Will Keytruda and Opdivo Finally Get Some Price Competition? | AMCP Nexus 2022

Next year could bring some long-awaited price competition to Keytruda (pembrolizumab), Opdivo (nivolumab) and the other PD-1/PDL-1 inhibitors, according to Bhavesh Shah.

But Shah, chief pharmacy officer hematology/oncology and specialty pharmacy at Boston Medical Center Health System, also told a large audience on the final day of the AMCP Nexus 2022 meeting that the “PD-1 disruptors” may be foiled by several developments.

Shah noted that the current crop of PD-1/PDL-1 are currently being tested in combination formulations. If clinical trial results show that those combinations are safe and effective, then PD-1/PDL-1 newcomers might have difficulty gaining acceptance, he said

Another possible obstacle is the push to test the established PD-1/PDL-1 drugs as adjuvant or neoadjuvant therapies, which he said might preclude the “downstream” use of the newcomers.

Shah’s co-presenter in the popular session on the oncology drug pipeline, Kaelyn Boss, Pharm.D., mentioned that competition to Keytruda and Opdivo might also be stymied by subcutaneous formulations that are currently in late-stage clinical trials. Currently, both drugs are formulated to be administered intravenously. Boss is a clinical consultant pharmacist at the University of Massachusetts Medical School.

As competitors on price, the PD-1 disruptors are akin to biosimilars, Shah said. The current crop of PD-1/PDL-1 inhibitors are similarly priced, and the manufacturers don’t use rebates and other pricing tactics. “We are looking at the PD-1 agents, which are having the biggest cost impact (of the cancer drugs) from a payer perspective, and we see no discounts,” Shah said.

The PD-1 disruptor that appears to be closest to coming to market is sugemalimab, which has tested in clinical trials as a treatment for nonsmall cell lung cancer, the most common form of lung cancer. About 80% of the spending on PD-1/PDL-1 inhibitors comes from their use as treatments for nonsmall cell lung cancer, so a price competitor in the treatment for that disease could have a significant effect, Shah noted. EQRx, the company developing the sugemalimab, doesn’t have a filing date but is discussions with the FDA and could file its application for agency approval next year, he said. The company has taken the unusual step of signing memos of understanding with payers and health systems prior to approval, according to Shah.

Shah said EQRx has indicated that it plans to market sugemalimib at at a price that is 40% lower than the other PD-1/PDL-1 inhibitors that are used as treatments for nonsmall cell lung cancer. Lilly also has plans to develop and launch a PD1-PDL-1 inhibitor with a price that is 40% lower than the competition, he said.

Shah listed five other PD-1/PDL-1 disruptors: tislelizumab, sintilimab, cosibelimab, toripalimab and zimberelimab.

Boss and Shah also discussed competition coming to CAR-T therapy for multiple myeloma. The FDA has approved two CAR-T for multiple myeloma, Abecma (idecabtagene vicleucel), priced at almost $420,00 and Carvykti (ciltacabtagene autoleucel), which is priced a little higher, at $465,000. The FDA is reviewing the application of teclistamab, a bispecific antibody that like Abecma and Carvykti, would be indicated as a fifth-line treatment for multiple myeloma. CAR-T requires harvesting the patient’s own T cells and genetically modifying them, so they recognize cancer cells. Boss and Shah said that teclistamab would be an “off-the-shelf” product that would, therefore, be more readily available and improve access to late-line treatment. Boss mentioned that teclistamab might be used as a bridge therapy to CAR-T.

It is difficult to say whether teclistamb will be prove to be less expensive than the CAR-T treatments, Shah noted. The CAR-T treatments are one-time treatments whereas teclistamab will be given regularly. Regardless, Shah said payers (and patients) may need to brace themselves for an era when the cost of late-line multiple myeloma treatment exceeds $1 million a year as patients cycle through treatment with antibody-drug conjugate therapies such as Blenrep (belantamab mafodotin), bispecific antibodies and the CAR-T treatments.