Pharmacy Daily | Omvoh fails to list, call for bold reform

PHARMA company Eli Lilly underscored the urgent need for reform of practices by the Health Technology Assessment (HTA) in Australia, impacting its inability to progress the PBS listing of Omvoh (mirikizumab) for the treatment of eligible adults with moderate-to-severe active ulcerative colitis.

Eli Lilly also confirmed that at this time, given the circumstances, it is unfeasible to make Omvoh available in Australia on private prescription for the disease.

The company was working to convert a positive PBAC recommendation from Jul 2023 into a PBS listing for its new first-in-class medicine for ulcerative colitis.

This is despite current pricing policies that require Lilly to accept the same price as the "lowest cost comparator", a decades-old biosimilar for the same illness.

However, Eli Lilly is unable to accept the eroding "lowest cost comparator" price resulting from ongoing price disclosure policies.

General Manager for Eli Lilly Australia, Tori Brown (pictured) commented, "this is not a decision we have taken lightly, as it will impact many patients and healthcare professionals".

"It is extremely disappointing that after investing in Australia as a location for Omvoh clinical trials, we cannot make the medicine available through the PBS to benefit patients," she said.

Brown thanked the many clinicians and advocates who had supported the company's PBAC submission and plans for launch.

She explained that throughout listing negotiations and launch preparations, "the goal posts continued to shift in terms of a launch price for Omvoh".

"It was clear that there was significant risk of further price erosion over time due to PBS reference pricing," Brown said.

"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."

As Omvoh illustrates, some aspects of HTA and pricing policy in Australia devalue innovative medicine and ultimately impede patient access, she remarked.

"Urgent policy change is needed, and 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."

Eli Lilly's submission to the HTA Review will highlight its experience with Omvoh to demonstrate the need for substantial policy change.

See PBS pricing policies HERE. JG