Biosimilars, Coverage Decision Making, and Getting the Answers You Need

February 21, 2016 •  Stanton R. Mehr

The fact of the matter is, a biosimilar won’t receive de facto preferred positioning on a health plan or insurer’s formulary. Over the past few years, we’ve come to realize that so many issues are in play, and many opposing factors that can relegate a new biosimilar agent to nonpreferred status or to put it at the head of the line in tier 2.

“It all depends…” is an answer that will have the most experienced pharmaceutical executives rolling their eyes. But in biosimilar product launches, marketing, and access, there are simply too many variables in a new market in which little real payer experience exists.

For example, let’s say Product X is a new biosimilar TNF inhibitor, and let’s assume for the sake of argument all the patent, exclusivity, and approval challenges have been worked out. The FDA did not designate the agent to be interchangeable to the reference product.

  • Did FDA grant the biosimilar the full slate of indications (i.e., extrapolation)?
  • What was the reference drug’s manufacturer reaction to the new product entering the market—did they cut net prices for their own product? Is the price of Product X now 20% lower than the new price of the reference product or maybe even par with it?
  • Are prescribers comfortable starting their newly diagnosed patients on Product X, or will they still prefer the reference product?
  • If the reference product fails to yield a satisfactory outcome, should Product X be tried next?
  • What about Medicare Part D or Part B coding and reimbursement?
  • Will the payer institute a separate biosimilar tier and will Product X be on it?
  • Will patient assistance programs make it easy to afford and access Product X?

The answers to these imperative questions will affect launch expectations as well as opportunities for gaining acceptance and marketshare. It is plain that blanket answers will be of limited use, as each health plan and insurer will set different priorities and react in different ways to a new biosimilar situation.