Driving BioPharma value, evidence, and access in the Czech Republic

Planning for biopharma access in smaller EU markets, such as the Czech Republic, is often overlooked until after an asset is reimbursed in the major European markets. Understanding the key considerations and evidentiary requirements ahead of time will support the development of a robust evidence package, aid launch sequence planning, and help secure optimum market access.  

This update focuses on value, evidence, and access in the Czech Republic and explores:  

• Cost-effectiveness as a key payer value driver 
• Temporary exemption from meeting an ICER threshold via the highly innovative treatment pathway 
• Financial considerations 
• Additional consideration for access teams 

The full report is available to download now and includes insight on Bulgaria, the Czech Republic, Finland, the Netherlands, and Romania. 

Czech Republic: cost-effectiveness is a key payer value driver 

One of the key considerations for market access in the Czech Republic is the role of cost-effectiveness within the highly innovative pathway. 

Source: “Value, Evidence, and Access: insights for markets outside of the EU5”  

HTA 

The State Institute for Drug Control (SUKL) performs a formal HTA to determine national reimbursement of products intended for hospital use. 

Cost-effectiveness analysis 

As part of the HTA, manufacturers are required to submit pharmacoeconomic analyses evaluating the cost-effectiveness and budget impact of the product versus the local standard of care. 

ICER threshold 

As in several other European markets, the incremental cost-effectiveness ratio (ICER) for a medicinal product versus its comparator must be below a defined threshold. In order to gain reimbursement, the ICER must not exceed 1.2 million Czech koruna per quality-adjusted life-year (QALY) gained (that is, approximately €50,000/QALY). This threshold can be met by offering confidential discounts on the list price. 

Highly innovative products 

There is, however, an exemption for products that meet the criteria for highly innovative status. Manufacturers may gain temporary reimbursement for eligible products for a period of up to 5 years. During this period, there is no requirement to meet the ICER threshold. 

Czech Republic: meeting the highly innovative pathway grants temporary exemption from meeting an ICER threshold 

In order to be eligible for highly innovative status, a product must meet certain criteria. 

Source: “Value, Evidence, and Access: insights for markets outside of the EU5”  

1. Eligibility

The target indication for a product must be considered a very serious disease, which is defined as a disease that, in spite of current treatments, leads to: 

• permanent or long-term hospitalization 
  
  
• repeated and frequent hospital re-admissions over a period several years 
  
  
• disability or permanent impairment of health 
  
  
• near-total loss of sight, hearing, speech, or movement, or 
  
  
• at least a 20% reduction in life expectancy. 

In addition, a product must address the unmet therapeutic need by offering: 

• a 30% improvement in the primary outcome measure (provided that this is considered a clinically relevant outcome that impacts a patient’s quality of life), or 

• at least a 30% improvement in median overall survival (but no less than 3 months). 

These improvements must be demonstrated versus the standard of care that is reimbursed locally. 

It is the manufacturer’s responsibility to demonstrate the seriousness of the disease as well as the added value of their product. SUKL evaluates the evidence provided and may not necessarily reach the same conclusions as the manufacturer. 

2. Temporary reimbursement and re-evaluation

If a product is deemed to meet the criteria, an initial 3-year period of temporary reimbursement can be granted with exemption from the ICER threshold. 

After this 3-year period, a product is re-evaluated to determine whether it still meets the highly innovative criteria. Potential reasons why a drug may no longer meet the criteria could include: 

• availability of a new reimbursed product or products that mean the disease is no longer considered to be very serious 
  
  
• new or longer-term published data for the product that suggests it no longer meets the clinical criteria for a 30% improvement. 

If the product continues to meet the criteria, the temporary period of reimbursement can be extended by an additional 2 years. 

3. Applying for permanent reimbursement

At the end of the period of temporary reimbursement (either 3 or 5 years), a product must meet the ICER threshold of 1.2 million koruna in order to be eligible for full reimbursement. 

If a manufacturer is unable to offer the product at a net price that meets this threshold, they are required to provide the product free of charge to all patients who are currently on therapy for the remainder of their treatment.
 

Czech Republic: despite being temporarily exempt from meeting the ICER threshold, a confidential discount and budget cap still apply for highly innovative products 

Although the highly innovative pathway provides exemption from having to meet the ICER threshold, there are still several financial considerations for eligible products. 

Once SUKL has agreed that a product meets the criteria, the manufacturer must reach a financial agreement with the health insurance companies. SUKL will also undertake a formal evaluation of the submitted cost-effectiveness and budget impact analyses. 

In order to reach an agreement, a substantial discount from the list price is required. The level of discount is confidential and subject to negotiation. 

Alongside a confidential discount, a budget cap will also need to be agreed. The patient numbers in the budget impact evaluated by SUKL will form the basis of the cap. 

Czech Republic: additional considerations for access teams 

The highly innovative pathway and temporary reimbursement process can facilitate market access; there are, however, several additional key considerations for market access teams. 

The HTA process in the Czech Republic can be considered rigorous. Positive decisions by other influential HTA bodies such as NICE and CADTH do not guarantee that SUKL will make similar positive recommendations. SUKL may raise further objections or request additional analyses, and it is likely that HEOR support will be needed. 

However, SUKL is likely to review all publicly available HTA reports. Any concessions made in other markets (such as the use of more conservative modeling methodology) will likely also be required in the Czech Republic. 

The submitted documentation will be made publicly available; therefore, commentary provided by SUKL may be seen by agencies in other markets within the Central and Eastern Europe region. 

Although manufacturers can mark certain information within the submitted documentation as confidential, this does not apply to ICER results (using the list price). 

This update was taken from the free report “Value, Evidence, and Access: insights for markets outside of the EU5“, which is available to download now.  

The report summarizes: 

• health technology assessment and market access processes in several smaller EU markets: Bulgaria, the Czech Republic, Finland, the Netherlands, and Romania 
  
  
• key considerations for manufacturers ahead of launch in these markets to drive operational excellence and secure timely, quality access 
  
  
• how operational excellence and the PRMA Navigator^® digital application can help maximize the likelihood of success in these markets.