1. The document discusses the ethical implications of scarcity of patients for health technology assessment, using the case study of discontinuing reimbursement of Mexiletine for patients with Non-myotonic Muscular Dystrophy due to lack of evidence of clinical effectiveness.
2. It proposes systematically identifying and resolving ethical issues by specifying general moral principles or "norms" to provide more nuanced guidance for concrete cases where principles may conflict.
3. By qualifying three proposed norms to account for individual consent, proportional evidence requirements, and access to healthcare, the analysis concludes that discontinuing Mexiletine reimbursement for these patients is ethically unfounded.
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Ethical implications of scarcity of patients for HTA
1. Ethical implications of scarcity of patients for HTA
Prof. dr. G. J. van der Wilt
Radboud University Medical Centre
Department of Epidemiology, Biostatistics & HTA
2. Case-study: discontinuation of
reimbursement of Mexiletine for
patients with Non-myotonic
Muscular Dystrophy (NMD) for lack
of evidence of clinical effectiveness
How can we identify and resolve the
ethical issues in a systematic and
transparent way?
3. The problem of moral inquiry
We can not deductively infer what follows
from our commitment to abstract, general
moral principles in concrete cases (‘open-
texture’ of moral principles)
The balancing or weighting of conflicting
moral principles is arbitrary
Possible solution: Specifying norms
(Richardson, 1990). Qualifying our moral
commitments in concrete cases by adding
clauses indicating what, how, by what
means, by whom or to whom the action is
to be, or may not not be done.
4. Identifying candidate norms
[1] All patients should be equally protected from
harmful interventions.
[2] Communities should be protected from health
care interventions that produce outcomes that
do not outweigh their costs and risks.
[3] Access to health care should be equal for all
patients.
Should the costs of Mexiletine for patients with
NMD be reimbursed? No (1 & 2) / Yes (3)
Can these general norms be specified in such a
way, that the conflict is resolved and yet the
reasonable motivation behind the initial,
unqualified norms is captured by what one ends
up doing?
5. [1] All patients should be equally protected from harmful
interventions and this may be achieved ex ante
(regulatory approval), ex post (notably through
conducting and reporting N-of-1 trials and careful
follow up), or both, provided that the individual
patient knows and understands the associated risks
and has consented to treatment.
[2] Communities should be protected from health care
interventions that produce outcomes that do not
outweigh their costs and risks and the level of
evidence of safety and (cost)-effectiveness that is
required (= the level of uncertainty that is deemed
acceptable) should be proportional to the associated
public health risk
[3] Access to health care should be equal for all patients.
The costs of Mexiletine should be covered
6. Discussion
It is important to be aware of the possibilities
and limitations of moral inquiry.
Systematic approaches such as specifying
norms may be helpful in identifying the
relevant ethical norms and in resolving
conflicts in a transparent and discursive
way.
Scarcity of patients poses ethical dilemmas
that deserve to be examined in such a
way.
The analysis suggests that the
discontinuation of the reimbursement of
Mexiteline for patients with NMD is
ethically unfounded.