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: 09 September 2021

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

The Consumer comments portal is open for comments for the November 2021 PBAC agenda

Before completing this form please read the general information sheet.

Comments to the Pharmaceutical Benefits Advisory Committee (PBAC)

Indication
Atopic dermatitis
Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
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.
Severe Crohn disease;
Moderate to severe ulcerative colitis.
Lambert-Eaton myasthenic syndrome
Metastatic hormone-sensitive prostate cancer who have low-volume disease, or who have high-volume disease and are too frail for chemotherapy.
Castration-resistant prostate cancer with no distant metastases on conventional imaging
Pompe disease
Relapsed or recurrent glioblastoma
Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Advanced carcinoma of cervix
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Metastatic colorectal cancer
Eosinophilic Oesophagitis (EoE)
Opioid dependence
Human Immunodeficiency virus (HIV)
Non-small cell lung cancer (NSCLC)
Squamous cell carcinoma (SCC)
Multiple sclerosis
Amyloid light-chain (AL) amyloidosis
Neuromyelitis optica spectrum disorder (NMOSD)
Chronic heart failure
Gyrate atrophy of the choroid and retina;
Urea cycle disorders
Rheumatoid arthritis;
Plaque psoriasis;
Ankylosing spondylitis;
Psoriatic arthritis;
Juvenile idiopathic arthritis;
Paediatric plaque psoriasis.
Severe asthma
Assisted reproductive technology
Acute myeloid leukaemia (AML)
Acute myeloid leukaemia (AML)
Chronic myeloid leukaemia (CML);
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL);
Myelodysplastic or myeloproliferative disorder (MDS/MPD);
Aggressive systemic mastocytosis (ASM) with eosinophilia;
Chronic eosinophilic leukaemia (CEL) or Hypereosinophilic syndrome (HES);
Dermatofibrosarcoma protuberans (DFSP);
Gastrointestinal stromal tumour (GIST);
Malignant GIST.
Diabetes mellitus
Non radiographic axial spondyloarthritis (nr-axSpA)
Solid tumours harbouring neurotrophic
receptor tyrosine kinase (NTRK) gene
fusions
Primary insulin-like growth factor 1 deficiency (Primary IGFD)
Chronic rhinosinusitis with nasal polyps
Non-HER-2-positive gastric cancer, gastroesophageal junction cancer or oesophageal adenocarcinoma
Prostate cancer
Uncontrolled severe asthma
Severe chronic spontaneous urticaria
Uncontrolled severe allergic asthma
Squamous cell carcinoma of the head and neck (SCCHN)
Oesophageal carcinoma or HER-2-negative gastroesophageal adenocarcinoma
Prevention of pneumococcal disease
Severe dry eye syndrome
Neuropathic pain
neuropathic pain
Prevention of preterm birth
Colorectal cancer
severe chronic plaque psoriasis
Non-Hodgkin’s lymphoma (NHL)
Chronic lymphocytic leukaemia (CLL)
Rheumatoid arthritis (RA)
Granulomatosis with polyangiitis (Wegener’s granulomatosis) (GPA)
Microscopic polyangiitis (MPA)
Breast cancer
Paediatric psoriasis
Idiopathic multicentric Castleman’s disease (iMCD)
Non-small cell lung cancer (NSCLC)
Metastatic (Stage IV) HER2 positive breast
Metastatic (Stage IV) HER2 positive
adenocarcinoma of the stomach or gastrooesophageal
junction
Early HER2 positive breast cancer
Wilson disease
Wilson disease

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 mailto:CommentsPBAC@health.gov.au">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.

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