Hello everyone, and welcome to this edition of Excelsior Solutions’ ICER Update.
- ICER has published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States. A summary of the full report can be found here.
Among the top drugs with price increases in 2020 that had substantial effects on U.S. spending, ICER determined that seven of 10 lacked adequate new evidence to demonstrate a significant clinical benefit that was not yet previously known. The 2020 unsupported price increases on these seven treatments, even after pharmaceutical rebates and other concessions, cost the U.S. health system an additional $1.67 billion beyond what would have been spent if their net prices had remained flat. ICER’s Chief Medical Officer David Rind, MD stated:
“While prescription drugs continue to arrive in the U.S. with increasingly high launch prices — often not aligned with those therapies’ ability to improve patients’ lives — year-over-year price increases have slowed considerably since ICER began issuing these UPI reports.
However, there remain many high-cost brand drugs that continue to experience annual price hikes, even after accounting for their rebates. The most extreme of these is Humira, with an ever-escalating U.S. price that contrasts starkly to its falling price in every country where Humira currently faces biosimilar competition. Even more concerning, several of these treatments have been on the market for many years, with scant evidence that they are any more effective than we understood them to be years ago when they cost far less. If new data emerge that show a treatment may be more beneficial than what was previously understood, perhaps some level of price increase is warranted. For seven of the 10 high-cost drugs we profiled in this year’s report, though, we found that the price increases lacked such justification.”
EXCELSIOR ACTION POINT:
Drugs included on ICER’s list had to meet the following criteria, consistent with ICER’s previous UPI reports:
- Were among the top 250 drugs by 2020 U.S. sales revenue;
- Experienced WAC (list) price increases that were more than 2 percentage points higher than the rate of medical inflation between the end of 2019 and the end of 2020;
- Even after rebates and other concessions, experienced net price increases; and
- After net price increases were vetted with manufacturers, were found to be the top 10 drugs whose price increases — as opposed to volume increases — contributed to the largest increase in U.S. spending.
Fortunately, the impact of these products on your pharmacy benefit plan is being mitigated through the implementation of practical, common sense utilization and formulary management tactics and strategies that we have discussed with you, and together, we will be vigilant going forward. The looming launch of the first biosimilar version of Humira at the end of January 2023 is at the forefront of our collective attention.
- ICER posted its revised Evidence Report assessing the comparative clinical effectiveness and value of tirzepatide (Eli Lilly) for the treatment of Type 2 diabetes.
“Tirzepatide is seen as an add-on therapy to metformin, like injectable semaglutide or empagliflozin,” said Jon Campbell, PhD, MS, ICER’s Senior Vice President for Health Economics. “It has a novel GIP and GLP-1 receptor agonist mechanism of action. When compared to injectable semaglutide in one head-tohead trial, tirzepatide showed a greater decrease in HbA1c levels and weight, as well as in triglycerides and blood pressure. The evidence suggests that tirzepatide may deliver important health benefits, but data are still limited on long-term cardiovascular and renal effects.”
EXCELSIOR ACTION POINT:
On Jan. 20, 2022, ICER convened a virtual meeting to review tirzepatide. The New England Comparative Effectiveness Public Advisory Council (CEPAC) reviewed comparative effective evidence and considered longterm value in terms of health benefits and costs. General diabetes formulary considerations were included in the policy discussion.
The discussions concluded that clinical evidence suggests a high certainty of benefit when tirzepatide was added to background therapy, given the observed reduction in hemoglobin A1c and weight loss benefits. CEPAC rated tirzepatide as “not worse” than either injectable semaglutide and empagliflozin. There were no serious safety concerns identified.
A majority of CEPAC members voted that the current evidence is adequate to demonstrate that the net health benefit of tirzepatide added to background therapy is superior to background therapy alone. A majority also voted that current evidence is not adequate to support that the net health benefit of tirzepatide added to background therapy is superior to adding injectable semaglutide or empagliflozin to background therapy. Said another way, it’s superior to metformin alone, but not necessarily to metformin plus other available treatments.
The American Diabetes Association (ADA) Standards of Medical Care in Diabetes (2022) recommends individualizing therapy based on comorbidities. Formulary design may require step-through positioning following drugs having proven cardiovascular, heart failure, and renal benefits, such as SGLTs, in patients having such concerns, since current evidence for tirzepatide does not include proven cardiovascular or renal benefits. Nonetheless, tirzepatide has demonstrated strong A1c lowering and weight loss potential.
In the next few months, payers (and Medi-Span!) will consider whether tirzepatide will be grouped with the GLP-1 class versus belonging to a new and separate GIP/GLP-1 class (for purposes of ST, formulary tiering, and other UM) relative to available GLP-1s.
Lilly filed a Biologics License Application (BLA) for tirzepatide with the FDA and anticipates a decision in the second quarter of 2022. ICER will publish a Final Evidence Report on or around Feb. 15, 2022, and we will be sure to share it with you when it is released.
Fortunately, the impact of several of these products on your pharmacy benefit plan is already being mitigated through the implementation of practical, common sense utilization and formulary management tactics and strategies that we have already discussed with many of you.
As always, if you would like to discuss the potential impact of this or any prior ICER reports, or any other aspects of your Pharmacy Benefit Plan, simply reach out to your Excelsior Solutions account team and we will be happy to quickly set up a call.
Until next time!
Bob Kordella, RPh, MBA