Accelerated Approval As A Proxy For High Drug Costs Is Misguided

WASHINGTON, Jan. 11, 2022 /PRNewswire/ — The Rare Access Action Project, (RAAP) submitted comments to the Oregon Health Authority’s (OHA) proposed renewal and amendment of its Section 1115 waiver for the July 1, 2022June 30, 2027, demonstration period.

RAAP supports OHA’s efforts to stabilize coverage to every eligible child and adult in Oregon.  However, RAAP believes that OHA’s proposals seeking the authority to implement a closed formulary and limit coverage of drugs approved under the FDA’s accelerated approval pathway will have the opposite result. If implemented, these policies will, in fact, reduce access to life saving therapies magnifying the health equity divide amongst Medicaid patients and between other Oregon residents.

Oregon seeks the ability to more closely manage pharmacy costs in its Medicaid program, through a two-part strategy. First, the state wishes to adopt a commercial style closed formulary approach, which ostensibly means that the state could only cover a single drug per therapeutic class. Second, Oregon seeks new flexibility under this waiver to exclude drugs approved under FDA’s accelerated approval pathway that the state deems to have limited or inadequate clinical efficacy under its closed formulary approach. RAAP believes that both proposals violate current law, specifically the Medicaid Drug Rebate Program,” stated Mike Eging, Executive Director of RAAP.

RAAP encourages the State of Oregon to work with the rare patient community to ensure new policies do not severely jeopardize patient access to care, given our belief that the Oregon Health Plan can achieve its objectives without any waiver of §1927.

To view RAAP’s full public comments to the Oregon Health Authority, please click the link:

RAAP, the Rare Access Action Project, is a coalition of life sciences and patient stakeholders that explore creative policy solutions to address structural issues in access and coverage. Our priority is to help ensure rare disease patients have access to the care and treatments they need. RAAP is a registered 501 c4 non-profit organization.

SOURCE Rare Access Action Project (RAAP)

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