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
Are Payers Ready, Willing, and Able to Provide Access to New Durable Gene Therapies?
Value in Health, June 2019Jane F. Barlow, Mo Yang, and J. Russell Teagarden Access to new gene therapies may be impacted by payer ability to absorb the cost of coverage. … Read More
Massachusetts Pilot Disease Selection
Rheumatoid Arthritis (RA) chosen as target for LEAPS Massachusetts (MA) Pilot (RAMA) to demonstrate the feasibility and impact of a sustainable and patient-centered healthcare learning ecosystem to optimize care regimens … Read More
Pediatric Gene Therapy Launches
Gene therapy cures for hereditary genetic conditions are likely to reach the United States market in the coming decades. Several disease areas with potential cures are orphan conditions, which affect … Read More
Model Contracts for Innovative Oncology Therapies
When there is substantial uncertainty about a new product’s expected value, stakeholders may have strong reasons to consider performance-based contracts. One of the hardest tasks in crafting such contracts is … Read More
Role of COE networks in curative cellular oncology therapies
COE networks currently play an important role in the delivery of care for specialized service lines, including but not limited to solid organ transplantation (SOT), hematopoietic cell transplantation (HCT) and … Read More
Adaptive Pathways create win-win scenarios for patients and pharma
QuintilesIMS, May 2017Jon Resnick In Europe, the concept of ‘adaptive pathways’ offers a faster route to critical medicines for patients with highest unmet needs through an iterative process of early … Read More
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities
Clinical Pharmacology & Therapeutics, December 1, 2016C. Bouvy, P. Jonsson, C. Longson, N. Crabb, and S. Garner Adaptive pathways for medicines have gained momentum and, in Europe, adaptive pathways have … Read More
“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?
Clinical Pharmacology & Therapeutics, September 21, 2016Hans-Georg Eichler A central question in the assessment of benefit/harm of new treatments is: how does the average outcome on the new treatment (the … Read More
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Clinical Pharmacology & Therapeutics, September 14, 2016G Hirsch, M Trusheim, E Cobbs, M Bala, S Garner, D Hartman, K Isaacs, M Lumpkin, R Lim, K Oye, E Pezalla, P Saltonstall, … Read More