Driving BioPharma value, evidence, and access in Finland

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

  • Reimbursement of medicinal products
     
  • HILA assessment of non-hospital medicinal products 

  • FIMEA assessment of new hospital-dispensed medicinal products 

  • FINOSE looking to increase the efficiency of HTA and reduce time to patient access 

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

 
Finland: the different HTA processes for outpatient and hospital-dispensed medicinal products 

Finland has a publicly funded healthcare system where general health insurance is paid as income tax. 

Drugs dispensed at community pharmacies are reimbursed by the national health insurance, while drug treatments administered in health centers and hospitals are covered by municipal financing. 

The Finnish Medicines Agency (FIMEA) is the regulatory authority responsible for the licensing of drugs in Finland. 


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

If a product does not have a marketing authorization in another EU country, Norway, or Iceland, a marketing authorization can be applied for via a national procedure. The application is submitted to FIMEA, which evaluates the evidence and determines whether a marketing authorization should be granted. 

If a medicinal product is already approved in another EU country, Norway, or Iceland, FIMEA automatically grants a marketing authorization in Finland based on the mutual recognition procedure. Marketing authorization can also be pursued via the centralized and decentralized procedures. 

Once authorized, the medicinal product can be placed on the market. A company can price its products freely if they are not included in the drug reimbursement system. However, if a company wishes to include an outpatient medicinal product in the drug reimbursement system, it must submit a pricing and reimbursement application. 

Hospital-dispensed products are not covered by national health insurance, and manufacturers therefore do not need to apply for reimbursement. Instead, the wholesale price of hospital products is determined through restricted tendering and competitive bidding; however, these medicines may still undergo an HTA. 

Different HTA processes are followed for outpatient and hospital-dispensed products. Outpatient products are assessed by the Pharmaceuticals Pricing Board (HILA) while hospital-dispensed products are appraised by FIMEA. 

 

Finland: HILA determines the national reimbursement status and reasonable wholesale price of retail pharmacy products 

HILA operates under the Ministry of Social Affairs and Health, and assesses retail pharmacy medicinal products, nutritional supplements, and basic ointments. 

Based on the outcomes of the assessment, HILA determines the reimbursement status and reasonable wholesale price of the product. Pricing and reimbursement applications are normally processed within 180 days. 



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

As part of the assessment, HILA considers input from the Social Insurance Institution, or KELA, as well as expert groups. KELA provides advice on the proposed wholesale price for the product and overall budget impact. 

The rate of reimbursement is determined by the reimbursement category assigned to the product. There are three reimbursement categories: a basic one, set at 40%, and two special reimbursement categories, which are set at 65% and 100%. 

When a drug is considered to have a reasonable price and has met the necessary reimbursement criteria, it is normally allocated to the basic category. A manufacturer must submit evidence to justify the added therapeutic value and cost-effectiveness of a drug before it can move to one of the special reimbursement categories. 

In practice, drugs are usually sold in the basic category for an average of 2 years; in a very few cases, a drug has been granted a higher level of reimbursement immediately. In addition, restricted reimbursement may be considered for products that are particularly expensive. 

 

Finland: new hospital-dispensed medicinal products are assessed by FIMEA, but the recommendations are non-binding 

New hospital-dispensed medicinal products undergo a rapid HTA-type appraisal by FIMEA. Input from the National HTA Coordination Unit, clinical experts, hospital representatives, and other national stakeholders is also included in the process. FIMEA then compiles a report that summarizes the therapeutic and economic value of the product. 



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

After the HTA report is published, the Council for Choices in Health Care in Finland, or PALKO, issues recommendations regarding the inclusion of the proposed product in the range of public health services as well as the appropriateness of the proposed price. However, the pricing recommendations are vague and specific price points are not mentioned. PALKOʼs recommendations are non-binding, but hospitals take them into account during price negotiations with the manufacturer. 

Hospitals make the final decision regarding the uptake and use of new medicinal products. Hospitals – either individually or in groups – are responsible for price negotiations with manufacturers. 

 

Finland: how the FINOSE collaboration network aims to increase the efficiency of HTA and reduce time to patient access 

Finland is also member of Nordic HTA collaboration network, FINOSE. The collaboration was initiated in 2017 by FIMEA, the Norwegian NoMA, and the Swedish TLV. In May this year, the Danish Medicines Council also joined FINOSE. 

The FINOSE collaboration seeks to improve the efficiency of HTA by sharing the work between the agencies, synergizing communication, and developing cross-border agreement on relative clinical effectiveness and some aspects of health economics. The ultimate goal of the joint initiative is to reduce the time for patient access to medicines. 


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

Manufacturers who have a new, but not yet authorized, medicinal product are invited to consider the possibility of conducting a joint FINOSE assessment and, if appropriate, to contact either of the HTA agencies. The joint assessment is then initiated after a positive opinion by the EMA’s Committee for Medicinal Products for Human Use. 

Manufacturers are required to submit a PICO summary and then participate in a scoping meeting, where the content and timelines of the assessment are agreed. A single dossier is developed based on the TLV or NoMA submission templates and is sent to all agencies. Country-specific materials are also submitted to the relevant HTA bodies. 

FINOSE develops a joint report which is supplemented with local details and is used to inform national decision-makers. The market-specific aspects of the assessment (such as budget impact analysis) are expected to occur in parallel with the FINOSE appraisal. The goal is to have the market-specific recommendations along with the final national report published shortly after the FINOSE assessment is completed. 

The FINOSE initiative aims to expedite Nordic HTA by completing the assessment process within 90 days. In practice, however, FINOSE assessments have taken approximately 170 days. 

Although the overall time for processing HTA submissions is generally thought to be reduced, the FINOSE framework has not yet eased considerably the burden of Nordic HTA submission to manufacturers. Market-specific assessments are still required and evidentiary requirements between markets are not yet aligned. 

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. 

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Value, Evidence, and Access Insights for markets outside the EU5

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