Meeting the Standards of Normal Science in Health Outcomes and Market ccess
Meeting the Standards of Normal Science in Health Outcomes and Market ccess
Meeting the Standards of Normal Science in Health Outcomes and Market Access for Pharmaceutical Products and Devices
Meeting the Standards of Normal Science in Health Outcomes and Market Access for Pharmaceutical Products and Devices

Establishing Standards for Evaluating the Credibility, Evaluation and Replication of Clinical and Cost-Effectiveness Claims

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. 

Maimon Research can also support health systems introduce claims evaluation standards to ensure manufacturers meet the standards of normal scioence in making clinical, cost-effective and budget impact claims. The key requirement is for all submissions for new oprodycts or products that are part of ongoing disease area and therapeutic class reviews to be accompanied by a study protocol for claims assessment.

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: are they credible, evaluable and replicable

  • 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.

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