FDA’s Gottlieb floats ideas on Medicare drug coverage


– Trump administration officials are eying office-administered drugs in crowded therapeutic categories for the switch from Medicare Part B to Medicare Part D as an early way to reduce spending on prescription drugs.

When the current Part B drug reimbursement scheme – average sales price plus an additional 6% to cover administration and storage – was developed, there was little competition in most of the covered therapeutic categories, Scott Gottlieb, MD, Food and Drug Administration commissioner, said May 15 at an event hosted by the Alliance for Health Policy.

Dr. Scott Gottlieb, FDA Commissioner Gregory Twachtman, MDEdge News

Dr. Scott Gottlieb, FDA Commissioner

“If you look within the categories of the TNF inhibitors and a lot of monoclonal antibodies, there wasn’t product competition in those categories,” Dr. Gottlieb said. “These were very novel drugs. They hadn’t been on the market, in many cases, for many years.”

The situation is different now. “Not only are these product categories multisource and in some cases quite crowded, but there is also a lot of therapeutic equivalence,” Dr. Gottlieb said. “There are a lot of other types of drugs [physicians] might use to try to address the same clinical condition.”

He specifically noted that autoimmune and inflammatory conditions have a wealth of products that address them in different ways, with the opportunity for therapeutic substitutions. He also mentioned drugs that are delivered through durable medical equipment as another area open to being moved into a more price-competitive space.

“I don’t think anyone envisioned how competitive these categories would become,” he said.

Switching drug coverage from Medicare Part B to Part D is just one of more than 50 proposals contained in a broad package introduced by the White House on May 11 to address the rising prices of prescription drugs.

“In situations where you have a lot of therapeutic variety ... you have [insurance] plans negotiating pricing using formularies and using things like step therapy, putting drugs on preferred tiers relative to the price concessions they are able to extract,” Dr. Gottlieb said.


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