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PHOENIX -- Dose-specific packaging could potentially result in substantial excess spending on lenvatinib (Lenvima) for endometrial cancer, a researcher reported.

Patients and payers may be on the hook for as much as $168 million in annual overspending for dose reductions for the disease -- spending that could be avoided with different packaging, reported Emeline Aviki, MD, MBA, of Memorial Sloan Kettering Cancer Center in New York City, at the Society of Gynecologic Oncology (SGO) meeting.

At SGO, Aviki updated her results with the news that, just prior to giving her presentation, she was informed by representatives of drug developer Eisai that the company is now committed to a completely revamped dose reduction program "so that it will cover all indicated dose reductions, and all pills that are unused by patients."

Aviki added that after the release of their SGO abstract, they were approached by company representatives, and made aware of a dose exchange program.

"This [exchange] program was unknown to members of the study team, which included pharmacy staff at three separate institutions, and a pretty extensive Google search." Aviki said.

Lenvatinib plus pembrolizumab (Keytruda) received FDA approval in 2021 for advanced endometrial cancer, based on results from the trial, which showed a 5.4-month overall survival benefit in women with microsatellite, stable, advanced disease after platinum-based therapy.

"Importantly, in that study, 70% of patients required one or more dose reduction, and 45% required two or more dose reductions," Aviki said. "So based on this very high number of dose reductions, the packaging of lenvatinib became a very important characteristic."

Aviki explained that the drug packaging requires patients to have a brand new 30-day dose pack -- which has a market price of $23,624.40 for dose pack -- for many of those dose reductions.

Aviki's group wanted to estimate the excess revenue generated in a year just due to the packaging associated with dose reductions. They constructed a decision model designed to simulate two scenarios:

• Scenario 1 (current dose packaging): 6 months of treatment with dose reductions that cost the market price for each new dose pack
• Scenario 2 (alternative packaging): 6 months of treatment that assumed dose reductions occurred with no additional costs to patients or payers

The assumptions of this decision model included a starting daily dose of 20 mg, and the probability of dose reductions based on KEYNOTE-775. All dose reductions required a new dose pack, except dose reductions from 18 mg to 14 mg, or 14 mg to 10 mg, and the 30-day cost of lenvatinib was based on the market price above.

Using data from the and available literature, the investigators estimated that 7,985 patients with endometrial cancer would be eligible to receive lenvatinib annually.

Assuming a 20-mg starting dose and accounting for expected dose reductions, Aviki and colleagues estimated that the 6-month cost of lenvatinib in scenario 1 was $1,299,735,346. However, if dose reductions occurred at no expense to patients or payers, as in scenario 2, the 6-month cost of lenvatinib dropped to $1,131,845,004.

"Therefore, overspending due to dose packaging alone, is estimated to be almost $168 million annually," Aviki said.

The investigators also modeled an alternative scenario that assumed a starting dose of 18 mg, which would result in an estimated 6-month cost of $1,131,845,004, and result in a reduction in overspending of $35,841,758.

The proposed exchange program allows for exchange of pills only for the first dose reduction from 20 mg to 14 mg, a maximum use of once per quarter, and the replacement of a 15-day supply.

"If we assume broad awareness and 100% use of the dose exchange program, the estimated overspending would still be almost $36 million," Aviki pointed out. "But if this program were to cover any indicated dose reduction, and any days the patient needed replaced, it would establish a new industry standard to avoid any excess revenues due to dose reductions to be paid for by patients or payers."

As for the developer's commitment to the dose exchange program, "we have to hold [the company] to it," Aviki stressed. "And I feel strongly they are committed to seeing it materialize."

SGO discussant Kemi M. Doll, MD, of the University of Washington in Seattle, said the study is an example of how a structural decision regarding packaging and price of drugs drives outcomes, rather than individual patient, provider, or hospital decisions.

"I would invite us to consider that, similarly to the rapid way in which this [data were] received and acted upon by Eisai, we could do the same with the structures that we control in gynecologic oncology, like our own clinical trial networks," she said.

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