Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jul;29(7):782-790.
doi: 10.18553/jmcp.2023.22436. Epub 2023 May 3.

Opportunities and challenges surrounding financial models for high-investment medications: A survey of access decision-makers and employers

Affiliations

Opportunities and challenges surrounding financial models for high-investment medications: A survey of access decision-makers and employers

Erin Lopata et al. J Manag Care Spec Pharm. 2023 Jul.

Abstract

BACKGROUND: As an increasing number of cell and gene therapies are US Food and Drug Administration approved, health care stakeholders are attempting to strike a balance between patient access to innovative treatments and overall affordability. Access decision-makers and employers are evaluating how implementation of innovative financial models can support coverage of high-investment medications. OBJECTIVE: To understand how access decision-makers and employers are using innovative financial models for highinvestment medications. METHODS: A survey was conducted with access and employer decision-makers recruited from a proprietary database of market access decision-makers from April 1 to August 29, 2022. Respondents were asked about their experiences using innovative financing models for high-investment medications. RESULTS: Across both stakeholder segments, stop-loss/reinsurance was the most utilized financial model, with 65% of access decision-makers and 50% of employers currently using this financial model. More than half (55%) of access decision-makers and nearly one-third of employers (30%) currently use a provider contract negotiation strategy, with similar percentages of access decision-makers (20%) and employers (25%) planning to implement this strategy in the future. Aside from stop-loss/reinsurance and provider contract negotiation, no other financial models exceeded 25% penetration in the employer market. Subscription models and warranties were the least common models currently used by access decision-makers (10% and 5%, respectively). The greatest growth for access decision-makers is expected for annuities, amortization or installment strategies, outcomes-based annuities, and warranties, with 55% of access decision-makers planning to implement each. Few employers are seeking to implement new financial models in the next 18 months. Both segments prioritized financial models that can address the actuarial or financial risk arising from uncertainty in the number of patients likely to be treated with a durable cell or gene therapy. Many access decision-makers cited a lack of opportunities from manufacturers as a reason for not using a model, whereas employers also identified lack of information and financial viability as reasons for not using a model. In most cases, both stakeholder segments prefer to work with current partners as opposed to a third party when executing an innovative model. CONCLUSIONS: Access decision-makers and employers are adopting innovative financial models as traditional management techniques are insufficient to manage the financial risk associated with highinvestment medications. Although both stakeholder segments see a need for alternative payment models, they also recognize the challenges and complexity associated with their implementation and execution of these types of partnerships. DISCLOSURES: This research was sponsored by the Academy of Managed Care Pharmacy and PRECISIONvalue. Dr Lopata, Mr Terrone, and Dr Gopalan are employees of PRECISIONvalue.

PubMed Disclaimer

Conflict of interest statement

This research was sponsored by the Academy of Managed Care Pharmacy and PRECISIONvalue. Dr Lopata, Mr Terrone, and Dr Gopalan are employees of PRECISIONvalue.

Figures

FIGURE 1
FIGURE 1
Current and Expected Adoption of Financial Models for High-Investment Medications Among (A) Access Decision-Makers and (B) Employer Stakeholders
FIGURE 2
FIGURE 2
Attributes Driving Adoption of Financial Models for High-Investment Medication Among (A) Access Decision-Makers and (B) Employee Stakeholders
FIGURE 3
FIGURE 3
Barriers to Adopting Financial Models for High-Investment Medications for (A) Access Decision-Makers and (B) Employer Stakeholders

References

    1. US Food and Drug Administration. Approved cellular and gene therapy products. Accessed September 4, 2022. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-produ...
    1. Alliance for Regenerative Medicine. Regenerative medicine in 2021: A year of firsts and records. Accessed September 4, 2022. http://alliancerm.org/wp-content/uploads/2021/08/ARM-H1-2021-Report.pdf
    1. Young CM, Quinn C, Trusheim MR. Durable cell and gene therapy potential patient and financial impact: US projections and product approvals, patients treated, and product revenues. Drug Discov Today. 2022;27(1):17-30. doi:10.1016/j.drudis.2021.09.001 - PubMed
    1. Barlow JF, Yang M, Teagarden JR. Are payers ready, willing, and able to provide access to new durable gene therapies? Value Health. 2019;22(6):642-7. doi:10.1016/j.jval.2018.12.004 - PubMed
    1. MIT NEWDIGS Research Brief 2022F204-v055 Self-Insured Employers. Accessed September 5, 2022. https://newdigs.tuftsmedicalcenter.org/wp-content/uploads/2022/06/FoCUS-...

Substances