Copy of public consultation survey for

items to be considered by the PBAC

(July 2023)

https://ohta-consultations.health.gov.au/ohta/pbac-july-2023

Consultation closing: 24 May 2023

Overview
Consultation is now open for items listed on the July 2023 PBAC agenda.

The PBAC welcomes input from patients, carers, health professionals, consumer
groups or organisations and members of the public on medicines submitted for PBAC
consideration.

The PBAC considers these public consultation inputs when considering the clinical
and economic evidence presented by the applicant.

Input can be submitted via the online survey. A copy of the questions asked in the
survey and additional guidance can be downloaded below under ‘Related’ to assist
your preparation.

There is the option to upload a file with your submission. The preferred file types
are PDF or Microsoft Word, however other file types will be accepted, provided they
are no larger than 25mb. If your file is too large, or you wish to upload more than one
file, please contact [email protected]

You can save and come back at any time to your response before the consultation
close date.

Once you have submitted, a copy of your submission will be emailed to the contact
email address provided.

Feedback can also be sent by emailing the survey in Word format, along with any
relevant files, to [email protected]

Providing input on more than one medicine? You will need to complete a separate
survey for each medicine. Alternatively, email your input to
[email protected]

Please note that in the last question we welcome your comments and suggestions on
ways to improve the survey and this process. All responses are considered after each
round of consultation, and improvements are then made to the survey and its guidance
where appropriate.

Privacy and consent

Privacy Information
Your personal information is protected by law, including the Privacy Act 1988 (Privacy
Act) and the Australian Privacy Principles (APPs), and is being collected by the
Department, via Citizen Space, for the purposes of conducting a consultation process
in relation to an application submitted to the Office of HTA. The Department will collect
your personal information at the time that you provide a submission. To protect
privacy, do not include identifying personal or sensitive information about another
individual (third party).

More information about privacy

You can obtain a copy of the Department’s privacy policy
(https://www.health.gov.au/resources/publications/privacy-policy)
by contacting the Department using the contact details set out below. The
Department’s privacy policy contains information about:
 how you may access the personal information the Department holds about you
and how you can seek correction of it; and
 how you may complain about a breach of
 the APPs; or
 a registered APP code that binds the Department; and
 how the Department has dealt with such a complaint.

You can contact the Department by telephone on (02) 6289 1555 or free call 1800 020
103 or by using the online enquiries form at: http://www.health.gov.au/.

How your input will be used

All input from individuals will be made available in summary form to the sponsor of the
application and the PBAC.

No identifying information about individuals or third parties will be included in the

summary. This type of information will be removed by the Department.

The PBAC may also have access to de-identified individual responses.

All input from groups or organisations will be provided in full to both the PBAC and its
subcommittees and the sponsor of the medicine. Any identifying information relating to
third parties detected will be removed prior to distribution.

In addition, all input received will be noted in the relevant Public Summary Document.
Public Summary Documents are available approximately four (4) months after the
PBAC meeting and outline the PBAC discussion and advice. See the PBAC calendar
(http://www.pbs.gov.au/info/industry/usefulresources/pbs-calendar) for publication
dates.
Please indicate your consent below.
Consent (Required)

I have read the above text on how public consultation input will be used and
consent to the input being used as described above

Contact details
Below is a section to provide your contact details. These details are not made public or
shared with the PBAC. We ask for these individual details only to ensure submissions
are recorded accurately and can be confirmed, if required.

1 What is your name? (Required)

2 What is your email address? (Required)

(If you enter your email address then you will automatically receive an
acknowledgement email when you submit your response.)

3 Are you providing input as an individual or on behalf of an organisation?

(Required)
We recognise that individuals can cross multiple categories. Please choose a category
that best describes the primary reason for your submission. Please select only one
item

Individual who would like to access the medicine to treat own health condition
Individual who has used this medicine for own health condition
Parent, partner or another person directly caring for an individual from the
above two groups
Consumer group/organisation submission
Health professional working in the area
Medical/other organisation submission
Other interested individual (including family members, friends, or members of
the public interested in the medicine but not directly caring for an individual
currently using or wanting access to the medicine)

For noting:
 If you are a health professional with experience treating the condition or using
the medication and are providing input that represents your own views, select
‘Health professional’. If you are a health professional providing input on behalf
of a group of clinicians or an organisation, please select ‘Medical/other
organisation’.

4 If you selected consumer group/organisation, or medical/other

organisation above, please provide the name of the group/organisation.

5 What is your phone number? (Required)

6 What is your state?
Please select your state. Please select only one item

ACT
TAS
NSW
QLD
WA
SA
NT
VIC

7 Select the medicine you would like to provide input on (Required)

Select a medicine. Please select only one item. To provide input for more than one
medicine you will need to fill out another survey.

ABIRATERONE AND METHYLPREDNISOLONE-Yonsa Mpred®:Metastatic

hormone sensitive prostate cancer
ACALABRUTINIB-Calquence®:Chronic lymphocytic leukaemia (CLL) or small
lymphocytic lymphoma (SLL)
ADALIMUMAB-Ardalicip®:Severe Crohn disease; moderate to severe
ulcerative colitis; Severe active juvenile idiopathic arthritis; Complex refractory
fistulising Crohn disease; Severe active rheumatoid arthritis; Severe psoriatic
arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis; Moderate to
severe hidradenitis suppurativa
ATOGEPANT-Aquipta®:Prophylaxis of migraine in adults
AVACOPAN-Tavneos®:Severe active granulomatosis with polyangiitis (GPA)
and severe active microscopic polyangiitis (MPA)
CABOTEGRAVIR-Apretude®:Pre-exposure prophylaxis of HIV infection
CALCIPOTRIOL WITH BETAMETHASONE-Enstilar®:Chronic stable plaque
type psoriasis vulgaris
DAPAGLIFLOZIN-Forxiga®:Chronic heart failure
DAPRODUSTAT-Jesduvroq®:Anaemia associated with chronic kidney
disease
DAUNORUBICIN WITH CYTARABINE-Vyxeos®:Acute myeloid leukaemia
DUPILUMAB-Dupixent®:Chronic severe atopic dermatitis
DURVALUMAB-Imfinzi®:Biliary tract cancer
ENOXAPARIN-ExaraneTM Exarane ForteTM:Thrombo-embolic disorders
ESKETAMINE-Spravato®:Treatment resistant depression
FOSLEVODOPA WITH FOSCARBIDOPA-Vyalev®:Advanced Parkinson's
Disease
IXEKIZUMAB-Taltz®:Non-radiographic axial spondyloarthritis (nr-AxSpA)
LUMACAFTOR AND IVACAFTOR-Orkambi®:Cystic fibrosis
MAVACAMTEN-Camzyos®:Hypertrophic cardiomyopathy
 MIRIKIZUMAB-Omvoh®:Moderate to severe ulcerative colitis
MOBOCERTINIB-Exkivity®:Locally advanced or metastatic non-small cell lung
cancer
MOLNUPIRAVIR-Lagevrio®:Mild to moderate COVID-19
NIVOLUMAB-Opdivo®:Non-small cell lung cancer
NUSINERSEN-Spinraza®:Pre-symptomatic treatment of spinal muscular
atrophy (SMA)
OLIPUDASE ALFA-Xenpozyme®:Acid sphingomyelinase deficiency (ASMD)
ONASEMNOGENE ABEPARVOVEC-Zolgensma®: Pre-symptomatic spinal
muscular atrophy (SMA)
PATISIRAN-Onpattro®:Hereditary transthyretin-mediated amyloidosis (hATTR
amyloidosis)
PEMBROLIZUMAB-Keytruda®:Breast cancer
POMALIDOMIDE-PomolideTM®:Relapsed/refractory multiple myeloma
RAVULIZUMAB-Ultomiris®:Paroxysmal nocturnal haemoglobinuria (PNH)
RIMEGEPANT-Nurtec ODT®:Acute migraine attacks
SACITUZUMAB GOVITECAN-Trodelvy®:Hormone receptor positive (HR+),
human epidermal growth factor receptor 2 negative (HER2-) advanced or
metastatic breast cancer
SECUKINUMAB-Cosentyx®:Hidradenitis Suppurativa (HS)
SELPERCATINIB-Retevmo®:Non-small cell lung cancer (NSCLC)
SOMAPACITAN-Sogroya®:Paediatric growth hormone deficiency (GHD)
SONIDEGIB-Odomzo®®:Metastatic or locally advanced basal cell carcinoma
(BCC)
TAFAMIDIS-Vyndamax®:Transthyretin amyloid cardiomyopathy
TAGRAXOFUSP-Elzonris®:Blastic Plasmacytoid Dendritic Cell Neoplasm
(BPDCN)
TIRZEPATIDE-Mounjaro®:Type 2 Diabetes Mellitus (T2DM
TRIENTINE-Trientine Dr.Reddy's®:Wilson disease
USTEKINUMAB-Stelara®:fistulising Crohn disease
VARICELLA ZOSTER VIRUS RECOMBINANT VACCINE-Shingrix®:
Prevention of herpes zoster and post-herpetic neuralgia

8 How did you find out about this consultation? (Required)

PBAC public consultation survey
The PBAC welcomes input from anyone with an interest in the medicine proposed to
be listed on the Pharmaceutical Benefits Scheme (PBS). You can submit input by
answering the five (5) questions below and/or by uploading a file. You can choose to
answer as many of the questions as you like but providing as much detail as you can
will be most helpful for the PBAC. Your input will be saved so you can come back at
any time to your response before the consultation close date. A copy of your
submission will be emailed to the contact email address provided.

1 Please outline your experience with the medical/health condition

Points for individual consumers to consider

 What is the impact of your health condition on your life? Try to be as specific as
possible including impacts on your everyday activities, work, family, friends,
mental and emotional health.
Please provide your comments

2 How is the medical/health condition currently treated?

Points for individual consumers to consider

 What is the effect of your current treatment on your health condition?
 Are there any symptoms which cannot be controlled with the current treatment?
 What side-effects have you experienced with current treatments? Are these
manageable?
 Do you have any issues accessing your current treatment? (For example,
where or how it is given, how it is funded, whether you fit the criteria to qualify
for access)
Please provide your comments

3 What do you see as the advantages of this proposed medicine, in

particular for those with the medical condition and/or family and carers?

Points for individual consumers to consider

 What are the specific positive impacts that you hope this treatment will have on
your health condition? (for example, reducing pain)
 What impact would you like it to have on your quality of life? (for example,
enabling you to return to work)
 If you have used this medicine what was your experience? What changed for
you?
 Are there advantages in the way the medicine is delivered? (For example,
where it is delivered (for example, home, GP, hospital), or how it is given (for
example, tablets rather than injection))
Please provide your comments
4 What do you see as the main disadvantages of this proposed medicine?

Points for individual consumers to consider

 Are there disadvantages in how you can access the medicine, for example
whether you meet the criteria, where it is delivered (for example, home, GP,
hospital), or how it is given (for example, tablets rather than injection)?
 Have you heard of any side effects from this medicine? Do you consider these
to be manageable?
 What side effects would stop you from taking this medicine?
 If you have used this medicine, what did you consider to be the disadvantages?
Please provide your comments

5 Please provide any additional comments you would like the PBAC to
consider.

If you would like to upload a file for this medicine please do so below.

Please note we do not accept petitions, duplicate submissions from the same author,
form letters (multiple copies of the same statements of support for access),or any
material that is inappropriate in language or tone.

Please ensure your file is under 25mb in size. The preferred file types are PDF or
Microsoft Word, however other file types (for example .jpg, .png, .mp3, .mp4,etc) will
be accepted.

Recorded consultation input (video or audio) will be accepted by PBAC, provided the
input is no longer than 10 minutes in duration. If the files are larger than 25mb, please
email the recording file or a link to the recording file (hosted via another accessible
platform such as YouTube or Vimeo) and/or its transcript directly to
[email protected].

Recordings longer than 10 minutes may not be considered by the PBAC.

Should you have any difficulties submitting this form, or you would like to submit a
file(s) larger than 25mb, please contact [email protected].

6 If you have any suggestion on ways to improve this survey please provide
these below.
Declaration of interests

Declaration of Interest Statement

The purpose of this declaration is to discover any financial, professional or personal

interest on the part of a person, or on the part of their immediate family, who is
providing consumer input to the PBAC.

Information on declaration of interests

For example, a patient has an interest in a particular medicine, because they are
currently using it, and wish to see it listed on the PBS. A doctor may be providing
comments and has also been involved in clinical trials investigating this medicine. A
family member may want to provide comments on a particular medicine that another
relative is using, and separately may also have shares in the company which
manufactures a number of pharmaceutical drugs, including this specific item.
Such interests may affect or have the appearance of affecting a person’s view on the
merits of a drug, vaccine or medicinal preparation being considered by the PBAC. The
existence of such interests may be a ‘conflict of interest’.
A conflict of interest is declared so that information provided can be assessed fairly
and in a transparent manner. The declarations are confidential to the PBAC, and do
not prevent anyone from providing their comments.

A conflict of interest can be declared, but does not mean a person should not still
provide their comments.

A financial interest may include, but is not limited to, any of the following involvement
with companies or other organisations engaged in the development, manufacture,
marketing or distribution of vaccines, drugs and medicinal preparations:

1. current shareholdings;
2. board memberships or other offices;
3. paid employment or contracting work;
4. grants
5. hospitality (including conferences, travel).

A professional interest may include, but is not limited to, involvement in any of the
following:

1. development, manufacture or marketing and distribution of vaccines, drugs and

medicinal preparations;
2. making a public statement about that company or a drug or other product of
that company.

A personal interest may include, but is not limited to, any of the following:

1. where you are writing to support a drug being listed on the PBS, because you
have a condition or illness for which that drug may be being considered by the
PBAC;
2. an immediate family is aware that a relative close to them suffers from a
condition for which a drug before the PBAC may be being considered by the
PBAC;
 3. where you or your immediate family has strong personal or religious beliefs
about a drug or treatment under consideration by the PBAC.

Please include any declarations you wish to make regarding the PBAC submission
upon which you are commenting. (Required)
Please select all that apply

No conflicts
Financial conflicts (describe below)
Professional conflicts (describe below)
Personal conflicts (describe below)

Conflicts Explained: