[The costs of new drugs compared to current standard treatment].
BACKGROUND
Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated.


METHODS
We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial.


RESULTS
If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions.
Arzneimittelkommission der deutschen Ärzteschaft, Berlin. Electronic address: mariam.ujeyl@akdae.de.
Mariam
M
Ujeyl
Claudia
C
Schlegel
Ursula
U
Gundert-Remy
D017046:Cost Savings / Q000191:economics / Q000331:legislation & jurisprudence; D003362:Cost-Benefit Analysis / Q000191:economics / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000191:economics* / Q000331:legislation & jurisprudence; D016527:Drug Costs / Q000331:legislation & jurisprudence / Q000639:trends*; D016568:Drugs, Generic / Q000191:economics*; D015507:Drugs, Investigational / Q000191:economics*; D019317:Evidence-Based Medicine / Q000191:economics / Q000331:legislation & jurisprudence; D005858:Germany; D006801:Humans; D009313:National Health Programs / Q000191:economics* / Q000331:legislation & jurisprudence; D055553:Prescription Drugs / Q000191:economics*
D016568:Drugs, Generic; D015507:Drugs, Investigational; D055553:Prescription Drugs
Arzneimittelbewertung; Arzneimittelpreis; Arzneimittelpreisbildung; Arzneimittelregulierung; Gesundheitspolitik; Pharmaceutical prices; drug assessment; drug regulation; health policy; pharmaceutical pricing