Essential Medicines in Palliative Care: the experience in Australia Debra Rowett Essential Medicines in Palliative Care meeting Salzburg 30 April - PowerPoint PPT Presentation

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Essential Medicines in Palliative Care: the experience in Australia Debra Rowett Essential Medicines in Palliative Care meeting Salzburg 30 April

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Pharmacy Guild of Australia. Consumers Health Forum. Medicare Australia ... Physical chemistry/ manufacturing data. Pre-clinical/animal toxicology data ... – PowerPoint PPT presentation

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Title: Essential Medicines in Palliative Care: the experience in Australia Debra Rowett Essential Medicines in Palliative Care meeting Salzburg 30 April


1
Essential Medicines in Palliative Care the
experience in AustraliaDebra Rowett
Essential Medicines in Palliative Care meeting
Salzburg 30 April 2 May 2006
2
The 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

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 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.

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

17
(No Transcript)
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 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

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 gt 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

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
30
A TAXONOMY OF PROFESSIONAL BEHAVIOUR CHANGE
31
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
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