Pharmacy Specialty Pharmacy and Biologics 2 — Questions and Answers
Question 1: An interchangeable biosimilar designation by the FDA means it can be substituted for the reference biologic:
- Only by a physician's written order
- At the pharmacy level without prescriber intervention, similar to generic substitution (where permitted by state law) (Correct answer)
- Never — interchangeable biologics still require a new prescription
- Only if the patient has failed the reference biologic
Correct 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.
Question 2: Hepatitis C treatment with direct-acting antivirals (DAAs) like sofosbuvir/ledipasvir is considered specialty pharmacy because:
- It requires monthly injections administered in a clinic
- It involves high drug costs, complex monitoring, and requires specialty training to ensure adherence and cure rates (Correct answer)
- It is a Schedule II controlled substance
- It is only available from hospital pharmacies
Correct 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.
Question 3: Which statement about monoclonal antibodies (mAbs) is correct?
- They are synthesized from petrochemicals like most small-molecule drugs
- They are highly targeted therapies ending in '-mab' that bind specific antigens (Correct answer)
- They are administered orally for systemic conditions
- They have no risk of immunogenicity reactions
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.
Question 4: Erythropoiesis-stimulating agents (ESAs) such as epoetin alfa are used in specialty pharmacy to treat:
- Rheumatoid arthritis
- Anemia associated with chronic kidney disease or chemotherapy (Correct answer)
- Inflammatory bowel disease
- Hepatitis B infection
Correct 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.
Question 5: Prior authorization (PA) is commonly required for specialty medications because:
- All specialty medications are controlled substances requiring DEA approval
- Payers require clinical justification to ensure appropriate use and manage high costs (Correct answer)
- PA is required by federal law for any drug costing over $500
- Specialty drugs cannot be dispensed without a pharmacist's clinical evaluation
Correct 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.
Question 6: Tyrosine kinase inhibitors (TKIs) like imatinib (Gleevec) used for CML represent which advancement in cancer treatment?
- Non-specific cytotoxic chemotherapy
- Targeted therapy that inhibits a specific oncogenic protein (BCR-ABL kinase) (Correct answer)
- Immunotherapy through checkpoint inhibition
- Hormonal therapy blocking estrogen receptors
Correct 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.
Pharmacy Specialty Pharmacy and Biologics 2
An interchangeable biosimilar designation by the FDA means it can be substituted for the reference biologic: