MTM Formulary Management & Drug Selection 4 — Questions and Answers
Question 1: A P&T committee is comparing two statins for formulary placement. Drug A has a lower AWP but no outcomes data; Drug B costs more but has proven cardiovascular mortality reduction. What is the best formulary decision?
- Place Drug A preferred because it is cheaper
- Place Drug B preferred because of superior outcomes evidence (Correct answer)
- Place both drugs on the same tier to offer patient choice
- Exclude both drugs until a head-to-head trial is completed
Correct answer: Place Drug B preferred because of superior outcomes evidence
P&T committees should weight proven clinical outcomes over acquisition cost alone, favoring Drug B for its demonstrated mortality benefit.
Question 2: Which federal program requires that drug manufacturers pay rebates to state Medicaid programs as a condition of Medicaid coverage?
- Medicare Part D
- The Medicaid Drug Rebate Program (MDRP) (Correct answer)
- The 340B Drug Pricing Program
- The Federal Supply Schedule (FSS)
Correct answer: The Medicaid Drug Rebate Program (MDRP)
The MDRP requires drug manufacturers to enter rebate agreements with CMS in exchange for having their drugs covered by Medicaid.
Question 3: What is the clinical significance of a drug's 'therapeutic index' when making formulary decisions for narrow therapeutic index (NTI) drugs?
- NTI drugs have wide margins, making generic substitution straightforward
- NTI drugs require careful monitoring because small dose changes can cause toxicity or treatment failure (Correct answer)
- NTI drugs are always excluded from formularies due to safety concerns
- NTI drugs are preferred on formularies because they have fewer side effects
Correct answer: NTI drugs require careful monitoring because small dose changes can cause toxicity or treatment failure
NTI drugs like warfarin, levothyroxine, and lithium have narrow ranges where efficacy and toxicity intersect, requiring careful management when switching products.
Question 4: A pharmacy benefit manager (PBM) negotiates manufacturer rebates. How do rebates typically influence formulary tier placement?
- Higher rebates always result in a drug being excluded from the formulary
- Drugs offering larger rebates may receive preferred tier status, lowering member cost-sharing (Correct answer)
- Rebates have no influence on formulary decisions per federal law
- Rebates only apply to generic drugs and do not affect brand placement
Correct answer: Drugs offering larger rebates may receive preferred tier status, lowering member cost-sharing
PBMs often grant preferred tier placement to drugs whose manufacturers offer larger rebates, which can reduce net plan costs despite higher list prices.
Question 5: An MTM pharmacist identifies that a Medicare Part D beneficiary is in the coverage gap ('donut hole'). How does formulary selection affect their out-of-pocket costs during this phase?
- All drugs are fully covered during the coverage gap regardless of tier
- Generic drugs still have lower cost-sharing than brands in the gap, making formulary generics more advantageous (Correct answer)
- Formulary placement has no effect; costs are fixed by statute in the gap
- Only specialty drugs are affected by tier placement during the gap
Correct answer: Generic drugs still have lower cost-sharing than brands in the gap, making formulary generics more advantageous
In the coverage gap, beneficiaries pay a percentage of the drug cost, so lower-cost generics on the formulary result in lower absolute out-of-pocket payments.
Question 6: What role does pharmacoeconomic analysis play in formulary management?
- It replaces the need for clinical trial data when making formulary decisions
- It evaluates the cost-effectiveness of drugs relative to clinical outcomes to inform resource allocation (Correct answer)
- It determines the maximum allowable price a plan can pay for any drug
- It is used exclusively to set manufacturer rebate amounts
Correct answer: It evaluates the cost-effectiveness of drugs relative to clinical outcomes to inform resource allocation
Pharmacoeconomic analyses such as cost-effectiveness and cost-utility analyses help P&T committees weigh drug value relative to clinical benefit when allocating formulary resources.
Question 7: Which of the following best describes a 'quantity limit' as a formulary management tool?
- Restricts how many different drug classes a patient can fill per month
- Limits the dispensed quantity of a drug to amounts consistent with approved dosing or safety guidelines (Correct answer)
- Prevents a patient from filling a prescription at out-of-network pharmacies
- Caps the total dollar amount a plan will spend on a member's drugs annually
Correct answer: Limits the dispensed quantity of a drug to amounts consistent with approved dosing or safety guidelines
Quantity limits restrict drug supply to approved dosing regimens, preventing stockpiling and ensuring utilization aligns with clinical guidelines.
MTM Formulary Management & Drug Selection 4
A P&T committee is comparing two statins for formulary placement.
Drug A has a lower AWP but no outcomes data; Drug B costs more but has proven cardiovascular mortality reduction.
What is the best formulary decision?