IMS Health report highlights potential of biosimilars
PARSIPPANY, N.J. — IMS Health on Tuesday published a new report about the potential for biosimilars in the United States and the European Union. The report, “Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets,” focuses on the savings that biosimilars can deliver for patients and payers, as well as the access to advanced treatments they offer payers.
“The prospect of more affordable biologic options that are safe and effective opens up opportunities for health systems to expand access to more patients, and frees up resources for investment in new areas,” said Murray Aitken, IMS Health SVP and IMS Institute for Healthcare Informatics executive director. “This also can yield significant cost savings—but not all markets are ready to fully benefit from the imminent surge of biosimilar molecules.”
According to the report, some 28% of the global pharmaceutical market spending will be going to biologic medications by 2020. In that same time frame, the biosimilars market — which was valued at about $46 billion in 2002, will grow to $390 billion. Also by 2020, the patents on eight biologic drugs — which had collective moving annual total sales of €43.3 billion as of Sept. 2015 across the United States, Germany, France, Italy, Spain and the United Kingdom — will expire.
The potential savings that biosimilar offer in Europe, the report says, total some €10 billion just between 2016 and 2020 as a result of direct competition with the original molecule biologics. Taken together, U.S. and E.U. savings could be between €49 billion and 98 billion.
The report notes that more biosimilars on the market also means more innovation from biologics makers, and the competition between biosimilars and biologic products means more choices for physicians and patients. Currently the pipeline for biosimilars — which had 41 products in it at the end of 2015 — promises to offer more choice when it comes to treatments for diseases treated by new active substances — a record number of which were approved by the Food and Drug Administration in 2015 and which treat rare diseases or offer a new treatment for chronic or serious diseases. These medications are also costly.
“The pressures — and need for choice — are only going to become more acute over time,” the report said. “The launch of new active substances provides significant additional benefit to patients, as new treatments are made available that improve patient outcomes. The flip side for payers, however, is that the pressure to provide access to the latest treatments also inevitably puts significant pressure on budgets.”
Many examples the report cites to illustrated the success biosimilars have for payers and patients are in Europe. Take, for example, Sweden’s Southern Healthcare Region, where the introduction of filgrastim (a biosimilar of Neupogen, which incidentally is currently the first and only biosimilar in the U.S.) allowed for a relaxation of prescribing restrictions. This, in turn, led to a five-fold increase in the uptake of G-CSF treatment for febrile neutropenia in the region.
“The presence of biosimilar medicines ultimately benefits patients, as they are able to receive the most suitable medicine at each decision point along the diagnosis/treatment pathway,” the report said. “Ultimately, this has the potential to improve overall outcomes for patients.”
Despite the savings that biosimilars offer, the report notes that some payers and policymakers might not be encouraging optimal competition, and highlights the need to “adopt policies that will ensure they can realize as much of these potential savings as possible.”
The optimal environment for biosimilars to thrive, the report says, is one in with a competitive market, one where “manufacturers are motivated to participate, and where physicians are at the heart of the decision-making process. The report singles out the United States as a place where disincentives for biosimilar use exist, pointing to the way in which the Centers for Medicare and Medicaid Services reimburse for a treatment. Six months after introduction, a blended reimbursement rate — which includes average sale price and the price of different biosimilar versions — takes effect, to potentially detrimental effect.
“The blended rate does not incentivize the use of individual lower-cost biosimilars,” the report said. “In addition, the blended rate means there is a risk that a single player can sink overall ASP by offering significant discounts/rebates.”
Another challenge the report identified is the inconsistency between countries over interchangeability of biosimilars and the original biologic, as well as inconsistent messages from manufacturers, which will sometimes emphasize physician choice in prescribing a biologic or a biosimilar, rather than allow a pharmacist to decide whether or not to substitute a biosimilar for a prescribed biologic.
As the biosimilars market grows, the report calls for better understanding of the benefits on the part of payers, patients and physicians, as well as better incentives to ensure stakeholders are encouraged to prescribe biosimilars.