Online Comments to the Pharmaceutical Benefits Advisory Committee (PBAC)

You are welcome to provide comments from a personal or group perspective for consideration by the PBAC when the submission is considered.

Page last updated: 27 April 2018

IMPORTANT: The PBAC operates to a fixed timetable and information received late cannot be considered.

Before completing this form please read the general information sheet.

Comments to the Pharmaceutical Benefits Advisory Committee (PBAC)

Indication
Non-premenopausal, hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer
Familial hypercholesterolaemia and clinical atherosclerotic cardiovascular disease;
Acute coronary syndrome and concomitant diabetes mellitus
Non-small cell lung cancer (NSCLC)
Unrestricted benefit
(for treatment of infections due to penicillin-sensitive micro-organisms)
Glioblastoma multiforme/Grade IV glioma (GBM)
Acute lymphoblastic leukaemia (ALL)
Focal spasticity of the lower limb
Crohn disease
Mild to moderate Crohn disease
Opiate dependence
Opiate dependence
Clear cell variant renal cell carcinoma (RCC)
Hyperphosphataemia
Severe chronic plaque psoriasis
Spasticity of the upper limb
Melanoma
Multiple myeloma
Chemotherapy-induced anaemia
Prophylaxis against venous thromboembolism (VTE)
Chronic migraine
Type 2 diabetes mellitus (T2DM)
Chronic Obstructive Pulmonary Disease (COPD)
Crohn's disease
Fistulating Crohn's disease
Ulcerative colitis
Ankylosing spondylitis
Psoriatic arthritis
Chronic plaque psoriasis
Type 2 diabetes mellitus (T2DM)
Cystic fibrosis (CF)
Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NETs)
Multiple myeloma – extend listing to include maintenance treatment
Multiple myeloma – amend current Authority Required (written) listing to Authority Required (STREAMLINED)
Prophylaxis of cytomegalovirus (CMV) infection or disease
Contraception
Chronic breathlessness
Known or suspected oiate overdose
Human epidermal growth factor receptor-2 positive (HER2+) early breast cancer (EBC)
Melanoma
Unresectable Stage III or Stage IV malignant melanoma
Melanoma
Vitreomacular traction syndrome (VTS)
Soft tissue sarcoma
Stage IV (metastatic) adenocarcinoma of the pancreas
Metastatic breast cancer
HER2 positive breast cancer
Acromegaly
Metastatic colorectal carcinoma (CRC)
Human epidermal growth factor receptor-2 positive (HER2+) early breast cancer (EBC)
Influenza
CD20 positive B-cell non-Hodgkin lymphoma
Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD)
Hyperphosphataemia
Urea cycle disorders (UCD)
Short Bowel Syndrome (SBS)
Cystic fibrosis (CF)
Chronic obstructive pulmonary disease (COPD)
Chronic obstructive pulmonary disease (COPD)
Systemic juvenile idiopathic arthritis
Giant Cell Arteritis
Ulcerative Colitis (UC)
HER2 positive breast cancer
HER2 positive breast cancer
Dietary management of conditions requiring a source of medium chain triglycerides

Below is a section to provide your contact details. These details are not made public or shared with the Committee. Your confidentiality and privacy are protected by the Departmental Officers collating the material. We ask for these individual details only to ensure submissions are recorded accurately and can be confirmed, if required.

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 Pharmaceutical Benefits Advisory Committee (PBAC).

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 Committee, and do not prevent anyone from still providing their comments as they to submit.

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 for overseas travel or conference expenses;
  5. significant hospitality.

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.

  • How does this condition/disease affect quality of life?
  • What would you most like to see from this treatment? Improved side effects? Slowing disease progression? More mobility? Other benefits?
  • If you have used or prescribed this new medicine, what was your experience of the beneficial effects?
  • If you have used or prescribed this new medicine, what side effects or toxicities did you experience or observe?
  • If you haven't used the new medicine yet, what are your expectations of it?
  • If you use other currently available therapies or medicines you use to manage your condition (or for prescribers, for your patient’s condition), what are the benefits and/ or the challenges?
  • Where did you obtain the information that helped form your views on this treatment?
    • I have been a patient on this medicine;
    • Your doctor;
    • Other patients stories/experiences
    • Professional colleagues;
    • Support networks;
    • Own research;
    • Other patient resources;
    • Direct experience as a health professional or carer;
    • Other – please provide details.

Thank you for your time and participation in this process.

*Agree to terms and conditions

The Department may use this information to verify that any individual or organisation is bonafide or if any comments need clarification. Personal information collected by the Department will not be provided to any other organisation or used for any other purpose. The personal information of individuals will be de-identified before comments are considered by the PBAC.

Disclaimer: The comments contained in this document are not those of the Department, the sponsor company or the PBAC and are the responsibility of the individual or group, making the submission.

If you have problems submitting this form please contact the PBAC Secretariat (CommentsPBAC@health.gov.au). If you are submitting a hardcopy of this form please mail to: PBAC Secretariat – MDP 952, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601 or fax to (02) 6289 4175.