Driving BioPharma value, evidence, and access in the Netherlands

Planning for biopharma access in smaller EU markets, such as the Netherlands, 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 Netherlands and explores:  

• Coverage of medicinal products via the basic healthcare package 
• HTA of non-hospital medicinal products to qualify for inclusion in GVS 
• Assessment of hospital products in ‘lock’ 
• Impact of changing ‘lock’ criteria 

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

The Netherlands: coverage via the basic healthcare package depends on the type of product (hospital vs non-hospital) and a decision from MoHWS 

The Netherlands has a universal healthcare system that combines public and private insurance. All residents are required to purchase basic health insurance from private providers; however, the cover of that basic healthcare package is regulated by the government. 

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

The Dutch reimbursement system distinguishes between non-hospital and hospital medicines. 

• Non-hospital medicines are managed via a closed system, where only products that are included in the Medicines Reimbursement System, or GVS, are eligible for reimbursement from the basic healthcare package. 
   
• Hospital medicines are managed via an open system, where products are usually admitted to the basic healthcare package without special price agreements. However, the Minister of Health, Welfare, and Sport (MoHWS) can decide to temporarily exclude expensive products or indications from the basic package by placing them in a ʻlockʼ. 
   

The National Health Care Institute, or ZIN, assesses of non-hospital medicines as well as hospital products that have been placed in the ʻlockʼ to determine whether they should be added to the basic healthcare package. 

ZIN formulates its recommendation based on four assessment criteria: necessity, effectiveness, cost-effectiveness, and feasibility. The MoHWS then makes the final decision on whether a new product should be added to the basic healthcare package. 

The Netherlands: all non-hospital products undergo HTA to qualify for inclusion in the GVS; ZIN also formulates advice on their positioning in treatment pathway 

All non-hospital products must undergo HTA to qualify for inclusion in the GVS. 

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

Within the GVS, medicines are organized into appendices: Appendix 1A includes clusters of interchangeable products, while Appendix 1B comprises unique medicines. 

Medicines are considered interchangeable if they have a similar indication, a similar route of administration, and are generally indicated for the same age category. 

If a product is placed in Appendix 1A, a reimbursement limit is set based on the prices of the other products in the cluster.  

If a product is considered non-interchangeable, it is listed in Appendix 1B. No reimbursement limit is applied to products in Appendix 1B; however, financial agreements may still be required, particularly if it is considered that the added therapeutic value of the product does not justify its proposed price. 

Products from Appendix 1A and 1B can also be placed in Appendix 2, which means that further conditions apply to their reimbursement (for example, if only a certain patient subpopulation is eligible for reimbursement). 

ZIN also formulates advice regarding the position of therapies in the treatment pathway relative to other products in the same indication area. The information is published in the Pharmacotherapeutic Compass and aims to guide prescribers. 

The Netherlands: only hospital products that are considered a risk to the quality, accessibility, and affordability of the basic healthcare package undergo HTA 

While all non-hospital products must be assessed by ZIN to secure reimbursement, only some hospital-dispensed products require an appraisal. 

ZIN only assesses hospital products that are considered a risk to the quality, accessibility, and affordability of the basic healthcare package. These are either therapies that have been placed in ʻlockʼ or products that do not meet the ʻlockʼ criteria but are still considered a risk. 

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

Throughout the year, ZIN conducts regular horizon scans to identify potential ʻlockʼ candidates. The scan monitors the arrival of new hospital products as well as indicating expansions for which a European authorization is expected within 2 years. 

From 1 July 2023, the ʻlockʼ criteria are changing so that hospital products will be subject to that measure if their projected annual costs exceed €20 million, rather than the current figure of €40 million. If this criterion is met, the expected new indication as well as all future indications of the product are placed in ʻlockʼ. 

The second criterion dictates admission to the ʻlockʼ of a new indication with costs per patient of more than €50,000 per year and total costs of more than €10 million per year. This criterion has remained unchanged. 

A medicine can be definitively placed in ʻlockʼ only after it has been approved by the EMA. The manufacturer can then submit an HTA dossier, on the basis of which ZIN assesses whether the medicine should be included in the basic package. In the event of a positive recommendation, ZIN indicates whether a price reduction is needed and which patients should benefit from the treatment. 

Following successful price negotiations and agreements on appropriate use, the MoHWS approves the inclusion of the hospital product in the basic healthcare package. 

 
The Netherlands: lock medicines are supposed to be assessed by ZIN within 120 days, but the average turnaround time in 2022 reached 159 days 

ʻLockʼ medicines are supposed to be assessed by ZIN within 120 days; however, the average turnaround time in 2022 was 159 days. According to ZIN, the main reason for exceeding the 120-day deadline was the submission of dossiers that did not contain sufficient information to allow a quick assessment. 

Following the change in the ʻlockʼ criteria in July 2023, more specialist products will need to undergo HTA to be reimbursed through the basic healthcare package. 

Therefore, being able to develop a robust and comprehensive HTA submission dossier will be even more imperative for maintaining competitive advantage and securing rapid patient access in the Netherlands.
 

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.