Every country around the globe struggles with attaining an appropriate balance between providing affordable health care and ensuring access to medical advances. In a recent article in the British Journal of Clinical Pharmacology, Prof Adrian Towse examines the issues from a UK perspective. Managing and containing costs in the NHS is a perennial challenge. Far less clear is how to accomplish this while still ensuring sufficient incentives for timely access to new medical therapies, particularly new medicines.
Since 2007, new medications may be paid for by the statutory health insurance funds (GKV) in Germany only if they are cost-effective. Willingness-to-pay analyses can be essential background for decisions about the pricing and reimbursement of prescription medicines.
The law signed in March 2010 eliminated some of the uncertainty about the future of biosimilars in the US. Still unclear is the impact biosimilars actually will have on costs and when any savings might appear.
Europe already has some experience with the impact of biosimilars on pricing, including a price war in Germany for EPOs. Whether that experience will be repeated, however, depends on a number of factors, including the originator's pricing strategy and reservations by payers and physicians about potential risks.
The OHE model varies from other models of biosimilar markets evolution by starting with transaction prices, rather than list prices, and factoring in the collection of 'Patient Safety Year' (PSY) data. These data will capture actual experience with a biosimilar, increasing the comfort level of prescribers and encouraging a gradual increase in market share. PSY data also have important implications for payers and governments, whose options also were outlined in this presentation.