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Market access pathways by country

Explore how an innovative medicine moves from approval to patient access.

Selected market

Australia

TGA registration and PBAC reimbursement recommendation are separate; pricing and risk-sharing follow before PBS listing.

TGA

PBAC

Department of Health

Minister / PBS

4 decision nodes13 cited sources

For education only — not regulatory, pricing or legal advice.

About the content and how to use it

Evidence checked through 2026-08-13A pathway is a decision map—not a launch-time promise

Locate the relevant route first

These choices define how to read the branches below. They do not predict a payer or provider decision.

1

Which supply programme applies?General Schedule, Section 100 and inpatient supply have different claims and providers.

2

What risk needs a deed?Financial risk and evidence uncertainty use different instruments.

Selected routeGeneral ScheduleSPA / budget risk8 applicable nodes

Authorization-to-patient timeline

See the selected route reach the patient

Updates immediately when a choice changes

1

TGA pre-submission and application进入评价时钟

2

TGA evaluation and ARTG entry法定可供应及 PBS 文件边界

3

PBAC submission正面建议是价格流程前提

4

Post-PBAC pricing offerdeed、restriction、政府程序

5

Government approval and PBS listing可申领的联邦补贴Selected branch

6

Supply route implementation首位及持续获资助患者Selected branch

7

First funded patientEligible patient + capable provider + authorization + product + clean payment

1PBAC recommendation converted into a complete pricing offer

2Restriction and deed signed before listing

3Correct PBS/Section 100 claim route configured

4State/hospital formulary and stock verified

Do not collapse these decisions

TGA approval is not PBS funding; PBAC recommendation is not listing; indication-specific economic prices do not mean multiple published PBS prices.

Decision map

What each local node actually produces

Select a row to inspect legal effect and downstream gates

#Local decision / ownerDecision outputDownstream dependencyEvidence

Decision question

申请是否完整并满足适用注册路径

Required evidence / materials

CTD、澳洲 Module 1、质量/非临床/临床资料、GMP、PPF

Can iterate or branch

Priority、Provisional、standard、variation 分支

Source date

AU-S01 · 2010-02-01

Node linked to cited dossier sourcesProduct/provider execution still requires live verification

What changed for this route

General ScheduleGeneral Schedule, Section 100 and inpatient supply have different claims and providers.
SPA / budget riskFinancial risk and evidence uncertainty use different instruments.

Structural differences

Indication-specific prices are economic inputs to one weighted published price.
SPA manages financial/list-to-net risk; MES manages resolvable evidence uncertainty.
PBS outpatient access does not prove public-hospital inpatient formulary adoption.

Price is a stack

1
PBAC-supported indication price
2
Single weighted published AEMP
3
SPA rebate / government net cost
4
State/hospital acquisition

Lifecycle triggers

New indication weighted-price recalculation
Deed renewal and reconciliation
MES evidence reassessment
F1 year-5/10/15 reductions: 5% / 5% / 26.1% (30% from April 2027)
First-new-brand and price disclosure

Special mechanisms and lifecycle

What can reopen price, coverage or procurement after launch

Dates below come from the cited policy record—not a product forecast

Mechanism / triggerDecision outputIteration / branchPolicy recordLatest observed

Restriction and deedSelected routePBS restriction、executed deed、SPA/RSA/MES 条款可谈判、变更、续期或终止AU-S03 · AU-S04 · AU-S06checked live

Lifecycle price managementweighted price 重算、deed 续期、SPR、WADP reduction多个机制可能叠加AU-S04 · AU-S05 · AU-S07 · AU-S08 · AU-S09checked live

New indication weighted-price recalculationDeed renewal and reconciliationMES evidence reassessmentF1 year-5/10/15 reductions: 5% / 5% / 26.1% (30% from April 2027)First-new-brand and price disclosure

Evidence & policy library

Official basis and policy dates

13 records · checked 2026-08-13