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Vote in May made FDA-approved biosimilars an "appropriate substitution" for brand-name biologics in NCCN guidelines.
Expensive, brand-name biologics have become an important part of American cancer treatment, so if biosimilars are ever going live up to their billing and put a serious dent in the spending on and cost of biologics — and American healthcare — they’re going to need to win over a considerable number of hearts and minds in organized oncology.
That may be beginning to happen.
“It is really only recently — the last year, year and a half that they have become practically, pragmatically available,” Wui-Jin Koh, senior vice president/chief medical officer of the National Comprehensive Cancer Network (NCCN), said in an interview this week with Managed Healthcare Executive.® NCCN, an alliance of 30 leading cancer centers headquartered in suburban Philadelphia, issues influential treatment cancer guidelines and other policies.
“Can we say it is a success?” said Koh about biosimilars. “I think I can say it has been an emerging success in terms of approvals and availability. It may not be the same success in terms of utilization.”
Koh said an NCCN steering committee voted unanimously in May to revise all of its guidelines to indicate that an FDA-approved biosimilar is an “appropriate substitution” for a brand-name biologic. Previously, some of NCCN panels for specific cancers had done so but the policy in May applied to guidelines for all cancers.
Of 28 biosimilars that the FDA has approved, 16 have indications for cancer treatment or for supportive care of cancer patient by increasing red and white blood cell counts.
Here is a list of the 16 biosimilars with indications that are related to cancer care:
And here is a list of the 12 other approved biosimilars that are not related to cancer:
Koh said more “real-world” data will need to be collected on biosimilars as they enter clinical practice to precisely evaluate their equivalency to their brand-name products. But he said that he doesn’t have any serious doubts about biosimilars.
“For all intents and purposes,” said Koh, “the efficacy, the safety, cannot be distinguished from the reference product.”
NCCN doesn’t have a specific policy about whether clinicians should tell patients whether they are prescribing a biosimilar instead of a brand-name reference product, according to Koh. but he said the organization does have general recommendations that “clinicians, in dealing with patients, should be fully transparent.”
Koh noted that NCCN has a clinical focus and usually doesn’t deal with cost or spending issues but that part of its mission is to promote access to cancer care as well as its quality and efficiency. “We recognize that cost will impact the cost and sustainability of the oncology care system.”
NCCN announced recently that it was working with Pfizer on a program that will award grants to oncology groups and other organizations to study and encourage the use of biosimilars. Koh said NCCN is acting as an adviser and that Pfizer will run the $1.5 million program. Pfizer currently lists six biosimilars of its website, five of which are used in cancer care: Nivestym, Retacrit, Ruxience, Trazimera and Zirabev.
Oncology groups and other organizations have till September 9 to apply for grant from the program.