Lenvatinib packaging for endometrial cancer linked to $168 million overspending
PHOENIX – Specific dose conditioning could potentially lead to substantial overspending on lenvatinib (Lenvima) for endometrial cancer, a researcher has reported.
Patients and payers could face up to $168 million in annual overspending for disease dose reductions — expenses 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 before giving her presentation, she was informed by representatives of drug developer Eisai that the company has now embarked on a completely dose reduction program. revamped “so that it covers all stated dose reductions, and all pills that are not used by patients.”
Aviki added that after their SGO summary was released, they were approached by company representatives and told about a dose-swap program.
“This [exchange] program was unknown to members of the study team, which included pharmacy staff at three separate facilities, and a fairly thorough Google search,” Aviki said.
Lenvatinib plus pembrolizumab (Keytruda) received FDA approval in 2021 for advanced endometrial cancer, based on results from the KEYNOTE-775 trial, which showed an overall survival benefit of 5, 4 months in women with microsatellite disease, stable and advanced after platinum therapy.
“It is important to note that in this study, 70% of patients required one or more dose reductions, and 45% required two or more dose reductions,” Aviki said. “So based on this very high number of dose reductions, lenvatinib conditioning became a very important feature.”
Aviki explained that the drug’s packaging requires patients to have a brand new 30-day dose pack – which has a market price of $23,624.40 for the dose pack – for many of these dose reductions. .
Aviki’s group wanted to estimate the excess revenue generated in a year solely due to conditioning associated with dose reductions. They built a decision model designed to simulate two scenarios:
- Scenario 1 (current dosage pack): 6 months of treatment with dose reductions that cost the market price for each new dosage pack
- Scenario 2 (alternative packaging): 6 months of treatment assuming dose reductions have occurred at no additional cost to patients or payers
Assumptions for this decision model included an initial daily dose of 20 mg and the likelihood of dose reductions based on KEYNOTE-775. All dose reductions required a new dose, except dose reductions from 18 mg to 14 mg or 14 mg to 10 mg, and the cost of lenvatinib over 30 days was based on the market price above .
Using data from the SEER database and available literature, the researchers estimated that 7,985 patients with endometrial cancer would be eligible to receive lenvatinib each year.
Assuming a starting dose of 20 mg and taking into account expected dose reductions, Aviki and colleagues estimated the cost of lenvatinib over 6 months in Scenario 1 to be $1,299,735,346. However, if dose reductions occurred at no cost to patients or payers, as in Scenario 2, the cost of lenvatinib over 6 months would drop to $1,131,845,004.
“Therefore, the overspending due to dose packaging alone is estimated to be nearly $168 million per year,” Aviki said.
Investigators also modeled an alternative scenario that assumed an initial dose of 18 mg, which would result in an estimated 6-month cost of $1,131,845,004 and a reduction in overspending of $35,841,758.
The proposed exchange program allows the exchange of pills only for the first dose reduction from 20 mg to 14 mg, a maximum use of once per quarter and replacement of a 15 day supply.
“If we assume broad awareness and 100% use of the dose exchange program, the estimated overrun would still be nearly $36 million,” Aviki pointed out. “But if this program were to cover any indicated dose reduction and all days the patient needed to be replaced, it would set a new industry standard to avoid any excess revenue due to dose reductions to be paid by patients or payers. .”
As for the developer’s commitment to the dose exchange program, “we have to take [the company] “, stressed Aviki. “And I am convinced that they are determined to see it materialize.
SGO commentator Kemi M. Doll, MD, of the University of Washington in Seattle, said the study is an example of how a structural decision about drug packaging and pricing determines outcomes, rather than individual patient, provider or hospital decisions.
“I invite us to consider that, like the speed with which this [data were] received and monitored by Eisai, we could do the same with the structures we control in gynecological oncology, such as our own clinical trial networks,” she said.
Aviki did not disclose any relationship with the industry.