Data gap analysis identifies what information about a medicinal product is still needed

A data gap analysis is a systematic method used to identify what information about a medicinal product or treatment is still missing and what data should be generated to support more reliable decision-making. This work is a core area of expertise at Medaffcon.

In a data gap analysis, gaps in the available information of the therapy area and data on a medicinal product are mapped and assessed against regulatory, scientific, and business requirements. The objective is to identify what critical information is missing, in what format it is needed, and how these gaps affect decision-making, product strategy and market access. According to Jarmo Hahl, Principal Consultant at Medaffcon, the analysis and evaluation process could well be described as a ‘launch readiness’ checklist from the payer perspective.

The gap analysis focuses on the knowledge of the therapy area and patients, clinical trial data, real-world evidence (RWE), and regulatory and payer requirements.

A well-executed data gap analysis accelerates market access

Through a data gap analysis, a pharmaceutical company ensures that the evidence required from a payer perspective is available to support market access. Any identified gaps are addressed in the most appropriate way to support submissions to competent authorities responsible for decisions on pricing, reimbursement, formulary inclusion, and ultimately the market access of the product in question.

A well-executed analysis supports risk management, accelerates market access, and improves the quality of decision-making. The results can also be leveraged in communications.

Key elements of a data gap analysis include assessing the current state, defining requirements, identifying and prioritizing gaps, and planning actions to mitigate identified gaps.

“The client provides us with the materials, and we check from a payer perspective whether all the necessary information is there. We go through everything point by point, critically reviewing what the data looks like and where the problems are. Is there something the client should do to address the gaps in time?” Hahl explains.

The Nordic context and differences

Recently, Medaffcon conducted a Nordic-level analysis for a global pharmaceutical company.

“Requirements vary somewhat in the Nordic context. Denmark, Sweden, Norway, and Finland each have slightly different expectations. In this analysis as well, we identified country-specific blind spots so that the company could address them,” Hahl says.

As Finland and Sweden are seeking to expand the use of conditional reimbursement, the importance of data gap analyses may increase further. More medicinal products are being introduced in situations where evidence is still limited. A data gap analysis is a tool for documenting these gaps.

Start the data gap analysis early

According to Hahl, a data gap analysis should be conducted well before launch. The earlier the analysis is performed, the more time there is to address any identified gaps.

“A good starting point is at least one to two years before the data are needed,” Hahl notes.

A data gap analysis is particularly valuable prior to applying for a new indication, when preparing for an HTA process in a new country, where additional evidence is required by a regulator, or when building a launch strategy for a new product.