The number of medicines recommended by the Pharmaceutical Benefits Advisory Committee but not listed on the PBS has blown to more than 50, with more than a dozen in limbo longer than a year.

Therapies awaiting public funding cover a wide variety of disease areas and range from and range from monoclonal antibodies and immunotherapies to DMARDs, hormone agents and assisted reproductive technology.

The figures come from documents tabled in Federal Parliament last month and show there are currently 49 medicines awaiting public funding, despite having receive positive recommendations from PBAC since June 2022 (full list below).

Beyond that are six which have been pulled entirely due to breakdowns in negotiations between the government and industry, including:

• Mirikizumab (Omvoh) for ulcerative colitis
• Mobocertinib (Exkivity) for NSCLC
• Two medications for severe dry eye syndrome
• Etanercept (Nepexto) for various rheumatic diseases
• Progesterone (Cyclogest) for infertility

In the case of mirikizumab, the issue simply came down to government policy on price, despite the drug’s endorsement from PBAC, according to its manufacturer Eli Lilly.

“The goal posts continued to shift in terms of a launch price for Omvoh,” said Eli Lilly Australia general Manager Tori Brown as she announced the company’ decision not to progress with PBS listing last month.

“It was clear that there was significant risk of further price erosion over time due to PBS reference pricing”.

“Unfortunately, it is no longer viable for Lilly to make Omvoh available through the PBS – not without significant policy change to recognise the full value of innovative medicines.”

Medicines Australia has also called for reforms, warning the average wait for patients to receive subsidised access to new cancer medicines remains above a year in Australia, far longer than in many comparable countries.

Analysis by the industry group shows it takes an average of 496 days for a cancer drug and 528 days for a cardiology drug to get on the PBS after being registered with the TGA.

Other therapy areas where drugs face prolonged average wait times for PBS listing include arthritis, Asthma/COPD and mental health, while vaccines typically take over three years to get the nod.

Clinical Oncology Society of Australia (COSA) president Professor Fran Boyle has previously said that with cost a major factor in government decision making, many medicines faced an uphill battle to gain funding.

“Drugs for early disease tend to struggle, as do those with co-dependent assessments to have a test approved as well,” she said.

“The third group are drugs that have not been trialled in Australia and are not owned by one of the usual local big pharma companies with the experience to take it through the system.”

“We see that with quite a few of the drugs coming out of Japan and China at the moment.”

Medicines approved by the PBAC by yet to receive PBS listing