Last Friday, 26 March, Painaustralia appeared before the House of Representatives Standing Committee on Health, Aged Care and Sport to give evidence into the Inquiry into Approval processes for new drugs and novel medical technologies in Australia.
My testimony at the Inquiry stressed the need for consumers to be at the centre of approval processes for new medicines and medical devices and that these are critical therapeutic options for people living with chronic pain.
Chronic pain is complex but access to safe and effective treatments are fundamental, particularly when there are a lack of affordable treatment options available. We need our approval system to be genuinely consumer-centred and take consumer experience into account.
Countries like the United States, Canada and the U.K. take a more systematic approach and use various methodologies when consulting consumers.
Health Technology Assessment International (HTAi) has established the international standard for how this consultation should be done. HTAi notes that ‘understanding the experiences of patients, their families and carers, is becoming widely recognised as an important component in any health technology assessment and further ‘it is now becoming standard practice for Health Technology Assessment bodies to request input during the assessment process.’
Patient-based evidence can provide insights into the symptoms, needs, perceptions, quality of life issues or experiences of the medicines or devices they are currently taking and fundamentally addresses what matters most to patients and where their greatest needs are. This enables decision-makers to balance consideration of just the cost of treating versus the likely health improvements.
When it comes to medicines approval in Australia, the body responsible is the Therapeutic Goods Administration (TGA) and for the subsidy of medicines, the Pharmaceutical Benefits Advisory Committee (PBAC) assesses whether medicines should be included the Pharmaceutical Benefits Scheme.
The PBAC has two consumer representatives who sit on the committee and they collate consumer feedback through an online web portal. However, without support from the organisations who represent those directly impacted like Painaustralia, consumers are often not aware of the processes for input or the potential impact and benefits of a medicine or device for their condition. Broader consumer input, particularly from patients with specific chronic pain or disease conditions who would benefit from the new medicine or device being considered, can provide insightful and valuable feedback for why it should be approved.
The value of consumer input into approval processes can be seen firsthand in Painaustralia’s recent experience in a listing process. Last year, we provided consumer input on the listing of belimumab for highly active autoantibody positive systemic lupus erythematosus (SLE), a debilitating chronic pain condition. We canvassed our consumer networks to provide input within the week we were given to consult.
PBAC acknowledged the clinical need for effective treatments for SLE, particularly for the group of patients who are not responding to current therapies.
Unfortunately, this consultation was limited in time and depth and the drug was not recommended for listing on the PBS, even though it was the only new therapy to be approved for this indication in 50 years.
While there may be good reasons for this, the lack of transparency in our PBS process and feedback leaves consumers disappointed and concerned their input is not being truly valued.
For the most part, Australia’s health system and approach in certain health areas is well ahead of other OECD countries. For example, Australia is the only country with a national strategy to address chronic pain and is working towards implementing a national action plan for chronic pain. We are still waiting for agreement from all state and territory governments and national funding for the strategies in the Plan.
However, if we are to have access to world class technologies and medicines, it is essential that our systems keep pace with the context in which these decisions are made and the experience of consumers who will directly benefit from these products. Developing a systematic way of consulting consumers throughout the regulatory process and ensuring that input is considered, valued and adopted in these decisions will result in enormous dividends to people living with chronic pain and other health conditions.