Orphan Drug Access: One-Third Of US Coverage Decisions Involve Restrictions, Study Finds
Tufts researchers report restrictions are more common for orphan drugs indicated for diseases with higher prevalence and that are more expensive.
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Coverage decisions are also often more restrictive than drug labeling, according to researchers from Tufts.
Germany uses government facilitated price negotiations between publicly funded insurers and manufacturers that are based on an independent assessment of how much added value a drug provides.
Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.