The Ethics of Restricting Patient Access to New Medicines

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The Ethics of Restricting Patient Access to New
Medicines

• Dr Mary Baker MBE

Dr Mary G Baker, MBE President European
Federation of Neurological Associations Patron
European Parkinsons Disease Association
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Healthcare for all citizens, based on need, not
ability to pay
Launch of the NHS

• Founding principle of the NHS
• Nye Bevan, 1946

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The Ethics of Restricting Patient Access to New
Medicines

• Problems
• A Malthusian attitude towards healthcare budgets
• Economic evaluations disadvantage the
  elderly/disabled
• Financial incentives deter uptake of new
  treatments
• Potential solutions
• Broaden perspective on cost of ill health
• Introduce genuine co-decision making
• Government commitment to long term progressive
  illness
• Further empower patients and carers
• Why change is required
• Rise in unmet medical need
• Discrimination of elderly and disabled not
  acceptable

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A Malthusian attitude towards cost of healthcare

• The power of population is indefinitely greater
  than the power in the earth to produce
  subsistence for man. crime, disease, war and
  vice required to control population Thomas
  Malthus, 1766
• World Population 1750 790 million
• World Population 2010 6.79 billion
• Has our need for healthcare genuinely outstripped
  our ability, as a society, to pay for it?
• Or, is the pie is only so big argument a
  pretence to deny healthcare to a growing,
  vulnerable population the elderly and disabled

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Titanic Example

• Allocating healthcare resources is not as simple
  as allocating 6 boats to 60 people i.e. 10 per
  boat. When the Titanic sank younger and wealthier
  could access the lifeboats easier than the old
  and poor. Today, those with neurological
  disorders are penned up in steerage and unable to
  make the decks. How can we unlock steerage
  without sinking the ship?

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Economic evaluations disadvantage the
elderly/disabled

• Over reliance on Quality Adjusted Life Years
  (QALYs) to determine resource allocation is
  discriminatory
• QALYs
• - favour those with long life expectancies
• - favour those with better prognosis
• failure to include social, personal and cost to
  carers in the cost per QALY calculation further
  exacerbates fate of the elderly and disabled
• Disability Adjusted Life Years (DALYs) may
  better capture impact of disability but will also
  favour young / able bodied

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Illustration of how QALYs Discriminate

• If an elderly/disabled person has QOL of 0.7 due
  to a co-morbidity
• 50 deterioration in their health QOL of 0.35
• If a medicine could return these patients to
  their original health state, you would need to
  treat 3 patients to achieve 1 QALY (3 x 0.35 1
  QALY)
• Compared to a normal person with a QOL score of
  1
• 50 deterioration in their health QOL of O.5
• If a medicine could return these patients to
  their original health state, you would need to
  treat 2 patients to achieve 1 QALY (2 x 0.5 1
  QALY)
• If cost of treating each patient is the same e.g.
  10
• Cost / QALY for elderly person 3 x 10
  30/QALY
• Cost / QALY for normal person 2 x 10
  20/QALY
• Conclusion More cost effective to treat normal
  rather than disabled

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Financial incentives deter uptake of new
treatments
Source Onmedica Survey Jan 2007
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Financial incentives deter uptake of new
treatments
Source Onmedica Survey Jan 2007
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Financial incentives deter uptake of new
treatments
Source Onmedica Survey Jan 2007
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We know what happens to people who stand in the
middle of the road. They get run over

• Nye Bevan

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Potential SolutionsBroaden perspective on cost
of ill health
Source Neurological Disorders, WHO, 2007
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Potential SolutionsIntroduce genuine
co-decision making
Commission Proposes Legislation
Parliament
Council
Appointment of Committees and Rapporteurs
Working Group Meetings
Committee Debates
Ambassadorial Meetings
1st Reading
Deadline for Amendments
Committee Vote
Ministerial Agreement
Commission amends proposal
Plenary Vote
Council Common Position Follows EP Plenary Vote
Or
No agreement
Agreement
2nd Reading
Agreement
Repeats procedure above
No agreement
Conciliation
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Potential SolutionsIntroduce genuine
co-decision making
NICE Propose Guidance
Patient Organisations
National Health Systems
Appointment of Expert leads and Committees
Working Group Meetings
Debate
Budgetary Impact
1st Reading
Amendments
Committee Vote
Agreement
NICE amends proposal
Opinion
Common Position
Or
No agreement
Agreement
2nd Reading
Agreement
Repeats procedure above
No agreement
Conciliation
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(No Transcript)
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Potential Solutions Government commitment to
long term progressive illness

• Evidence shows that progress is made in those
  disease areas that are a Government priority
  cancer, cardiovascular disease
• Past initiatives have focused on mental health,
  in particular suicide not long term progressive
  illness
• Elephant on the table Alzheimers Disease
  will double every 20 years

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Potential Solutions Empower Patients and Carers

• Patient organisations must improve their
  understanding of HTA
• Patient organisation must improve how they convey
  socio-economic information not rely purely on
  distress
• Patients and carers must play an active role in
  speeding the uptake of clinical and
  cost-effective treatments
• Greater availability of information for patients
  on disease and treatment
• Encourage a culture where it is acceptable to
  challenge prescribers practice
• Challenge assumption that patients have
  insatiable appetite for medicines or that carers
  are unreasonable in their expectations

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Why? Rise in unmet medical need

• Aging population leading to increase prevalence
  and incidence of brain disorders research shows
  that they are the most challenging and expensive
  to manage
• Parkinsons Disease
• Stroke
• Alzheimers Disease
• Intolerable economic burden neurological
  disorders in Europe already estimated to cost
  139 Billion in 2004 (WHO, 2007)
• Changing role of women

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Why? Discrimination of elderly and disabled not
ethical

• Failure to recognise that stigma is still
  attached to certain disease, particularly
  neurological disease
• Unethical to change the goalposts for those who
  have no ability to adapt to the new social order
  - Healthcare for all citizens, based on need,
  not ability to pay
• Greater ethical care required due to
  vulnerability and isolation

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• Lastly John F. Kennedy in a message to Congress
  said that
• "On the basis of his study of the world's great
  civilizations, the historian Toynbee concluded
  that a society's quality and durability can best
  be measured 'by the respect and care given its
  elderly citizens.