Evidence Synthesis in the EU
In this webinar, ISHEO and AREX Advisor focused on presenting an overview of how different EU countries apply Evidence Synthesis to provide a compass and help professionals navigate the sea of uncertainty created by the vast set of studies present today. Together, we tried to answer why Evidence Synthesis is crucial to implementing a successful market access strategy in the EU.
Value theory and evaluation methods in Europe (Davide Integlia, Director of ISHEO)
To understand the importance of evidence synthesis in the pharmaceutical market, you need to understand its fundamental aspects. In healthcare, we don’t determine pricing by supply and demand, and health is not an interchangeable asset with other individuals. Therefore, the pharmaceuticals market must be finely regulated by acquiring data that assess the impact of the product and define a Price and Reimbursement (P&R) scheme.
The primary objective of Evidence Synthesis is to support the definition and measurement of healthcare products and services’ value. In economics theory, there are two different “value theory”:
- Objective theory or Intrinsec theory of value: the value of a good or service consists of the cost of producing the raw material and the cost of human labor required. Therefore, the price is linked to the cost of the factors of production;
- Subjective theory: the value of a good or a service is the value necessary to obtain users’ desired result. In this case, the price is related to the value of the results.
In Europe, the value of a drug and other health technology depends on the institutionalized payers» subjective perception. For that reason, in Europe, evidence synthesis strongly contributes to building this perception, then the acceptable price.
Moreover, in the market access perspective, there are several barriers that companies encounter in the process of placing a drug on the market:
- the trade-off between the price and the conditions of delivery;
- the selection of a target patient population;
- the procedures for prescribing and financing.
These barriers often result in a non-optimal reimbursement, which inevitably involves restricting the scope of the prescription. Through an appropriate Evidence Synthesis strategy, the marketing authorization holder can overcome all these barriers.
You can assess value via comparative efficacy from clinical trials of the drug, primarily RCTs, although patient-reported outcomes (PROs) are taking on an increasing role. In recent years, Network Meta-analysis (NMA) are assuming strategic importance in accessing the market.
Nevertheless, we can assess “value” by comparing efficacy from real-life data on drug use.
- First of all, it is necessary to evaluate the statistical effect’s size for the additional benefit;
- Secondly, we must consider the safety, administration route, organizational impact, and quality of life from the patient’s perspective;
- Also, you should take the transferability of clinical trial data between jurisdictions and real life into account.
- Finally, we have two other types of value assessment: the cost-benefit ratio (ICER, CEA, QUALY); Budget Impact analysis allows to assess whether the intervention is accessible to the payers current budget.
The reimbursement process in the Nordics (Susanne Schuurman – Head of Market Access at Arex Advisor)
The Nordic countries (Denmark, Finland, Norway, and Sweden) have certain similarities in their reimbursement processes. For example, separate processes govern inpatient and outpatient market access. The main differences between the countries include whether the reimbursement is indication-based (DK, FI, and NO) or not (SWE). Finland follows a two-step reimbursement process with a time limitation for the reimbursement.
In general, reimbursement decision-making in the Nordics focuses on relative effectiveness, cost-effectiveness (with Denmark introducing this for hospital drug decision-making in early 2021), and budget impact. However, in addition to this, the Norwegian agency expects a calculation for the severity of the disease, also called the absolute shortfall, which will have an impact on the willingness to pay (no formal threshold exists).
Evidence synthesis in Finland and Sweden.
For this webinar, we discussed the expectations regarding evidence synthesis for Sweden’s Tandvårds-och läkemedelsförmånsverket (TLV) and Finland’sFinland’s Pharmaceuticals Pricing Board (HILA) to plan evidence generation and commercial launches in the respective countries. Despite each situation and submission being unique, there is some general clinical and economic evidence to be included:
- Local data in terms of the patient population;
- Economic analysis including healthcare and social cost versus the most cost-effective comparator relevant in local clinical practice;
- For Finland also the realistic sales at launch and during the upcoming three years.
We see that the more uncertainties exist in the available data, the higher is the importance of the subgroup analysis, and the more limited reimbursement is, as a result. Also, despite being ICER countries, the Nordics maintain budget considerations as a more important aspect of decision-making, especially at the local/regional level.
About AREX ADVISOR
Arex Advisor offers support to prepare companies in gathering the most relevant evidence to enter the Nordic market. Our team has experience developing reimbursement dossiers and the local footwork in terms of negotiations with the relevant payers. At Arex, we are committed to the process of bringing medicines to the market without detours.
Integrated Solutions of Health Economics and Organizations –support Biopharmaceutical and Medtech Companies that are launching innovative medicines and medical devices after years of investment and effort. We have developed ten years of experience in market access strategy and reimbursement dossiers, focusing primarily on the Italian market and expanding to the European one.