Under Medicare, eligible individuals are generally referred to as beneficiaries, but once they enroll in a plan, they are considered enrollees in that plan. (see Enrollee)

Benefits consultants are experts in health care benefits who advise employers and other plan sponsors in developing requests for proposals (RFPs) that set forth detailed requirements for the sponsor’s health benefit offerings, including pharmacy benefits. For pharmacy benefit carve-outs, the consultants help select and then negotiate the contract with the PBM to best achieve the plan sponsor’s desired pharmacy benefit design.

The Medicaid best price policy requires drug manufacturers to give Medicaid programs the lowest price among purchasers with a few exceptions. Medicaid in turn must cover all the manufacturer’s drugs. Exceptions to best price include prices paid by the Department of Defense, the Veterans Administration, and under 340B, as well as prices negotiated under Medicare Part D.

 

The primary goal of a BLA is to demonstrate the safety and effectiveness of a biologic product allowing the FDA to evaluate and ultimately approve the biologic for marketing. A BLA contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and the medical effects of the biologic product (see biological product). If the information provided meets FDA requirements, the application is approved and a license is issued, allowing the firm to market the product. Biological products are approved for marketing under the provisions of the Public Health Service Act (PHSA), which require a firm that manufactures a biologic for sale in interstate commerce to hold a license for the product.

Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs. Because they are manufactured from living cells, subsequent batches of these products are never exact replicas, but they produce the same predictable results in patients. The biological products are approved under a BLA and listed in the FDA Purple Book (see Purple Book).

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference biological product. Biosimilar Substitution – See Interchangeable Product.

BER is the relative rate of the full cost of pharmacy reimbursement (drug ingredient cost and dispensing fee) of all brand drugs over a defined period of time expressed as a discount of the total weighted average AWP for those same brand drugs over the specified time period. Reimbursement in some preferred pharmacy networks may be based at least in part on BER. Effective rate contracts may be used by PBMs to provide stability to the reimbursements that pharmacies receive in a given calendar year. (Also see GER)

A brand-name drug is a drug marketed under a proprietary, trademark protected name. Brand name drugs typically receive multi-year patent protection upon approval by the FDA, which allows the innovator manufacturer to market its product exclusively.

A process that leverages a specialty pharmacy to safely dispense certain provider-administered drugs directly to the patient for delivery to a provider’s office, where the provider then administers the drug to that patient. The specialty pharmacy bills the plan sponsor directly for the medication. (also see White Bagging)