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NCCN Guidelines May Aid US Biosimilar Uptake


The National Comprehensive Cancer Network (NCCN) Guidelines may help get biosimilars into circulation because the NCCN will recommend them for off-label uses.

The National Comprehensive Cancer Network (NCCN) can be very helpful for biosimilar uptake because its guidelines allow for more breadth of use than FDA-approved indications, according to a panel of experts who spoke recently.

Payers view the NCCN Guidelines as a gold standard for making reimbursement decisions. Thus, if biosimilars are listed in the guidelines, especially for indications that are off label, it could influence physician prescribing practices and lead to an uptake in biosimilar use, said Bhavesh Shah, RPh, BCOP, senior director of specialty and hematology/oncology pharmacy at Boston Medical Center Health System (BMCHS) of Massachusetts.

Tim Peterson, PharmD, BCOP, clinical pharmacy specialist at Memorial Sloan Kettering Cancer Center in New York, New York, said biologics have been “a significant game changer” over previous, conventional chemotherapy agents. “But we’re now seeing this shift in the paradigm to biosimilars becoming available in different settings, and we’ll start to see more how those are adopted in clinical practice,” he said.

If the NCCN feels “comfortable giving these biosimilar agents in what is an off-label indication, that means that they’ve largely accepted likely the same scenarios that the FDA would require for a manufacturer for extrapolation of indications,” Peterson said.

For example, the filgrastim biosimilar Granix was approved in 2012 as a generic for the originator filgrastim (Neupogen), prior to the biologics approval pathway for protein-based agents under the Biologics Price Competition and Innovation Act. Granix was FDA approved for severe neutropenia—just 1 of the 5 indications for the originator product. “It actually doesn’t have all the indications that the other [filgrastim] biosimilars do, but that’s another option that we have,” Peterson said.

A recent study found that 55% of Granix claims for employer plans were for off-label usage.

“When we’re looking at when physicians are actually going to incorporate these agents… I think [NCCN Guidelines are] going to specifically drive how these are incorporated into practice,” he added.

Also, the discrepancy between how many biosimilars that are FDA approved versus on the market has caused confusion for many physicians, nurses, and pharmacists.

“It may not be available for a certain period of time, and we didn’t always know that. That caused some confusion as well about how many products we have, what we can use, and when,” noted Marc Earl, Pharm D, BCOP, director of pharmacy at Cleveland Clinic of Ohio.

One reason many approved biosimilars take a long time to come to market is that many get held up in patent litigation with originator manufacturers.

“Now that we’re starting to open up into the oncology world, a lot of these drugs, these antibody therapies, are starting to come off patent. This area is really going to explode,” said Peterson.

Peterson expects patent litigation for biosimilar denosumab, a RANK ligand inhibitor used for osteoporosis or skeletal-related events in prostate and breast cancer or multiple myeloma, as it was originally approved for a different indication. “I envision that one taking quite a while to become commercially available.”

The panel was moderated by Anthony Mato, MD, MSCE, director of the Chronic Lymphocytic Leukemia Program at Memorial Sloan Kettering Cancer Center.

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