DRIVERS OF CROSS-JURISDICTIONAL VARIATION IN HTA RECOMMENDATIONS FOR OLAPARIB ACROSS ONCOLOGY INDICATIONS: EVIDENCE FROM ENGLAND, SCOTLAND, CANADA, AND AUSTRALIA
Author(s)
Fatimah Alyami, BSPharm, MS, PhD.1, Aljawharah Fawaz Alkoraishi, II, RPh2, Ahmad Hecham Alani, PharmD3.
1Center for Health Technology Assessment, Riyadh, Saudi Arabia, 2King Saud University Medical City, Riyadh, Saudi Arabia, 3Hive Health Optimum Ltd., London, United Kingdom.
1Center for Health Technology Assessment, Riyadh, Saudi Arabia, 2King Saud University Medical City, Riyadh, Saudi Arabia, 3Hive Health Optimum Ltd., London, United Kingdom.
OBJECTIVES: To compare health technology assessment (HTA) recommendations for Olaparib across four agencies and multiple oncology indications, and characterize the clinical and economic factors underlying divergent decisions.
METHODS: We extracted all publicly available HTA recommendations for olaparib from NICE (England), SMC (Scotland), CDA-AMC (Canada), and PBAC (Australia) issued between March 2020 to March 2024. For each decision, we coded the indication, agency, outcome (unrestricted, restricted, or rejected), submission type, imposed clinical and economic restrictions, and reported clinical and economic uncertainties. HTA outcomes and decision drivers were summarized descriptively across indications.
RESULTS: Twenty decisions were identified across three tumor types: prostate (n=8), ovarian/fallopian/peritoneal (n=7), and breast (n=5). NICE, SMC, and CDA-AMC recommended Olaparib in all 12 of their assessments (all restricted), whereas PBAC listed four and rejected four. The pattern recurred across indications: in both prostate and breast cancer, an initial PBAC rejection was reversed to a listing on initial submission. Overall, 14/20 (70%) positive or conditional recommendations required a price reduction, patient access scheme, or risk-sharing arrangement, and 7/20 carried clinical eligibility restrictions (e.g., BRCA mutation, prior therapy). Frequently cited clinical uncertainties related to were evidence quality, study design, magnitude of uncertain clinical benefit, population generalizability, and pivotal trial comparator choice; economic uncertainties centred on model structure, utilities, and comparator selection. PBAC rejections commonly reflected comparators judged not to reflect local practice and uncertain cost-effectiveness.
CONCLUSIONS: HTA recommendations for Olaparib were consistent across England, Scotland, and Canada but were generally contingent on confidential pricing or access agreements. In contrast, Australian assessments were initially more restrictive, although several were reversed following resubmission. Comparator choice and cost-effectiveness uncertainty were recurrent drivers of divergence, underscoring the role of jurisdiction-specific evidentiary requirements in HTA outcomes.
METHODS: We extracted all publicly available HTA recommendations for olaparib from NICE (England), SMC (Scotland), CDA-AMC (Canada), and PBAC (Australia) issued between March 2020 to March 2024. For each decision, we coded the indication, agency, outcome (unrestricted, restricted, or rejected), submission type, imposed clinical and economic restrictions, and reported clinical and economic uncertainties. HTA outcomes and decision drivers were summarized descriptively across indications.
RESULTS: Twenty decisions were identified across three tumor types: prostate (n=8), ovarian/fallopian/peritoneal (n=7), and breast (n=5). NICE, SMC, and CDA-AMC recommended Olaparib in all 12 of their assessments (all restricted), whereas PBAC listed four and rejected four. The pattern recurred across indications: in both prostate and breast cancer, an initial PBAC rejection was reversed to a listing on initial submission. Overall, 14/20 (70%) positive or conditional recommendations required a price reduction, patient access scheme, or risk-sharing arrangement, and 7/20 carried clinical eligibility restrictions (e.g., BRCA mutation, prior therapy). Frequently cited clinical uncertainties related to were evidence quality, study design, magnitude of uncertain clinical benefit, population generalizability, and pivotal trial comparator choice; economic uncertainties centred on model structure, utilities, and comparator selection. PBAC rejections commonly reflected comparators judged not to reflect local practice and uncertain cost-effectiveness.
CONCLUSIONS: HTA recommendations for Olaparib were consistent across England, Scotland, and Canada but were generally contingent on confidential pricing or access agreements. In contrast, Australian assessments were initially more restrictive, although several were reversed following resubmission. Comparator choice and cost-effectiveness uncertainty were recurrent drivers of divergence, underscoring the role of jurisdiction-specific evidentiary requirements in HTA outcomes.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA343
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
Oncology