Biosimilars in the Swiss healthcare system
In the early 1980s, genetically engineered drugs, so-called biopharmaceuticals, were produced and marketed for the first time. Since then, their importance has grown steadily. In 2019, sales of cash-payable biopharmaceuticals will amount to approximately 1.642 billion Swiss francs*, which corresponds to a growth rate of +10.5 percent compared to the previous year. Consumption is 98.3 million daily doses or +7.5 percent.
In terms of value, biopharmaceuticals now account for 24 percent of the reimbursement market, compared to only 2 percent of all daily doses dispensed. As in the previous year, the dominant application areas are immunology, oncology and metabolic diseases, which together account for 74 percent of biopharmaceutical sales. Metabolic diseases such as diabetes or osteoporosis account for approximately 66 percent of all daily doses, followed by immunology with 9 percent.
Recombinant drugs have long since become indispensable in medical practice, as they often represent the only alternative therapy and improve the quality of life of many patients. Since the expiry of patents for high-turnover biopharmaceuticals, biosimilars have played an increasingly important role in the cost-efficient use of these drugs. Compared to other drugs, biosimilars have two important advantages: They are part of a dynamic growth market, but are more cost-effective than their original reference products in use.
Biosimilars offer comparable efficacy and safety to the reference drug, especially since the quality requirements are the same. In comparison to generics with chemically synthetic active ingredients, the production of biosimilars is much more complex, and high requirements have to be met for their approval. However, since not all development steps are required before they are ready for the market, they can be offered at lower cost. According to the Federal Office of Public Health, a biosimilar at the expense of OKP is regarded as cost-effective if the price difference to the reference drug is at least 25 percent at launch.
In 2006 and 2007, the first biosimilars were approved in the EU by the EMA in a central procedure. Somewhat belatedly, Swissmedic granted the first authorisations for the Swiss market in 2008. Currently, 21 biosimilars for twelve active substances are on offer, which is significantly fewer than in the EU (53 biosimilars).
In the past year, four active substances became biosimilars: the parathyroid hormone analogue teriparatide (osteoporosis), the antibody trastuzumab (oncology), the haematopoietic growth factor pegfilgrastim (neutropenia) and the TNF alpha inhibitor adalimumab (autoimmune diseases). Due to their late launch, none of these have yet had a major impact.
The share of biosimilars in the biopharmaceuticals market eligible for health insurance has increased dramatically in recent years and currently stands at 25.9% by value and 17.4% by volume. Although the costs are reimbursed by the OKP, biosimilars do not yet play an important role in the doctors’ prescription repertoire. They combine a turnover of 48.1 million francs*, albeit with double-digit growth rates.
The market penetration of biosimilars varies depending on the active ingredient. On average, the original drugs are
20.9 percent by value and 12.8 percent by volume replaced or exchanged. The savings volume realized is correspondingly modest at CHF 12.8 million at ex-factory prices. At the expense of the OKP, slightly more was saved, namely 14.6 million francs. As in many other countries, the automatic substitution of biopharmaceuticals is not permitted in Switzerland. In the case of complete substitution, the theoretical savings potential would have been 56.7 million francs.
Since active ingredients produced by genetic engineering are generally very cost-intensive, biosimilars are considered to have great savings potential. As soon as the patents expire and the complex developments are completed, the launch of further biosimilars can be expected. The expected savings volume largely depends on the price level, market entry and market penetration of the biosimilars. Annual savings of up to CHF 100 million should be possible.
The therapy costs for genetically engineered biopharmaceuticals amount to an average of 16.70 Swiss francs per daily dose* and are thus more than ten times higher than the average costs of all specialities permitted for health insurance.