This brief highlights some key steps and considerations for biopharmaceutical developers of novel, high-value therapies seeking to successfully implement CMS’s Multiple Best Price rule. The rule, which went into effect … Read More
Managing the Challenges of Paying for Gene Therapy: Strategies for Market Action and Policy Reform
Gene therapies delivered through a single administration have revolutionized treatment possibilities for many patients living with serious or fatal conditions such as spinal muscular atrophy, hemophilia, and sickle cell disease. … Read More
Analyzing 340B and ASP interactions: Do Federal program rules disincentivize the use of VBCs, despite Medicaid Best Price reform?
This paper describes the interactions among Medicaid Best Price rebate calculations and those for 340B Ceiling Prices and Average Sales Prices which can create disincentives for providers and therapy developers … Read More
Medicaid best price reforms to enable innovative payment models for cell and gene therapies
Expert Review of Pharmacoeconomics & Outcomes Research, 23(2), 191–203.Quinn, C., Ciarametaro, M., Sils, B., Phares, S., & Trusheim, M. Cell and gene therapies promise durable benefits but face financial challenges … Read More
Updated projection of US durable cell and gene therapies product-indication approvals based on December 2019 development pipeline
Ongoing pipeline modeling by the MIT NEWDIGS FoCUS team projects 10X growth from July 2020 levels, but with large uncertainties. Download FoCUS Research Brief 2020F207v51Share the research
Impact of FDA Guidelines on Communication between Developers and Payers on Metrics in Performance-Based Agreements
The FDA regulates communications from pharmaceutical developers to ensure that statements about products are appropriately supported by evidence. In this Research Brief, we explore the possible impacts of these regulations … Read More
Tools for Implementation of Precision Financing Solutions Within Medicaid Plans
Implementation of precision financing solutions is a challenge for state Medicaid payers given the complexity of the environment. This white paper provides example templates to support state Medicaid plans, manufacturers, and … Read More
Payer Perspectives on Financing and Reimbursement of One-time High-cost Durable Treatments
An online 15-question survey was conducted with clinical and financial health plan leaders from US payers between September 2018 and April 2019. The survey was focused on assessing payer perspectives … Read More
Tracking Medicaid Coverage of Durable Cell and Gene Therapies
Durable cell and gene therapies represent a unique challenge to the US healthcare insurer/payer landscape, given the one-time treatment and associated high upfront cost but potentially durable outcomes. This study … Read More
State Insurance Regulations Regarding Benefit Design (Deductible and Co-Pay Waivers)
FoCUS has identified an issue that may be a barrier to timely patient access to durable therapies. The advent of expensive, one-time durable therapies will require changes in private payer … Read More
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