It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be both challenging and sometimes complicated to accomplish – securing reimbursement approval and thereby gaining market access for your drug.
Choosing the right Pricing and Reimbursement (P&R) strategy, and doing so early in product development, is crucial to achieving reimbursement of your drug. Using our team’s significant experience helping clients obtain reimbursement, here is a brief guide to help you through the critical steps and challenges that need to be addressed.
Importance of Understanding P&R Processes in the Nordics
While regulatory market approvals are usually a centralized process handled by the European Medicines Agency (EMA) in Europe, Pricing and Reimbursement approval of your drug requires separate national applications throughout the EU member states.
Likewise, in all Nordic countries, the overall responsibility for the healthcare sector rests at a national level with the national health service covering all residents in each respective country. A key feature of the Nordic healthcare system is the predominance of tax-financed public provisions.
As a general rule of thumb, self-administered drugs should be included in the national reimbursement systems in each country, where local funding can be considered in specific cases. However, for the Nordic countries, the healthcare systems are organized differently with unique price regulations for inpatient and outpatient drugs. Examples of this include:
- The price for prescribed drugs is set due to external reference pricing for all drugs in Norway, while Sweden and Denmark have free price setting.
- Price regulations for generic drugs and application forms, processes, and documentation requirements differ between each Nordic country. There are different requirements for price increases of already reimbursed drugs and the reimbursement assessment of new treatment indications.
In addition, several parts of the application processes are only available in the local language of each individual country.
Finding the right price level for your drug in each Nordic country is an important part of achieving reimbursement. There are several factors that influence a product’s price level, for example; a higher price can be accepted for a treatment of a severe disease, or if the patient population is limited (i.e. for orphan drugs that treat rare and severe diseases).
Since there are several differences in the P&R process between the Nordic countries, experience and knowledge of each country’s healthcare financing system of pharmaceuticals is critical to success. A partnership with an experienced consultant can provide you with information and landscape reviews, as well as assist with the identification of potential price levels for your drug in each Nordic country.
Documentation Needed in a Pricing and Reimbursement Application
The efficacy and safety of the drug is, to some extent, always considered in a P&R application. Generally, the higher the asking price, the higher the burden of evidence on the Marketing Authorization Holder (MAH). In all of the Nordic countries, the P&R process is different for a chemical entity with market exclusivity compared to drugs where there is generic competition. As soon as there is one approved drug in the reimbursement system, this will be the reference for all of the following generic products entering the market. Price regulations for generic drugs also differ amongst each of the Nordic countries.
Even though efficacy and safety of the drug is always considered in a P&R assessment, the clinical benefits should also be weighed against the price, quality of life, and the economic benefits of your drug in comparison to its relevant comparator. This is the health economic component of the P&R assessment.
Value of Knowing Health Economics
Health economics uses economic concepts and methods to understand and explain how people make decisions regarding their health behaviors and their use of health care. This evaluation is an economic method that generates evidence-based information, mainly through cost-effectiveness or cost-benefit analysis, to assist and improve decision making of allocating healthcare resources.
Health economic assessments for decision making within the healthcare system have continuously been an integrated part of the P&R assessments of pharmaceuticals in almost every Nordic country.
Health economic modeling and economic evaluation is required in a P&R application for most drugs and therapeutic areas. However, the demands for complexity of the models does differ between the Nordic countries. For instance, Norway has one of the more comprehensive health economic templates for their reimbursement application and Denmark is in the start-up phase of including quality of life measurements in their economic evaluations.
Extensive knowledge in health economics and cost-effectiveness models is a major advantage when preparing P&R applications.
Improve Your Possibilities for Reimbursement in the Nordics
There are several factors that will improve your chances of gaining reimbursement for your drug in the Nordics. For example, it could depend on product and disease awareness in each country at an early stage, even before market regulatory approval.
As such, a market access strategy and landscape review for your specific product is recommended as early in development as possible, and ideally before initiation of your phase III trials, where potential primary and secondary endpoints also are reviewed from a health economic viewpoint. It may be worth including quality of life measurements in your phase III clinical trial to increase the level of evidence of your drug in a future reimbursement application. In addition, suggestions on potential future comparative drugs should also be discussed and taken into consideration at an early stage.
Since our Nordic P&R Team is made up of former payers, we can provide direct insight to both formal and informal processes concerning your application, documentation, and dialogue with the Nordic authorities.
Consult with ProPharma Group’s Nordic Pricing and Reimbursement Team
Our team of Nordic Pricing and Reimbursement experts has extensive experience from previous work as P&R assessors. This gives our team unique insight and expert knowledge from a payer’s perspective, which is essential to developing a successful Pricing and Reimbursement strategy.
ProPharma Group’s experts have performed numerous successful Pricing and Reimbursement submissions in all of the Nordic countries, including health economic modeling and model adaptations to local conditions.
Our knowledge and experience in over 100 therapeutic areas, including rare diseases with successful reimbursement of orphan drugs, enables us to provide our clients with professional advice and assistance that improves your ability to get your drug reimbursed and maintain reimbursement in any of the Nordic countries.
To learn more about our services and how our Nordic P&R Team can help you to improve your understanding of the P&R process and your P&R application, contact us today.
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