Title: Essential Medicines in Palliative Care: the experience in Australia Debra Rowett Essential Medicines in Palliative Care meeting Salzburg 30 April
1Essential Medicines in Palliative Care the
experience in AustraliaDebra Rowett
Essential Medicines in Palliative Care meeting
Salzburg 30 April 2 May 2006
2The policy context
- Australias 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
4The 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 patients
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.
-
7PCMWG 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
10Identifying 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
11The 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.
12Determination 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
13The 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
14First 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 17(No Transcript)
18Clinical 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
19Clinical 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
20TGA ( Drug Regulator)
- Data
- Physical chemistry/ manufacturing data
- Pre-clinical/animal toxicology data
- Clinical/human data
- Approval Process
- ADEC reviews TGA delegates 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
21PBS (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
22PBS
- 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 gt 10
million/year
23Matching 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).
26Requirements for PBS listing
Is there a sponsor? ?
TGA Indication approved? ?
Form of drug approved? ?
Route of drug approved? ?
PBAC Is the drug listed in any form? ?
Is the indication appropriate OR Is there a very similar indication? ?
If the evidence of efficacy is present, can agreement be reached on price? ?
Is a new listing required and feasible? ?
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
30A TAXONOMY OF PROFESSIONAL BEHAVIOUR CHANGE
31Social 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
32Acknowledgement 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