NICE Says Nope to Tirzepatide

The TableAfter four exhilarating days of new possibilities for overcoming diabetes and obesity at ADA2023, we had to come back down to earth. The National Institute for Health and Clinical Excellence in the UK stepped up to this task right away. On Tuesday, NICE said nope to recommending tirzepatide use for type 2 diabetes in the NHS – for now.

More specifically, reviewers at the institute concluded they simply don’t have enough evidence to recommend tirzepatide (also known by its brand name, Mounjaro) yet.

So this nope from NICE for tirzepatide is not forever.

A Qualified Nope

Make no mistake, NICE was not entirely negative about tirzepatide. In fact, the institute wrote:

“Evidence submitted to the committee from clinical trials showed the use of tirzepatide at any dose resulted in better glucose control and lower weight compared with semaglutide or insulin therapy.

“Our committee can see the promise in tirzepatide but it requires more evidence to be able to evaluate both its clinical and cost effectiveness.

“We look forward to working with the company to ensure our committee receives the evidence it has requested so at their next meeting they can fully understand the benefits and the value of this new treatment option.”

Seeking Robust Outcome Data

In their review document (here), NICE expressed concerns about uncertainties regarding evidence for clinical outcomes and cost effectiveness, especially in comparison to other available data. In particular, the institute mentioned a need for comparisons to semaglutide data from SURPASS-2 presented in the last week at ADA2023. Among other factors, they sought information about weight outcomes.

NICE also noted that the proposed price to the NHS is confidential at this time.

This is a process that serves a straightforward purpose for the NHS – to evaluate whether new drugs offer good value for money. No such system exists for the U.S., which may contribute to the fact that this country bears some of the highest prices for pharmaceuticals in the world.

While NICE asks tough questions about value, U.S. prices can go as high as the market will bear. The deals that PBMs cut to sustain their profitability don’t really help. The contrast is stark.

Click here, here, and here for more on the decision from NICE.

The Table, papier collé by Juan Gris / WikiArt

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June 29, 2023