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Australia’s National Medicines Policy. Libby Roughead University of South Australia. Health expenditure as a proportion of GDP. Per capita health expenditure 2001. Healthy life expectancy at birth: 2002. Pharmaceutical expenditure as a proportion of health expenditure.

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Australia s national medicines policy

Australia’s National Medicines Policy

Libby Roughead

University of South Australia








Australia s national medicines policy1
Australia’s National Medicines Policy expenditure

  • 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 expenditure

to necessary

medicines

Quality use of

medicines

Medicines of

high quality safety

and efficacy

A viable & responsible local pharmaceutical

industry


Medicines meeting appropriate standards of quality safety and efficacy
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
Maintaining a responsible and viable pharmaceutical industry and efficacy

  • 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
Pharmaceutical Benefits Scheme cost the individual and the community can afford

  • 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
Assessment of medicines for subsidy cost the individual and the community can afford

  • 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 subsidy1
Assessment of medicines for subsidy cost the individual and the community can afford

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
USA-Australian Free Trade Agreement cost the individual and the community can afford

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
Quality Use of Medicines cost the individual and the community can afford

  • 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) cost the individual and the community can afford

National Facilitation & Co-ordination

Australian National Formulary

Consumer education for self-reliance

Awareness Motivation Confidence

Stimulate teamwork

General awareness

Objective Information

Education & Training

Consumer Services

Provider Services

Campaigns

School kits & adult learning

Academic detailing

National Therapeutic Guidelines

Medication records

Elderly

Core curricula for providers

Models of practice

Asthma

Medication review

Australian Prescriber

Analgesics

Undergraduate, postgraduate & continuing ed’n

Audit & feedback

Compliance aids

Consumer Medicines Information

Out-of-date medication

Disposal of unwanted medicines

Critical appraisal of promotion

Multidisciplinary team approach

Ethical promotion

Targeted Grants for Further Development


The Original Vision for QUM (1992) cost the individual and the community can afford

Objective Information

Education & Training

Consumer Services

Provider Services

Campaigns

National Facilitation & Co-ordination

Australian National Formulary

Consumer education for self-reliance

Awareness Motivation Confidence

Stimulate teamwork

General awareness

School kits & adult learning

Academic detailing

National Therapeutic Guidelines

Medication records

Elderly

Core curricula for providers

Models of practice

Asthma

Medication review

Australian Prescriber

Analgesics

Undergraduate, postgraduate & continuing ed’n

Audit & feedback

Compliance aids

Consumer Medicines Information

Out-of-date medication

Disposal of unwanted medicines

Critical appraisal of promotion

Multidisciplinary team approach

Ethical promotion

Targeted Grants for Further Development


QUM services and resources (2005) cost the individual and the community can afford

Objective Information

Education & Training

Consumer Services

Provider Services

Campaigns

National Facilitation & Co-ordination

Australian National Formulary

Consumer education for self-reliance

Awareness Motivation Confidence

Stimulate teamwork

General awareness

Academic detailing

School kits & adult learning

National Therapeutic Guidelines

E-medication record developing

Elderly

Core curricula for providers

Models of practice

Antibiotics

Medication review

Australian Prescriber

Analgesics

Undergraduate, postgraduate & continuing ed’n

Audit & feedback

Compliance aids

Consumer Medicines Information

Out-of-date medication

Disposal of unwanted medicines

Critical appraisal of promotion

Multidisciplinary team approach

Ethical promotion

Targeted Grants for Further Development


Ensuring quality use of medicines
Ensuring quality use of medicines cost the individual and the community can afford

  • Over $100 million committed over next four years


The challenge
The challenge cost the individual and the community can afford

  • Is the policy framework holding the tensions?


Cost effectiveness assessments and impact on pricing
Cost-effectiveness assessments and impact on pricing cost the individual and the community can afford

  • 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 pricing1
Cost-effectiveness assessments and impact on pricing cost the individual and the community can afford



Conclusions
Conclusions molecular entities

  • 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 needspharmacy needs versus medicines needsconsumer needs versus health professional needs


Conclusions1
Conclusions molecular entities

  • 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


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