Updated projection of US durable cell and gene therapies product-indication approvals based on December 2019 development pipeline

Eric NormanFoCUS, Research Briefs

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

Eric NormanFoCUS, Research Briefs

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

Eric NormanFoCUS, Whitepapers

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

Eric NormanFoCUS, Whitepapers

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

Eric NormanFoCUS, Research Briefs

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)

Eric NormanFoCUS, Research Briefs

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

Incorporation of Value-Based Payment Agreements into the Calculation of Medicaid Drug Rebates

Eric NormanFoCUS, Research Briefs

Value-Based Payment (VBP) agreements will play an important role in mitigating uncertainty in durable therapies, where it is unclear whether a large upfront payment is justified based on limited clinical … Read More

Payers Open to Innovative Financing Mechanisms for High Cost Gene Therapies

Eric NormanFoCUS, Research Briefs

In a broad survey, payers favor performance based milestone contracts and risk pools strategies to absorb the surge of high cost gene therapy products expected to enter the market over … Read More