The following article features coverage from the SGO 2022 Annual Meeting on Women’s Cancer. Click here to read more of Cancer Therapy Advisor’s conference coverage.

The dose-specific packaging of lenvatinib may cost endometrial cancer patients and payers as much as $168 million annually for dose reductions, new research suggests.

The packaging for a 30-day supply of lenvatinib is based on daily dose, which means most dose reductions require that patients receive new 30-day packs. Patients can exchange higher-dose pills for a lower dose at no additional cost, but only for a certain number of pills and in certain circumstances.

After researchers found that this setup may result in anywhere from $36 million to $168 million in overspending, Eisai Inc., the manufacturer of lenvatinib, committed to changing the company’s dose exchange program. That change will allow patients who require a dose reduction to exchange all unused lenvatinib pills for the same number of pills at the reduced dose at no additional cost.

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This research and announcement were presented at the SGO 2022 Annual Meeting on Women’s Cancer by Emeline Aviki, MD, of Memorial Sloan Kettering Cancer Center in New York, New York.

Study Details and Results

For their study, Dr Aviki and colleagues used a decision model to estimate the annual overspending for lenvatinib in 2 scenarios.

In the first scenario, patients received 6 months of treatment with dose reductions that required new dose packs of lenvatinib at the market price, which is $23,624.40, regardless of the dose. In the second scenario, patients received 6 months of treatment with no additional cost for dose reductions, via a dose reduction-friendly starter pack or a no-cost pill exchange.

The researchers assumed a starting daily dose of 20 mg or 18 mg, with patients requiring dose reductions based on those in the KEYNOTE-775 trial ( Identifier: NCT03517449). All dose reductions required a new dose pack except the reduction from 18 mg to 14 mg or from 14 mg to 10 mg. All dose reductions were assumed to occur on the 15th day of a 30-day dose pack.

Using data from the SEER database and the literature, the researchers estimated that 7985 patients with endometrial cancer in the United States will be eligible to receive lenvatinib each year.

Assuming a 20 mg starting dose and accounting for the expected dose reductions, the 6-month cost of lenvatinib for this population was estimated to be about $1.3 billion ($1,299,735,346).

If a starter pack or a no-cost pill exchange were offered, the 6-month cost would be reduced to roughly $1.1 billion ($1,131,845,004). That means that overspending due to dose packaging alone is estimated to be nearly $168 million ($167,890,342) annually, Dr Aviki said.

In the scenario assuming an 18 mg starting dose, the estimated overspending would be nearly $36 million ($35,841,758).

Existing Program and New Manufacturer Commitment

After the abstract for this study was released, individuals from Eisai Inc. approached the study team and informed them of the existing dose exchange program for lenvatinib.

“This program was unknown to members of the study team, which included pharmacy staff at 3 separate institutions and a pretty extensive Google search,” Dr Aviki said.

The program allows for the exchange of pills only for the first dose reduction from 20 mg to 14 mg. It can be used a maximum of once per quarter, and a maximum of 15 pills can be replaced.

Even with this new information taken into account, and assuming broad knowledge of and use of this program, overspending on lenvatinib would still be an estimated $36 million per year, Dr Aviki noted.

“Remarkably, just prior to entering this meeting to give this talk, I was approached by members of Eisai, the manufacturers of lenvatinib, and they have given a commitment to completely revamp their dose exchange program so that it will cover all indicated dose reductions and all pills that are unused by patients,” Dr Aviki said, to a round of applause from the audience.  

“We have to hold them to that,” she added. “I feel very strongly they are committed to seeing it materialize.”

Disclosures: Dr Aviki declared no relevant conflicts of interest.

Read more of Cancer Therapy Advisor’s coverage of SGO 2022 by visiting the conference page.


Aviki E, Moss H, Albright B, et al. Overspending driven by dose-specific packaging of lenvatinib for endometrial cancer. Presented at SGO 2022; March 18-21, 2022. Abstract 18.