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Sandoz Policy Expert Discusses Biosimilar Barriers


Education is often noted as a barrier to uptake, but a prominent pharmacy expert said multiple private and public policies also stand between patients and biosimilars.

Policies on biological drug interchangeability, prior authorization, and nonmedical switching are holding back US biosimilar uptake, according to Mary Jo Carden, RPh, JD, head of policy for Sandoz, who spoke on the subject recently in an Academy of Managed Care Pharmacy—sponsored webinar.

In rheumatology and oncology, physicians and patients have a lingering concern that biosimilars may not be as safe or effective as reference products, although the FDA in authorizing biosimilars certifies that they have no clinically meaningful differences.

But there are other barriers to uptake, Carden said.

Interchangeability Status Is Hard to Get

Currently, the FDA may require biosimilar manufacturers to conduct a comparative clinical immunogenicity study to gain interchangeability status. Interchangeability would allow pharmacists to fill prescriptions with biosimilars rather than reference products without consulting the physician. So far, no biosimilars have an interchangeability designation, making it harder for patients to access biosimilars.

However, “as we get more biosimilars on the market, we are seeing a growing body of evidence on immunogenicity and how biologics and biosimilars can be used interchangeably and safely with few immunogenicity issues even without a designation of interchangeability,” Carden said.

Prior Authorization for a Similar Product?

Payers may require prior authorization for use of reference products, but prior authorization may also be required for biosimilars. “We think that is redundant. While prior authorization may be necessary for the reference product, once you have it with a reference product, you should not have to then get it for the biosimilar,” Carden said.

Nonmedical Switching May Go Against Biosimilars

States have been fighting “nonmedical switching” of drugs, which occurs when payer policies or pharmacy actions change the drugs that a patient has access to. One of the concerns about nonmedical switching is that, through this process, a patient may be transferred from a drug that works to a drug that doesn’t work as well.

Anti—nonmedical switching laws may be well-intentioned, but patients may lose access to affordable biosimilars that are clinically equivalent to more-costly reference drugs, Carden said.

“When you have biosimilars to a reference product, you can use these interchangeably, as noted [by a physician]. Pharmacies would have to call [the physician to confirm], but there's no reason why a patient cannot get switched from an innovator product to a biosimilar,” she said.

These 3 barriers to uptake, well-intentioned or not, prolong the dominance of reference products and make it harder for patients to receive affordable treatment. States such as Minnesota and West Virginia have been pushing for legislation that would restrict biosimilar access further, she said.

“It's interesting that when the sponsors of the bills find that the impact is to really lock out biosimilars, they think twice. So, there's really an opportunity to work with states on these initiatives that we're seeing,” said Carden.

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