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News & Trends - Pharmaceuticals

Leaders from Lilly, Roche, Bayer voice access roadblocks to novel medicines at Inquiry hearing

Health Industry Hub | May 10, 2021 |
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Pharma News: A third day of public hearings in Sydney was held on Friday as part of the Health, Aged Care and Sport Committee’s ongoing inquiry into approval processes for new drugs and novel medical technologies in Australia.

The Chair of the Committee, Mr Trent Zimmerman MP, noted that “the inquiry has received a lot of interest with more than 185 submissions to date.

“The Committee is interested in hearing about new innovative drugs and novel therapies that are being developed in Australia and overseas. The repurposing of drugs to treat new conditions will also be discussed. Two other important aspects to be reviewed include making the approvals process for new drugs and novel medical technologies more efficient, and consideration as to how Australia could be a more attractive location for clinical trials,” Mr Zimmerman said.

Leaders from Lilly, Roche and Bayer voiced the key access roadblocks to novel medicines including the challenges of navigating the approval and reimbursement processes of new therapies that pan across the Pharmaceutical Benefits Advisory Committee (PBAC) and Medical Services Advisory Committee (MSAC) jurisdictions.

Benjamin Basil, President and General Manager Australia, New Zealand and North Asia-Pacific, at Eli Lilly said “It’s critical that the value of investing in innovative medicines is recognised, and certainly investment in the PBS needs to keep pace so that patients benefit.

“If we had a framework that allowed us to present broader data about the value of our medicines, including productivity gains and the ability to work, and if this data would be recognised and have a meaningful impact on the decision-making process, we could have a more constructive conversation about the value of such medicines. Instead, because the payer systems have been rigid and don’t currently apply the value of the socio-economic benefits, we have a narrower assessment of value as is the case with our migraine product Emgality. This has been a very arduous and restrictive process which makes it very difficult to find a viable solution.

“On top of access, I wanted to add Lilly’s concern regarding the National Health Amendment (Pharmaceutical Benefits Transparency and Cost Recovery) Bill 2021. Because of the lack of safeguards, the Bill will likely have unintended consequences of further delays in the submission of new medicines in Australia until commercial information is deemed completely internationally safe for the corporations. In some cases, it can even be worse in terms of the potential to bring that innovative medicine to Australians. Of particular concern would be the negative impact to special negotiated prices. I’m concerned this Amendment when combined with the international price referencing news could have a significantly negative impact on Australians,” said Mr Basil.

Stuart Knight, General Manager of Roche Products represented the three parts of the Roche business operating in Australia; diagnostics, pharmaceuticals and diabetes care.

Mr Knight opened with commentary on personalised healthcare. “Everyone in this room is unique. However, our health system, typically treats people with similar medical conditions with a one size fits all approach.

“While treatment approaches have progressed, our systems to evaluate these innovations have not. This is leading to delays. Australia’s HTA processes need to evolve and become more flexible to allow the full benefits of a personalised healthcare approach.

“In our portfolio we have a new combination ophthalmology treatment that brings together a medicine, a device and a healthcare application. The port delivery service which is about the size of a grain of rice delivers the medication to the eye over a six-month period, and the application measures the visual acuity of the patient thereby reducing the need for specialist visits.

“This combination of three co-dependent technologies under our present system will have to be evaluated by MSAC, PBAC and the Prosthesis List Advisory Committee. Currently there is no way for us to know how we navigate the system.”

Mr Knight proposed the development of a 10-year personalised healthcare strategic plan with clear actions that aim to build greater flexibility into the systems and overseen by a dedicated section in the Department of Health. He also proposed the development of a single point of entry model that considers all health innovations, and that provides clear guidance on a way forward for approvals and reimbursement.

Ashraf Al-Ouf, General Manager of Bayer Australia said “There is a significant opportunity to improve the system to make novel medicines available faster. In oncology, Australia is almost 10 times slower than countries like Germany, Austria and Denmark in the process timelines between registration and reimbursement.

“Health technology assessment of emerging therapies such as precision medicine is complex and relies on co-dependent submission pathways between PBAC and MSAC.

“Our system tends to assist patients by cancer type rather than by specific gene mutation. This current approach does not support companies looking to bring innovative precision medicines to market, with a need for genomic testing.

“Citizens in many countries in the developed world – UK, US Belgium, Denmark, France, Germany, Netherlands – have superior access to genomic testing.

Mr Al-Ouf concluded “Our recommendations would be to reduce delays by ensuring consistency of pre-submission advice and cost efficiency benchmarks jointly across TGA, PBAC and MSAC, enable universal access to genomic testing, and develop a 5–10-year strategic plan through broad stakeholder review for new parameters of evaluating medicine and medicines value.”


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