic
• Scaling up HAART is a function the funding available
• The Global economic crisis had a negative impact in HAART programmes funding e.g. TAC, budget
• In the light of the economic effects of the global economic crisis, UNAIDS recommended that governments should among other things:
i. Conduct more rigorous evaluations to discover which interventions in prevention generate results
ii. Improve the cost‐effectiveness of interventions by focusing on reducing costs in the immediate future
iii. Improve allocation of resources by ensuring budgets cuts do not affect predominantly areas that are crucial for reversing the course of the epidemic (UNAIDS 2009)
Introduction & Background
Aims
• It was therefore in this light that we aimed to describe and quantify economical consequences and discuss the ethical issues related to adherence and non‐adherence to HAART from the provider’s perspective.
• In our economic evaluation, we used cost‐effectiveness analysis for ART provision to both adherent and non‐adherent patients.
• Using Treeage software (2009), we developed a Markov model for cost effectiveness analysis of Anti‐Retroviral Therapy (ART)
• Using secondary input data obtained from literature on the following costs: i) inpatient costs, ii) clinic visits and iii) ARV drug costs, a projection was made on the economical and treatment outcomes for a hypothetical cohort of HIV positive patients on HAART in South Africa.
Method
Method• We created 2 Markov bubbles
Markov tree
Input Parameter Value Range Source(s)
Adherence
Typical adherence rates 80‐95%
Proportion of those on ART who are adherent 0.565 Nachega et al., 2004; Orrell et al., 2003
Proportion of those on ART who are non‐adherent
0.435 Nachega et al., 2004; Orrell et al., 2003
Costs (US$)
1st Line ART drugs 346.21 128.82‐460.42 ASPEN & ABBOTT**
2nd Line ART drugs 782.67 ASPEN & ABBOTT**
In‐patient cost for adherent patient 335.50 280‐399 Badri et al., 2006
In‐patient cost for a non‐adherent patient 2054 1884‐2239 Badri et al., 2006
Out‐patient cost for adherent patient 269 251‐289 Badri et al., 2006
Out‐patient cost for non‐adherent patient 181 162‐219 Badri et al., 2006
Utilities
Adherent 0.80 0.73 ‐ 1 Louwagie et al., 2007; Jelsma et al., 2005
Non‐adherent 0.69 0.66 ‐ 1 Louwagie et al., 2007; Jelsma et al., 2005
Table showing input variables for Markov modeling
Markov Assumptions• It was assumed that there is insignificant transition between the two Markov bubbles
• Given that full therapeutic benefit of ART is not achieved in non‐adherent HIV positive patients as they fail to achieve the minimal inhibitory concentration of the drug, we assumed that the frequency of hospital visits and days of hospitalization of a non‐adherent HIV positive patient are similar to those of HIV positive patient not already on ART.
Results
CostUS$
IncrementalCost (US$)
Eff.QALYs
Incr.Eff.(Yrs)
C/EUS$/Yr
Incr C/E(ICER)
Undiscounted
Adherent 15, 983 13.36 1, 196
Non‐Adherent 19, 569 3, 586 4.76 ‐8.6 4, 111 (Dominated)
Discounted
Adherent 9, 771 8.18 1, 195
Non‐Adherent 14.762 4, 991 3.62 ‐4.55 4, 074 (Dominated)
Table showing undiscounted and discounted Cost-effectiveness of HAART for theAdherent and Non-adherent populations
Results
Variable Range of value used Range of ICER Sensitivity Decision
Cost of 1st line HAART US$ 120 – US$ 920 Non‐adherent dominated
Not sensitive
Cost of 2nd line HAART US$ 400‐US$ 1 200 Non‐adherent dominated
Not sensitive
Cost of in‐patient care for non‐adherent
US$ 500‐US$ 2 500 Non‐adherent dominated ‐ 620
Sensitive
Discount rate 2% ‐ 10% Non‐adherent dominated
Not sensitive
Table showing one way sensitivity analysis on cost of 1st line HAART Drugs, 2nd
line HAART Drug, in-patient care for non-adherent and discount rate
Discussion• Starting ART in adherent patients is consistently less costly than initiating therapy in non‐adherent patients.
• Non‐adherent patients lose 4.55 QALYs which could be gained through improved adherence
• Looking at the incremental cost‐effectiveness ratio (ICER); adherence to therapy dominates non‐adherence, thus suggesting that adherence to therapy is both less costly and more effective.
• Initiating and continuing therapy for non‐adherent patients has been shown to be associated with greater unmet needs
Equity• Decisions to continue therapy for the non‐adherent patients exacerbate inequalities in HAART programmes. (Expensive drugs vs the budget)
• It then becomes difficult to decide who receives therapy thus augmenting inequity in access to services.
• Equity was identified by World Health Organisation (WHO) as one of the major ethical principles that should underlie HAART distribution.
• measures addressing non‐adherence to therapy would help to address equity issues
Externalities• In addition to addressing equity issues, measures addressing non‐adherence to HAART, which also addresses antiretroviral resistance indirectly, responses to economists’ notion of antimicrobial or antiretroviral resistance as a negative externality (Coast et al., 1998, p29).
• an externality (or transaction spillover) is a cost or benefit, not transmitted through prices, incurred by a party who did not agree to the action causing the cost or benefit
• antiretroviral resistance as a negative externality is premised on the notion that the resistance is unlikely to be felt by the consumers or manufacturers of the ARVs, but by the innocent people of society (Schmidtz, 2006, p10).
• The suggestion of restricting HAART access to adherent patients only can therefore be viewed as an appropriate policy response in order to internalize the externalities, as well as a framework to generate positive rather than negative externalities.
Externalities
Risk, Precaution and Prevention• HAART has been used as a public health intervention (10 & 20 prevention)
• The use of HAART as a preventative method was premised on the findings that the number of new secondary cases generated was proportional to the duration of infectiousness, contact rate and transmission probability (Garnnett and Anderson, 1996, p. 137)
Ro=Dcβ where: • Ro = the number of secondary cases generated• β = Probability of transmission• c = Contact rate• D = Duration of infectiousness
• The use of HAART in this regard can be taken as a duty in risk management that is anticipatory and involves taking precautionary measures to prevent or minimize unacceptable harms.
• In context, conflicts arise in risk management when one’s private behaviours expose others to the risk of harm posed by HIV.
• Resolution of private‐public conflicts call on the use on normative arguments since risk management cannot be separated from public policy and ethics (Perri, 2000, p. 139).
• In this regard we can suggest that a normative argument that limits the liberty of non‐adherent patients to HAART has merit. P1: Restriction of an individual’s liberty is morally acceptable when, through an individual’s actions or inactions, he / she causes harm to other members of society.P2: Patients who are non‐adherent to HAART, through their own actions or inactions, cause harm to other members of society.C: To avoid harm to other members of society, it is morally acceptable to restrict the liberty of access to HAART in patients who, through their own actions or inactions, are non‐adherent.
• P1 may be called a risk management premise• Physically harming or defrauding other members of one’s society, regardless of religious or cultural beliefs, is generally accepted as a wrong action
• On harm, its moral justification is entrenched in the utilitarian J.S. Mill’s (1806‐1873) Harm Principle. He writes:
• ... the sole end for which mankind are warranted to, individually or collectively, in interfering with the liberty of action of any of their number, is self‐protection. That the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not sufficient warrant ...
• Much of the second premise’s acceptability is hinged on the probability of occurrence of such harm.
• This makes it also a “risk management” premise.• It could be argued that there is no connection between non‐adherence to HAART and harm to others.
• In this perspective, if an individual chooses not to take HIV medication as prescribed, then the individual harms only his/her self, and not other members of society.
• However, such harm to others could result from self harm as in the transmission of HIVDR strains to one’s sexual partner (s) or to one’s neonate.
• Another way self harm could harm other members of the society is through looking at the economic harm.
• Recall, we identified that the lifetime treatment of a non‐adherent patient would be at the cost of two other adherent patients.
• In countries where resources are constrained, affording HAART to a non‐adherent patient would mean limiting access of two individuals not on treatment.
• Restricting access to HAART in this case would not be an attempt to foster certain virtues in the non‐adherent individuals.
• Rather it could be an attempt to recover marginal costs associated with HAART
• Failure to effectively use HAART as a primary or secondary prevention intervention could result in a crisis.
• We are reminded that the use of “rescue medicine” in crisis intervention can only produce marginal returns
• Although restricting access to HAART only to adherent patients is economically and morally justifiable, it also most likely would be politically unpopular.
• Health care (HAART in this case) is just more than medical, political, procedural, policy and economic challenges for it has an impact on
human life. • Individual entitlements (Rights) may lead futility and neglecting the
collective element which such rights should hold• Treating non‐adherent patients could be futile treatment
