Our Nordic region features world-class healthcare. Understanding the Nordic healthcare and market access landscape is crucial for successful pricing and reimbursement of your pharmaceutical product. After reading this, you will have a basic knowledge of the key steps to create a successful pricing and reimbursement strategy for your product as you navigate the Nordic markets - Sweden, Norway, Denmark, Finland, and Iceland. This will increase the likelihood of receiving a fairly priced product and a positive reimbursement decision for your pharmaceuticals from each of the Nordic Health Technology Assessment (HTA) authorities.
What is Market Access?
Market access and pricing and reimbursement are used to describe activities and processes that pharmaceutical and biotech companies undertake to secure a price and market sales for their product.
Market access can mean different things in different parts of the world. In the US, it is about evolving policy in access and coverage, from upcoming Medicaid payment changes to Medicare coverage and payment for innovative drugs. In many parts of Europe, including the Nordics, it is more about evidence generation and value communication and reflecting the product’s value both from a clinical and financial perspective to get the product reimbursed and priced. Here we are focused purely on the pricing and reimbursement of pharmaceutical products in the Nordics.
Market Access & Pricing and Reimbursement in the Nordics
The entire resident population of the Nordic region is covered by publicly financed comprehensive healthcare systems. These guarantee access to high quality healthcare at minimal or no direct patient cost. Access, treatment, and public health are the three key dimensions of the healthcare policy in the Nordic countries.
Overall, for the Nordic markets, the health care system is a single payer system with primarily public provision, based on tax contribution. This means that the health system is financed by a single entity, in this case the government, and health care is part of the social protection, where healthcare funding comes primarily from regional taxes.
Reimbursed products are also mainly covered by a government grant. Without a positive reimbursement recommendation in the Nordic markets, it is very difficult for pharmaceutical companies to bring new products into the markets. Reimbursement processes and status can also look different whether the product is a prescription drug or a hospital drug. This means that the routes of making medicines available for the Nordic markets differ for medicines used in different settings. Hospital medicines for instance, are classified as reimbursed if it has been approved by either the European Medicines Agency (EMA, centralized procedure) or by each Nordic country (decentralized procedure), and has a positive recommendation from the national medicine agency. Prescription drugs on the other hand, are classified as reimbursed if they have been approved by EMA or each Nordic country and have received a positive reimbursement decision from the national medicine agency.
It is important to recognize that even in the Nordic markets, which still consists of five different countries (Denmark, Sweden, Norway, Finland, and Iceland), the reimbursement of drugs is subject to local rules formulated by local governments and the rules vary from one Nordic country to another. For instance, similar reimbursement functions are organized at the national level for outpatient drugs in the three countries Sweden, Norway and Denmark, but differs in Finland.
Reimbursement is granted as general reimbursement or restricted to subgroups of patients. In addition, in the case of Denmark and Norway, reimbursement is possible on an individual case by case basis in which the physician may apply reimbursement for the patient for a drug that does not have reimbursement status, or for which the patient does not meet the reimbursement criteria.
In Denmark and Sweden, the financial responsibility of outpatient drugs lies with the regions, while prescription drugs are paid for by a national insurance scheme in Norway.
Why is a Good Pricing and Reimbursement Strategy so Important?
Reimbursement is a critical function of a drug's development and go-to-market strategy, as it sets the stage for a successful product launch.
Over the last ten years, there has been increased pressure on healthcare system budgets, a trend toward greater transparency, and the introduction of increasingly complex and expensive technologies in the market. Both with expensive oncology drugs and very costly orphan drugs indicated for the treatment of rare diseases. And recently, with the very costly one-shot therapies such as ATMPs (Advanced Therapy Medicinal Products), that can only show benefit in a longer-term perspective, further limit the affordability for public and private payers and reduce patient access to treatment for what are often life-threatening conditions.
Due to rising health care costs, elaborate public control of health care and technological innovation, Denmark, Norway and Sweden were among the first countries in the world to list priority setting principles for rationing health care resources on a national level. These priority setting principles are reflected in the countries’ current outpatient reimbursement criteria and show similarities between the countries: Norway and Sweden put emphasis on need, stating that priority should be given to those in most need. Further, the treatment must be considered cost-effective. Other reimbursement criteria include that the treatment must be well documented (Norway), and similarly, that the treatment must be safe, efficacious, and have a well-defined indication (Denmark).
Considering these structural similarities and differences in HTA processes, it is crucial for a company to understand the pricing and reimbursement processes and requirements in each market, and the differences and similarities.
If a company fails to understand each country’s needs and priorities, as well as how they differ from other European markets, it will be very challenging to prepare the right documents and receive a positive reimbursement decision in the Nordics.
To cope with these challenges, there are some key steps to follow for successful pricing and reimbursement of your pharmaceutical product in the Nordic markets. By following these steps, the companies will maximize the possibility for pharmaceutical product to achieve optimal pricing and reimbursement in the Nordic markets and enable successful delivery of their product to the patients who will benefit the most from it.
Key Steps for Creating a Successful Pricing and Reimbursement Strategy in the Nordics
The right pricing and understanding of your product’s value in each of the Nordic markets in which you’re seeking reimbursement is the key to successful reimbursement. Without a proper price and value proposition plan customized to each country’s policy and requirements, it is very easy to miss your opportunity to enter the Nordic markets after your market authorization approval, even if you have your product reimbursed in other European markets.
We have comprised three key steps to define your pricing and reimbursement strategy before entering the Nordic markets. All these steps and activities must be carefully planned and developed early to avoid mistakes in product positioning; evidence gaps, or wrong study designs (clinical, social, economic); and to avoid unexpected costs with the need of new studies or adapting the launching strategy.
Step 1: Early Assessment
Define your pricing and reimbursement strategy at an early stage.
Define your pricing and reimbursement strategy in the development of phase I and II trials for medicines. This means that it is important to adapt clinical trial design and other studies to be developed (including health economic outcomes research (HEOR) and/or real-world evidence (RWE) studies) from payer, physician, and patient perspectives as early as the clinical development phase of the product.
Nordic-specific clinical development also needs to be considered in the clinical plans and programs. For instance, an early launch could be planned by implementing early access programs (EAPs) for pharmaceutical products and patient level data could be derived from these EAPs and further analyzed and used in Nordic HTAs when applying for reimbursement. Early access programs can already be applied with robust phase II data but are usually used in phase III trials. Early access programs can also fill the gap between regulatory approval and finalization of the pricing and reimbursement applications in the Nordics.
Moreover, having a robust business case in place early in the product development phase is also recommended, to create and have the product's value story in place well ahead in time. Supporting evidence in the business case can include testing different assumptions with key stakeholders in each Nordic market, considering different scenarios on the target population, and a list of potential hurdles and challenges to carefully monitor and follow-up on.
Step 2: Know the Market
Establish a good understanding of the market and the healthcare system.
This step needs national, regional, and local expertise and includes the type of health care provided, its organization and expenditure, the possible commercial and dispensation channels, the specific regulations, and main bodies. It is also about understanding the different access pathways, the different HTA and pricing and reimbursement processes and pathways, the level of evidence required, the key decision drivers and the different pricing mechanisms in each Nordic market.
Both HTA development and pricing and reimbursement processes are key factors for market access. It is very important to understand that these processes and regulations look different in each Nordic country and that the clinical evidence and the price and comparator to the product in one country might not be fully adaptable to the other country, even if all look similar in the Nordics from outside.
For instance, in Norway there might be price negotiations and financial and performance-based agreements, while in Sweden there could be very clear and straight forward rebates for the same product.
To target each market appropriately we recommend stakeholder mapping, consisting of relevance and roles in the decision process of different HTA and pricing and reimbursement bodies, Key Opinion Leaders (KOLs), and patient representatives.
Step 3: Economic Models
Develop value package and economic models.
When the business case is in place, value messages have been validated, and the understanding of each Nordic market's processes and requirements is clear, the development of the global value dossier (GVD) and economic models can start. Usually when there is a product entry into the Nordic markets there is already a GVD and global health economic model in place. Here we can customize the GVD and model to each Nordic market’s preferences and requirements to be submitted to each national agency, as well as any other relevant materials depending on the outcomes from previous steps. The economic models look different depending on the clinical landscape, competitive market, price structure and the local processes and requirements. In Sweden, Norway, Denmark and Finland, a cost-effectiveness model with quality of life (QoL) as an outcome is required.
How can ProPharma Support You With Pricing and Reimbursement in the Nordic Markets?
ProPharma is a unique partner who can support pharmaceutical companies with these pricing and reimbursement key steps above in all Nordic markets, each with their unique local expertise and understanding of their processes and language skills.
The market access team at ProPharma also works in close collaboration with our internal teams from clinical regulatory, CMC (Chemistry, Manufacturing, and Controls), QA (Quality Assurance), PV (Pharmacovigilance), Clinical research, and lifecycle management to help you streamline the development and launch of your new products throughout your product's life cycle in all Nordic markets.
