Published by Mikael Bergholdt Asmussen, Chief Advisor Market Access, Signum

In terms of introducing new medicines to the market, the pharmaceutical industry and healthcare sector has a shared need for time-cost efficiency to get the most value for money. Yet, healthcare often also demands an increased amount of caution and vigilance. This creates a divergence between two contradictory ways of thinking in terms of optimizing time, money and other resources spent in the launch and implementation of a new medicine.

In the Nordic region, the terms of introducing new medicines and new indications to the market have witnessed a growth in complexity and stringency. These heightened standards necessitate a wealth of comprehensive clinical trial data, prolonged safety assessments to survey long-term effects and evaluations of the benefit-risk profiles of pharmaceutical products.

As Chief Advisor and Team Lead in Signums Market Access team, Mikael Bergholdt Asmussen experiences the authorities’ caution towards implementing new medicines firsthand in his daily work with creating launch acceleration for new drugs:

“As I see it, accessing the medicine market is becoming more bureaucratic, and more stumbling blocks emerge. These are all hurdles that need to be overcome in order to get medicine on the complex market. This means that one must prepare for at least three years before launch and have a well-structured strategy. Furthermore, it is necessary to try to anticipate how the authorities will challenge your medication.”

Pharmaceutical Innovation: Navigating Market Challenges

In the pharmaceutical industry we see an urgency to accelerate the drug development process and to discover new innovative ways to create new medicines, reflecting the industry’s desire to swiftly address patients’ needs.

But the advancements in technology, robust research capabilities and heightened awareness of the urgency to combat various diseases also leads to an increased importance for a time-efficient approval and launch process for new medicines.

Overall, the path to accessing the market has become more challenging due to rising cost, regulatory requirements, and a more intense focus on safety and cost-effectiveness.

Mikael Bergholdt Asmussen elaborates:

“It’s becoming clear that the national Nordic Health Technology Assessment (HTA) requirements are becoming harder for our customers to navigate. There are numerous regulations in place, and as a result, we have refined an approach aimed at expediting the launch of new compounds/indications.”

When reality hits: The barriers to implementation

The industry may be facing barriers concerning whether the medication is included in the prescription system used in the healthcare facilities. Even if health authorities recommend a certain product, the healthcare sector still must be inclined as well as ready and able to meet the transformation and innovation from the pharmaceutical companies.

The complexity of accessing a potential market also includes the application process with different HTAs:

“Different countries impose varying requirements for what should be included in an application within their respective hospital processes. Consequently, pharmaceutical companies must effectively craft separate applications for each country they intend to enter.

While there may be opportunities to reuse certain aspects of the clinical component, the health economic context typically demands a tailored approach for each specific Nordic country. This intricate process introduces delays and complexities, exacerbated by differing methodological requirements and specific criteria for the incorporation of Real-World Evidence (RWE), which also plays a significant role in the HTA processes.”

Timing and efficiency

When companies introduce pharmaceuticals to the Nordic market, key factors are always timing, and the efficiency of resources spent on getting their product launched.

“At Signum, we uncover the current status and examine the recommendations at both regional and national levels, analyzing the market to provide an indication of the position that the customer’s medication can attain. In addition, we conduct competitor analyses, scrutinize how similar drugs have been received, and, through data, increase the customer’s chances of success.”

“In addition, it is crucial to create a prioritized, structured roadmap providing an overview of relevant activities to optimize the likelihood of ensuring the relevant patients access to the medication. By creating this roadmap, it is possible, with open eyes, to prioritize which activities should be initiated to support the launch”.

Streamlining Market Access: Navigating Complex Nordic Markets

Unwrapping the market access setting of a market, in order to understand the health care and treatment setting your product enters, is a vital part of the launch process that can help companies access the complex Nordic market.

Here Mikael elaborates:

“We tailor our approach for companies whose product is in a launch phase burdened by many unknowns. By using our action plan, we identify barriers and opportunities – from structural and organizational to patient-centered – and, in collaboration with our customer, develop a strategy to expedite their product’s journey through HTA processes to enter the market.”

Navigating the complex journey of getting a drug approved for market access can be a daunting task, especially for products that are affected by uncertainties in the launch phase:

“It is important for companies to be prepared for the respective challenges they will face in the process during a launch. There will always be formal and informal obstacles and some elements that customers have understandably not investigated.

At Signum, we have an in-depth knowledge of all the processes involved in getting a drug approved, and through our Performance Data and the collaboration with the pharmaceutical industry, we leverage our resources to make the journey to approval smoother and faster. Moreover, we have extensive experience with the key stakeholders in the process.”

Launch Acceleration – Connect with Signum for expert guidance

In the future, access to innovation in the pharmaceutical area will depend, among other things, on how good we in the industry are at obtaining and working with data. A strong and relevant data foundation early in the process can contribute to faster regulatory approval, which is a prerequisite for patients benefitting from new therapies.