Jeremy Schafer Discusses New HCV Survey in Managed Healthcare Executive Uncovering Unmet Needs of Payers
Precision for Value’s Jeremy Schafer talks with Managed Healthcare Executive about a recent Precision HCV survey, highlighting unmet needs cited by payers, and what can be done to encourage payers to ease coverage policies for the next wave of HCV drugs.
PHE’s ESGC Provides Critical Support to New Legislation, FDA Guidelines
Congratulations to Precision Health Economics, and in particular the Evidence Strategy, Generation, and Communication (ESGC) practice group, for their outstanding efforts in support of the development of new legislation and FDA guidelines allowing biopharmaceutical manufacturers to more proactively share clinical and economic information with population health decision-makers on emerging therapies.
Precision’s Blandford in STAT First Opinion: The time for expansion of value-based drug reimbursement is now
Precision for Value’s Larry Blandford offers a new commentary in STAT First Opinion, insisting that payers and the pharmaceutical industry come together to develop a value-based drug reimbursement system. He suggests taking a page from the playbook developed for electronic prescribing as the key to moving forward.
Precision for Medicine and Philips Team Up to Achieve FDA Approval of the First Digital Pathology Solution for US Diagnostic Use
Congratulations to the clinical trial and regulatory teams at Precision for Medicine: The FDA has just announced that the Philips PIPS (Philips IntelliSite Pathology Solution) has been approved through the de novo premarket review pathway as the first digital pathology solution for primary diagnostic use in the US.
This regulatory clearance signals a significant leap forward for the pathology services industry, and is expected to greatly boost adoption of digital pathology and collaboration.
Precision provided instrumental support to Philips in achieving this approval, monitoring the pivotal trial and working directly on the FDA strategy, including the successful effort to down-classify the system from a PMA Class III device to a Class II device (representing devices of a new type with low-to-moderate risk). This down-classification not only shortened the review time, but also reduces the regulatory burden going forward and streamlines the process for bringing incremental innovations to the US market.
For more information, click the link below to view the FDA press release.
Precision’s David Parker Discusses CDx Development Relationships with Clinical Omics
Precision’s David Parker, PhD, senior vice president, diagnostics solutions, recently spoke with Clinical OMICs Editor-in-Chief Chris Anderson about some of the issues inherent in CDx development relationships.