Pharmacist Questions:

1.  Which of the following is true?

  1. Major diseases treatable by biologics are less prevalent
  2. Biologics for major disease states are less expensive per prescription than those for small molecules
  3. Asthma is the most common condition treated with biologics
  4. Major diseases treatable by small molecules are less prevalent

2.  Which is true about specialty drugs?

  1. They represent 10% of all US prescriptions
  2. By the year 2020, they are predicted to account for less than 73% of all medication spending
  3. They make up 1/3 of prescription drug spending in the US
  4. They were responsible for 50% of overall prescription spending growth over the last 5 year

3.  Which is true regarding the cost of biosimilars?

  1. The processes for production are well-known and developed and therefore manufacturing costs are low
  2. The introduction of multiple biosimilars for one biologic is crucial to cutting costs
  3. The United States can expect price reductions of upwards of 50% when biosimilars are introduced
  4. There is a substantial price difference between innovator biologics and their biosimilar counterparts

4.  Which of the biosimilar drugs currently in development might be expected to be the least expensive?

  1. Cetuximab
  2. Trastuzumab
  3. Filgrastim
  4. Pegfilgrastim

5.  One of your patients is picking up a new prescription for infliximab-dyyb (Inflectra) for treatment of Chron’s Disease. They were previously on infliximab (Remicade) and have not had a flare-up in quite some time. What can you tell them to ease their hesitation to switch?

  1. Inflectra is an interchangeable biological product, so has been shown to produce the same clinical result as Remicade.
  2. Clinical data shows that Inflectra is “highly similar” to Remicade and your prescriber feels that you will continue to benefit from this less-expensive option.
  3. The makers of Inflectra had to show there was no danger in switching to-and-from Remicade in order to be approved.
  4. Talk to your doctor, I have no idea if they will work the same.

6.  Which of the following can be used to describe a biologic drug?

  1. Low molecular weight
  2. Highly stable final product
  3. Complex three-dimensional structure
  4. Small chemical structures

7.  Which drug may be prevented from automatic generic substitution in selected states?

  1. Lorazepam
  2. Lansoprazole
  3. Lisinopril
  4. Lamotrigine

8.  Which is correctly paired?

  1. Biologics Price Competition and Innovation Act of 2009 & approval of biosimilar and interchangeable biological products
  2. FDA “Orange Book” & AB-rated interchangeable biological products
  3. Drug Price Competition and Patient Term Restoration Act of 1984 & approval of biosimilar and interchangeable biological products
  4. “Purple Book” & AB-rated interchangeable biological products currently in development

9.  Interchangeable biologic products are which of the following:

  1. Structurally identical to an FDA-approved reference product
  2. Expected to produce the same clinical result as the reference product
  3. Required to cost the same as the reference product
  4. Associated with decreased risks compared to the reference product

10.  A patient asks why her adalimumab (Humira) for psoriasis costs so much more than the generic cream she was prescribed previously. Which is the best explanation?

  1. Biologic drugs are more in-demand and therefore drug companies charge more
  2. Manufacturers of biologic drugs are held to higher purity standards
  3. Biologic drugs are more difficult to produce and store
  4. Drug manufacturers want to encourage the use of topical drugs first

11.  Which is true of orphan drugs?

  1. Research and development spending is low due to low prevalence of orphan diseases
  2. Drug costs are kept low by the Orphan Drug Act of 1984
  3. Biologic drugs are too expensive to be developed as orphan drugs
  4. Manufacturers have smaller sample size requirements

12.  Why can’t exact copies be made for biologic drugs?

  1. The law does not allow it
  2. The molecules are too small to replicate
  3. Growth conditions and cell lines are unique and proprietary information difficult to duplicate
  4. Harvesting, isolating, and purifying the cell lines is too costly

13.  A patient approaches you with concerns about the cost of her adalimumab (Humira) treatment for rheumatoid arthritis. She heard about a “generic” version and would like to switch. What actions should you take?

  1. Interchange the patient to adalimumab-atto (Amievita)
  2. Interchange the patient to adalimumab-adbm (Cyltezo)
  3. Call the prescriber to initiate a change to a biosimilar medication
  4. Apologize to the patient for the misinformation and explain that paying for her current treatment is the only option

14.  What is needed for a generic small molecule drug to gain “AB”-rating over “A”-rating?

  1. Demonstration of significant cost savings to the patient
  2. Evidence of a smaller side effect profile than the innovator drug
  3. No evidence of liver/kidney impairment in clinical trials
  4. In vivo or in vitro evidence of bioequivalence in clinical trials

15.  Which is true about manufacturing of biologics?

  1. Many biologics are monoclonal antibodies, enzymes or hormones
  2. Variability in cells cultivated ensures drugs will be effective
  3. Weaker cell lines are chosen in order to ensure the resulting drugs will not be toxic
  4. Controlled environments are used to kill the cells for isolation and purification

16.  What is a good counseling point for all patients on biologics?

  1. Biologics can be returned to the refrigerator without harm if exposed for less than 15 minutes to controlled room temperature
  2. Never leave your biologic in the car unless it is packed in a cooler
  3. Airport security will never allow biologic medications on a plane, so always plan to travel by car
  4. Package inserts do not address storage information, and the manufacturer must be called with all questions

17.  A patient who is apprehensive about switching to a biosimilar from an innovator product can be counseled that:

  1. The biosimilar is always made by the same company as the reference product
  2. Clinical trials show that the safety, purity, and potency are the same for the approved condition for which it is interchangeable
  3. The structure of the biosimilar is identical to that of the reference product
  4. Honestly, the risks of switching are not assessed for approval and the patient is risking therapy failure

18.  Which is true of biologic medications?

  1. They show efficacy in previously refractory patients
  2. They have a slower onset of benefit due to their small size
  3. They have a larger side effect profile due to complex mechanisms of action
  4. Treatment specificity opens up the size of the market that can be targeted

19.  What is the most common indication for currently FDA-approved biosimilar medications?

  1. Cancers
  2. Neutropenia
  3. Inflammation
  4. Anemia

20.  How are biosimilars and interchangeable biological products expected to affect the US in years to come?

  1. More medication errors will occur due to automatic interchange
  2. The healthcare system will save billions of dollars
  3. Increased overall costs to drug manufacturers will make it harder to produce small molecule generics
  4. Pharmacists will be allowed to prescribe biologic medications