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Innovative Insurance to Improve US Patient Access to Cell and Gene Therapy.

Rena M Conti1,2, Patrick Demartino3, Jonathan Gruber1,4

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Summary

The annual cost to cover cell and gene therapies (CGTs) in the US is estimated at $20.4 billion, or $15.69 per person. Policies are needed to improve CGT coverage and affordability for patients.

Keywords:
Medicaidaccessadverse selectioncell and gene therapyinsurancereinsurancesickle cell diseasespendingstatesstop loss

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Area of Science:

  • Health Economics
  • Biotechnology
  • Genetics

Background:

  • Cell and gene therapies (CGTs) offer life-saving treatments for rare diseases.
  • High costs and uncertain outcomes lead insurers to restrict patient access, potentially worsening health disparities.
  • Reinsurance is a tool insurers use to manage high-cost claims, but current plans may not adequately cover CGTs.

Purpose of the Study:

  • To estimate the incremental annual per-person costs of covering existing and expected CGTs in the US from 2023-2035.
  • To analyze these costs by payer type, including commercial plans and state Medicaid programs.
  • To assess the impact of reinsurance fees on overall CGT coverage costs.

Main Methods:

  • Simulated incremental annual per-person reinsurer costs for CGTs (2023-2035).
  • Utilized published estimates of US CGT spending and assumed a US population of 330 million.
  • Calculated costs based on current CGT reinsurance fees and illustrated with sickle cell disease-targeted CGTs.

Main Results:

  • Estimated annual incremental spending on CGTs to reach $20.4 billion ($15.69 per person) between 2023-2035.
  • Spending is projected to be concentrated among commercial insurance plans.
  • Sickle cell-targeted CGTs may add up to $0.78 PMPM, primarily impacting state Medicaid programs; reinsurance fees increase total costs.

Conclusions:

  • Annual per-person costs for CGT access are expected to be concentrated in commercial and state Medicaid plans.
  • Current insurance policies may not sufficiently cover CGTs, necessitating policy improvements.
  • Enhanced policies are crucial for improving CGT coverage and affordability to ensure patient access.