New open access policy analysis from Institute for Clinical and Economic Review (ICER) and NEWDIGS Initiative at Tufts Medical Center analyzes the challenges and potential policy options for paying for … Read More
Implementation Brief: Considerations for developers in applying the Multiple Best Price (MBP) rule to improve access to novel therapies
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
Implementation Brief: Understanding access issues for new therapies
Our first implementation brief outlines several major barriers to patient access for novel cell and gene therapies. It also describes how providers, payers, and developers may overcome these barriers, with … 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
Better Outcomes Tracking: A First Step In Improving Access To New Treatments
New article in Health Affairs Forefront Transformative new pharmaceutical treatments hold the promise of changing patients’ lives by slowing and curing disease, improving well-being, and advancing quality of life. Yet, … Read More
Are Cell and Gene Therapy programs a better bet?
Compared to traditional drug development programs, do durable cell and gene therapy (CGT) programs experience higher or lower clinical success rates? Estimating the Probability of Technical and Regulatory Success (PTRS) … Read More
How can self-insured employers prepare for the portfolio impact of highcost gene therapies coming to market?
Self-insured employers (SIEs) currently rely on traditional stop-loss insurance to protect against unexpected high-cost claims, including those for cell and gene therapies. Given that current approvals are in rare diseases, … Read More
Precision for Whom? Partnering with patients to ensure that Precision Medicine targets what matters
Despite decades of growth and adaptation in patient engagement, knowing or being able to find guidance for whichmodel or approach will be most impactful in which healthcare or research context … Read More
Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997–2020)
Ivica NA, Young CM. Healthcare. 2021; 9(8):1062. Chimeric antigen receptor and T-cell receptor (CAR-T/TCR-T) cellular immunotherapies have shown remarkable success in the treatment of some refractory B-cell malignancies, with potential … Read More
Emerging market solutions for financing and reimbursement of durable cell and gene therapies
The FoCUS project was launched in 2016 with the aim of developing precision financing solutions that address the challenges and financial impact created by durable cell and gene therapies entering … Read More