Medicare CED Not A Good Fit With Groundbreaking Products, Drug Firms Argue
In comments on CMS’ recent draft guidance on Medicare coverage with evidence development, Onyx Pharmaceuticals recommends that cutting edge therapies with postmarketing commitments like its cancer drug Kyprolis should be exempted, and Amyvid marketer Lilly says CED is not appropriate for radiopharmaceuticals.
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CMS’ guidance on its “coverage with evidence development” policy for Medicare Part B does not elaborate on the scope of its application to off label drug use, only stating the agency could apply CED to drugs that have received FDA approval for at least one indication.
CVS Caremark and Express Scripts agree that direct government involvement in pricing and coverage policies is not needed to contain the high cost of specialty drugs such as Gilead’s Sovaldi.
Onyx is pricing new myeloma drug carfilzomib at $9,950 per cycle, 65% higher than Takeda/Millennium’s pioneering proteasome inhibitor Velcade. Launch plans include financial assistance for providers, comprehensive patient assistance program and transition for expanded access patients to commercial drug.