Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States

Gene therapies hold the promise of delivering groundbreaking improvements in health outcomes for previously intractable diseases. These therapies possess unique characteristics that differ from traditional small molecule or biologic treatments, posing new challenges for healthcare stakeholders. Wh...

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Main Authors: Tyler D Wagner, Lisabeth Buelt, Kimberly Westrich, Jonathan D Campbell
Format: Article
Language:English
Published: Becaris Publishing Limited 2024-11-01
Series:Journal of Comparative Effectiveness Research
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author Tyler D Wagner
Lisabeth Buelt
Kimberly Westrich
Jonathan D Campbell
author_facet Tyler D Wagner
Lisabeth Buelt
Kimberly Westrich
Jonathan D Campbell
author_sort Tyler D Wagner
collection DOAJ
description Gene therapies hold the promise of delivering groundbreaking improvements in health outcomes for previously intractable diseases. These therapies possess unique characteristics that differ from traditional small molecule or biologic treatments, posing new challenges for healthcare stakeholders. While previous analyses have predominantly focused on the payment challenges associated with emerging gene therapies, a more holistic examination reveals numerous obstacles that currently hinder optimal patient access. In the United States (US), these include production and distribution issues, logistical and treatment administration challenges and coverage and reimbursement limitations imposed by US healthcare payers. Several opportunities exist to address these challenges and improve patient access, including the use of appropriate value assessment methods, the development of innovative payment solutions, the removal of inappropriate access barriers imposed by payers and improving education and awareness regarding treatment availability, benefits and risks. Moving forward, we must collectively strive for comprehensive policy and market solutions that are sensitive to the uniqueness of gene therapies to ensure their full potential is realized and these treatments are made available to those in need.
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spelling doaj-art-6c95e5fd45f746ab9802ccd905e789db2025-08-20T02:07:12ZengBecaris Publishing LimitedJournal of Comparative Effectiveness Research2042-63132024-11-01131210.57264/cer-2024-0098Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United StatesTyler D Wagner0https://orcid.org/0000-0001-7248-4890Lisabeth Buelt1Kimberly Westrich2https://orcid.org/0000-0001-9392-7670Jonathan D Campbell3https://orcid.org/0000-0001-6539-1258National Pharmaceutical Council, Washington DC 20006, USANational Pharmaceutical Council, Washington DC 20006, USANational Pharmaceutical Council, Washington DC 20006, USANational Pharmaceutical Council, Washington DC 20006, USAGene therapies hold the promise of delivering groundbreaking improvements in health outcomes for previously intractable diseases. These therapies possess unique characteristics that differ from traditional small molecule or biologic treatments, posing new challenges for healthcare stakeholders. While previous analyses have predominantly focused on the payment challenges associated with emerging gene therapies, a more holistic examination reveals numerous obstacles that currently hinder optimal patient access. In the United States (US), these include production and distribution issues, logistical and treatment administration challenges and coverage and reimbursement limitations imposed by US healthcare payers. Several opportunities exist to address these challenges and improve patient access, including the use of appropriate value assessment methods, the development of innovative payment solutions, the removal of inappropriate access barriers imposed by payers and improving education and awareness regarding treatment availability, benefits and risks. Moving forward, we must collectively strive for comprehensive policy and market solutions that are sensitive to the uniqueness of gene therapies to ensure their full potential is realized and these treatments are made available to those in need.accesseducationgene therapypatientspaymentvalue
spellingShingle Tyler D Wagner
Lisabeth Buelt
Kimberly Westrich
Jonathan D Campbell
Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States
Journal of Comparative Effectiveness Research
access
education
gene therapy
patients
payment
value
title Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States
title_full Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States
title_fullStr Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States
title_full_unstemmed Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States
title_short Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States
title_sort improving access to gene therapies a holistic view of current challenges and future policy solutions in the united states
topic access
education
gene therapy
patients
payment
value
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AT lisabethbuelt improvingaccesstogenetherapiesaholisticviewofcurrentchallengesandfuturepolicysolutionsintheunitedstates
AT kimberlywestrich improvingaccesstogenetherapiesaholisticviewofcurrentchallengesandfuturepolicysolutionsintheunitedstates
AT jonathandcampbell improvingaccesstogenetherapiesaholisticviewofcurrentchallengesandfuturepolicysolutionsintheunitedstates