Tony Hagen is senior managing editor for The Center for Biosimilars®.
A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.
It is often stated that Europe is ahead of the United States in its acceptance of biosimilars, but each country in Europe is a separate market and differs in its own way on biosimilar success, based on local policies and practices.
In an ambitious attempt to understand how well each of these markets is bringing biosimilars to patients, the IQVIA Institute for Human Data Science developed a scorecard system for rating countries on various measures of biosimilar success and came up with ratings-based profiles of 12 countries across the European zone.
The project was done in cooperation with Medicines for Europe, a trade industry association representing manufacturers of generic and biosimilar products.
For biosimilar aficionados in the United States, it may be the clearest look so far at how these countries—from Norway to Poland to the United Kingdom—compare with one another in their policies on biosimilar acceptance.
“The importance of biosimilar medicines’ role is greater than ever, and the systematic tracking of their contribution is a critical means for policymakers and stakeholders to measure progress and achievement of goals for patients and the entire health system,” said Murray Aitken, executive director of IQVIA.
How It Works
The scorecard measures biosimilar penetration in each of the countries by using 3 basic measures: the amount of biosimilar competition, how far prices have fallen following the introduction of biosimilars, and the increase in overall use of the underlying drug (ie, infliximab), as opposed to reference drugs or biosimilars separately. Each country's evaluation includes a sustainability report that shows how well the biosimilar market is poised to grow and develop.
IQVIA has also produced a policy analysis for each of the 12 countries that presents a list of achievements, challenges, and measures that the countries could take to improve their biosimilar markets.
For example, the Netherlands has been one of the most successful countries at introducing biosimilars, according to the scorecard. For products spanning tumor necrosis factor inhibitors (anti-TNF), insulins, and drugs such as rituximab and trastuzumab, the country has high levels of competition between biosimilars and originator products.
On sustainability measures, biosimilars in the Netherlands tend to reach the market very soon after European Medicines Agency (EMA) approval, and physicians are granted strong latitude in switching from reference products to biosimilars.
In its policy analysis for the Netherlands, IQVIA states that payers there recognize the value of biosimilars and incentivize hospitals to save money with biosimilars. Further, the market allows multiple biosimilar manufacturers to participate. The downside, IQVIA states, is that there are multiple biosimilar contracts, “with over 50 agreements in place being commonplace,” which leads to “fragmented” knowledge of these agents.
Poland, by contrast, has high levels of biosimilar competition. Prices have dropped by at least 50% for adalimumab and etanercept, and volume development, or additional access to the underlying drug, is greater than 25% in many cases, according to the IQVIA report.
On sustainability, Poland has done worse than the Netherlands. The average time to market following approval is 11 to 14 months, and literature and guidelines tend to discourage using biosimilars. Pharmacists are permitted to substitute biosimilars for reference products, but physicians may not switch patients from one biosimilar to another, according to the report.
Biosimilars have achieved widespread penetration in Poland, and there are healthy levels of competition, IQVIA said. On the negative side, there are reimbursement problems, and mandatory price cuts after patents expire make the Polish market unattractive for manufacturers of originator products.
The United Kingdom, according to the scorecard, has high levels of competition, prices have dropped significantly (30%-49%, mostly), and volume growth has sometimes exceeded 25%, although in some instances volume growth has been less than 5% (eg, insulin glargine, rituximab, trastuzumab).
Across multiple measures, the United Kingdom achieved very high marks for sustainability. Biosimilars reach market soon after EMA approval (0-5 months), guidelines and educational resources for physicians and patients are robust, and substitution policies are liberal. In addition, there are no mandatory price cuts imposed on originator products. IQVIA also noted that the market determines pricing rather than government-imposed reference price systems.
“A very clear policy with clear targets has been articulated by [the National Health Service] in favor of competition and encouraging use of best value biologic medicines,” IQVIA wrote about the UK system. However, IQVIA also wrote that uptake is variable depending on health trusts and region, and national targets for use of biosimilars “make it difficult for doctors to remain independent prescribers.”
Adrian van den Hoven, director general of Medicines for Europe, described the scorecard report as helpful for policy makers to develop sustainable markets for biologic medicines. “While the report shows that policy measures should be tailored to national contexts, it provides clear recommendations on how measures can be combined and adapted to deliver effective results,” he said.
Europe has many lessons about biosimilars for the United States; however, single-tender, or winner-take-all systems, which are common in Europe, tend to create an imbalance, according to a recent conference presentation. The IQVIA report also mentions single-tender systems as being detrimental to a healthy, competitive market for biosimilars.