Insurance Companies Starting to Cover Anktiva, a Bladder Cancer Immunotherapy

More than a dozen insurance plans, with more than 100 million covered lives in United States, are now providing access to Anktiva (nogapendekin alfa inbakicept-pmln), according to its developer ImmunityBio. No information, however, is available about which insurance plans are providing coverage of Anktiva or what the utilization management requirements are.

Anktiva was approved in April 2024 and launched in May 2024 to treat patients with non-muscle invasive bladder cancer. Anktiva is an immunotherapy indicated to be used in combination with Bacillus Calmette-Guérin (BCG) vaccine. It has a mechanism of action that leads to the proliferation of natural killer and T cells. This provides a boost to the immunological response generated by BCG vaccine, which is the standard of care for this cancer.

Related: FDA Approves Bladder Cancer Immunotherapy

In May 2024, the National Comprehensive Cancer Network (NCCN) added Anktiva to its guidelines for bladder cancer.

Anktiva has a list price of $35,800 per dose, and ImmunityBio offers a copay program for eligible patients that provides Anktiva at $100 per dose, with a maximum benefit of $25,000. In the second quarter of 2024, Anktiva generated revenue of $990,000. Anktiva is ImmunityBio’s only marketed producted that is generating revenue.

The company is currently recruiting patients for a pivotal trial of patients with bladder cancer who are BCG naive. The trial is investigator Anktiva in combination with BCG for these patient

Anktiva is also being developed to treat patients with other cancers. In non-small call lung cancer, it has been assessed in patients who have been unresponsive to a checkpoint inhibitor. ImmunityBio announcedthat positive results form the QUILT 3.055 study, which found that the addition of Anktiva prolonged overall survival. These results were noted regardless of the patient’s PD-L1 status.

“We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or of tumor location. As with non-muscle invasive bladder cancer, we believe that Anktiva enhanced the NK and T cell activity critical for targeting and killing cancer cells which have entered the phase of tumor evasion and resistance,” Patrick Soon-Shiong, M.D., executive chairman and global chief scientific and medical officer at ImmunityBio, said in a news release in April.

Additionally, last week, ImmunityBio announced that it is beginning a phase 1/2 study of Anktiva in combination with the investigational AdHER2DC vaccine (autologous dendritic cells transduced with HER2 expressing adenovirus) in patients with HER2-expressing endometrial cancer.

AdHER2DC is an autologous vaccine that targets the HER2 protein, which is elevated in 30% of patients with endometrial cancer and in more than 50% of high risk subtypes. AdHER2DC is an agent of the National Cancer Institute and will be manufactured by the NCI for ImmunityBio’s trial.

ImmunityBio has also partnered with the NCI for use of Anktiva Lynch syndrome, a genetic condition that is linked with significantly increased incidence of cancers, particularly colon cancer.