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
Severe active rheumatoid arthritis; Severe psoriatic arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis, Severe active juvenile idiopathic arthritis, Severe Crohn's disease; Refractory fistulating Crohn's disease; Moderate to severe ulcerative colitis; Moderate to severe hidradenitis suppurativa
Severe active rheumatoid arthritis; Severe psoriatic arthritis; Ankylosing spondylitis; Severe chronic plaque psoriasis, Severe active juvenile idiopathic arthritis, Severe Crohn's disease; Refractory fistulating Crohn's disease; Moderate to severe ulcerative colitis; Moderate to severe hidradenitis suppurativa
Severe active rheumatoid arthritis (RA)
Parkinson disease
Schizophrenia
Metastatic merkel cell carcinoma
Prevention of recurrent clostridium difficile infection (rCDI)
Acute lymphoblastic leukaemia (ALL)
Refractory or relapsed CD30 positive cutaneous T-cell lymphomas (CTCL)
Mild to moderate Crohn's disease
Severe dry eye syndrome
Neuronal ceroid lipofuscinosis type 2 (CLN2) disease (also known as tripeptidyl peptidase 1 deficiency)
Relapsing remitting multiple sclerosis (RRMS)
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) with a ROS1 gene rearrangement confirmed by fluorescent in situ hybridisation (FISH) testing
Chronic iron overload
Multiple myeloma (MM)
Human immunodeficiency virus (HIV) infection
Severe atopic dermatitis
Chronic migraine
Type 2 diabetes mellitus (T2DM)
Type 2 diabetes mellitus (T2DM)
Type 2 diabetes mellitus (T2DM)
Type 2 diabetes mellitus (T2DM)
Type 2 diabetes mellitus (T2DM)
Hypercholesterolaemia with symptomatic atherosclerotic cardiovascular disease (ASCVD) who do not have underlying familial hypercholesterolaemia
Iron deficiency anaemia
Active non-radiographic axial spondyloarthritis (nr-axSpA)
Attention defecit hyperactivity disorder (ADHD)
Severe chronic plaque psoriasis
Unrestricted (indicated for diabetes mellitus)
Severe active psoriatic arthritis
Unresectable hepatocellular carcinoma
Locally advanced or metastatic differentiated thyroid cancer
Prophylaxis of cytomegalovirus (CMV) infection or disease
Primary systemic carnitine deficiency; Secondary deficiency in patients with inborn errors of metabolism
Cystic fibrosis (6-11 years)
Cystic fibrosis (12 + years)
Meningococcal disease
Ulcerative colitis; Crohn's disease
Severe active rheumatoid arthritis; Severe psoriasis
Acute myeloid leukaemia (AML)
Malignant melanoma
Malignant melanoma
Renal cell carcinoma (RCC)
Chronic lymphocytic leukaemia (CLL)
Functional carcinoid tumour; acromegaly; Vasovactive intestinal peptide secreting tumour (VIPoma)
Locally advanced (Stage IIIB) or metastatic (Stage IV) epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC)
Chemotherapy-induced neutropenia
Squamous cell carcinoma for the head and neck (SCCHN)
Locally advanced or metastatic urothelial cancer (LA or mUC)
First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)
Human epidermal growth factor receptor-2 positive (HER2+) early breast cancer (EBC)
Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma; Severe active granulomatosis with polyangitis (Wegener's granulomatosis); Severe active microscopic polyangitis; Previously untreated or relapsed/refractory CD20 positive lymphoid cancer; Previously untreated or relapsed/refractory CD20 positive acute lymphoblastic leukaemia; Severe active rheumatoid arthritis
Growth disturbance due to insufficient secretion of pituitary growth hormone, or growth disturbance associated with gonadal dysgenesis (Turner syndrome) or chronic renal insufficiency
Short Bowel Syndrome (SBS)
Severe chronic plaque psoriasis
Severe active rheumatoid arthritis
Autosomal dominant polycystic kidney disease (ADPKD)
Metastatic colorectal cancer
Chylous ascites; Chylothorax; Hyperlipoproteinanaemia Type I; Long chain fatty acid oxidation disorders
Prevention of seasonal influenza

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.