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ACI Panelists Discuss Misaligned Incentives in the Biosimilars Market

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Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.

Health care consumers are routinely blitzed with advertisements by drug companies, so how are they to find out about biosimilars? And further, providers and payers aren’t necessarily going to agree on what drugs should be prescribed to patients. Should they be lowest-cost or should the manufacturer with the most reliable supply chain be granted preference on formulary?

A panel of industry experts moderated by an economist addressed these issues in a recent talk at the American Conference Institute’s 2021 Summit on Biosimilars and Innovator Biologics.

Interchangeability almost has become an unnecessary stumbling block to implementation of biologics and biosimilars

“The thing that sometimes is indicative of our market is that with so many different stakeholders, incentives are not always aligned,” said Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi.

He joined panelists Terry Rea, vice chair of the Intellectual Property Group at Crowell & Moring in Washington, DC, and Sonia T. Oskouei, vice president of biosimilars at Cardinal Health, in the discussion conducted by Joseph P. Fuhr, professor emeritus of economics at Widener University.

“I’m afraid that consumers are overwhelmed with anecdotes on biosimilars. I mean, we advertise to them directly. We have insurance companies that advertise constantly on TV,” Rea said. The world was a lot simpler years ago, but things have gotten more specialized, and with that, complexity has crept in. “Our complex system is delaying getting good medications to patients.”

Kaiser Permanente is a managed care consortium that has had tremendous success in getting biosimilars into use by patients, but it’s the integrated nature of that network that has been key to this accomplishment, Ahmed said. “It’s not that I’m advocating for full integration of every health plan with a network, but it does show the power of aligning incentives.”

Interchangeability

Six years after biosimilars first appeared in the United States, a new level of complexity is about to surface with the pending arrival of biosimilars designated as “interchangeable,” which would enable pharmacists to dispense them in place of originator biologics without a prescriber’s express authorization.

Panelists said the interchangeable designation has already added new wrinkles to biosimilar adoption. Manufacturers may not see any value in seeking interchangeable designations for their biosimilars, and they may not even qualify. The FDA requires studies to demonstrate no changes in outcomes for patients who switch multiple times between originator and biosimilar agents.

“Some of these products could be waiting a lifetime and not have that designation, and there continues to be a knowledge gap around what the designation means and the implications of it,” Oskouei said.

The first interchangeable insulin biosimilars are expected to be approved soon, and this will be an opportunity to observe how the interchangeable designation functions, particularly in the managed care setting, Oskouei said.

“If there’s ever an opportunity to bring more affordable medicine to diabetes care in the United States, this is a great, great event,” she said.

You can see good uptake of biosimilars in oncology, but the same is not true across the board, Ahmed said. “I’m not sure whether spending all that extra time doing the clinical trials to get that interchangeable designation is really worth the squeeze. It will really depend on product.

“Maybe in the autoimmune space there could be more value to it, although you could still argue that working closely with a pharmacy benefit manager and a payer to get a preferred formulary position would be actually more valuable than having an interchangeable designation,” he said.

I do think that the number of patents that protect some of these molecules extends the patent term, or the time of a period of exclusivity, far beyond anything that was expected in the beginning

Still, an interchangeable designation may mean less to a provider who is trained to consider the clinical evidence supporting a treatment and base medical decisions on that. As a manufacturer, “You might be better off investing in health economic data. You know, how many times does a patient have to return to the hospital or the clinic?” Ahmed said.

“Interchangeability almost has become an unnecessary stumbling block to implementation of biologics and biosimilars,” Rea said. “It’s actually misleading and frustrating.”

Interchangeability is not likely to cause payers to put more emphasis on use of biosimilars, Ahmed said, speaking from the manufacturer’s point of view. “I think adoption and pricing and manufacturing capabilities and who you are in the market in terms of having a sales force that can pull that drug through the channel” will be more important to whether a payer grants preferred access or, simply, formulary access, he said.

Patent Obstacles

A real barrier to biosimilar use is the patent portfolios that originator companies acquire to protect their product exclusivity, Rea said.

“I’m primarily a patent attorney, and I’d like to see manufacturers or the innovators be limited with the number of patents or the patents they’d like to assert [in litigation], because right now I do think we are delaying the number of biosimilars that are on the market, or preventing companies from even getting into that space, because of the huge number of patents,” she said.

“I do think that the number of patents that protect some of these molecules extends the patent term or the time of a period of exclusivity, far beyond anything that was expected in the beginning,” she said.

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