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Orphan Drugs: Increase In Approvals But High Pricing Impacts Patient Access

July 10, 2014

The Tufts Center for the Study of Drug Development (CSDD) is an independent academic non-profit research group at Tufts University in Boston, Massachusetts.

One of Tufts CSDD products is the bi-monthly Impact Reports, which summarize current original research from the organization in an easy compact format. This series of reports analyzes data and provides information on current drug regulatory and development issues.

The latest Impact Issue is the July/August 2014 issue titled, “Patients face new challenges accessing a growing number of orphan drugs”. The Summary Report is available for FREE. The latest CSDD Impact Report concludes that while the number of orphan drug approvals in both the United States and Europe has increased, the high cost of the orphan drugs is limiting patient access for these medications.

Here are a few key conclusions from the Summary Report:

•   From 2000 – 2013, 86 orphan drugs are approved in the US, while in Europe 96 orphan drugs are approved

•   Since 1983, 7% more orphan drugs are approved in the US than in Europe

•   Since 1983, 17% more orphan drugs are approved 1st in the US than in Europe

•   Denials of orphan drug coverage by US payers is less than denials by European payers

•   Cost-sharing by patients of orphan drugs is higher in the US than in Europe

•   US payers often require prior authorization for orphan drugs, while European health authorities use stricter conditions (i.e. step edits, evidence development) for reimbursement.

Please Note: “Spinning Device To Mix Tissue Culture Medium” by National Cancer Institute [Public domain] | Wikimedia Commons.

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