Czech ministry proposes changes in medicines price setting approach [Advocacy Lab Content]

The Czech Health Ministry has introduced amendments to the public insurance law to enhance healthcare accessibility and ensure sustainable medical treatment costs – a move welcomed by Czech pharmaceutical companies.

The legislative change aims to bolster the resilience of the pharmaceutical market and improve drug availability.

The amendment introduces a refined methodology for setting maximum prices for specific medicinal products. Now the maximum price calculation will average prices across up to seven reference basket countries.

Alternatively, if this approach proves unsuitable, an average across all EU countries or based on the cost of a therapeutically similar product within the Czech Republic or the EU may be considered. This approach aims to mitigate the risks of drug unavailability due to market fluctuations.

Czech generic drug manufacturers welcomed the proposed measure.

“The amendment gives the health ministry the possibility to establish a list of endangered groups of medicinal products, for which the method of setting the maximum price will be adjusted so that the price is higher than under the current rules,” Filip Vrubel, director of the Czech Association of Pharmaceutical Companies, explained to Euractiv.

Improving the availability of medicines

According to Vrubel, current price levels are one of the main reasons behind the uncertainty of medicine supplies in periods of drug shortages, which can affect not only Czechia but also other EU countries.

The criteria for selecting a reference medicinal product, which determines the basic reimbursement, will also be more stringent.

The product must hold at least a 5% share of total sales volume, up from the previous 3%. If a product is proven to be unavailable in the market, it will be excluded from referencing. According to the Czech Ministry, such changes ensure that reimbursement rates reflect the most current and realistic market conditions.

To increase the availability of drugs for the largest number of patients, if the reimbursement price drops by at least 80% over five years, indication restrictions will be abolished. This measure is expected to expand the therapeutic options available to patients by allowing drugs to be used across all approved therapeutic indications.

“The situation in which the health insurance company contributes to a medicine for one indication of a particular medicine and not for another indication of the same medicine will be eliminated,” said Vrubel.

There should also be no situation where a drug is only covered for patients with a more serious condition, even though it could help patients with a milder course of the disease.

Guaranteed refunds for insurers

A significant change is the proposed modification in the definition of Highly Innovative Medicinal Products (VILP). The amendment allows for conditional reimbursement of products with temporary registration when no paid alternative exists.

According to the Czech Ministry, this change could accelerate the introduction of new molecules into areas with unmet medical needs.

However, this comes with a high degree of uncertainty, given the temporary registration status. Thus, should these products not secure permanent reimbursement, insurers are guaranteed a refund of the expended resources.

“We consider the proposal to modify the definition of highly innovative medicinal products (HMPs) to be a significant improvement that will lead to an increase in the number of products of this type available to Czech patients in the future,” said David Kolář, director of the Czech Association of Innovative Pharmaceutical Industry.

However, Kolář emphasised that the proposal also includes some negative aspects. “The proposal is generally consensual in this part, containing several positives and negatives. As such, it can be considered a good starting point for further discussions,” he explained.

He also highlighted that the ministry should have proposed the amendment earlier, as the current Czech parliamentary term is coming to an end, and it is not sure if the legislative bodies will have the opportunity to discuss and even approve the proposal before the 2024 Czech parliamentary elections.

“We know from past hearings on this bill that the legislative process itself often drags on for at least 12 months,” Kolář said.

The proposal affects not only medicines policies but also promotes prevention and tries to ensure access to dental care. It also includes provisions related to reimbursement of cross-border care.

The Czech Health Ministry is currently collecting feedback on the proposal, and this phase will close on 14 May. Then, after processing the feedback, the ministry will send the amendment to the Czech lower chamber of the Parliament.

[By Aneta Zachová, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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