Self-Injectable Biosimilar Drugs and the Pharmacy Benefit

With the approval of the first ranibizumab biosimilar and its launch by Samsung Bioepis/Organon earlier this month, the question arises as to whether this drug will be covered under the medical or pharmacy benefit. Typically, biologics infused or injected in the provider’s office are covered under the medical benefit for commercial insurers or Part B for Medicare eligibles. This is not a rule set in stone, however. On the other hand, insulin is virtually always self-injectable and covered under the pharmacy benefit.

Certainly, ranibizumab is not a simple category. We now have ranibizumab port systems that extend the duration between injections. A large segment of patients receiving intra-ocular injections for age-related macular degeneration are given compounded bevacizumab. Aflibercept injections are more frequently administered than is ranibizumab. But there will not be considered a self-injectable formulation of these drugs any time in the future. Even with sophisticated autoinjectors, it would be hard to believe anyone would be capable of injecting themselves with these products. Have you heard the expression of fear or discomfort “like putting a needle in my eye”? I was reminded of this by our friend Gillian Woollett, PhD, at the recent ACI biosimilar conference in Boston. In fact, even talking about the pharmacy versus medical benefit can cause some to invoke this exclamation!

It is still possible that ranibizumab can be covered under the pharmacy benefit, even without patients putting needles in their eyes. This would be accomplished through the use of “white bagging”; that is, the health plan or insurer purchases the biosimilar or reference product from a manufacturer and distributes it to the providers office via specialty pharmacy. This is done with several biologics to avoid the need for physicians purchasing the drug from a distributor and billing back the cost (plus a profit) to the payer. This also opens up the possibility for a drug to be managed under the pharmacy benefit, but reimbursed under the medical benefit. Don’t fear, we won’t get into that scenario here.

The Specialty Pharmacy Route

For existing biosimilars, patients can self-inject pegfilgrastim or receive their injections through infusion clinics. For the self-injectable biosimilar form, the drug and injector device are supplied to the patient through the specialty pharmacy and covered by the pharmacy benefit. This option is infrequently used for pegfilgrastim, but this is largely the case with Humira^® and will be the primary coverage avenue for the adalimumab biosimilars, which are also self-injectable.

The other interesting pharmacy benefit angle is in the infliximab category. Currently, an infusion covered through the medical benefit, Celltrion’s subcutaneous formulation could inject some pharmacy benefit coverage into this class. This form of Inflectra^® is still awaiting FDA submission, although it is already approved in Europe and Canada. It has, according to Celltrion’s most recent earnings report, a modest share of the uptake where it has launched. However, it could receive a boost if approved in this country if US payers are interested in gaining better control of this category (which they can do via the pharmacy benefit). As a reminder though, Inflectra SC would not be approved as a biosimilar, but as a new 351(a) pharmaceutical, because there is no subcutaneous reference product. Does that mean it can’t be readily switched for the infusible formulation? Celltrion’s data seems to say yes.

In Other Biosimilar News

As reported July 7 by FiercePharma, the FDA plans to team up with the U.S. Patent and Trademark Office (PTO) on an area of importance to biosimilar makers. They seek to join forces to restrict the issuing of patents “for incremental, obvious changes to existing drugs that do not qualify” for additional intellectual property safeguards. This would make patent thickets less likely for future biologics.

According to the report, FDA and PTO have been talking about collaboration since September 2021, as part of the Biden Administration’s directive for agencies to work together to promote innovation and competition in pharmaceuticals. Policies are said to be in the development stage at this time.