Title: Cancer & Oncology
Introduction: Ovarian cancer (OC) is the second most common gynecologic malignancy and the most common cause of gynecologic cancer death worldwide. Since 2014 Poly (ADP-ribose) polymerase (PARP) inhibitors (PARPi) play a pivotal role in the management of OC in the adjuvant and recurrence setting. In recent years the rise in access and availability of medical cannabis among cancer patients has resulted in its’ integration as a mainstay of supportive care. Pre-clinical studies demonstrated immunomodulatory and epigenetic properties of cannabis. Therefore, cannabis may induce epigenetic modifications, potentially interfering with the beneficial clinical effect of PARPi therapy. We aimed to study whether cannabis affect oncological outcomes among OC patients treated with PARPi in the adjuvant and recurrent setting.
Methods: We conducted a retrospective analysis of 93 OC consecutive patients with germline, somatic or wild type (WT) BRCA mutation, treated at the Tel Aviv Sourasky Medical Center (TASMC) with PARPi. Majority of patients received PARPi for recurrent disease n=68 39 (73.11%). Cannabis was administered either by smoking, nebulizer, oil or combination. We compared oncological outcomes of patient treated with maintenance PARPi and patients treated with maintenance PARPi and cannabis. We evaluated progression free survival (PFS), overall survival (OS) and duration of response on maintenance PARPi’s therapy (DOR).
Results: Among 93 patients treated with PARPi, 29 (31.18%) women used simultaneously cannabis during the same period (cannabis group). Median PFS was 21.03 months in the PARPi group, and 20.04 months in the cannabis group (P=.77). However, median OS in patients receiving PARPi in the recurrent setting was longer in the cannabis group compared to PARPi only group 129.28 Vs 99.02 months, respectively (P=.03). The median time on PARPi therapy was similar in both groups, 9.5 months in the PARPi only group and 12.11 months in the cannabis group (P=.894).
Conclusion: The use of supportive cannabis during PARPi treatment did not compromise OS, PFS or DOR on maintenence PARPi therapy. Considering the limitations of this work, further larger prospective clinical studies are warrented.
Tamar Safra is from Tel Aviv University, Tel Aviv, Israel completed his work on The effect of cannabis use on oncological outcomes in ovarian cancer patients treated with PARP inhibitors.
Title: Challenges facing payers towards biosimilars in cancer
Background & Aim: With the presence of concept of biosimilar products at last decade which defined by WHO as a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. Interchangeability concepts for Biosimilars were raised by the payers to develop multidisciplinary tools for policy analysis which is the main core of Health Technology Assessment (HTA). The main objective for this study is to determine the roles that can HTA body play for biosimilar products starting from regulatory step finished by decision for reimbursement.
Method: Integration between a systematic literature review and descriptive analysis of (FDA, WHO EMA, local guidelines and local data from regulatory body for efficacy, safety, quality) for biosimilars and ISPOR guidelines for HTA. Interviews was conducted with key stock holders for health system in Egypt, Tunisia, Jordan and Saudi Arabia, United Arab Emirates, Spain, Turkey, Germany and industry representative.
Results: A framework was proposed for biosimilars reimbursement decision making which included price and four non-price criteria. Pharmaceutical price (20% weight), quality module (33%), regulatory body approval for interchangeability (25%) post marketing studies (11%) clinical decision (11%).
Conclusion: Biosimilars should not be treated as generic products. In terms of HTA there is a need to conduct a selection criteria specialized for biosimilars; pricing process should be on case by case basis due to the nature of technology of biosimilars. The need for evidence base data for switching from innovator products to biosimilars should be mandatory during marketing authorization process. Integration between regulatory body and HTA should be initiated. As both bodies differ for their prospective and they need to integrate in order to minimize time consumption and unifying concepts for biosimilars. Effective assessment and evaluation for biosimilars, the comparator of HTA should be a different standard of care may and may not contain the reference product or second generation of Biosimilar.
Abdalla Abotaleb is one of the most profound experts in healthcare policy and regulations in the Middle East. His expertise extends from HTA and reimbursement policies to regulatory and supply chain strategies in the public sector. He has been involved in the fields of health economics, outcomes research and reimbursement policy within the healthcare industry for 15 years, with experience across the pharmaceutical, biologicals, and vaccines. Currently, he is working for WHO as a Project Manager at Health Care Reforming area.
Title: Gynecologic cancer