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Australia’s National Medicines Policy
Libby RougheadUniversity of South Australia
Health expenditure as a proportion of GDP
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14
16
%
Australia USA
Per capita health expenditure 2001
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1,000
2,000
3,000
4,000
5,000
6,000
7,000
$Aus
Australia USA
Healthy life expectancy at birth: 2002
65
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75
Australia USA
Pharmaceutical expenditure as a proportion of health
expenditure
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%
Australia USA
Costs of providing medicines are increasing
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82/83 91-92 94/95 98/99 00/01 02/03
Medicines are consuming a larger part of the health budget
Other health
expenditure
91%
Pharmaceuticals
9%
Other health expenditure
85%
Pharmaceuticals15%
1984-85 2002/03
Australia’s National Medicines Policy
• Endorsed by parliament in 2000
Goal:• To meet medication
and related service needs, so that both optimal health outcomes and economic objectives are achieved
http://www.health.gov.au/haf/nmp/objectives/policy.htm
Equitable access to necessary
medicines
Medicines of high quality safety
and efficacy
Quality use of medicines
A viable & responsible local pharmaceutical
industry
Medicines meeting appropriate standards of quality, safety and efficacy
• Achieved via the Therapeutic Goods Administration (est 1958)
• Approves for marketing– Prescription medicines– Over-the-counter medicines– Complementary therapies
• Current policy development, harmonisation of regulatory arrangements with New Zealand
Maintaining a responsible and viable pharmaceutical industry• Australia has had an industry development
program since 1988• In 2004, Pharmaceuticals Partnerships
Program (P3) was launched • Provides $150 million over the five years to
support R&D in Australia• Pharmaceuticals are Australia’s third largest
manufactured export after automobiles and wine
Timely access to the medicines that Australians need, at a cost the
individual and the community can afford
• Australia’s Pharmaceutical Benefits Scheme– Universal access to necessary medicines– Initiated in 1950, with 139 life saving and
disease preventing medications available free
– Today, 593 drugs (1451 forms, 2558 products)
– Restrictions apply to 778 of the items, 288 of which require prior authorisation
Pharmaceutical Benefits Scheme
• Accounts for over 90% of all community medicine use in Australia
• Consumers pay a proportion of total costs
– $4.60 for concession card holders – $28.60 for general beneficiaries– Safety net system
• Maximum concession card holders annual costs $239.20, then supplied free.
• Maximum costs of $874.90 per annum for general beneficiaries
Assessment of medicines for subsidy
• Pharmaceutical Benefits Advisory Committee (PBAC)– Statutory committee established under
the National Health Act– Health minister cannot list a medicine
under the scheme without a positive recommendation from the PBAC
Assessment of medicines for subsidy
In assessing medicines for listing, the committee is required by legislation to consider:
• Comparative efficacy• Comparative safety• Cost-effectiveness
– Cost-minimisation assessment or cost-effectiveness assessment
• Cost-effectiveness has been mandatory since 1993
USA-Australian Free Trade Agreement
Current policy developments due to the agreement• An independent review process of PBAC decisions
– where the PBAC decided not to list a medicine– PBAC is still the final arbiter of the decision
• Hearings before the PBAC; limited in scope & to specific issues
• Improved transparency of PBAC decisions with publication of public summary documents; previously all material was commercial in confidence
Quality Use of Medicines
• National Strategy for Quality Use of Medicines
• Established 1992• In response to
strong consumer lobby
http://www.health.gov.au/haf/nmp/quality.htm
The Original Vision for QUM (1992)
National Facilitation & Co-ordination
Objective Information
Education & Training
Consumer Services
Provider Services
Campaigns
Australian National Formulary
National Therapeutic Guidelines
Australian Prescriber
Consumer Medicines Information
Consumer education for self-reliance
School kits & adult learning
Core curricula for providers
Ethical promotion
Undergraduate, postgraduate & continuing ed’n
Multidisciplinary team approach
Awareness Motivation Confidence
Medication records
Compliance aids
Disposal of unwanted medicines
Stimulate teamwork
Academic detailing
Models of practice
Audit & feedback
Critical appraisal of promotion
General awareness
Elderly
Asthma
Analgesics
Out-of-date medication
Targeted Grants for Further Development
Medication review
The Original Vision for QUM (1992)
National Facilitation & Co-ordination
Objective Information
Education & Training
Consumer Services
Provider Services
Campaigns
Australian National Formulary
National Therapeutic Guidelines
Australian Prescriber
Consumer Medicines Information
Consumer education for self-reliance
School kits & adult learning
Core curricula for providers
Ethical promotion
Undergraduate, postgraduate & continuing ed’n
Multidisciplinary team approach
Awareness Motivation Confidence
Medication records
Compliance aids
Disposal of unwanted medicines
Stimulate teamwork
Academic detailing
Models of practice
Audit & feedback
Critical appraisal of promotion
General awareness
Elderly
Asthma
Analgesics
Out-of-date medication
Targeted Grants for Further Development
Medication review
QUM services and resources (2005)
National Facilitation & Co-ordination
Objective Information
Education & Training
Consumer Services
Provider Services
Campaigns
Australian National Formulary
National Therapeutic Guidelines
Australian Prescriber
Consumer Medicines Information
Consumer education for self-reliance
School kits & adult learning
Core curricula for providers
Ethical promotion
Undergraduate, postgraduate & continuing ed’n
Multidisciplinary team approach
Awareness Motivation Confidence
E-medication record developing
Compliance aids
Disposal of unwanted medicines
Stimulate teamwork
Academic detailing
Models of practice
Audit & feedback
Critical appraisal of promotion
General awareness
Elderly
Antibiotics
Analgesics
Out-of-date medication
Targeted Grants for Further Development
Medication review
Ensuring quality use of medicines
• Over $100 million committed over next four years
The challenge
• Is the policy framework holding the tensions?
Cost-effectiveness assessments and impact on
pricing• Costs of selected new medicines:
Australia and USA• Etanercept
– Aus PBS price 4x25mg = $US 734; – US FSS price $US 360 DrugStore.com
$US600• Imatinib 400mg 30
– Aus PBS price $US 2934; – US FSS price $US 2413 DrugStore.com
$US2440
Cost-effectiveness assessments and impact on pricing
Cost-effectiveness assessments and impact on uptake of new molecular
entities
Conclusions
• Australia’s national medicines policy aims to hold the tensions between the major objectives of the policy at the macro and micro levels– Macro level tensions, such as industry
development versus access and affordability– Tensions also need to be acknowledged and
held at the local level • eg hospital needs versus community needs
pharmacy needs versus medicines needsconsumer needs versus health professional needs
Conclusions
• Lack of comprehensive linked data sets in Australia limit conclusions, about how well the Australian framework balances the competing tensions.
• However, currently the policy appears to be meeting its major objectives as measured by the national indicators. The real test will be if the policy framework achieves these objectives in 2020