Australia has one of the worldโs strongest publicly funded medicine reimbursement systems. The Pharmaceutical Benefits Scheme (PBS) has been central to equitable access for decades, reducing the financial burden of medicines for millions of Australians. But for a growing number of patients, the path to treatment is no longer straightforward.
Scientific innovation is changing the shape of medicine access. Precision therapies, orphan medicines, oncology treatments and highly targeted interventions are increasingly designed for smaller, more specific patient populations. At the same time, regulatory approval, reimbursement assessment, commercial launch sequencing and local health system readiness do not always move at the same pace as patients need.
The result is a widening access gap.
Medicines Australia cites an average delay of 466 days between TGA approval and PBS listing for new medicines, while other patient access research has suggested that some patients may wait even longer depending on the medicine, indication and reimbursement pathway.
For patients with serious, progressive or rare conditions, those delays are not abstract policy issues. They can determine whether a treatment is practically available at the point it is clinically needed. This is where managed access programs are becoming increasingly important.
Managed access programs are no longer simply a compassionate fallback mechanism. They are becoming a strategic part of modern patient access: a way to bridge the period between regulatory approval and reimbursement, support continuity after clinical trials, enable access for highly defined patient cohorts, and provide structured supply in circumstances where traditional commercial channels are not sufficient.
The reimbursement pathway remains essential, but it is not universal
The PBS remains the foundation of medicine access in Australia. It provides scale, equity and affordability in a way that few alternative models can replicate. However, reimbursement systems are not designed to solve every access scenario.
Some patients fall outside PBS criteria. Some medicines are registered but not yet reimbursed. Some indications are too narrow, too early, or too complex to support immediate public funding. Some products may be available overseas before they are commercially launched or reimbursed in Australia. In other cases, patients may complete a clinical trial and face uncertainty about continued treatment access while registration or reimbursement decisions are still pending.
These gaps are becoming more visible as therapeutic innovation becomes more specialised.
Rare diseases are a clear example. Australiaโs National Strategic Action Plan for Rare Diseases identifies approximately two million Australians living with a rare disease, across thousands of different conditions. For many of these patients, the traditional access model is challenged by small populations, limited clinical evidence packages, specialist prescribing requirements and complex funding decisions.
Oncology presents a similar dynamic. New therapies may target increasingly specific biomarkers, mutations or lines of therapy. The population eligible for treatment may be small, but the clinical need may be urgent.
The question for manufacturers is therefore no longer simply:
โHow do we achieve reimbursement?โ
It is also:
โHow do we support appropriate, compliant and sustainable access before, beside or beyond reimbursement?โ
Managed access is becoming a strategic capability
Historically, many access programs were developed reactively. A patient need emerged. A clinician made a request. A manufacturer responded through a compassionate use pathway, special access arrangement or bespoke supply model. That approach still has a role. But it is increasingly insufficient.
Modern access programs require governance, compliance, operational infrastructure, data visibility, pharmacovigilance pathways, inventory controls, healthcare professional engagement and patient privacy safeguards. They also need to function across hospitals, community pharmacies, wholesalers, logistics providers and, in some cases, direct-to-patient models. That makes managed access a strategic capability, not an administrative workaround.
For manufacturers, these programs can support several objectives:
- Helping to bridge the gap between TGA approval and PBS reimbursement.
- Supporting patients who do not meet public funding criteria but may still have a legitimate clinical need.
- Providing continuity of treatment after a clinical trial.
- Enabling controlled early experience with a therapy in defined clinical settings.
- Supporting access for small or geographically dispersed patient populations.
- Helping manufacturers better understand real-world operational considerations before broader launch.
But this only works if the program is designed with the same discipline as any other regulated healthcare activity.
Compliance is not optional
Australiaโs regulatory environment places clear boundaries around how prescription medicines may be promoted and supplied. Direct-to-consumer advertising of prescription medicines is not permitted, and unregistered therapeutic goods cannot be advertised to consumers or healthcare professionals. That has important implications for managed access.
Manufacturers cannot simply communicate directly with patients, create demand, or use access programs as promotional vehicles. Programs must be structured around legitimate clinical need, appropriate healthcare professional involvement, compliant information flows and clear separation between commercial objectives and patient-facing care.
The Medicines Australia Code of Conduct provides a principles-based framework for ethical conduct when companies promote prescription products and interact with healthcare professionals, patient organisations, the general public and other stakeholders. In practice, that means managed access programs need to be carefully designed around permitted channels.
Examples include:
- Hospital-based pathways may be appropriate where specialist prescribing, institutional governance or inpatient/outpatient administration is required.
- Community pharmacy models may support broader geographic reach, but they require pharmacy onboarding, training, stock control and consistent patient experience.
- Clinic-based models may suit some therapies but can increase the administrative burden on prescribers and practice staff.
- Central pharmacy or hub models can support structured dispensing and direct delivery, but they require robust privacy, logistics, counselling, adverse event and escalation processes.
Each channel has benefits. Each also creates operational and compliance risk if poorly designed.
The system is becoming more complex
Managed access programs sit at the intersection of healthcare delivery, pharmaceutical regulation, ethics, logistics and commercial strategy. That makes them difficult to execute well.
A single program may need to coordinate eligibility criteria, prescribing authority, patient consent, pharmacy enrolment, ordering, stock allocation, cold chain logistics, dispensing, pharmacovigilance, adverse event reporting, audit trails, invoicing, financial caps, discontinuation criteria and reporting back to the manufacturer.
These requirements become more complex when programs operate nationally, involve multiple hospitals, include community pharmacy supply, or support patients in regional and remote settings.
Australia has a large and distributed community pharmacy network, with the Pharmacy Guildโs 2024 profile identifying 5,935 community pharmacies nationally. That network is a major access asset. But for manufacturers, coordinating consistent program delivery through a distributed network can be difficult without appropriate infrastructure.
Hospital systems present a different challenge. Governance requirements, formulary processes, pharmacy workload, procurement rules and site-level variation can all affect implementation.
The access problem is therefore not simply whether a medicine can be supplied. It is whether the supply model is reliable, compliant, scalable and clinically appropriate.
Post-trial access is raising the ethical bar
Clinical trials add another layer of complexity. Patients who participate in clinical research may receive meaningful benefit from an investigational therapy. When a trial ends, the question of continued access can become ethically and clinically significant, particularly where there are no reasonable alternatives.
Australiaโs clinical trial governance framework is grounded in the National Statement on Ethical Conduct in Human Research, which is the ethical standard used by Human Research Ethics Committees when reviewing human research, including clinical trials.
While the specific obligations will depend on the protocol, sponsor commitments, ethics approvals and clinical context, the broader direction is clear: continuity of care matters.
For manufacturers, this creates a need to plan beyond the trial itself. Post-trial access can no longer be treated as an afterthought. It needs to be considered as part of lifecycle planning, particularly where a medicine may have a long pathway to registration, reimbursement or routine supply.
The economics are changing
Managed access also reflects a shift in the economics of pharmaceutical commercialisation. In a traditional mass-market model, infrastructure could be justified by scale. A widely used medicine could support broad sales teams, large distribution networks and standardised reimbursement pathways. That model does not always fit precision medicine.
When patient populations are small, geographically dispersed or highly specialised, the cost of bespoke access infrastructure can quickly become disproportionate. Manufacturers may need to support only dozens or hundreds of patients, but the compliance and operational burden can be similar to a much larger program. This creates a strategic tension.
Patients and clinicians expect access. Manufacturers have ethical, reputational and commercial reasons to support it. But building a bespoke program for every product, indication or patient cohort can be inefficient and difficult to sustain.
That is why scalable access infrastructure is becoming increasingly important. The future of managed access will likely depend less on ad hoc program creation and more on reusable operating models: defined governance, standardised workflows, configurable eligibility rules, integrated pharmacy networks, secure data capture, transparent reporting and clear compliance controls.
Australiaโs access challenge is also a regional opportunity
Australia is not alone in facing these issues. Across the Asia-Pacific region, medicine access is shaped by regulatory variation, reimbursement timelines, local evidence requirements, affordability constraints, fragmented healthcare delivery and differing rules around promotion and supply.
For global and regional manufacturers, this creates a need for access models that are locally compliant but operationally scalable.
Australia can play an important role in that evolution. It has a sophisticated regulatory environment, strong clinical standards, established public reimbursement infrastructure, a national pharmacy network and a high level of healthcare professional capability.
If managed access can be delivered well in Australia, the underlying principles may be relevant across the region: structured access, compliant separation, healthcare professional-led engagement, secure patient data handling, and flexible supply models that can adapt to different healthcare systems.
From exception pathway to access strategy
Managed access programs should not be seen as a substitute for reimbursement. Public funding remains the most equitable and sustainable route for broad patient access. But reimbursement is not always immediate, and it is not always available for every patient scenario.
As medicine becomes more personalised, access pathways also need to become more flexible. The strategic case for managed access is therefore becoming stronger. These programs can help bridge delays, support continuity, respond to narrow patient needs and maintain appropriate governance in areas where traditional access routes are limited.
However, the operational model matters. Poorly designed programs can increase administrative burden, create inconsistent patient experiences, expose manufacturers to compliance risk and frustrate healthcare professionals. Well-designed programs can do the opposite: improve access, reduce friction, support transparency and strengthen trust across the healthcare ecosystem.
The next challenge is scale. Managed access can only fulfil its potential if it moves beyond manual processes, fragmented spreadsheets and case-by-case administration. As patient cohorts become more specific and access pathways more complex, technology will become central to making these programs sustainable.
The need is clear. The access gap is real. The opportunity now is to build managed access models that are compliant, scalable and genuinely patient-centred.
About Akesa
Akesa supports pharmaceutical manufacturers with compliant, scalable medicine access solutions across Australia and the region. To learn more about managed access program design and delivery, contact the Akesa team.
The content published on this website is provided for general information purposes only. It does not constitute regulatory, legal, clinical, financial, or professional advice. Akesa makes no representation that content is current, complete, or applicable to any specific situation. Readers should seek appropriate professional advice before acting on any information published on this site. Content reflects Akesa’s view at the date of publication and may be updated without notice.
