Australia’s Pharmaceutical Benefits Scheme (PBS) has been criticized by patient groups and pharmaceutical companies for its stringent criteria governing access to newer, more effective medications. These restrictions require patients to first exhaust treatment options using older, less expensive drugs before qualifying for publicly funded next-generation therapies, a process some describe as a “rationing system.”

This approach affects millions of Australians suffering from conditions such as migraine, rheumatoid arthritis, Crohn’s disease, and other inflammatory autoimmune disorders. Advocates argue that early access to advanced treatments, which can modify disease progression and minimize long-term damage, is often delayed by PBS regulations that insist on failure with cheaper medications first.

One prominent example is the treatment of migraine, a neurological condition impacting about 20% of Australians, with some experiencing severe, debilitating symptoms. New migraine-specific drugs known as calcitonin gene-related peptide (CGRP) inhibitors have shown promising results by targeting the protein responsible for triggering migraine inflammation. While three CGRP medications have been listed on the PBS since 2023, patients must have failed trials of at least three other drug classes, including beta-blockers, antiepileptics, or antidepressants, before becoming eligible for government-subsidized access.

Carl Cincinnato, head of Migraine and Headache Australia, emphasized the need for broader availability of such treatments given their safety and efficacy. Similarly, migraine sufferer and advocate Sarah de Somer highlighted the challenges imposed by the system, stating that patients must endure ongoing symptoms—often 15 or more migraine days per month—and unsuccessful treatment attempts with multiple drug classes before accessing these newer therapies. She described the PBS framework as prioritizing cost containment over patient outcomes by “exhausting all the cheaper options” before approving more expensive medications.

The Australian government acknowledges these concerns and is working to modernize drug pricing policies. Health Minister Mark Butler noted the difficulties in balancing taxpayer interests against the financial risks of funding innovative, patented medicines while maintaining Australia’s status as a key market for new pharmaceuticals. He argued that ensuring ongoing market access for novel treatments requires careful judgment, including benchmarking against long-established generic drugs.

Pharmaceutical companies warn that restrictive pricing policies threaten patient access to cutting-edge therapies. A spokesperson for AstraZeneca criticized the PBS for using outdated pricing comparators and evaluation methods that underestimate the clinical value of precision medicines and fail to account for their long-term benefits. Industry representatives also expressed concerns that these policies increase the risk of medicine shortages, as manufacturers may prioritize more lucrative markets.

Medicines Australia, representing the pharmaceutical sector, pointed to disparities in access to targeted cancer therapies. For instance, Trastuzumab deruxtecan, used to treat HER2-positive breast cancer and listed on the PBS, is not subsidized for patients with HER2-positive gastric cancer—a condition with a poor prognosis—despite being reimbursed for this indication in at least 16 countries, including Germany, France, South Korea, and Canada.

Patient and industry voices call for reform of the PBS to better align with international standards and to provide timely access to innovative treatments, asserting that current policies may compromise patient care by maintaining unnecessary barriers to newer medications.