IMPLEMENTATION FRAMEWORK
Biosimilar Awareness Initiative
Version 2
November 2015
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Contents
Introduction ............................................................................................................................................................ 3
Why do we need an awareness initiative? ......................................................................................................... 3
Purpose of the framework ................................................................................................................................. 3
Objective of the awareness initiative ................................................................................................................. 3
Background ............................................................................................................................................................. 4
Biosimilars in Australia ....................................................................................................................................... 4
Biosimilars and the PBS ...................................................................................................................................... 4
Substitution and PBS biosimilars ........................................................................................................................ 4
Research into Biosimilars Awareness ................................................................................................................. 5
Previous Communication Activity ...................................................................................................................... 5
Implementation planning ....................................................................................................................................... 6
Operational arrangements and governance ...................................................................................................... 6
Project Steering Committee........................................................................................................................... 7
Reference Group ................................................................................................................................................ 7
Timeframe .......................................................................................................................................................... 7
Risk Management ............................................................................................................................................... 8
Resources ........................................................................................................................................................... 8
Personnel ....................................................................................................................................................... 8
Funding .......................................................................................................................................................... 8
Roles and Responsibilities .................................................................................................................................. 9
The Role of the Department of Health .......................................................................................................... 9
Communication Activities ....................................................................................................................................... 9
Communication Focus Areas .............................................................................................................................. 9
Communication Methods................................................................................................................................. 10
Target audience................................................................................................................................................ 10
Stakeholder Consultation ..................................................................................................................................... 10
Consultation arrangements will be based on advice from the Steering Committee and Reference Group.
..................................................................................................................................................................... 10
Opportunities for Partnering ....................................................................................................................... 10
Ongoing Stakeholder Consultation .................................................................................................................. 11
Activities to support specific biosimilar listings on the PBS.................................................................................. 11
Listing of Inflectra on the PBS .......................................................................................................................... 11
Further information .............................................................................................................................................. 12
Attachment A – Stakeholder list ........................................................................................................................... 13
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Introduction
In May 2015 the Minister for Health, the Hon Sussan Ley MP announced the government’s
Pharmaceutical Benefits Scheme (PBS) Access and Sustainability Package. The reforms followed
consultations and negotiations across the pharmaceutical supply chain including consumers,
pharmacists, medicines, manufacturers, wholesalers and doctors.
As part of the package, funding of $20 million has been committed over three years (2015-16 to
2017-18) to undertake awareness and education activities. These are intended to support
awareness of, and confidence in, biosimilar medicines.
Engagement with stakeholders is critical to the success of the initiative, to ensure that messages are
accurate and consistent and that key issues are addressed through the project.
Why do we need an awareness initiative?
Similar to the development of the generic medicines industry, biosimilar medicines offer an
opportunity to increase access for patients and treatment options and, as a result of the increased
competition, achieve better prices for PBS medicines. This benefits patients through improved
access and treatment options. It also benefits the broader community, by ensuring efficient use of
the taxpayer investment that funds the PBS. However, unlike generic medicines, biosimilars are not
an exact copy of the original (reference) product. Their unique nature and (current) small volume
means they are not always well understood.
In July 2015, the Pharmaceutical Benefits Advisory Committee (PBAC) hosted a consumer hearing on
biosimilars. The PBAC noted that there appeared to be a level of misunderstanding about
biosimilars and matters relating to biosimilar substitution. Anecdotal evidence also suggests that
there are varying levels of understanding about biosimilars amongst prescribers, pharmacists and
patients. Further, there appears to be a variable understanding of the framework in Australia that
governs prescribing. An initiative is therefore required to support patients to make informed
decisions, in consultation with their prescriber and/or pharmacist.
Purpose of the framework
The purpose of this document is to share an outline of the proposed framework for the biosimilars
awareness initiative with key stakeholders and encourage their participation in the initiative.
The framework will also be used as a mechanism to engage stakeholders and seek feedback on the
awareness initiative. Version 1 of the Implementation Framework was released on 8 October 2015
and consultation was held through an online survey between 8 and 26 October 2015. Version 2 of
the Implementation Framework incorporates amendments in response to the input received as part
of the consultation process.
Objective of the awareness initiative
The aim of the initiative is to improve awareness of, and confidence in, biosimilar medicines for
patients and the broader community, as well as for healthcare professionals, including prescribers
and pharmacists. The desired outcomes identified to date include:
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improving overall awareness of the PBS and the future potential of biosimilar medicines across
the community;
supporting and maintaining patient choice, by improving understanding of the medicines by
patients and their families;
providing education and/or refreshing previous education to support healthcare professionals
to meet the clinical and information needs of their patients with regard to both prescribing and
dispensing the medicines; and
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supporting the specific communication and information needs of stakeholders, including the
PBAC, at times when a particular biosimilar medicine is being considered/recommended for
listing on the PBS, especially where brand substitution may apply.
Background
Biosimilars in Australia
Biologic medicines have become increasingly popular in the last decade to treat conditions like
arthritis. This is reflected in the PBS, where biologics have grown from about 4 per cent of the PBS
budget 10 years ago, to about 25 per cent today.
A biosimilar is a similar version of an original biological medicine that is introduced after the patent
on the original medicine has expired, and is marketed with a different brand name to the original.
Biosimilars are projected to cost at least 20%-30% less than reference biologics, however there are
examples internationally where they have reduced costs by up to 70%.
Australia was one of the earliest countries to establish processes for the regulation of biosimilar
medicines, in 2008. Aczicrit® and Grandicrit® (epoetin lambda) were the first products approved in
Australia as biosimilars in 2010. To date, a total of nine biosimilars have been approved for use in
Australia - within the product classes of human growth hormone, granulocyte colony-stimulating
factor, insulin and erythropoietin.
The complexity of the conditions that can be treated with biologicals/biosimilars and the specialist
nature of the medications mean that the bulk of biologicals/biosimilars are currently prescribed in a
hospital setting. However, community pharmacies are increasingly becoming involved in supply of
these medicines and this will continue.
Biosimilars and the PBS
As of 1 September 2015, there are four biosimilars listed on the PBS:
Active ingredient
Brand name
Date first listed on
the PBS
Indication
Filgrastim
Tevagrastim
cancer
1 March 2012
Filgrastim
Zarzio
cancer
1 September 2013
Filgrastim
Nivestim
cancer
1 April 2011
Epoetin lambda
Novicrit
Anaemia caused
by renal disease
1 January 2015
Cost
2013-14
$12,830,077
2014-15
$25,431,290
Increasing numbers of biosimilar medicines are seeking listing on the PBS. The Pharmaceutical
Benefits Advisory Committee (PBAC) considered applications for biosimilar medicines at its March
2015 and July 2015 meetings, and applications for biosimilar medicines are expected to continue.
Over the period 2015-2018 the PBAC is expected to consider further biosimilar medicines,
predominantly for treatments for patients with rheumatoid conditions, diabetes and cancer.
Substitution and PBS biosimilars
Brand substitution is the practice of dispensing one brand of a medicine (drug) instead of another
brand of the same medicine at the pharmacy level without needing to go back to the prescriber.
Brand substitution, known as ‘a’ flagging, is applied to certain PBS medicines to facilitate prescriber
and patient choice.
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In light of the expected increase in treatment options using biosimilar medicines, in April 2015 the
PBAC was asked to provide advice on the reimbursement of biosimilar medicines on the PBS by the
Minister for Health. The PBAC advised that biosimilar products would be ‘a’ flagged, and therefore
suitable for substitution at the pharmacy level, where the data are supportive of this conclusion.
The PBAC considered that when data supported biosimilarity but there was insufficient data to
support ‘a’ flagging, it may be appropriate for data pertaining to ‘a’ flagging to be collected to
facilitate future reconsideration.
Importantly, the PBAC has stated that its policy is to consider every biosimilar on a case-by-case
basis.
Research into Biosimilars Awareness
In December 2012 the International Alliance of Patients Organisations (IAPO) held an online
consultation with its membership to understand the level of awareness of biological and biosimilar
medicines, their regulation and use and what the most important issues and concerns were for
patient organisations. A range of stakeholders, including biosimilar manufacturers, regulatory
agencies, industry trade associations, medical associations and academics were also consulted about
the issues they thought were important.
The majority of patient organisations that responded to the consultation were based in Europe,
North America or Australia. The consultation found:
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There was varied awareness of biosimilar medicines among the respondents.
Just over half (54%) of the patient organisations who responded represented patients currently
using biological medicines.
20% represented patients who were using biosimilars.
60% did not know whether their patients were using biosimilars.
Most had some (32%) or no awareness (36%) of how biosimilars were regulated in their country
or region.
The most important issues for patients regarding biosimilars (identified by patient
organisations) were:
 Safety (side effects, reliability, regulation).
 Patient information and education on biosimilars.
 Switching between a biosimilar and its reference medicine.
 How biosimilars are monitored and tracked.
 Availability and access to biosimilars.
Since the announcement of the funding in May 2015, the Department of Health has not
commissioned specific research on biosimilars. Consultation with stakeholders has commenced and
will continue. It is envisaged that further consultation will inform the next stages, including whether
or not further research is required.
Previous Communication Activity
The Department of Health has previously provided national communication activities to support
understanding of the PBS. There is an opportunity to build on existing knowledge of the PBS to
specifically improve awareness of the existing framework that governs prescribing and dispensing of
biosimilar medicines.
Previous and recent activities include:
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In 2002/03 the department conducted a communication campaign to educate Australians about
the PBS and encourage them to play a role in sustaining the scheme.
The department has provided communication support to PBS listings through media releases.
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The Government has funded the National Prescribing Service (NPS) MedicineWise to provide
information and education on the use of generic medicines in 2006 and 2010.
In May 2015 the Minister announced government’s PBS Access and Sustainability Package.
In June 2015 the Minister for Health announced the PBAC recommendation on ‘a’ flagging.
In August 2015 the department published fact sheets for consumers, prescribers and
pharmacists on the PBS website.
Implementation planning
Operational arrangements and governance
To ensure effective stakeholder engagement is supported and governance arrangements are in
place, a Steering Committee and Reference Group will be established to support this initiative, as
depicted below.
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Project Steering Committee
A Steering Committee will be formed to provide strategic oversight to the Awareness Initiative. The
Steering Committee will provide advice on research and communication activities and will make
decisions regarding the expenditure of funds relating to the project. The Steering Committee will be
comprised of primarily Departmental staff, with representatives from the PBAC and selected
technical experts in the medical and communications fields.
Reference Group
A Reference Group will provide a forum for formal consultation with representatives of key
stakeholder groups. This group will guide the Awareness Initiative and ensure key messages are
clearly articulated and appropriately targeted. It is anticipated that the Reference Group will be
composed of representatives from:
 Medicines Australia;
 Generics and Biosimilar Medicines Association;
 Royal Australian College of Physicians;
 Australian Medical Association;
 National Prescribing Service;
 Pharmaceutical Society of Australia; and,
 Consumers’ Health Forum.
Representatives from condition specific groups may be invited to Reference Group meetings where
input relating to a particular treatment area or medicine is required, such as when a new biosimilar
has been recommended for listing on the PBS. The Reference Group will be consulted on
communication activities to ensure that key messages are identified and communicated effectively.
Timeframe
The funding allocated through the Access and Sustainability Package provides for the Awareness
Initiative to be conducted over the period 2015-2018.
The main communication activities will occur in three stages: early communications, market
research, data collection, and development of key messages; main awareness building activities;
and, evaluation and re-focussing of key messages (if required). To ensure that information on
biosimilars is made available to stakeholders, early communication activities will be conducted in
2015 to provide general information about biosimilars. In addition, a range of information will be
provided, on a case by case basis, to support understanding of any biosimilar medicines that are
recommended by the PBAC for listing on the PBS.
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Ongoing
Awareness activities to support understanding of biosimilars recommended for listing on the
PBS
Stakeholder consultation
Stage 1
• early biosimilars
information
• market research
• data collection
• development of key
messages
Stage 2
• main awareness activities
informed by activities
undertaken through Stage 1
Stage 3
• evaluation
• re-focussing of key
messages
Risk Management
The key risks for this project include the provision of incomplete or poorly targeted information to
key stakeholders. To mitigate these risks, the following will be employed:
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establishing a governance framework comprised of a Steering Committee and Reference Group
to guide the project, and particularly the development of communication materials;
providing consistent information to a range of groups, whether or not they have relevant
scientific knowledge;
making the information readily available, especially where the need is time-critical;
ensuring that all relevant stakeholders are identified and opportunities for collaboration are
utilised;
using existing distribution networks and key representation groups to disseminate
communications;
managing the interests of diverse groups and preventing misinformation; and
monitoring perceptions and adjusting messaging, as required, over an extended period.
Resources
Personnel
The Department of Health will use existing staff, and recruit additional staff where necessary, to
develop and implement the project. Specific tasks may draw upon the expertise of personnel from
relevant stakeholder groups. Where necessary, the funds may provide for the use of specialist
support (eg market research). Consultants or contractors will be engaged when and if required to
assist with national consultation, design and implementation.
Funding
Total funding of $20 million has been made available for this initiative:
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$6.5 million in 2015-16;
$6.7 million in 2016-17; and
$7.1 million in 2017-18.
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Roles and Responsibilities
The Role of the Department of Health
This project will be led by the Pharmaceutical Benefits Division in the Department of Health.
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The Senior Responsible Officer for this project is the First Assistant Secretary of Pharmaceutical
Benefits Division.
The Action Officer for this project is the Assistant Secretary of Pharmaceutical Policy Branch.
The project will be managed by the National Medicines Policy section.
The Communication Branch of the department will assist with the development and implementation
of communication activities to support the biosimilars project.
Communication Activities
Research and consultation will be conducted to inform the development of key messages and
materials before the main awareness activities commence. To ensure that some information is
readily available while this is being developed, early communications regarding biosimilars and the
process of ‘a’ flagging have been released in the form of fact sheets for consumers and health
professionals. Communications specific to any listings on the PBS arising from a PBAC
recommendation will be developed and released as needed.
Communication Focus Areas
The discussion points identified in Version 1 of the Implementation Framework have been refined in
response to feedback received from the initial stakeholder survey to reflect the key areas that
should be addressed in communication activities. This is not an exhaustive list, and additional
communication points may be added as the need arises. The communication focus areas include:
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What is a biosimilar, including:
o The difference between a generic and a biosimilar;
o The difference between a reference biologic and a biosimilar;
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The safety and efficacy of biosimilars, including what and how this is assessed;
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The regulatory and reimbursement framework for biologic and biosimilar medicines,
including:
o The role of the TGA and its regulatory process;
o The role of the PBAC;
o What the PBAC considers to recommend biosimilarity;
o What the PBAC considers to recommend a-flagging;
o The case-by-case approach to considering biosimilars;
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What is substitution and how may it occur;
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What support is available to clincians, pharmacists and patients regarding biosimilars and
substitution;
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The control that patients and prescribers have to exercise choice in substitution;
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Previous experience with biosimilars, such as in the hospital setting;
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The impact of biosimilars on the affordability of medicines, both to patients and the PBS;
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How improved cost-effectiveness may benefit more patients by enabling the listed
indications to be expanded;
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That cost does not reflect quality; and,
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Continued data collection to inform the understanding of the impact of biosimilars on
prescribing and patients.
Communication Methods
Communication and awareness activities will be through a number of different forms, including but
not limited to:
 fact sheets;
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information brochures;
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letters to the prescriber, pharmacist or patient;
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seminars or presentations; and,
 educational opportunities.
Consideration will be given to the method of disseminating information, to ensure the appropriate
audience is reached.
Target audience
The initiative aims to increase awareness for all Australians. Where possible, information will be
targeted to meet the needs of key groups, including:
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Consumers, including patients and their families, as well as the broader community; and
Health care professionals, including prescribers (general practitioners, specialists) and
dispensers (pharmacists in both community and hospital settings).
Stakeholder Consultation
Stakeholder consultation is an important component of the Awareness Initiative and will be
conducted throughout all stages. A list of main stakeholders is at Attachment A. If a stakeholder is
not on this list and wishes to be included in communications, they are encouraged to contact the
Department via email to nmp@health.gov.au.
Feedback from stakeholders regarding the information to be provided, and the means by which it
will be presented, will be important in shaping the messages that are disseminated, and assessing
the success of the education process.
A key priority of the stakeholder consultation is to seek feedback from stakeholders on:
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their understanding of the Australian system;
their position on biosimilars;
what they believe the issues and risks are for communication;
what they believe the key messages for prescribers, pharmacists and consumers should be;
what communication channels and tools they currently use to communicate and a
recommendation on their effectiveness;
their willingness to assist in the distribution of communication material on biosimilars; and,
the effectiveness of proposed communication strategies and materials.
Consultation arrangements will be based on advice from the Steering Committee and Reference
Group.
Opportunities for Partnering
Consistent with the National Medicines Policy, this initiative will require a collaborative effort
between the department, healthcare professionals, consumer groups and industry. This includes
work with the GBMA, in accordance with the strategic agreement.
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Given the importance of meeting the needs of the target audience, further partnering opportunities
exist to work with peak bodies that can support this initiative for the benefit of both consumers and
healthcare professionals.
Partnering may include the collection and/or sharing of research and data. It could also include
development and/or distribution of communication materials through existing networks.
Ongoing Stakeholder Consultation
Broader stakeholder consultation, where all interested parties will have an opportunity to make a
contribution, will also be conducted throughout the Awareness Initiative, this may include:
 surveys;
 calls for submission;
 market research and testing;
 a stakeholder forum; and,
 individual meetings.
Stakeholders are also able to provide input at any time by emailing nmp@health.gov.au.
The first open consultation process was conducted via an online survey seeking comment on
Version 1 of the Implementation Framework. Members of the PBAC and Departmental staff have
also made presentations to key stakeholder groups and held discussions to inform the progression of
the Implementation Framework.
Activities to support specific biosimilar listings on the PBS
Throughout the Awareness Initiative, information will be required to support the PBAC
recommendations for the listing of specific biosimilar medicines. The information to accompany the
listing of medicines will have individual needs and timeframes attached to it.
Activities to support individual listings could include:
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update of fact sheets on the PBS website and provision to stakeholders;
identification of key stakeholders for direct communications; and,
identification of key advocates to disseminate information.
Implementation Plan for Listing of Inflectra on the PBS
At the July 2015 meeting the PBAC recommended the listing of infliximab (Inflectra®) as a biosimilar
of infliximab (Remicade®). The PBAC advised the Minister that it considered the Remicade® and
Inflectra® brands of infliximab could be marked as equivalent in the Schedule of Pharmaceutical
Benefits (‘a’ flagged), for the purposes of substitution by the pharmacist at the point of dispensing.
To support the listing of Inflectra® on the PBS, a range of activities are being undertaken.
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Publication of a ‘Biosimilar infliximab on the PBS’ fact sheet on the PBS website, which
provides information relating to the listing of Inflectra® and addresses the common
questions and misconceptions associated with biosimilars and ‘a’ flagging.
Publication of two info graphics explaining what biosimilars are, and the process of
‘a’ flagging, these will be published in time to support the listing of Inflectra®, but will also
support the Biosimilars Awareness Initiative more broadly.
A letter to health professionals providing them with information on the listing of Inflectra®.
A copy of the fact sheet and the info graphics will also be included to assist clinicians in their
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conversations with their patients. Key clinician and patient representative groups will be
identified and provided with this information material to be disseminated to their members.
Members of the PBAC and Departmental staff have made presentations to the Australian
Rheumatology Association and the Royal Australian College of Physicians to provide more
detailed communication regarding the recommendation of Inflectra®. Individual meetings
are ongoing.
Development of a data collection program to provide focussed pharmacovigilance and
monitoring of the implementation of ‘a’ flagging on biosimilars. The Department is
currently in discussions with the Australian Rheumatology Association (ARA) to establish
data collection ability in relation to the use of these medicines from rheumatologists, and
build on their existing database of patient reported outcomes.
o The data collection is proposed to capture information such as biosimilar
prescribing, adverse events, and reasons for switching agents, and link this to the
patient reported outcomes data in the ARA database.
o The ARA would utilise their existing relationships with rheumatologists, who
prescribe approximately 70% of the bDMARDS, including infliximab. Data collected
in the process could be used in pharmacovigilance and to inform the
communication activities of the Biosimilars Awareness Initiative. This proposal
would enable monitoring of the Inflectra® listing implementation and also support
the monitoring of further listings of biosimilar bDMARDS if they occur.
Further information
For further information, please refer to the biosimilar information available on the PBS website.
Information is also available through the Therapeutic Goods Administration website.
If, after reading the information available on the internet, you still have questions or concerns please
contact:
National Medicines Policy section
Department of Health
Phone: 1800 020 613
Email: nmp@health.gov.au
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Attachment A – Stakeholder list
Consumer
Consumer Health Forum
Patient support groups (Crohn’s & Colitis Australia; Arthritis Australia; Diabetes Australia; Lymphoma
Australia; Creaky Joints; Association of Independent Retirees; Arthritis & Osteoporosis NSW, Access
Australia, Australian Rheumatology Association)
Patient information (RealTime Health; HealthInsite; The Health Consumers' Council; Health Issues
Centre)
Council of the Ageing
Cancer Council Australia
Prescriber /Clinician
Royal Australian College of Physicians
Royal Australian and New Zealand College of Radiologists
Royal Australian College of General Practitioners
Royal Australian and New Zealand College of Ophthalmologists
Australian Medical Association
Specialist groups (Aust Rheumatology Assn; Medical Oncology Group of Australia;
Gastroenterological Society of Australia; Haemotology Society of Australia and New Zealand;
Australian College of Dermatologists)
Council of Australian Therapeutic Advisory Groups
Medical Oncology Group of Australia
Generic and Biosimilar Medicines Association
Australasian College of Dermatologists
Gastroenterological Society of Australia
Clinical Oncology Society of Australia
Pharmacy
Pharmaceutical sponsors
Generic and Biosimilar Medicines Association (formerly GMiA)
AusBiotech
Medicines Australia
Pharmaceutical Society of Australia
Society of Hospital Pharmacists of Australia
Pharmacy Guild
Australian Association of Consultant Pharmacy
Medical Software Industry Association
Emerald Corporate Group
Nursing
Australian College of Nursing
Australian Nursing and Midwifery Federation
International Council of Nurses
National Nursing Organisations
Australian Primary Health Care Nurses Association
Government / Regulatory
Therapeutic Goods Administration
Pharmaceutical Benefits Advisory Committee
National Health and Medical Research Centre
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Department of Industry
Department of Veterans’ Affairs
Department of Human Services
Australian Commission of Safety and Quality in Health Care
State government - Departments of Health
Non-Government / Not For Profit
NPS Medicinewise
Research
Queensland University of Technology
MS Research Australia
International
World Health Organization
Consumers International
International Alliance of patient Organisations
US – Food and Drug Administration
UK – National Institute for Health and Care Excellence
EU – European Medicines Agency
Biotech Industry Organization
Alliance for Safe biologic Medicines
Proteome Sciences
International Cancer Advocacy Network (ICAN)
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
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