APPROVAL AFTER REJECTION – AN INSIGHT IN HTA RE-EVALUATIONS
Author(s)
Sweeney N, Andreykiv M, Wiebinga CQuintiles Consulting, Hoofddorp, Netherlands
Presentation Documents
OBJECTIVES: To gain insight into the re-evaluation process of HTA agencies after an initial rejection and identify the adaptations that led to the approval of re-submitted dossiers. METHODS: Phase I: manual search of 57 health care agencies’ websites for published diabetes-related assessments (January 2007-May 2010). Phase II: the two most re-assessed drugs for which detailed information was available were selected for further evaluation (insulin glargine and exenatide). For these drugs, all reports published prior to 2007 were also included. RESULTS: Phase I identified 117 relevant single technology appraisals; 18 were re-evaluations. Six agencies performed re-evaluations of the same drug after an initial rejection: CADTH, CVZ, HAS, PBAC, AHTAPol and SMC. To date, SMC evaluated 32 submissions for 13 anti-diabetic drugs, PBAC published 20 (8 drugs), CADTH 13 (4 drugs), CVZ 14 (4 drugs) and AHTAPol 10 (2 drugs). In phase II insulin glargine (4 re-submissions to PBAC and 1 to CADTH) and exenatide (2 re-submissions to PBAC, 1 to CVZ and 1 to AHTAPol) were evaluated. It became clear that payers do focus on overall cost. The approach that was chosen for those two drugs was to control overall cost either by restricting access or by settling on a lower price. CVZ accepted exenatide for reimbursement only after restricting access to a subgroup of obese type 2 diabetes mellitus patients (with an ICER of €5.231). Instead of patient segmentation PBAC insisted on lowering the price for both medications (rationale for insulin glargine being concern that prescribing cannot be contained within the defined population). AHTAPol limited exenatide reimbursement to 50% to control prescribing rates. CONCLUSIONS: For the diabetes cases analysed HTA agencies attempted to control healthcare expenditure by either lowering drug costs or by narrowing the definition of the target population, the latter inevitably allowing fewer patients access to the drug.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
PDB85
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Diabetes/Endocrine/Metabolic Disorders