The Rx Price IndexTM is in the process of revamping one of its countries currently on the database; Romania.  This is to include two different new price types to the platform:  the CANAMED and the Public Catalogue prices. 

But what do these prices actually represent?  Read on to find out more about what these price types represent as well as how they fit within the pharmaceutical landscape.

How does Romania set its pharmaceutical prices?

Romania has three regulatory bodies that have jurisdiction over drugs, biologicals and medicinal devices; these are the Ministry of Health, the National Agency for Medicines and Medical Devices and the National Health Insurance House.  These three regulatory bodies play a central role in making decisions regarding Marketing Authorisation, Distribution, Pricing and Reimbursement of pharmaceutical products.

Pricing in Romania is set according to External Reference Pricing.  This system was first implemented in 2009 during the financial crisis and was one of the multiple measures that were implemented to control pharmaceutical expenditure.  The reference countries used by Romania are the Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany.  For almost all products, apart for immunologic medicines and medicines derived from blood or human plasma, the price proposed by the manufacturer needs to be either the lowest or equal to the lowest price that product is listed in all reference countries.

This process determines the list price, that is the maximum price that the manufacturer will be able to sell the drug in Romania.  All list prices set in this way will be collected in the National Catalogue of Medicines or CANAMED. 

A second list exists, the Public National Prices Catalogue.  The prices that are included in this catalogue are calculated based on the average of the three lowest prices for the comparison product in the reference countries. 

For both catalogues, product prices are calculated exclusively in Romanian Lira (RON). The different ways that the prices are calculated in the two catalogues makes Romania a country that operates with a dual pricing system for pharmaceutical products.  This has created a lot of confusion over time, especially at the start and a lot of uncertainty still persists around this system.

CANAMED

The National Catalogue of Medicinal Products or CANAMED is a catalogue that contains all “list” prices for products that are allowed to be sold on the Romanian territory.  It is set as the lowest or same as the lowest price between a minimum of 12 reference countries.  The CANAMED is used by wholesale distributors or suppliers of medicinal products that have a contractual relationship with the Public Health departments or insurance houses.  This means that they will have access to lower pharmaceutical product price.

Public National Prices Catalogue

The public national prices catalogue or “Public Catalogue” is a list that sets the maximum prices that manufacturers are allowed to sell a pharmaceutical product in Romania that may be used by community pharmacies, local distributors and other entities that do not have any contractual relationship with Public Health departments or insurance houses. 

Public Catalogue prices are set as an average of the three lowest same product prices in the reference country basket.  Due to the way this is calculated, there is a difference between CANAMED prices and Public Catalogue prices with the latter usually displaying higher prices. 

Due to this difference in prices between the catalogues, there is concern that manufacturers will prefer one catalogue over another when setting prices thus increasing cost to patients.  However, Romania has decided that for any External Reference Pricing calculations the Public Catalogue prices will be used.  Romania is a reference country under External Reference Price calculations for other 12 European markets, and as such any pricing changes will have a knock-on effect to these markets. 

CANAMED and Public Catalogue Updates

Prices for pharmaceutical products within both catalogues are reviewed annually.  During these reviews both catalogues are subject to currency exchange rate between EUR/RON updates.  As Romania uses RON as the preferred currency to deal with pharmaceutical products it has opted for using a static currency value when updating both catalogues.  The currency exchange rate used is the average rate between EUR/RON from the first quarter of the year in which the update is done.

This has caused multiple situations where a manufacturer has decided not to launch within the Romanian market as the currency exchange rate is locked and not favourable.  This may also cause shortages or other issues for the patient.

When the currency exchange rate is updated, all prices are recalculated according to the new exchange rate.  Furthermore, all initial approval conditions are reassessed according to the most applicable legislation.  This may lead to additional changes in price.

Wholesaler and Pharmacy Margins

Both the CANAMED and the Public Catalogue, list the maximum manufacturer/producer price allowed in the Romanian territory depending on an interaction with the Public Health departments or insurance houses.

Wholesaler and pharmacy prices are subject to margins that are added to the previous price.  This means that the margin for the wholesaler price will be calculated from the manufacturer/producer price whilst the margin for the pharmacy price is applied to the wholesaler price.

For both the wholesaler and the pharmacy, the margins are regressive and the price is established based on both a percentage and a fixed quota specific to each price bracket.

At Black Swan Analysis we have revamped the data for Romania and will be including CANAMED as well as Public Catalogue Prices. This allows our customers to get powerful insights and the most up-to-date pharmaceutical pricing data for this country that operates with a dual pricing system for pharmaceutical products. Find out more about the Rx Price IndexTM   here.

By Fabio De Cristofano, Sr Analyst, Rx Price IndexTM