This tip sheet has been written to encourage patients and health consumers to start getting ready to provide input to PBAC well before a treatment is listed on the agenda. By starting early you’ll be better equipped to provide information that answers the questions that come up during a PBAC assessment. Some of the tips should also help if you are already within the six-week period leading to making a Consumer Comment or if you are preparing for a Consumer Hearing or Stakeholder Meeting. If you are active in an online patient community, you may also find the sheet for patient groups helpful.
Find out what medicines are in the pipeline. Soon more information will be available to Australians, but these ideas may help.
- Talk to your doctor or support group
- Australian New Zealand Clinical Trials Registry
- Australian Registry of Therapeutic Goods
- The websites of overseas regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will show you new medicines being approved for the US and Europe.
- If you can’t attend conferences and training days, look for opportunities to connect online or in your local community, including the Patient Voice Initiative facebook page.
Find out what information is wanted. It is essential that you understand that PBAC works by answering questions with specific information or evidence. So, a large number of Consumer Comments from patients stating they need the medicine will have no impact on the PBAC advice. Whereas one or two Consumer Comments containing specific information about why a medicine is important based on your experience, needs and preferences can impact PBAC advice. Knowledge of the way services are provided and treatments used in practice is also valuable.
Ask questions. It’s easy to misunderstand. A lot of people approach Consumer Comments the wrong way and so it’s easy to get the wrong idea.
- Contact the Consumer Engagement and Evidence Unit, email: HTAconsumerengagement@health.gov.au
- Take part in a Patient Voice Initiative workshop or Facebook event or discussion
- Talk to a PBAC Consumer Representative.
Identify what you know. That sounds a bit obvious, but sometimes we don’t realise how much we know from living with a condition. Because living with a condition is not just learning about the condition and treatments, it’s about learning how to live with the condition. PBAC already has all the trial data and economic models and information about your disease or condition and trial data about the medicine. What they don’t know is all the things you’ve learnt by living with a disease or condition.
- Use the questions on the Patient Voice Initiative PBAC preparation activity sheet to reflect on your experience.
- If you keep a journal, review it to see if it reminds you of insights to share with PBAC.
- Reflect on the issues you’ve sought help and advice with from your doctor, support groups, including online groups
- Keep notes or even a draft comment so that it is easier to submit a consumer comment regardless of your health when a medicine is on the PBAC agenda.
- Find out if your patient group is making a comment and if you can contribute in anyway.
Making a comment
When the medicine of interest is published on the PBAC agenda, note the date that your comment is due. It will be 6 weeks from the time the agenda is published.
Start ASAP so you don’t miss the deadline
Find out everything you can about the Sponsor’s (usually manufacturer or importer) Submission for the medicine. This may involve contacting the sponsor because the PBAC is restricted in what it can publish. You want to know under what conditions it is requesting the medicine is used, for example:
- what condition, stage and/or subgroup
- where and when in the treatment process
- what has the sponsor compared it to (the comparator)
- specific risks and benefits of the medicine
If you can’t use the online form, you can make your comment by letter and it may even be accepted by phone. Speak to the Consumer Evidence and Engagement Unit to find out.
Remember, what you have to say is more important than how you say it. Don’t be afraid to put in a comment because you don’t use technical language or don’t have perfect spelling and grammar. These things aren’t considered by the committee. You are an expert on living with your disease and even a short, well considered comment might contain something valuable to the committee.