MTM Formulary Management & Drug Selection 5 — Questions and Answers
Question 1: Under Medicare Part D, what is a 'protected class' of drugs and why are these classes significant for formulary management?
- Drugs that are protected from generic competition by patent law
- Six drug classes CMS requires Part D plans to cover all or substantially all drugs within (Correct answer)
- Drug classes that are exempt from prior authorization requirements under federal law
- Drugs that are protected from formulary removal mid-plan year
Correct answer: Six drug classes CMS requires Part D plans to cover all or substantially all drugs within
CMS designates six protected classes (e.g., antiretrovirals, antidepressants, antipsychotics) in which Part D plans must offer broad formulary coverage to protect vulnerable patient populations.
Question 2: When evaluating biosimilars for formulary placement, a P&T committee should consider which of the following as most clinically relevant?
- Whether the biosimilar has a catchy brand name
- FDA interchangeability designation and evidence of comparable efficacy and safety to the reference biologic (Correct answer)
- The biosimilar's market share in Europe
- Whether the reference biologic's patent has expired
Correct answer: FDA interchangeability designation and evidence of comparable efficacy and safety to the reference biologic
FDA interchangeability designation means the biosimilar may be substituted for the reference biologic without prescriber intervention, making it highly relevant for formulary substitution policies.
Question 3: A health plan wants to reduce inappropriate antibiotic prescribing through formulary design. Which formulary management strategy would be most effective?
- Removing all broad-spectrum antibiotics from the formulary
- Placing narrow-spectrum antibiotics on preferred tiers and requiring step therapy or PA for broad-spectrum agents (Correct answer)
- Requiring quantity limits on all antibiotics regardless of indication
- Placing all antibiotics on the specialty tier to deter use
Correct answer: Placing narrow-spectrum antibiotics on preferred tiers and requiring step therapy or PA for broad-spectrum agents
Preferring narrow-spectrum agents and requiring documentation for broad-spectrum use stewards antibiotic use without removing necessary treatment options.
Question 4: In formulary benefit design, what is the difference between 'cost-sharing' and 'cost containment'?
- Cost-sharing shifts drug expenses to members; cost containment reduces total drug expenditure for the plan (Correct answer)
- Cost-sharing is used only in Medicare; cost containment is used only in commercial plans
- They are interchangeable terms in pharmacy benefit management
- Cost containment increases drug prices; cost-sharing decreases them
Correct answer: Cost-sharing shifts drug expenses to members; cost containment reduces total drug expenditure for the plan
Cost-sharing strategies (copays, coinsurance) transfer some drug expense to members, while cost containment strategies (rebates, generics, step therapy) reduce the plan's total drug spend.
Question 5: A patient's oncologist prescribes a non-formulary chemotherapy agent. The plan's formulary includes an alternative with different toxicity but comparable response rates. What should the MTM pharmacist prioritize?
- Automatically substitute the formulary agent without consulting the oncologist
- Review the individual patient's comorbidities and discuss clinical nuances with the oncologist before any formulary switch (Correct answer)
- Deny the non-formulary drug without review because an alternative exists
- Approve the non-formulary drug immediately because oncology drugs are exempt from formulary rules
Correct answer: Review the individual patient's comorbidities and discuss clinical nuances with the oncologist before any formulary switch
Oncology formulary decisions require individualized clinical review because toxicity profiles may be critical for patients with specific comorbidities or prior treatment histories.
Question 6: What is the primary purpose of a 'medication formulary exception appeal' process for Medicare Part D beneficiaries?
- To allow beneficiaries to request lower copays for any drug on the formulary
- To provide access to non-formulary or higher-tier drugs when the standard formulary options are medically inappropriate (Correct answer)
- To dispute prescription drug claims denied for non-medical reasons such as billing errors
- To request that CMS add a drug to the protected class list
Correct answer: To provide access to non-formulary or higher-tier drugs when the standard formulary options are medically inappropriate
The Part D exception and appeals process ensures beneficiaries can access medically necessary drugs not covered by the standard formulary when alternatives are clinically contraindicated.
Question 7: Which statement best describes the relationship between formulary management and medication adherence in MTM practice?
- Formulary restrictions have no documented effect on medication adherence
- High cost-sharing and restrictive formularies can reduce adherence, making formulary optimization a critical MTM target (Correct answer)
- Closed formularies always improve adherence by simplifying drug choices
- Adherence is solely the patient's responsibility and is outside formulary management scope
Correct answer: High cost-sharing and restrictive formularies can reduce adherence, making formulary optimization a critical MTM target
Research consistently shows that high out-of-pocket costs and step therapy burdens can reduce adherence, so MTM pharmacists target formulary optimization to remove cost barriers.
MTM Formulary Management & Drug Selection 5
Under Medicare Part D, what is a 'protected class' of drugs and why are these classes significant for formulary management?