The failure of the current belief system in health technology assessment with its rejection of the standards of normal science and fundamental measurement needs to be recognized by formulary committees and other health system decision makers. To achieve this there must be the adoption of new standards in submissions from manufacturers and other to support approval for formulary placement and provisional pricing. This NEW START in submission guidelines rests on two premises:
1. All value claims for a product or therapeutic intervention must refer to a single attribute that meets the demarcation standards for normal science: all value claims must be credible, evaluable and replicable
2. All value claims must be consistent with the limitations imposed by the axioms of fundamental measurement: they must be unidimensional and meet interval or ratio measurement standards
These premises apply to value claims that are disease or target patient population specific, where every claim is supported by a reporting and assessment protocol.
As a first step, the first draft of the proposed NEW START guidelines is listed for review and comment.