2025 Highlights & Healthcare Policy Updates

✅HTA Framework Reform Implementation Challenges

Australia has been pursuing a major HTA Policy and Methods Review, with the Implementation Advisory Group issuing interim guidance in 2025. Reform implementation remains a priority, but progress has been gradual.

✅Cost-Effectiveness and Pricing Pressures

Pricing remains a central HTA issue:

🔹Sponsors have withdrawn applications e.g Pfizer’s abrocitinib and Eli Lilly’s lebrikizumab (Ebglyss for moderate-to-severe atopic dermatitis) due to perceived unsustainable pricing or risk-sharing requirements in HTA pricing arrangements

🔹High therapeutic value and invocative medicines recommended by the PBAC that remain unfunded on the PBS many months later, such as Heplcudex (bulevirtide) for Hepatitis D, Joenja (leniolisib) for activated phosphoinositide 3-kinase delta syndrome (APDS), and Tepezza (teprotumumab) for Thyroid Eye Disease

✅ Horizon Scanning

Medicines Australia’s submission to Treasury’s Economic Roundtable in July 2025 on key reform priorities. The overarching theme being the need to move beyond identifying innovations to building the structures, policies and processes required to deliver on 3 themes:

🔹Fit-for-purpose regulatory and reimbursement pathways for timely patient access

🔹The importance of a values framework and methods for health technology assessment

🔹System preparedness for personalised therapies

Our team actively participated in events locally and globally:

✴️ AusBiotech and Medicines Australia’s Women in Life Sciences Luncheon

✴️ AusMedtech 25 George Papadopoulos & Blaise Agresta led “Reimbursed & Ready Winning in the Australian Market” session

✴️ Sydney University Pharmacy School by Cicada Innovations. George returned to present on healthcare and market access strategy

✴️ ARCS Australia Annual Conference 2025

As well as hosting our stand, the team participated in the sessions:

🟢 Horizon Scanning and HTA: Past, Present and Future

🟢 Medicine Access: Innovation in Action to Drive Patient Access

🟢 Future Horizons: Professional Evolution

✴️ George Papadopoulos & Michael Aristides attended Medicines Australia’s Horizon Scanning, PharmAus 2025 and Neurological Alliance Australia’s National Action Plan Launch in Canberra

✴️ Medical Technology Association of Australia (MTAA) MedTech Conference 2025

✴️ ISPOR Europe 2025 – Michael Lees attended & we showcased our 12 abstracts with Skyward Analytics

You can view and download all 12 ISPOR Eurupe 2025 Abstracts HERE

News & Milestones

➡️ George Papadopoulos appointed to Oncothera Advocacy Board of Directors

➡️ Michael Lees joins our team

➡️ We marked a decade of Lucid Health Consulting! Founded by George Papadopoulos, Michael Aristides & Steve Crowley

Thanks to our team, clients and partners for your collaboration and support in 2025. Best wishes for the festive season and 2026 🎉

Partner with Lucid Health Consulting 

At Lucid Health Consulting, we have a proven track record of enabling companies and organisations to optimise the entry of their pharmaceuticals, biotech products, medical devices, and technologies into the Australian, New Zealand and Asia-Pacific markets.

Need support with market access or regulatory strategy in Australia, New Zealand or the APAC region?
Let’s connect. Lucid Health Consulting is ready to help you bring your pharmaceutical, medical device, or biotech product or technology, to market with confidence.

Contact and follow us to learn more about our Regulatory Affairs, Quality and Advocacy services.

🔹 www.lucidhealth.com.au

🔹 info@lucidhealthcon.com

🔹 Lucid Health Consulting on LinkedIn

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At Lucid Health Consulting, we understand that bringing a product to market in Australia involves more than meeting clinical milestones, it requires a strategic regulatory approach tailored to the Therapeutic Goods Administration (TGA) and regional compliance requirements.

Here we share our key insights and practical tips to help your company navigate the path to regulatory approval and achieve market success more smoothly.

1. Start with Regulatory Intelligence & Product Positioning

Understanding the regulatory expectations early in development can save time and prevent costly delays. At Lucid Health Consulting, we use real-time regulatory intelligence and a deep understanding of TGA and international standards to:

• Assess the best classification and pathway for your product
• Develop a tailored regulatory strategy aligned with market goals
• Position your product for efficient approval and stronger market adoption

2. Conduct a Regulatory Feasibility & Gap Analysis

Before advancing too far in development, it’s essential to identify any regulatory gaps that could impact your submission. However, our team can conduct detailed feasibility studies to:

• Evaluate your current documentation and evidence
• Identify missing data, regulatory hurdles or non-compliance risks
• Provide a strategic plan to address these gaps

Tip: Conducting a gap analysis early in development helps identify potential issues before they become costly problems. This proactive approach reduces rework, supports a stronger regulatory strategy, and increases the chances of a smooth, timely market entry.

3. Plan for TGA Pre-Submission Meetings

The TGA encourages pre-submission meetings, particularly for novel products or complex submissions. At Lucid Health Consulting, our exert Regulatory Affairs team helps your organisation to:

• Prepare a clear and concise briefing document
• Coordinate meeting logistics and timelines
• Formulate key questions and discussion points

4. Build a Clear Submission Roadmap

Navigating submission timelines, documentation requirements, and fees can be overwhelming. Our team creates structured roadmaps that include:

• A step-by-step plan for submission preparation
• Estimated timelines, resource needs, and fee schedules
• Strategies for proactive risk management

Tip: Treat regulatory planning like a project, assign owners, set milestones, and track progress to allow efficient resource allocation and proactive risk management.

5. Think Beyond Market Entry: Plan for Lifecycle Management Strategies

Approval is only the beginning. Accordingly, ongoing regulatory obligations, including post-market surveillance, change control, and compliance with evolving standards ideally should be planned in advance.

Lucid Health Consulting supports:

• Change management and variation filing strategies
• Ongoing risk and compliance monitoring
• Long-term regulatory maintenance and updates

By Incorporating lifecycle planning into your product strategy early on it will help to avoid compliance pitfalls down the line.

6. Leverage Regional Expertise for Asia-Pacific Expansion

Australia is often a strategic gateway to the broader Asia-Pacific region. As well, our team offers regulatory and quality support that extends beyond Australia, helping you build scalable strategies for regional growth. Our strategic partnership with Vista Health, headquartered in Singapore, enables us to combine both expertise and extensive regional network to deliver tailored advice, actionable insights, and seamless implementation, paving the way for your successful market entry across the Asia-Pacific region.

Partner with Lucid Health Consulting for Regulatory Confidence

The Regulatory, Quality, and Compliance team at Lucid Health Consulting, possesses in-depth knowledge of the complex regulatory environment in Australia as well as the Asia-Pacific region. With deep regulatory expertise, our team is adept at identifying, guiding, and fully supporting our clients through negotiations and formal appeals processes. We’re here to guide you, from early feasibility to post-market success.

Need support with your regulatory strategy in Australia, New Zealand or the APAC region?
Let’s connect. Lucid Health Consulting is ready to help you bring your pharmaceutical, medical device, or biotech product or technology, to market with confidence.

Contact and follow us to learn more about our Regulatory Affairs, Quality and Advocacy services.

🔹 www.lucidhealth.com.au

🔹 info@lucidhealthcon.com

🔹 Lucid Health Consulting on LinkedIn

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➡️ Medicines Australia’s Horizon Scanning: Medicines of Tomorrow

A gathering of patients, policymakers, researchers, regulators, and industry leaders, all united by a vision for an agile, equitable system that keeps patients at the centre.

As proud members of Medicines Australia, Lucid Health Consulting shares their vision to make the PBS stronger and more responsive to the needs of patients.

➡️ Medicines Australia’s PharmAus 2025

From Minister Mark Butler’s commitment to advancing HTA reform, to interactive exhibits that brought patient experience to life (VR disease simulations, postpartum haemorrhage demos, vision impairment goggles, and more) this event reminded us that innovation only matters if it improves lives.

➡️ Neurological Alliance Australia’s National Action Plan Launch.

The Blueprint for a National Action Plan for Neurological Conditions at Parliament House in Canberra.

The plan outlines how Australia could save $7 billion annually by implementing a national strategy for neurological conditions. Commissioned by the Neurological Alliance Australia (NAA) and developed by our team at Lucid Health Consulting, new economic modelling identifies significant opportunities to improve productivity, reduce preventable hospitalisations, and deliver more coordinated care across the health, disability and aged care systems.

This launch was a vital step toward coordinated, inclusive care as well as person-centred, data-driven policy. We are so proud to be part of this important guide for long-term national reform.

👉 View the Blueprint here: https://lnkd.in/gFgt3cWD

➡️ Rare Cancers Australia’s CanForum 25

A decade strong, this forum put rare cancer patients and families at the heart of the conversation, weaving personal stories with policy, genomics, and supportive care. A powerful reminder that empathy must sit alongside evidence in cancer care.

At Lucid Health Consulting, we know that real change in healthcare happens when diverse voices come together. Patients, policymakers, researchers, and industry, to turn ideas into action. With over 75 years of combined experience, our leadership team is supported by specialists across health economics, regulatory affairs, reimbursement, HTA, market and patient access, and statistics.

EMAIL: info@lucidhealthcon.com

PHONE: + 61 2 8964 9600

Follow us on LinkedIn HERE

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Our research spans a diverse range of timely topics, and we look forward to contributing fresh insights to this year’s discussions.

📍 Glasgow, UK | 9–12 November 2025
ISPOR Europe is a must-attend event for healthcare stakeholders, bringing together researchers, academicians, regulators, payers, policy makers, industry leaders, providers, and patient organisations.

This year’s conference theme, “Powering Value and Access Through Patient-Centered Collaboration,” highlights the importance of building strong partnerships across the healthcare ecosystem to accelerate patient-focused decision-making on value and access.

Over the coming weeks, we’ll be sharing more details about our abstracts, presenters, and attendees. If you’re heading to ISPOR Europe, please reach out via our email info@lucidhealthcon.com

👉 Learn more about ISPOR Europe 2025 and explore the full program here: ISPOR Europe 2025

EMAIL: info@lucidhealthcon.com

PHONE: + 61 2 8964 9600

Follow us on LinkedIn HERE

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Horizon Scanning is a systematic approach to identifying early signals of emerging health technologies, trends, and disruptions. In healthcare, it plays a vital role in managing risk, supporting early planning for costs, infrastructure, workforce needs, and patient access before new technologies reach the system.

In Australia, many stakeholders have called for the re-establishment of a national Horizon Scanning system. However, to date, there has been a lack of consensus on the purpose(s) for horizon scanning.

At the 2025 ARCS Australia Annual Conference, our Director George Papadopoulos joined Orin Chisholm and Franz Pichler to present the session: Horizon Scanning and HTA – Past, Present and Future. This thought-provoking discussion explored the evolving role of Horizon Scanning in supporting Health Technology Assessment (HTA). As well as how it can adapt to meet the goals of Australia’s HTA Reform.

📄 Download the full presentation via the RESOURCES page on our website HERE

This presentation outlines how Horizon Scanning can evolve to address current limitations, and why a structured, forward-looking approach is essential to align innovation pipelines with patient needs.

Additionally, the Horizon Scanning and HTA – Past, Present and Future session was highlighted by Megan Brodie and MedNews Aust/NZ for its relevance and timeliness.

🔜 What’s next?

George Papadopoulos will continue contributing to this vital conversation as a participant in the Horizon Scanning: Medicines of Tomorrow Forum. Presented by Medicines Australia in partnership with the Australian Government Department of Health, Disability and Ageing.

The event will take place at Parliament House, Canberra, on Wednesday, 3 September 2025.

This national forum brings together key stakeholders across government, industry, and patient advocacy. To spotlight emerging and disruptive technologies that are likely to shape Australia’s health landscape over the next decade and that require planning today.

The event provides a critical platform to:

🔷 Showcase major therapeutic advances approaching regulatory or reimbursement systems

🔷 Highlight potential disruptions to existing treatment paradigms

🔷 Explore what’s needed in terms of system readiness, resource planning, and health infrastructure adaptation

Importantly, the forum will also address the policy implications of these innovations and the importance of early coordination to ensure that health systems and patients are prepared for the future.

The 2025 Horizon Scanning program will be announced in July and Medicines Australia Members and invited guests will be invited to register. For more information including registration details, email events@medicinesaustralia.com.au

🎉 We also extend our congratulations to the Australian Health Innovation Observatory on securing significant funding to establish a nationally coordinated horizon scanning capability. Congratulations as well to Dr Orin Chisholm from the University of Sydney, who will lead efforts to identify emerging medical and health technologies in Australia. Supporting the key priorities of both Commonwealth and state government decision makers and aiming to reduce patient delays in accessing new health technologies. Also, congratulations to George’s ARCS 2025 co-presenter, Franz Pilcher who is also part of the delivery team.

Stay tuned as we share more updates on this critical conversation shaping the future of healthcare in Australia.

At Lucid Health Consulting we provide expert advice in market access, health economics, pricing & reimbursement and regulatory affairs in Australia, New Zealand and the Asia Pacific region.

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How do health technology assessment (HTA) processes differ between Singapore and Australia and what are the strategic implications for those working across both markets?

In this piece, together with our Asia-Pacific partner, Vista Health, we unpack the core principles, key differences, and regulatory considerations that matter most to stakeholders navigating the HTA landscape.

Access the full analysis and explore more expert insights, on our Publications website page HERE

Have questions or want to discuss the findings? Send us an email or reach out to our team of market access, health economics, pricing & reimbursement and regulatory affairs experts anytime.

EMAIL: info@lucidhealthcon.com

For more insights and updates, follow us on LinkedIn

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The AusMedtech Annual Conference is Australia’s premier event for the medical technology industry, bringing together visionary leaders, innovators, and changemakers to shape the future of healthcare. This year’s theme, “Innovation to Impact,” highlights how medtech innovation translates into real-world, life-changing outcomes.

In today’s rapidly evolving health landscape, medtech stands at the forefront of breakthroughs that save lives, enhance quality of care, and drive economic growth. The medtech conference invites stakeholders to reflect on how we can collectively address unmet medical needs, reduce healthcare disparities, and ensure equitable access to the benefits of innovation.

AusMedtech 2025 is more than a celebration of progress, it’s a platform for action, connection, and collaboration.

👥 Join us for our “Reimbursed & Ready – Winning in the Australian Market” workshop, part of the pre-conference activities at AusMedtech 25. Led by our Director, George Papadopoulos, and Reimbursement & HTA Lead, Blaise Agresta, this session will provide attendees with a practical understanding of Australia’s healthcare system, including key pathways, influential decision-making and effective strategies for reimbursement success.

George and Blaise will be at the conference too and are looking forward to catching up with delegates and sharing how Lucid Health Consulting helps clients navigate reimbursement pathways and unlock market access across Australia, New Zealand, and the Asia-Pacific.

🔗 Find out more and register here: AusMedtech 2025

We look forward to seeing you there!

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🌟 2024 Highlights

 Healthcare Policy Updates

📌 The HTA Review Report was released in May, featuring 50 recommendations to improve equity, streamline processes, and enhance access to new technologies, including:

• Equitable access for under-represented patient groups.
• Streamlined pathways for timely technology adoption.
• Enhanced real-world data for informed HTA decisions.

📌 New HTA Committee Appointments:

• PBAC Chair: Professor Robyn Ward AM from 5 May 2024.
• MSAC: Professor Jonathan Craig as the Chair of MSAC from 1 April 2024, Professor Kwun Fong as Co-Deputy Chair of MSAC from 1 April 2024 and Associate Professor Sarah Norris as Co-Deputy Chair of MSAC from 1 July 2024.

📌 Horizon Scanning Forum 2024

• Continuing with the theme of the first Horizon Scanning Forum held in 2022 four therapeutic areas where innovative new classes of medicines and treatments stand to disrupt treatment paradigms in Australia and require innovation in system planning were presented and discussed. These were:
  • • Cell and gene therapies,
    • Vaccine technology for infectious diseases,
    • Novel antimicrobials
    • Digital health

Industry Engagement – Lucid Health Consulting team

Our team actively participated in leading events locally and globally, such as:

• AusBiotech’s International Women’s Day Luncheon
• 2024PTA-C, the inaugural Pathology Technology Australia Congress
• The Medicines of Tomorrow: Horizon Scanning Forum 2024
• ISPOR Global (Atlanta) and Europe (Barcelona)
• ARCS 2024 Annual Conference, including sponsoring the inaugural CEO Breakfast as well as hosting a booth in the exhibition hall
• The HTA Roadmap – Ideal Outcomes and Reforms workshop
• ISPOR Australia Chapter, Real-World Evidence and HTA Reform Workshop
• AusBiotech 2024, the premier event for Australia’s life sciences community
• Hosted two interns from the USA as part of the nonprofit study abroad and intercultural exchange organization CIEE.

In the News

We were honoured to help our client Tryptamine Therapeutics Limited (ASX:TYP) on the registration and reimbursement strategy for their treatment, TRP-8803 (IV-infused psilocin) globally.

Insights and Research

• Our Director Steve Crowley presented at the Asia-Pacific Value-Based Contracting Webinar Series on transparency in Managed Access Programs.

• Our Director George Papadopoulos, returned to run a session on Healthcare and Market Access Strategy at the CICADA Training Program.

• Our Director George Papadopoulos joined a panel discussing reimbursement in MedTech healthcare and the need for Australia’s HTA system to evolve in response to global trends, at AusMedtech 2024.

• Our Director Michael Aristides co-authored a joint abstract on “The cost-effectiveness of axicabtagene ciloleucel versus standard of care as second-line therapy in patients with large B-cell lymphoma in Australia.”

 Looking Ahead to 2025, Upcoming Industry Events

• AusMedTech 2025: 7–8 May, ICC, Sydney. Find out more HERE
• ISPOR Global 2025: 13–16 May, Montreal, Canada. Find out more HERE
• ARCS Annual Conference: 3–5 June, ICC, Sydney. Find out more HERE
• ISPOR Europe 2025: 9–12 November, Glasgow, Scotland. Find out more HERE
• Medicines Australia: PharmAus 2025, September 2025, Canberra.

Our Online Tools, Resources and Publications

Explore our tools via our website RESOURCES page. See our 🛠️ PBS Price Calculator | MAOSS Database | easySLR | PBS Calendar (launching soon!)

Missed our 10th Annual Drugs and Devices Australia Reimbursement Update Webinar? The recorded session is available here.

We deeply appreciate your trust and collaboration throughout 2024. Here’s to another year of innovation, progress, and partnership in 2025.

The Lucid Health Consulting Team

Providing expert advice in health economics, pricing a& reimbursement, market access and regulatory affairs in Australia and the Asia-Pacific. At Lucid Health Consulting, we have a proven track record of enabling companies and organisations to optimise the entry of their pharmaceuticals, biotech products, medical devices, and technologies into the Australian market. We understand that getting your products, devices and technologies, successfully into the Australian market matters. That getting the right price for your reimbursements matters. It matters to the patients who need your life-altering products or services at a reasonable price, and it matters to keep your business thriving.

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📽 Missed the webinar?  You can catch the full webinar replay and access a PDF copy of our Drugs & Devices Australia, Reimbursement Update 2024 slide deck via our VIDEOs page on our website HERE

We invite you to join our Director George Papadopulos and MedTechnique Consulting’s Director, Sarah Griffin for their much-anticipated webinar on the latest developments in reimbursement strategies for the Australian market.

📅 When: 28 November, 8:30am AEST and 27 November 2024, 1:30pm PST.

During this session, George and Sarah will share valuable insights on navigating the complex landscape of drug and device reimbursement applications. Together, they will review the key trends from the past year and address your questions live during the webinar.

Why Attend?

✳ Stay up-to-date on the latest changes in Australia’s reimbursement policies
✳ Get a comprehensive overview of the Australian Healthcare Landscape in 2024
✳ Ask questions and get answers from industry leaders

This webinar is eagerly anticipated, don’t miss your chance to attend this informative session. Register Now by clicking here to register 🔗 REGISTER FOR THE 10TH ANNUAL DRUGS & DEVICES 2024 WEBINAR HERE

Upon registration, you’ll receive a confirmation email with details on how to join the webinar.

We look forward to sharing our expertise, reflecting on the past year, and engaging with you during our 10th Annual Drugs & Devices Australia Reimbursement Update.

ABOUT THE SPEAKERS

George Papadopoulos, Director at Lucid Health Consulting.

George is a healthcare pricing and reimbursement professional with over 30 years’ experience across in local and international healthcare companies.  George worked in both local operating company and global levels in increasing levels of responsibility for leading pharmaceutical companies in Australia, Belgium and the United States.

Connect with George Papadopoulos on LinkedIn

Sarah Griffin, Director at MedTechnique Consulting 

Sarah is Founder and Director at MedTechnique Consulting. She is an experienced health economist, reimbursement strategist, health policy advocate and speaker. Connect with Sarah Griffin on LinkedIn.

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