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. 2023 Oct 13:5:100103.
doi: 10.1016/j.hpopen.2023.100103. eCollection 2023 Dec 15.

Variation in Medicaid and commercial coverage of cell and gene therapies

Molly T Beinfeld  1 , Julia A Rucker  1 , Nola B Jenkins  1 , Lucas A de Breed  2 , James D Chambers  1
Affiliations

Variation in Medicaid and commercial coverage of cell and gene therapies

Molly T Beinfeld et al. Health Policy Open. .

Abstract

Growth in the availability of cell and gene therapies (CGTs) promises significant innovation in the treatment of serious diseases, but the high cost and one-time administration of CGTs has also raised concern about strain on health plan budgets and inequity in access. We used coverage information from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database for 18 large commercial health plans in the US and information from state Medicaid websites to examine variation in coverage of 11 CGTs in August 2021. We found that US commercial and Medicaid health plans imposed restrictions in 53.5 % and 68.3 % of their coverage policies for the 11 included CGTs, respectively. In addition, we identified significant variation in access to CGTs across commercial plans and across Medicaid plans. Coverage restrictions for certain CGTs were more common than others; clinical requirements were often (but not always) consistent with the inclusion criteria for the clinical trial central to the drug's approval. We conclude that there is variation in access to CGTs, creating differential patient access.

Keywords: Genetic therapy; Health care economics; Health policy; Insurance; Medicaid.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Proportion of Cell and Gene Therapy Coverage Policies More Restrictive than FDA Label, Commercial vs Medicaid Health Plans, 2021. Source/Notes: Source: SPEC Database. Notes: Inclusion criteria requires US Medicaid and Commercial health plans to have a coverage policy present in August 2021. A coverage restriction includes at least one of the following coverage requirements that go beyond a drug’s label indication: clinical requirement, step therapy protocols, prescriber requirements, and/or other requirements.
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References

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