Survey Highlights Patient Concerns With Automatic Biosimilar Substitution

A recent survey shows that some patients have greater concerns about automatic substitution of biosimilar products than they do about the high cost of biologic drugs.

The survey, conducted by the Canadian group Consumer Advocare Network from May to June 2017, assessed the views of 588 patients, half of whom were currently taking a biologic medicine. The patients had been diagnosed with diseases including arthritis, diabetes, gastrointestinal disorders, cancers, and rare diseases. The survey found the following:

• 90% of respondents said that they had the right to make an informed choice about their treatment, and did not support automatic substitution of a biosimilar for a reference product
• 80% believed that they should have the right to take a more expensive reference product
• 80% believed that a biosimilar would not be as effective as a reference biologic, and that a biosimilar could have different side effects
• 75% were concerned about the extrapolation of indications for biosimilars
• 60% viewed pharmacovigilance as “very important”
• 20% said that the lower cost presented by biosimilars was important

“The bottom line is that patients want to be sure that the biologic medicines they are taking have been tested for their condition, they have a choice as to which biologic is prescribed, and what they are prescribed is what they get,” Consumer Advocare Network said in its press release announcing the survey results.

Automatic substitution is the norm in Canada, where lower-cost products may be automatically substituted for reference products. In the United States, however, 33 states and Puerto Rico have taken legislative action concerning biosimilar substitution, with most states prohibiting automatic substitution and protecting the physician-patient relationship by ensuring communication concerning substitution of a biosimilar for a reference drug.

Despite patients’ concerns about being moved to biosimilars against their will, and despite legislative action seeking to leave choices concerning the use of biosimilars in the hands of physicians, other factors—such as formulary design—could push patients from reference products to biosimilars.

This week, Express Scripts, a leading pharmacy benefit manager (PBM), released its 2018 National Preferred Formulary. This updated formulary introduces several drug exclusions, including replacing filgrastim (Neupogen) with its competitors, TBO-filgrastim (Granix) and the biosimilar fligrastim-sndz (Zarxio).

The company notes that it is also considering changes to drugs treating inflammatory conditions, and that it could expand the list of excluded products to include such treatments when it releases its final 2018 list on or before September 15, 2017. It remains to be seen whether Merck and Samsung Bioepis’ newly launched infliximab biosimilar, Renflexis (introduced at a 35% discount to the reference Remicade), could push the originator product off formularies, leaving patients and providers with fewer, yet cheaper, options for biologic treatment.