The policy context

1. Essential Medicines in Palliative Care: the experience in AustraliaDebra RowettEssential Medicines in Palliative Care meeting Salzburg 30 April – 2 May 2006

2. The policy context Australia’s National Medicines Policy integrates the Policy on Quality Use of Medicines and provides a framework to achieve appropriate medication use and improved health outcomes.

3. National Medicines Policy has four central objectives • Timely access to and affordable cost of medicines • Appropriate standards of quality, safety, efficacy • Quality use of medicines • Maintaining a responsible and viable medicines industry

4. The policy context A key aim under the National Palliative Care Strategy and National Palliative Care Program is to improve equity of access and increase the ability of all clinicians to improve the provision of palliation in the place of patient’s choice.

5. The Palliative Care Medicines working Group (PCMWG) Established to investigate problems associated with access to palliative care medications in the community, and encourage appropriate access and quality of care Membership of the PCMWG is multidisciplinary and includes representatives from the broad range of stakeholders necessary to support the delivery of high quality effective palliative care across all settings

6. Palliative Care Australia • Palliative Care Intergovernmental Forum • Joint Therapeutics Committee for Palliative Care Australia, • Australian New Zealand Society for Palliative Medicine and the Clinical Oncological Society of Australia • Cancer Council Australia • National Prescribing Service (NPS) • Australian Pharmaceutical Advisory Council • Drug and Therapeutics Information Services • Medicines Australia • Rural Doctors’ Association of Australia • Community Nursing • Pharmacy Guild of Australia • Consumers Health Forum • Medicare Australia • Therapeutic Goods Administration (TGA) • Pharmaceutical Benefits Advisory Committee (PBAC) Secretariat • Department of Health and Ageing.

7. PCMWG role in increasing rational prescribing Improve access for palliative care medicines on the PBS. AND Raise awareness within the primary health care workforce of existing palliative care medicines already listed on the PBS. AND Promote quality use of palliative care medications to health professionals and the broader community

8. Challenges identified by the PCMWG in the supply or subsidisation of medicines for palliative care use included: • the medicine not registered for supply in Australia for use in any medical condition • the medicine registered but not PBS-listed for indications for use in palliative care • the specific dosage and formulation needs for administration to palliative care patients, and • the discontinuation of older or low usage medicines by manufacturers.

9. PCMWG works with • Therapeutic Goods Administration (TGA). • Pharmaceutical Benefits Advisory Committee (PBAC) • Sponsors (Pharmaceutical industry) to support the listing of priority palliative care medicines on the Pharmaceutical Benefits Scheme which is the Government subsidised medicines scheme in Australia and greater than 90% of all medicine used in Australia in the community is via this scheme

10. Identifying priority palliative care medicines National Priority setting* - national survey of clinicians about palliative medication use List of priority drugs drawn up by the Joint Therapeutics Committee *Priority setting - essentially attempts to combine an assessment of need, an estimation of the likelihood of success, resource requirements, and the underlying values of those making the decisions. WHO Essential Medicines

11. The Essential Drugs in Palliative Care Survey was completed by members of the Australian New Zealand Society for Palliative Medicine and this survey provided the initial list of medications for consideration by the PCMWG.

12. Determination of the list of priority medications for access in palliative care was developed in line with the WHO essential Medicines policy and addressed a range of issues including need, resource requirements to take the medications forward and the underlying values of those making the decisions

13. The criteria developed to provide a framework for review of medications for possible PBS listing as medications for use in palliative care included:availability of robust data for indications and/or routes of administration proposedwide consensus within palliative medicine and the seriousness of the problem being addressedlikelihood of a number of palliative indications for the one medicationmedications that were likely to help avoid hospitalisationno equivalent medicine available on the PBSmedications able to address frequently encountered symptomsthe most community friendly form of administration/transport/storage of medication available if there is equivalent efficacy between two medicationsrelative cost effectiveness if there is equivalent efficacy between two medications

14. First phase25 medications were identified for detailed review with these criteria Minor submissions for 9 medications were considered by the PBAC in 2003. A group of 10 medications, some of which have not been assessed by the TGA for use within a community setting were identified to be developed for consideration under a second phase of this initiative

15. For each medication under consideration, a systematic analysis of the available evidence was completed to determine: ● evidence that could support the proposed change(s) to the current registered TGA indication and/or support a submission to the PBAC for listing under the PBS● patient groups with estimates of the size of the population likely to benefit through access to the medication through the PBS ● current palliative care usage within the hospital and community setting● gaps in the evidence needed to support the proposed palliative care indication and/or PBS listing, and ● clinical study development necessary to support the proposed palliative care indication and/or PBS listing.

16. The PBS – getting listed

18. Clinical trials Phase 1 First exposure in humans Safety, pharmacokinetics (absorption, distribution, metabolism, elimination) Dose finding Phase 2 First exposure in patients Safety and efficacy Pharmacodynamics Dose confirmation

19. Clinical trials (cont) Phase 3 Efficacy/clinical benefit Safety, tolerability Dose range Larger number of patients Phase 4 Post marketing surveillance Pharmacovigilance Comparisons with already marketed drugs

20. TGA ( Drug Regulator) Data Physical chemistry/ manufacturing data Pre-clinical/animal toxicology data Clinical/human data Approval Process ADEC reviews TGA delegate’s overview summary of safety, efficacy, quality Delegate provides draft recommendation to ADEC for approval or rejection Final decision rest with TGA delegate TGA registers drug for specific indication, route of administration and formulation

21. PBS (Government Subsidy) Analyses cost effectiveness of drug ie relative efficacy, safety and cost versus appropriate comparator already available on PBS for specified indication or if no existing drug with standard non-drug treatment

22. PBS Approval Process Involves several external independent expert committees PBAC – recommends whether to list on PBS and price range PBAC Economic Sub-Committee (ESC) – conducts health economic evaluation for PBAC PBAC Drug Utilisation Sub-Committee (DUSC) – analyses drug utilisation of listed medicines and considers uptake in light of prevalence and incidence of proposed indication for use Pharmaceutical Benefits Pricing Authority – establishes fina price details and logistics with sponsor Health Minister approves PBAC recommendations Cabinet final decision if net cost is > $10 million/year

23. Matching the priority list to PBS list For each medicine: Is the medicine ALREADY listed on PBS? If YES- • Is the listing for the right indication? • Is the listing for the preferred route of administration and formulation?

24. If there is NO PBS listing Is there a TGA approval for: the drug? the indication? the preferred route of administration and formulation for palliative care? TGA only approves if there is robust evidence to support the quality, safety and effectiveness of the medicine for ALL of these factors

25. Only medicines that are appropriately listed by TGA can be listed on the PBS Only the sponsor (pharmaceutical company) can list a medicine or change a listed indication on the Australian Register of Therapeutic Goods (ARTG).

26. Requirements for PBS listing For each drug:

27. What has been achieved to date? • A framework to support the listing of palliative medicines through the PBS • A palliative care section within the PBS • Medicines not previously PBS listed now available • Establishment of a national Communication Network of the PCMWG for the health workforce and community • Commitment to funding a national multi-site collaborative clinical study network to improve the availability of evidence of clinical interventions in the palliative care setting through systematic investigation with rigorously designed and performed prospective clinical trials

28. Future and ongoing work: • Encourage Sponsors to consider palliative indications as part of the registration process on the Australian Register of Therapeutic Goods • Assist with the gathering of evidence to demonstrate quality, efficacy and safety of the medicines prioritised • Evidence based implementation strategies for health professionals and consumers to improve the quality use of palliative medicines

29. A key public health challenge Evidence Policy and Practice

30. PATIENT MEDIATED INTERVENTIONS AUDIT & FEEDBACK MARKETING EDUCATIONAL MATERIALS LOCAL CONSENSUS PROCESSES MASS MEDIA ACADEMIC DETAILING PROVIDER ORIENTED FINANCIAL OR ORGANISATIONAL INTERVENTIONS PATIENT ORIENTED FINANCIAL OR ORGANISATIONAL INTERVENTIONS LOCAL OPINION LEADERS EDUCATIONAL MEETINGS REMINDERS A TAXONOMY OF PROFESSIONAL BEHAVIOUR CHANGE

31. Motivation Policy Education Social marketing Comprehensive social marketing campaign Individual behaviour change System change Advocacy Palliative Care Section PBS Provision of information Persuasion Clinical Champions Change Agents Academic Detailing

32. Acknowledgement Palliative Medicines Working Group, Chaired by Professor Peter Ravenscroft Communications working group Chaired by Associate Professor Geoff Mitchell Palliative Care Australia CEO Donna Daniels Department of Health and Ageing Professor David Currow on behalf of the study teams which conducted the research on access to palliative medications in the community and the Palliative care medications scoping and research study Sue Kennedy for her inspiration