Lilly defers Alzheimer's drug filing after CMS' 'disappointing' decision

Eli Lilly has backed away from plans to file Alzheimer's drug donanemab in the first quarter of this year, saying the proposal to limit reimbursement of Biogen's first-to-market Aduhelm has made going down the accelerated approval route all-but pointless.

The company has planned to filed for speedy approval of donanemab based on the results of its TRAILBLZAR-ALZ study, in the hope of being allowed by the FDA to make the drug available to patients while its confirmatory TRAILBLAZER-AZ 2 trial is still being run.

Aduhelm (aducanumab) was approved using the same mechanism, but the recently unveiled draft plan by the Centres for Medicare and Medicaid Services (CMS) to limit reimbursement of Biogen's drug to patient enrolled in approved clinical trials has forced Lilly to rethink.

Lilly is a little vague on when it will now file donanemab with the FDA – suggesting on its fourth quarter 2021 results call that it may do so later this year – but reiterated that it has little hope of the drug being used ahead of the readout of TRAILBLAZER-ALZ 2 in mid-2023.

"We're disappointed with the position that [CMS] has taken in its draft national coverage determination decision," said Lilly's chief scientific and medical officer Dan Skovronsky on the call, adding that it "essentially negates" the intention of providing patient benefit in areas of unmet medical need.

"Those low expectations could now extend for some months beyond the TRAILBLAZER-ALZ 2 readout if reconsideration of CMS coverage determination is required, given historical time lines for this process," he continued.

By the time the confirmatory trial generates results, the company hopes that the situation on Medicare reimbursement – which will likely be mirrored in private health insurance coverage – will be clearer.

"What hasn't changed for us is the importance of the TRAILBLAZER-ALZ 2 readout and our confidence in both donanemab and the unique study design," said Skovronsky.

"Given the impact of this devastating disease, we believe that if TRAILBLAZER-ALZ 2 provides positive confirmatory data, we can't see a scenario where there's not global reimbursement, patient access and broad use of donanemab."

Biogen reported yesterday that Aduhelm continued to make meagre sales in the fourth quarter of 2021, bringing in just $1 million in the three-month period.

While donanemab has moved towards the back burner, Lilly has been lifted by fourth-quarter results that beat expectations for both revenue and earning, thanks to a strong performance by diabetes therapy Trulicity (dulaglutide) and its COVID-19 therapies.

Trulicity contributed $1.9 billion, up 25%, while COVID-19 antibodies bamlanivimab and etesevimab added another $1.1 billion to the pot and JAK inhibitor Olumiant (baricitinib) grew 59%  to $306 million, fuelled by its use to treated hospitalised coronavirus patients.

There were also strong gains for psoriasis therapy Taltz (ixekizumab), diabetes and heart failure therapy Jardiance (empagliflozin), and breast cancer therapy Verzenio (abemaciclib).