Ethics in the context of medicine. How to develop professional values in dealing with economic issues. Isabelle Durand-Zaleski (Paris, France)

Transcription

1 DISCLOSURE Dr. Isabelle Durand-Zaleski, the California Northstate University College of Medicine and Dignity Health have reported no relevant financial interests/relationships with commercial entities that may have ties to this presentation

2 Ethics in the context of medicine. How to develop professional values in dealing with economic issues Isabelle Durand-Zaleski (Paris, France)

3 Outcome Objectives At the end of this presentation, the attendee will be able to 1) describe the key ethical issues in health economics 2) communicate why and how the underlying values of a healthcare system affect the provision of health 3) Present the disconnect between population-based and individual-based medical decisions 4) Relate ethical principles (e.g. autonomy) to policy decision 5) Describe how the choice between paternalism, altruism and welfarism affects health policy decisions

4 Definition of the conflict between the society and the individual Eddy (1991) The conflict can arise whenever an individual receives a disproportionate amount of resources (e.g. services) without replenishing them (e.g. paying for them). Failure to replenish a resource can occur directly (e.g. the individual is billed for a service but does not pay the bill) or indirectly (e.g. an insurance premium does not anticipate the cost of the service). When either occurs, other people can be harmed in two main ways, depending on whether and how the resources eventually are replenished. If the funds are not replenished, the harm is to health; other people do not get the benefits of the lost services. If the funds eventually are replenished, the harm is financial; other people must pay to replenish the funds. In both cases, the other people are what we call society.

5 Societal values and trade offs Choice Efficiency Equity

6 Who chose what? efficiency choice equity

7 Who chose what? USA efficiency Scandinavia, UK, Beveridge choice equity France, Germany, Bismarck

8 Choice: why The autonomy of the patient is the main ethical principle that refers to the right to make voluntary, well informed and rational decisions from all available alternatives Value in Health,15, A2-A2.

9 Choice: why does it conflict with other values patients and doctors might choose some treatments that provide very little benefit at a high cost. conflict between societal interests & individual interests.

10 Efficiency Based on the cost effectiveness ratio Assumes that society wants to maximize a global health gain, Regardless of the beneficiaries

11 Assessment of a new technology compared to the reference treatment Cost Laupacis & al. Can Med Assoc J, 1992 More costly, worse outcome (+) More costly, better outcome dominated How much is the better outcome worth? (-) outcome (+) Less costly, worse outcome Less costly, better outcome Are we ready to reduce quality in order to contain costs? (-) dominant

12 Ann Int Med 2009 vol. 151 no

13 COST + outcome + cost ++ outcome + + cost ++ outcome ++ cost + OUTCOME +

14 Cost effectiveness: conflicting with choice Determined at the population level Not applicable to the individual Soc Sci Med Apr;56(8): «Physicians are relatively reluctant to abandon common screening strategies, even when they learn that they are expensive, and are hesitant to adopt unfamiliar screening strategies, even when they learn that they are inexpensive.

15 Conflicts with equity QALYs in CEA: whose utilities? Patients General population End of life Orphan diseases

16 Kidney cancer and antiangiogenics «Professor Peter Littlejohns, the clinical and public health director of the National Institute for Clinical Excellence (NICE), said the institute took account of how much extra a new drug would cost to produce an extra year of healthy life. The four kidney drugs cost up to six times the normal NHS limit of about 30,000 a patient per quality-adjusted life year (QALY). $50,000 He added: "Although these treatments are clinically effective, regrettably, the cost to the NHS is such that they are not a cost-effective use of NHS resources."

17 Renal cell carcinoma sunitinib vs IFN as first line therapy 71,462 per QALY $120,000 bevacizumab plus IFN vs. IFN as first line therapy 171,301 per QALY $285,000 temsirolimus vs. IFN as first line therapy in patients with poor prognosis 94,385 per QALY $157,000 sorafenib vs. BSC as second line therapy 102,498 per QALY $170,000

18 COST + Bevacizumab, Sunitinib, Temsirolimus, Sorafenib 45,435 B ($76,000) 31,185 Su 30,000 per QALY ($50,000) 24,001 So 22,272 T 1x per capita GDP/ QALY effectiveness +

19 August 7, ,000-a-year kidney cancer drugs too costly for NHS $58,000 Veto on basis of price is outrage to kidney patients, says specialist

20 U-turn as Nice approves NHS kidney cancer drug Wednesday 4 February 2009 A kidney cancer drug rejected for NHS use will today be approved by the government's advisory body, after a furore that led to a change in the rules - but three others are still banned on the grounds that they do too little and cost too much. While campaigners have hailed the decision by Nice, the National Institute for Healthcare and Clinical Excellence, as a U-turn, it is only a qualified victory. Pfizer, the manufacturer of Sutent, is bringing down the cost of the drug by offering to pay for the first cycle of treatment. If it seems to be working, the NHS will then pay.

21 The sequel: NICE recommends kidney cancer drug it previously rejected on grounds of cost NICE has recently introduced new arrangements for taking into account the added value that society puts on treatments that extend life. These state that treatments with demonstrable benefits in terms of survival can be recommended for patients who are not expected to live more than 24 months, even if the incremental cost effectiveness ratio exceeds the current limit of per QALY gained $50,000 BMJ 2009;338:b3

22 Orphan drugs: «Orphan Drug Regulations Strain State Payors» lack or inadequacy of alternative treatments for the disease concerned, seriousness of the patient s condition perceived need in the community, pursuit of equity, the rule of rescue, access and affordability from the patient perspective Financial implications for the government. Eurohealth Vol 14 No 2

23 How do we deal with equity issues PTO equity weights Structured discussion with stakeholders target therapy to patients achieving substantial clinical benefit. establish stopping rules British Medical Journal 2004;329:244 27

24 Thank you very much for your attention

25 references Espinoza, M. A., Manca, A., Sculpher, M. J. & Claxton, K IndividualDecisions and Social Value: A Conceptual Framework to Explore Alternative Decision-making Approaches and the Value of Heterogeneity in the Era of Individualized Care. Value in Health,15, A2-A2. Ubel PA, Jepson C, Baron J, Hershey JC, Asch DA.The influence of cost-effectiveness information on physicians' cancer screening recommendations. Soc Sci Med Apr;56(8): Kmietowicz Z. NICE lifts cost limit on drugs to improve access to end of life treatments BMJ 2009; 338 doi: Rawlins MD, Culyer AJ. National Institute for Clinical Excellence and its value judgements. British Medical Journal 2004;329: