Purpose of the Study:The indigenous design and technology development for processing large scale zirconium molybdate-Mo-99 (ZrMo-99) Geltech generator was successfully commissioned in Board of Radiation and Isotope Technology (BRIT), India, in 2006. The generator production facility comprises of four shielded plant facilities equipped with tongs and special process gadgets amenable for remote operations for radiochemical processing of ZrMo-99 gel.Results:Over 2800 Geltech generators have been processed and supplied to user hospitals during the period 2006-2013. Geltech generator supplied by BRIT was initially not sterile. Simple elution of Tc-99m is performed by a sterile evacuated vial with sterile and pyrogen free 0.9% NaCl solution to obtain sodium (Tc-99m) pertechnetate solution. A special type online 0.22 μm membrane filter has been identified and adapted in Geltech generator.Conclusions:The online filtration of Tc-99m from Geltech generator; thus, provided sterile Tc-99m sodium pertechnetate solution. Generators assembled with modified filter assembly were supplied to local hospital in Mumbai Radiation Medicine Centre (RMC) and S.G.S. Medical College and KEM Hospital) and excellent performances were reported by users.
Objectives: HTA is a rapidly growing area interest for healthcare systems in APAC. The APAC HTA landscape comprises a patchwork of emerging and developed economies, levels of experience, capabilities, requirements and recommendation frameworks. Cancer drugs represent expensive treatments that benefit from HTA to optimize resource use. APAC has one of the fasting growing cancer populations and an increasing demand for quality care. The current research considers HTA reviews from APAC countries for the last 5 years, assessing number of evaluations, trends in drugs evaluated, probability of success, drivers of success and evidence considerations. Methods: Secondary research of HTA reports in Japan, South Korea, Taiwan, Singapore and Indonesia, narrative synthesis of Information meeting study objectives. Results: 89 reports were identified, overwhelmingly from Korea and Taiwan (79/89). All countries primarily evaluated targeted therapies/immunotherapy drugs (82%-100%) apart from Singapore where chemotherapies were common (40%). CEAs were submitted for 16% of Taiwanese and 60% of Korean submissions. Korea offers CEA waivers for select drugs, instead developing RSAs with manufacturers. CEAs are not mandated for Taiwanese submissions. For all other countries CEAs are universally considered. Taiwan and Singapore considered external HTA evaluations where there was limited data for an economic model. The proportion of successful submissions varied from 0% (Japan) to 86% (Korea, 98% including resubmissions). All except Taiwan have rejected submissions on solely economic grounds. Budget impact was most explicitly considered in Taiwan, where uncertain/high budget impact were used to drive MEAs or price reductions. Korea and Taiwan made extensive use of recommendations with MEAs, RSAs and price reductions. Decisions informed public reimbursement in Korea, Singapore and Taiwan while informing pricing adjustments in Japan. Indonesian decisions informed formulary optimization, uniquely including recommendations for disinvestment. Conclusions: HTA oncology review processes in APAC differ considerably across countries in all categories evaluated. Pan-APAC market access strategies will benefit from country-specific tailoring.
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