Prices and reimbursement of medications

A basic criterion determining whether the medical drug price is regulated or not is whether the medical product is covered by public insurance funds. If the product is covered, its price is regulated.

Final price = Manufacturer’s price + trade markup + VAT

Manufacturer’s prices and trade markup are regulated separately.

Fixed maximum price

The maximum price is set on the basis of a request by the State Institute for Drug Control (SÚKL) in an administrative procedure. It proceeds in accordance with administrative regulations, the Act on Public Health Insurance and the relevant legislation.

The Act on Public Health Insurance (section 39a paragraph 2) sets out three basic rules for the determination of the maximum manufacturer's price, i.e. a price that cannot be exceeded by the manufacturer when introducing the product onto the market.

1st rule:

The maximum price is set at an average of the three lowest prices of the manufacturer of the given medicine from the countries of the reference basket (EU countries with the exception of Bulgaria, the Czech Republic, Estonia, Luxembourg, Austria, Romania, Greece, Cyprus, and Malta).

2nd rule:

If the medical product is not on the market of three countries from the reference basket, the maximum price is determined based on the price of the manufacturer of the given drug included in the written agreement between the manufacturer and health insurance companies (maximum price agreement – DNC).

3rd rule:

If the medical product is not on the market of three countries from the reference basket and a maximum price agreement has not been decided, the maximum price is set at the price of the manufacturer of the closest therapeutically comparable medicinal product.

TRADE MARKUP

Trade markup = the output price of the distributor and pharmacy

The maximum trade markup is given in the Price Regulations of the Czech Ministry of Health. A trade markup is designed as a joined one – i.e. the sum of the commercial mark-up and pharmacy markup cannot exceed the maximum commercial markup.

Payment from the public health insurance funds is determined by SÚKL in an administrative procedure. Usually, the reimbursement is determined in one administrative meeting with a maximum price (provided that the medicinal product is regulated by a maximum price).

The reimbursement has two basic parts:

• payment amount

• payment conditions

PAYMENT AMOUNT

A basic principle of determining the reimbursement is the requirement of the same reimbursement for the same effect.

For this purpose, medicinal substances are grouped into reference groups – groups of essentially therapeutically interchangeable medications with similar efficiency, safety, and clinical use.

There is a basic reimbursement determined for each group for the usual daily dose (ODTD) – a standard dose with comparable efficiency for the average patient in the reference indication.

Rules for determining the basic reimbursement of the reference group

1st rule

The basic reimbursement is set at the lowest manufacturer’s price per ODTD of any medicinal product from the reference group found in any EU country.

2nd rule

The basic reimbursement is set at the daily cost of another therapy reduced by commercial surcharges and applies value added tax if it is comparably effective and cost effective in comparison to another medical product included in the reference group.

3rd rule

The basic reimbursement is set at the producer price included in the agreement on the highest price of any medicinal product included from the reference group concluded between the producer and insurance companies (DNC).

4th rule

The basic reimbursement is set at the amount of reimbursement included in the written agreement, concluded in the public interest between the producer and health insurance companies (DoU).

The basic reimbursement is set at the lowest amount determined according to the previous rules.

The Public Health Insurance Act allows the basic payment to be increased. If after calculating the basic payment according to rules 1- 4, it is discovered that the given reference group belongs into one of the groups of Appendix No. 2 of the Public Health Insurance Act and there is no fully paid product, the basic reimbursement will be increased so that at least one product is fully covered (i.e. the price and reimbursement must be set at the same amount).

The reimbursement amount for individualproducts is calculated from the basic reimbursement, according to the procedure specified in the implementing legislation.

The reimbursement amounts of individual products are shown in the List of Reimbursed Medicinal Substances published on the SUKL website.

PAYMENT TERMS

Payment terms are set by SÚKL in particular:

• if required by the professional considerations or safety considerations connected to the treatment with this medical preparation,
• if necessary to ensure an efficient and economical use of the medicinal product.

Payment terms are:

• prescription – which doctor can prescribe the medicinal product for it to be paid for,
• for what diagnosis the medicinal product can be prescribed to be paid for.

Payment terms do not have to be set. For example, in that case, the medicinal product is covered to the extent as to which it can be prescribed by the doctor – that is in agreement with the Summary of Product Information (SPC).

PRESCRIPTION LIMITATIONS

If in consideration of effectiveness safety and public interest, reimbursement will be limited to being prescribed by a doctor with specialized qualifications according to the decision.

• Transferable (“L”)

A doctor, with a specialized qualification specified in the decision, can transfer further prescribing of the medicinal product to another (practicing) doctor.

• Non-transferable (“E”)

If, with regard to the effectiveness and safety of the medical product, transferring the prescribed medicinal product is not appropriate, only the doctor with specialised qualifications according to the decision can prescribe the medicinal product.

If considering the effectiveness and safety of the medicinal product as well as public interest, it is expedient to condition the reimbursement of the product by the approved revision health insurance doctor or by a physician authorized by them to do so with the given specialized competence stated in the decision, this preparation shall be marked in the decision by the symbol “W.”

If SÚKL decides to establish this payment term, it also establishes indicative restrictions.

INDICATION RESTRICTIONS

SÚKL stipulates indication restrictions for the medicinal product if expedient in accordance with effectiveness and safety of public interest.

Indication restrictions may include:

• exactly stated indications including commencement and termination of treatment,
• use for named patient groups,
• the condition of failure, contraindication or insufficient effectiveness of previous line of treatment.