- What are the standards of normal science, including fundamental measurement, that formulary committees should set and manufacturers should address in responding to requests for a formulary submission?
- To what extent, if any, should formulary committees accept modeled claims for products if the model fails to produce credible, empirically evaluable and replicable claims?
- What should be the real world evidence standards that formulary committees require to support provisional formulary listing for new products and devices?
- What evidence standards, including prospective claims assessment and reporting should formulary committees require of a manufacturer to support provisional listing and pricing?
- Should formulary committees consider the role of prospective disease area and therapeutic class reviews for revisiting product placement, pricing and access in setting formulary submission standards?
- What should be the minimum evidence standards for monitoring and reporting provisional claims in an observational tracking environment?
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