Immunotherapy Stewardship Could Save Tens of Millions a Year

Implementing stewardship strategies for immune checkpoint inhibitor (ICI) therapy, including personalized weight-based dosing, dose rounding, and pharmacy-level vial sharing, could generate savings of as much as $74 million each year for the Veterans Health Administration (VHA), a new analysis suggests.

That $74 million in savings would translate to nearly 14% less spent on ICI therapy annually.

“Our work suggests that implementing these strategies across the VHA could lead to tens of millions of dollars in annual savings — and that’s just for immunotherapy — without sacrificing outcomes,” first author Alex Bryant, MD, University of Michigan, Ann Arbor, told Medscape Medical News.

The study was published this month in Health Affairs.

ICI therapy is used in about 40 unique cancer indications and, in 2020, accounted for more than $6 billion in Medicare Part B spending.

Two of the most prescribed ICIs — pembrolizumab and nivolumab — initially received their US approval at personalized weight-based doses. But at the request of the manufacturers, the U.S. Food and Drug Administration (FDA) approved “one-size-fits-all” flat doses, despite a lack of data to support this strategy compared with weight-based dosing.

With a fixed dose strategy, “patients with cancer not only tend to get too high a dose of the drug, but costs go up significantly,” Daniel Goldstein, MD, a medical oncologist at the Rabin Medical Center, Petah Tikva, Israel, told Medscape last year. “Why should we give a higher dose with the same efficacy when that dose will cost significantly more and has the potential to increase adverse events?”

To compare the cost of a weight-based vs fixed-dose strategy, Bryant and colleagues conducted a simulation analysis under four stewardship scenarios, using data from the VHA and Medicare drug prices. Strategy one looked at weight-based dosing; strategy two combined weight-based dosing and dose rounding but not single-use vial sharing; strategy three used weight-based dosing and single-use vial sharing but not dose rounding; and strategy four, the most aggressive, combined all three.

ICIs in the VHA national formulary included pembrolizumab, nivolumab, atezolizumab, durvalumab, and cemiplimab-rwlc.

Using an algorithm to extract data, the team identified 49,851 administration events in 8276 unique patients in 2021 — just over half were pembrolizumab, nearly 23% were nivolumab, and the remaining 26% largely included atezolizumab (12.1%) and durvalumab (11.9%).

The team found that the VHA spends roughly $537 million annually on ICIs. But implementing the stewardship measures that combined weight-based dosing, dose rounding, and vial sharing could save the VHA $74 million, or about 14%, annually on ICIs.

Most of the savings came from dosing changes to pembrolizumab and nivolumab, with greater savings achieved by combining more stewardship strategies. For instance, using strategy one (weight-based dosing alone) could lead to annual pembrolizumab savings of $14 million. Adding dose rounding (strategy two) could reduce pembrolizumab spending by $24 million. And using strategy four, with an unlimited window for vial sharing, could mean annual savings of nearly $60 million.

“Our results should prompt cost-conscious systems and payers to ask whether the amounts of drugs they’re providing to patients and how they go about making those doses are the most cost-effective approaches,” said corresponding author Garth W. Strohbehn, MD, of the University of Michigan and the VA Ann Arbor Healthcare System.

Strohbehn said the prospect of adopting these strategies hinges on several factors, with financial incentives at the prescriber and medical center level likely being the most influential.

“In fee-for-service systems, reimbursement scales with the amount of drug administered, so there can be a financial disincentive to decreasing overall drug usage,” Strohbehn explained.

“Conversely, integrated systems such as Kaiser-Permanente or the VHA and large self-insured employers are incentivized to contain costs and take great care of patients, so they may be more inclined to promote these strategies,” he added.

However, Adam C. Powell, PhD, president, Payer+Provider Syndicate, who wasn’t involved in the analysis, cautioned that such a shift may come with unintended consequences.

The Infrastructure, Investment and Jobs Act of 2021 let the Centers for Medicare and Medicaid Services (CMS) seek reimbursement for discarded drugs — in effect, changing the reimbursement model for medications. That led pharmaceutical manufacturers to respond in kind by changing the dosing model, Powell said. 

“Drugs that previously had personalized weight-based dosing were moved to uniform flat dosing, eliminating the potential for the manufacturer to have to issue a reimbursement if the patient’s personalized dose fell short of the amount in the single-use vial,” Powell added.  

If there is a substantial migration to weight-based dosing, “it is possible that pharmaceutical manufacturers will rethink their dosing and pricing models, just as happened previously,” he cautioned.

However, these strategies could also provide relief for another escalating issue: drug shortages. Especially in the current moment, having a stewardship mindset, “might be helpful in navigating drug shortages,” Strohbehn said.

This research had no commercial funding. Bryant, Strohbehn, and Powell report no relevant financial relationships.

Health Affairs. July 2023. Abstract.

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