This tip sheet has been written to encourage patient groups 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 address gaps and uncertainties and add value to the PBAC assessment. Some of the tips should also help if you are working within the six-week period leading to making a Consumer Comment or if you are preparing for a Consumer Hearing or Stakeholder Meeting.
Find out what medicines are in the pipeline. Soon more information will be available to Australians, but these ideas may help.
- 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.
- Patient groups like yours overseas may have access to information, however there may be important differences in the Australian market
- Networking. If you can’t attend conferences and training days, look for opportunities to connect online or in your local community.
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 knowledge of patients’ experiences, 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. Remember, PBAC already has all the trial data and economic models and information about your disease or condition. What they don’t know is all the things you’ve learnt by living with it. You can look at:
- Themes found in patient correspondence, social media, information requests, existing reports and logs of patient phone calls
- Existing patient data from past surveys or registries
- Relevant reports and work by other patient groups or research into patient aspects. Remember patient groups like yours may be preparing material to make submissions in their own jurisdictions. For example, similar processes are used in English-speaking countries like Canada, England and Scotland and patient groups there may be worth contacting. Some patient groups publish their own version of a Consumer Comment on their websites.
Identify what you don’t know
- Identify where you don’t have information about key needs, preferences and experiences of the patients you represent. Consider if there is something different about the new medicine which creates an uncertainty about patient preferences.
- Consider the time and resources you have, but also if you need information for several PBAC Consumer Comments because you know several medicines are in the pipeline.
- Work out a plan for how you will collect this information. You could approach a research institute to discuss a collaborative research project, approach a professional research for advice or collect information yourself. If collecting information yourself, you might find the HTAi guide for collecting and reporting information for patient group submissions or its guide to ethical considerations useful.
- Check that you’re on the right track by talking to a PBAC consumer representative, the Consumer Evidence and Engagement Unit or the Patient Voice Initiative
determine if you need additional information to complete the submission
identify what information you will collect
decide who you want information from
select a method to recruit participants
decide on a method to collect information
summarise and report the information you have collected
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, while it is helpful for decision makers to have the best information, a short, well-constructed comment is better than not making a submission at all! Decision makers are looking for helpful information, not perfection.