1. Australia’s National Medicines Policy Libby Roughead University of South Australia

2. Health expenditure as a proportion of GDP

3. Per capita health expenditure 2001

4. Healthy life expectancy at birth: 2002

5. Pharmaceutical expenditure as a proportion of health expenditure

6. Costs of providing medicines are increasing

7. Medicines are consuming a larger part of the health budget 1984-85 2002/03

8. 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

9. Equitable access to necessary medicines Quality use of medicines Medicines of high quality safety and efficacy A viable & responsible local pharmaceutical industry

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. The Original Vision for QUM (1992) 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

19. The Original Vision for QUM (1992) 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

20. QUM services and resources (2005) 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

21. Ensuring quality use of medicines • Over $100 million committed over next four years

22. The challenge • Is the policy framework holding the tensions?

23. 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

24. Cost-effectiveness assessments and impact on pricing

25. Cost-effectiveness assessments and impact on uptake of new molecular entities

26. 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 needspharmacy needs versus medicines needsconsumer needs versus health professional needs

27. 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