Utilization Management Strategies Are Impacting Biosimilar Uptake, Says Report

Avalere has issued a new report that finds that utilization management strategies, including preferential formulary design and step therapy, are impacting the uptake of biosimilars in the United States.

While the Congressional Budget Office (CBO) in 2009 projected that the United States could achieve a $5.9 billion savings from biosimilars over 10 years, Avalere estimates the actual savings realized since the inception of the US biosimilars pathway at just $241 million, or 8% of the CBO’s projection for the period. (Notably, the savings estimate includes savings from tbo-filgrastim, which was not approved as a biosimilar but as a follow-on version of filgrastim.) While there are multiple factors at work that have led to somewhat disappointing cost-savings, the report suggests that payer policies are playing a significant role.

The report’s authors assessed commercial plan coverage and formulary design concerning biosimilars for the top 25 payers—covering approximately 189 million lives—in the United States, using publicly available policies. For each plan, they sought to determine the order of therapy (or step therapy) for biosimilars or other products in a given indication. Namely, they identified whether a particular product was the preferred first step, whether a patient had to use that product for a specified period of time before changing to the next preferred step or steps, and whether there were exceptions allowed.

Of the plans reviewed, 18 had available documents related to infliximab and its biosimilars:

• 4 plans had no step therapy required for a patient to receive any of the 3 available infliximab products (the reference Remicade and the biosimilars Inflectra and Renflexis).
• 7 required use of generic disease-modifying anti-rheumatic drugs (DMARDs) first, alone, or in combination with a biologic.
• 10 required use of the reference infliximab first, alone, or in combination with a DMARD.
• 1 allowed for either the reference or of 1 biosimilar (Inflectra) first.
• 1 plan required the use of 1 biosimilar infliximab (Inflectra) first.
• 2 plans required 12- or 14-week treatment periods to demonstrate treatment failure.
• 6 plans required testing for neutralizing or serum antibodies.
• 4 plans have different policies for the use of infliximab in different approved indications.

The report highlights the fact that, in many cases of step therapy that require a patient to start with a reference biologic, the biosimilar of the same product will only be covered if the patient fails to respond adequately to the reference. This practice, they note, contradicts the European League Against Rheumatism’s recommendations that switching to another drug—not a biosimilar of the same drug—may be appropriate in the case of treatment failure.

The same 18 plans had medical benefit information available for filgrastim and its biosimilar (Avalere did not include tbo-filgrastim in this portion of the analysis):

• 5 plans preferred biosimilar filgrastim.
• 5 plans preferred reference filgrastim.
• 8 plans did not indicate a preference through their formulary design.

The authors write that, while it is to be expected that payers will act to protect their short- to medium-term cost-savings interests by employing utilization management strategies to biosimilars, “The extent to which such policies are necessary, will continue to be put in place, and/or will be effective, remains to be seen,” and the clinical appropriateness of such policies will need to be evaluated.