A managed access program (MAP) in Australia is a structured, governed pathway that enables patients to access medicines before they are routinely available through standard supply or funding channels. For pharmacy teams, understanding how these programs work in practice matters as much as knowing they exist.
What is a managed access program?
MAPs are commonly used when a medicine has received regulatory approval but reimbursement or commercial supply has not yet been established. They are also used when a medicine is being supplied under a special access pathway, when patients require ongoing access following a clinical trial, or when a treatment needs controlled distribution and monitoring due to its complexity or risk profile.
The gap between a medicine receiving TGA approval and becoming available on the Pharmaceutical Benefits Scheme (PBS) is not a short one. Medicines Australia has reported an average delay of 466 days between TGA approval and PBS listing. During that period, MAPs are often one of the few mechanisms available through which eligible hospital patients can access a newly approved therapy. From a pharmacy perspective, that means these programs are not edge cases. They are becoming more routine and a growing part of medicines management.
Common types of managed access programs
MAPs operate under several different names depending on their purpose and the stage of product development.
The most common types of pharmacy teams will encounter are:
- Compassionate access programs: for patients with serious or life-threatening conditions who have limited or no other treatment options, and where the medicine is not yet commercially available in Australia.
- Early access programs: allow use of a medicine before full commercial launch or PBS reimbursement, typically where there is strong clinical evidence, but listing has not yet been finalised.
- Post-clinical trial access provides continued access to a medicine for patients who were enrolled in a clinical trial and are still benefiting from treatment after the trial has closed.
- Patient support programs: coordinate ongoing supply and, in some cases, education, adherence support, or financial assistance for patients requiring long-term access to high-cost or complex therapies.
These program types are not always clearly distinguished in sponsor documentation. Pharmacy teams often encounter them described simply as “early access” or “compassionate supply” regardless of the specific pathway in use. The terminology in the agreement documents and the CATAG Guiding Principles for MAPs in Australian Hospitals should be the reference point, alongside the program name a sponsor uses.
The regulatory framework: where MAPs sit in Australia
In Australia, managed access programs operate in parallel with TGA regulatory pathways rather than as a separate system. The Special Access Scheme (SAS) is the primary TGA mechanism for individual patient access to unapproved or unlisted medicines. It has three categories:
- Category A: for patients with immediately life-threatening conditions. Treatment can begin immediately; the prescriber notifies the TGA after initiating supply.
- Category B: requires TGA pre-approval with detailed clinical justification before prescribing. This is the most common SAS pathway for structured MAPs involving medicines not yet registered in Australia.
- Category C: a streamlined notification pathway for lower-risk products with an established use history.
- The prescriber must submit a completed form to the TGA within 28 days of supply. Failure to notify is an offence carrying a financial penalty.
MAPs may also operate under theAuthorised Prescriber pathway, where a medical practitioner is approved by the TGA to prescribe a specific unapproved medicine to a class of patients without needing individual patient approval each time. The right pathway depends on the medicine, the patient population, and the sponsor’s program design. Pharmacy teams should confirm which pathway applies before a MAP commences at their site.
Where pharmacies fit in MAP delivery
MAPs in Australia are delivered through hospital pharmacies or community and specialist pharmacies, depending on the medicine type, treatment complexity, funding arrangements, and where the patient receives care. For most hospital-based programs involving complex or high-cost therapies, supply runs through the hospital pharmacy.
What distinguishes MAP dispensing from standard medicines management is the additional layer of governance, documentation, and oversight that sits on top of normal dispensing. The CATAG Guiding Principles are the national framework that governs how MAPs operate in Australian public hospitals. They are not state-specific. They are developed by CATAG, the peak national advisory body for quality use of medicines in hospitals with all states and territories as members, and implemented through each state and territory’s therapeutics advisory group.
Under these principles, MAP dispensing differs from standard dispensing in several important ways:
- Dispensing pathway: non-PBS medicines supplied under a MAP are typically handled as private scripts, with different ordering workflows, cost-coding, and stock management from PBS-subsidised supply.
- Labelling: MAP medicines are not subject to the Annex 13 labelling requirements that apply to investigational medicinal products in clinical trials. The TGA’s guidance on investigational medicinal products is explicit on this point. The applicable labelling standard depends on the medicine’s registration status and the terms of the sponsor agreement.
- Adverse event reporting: under all SAS pathways, the prescribing practitioner is responsible for reporting adverse events and product defects to the TGA through the Australian Adverse Drug Reactions System. Pharmacy teams should confirm this obligation is understood by prescribers before program commencement, not after the first adverse event.
Hospital governance: what pharmacy teams need to know
A MAP cannot commence at a hospital site without institutional approval. The CATAG Guiding Principles are clear: management and oversight must be delegated to a Medicines and Therapeutics Committee (MTC) or Drug and Therapeutics Committee (DTC), and committee approval must be obtained before any patient is enrolled. A formal written agreement between the pharmaceutical sponsor and the hospital must also be in place, covering supply terms, adverse event reporting obligations, and cost arrangements.
Cost recovery is a practical consideration that is frequently underestimated during MAP setup. Hospitals generally recover costs associated with running a MAP from the sponsor, including pharmacy staffing, dispensing, storage, and administration. The specific cost-recovery approach varies by institution and program type, but it needs to be agreed and documented before supply begins. Pharmacy teams should not assume a cost position without it being confirmed in the written agreement.
Governance requirements apply nationally. The CATAG framework is the foundation across all Australian states and territories. Individual health services interpret and apply these principles through their own DTC or MTC processes, which means the practical requirements for MAP approval may differ between a metropolitan tertiary hospital and a regional facility. The starting point for any pharmacy team setting up a MAP is the CATAG Guiding Principles.
Getting a managed access program set up correctly
Treating MAP setup as a lighter version of clinical trial activation is a common mistake. It is not lighter. It is different.
The foundations that need to be confirmed before supply begins include:
- SAS category or Authorised Prescriber pathway confirmed for the specific medicine and patient population.
- DTC or MTC approval obtained and documented before any patient is enrolled.
- Written sponsor agreement in place, signed by the hospital, covering supply terms, cost recovery, and adverse event obligations
- Dispensing process documented: ordering workflow, private script handling, cost-coding, stock management, and minimum stock triggers.
- Adverse event reporting pathway confirmed and communicated to all prescribers involved in the program.
- Reorder and escalation process established for when supply is delayed or the program terms change.
The CATAG Guiding Principles also require that sponsors commit to continuing supply for as long as the patient’s treating prescriber judges there is a clinical benefit. For the pharmacy team, that commitment requires a corresponding supply continuity process from day one. A MAP that runs out of stock mid-treatment because reorder processes were not set up at the outset is a governance failure, not a logistics problem.
MAPs and patient access
Managed access programs exist because the pathway from medicine approval to routine patient access takes time, and for patients with serious or complex conditions that time matters. The 466-day average gap between TGA approval and PBS listing means that for many therapies, a MAP is not a temporary workaround. It is the primary access mechanism for months or years.
For pharmacy teams, running these programs well is part of the broader commitment to patient access. The governance and documentation requirements are not bureaucratic overhead. They are what makes it possible to provide patients with ongoing, safe, and compliant access to medicines that are not yet part of standard supply channels.
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 the 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.
