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04/21/2016

Biosimilars and P&T Committees

Imagine that you are on an APPE rotation at a local managed care organization (MCOs) and your preceptor asks you to research a medication that is being considered on the Pharmacy and Therapeutics Committee (P&T Committee). Because P&T Committees are inter-professional committees designed to consider whether to add a new medication to a formulary, you as a student pharmacist are expected to find information to help make that decision. Since pharmacists are expected to speak the language of business and science, your research must cover a broad area. As you begin to research the medication, you notice that it is a biosimilar to a reference drug the hospital already carries. With biosimilars still new to the United States and only a one or two examples to learn from, your research becomes more challenging than you had expected. This scenario will be a reality for many student pharmacists as the number of biosimilar continue to increase. This blog will address some of the new considerations health care providers need in order to appropriately integrate biosimilars to their practice.

The first of these considerations is the savings that a biosimilars will bring to the MCO. The way to go about understanding this is to see where it will stack up in the Medicare Part D Formulary Tiers. This system is used by Medicare to represent how much the beneficiary will pay for a drug. Drugs in the lowest tier are preferred generics which are the least costly. Drugs in the highest tier are typically specialty drugs which are the most expensive. Since biosimilars cannot go through the more direct pathway that generics use to get to the market, they will most likely be placed in a higher tier than generics. With that being said, biosimilars are not starting completely from scratch like reference drugs meaning that they will be on or below the reference drug’s tier. It is therefore reasonable to assume that the lowest tier a biosimilar will reach is the second tier. This is preferred brand tier which is in the middle of the pack in terms of cost. Since reference products could be placed in tiers two through five, the saving a biosimilar could offer will vary.

The next step in determining whether or not to add a biosimilar to a formulary is to anticipate what challenges the biosimilar could face. Suppose the biosimilar you are researching has fewer indications than the reference product. This means that while some of your patients may be placed on the lower cost biosimilar, other will still require the reference product. If that is the case, then the formulary will still require both the biosimilar and reference product be available in the pharmacies which will increase costs. The costs of still carrying the reference drug in the inventory may offset any savings. Another consideration is whether or not the biosimilar will face shortages. Biosimilars are not equivalent to one another in the same sense as generics. This means that if there are two biosimilars to the same reference product and one of them becomes available, a pharmacy cannot automatically switch to the other. P&T committees must account for this when they select a biosimilar and understand that shortages may create costs which again offset savings. These are just two examples of unique issues that must be thought about with biosimilars.

Of course, biosimilars will still have many similarities to other drugs in the context of a P&T committee. Considerations like available dosage forms, medication safety, pharmacokinetic profile will be examined like with any drug. As medication experts who are knowledgeable about the science and business of drugs, responsibility is likely to fall to the pharmacist to bring these new considerations to the table.

Robert Bond, PharmD '18

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