Tirzepatide Gets Middling Grade From ICER

The cost-effectiveness group say Lilly’s diabetes treatment should have an annual price of between $5,500 and $5,700. The FDA is expected to make a decision on whether to approve tirzepatide this year.

Tirzepatide, Eli Lilly’s novel diabetes treatment, stacks up well against Ozempic (injectable semaglutide) and Jardiance (empagliflozin) when it comes to weight loss and controlling HbA1c, lipid and blood pressure levels, according to an evidence report issued today by the Institute for Clinical and Economic Review (ICER). But because of the lack of data about cardiovascular and renal outcomes control, ICER graded the new treatment as having comparable or incremental net health benefits(a C+) rating with respect to Ozempic and just a slightly better grade with respect to empaglifozin (a C++ rating).

Using standard the standard cost-effectiveness thresholds, ICER said tirzepatide should be priced at between $5,500 and $5,700 a year.

ICER is a private group funded by foundations and other groups, so its evidence reports are merely recommendations and have no force of law behind them. However, the reports are used by drug manufacturers, payers and others involved in setting drug prices and paying for them. 

Lilly has submitted an application to the FDA seeking approval of tirzepatide. The agency is expected to make a decision about the treatment this year.

The ICER’s evidence report will be discussed on Jan.20 at a meeting of the New England Comparative Effectiveness Public Advisory Council, one of the three outside groups that ICER uses to vote on its evidence reports before making final.

If the FDA approves tirzepatide and it comes on the market, it will join a growing number of therapies for people with diabetes whose blood sugar levels haven’t been brought under control (the ICER says that is true for nearly half of the 34 million Americans with type 2 diabetes).

But diabetes treatment has gotten more complex as an increasing number of treatments have been found to do double , even triple, duty, lowering the risk of cardiovascular disease and kidney as well as controlling blood sugar levels (as measured by HbA1c levels) and helping with weight loss. People with type 2 diabetes who are at higher risk of atherosclerotic cardiovascular disease or chronic kidney disease — and a large percentage are in that category— are often prescribed an SGLT-2 inhibitor, such as Jardiance, Invokana (canagliflozin) or Farxiga (dapagliflozin) because of their demonstrated effect on cardiovascular risk. The same is true of the GLP-1 receptor agonists, a class that includes Trulicity (dulaglutide), Victoza (liraglutide) as well as Ozempic and other drugs.

Tirzepatide is a combination of a GLP receptor agonist with glucose-dependent insulinotropic polypetitde (GIP) that is administered as a once-a-week injection.

The ICER evidence report says that tirzepatide was compared in a head-to-head, randomized trial with Ozempic. The results showed it was superior to with respect to HbA1c levels, weight loss, triglycerides and blood pressure, according to ICER. But trial results also showed that gastrointestinal side effects were more common in people who took the novel Lilly drug than those treated with Ozempic and that people assigned to the tirzepatide were also more likely to quit taking their medication.

According to the ICER report, there is no direct comparison between tirzepatide and Jardiance to go by, so they used study results and statistical techniques to make indirect comparisons instead. Although the results are not quite as certain as those from a head-to-head trial, the indirect comparisons suggest that tirzepatide is more effective than Jardiance at lowering HbA1c levels, weight, lips and blood pressure. The report said it wasn’t possible to compare adverse event rates using the currently available data.

The executive summary of the 151-page ICER report says that data from the SURPASS-4 trial suggest a trend toward cardiovascular benefit from tirzepatide. But the executive summary also taps the brakes, saying that “definitive data” are needed to understand the therapy’s effect on cardiovascular and renal outcomes.

The summary also notes that the type 2 diabetes is more prevalent among minorities, so treatments that had benefits across racial groups would provide greater proportional benefit to those populations. However, the ICER reviewers also say the studies conducted so far have not included enough people from minority populations to show such a benefit across racial groups.