Pharma company Eli Lilly has announced it will not progress a PBS listing for its ulcerative colitis medicine, mirikizumab, despite it receiving a positive recommendation from the Pharmaceutical Benefits Advisory Committee.

Branded Omvoh, the  IL-23 inhibitor was endorsed last July for the treatment of moderate-to-severe ulcerative colitis in patients who have had an inadequate response, lost response, or are intolerant/contraindicated to conventional treatments or DMARDs.

At the time, the PBAC assessed the first-in-class drug as having “non-inferior” comparative effectiveness to the eight alternative therapies on the market, although it stressed head-to-head trials were lacking against several currently available medicines.

It also acknowledged input from health professionals stating that while a range of therapies were available, a significant proportion of patients did not respond to any and required surgery.

This commentary stated that there was a strong need for more classes of effective medical therapy to be available through the PBS, adding benefits of mirikizumab, including its safety profile and convenient dosing.

However, the committee did include a heavy caveat with its recommendation, declaring its endorsement was based on, amongst other matters, a finding that the cost-effectiveness would be acceptable if it were minimised to that of the least expensive available b/tsDMARD.

It also rejected a submission from the company that mirikizumab had “superior effectiveness” to adalimumab based on the evidence provided.

The upshot was that post-meeting negotiations broke down over the issue of price, said Eli Lilly Australia general Manager Tori Brown.

“The goal posts continued to shift in terms of a launch price for Omvoh, she said.

“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.”

Ms Brown said longstanding government policies around medicine pricing were to blame for the breakdown, which she said underscored the need for reform of the Health Technology Assessment (HTA) process.

“As Omvoh illustrates, some aspects of HTA and pricing policy in Australia de-value innovative medicine and ultimately impede patient access,” she said.

“Urgent policy change is needed. Lilly hopes that with bold and meaningful HTA reform, first-in-class medicines such as Omvoh will be made accessible to Australian patients in the future.”