Using multicriteria decision analysis during drug development to predict reimbursement decisions.

Background: Pharmaceutical companies design clinical development programs to generate the data that they believe will support reimbursement for the experimental compound.

Objective: The objective of the study was to present a process for using multicriteria decision analysis (MCDA) by a pharmaceutical company to estimate the probability of a positive recommendation for reimbursement for a new drug given drug and environmental attributes.

Methods: The MCDA process included 1) selection of decisions makers who were representative of those making reimbursement decisions in a specific country; 2) two pre-workshop questionnaires to identify the most important attributes and their relative importance for a positive recommendation for a new drug; 3) a 1-day workshop during which participants undertook three tasks: i) they agreed on a final list of decision attributes and their importance weights, ii) they developed level descriptions for these attributes and mapped each attribute level to a value function, and iii) they developed profiles for hypothetical products 'just likely to be reimbursed'; and 4) use of the data from the workshop to develop a prediction algorithm based on a logistic regression analysis.

Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study.

It is common practice for developers of new health care technologies to engage in early dialogue with the major regulatory agencies; such discussions frequently center around the proposed clinical trial designs to support the registration of new interventions and suggestions on their improvement. Pricing and reimbursement agencies are increasingly using the results from health technology assessments to inform their decision making for new technologies. Such assessments are invariably underpinned by the phase 3 clinical trial evidence which may not provide answers to the key questions.

Using GI-specific patient outcome measures in renal transplant patients: validation of the GSRS and GIQLI.

Introduction: Gastrointestinal (GI) side-effects occur frequently as a result of immunosuppressant regimens used in renal transplant patients. Little effort has been made to quantify the impact of these side-effects on patients' health-related quality of life and symptom severity.

Objective: To assess the psychometric characteristics of two GI-specific outcome instruments (the Gastrointestinal Rating Scale (GSRS) and the Gastrointestinal Quality of Life Index (GIQLI)) for use in post-renal transplant patients.

Resource use and treatment costs after kidney transplantation: impact of demographic factors, comorbidities, and complications.

Background: Our goal was to quantify outcomes, resource use, and treatment costs for the first 2 years after renal transplantation in a "real-life" European setting and to assess the impact of preoperative risk factors and postoperative complications on treatment costs.

Methods: Inpatient and outpatient records of all patients who received a renal transplant at Medizinische Hochschule Hannover, Germany, between January 1998 and July 2000, were evaluated. Key clinical events were recorded.