Submission Evaluation: Quality Controls

Given the concerns expressed by a number of clients regarding the content of formulary submissions and the status of modeled claims, Maimon Research can provide an assessment of Global Value Dossiers and submissions that have been prepared to support new products and devices. 

This assessment considers the extent to which claims for product or device impact, to included modeled claims for cost-effectiveness, meet standards for claims evaluation.

The criteria applied by Maimon Research follow the PROST validation protocol standards and focus on the extent to which the modeled claims presented in a Global Value Dossier or formulary submission address the questions a formulary committee should ask evaluating the claims:

• Objectives: Has the validation protocol provided a summary of the study objectives?Does the protocol abstract provide a summary of (i) population targeted; (ii) comparators; (iii) timeframe; (iv) data source; (v) endpoints; and (vi) reporting format?

• Context: Has the validation protocol provided a systematic review to establish the context for the claims to be validated and the contribution this validation may have to an overall assessment of comparative treatment benefits and harms in the population targeted and indication for the product?

• Claims: Has the validation protocol provided a summary of the modeled claims for cost-effectiveness to be validated. Has the protocol identified claims for (i) clinical benefits; (ii) safety; (iii) resource utilization; (iv) direct medical costs; (v) cost-effectiveness and (if required) (vi) budget impact?

• Targeted population: Has the validation protocol provided a rationale for the population to be targeted, to include (i) demographic characteristics; (ii) clinical status ; (iii) disease stage; (iv) comorbidities?

• Study design: Has the validation protocol provided a rationale for the study design (e.g., prospective effectiveness trial, cohort/ observational study) Were alternative study designs proposed? Were risks of bias and other limitations described?

• Reporting: Has the validation protocol provided a reporting format for study results and a timeline for delivery of those results?

Maimon research will provide a confidential assessment to the client and recommendations for revising claims to meet standards for assessment and reporting.