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New Product Assessment Form - Guidance For Manufacturers

SMC have issued an updated Guidance to Manufacturers document for completion of the New Product Assessment Form. This new guidance must be adhered to by the 6th August 2012 deadline. A list of key changes or clarifications is noted below:

  • 5 g) – Clinical Effectiveness
  • 6.7.2 - Comparators
  • 6.7.4 - Types of Economic Evaluation
  • 6.8.1 - Indirect Comparison
  • 6.10.1 - NHS and Social Work Costs
  • 6.14 – Orphan Drugs and Decision Modifiers
  • 6.15 - Patient Access Schemes
  • Annexe 3 - Mapping of Quality of Life Studies

(Updated March 2012)