The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.
Interchangeable biosimilars are starting to emerge and with them, pharmacists are gaining the right to make automatic substitutions, without physician intervention. The Alliance for Safe Biologic Medicines has just appointed a new chair who vows to fight to preserve physician discretion over biosimilar use.
“Biosimilars are a helpful tool in controlling health costs,” said Ralph McKibbin, MD, the incoming chairman of ASBM, who began his term September 1, replacing Madelaine Feldman, MD. “It is also important to me that my patients are able to maintain control over their condition without unnecessary or inappropriate switching.”
The group is opposed to payer policies that emphasize the use of biosimilars over originator biologics on the basis of cost alone, which is known as nonmedical switching. ASBM was founded in 2010, approximately 5 years before the first biosimilar (Zarxio; filgrastim) was approved and launched in the United States.
However, the ASBM has also gone on record with concerns about the approval of interchangeable biosimilars. In recommendations to the FDA on allowing interchangeable biosimilars, the group advised that the FDA not grant interchangeable designations unless the biosimilar drug application sponsors can provide evidence supporting interchangeability for all indications of the reference drug. Otherwise, the group said, only biosimilar status should apply.
The ASBM contended there are therapeutic differences between biosimilars and their reference products. "The clinical reality is that if a biologic is approved as interchangeable for 1 indication, it will be assumed that it is interchangeable for all conditions of use, regardless of whether the agency has considered sufficient supporting evidence. This assumption is hard-wired into clinician behavior as a result of decades of experience with generic medicines, where therapeutic equivalence, once demonstrated, applies across all indications.
"This approach is not appropriate for biologic medicines and has the potential to lead to inappropriate substitution that can put patient safety at risk," the group wrote.
This is not the position of the FDA. The FDA defines biosimilars as having no clinically meaningful differences in terms of safety, purity, or potency from their reference or originator products. The FDA has defined interchangeables as biosimilars that have been demonstrated to produce the same clinical results as their reference products in any given patient and states that there is no additional safety or diminished efficacy risk from switching between the reference product and biosimilar.
McKibbin is a practicing gastroenterologist based in Altoona, Pennsylvania. He is past president of the Pennsylvania Society of Gastroenterology and the Digestive Disease National Coalition (DDNC). Besides his opposition to nonmedical switching, he has published editorials against insurance industry utilization management tactics such as step therapy and copay accumulator adjustments. Copay accumulator adjustments make it impossible for manufacturer drug coupons to count against patients' out-of-pocket maximums or deductibles. He recently co-authored a paper for the DDNC on protecting the ability of patients and providers to make care decisions.
McKibbin has previously lobbied in favor of legislation in his home state of Pennsylvania that would prevent nonmedical switching. Increasingly, payers are putting biosimilars onto preferred tiers in order to realize savings, taking advantage of FDA assurances that these agents are safe to use in place of reference biologics.
Payers vs the Medical Community
CVS recently explained in an interview with The Center for Biosimilars® that biosimilars are helping to keep medical inflation under control and save money for patients. “CVS Health’s PBM relies on a range of strategies to drive towards the lowest net prescription drug cost for our clients and members, including generating more competition through biosimilars,” said Phillip J. Blando, spokesman for CVS. “These strategies helped us keep the rate of growth in prescription drug costs for our clients to less than 3% in 2020.”
However, sometimes these policies go too far, according to the American Academy of Ophthalmology (AAO), which earlier this summer sounded the alarm when payers increasingly began to prefer biosimilar versions of bevacizumab for ophthalmologic treatment. The originator product, Avastin, is used off-label for these conditions, and this is based on extensive clinical study and positive evidence, but bevacizumab biosimilars may have hidden safety risks in intravitreal (in the eye) injections and also deserve extensive clinical evaluation, the AAO said.
The AAO said some payers put bevacizumab biosimilars into the preferred position for ophthalmic conditions following shortages of Avastin. Some payers defend their decisions to prefer these products; UnitedHealthcare changed its policy on recommending use of Mvasi and Zirabev, both bevacizumab biosimilars, following a discussion with the AAO about this issue.