The Foundation for Building a Clinician's Confidence Over a Biosimilar Drug

December 9, 2016
Stanton R. Mehr

Physicians will make their own decisions as to which patients might benefit most from biosimilars therapy.

Consider the following situation: the Food and Drug Administration (FDA) has approved biosimilar-xxyy (no matter for which disease).

The main questions of structural and molecular similarity have been answered by the FDA. The clinical trials for one indication show no clinically meaningful difference compared with the originator drug, and the FDA approves extrapolation to second indication for a different class of disorder.

Assuming the payer will make a decision to cover this agent on a preferred copayment tier for this self-administered biologic, physicians will now have to make their own decisions as to which patients might benefit most from therapy with this biosimilar, and in whom it might be safest, from their point of view, to start prescribing it.

We speak constantly today about overcoming barriers to physician uptake of new biosimilars. A large part of this involves education and information. Their sources of information on biosimilars will be only slightly different than the information pipeline for any biologic. The difference is that this is a biologic, and professional societies (and even patient groups) may have taken a stand to be extra cautious about its use.

Without pressure from payers to switch patients who are stable taking the originator product, it will then be a physician-based or patient-physician decision. Logically, this will be limited to patients who have not been treated with biologics in the past. For these patients, the risk of immunogenicity or adverse events is really no different than if they received the originator product for the first time. And a conversation will often take place with their colleagues about whether they had used the biosimilar, and was the outcome as intended.

However, another conversation that may well take place before prescribing is between the physician and the practice manager. The content of that discussion may be of an administrative nature, such as, “if I order this drug, will it be reimbursed without any problem?” In the case of a payer who has not yet held a Pharmacy & Therapeutics (P&T) Committee meeting to determine coverage, the same question may be asked but more urgently. “Do we even know what the patient copay may be? Do we have to acquire additional prior authorization approvals?” Additionally, the practice manager will wonder whether the biosimilar manufacturer has set up a “hub” to offer the payment and access assistance needed to smoothly order and deliver the product.

Ensuring the comfort of the practice manager is sometimes given too little consideration. This can go a long way to easing the physician into prescribing biosimilar-xxyy for that first patient.