EVIDENCE REQUIREMENTS FOR REIMBURSEMENT OF PHARMACEUTICALS ACROSS EUROPE.

OBJECTIVES: The objective of this study was to compare evidence requirements for health technology assessment of pharmaceuticals by national agencies across Europe responsible for reimbursement decisions focusing specifically on relative effectiveness assessment. METHODS: Evidence requirements from thirty-three European countries were requested and twenty-nine national agencies provided documents to review. Data were extracted from national documents (manufacturer's submission templates and associated guidance) into a purpose-made framework with categories covering information about the health condition, the technology, clinical effectiveness and safety. RESULTS: The level of detail in the required evidence varies considerably across countries. Some countries include specific questions while others request information under general headings. Some countries include all information in a single document, which may or may not include guidance on how to complete the template. Others have specific guidance documents or methods and process manuals that help with the completion of the submission templates. Despite differences in quantity and detail, the content of the evidence requirements is broadly similar. All countries ask for information on the health technology, target disease, and clinical effectiveness and safety. However, one country only requests clinical effectiveness information as part of cost-effectiveness analyses. We found twenty-six evidence requirements for which generic answers may apply across borders and nineteen in which countries requested nationally specific information. CONCLUSIONS: This work suggests that it would be possible to put together a minimum set of evidence requirements for HTA to support reimbursement decisions across Europe which could facilitate collaboration between jurisdictions.

Identifying effective techniques within psychological treatments for irritable bowel syndrome: a meta-analysis.

OBJECTIVES: Psychological interventions can alleviate the symptoms of irritable bowel syndrome (IBS) and psychological distress commonly reported among IBS sufferers. However, the theoretical underpinnings and intervention techniques used by such interventions vary considerably. This study aimed to identify which theoretical approaches and techniques lead to greater improvements in IBS symptoms and psychological well-being within psychological interventions for IBS. METHODS: Outcome data were extracted from 48 randomized controlled trials testing psychological treatments for IBS. Theoretical intervention targets and intervention techniques of each study were identified. Cumulative effect sizes were calculated for pain, bowel dysfunction, composite symptom scores, psychological distress, and health-related quality of life. Comparative analyses contrasted the effect sizes of studies which included each intervention technique to those which did not. RESULTS: Cumulatively, interventions significantly improved all outcomes, with effect sizes (Hedges' g) ranging from 0.32 to 0.64. Interventions which stated a theoretical intervention target, prompted self-monitoring of symptoms and cognitions, provided tailored feedback linking symptoms and cognitions, utilized problem solving or assertiveness training and provided general support had greater effects upon symptom and well-being outcomes than interventions which did not (all P<.05). Across all studies, improvements in psychological distress were associated with improvements in composite symptom scores (P<.01). CONCLUSIONS: This study identifies a set of techniques associated with improvements in IBS symptoms and psychological well-being in existing interventions, and provides initial evidence for the link between improvements in psychological distress and IBS composite symptom scores. These findings can aid the development and refinement of psychological treatments for IBS.