PP403 New Medical Technology Adoption In Asia Pacific: Focused On South Korea And Japan

IntroductionThis study is the first to analyze and compare the distinctive market access process of new medical technologies focused on technical fee creation in South Korea and Japan. The purpose of this study is to derive implications for each country through analysis and comparison of the market access process and propose improvements of new medical technology adoption program by referring the United States’ incentive program for innovative technology.MethodsIdentification and review the published articles and health polices, and reports related to the medical procedure (medical technologies) coding and payment rule in South Korea, Japan and the United States.ResultsIn Korea, for the rapid introduction of new medical technologies, a One-Stop Service program (aka parallel review process) is operated that simultaneously conducts regulatory approval and new health technology assessment (nHTA) process. In Japan, the Sakigake designation program aims to give patients better access to innovative pharmaceuticals, medical technologies, and regenerative medicines by streamlining the approval and pricing process but it doesn't provide immediate coverage after approval. Medicare Coverage for Innovative Technology (MCIT) is one of the incentive programs for innovative technology which aims to improve patient access to new medical technologies through rapid market access process in the United States. Medical technologies designated a Breakthrough Device receive immediate Medicare Coverage for 4 years by MCIT.ConclusionsIt is recommended for Korea and Japan to actively implement the accelerated patient access process and grant affordable premium prices for the innovative medical technologies. MCIT can be considered as a breakthrough for innovative medical technology adaption.

Medication adherence among prostate cancer patients using advanced oral therapies.

44 Background: Prostate cancer (PC) is associated with a high clinical and economic burden. Advanced oral (AO) therapies have become the standard of care for patients with advanced PC, but real-world data on treatment patterns and their impact on healthcare resource utilization (HRU) are lacking. This study aims to describe treatment adherence, factors associated with adherence, and its impact on HRU in patients with PC initiated on AOs. Methods: Adults with a PC diagnosis initiated on apalutamide, enzalutamide, or abiraterone acetate were identified using Symphony Health Solutions Patient Transactional Databases (10/01/2014-09/30/2019). Patients were included if they had ≥6 months of continuous clinical activity before and after AO initiation (index date) and no other cancer diagnoses. Adherence was defined using the proportion of days covered (PDC) by AOs during the 6-month period following the index date. Patients with a PDC≥80% were considered adherent. Multivariable logistic regression was used to evaluate baseline characteristics associated with AO adherence. All-cause and PC-related HRU was assessed from 6 to 18 months post-index and compared between adherent and non-adherent patients using multivariable Poisson regression. Results: A total of 27,322 patients initiated on an AO were identified. Most patients were aged ≥65 years (81%), were white (60%), had Medicare coverage (48%), and had metastatic PC (56%). At 6 months, 57% of patients were adherent to AOs. Patients aged 55-64 and 65-74 years had greater odds of being adherent versus those aged ≥75 years (24% and 22%, respectively), while Black patients had 17% lower odds of being adherent relative to white patients (all p<0.01). Medicare coverage was associated with 23% greater odds of being adherent relative to commercial insurance (p<0.01). Patients with a below median primary insurer paid amount for their first AO claim had 13% greater odds of being adherent relative to the above median amount (p<0.05). Adherent patients generally had fewer HRU compared to non-adherent patients. More specifically, adherent patients had 25% fewer all-cause inpatient days, 16% fewer all-cause emergency room (ER) visits, 18% fewer all-cause other non-outpatient services use, as well as 30% fewer PC-related inpatient days and 24% fewer PC-related ER visits (all p<0.01) relative to non-adherent patients. Conclusions: In this study, non-adherence over a 6-month period following AO initiation was associated with substantially higher HRU, including inpatient and ER visits. Moreover, non-adherence was widely observed, impacting over 40% of advanced PC patients in the first 6 months after AO initiation. Identifying factors linked to lower adherence and defining strategies to improve adherence may improve patient outcomes and associated medical resource utilization. (1)Abiraterone acetate plus prednisone is the approved therapy although the combination was not imposed.

Private Payer and Medicare Coverage for Circulating Tumor DNA Testing: A Historical Analysis of Coverage Policies From 2015 to 2019

Background: Clinical adoption of the sequencing of circulating tumor DNA (ctDNA) for cancer has rapidly increased in recent years. This sequencing is used to select targeted therapy and monitor nonresponding or progressive tumors to identify mechanisms of therapeutic resistance. Our study objective was to review available coverage policies for cancer ctDNA–based testing panels to examine trends from 2015 to 2019. Methods: We analyzed publicly available private payer policies and Medicare national coverage determinations and local coverage determinations (LCDs) for ctDNA-based panel tests for cancer. We coded variables for each year representing policy existence, covered clinical scenario, and specific ctDNA test covered. Descriptive analyses were performed. Results: We found that 38% of private payer coverage policies provided coverage of ctDNA-based panel testing as of July 2019. Most private payer policy coverage was highly specific: 87% for non–small cell lung cancer, 47% for EGFR gene testing, and 79% for specific brand-name tests. There were 8 final, 2 draft, and 2 future effective final LCDs (February 3 and March 15, 2020) that covered non–FDA-approved ctDNA-based tests. The draft and future effective LCDs were the first policies to cover pan-cancer use. Conclusions: Coverage of ctDNA-based panel testing for cancer indications increased from 2015 to 2019. The trend in private payer and Medicare coverage is an increasing number of coverage policies, number of positive policies, and scope of coverage. We found that Medicare coverage policies are evolving to pan-cancer uses, signifying a significant shift in coverage frameworks. Given that genomic medicine is rapidly changing, payers and policymakers (eg, guideline developers) will need to continue to evolve policies to keep pace with emerging science and standards in clinical care.