According to Dr Colman Taylor and Alasdair Godfrey from Health Technology Analysts, in designing a technology funding system for the future, pressure points on our two main pathways must be identified and relieved to ensure sustainable and equitable access.
The Medical Services Advisory Committee (MSAC) presents a unique challenge for sponsors and the government. The committee is compelled to make decisions regarding diverse technologies based on a complex but generic process.
The MSAC process has had to demonstrate more adaptability in the evaluation of CAR-T therapies, whole genome sequencing, blood products, prognostic tests, co-dependent technologies and therapeutic technologies.
There is a real question over whether this is practical and sustainable.
What is the process?
The MSAC process is complex.
It includes the development of a submission framework (PICO confirmation) followed by the evaluation of a full submission. This process has been designed based on the evidence requirements for new medicines evaluated through the Pharmaceutical Benefits Advisory Committee (PBAC).
The shortest possible timeframe to get through the MSAC process is approximately 18 months.
The success rate for submissions is low. This leads to submission churn and long pre-funding timelines. Meanwhile, patients either pay out-of-pocket or simply wait to access the potentially beneficial services and innovative technologies under consideration.
Who is missing out?
It has a broad remit but a plethora of new technologies do not qualify for assessment by MSAC. These include clinical decision support tools, healthcare programs and interventions delivered by healthcare professionals without a Medicare provider number.
The continuing progress of Artificial Intelligence, internet connected devices, ‘digipeutics’, telehealth and blockchain, just to name a few, is only going to add pressure on the MSAC process and the entire healthcare system.
It should also be remembered that MSAC is a non-statutory committee – unlike the PBAC, its role and decision-making is not covered by a legislative framework. As a result, there can be some uncertainty about the outcome of decisions, especially where hospitals or other bodies such as the National Blood Authority are involved.
In contrast to MSAC, the pressure points on the PBAC process are nothing new – most relate to providing timely access to new medicines and vaccines.
Yet there has been an undeniable shift in the types of medicines it considers
The changing nature of medicine
In the past small molecule chemical drugs, such as cholesterol-lowering statins, were developed to service large patient populations. These drugs could be easily genericised leading to price erosion and savings to fund new drugs.
Biologic medicines are increasingly developed from living organisms. These are more challenging to copy and this means the savings generated for government will struggle to match that seen with generics.
Biologic medicines generally interfere with specific genotypes, receptor molecules or signalling pathways targeting smaller patient populations.
In practice, this means two patients with a similar disease like lung cancer could have access to different medicines, based on their genetic profile. This creates ‘rare’ underserviced populations within diseases. These populations may have been previously serviced with less efficacious but easily applied therapies.
Ironically, the number of ‘rare’ diseases will grow as technology advances and treatments become more targeted.
The increasingly empowered patient voice
Information has never been more accessible for patients. They are more informed about treatment options, in Australia and overseas, and are demanding access.
The PBAC guidelines were updated in 2016 but the essential elements of the process with respect to patient input have remained largely unchanged.
As a consequence, patients and decision makers face an uneven playing field depending on the strength and connections of patient organisations – equity of access. Meanwhile, reimbursement decisions remain unclear to the general public.
What about the future?
For both systems, MSAC and PBAC, the key challenge remains improving timely access to innovative medicines and technologies without creating inequality.
A key question relates to whether the two reimbursement systems and ‘gatekeeper’ committees are sufficient to evaluate increasingly complex and diverse health technologies. Additional pathways may be required. Yet how this would work is uncertain, especially without a new legislative framework.
There is a bipartisan political commitment to a review of the National Medicines Policy. This review cannot focus on medicines alone. Ensuring Australia’s technology funding systems can accommodate all technologies in a consistent and equitable way means the review must look beyond an out-dated concept of medicines to the range of new health technologies.