Recognized Sources for Foreign Price Verification and Formulas: 2015
France
The recognized price source for France is Vidal, in which prices are reported in euros. There is no need to “back-out” prices from France if Vidal is used: the Px-Achat price corresponds to an ex-factory pharmacy price, and the PFHT price corresponds to an ex-factory wholesale price. There are no prices comparable to an ex-factory hospital price.
Germany
Rote Liste
The recognized price source for Germany is Rote Liste, in which the formulary price is reported in euros.
The formulary price (FP) includes a 19% value-added tax (VAT) as well as several regulated margins. After first calculating the net formulary price (FPN) by eliminating the VAT, ex-factory prices can then be “backed-out” through applying the following formulas.
The formulary price net (FPN) is calculated as follows:
FPN= FP/1.19
The ex-factory pharmacy price (PP) is calculated as follows:
PP= (FPN-8.51)/1.03
The ex-factory wholesale price (WP) is calculated as follows:
WP= (PP-0.70)/1.0315
There is no price comparable to an ex-factory hospital price available for Germany in the Rote Liste.
Lauer-Taxe
The PMPRB is transitioning to a new recognized price source for Germany, the Lauer-Taxe. It is necessary to deduct the publicly available rebates from the prices published in the Lauer-Taxe to determine customer class specific ex-factory prices. Effective January 2016, the Rote Liste will be replaced by the Lauer-Taxe as the recognized source for Foreign Price Verification. Patentees are encouraged to file the Lauer-Taxe prices in their Block 5 data.
Prices published in Lauer-Taxe do not include the 19% value-added tax (VAT) with the exception of the list prices (‘Listenpreise’).
The ex-factory wholesale price can be calculated by subtracting statutory rebates (‘Pflichtrabatt d. ph. Unternehmers‘) from the APU (‘APU/HAP Herstellerabgabepreis‘) price.
The ex-factory wholesale price is calculated as follows:
Ex-factory price = (APU - ‘Pflichtrabatt d. ph. Unternehmers‘)
In rare occasions where there is no APU but there is a ‘Taxe-Klinik EK’ price (i.e., a drug only sold in hospitals and sold directly by the manufacturer to the hospital), then the Taxe-Klinik EK is an acceptable ex-factory hospital price. Otherwise, there are no equivalents to ex-factory pharmacy or ex-factory hospital prices in the Lauer-Taxe.
Italy
The recognized price source for Italy the L'Informatore Farmaceutico, in which the formulary price is reported in euros.
The formulary price (FP) includes a 10% VAT as well as several regulated margins. After first calculating the FPN by eliminating the VAT, ex-factory prices can then be “backed-out” through applying the following formulas.
The formulary price net (FPN) is calculated as follows:
FPN= FP/1.10
The ex-factory pharmacy price (PP) is calculated as follows:
PP= FPN x 0.6965
The ex-factory wholesale price (WP) is calculated as follows:
WP= FPN x 0.6665
L'Informatore Farmaceutico publishes hospital prices, denoted by an ‘H’. Only the ‘H’ class prices marked with an asterisk (*) are ex-factory prices.
Sweden
The recognized price source for Sweden is the Dental & Pharmaceutical Benefits Agency (TLV), in which prices are reported in Swedish kronas.
There is no need to “back-out” prices from Sweden if TLV is used: the AIP price corresponds to an ex-factory pharmacy price. There are no prices comparable to ex-factory wholesale or hospital prices.
Switzerland
The recognized price source for Switzerland is the Federal Office of Public Health, in which prices are reported in Swiss francs.
There is no need to “back-out” prices from Switzerland if this price source is used: the formulary price reported corresponds to an ex-factory wholesale price. There are no prices comparable to ex-factory pharmacy or hospital prices.
United Kingdom
The recognized price source for the UK is the Monthly Index of Medical Specialties (MIMS), in which prices are reported in UK pounds.
There is no need to “back-out” prices from the UK if the MIMS is used: the formulary price corresponds to an ex-factory pharmacy price. There are no prices comparable to ex-factory wholesale or hospital prices.
United States
There are several recognized sources for the US depending on the price under consideration, all of which report prices in US dollars.
The Red Book publishes a Direct Price, which corresponds to ex-factory pharmacy, ex-factory wholesale and ex-factory hospital prices.
The Red Book also publishes a Wholesale Acquisition Cost (WAC) which corresponds to the ex-factory wholesale price.
Furthermore, the PMPRB requires submission of the Federal Supply Schedule (FSS) prices published by the Department of Veterans Affairs.