generic drugs and drug economics m.t. piascik. objectives 1)review generic drug law. 2)know the...
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Generic Drugs and Drug Economics
M.T. Piascik
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OBJECTIVES
1) Review generic drug law.
2) Know the difference between “breakthrough” and “me too” drugs.
3) Have an understanding of the economics of prescription drugs.
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A REVIEW OF GENERIC DRUG LAW
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FORMULARY SUBSTITUTION This is NEW.
A pharmacist is presented a prescription, which is Rejected upon adjudication to the patient’sthird party insuranceNOW the pharmacist may substitute with another drug
--if the prescription has “Formulary Substitution” written on it—if the phrase is stamped on it the prescriber must still make an affirmative notation that FS is OK -- in the same class
--the substitution must be OK with the third part insurance
--the prescriber must be informed in writing within 24 h
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FACTORS DETERMINING DRUG PRICING
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A BREAKTHROUGH drug is a unique therapeutic entity that opens a new approach to the treatment ofa given pathophysiology. The discovery of breakthrough drugspresents the greatest financial risk.
A ME TOO drug is a structuralanalogue, an existing therapeuticentity. Because me toodrugs are derived from establisheddrugs the risk associated with theirdevelopment is not as great as forbreakthrough drugs.
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WHY ARE PRESCRIPTION DRUGS SO EXPENSIVE?
OR
“There is gold in them thar pills”
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The Cost of Direct to Consumer (DTC) Advertising
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•PepsiCo spent $125 million advertising its premier product, Pepsi – less than the top promoted drug Vioxx with DTC ad spending of $160 million.
•Vioxx also beat out Budweiser beer, with an ad spending of $146 million in 2000,and was close to the most heavily advertised car – GM’s Saturn – with ad spending of $169 million in 2000.
•Each of the top seven most heavily advertised drugs beat out Nike’s ad budget of $78.2 million for its top shoes.
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OBJECTIVES
1) Review generic drug law.
2) Know the difference between “breakthrough” and “me too” drugs.
3) Have an understanding of the economics of prescription drugs.
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What has been the effect of DRC marketing?
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A BREAKTHROUGH drug is a unique therapeutic entity that opens a new approach to the treatment ofa given pathophysiology. The discovery of breakthrough drugspresents the greatest financial risk
A ME TOO drug is a structural analogue, an existing therapeutic entity. Because me too drugs are derived from established drugs the risk associated with their development is not as great as forBreakthrough drugs.
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