Minnesota Guidelines, next generation sequencing, evaluation credibility, submission protocols


The principal objective in introducing Version 2 of the proposed Minnesota Guidelines for Formulary Evaluation is to recognize the challenges faced by formulary committees and other health care decision makers with the introduction of next generation sequencing (NGS) in therapy choice across a range of disease areas. The adoption of NGS promises to disrupt accepted standards in product development and formulary assessment. Although the standards expected in presenting, evaluating and replications clinical and cost-effective claims will still be central to the assessment process, the application of NGS platforms to link therapy choices to identified mutation clusters will require a robust evidence base. These Guidelines are intended to provide the framework for that evidence base by setting protocol driven standards for (i) choosing the appropriate NGS platform and (ii) evaluating NGS platforms in the identification of therapy pathways for target populations in disease states.

Conflict of Interest