Chapter 12 — Quiz

22 items. Cover the answer key until you have committed to an answer for each — the value of a quiz is almost entirely in the commitment, not the score.

1. Which of the four prices in §12.1 is not publicly knowable?

  • A. List price
  • B. Net price
  • C. Out-of-pocket cost for a specific plan design
  • D. Cash price

2. A confidential rebate paid by a manufacturer primarily lowers:

  • A. The list price for everyone
  • B. The net price paid by the plan
  • C. The cash price paid by an uninsured patient
  • D. The manufacturer's cost of goods

3. STEP 1 studied semaglutide 2.4 mg weekly in adults with overweight or obesity without diabetes. Approximately what weight change from baseline was reported at 68 weeks, and against what comparator result?

  • A. −10% versus −2.4% placebo
  • B. −15% versus −2.4% placebo
  • C. −15% versus −10% placebo
  • D. −20% versus −5% placebo

4. STEP 2 studied the same weekly dose in adults with type 2 diabetes. The reported weight change was approximately:

  • A. −5%
  • B. −10%
  • C. −15%
  • D. −20%

5. SELECT enrolled approximately how many participants, and for roughly how long?

  • A. 1,700 for 1 year
  • B. 17,000 for 3 years
  • C. 170,000 for 3 years
  • D. 17,000 for 10 years

6. SELECT reported a 20% relative reduction in major adverse cardiovascular events. In absolute terms, the event rate moved approximately:

  • A. From 20% to 16%
  • B. From 8% to 6.5%
  • C. From 8% to 1.5%
  • D. From 3% to 2.4%

7. True or false: quoting SELECT's relative risk reduction without the absolute risk reduction is factually incorrect.

8. Which population did SELECT enroll?

  • A. Adults with type 2 diabetes and no cardiovascular disease
  • B. Adults with established cardiovascular disease and overweight or obesity, without diabetes
  • C. Adults with obesity and no other conditions
  • D. Adults with established cardiovascular disease and type 2 diabetes

9. The binding constraint during the GLP-1 shortage was:

  • A. Solid-phase peptide synthesis capacity
  • B. Availability of the fatty acid used in the conjugation
  • C. Aseptic fill-finish capacity and injector-pen assembly
  • D. Cold-chain shipping capacity

10. Why can a manufacturer not solve that constraint quickly with money?

  • A. The chemistry is proprietary and cannot be licensed
  • B. Sterile filling lines and pen assembly require construction, validation, and line-by-line regulatory approval
  • C. The raw materials are geologically scarce
  • D. Regulators cap the total supply of any single product

11. US law generally bars compounding a copy of an approved drug. The main exception operating in the semaglutide episode was:

  • A. A physician's written attestation of medical necessity
  • B. The drug appearing on the FDA shortage list
  • C. Patient inability to pay the list price
  • D. A state board of pharmacy waiver

12. Which statement about compounded products is correct?

  • A. 503B products are FDA-approved; 503A products are not
  • B. Neither 503A nor 503B products are FDA-approved
  • C. Both are FDA-approved but under an abbreviated pathway
  • D. Approval depends on whether the drug is on the shortage list

13. A 503B outsourcing facility differs from a 503A pharmacy in that it:

  • A. May produce larger batches without patient-specific prescriptions and must comply with CGMP
  • B. May sell directly to consumers without a prescriber
  • C. Is exempt from FDA inspection
  • D. Is permitted to make copies of approved drugs at any time

14. Regulators stated that semaglutide sodium and semaglutide acetate:

  • A. Are equivalent to semaglutide base for compounding purposes
  • B. Are not the same substance as semaglutide base, and their safety and effectiveness had not been established
  • C. Are more stable than semaglutide base and therefore preferable
  • D. Were approved for compounding but not for commercial manufacture

15. Among the dosing-error concerns regulators raised about compounded semaglutide was:

  • A. Confusion between units of measurement when a vial and syringe replace a pre-filled pen
  • B. Patients doubling doses to accelerate weight loss
  • C. Incorrect refrigeration
  • D. Interaction with over-the-counter analgesics

16. Off-label prescribing in the United States is:

  • A. Illegal
  • B. Legal for prescribers, while off-label promotion by manufacturers is not
  • C. Legal only in oncology and pediatrics
  • D. Legal only with written regulator approval

17. The clause "as an adjunct to a reduced-calorie diet and increased physical activity" in the label is best understood as:

  • A. A moral requirement placed on the patient
  • B. The trial protocol written into the label
  • C. A legal disclaimer with no evidentiary content
  • D. Evidence that the drug alone does not work

18. Which of Chapter 11's five rationing features do GLP-1 agonists not share with insulin?

  • A. Perfectly inelastic demand
  • B. The patient as residual payer
  • C. Interruption being rapidly life-threatening
  • D. Coverage discontinuity at life transitions

19. Because of that missing feature, cost-driven discontinuation of GLP-1 therapy is predicted to produce:

  • A. A smaller total harm than insulin rationing, and a more visible one
  • B. A potentially larger total harm than insulin rationing, and a nearly invisible one
  • C. No harm, because the drug is not life-sustaining
  • D. Harm that will be captured accurately in existing death certificate data

20. "A drug that works on a system is not evidence that the system caused the condition." This statement is:

  • A. A restatement of Chapter 5's rule against upgrading a rating with a mechanism, running in reverse
  • B. An argument that GLP-1 agonists do not work
  • C. An argument that obesity is not a disease
  • D. An argument that obesity is a disease

21. Weight regain after discontinuation of a GLP-1 agonist is best described as:

  • A. Evidence the drug does not work
  • B. Expected physiology, because the drug overrides an intact regulatory system rather than replacing an absent hormone
  • C. Evidence of a rebound effect unique to this drug class
  • D. A sign that the original dose was too high

22. Trials of GLP-1 agonists for weight management generally excluded people with active eating disorders. The correct interpretation of the resulting absence of a safety signal in that population is:

  • A. The drugs are safe in eating disorders
  • B. The drugs are unsafe in eating disorders
  • C. There is an absence of data, not evidence of safety
  • D. The exclusion was unethical and invalidates the trials
Answer key **1. B.** Net price is set by confidential rebate negotiation and is not published. List price is public; out-of-pocket cost is knowable from a specific plan's design; cash price is quotable at a pharmacy. **2. B.** Rebates flow from manufacturer to plan or benefit manager and lower what the plan pays. They do not lower list price, which is why the uninsured — outside the rebate structure — remain exposed to something near ①. This is the residual-payer structure Chapter 11 identified. **3. B.** Roughly −15% of baseline at 68 weeks versus roughly −2.4% on placebo, with both arms receiving lifestyle intervention. **4. B.** Roughly −10%. **5. B.** Approximately 17,000 participants followed roughly three years. **6. B.** Roughly 8% to roughly 6.5% — about 1.5 percentage points — corresponding to a number needed to treat of roughly 65 to 70 over that period. **7. False.** The relative risk reduction is factually correct. Quoting it *alone* is misleading rather than incorrect, because a relative reduction is uninterpretable without a baseline risk. The distinction matters: the objection is to incompleteness, not to falsity. **8. B.** Adults with established cardiovascular disease and overweight or obesity, without diabetes. The population is part of the claim. **9. C.** Aseptic fill-finish capacity and injector-pen assembly. Peptide synthesis was not the constraint. **10. B.** Sterile filling lines are buildings requiring classified space, validation campaigns, and line-by-line, product-by-product regulatory approval; pen assembly is precision mechanical manufacturing at enormous scale. Both take years. **11. B.** Listing on the FDA shortage list. When the shortage resolved and the listing was removed, the permission narrowed — amid litigation and transition periods. **12. B.** Neither is FDA-approved. 503B facilities are more heavily regulated (CGMP, FDA inspection), but *inspected* and *approved* are different words for different things. **13. A.** Larger batches without patient-specific prescriptions, plus CGMP compliance and FDA inspection. **14. B.** Not the same substance as semaglutide base; safety and effectiveness not established. **15. A.** Errors arising from vial-and-syringe administration in place of a metered pen, including confusion between units of measurement. **16. B.** Legal for prescribers; off-label promotion by manufacturers is not. Much of pediatrics and oncology depends on it. **17. B.** It describes the conditions under which the effect was measured — in STEP 1 both arms received lifestyle intervention. It is not a character test, and it does not establish that the co-intervention is necessary. **18. C.** Interruption is not rapidly life-threatening. They share ③ inelastic demand, ④ residual payer, and ⑤ coverage discontinuity, and share ② partially. **19. B.** No acute deaths and no named victims means no headlines and no legislation — while the eligible population is an order of magnitude larger, so the aggregate lost benefit may be far greater. The harm is large and illegible at the same time. **20. A.** Chapter 5's third rule in reverse: there, the error is inferring efficacy from mechanism; here, inferring etiology from efficacy. The statement is neutral between all four §12.9 positions. **21. B.** The drug applies a sustained override to an intact system defending a set point. Removing the override restores the status quo. This makes it chronic therapy, like an antihypertensive — and the expectation of permanence after stopping is applied to no other chronic therapy. **22. C.** Absence of data. The trials were not looking, so they could not have found a signal. This is one of the most consistently misread situations in the whole evidence literature.