Specialty Pharmacy and Biologics Flashcards

An interchangeable biosimilar designation by the FDA means it can be substituted for the reference biologic:

Answer: At the pharmacy level without prescriber intervention, similar to generic substitution (where permitted by state law)

FDA 'interchangeable' designation means the biosimilar may be substituted at the pharmacy without the prescriber's intervention (subject to state pharmacy laws), similar to generic drug substitution.

Hepatitis C treatment with direct-acting antivirals (DAAs) like sofosbuvir/ledipasvir is considered specialty pharmacy because:

Answer: It involves high drug costs, complex monitoring, and requires specialty training to ensure adherence and cure rates

DAA regimens for HCV are highly effective (95%+ SVR) but costly, requiring prior authorization, adherence support, drug interaction screening (especially with P-gp/CYP inducers), and monitoring for viral response.

Which statement about monoclonal antibodies (mAbs) is correct?

Answer: They are highly targeted therapies ending in '-mab' that bind specific antigens

Monoclonal antibodies (mAbs) are highly targeted biologics produced from a single B-cell clone, ending in '-mab' (e.g., rituximab, trastuzumab). They bind specific antigens and are typically given by injection.

Erythropoiesis-stimulating agents (ESAs) such as epoetin alfa are used in specialty pharmacy to treat:

Answer: Anemia associated with chronic kidney disease or chemotherapy

ESAs stimulate red blood cell production in the bone marrow. They are used for anemia in CKD (dialysis and non-dialysis), chemotherapy-induced anemia, and myelodysplastic syndrome.

Prior authorization (PA) is commonly required for specialty medications because:

Answer: Payers require clinical justification to ensure appropriate use and manage high costs

Prior authorization requires prescribers to document medical necessity, step therapy, or clinical criteria before insurers will cover high-cost specialty drugs, managing utilization and ensuring evidence-based prescribing.

Tyrosine kinase inhibitors (TKIs) like imatinib (Gleevec) used for CML represent which advancement in cancer treatment?

Answer: Targeted therapy that inhibits a specific oncogenic protein (BCR-ABL kinase)

Imatinib targets BCR-ABL, the abnormal kinase produced by the Philadelphia chromosome translocation in CML, representing a paradigm shift from cytotoxic to molecularly targeted cancer therapy.