Background: The demand for implementing a new listing scheme to expedite patient access to novel oncology drugs has increased in South Korea. This study was conducted to compare the prices of anticancer drugs between eight countries and to explore the feasibility of a ‘pre-listing and post-evaluation’ scheme to expedite patient access to oncology drugs. Methods: This study included 34 anticancer drugs, which were reimbursed between 1 January 2007 and 31 December 2017. The unit price and sales volume of the study drugs were collected from eight countries and IQVIA data, respectively. The prices were adjusted to estimate the ex-factory prices using the discount/rebate rate suggested by the Health Insurance Review Agency (HIRA). The four price indices of Laspeyres, Paasche, Fisher, and the unweighted index were calculated using the price in each country, the average price, and lowest price among the study countries. Each currency was converted using the currency exchange rate and purchasing power parity (PPP). The budget impact of implementing the proposed pre-listing and post-evaluation scheme on payers was calculated. Results: Based on the currency exchange rate, anticancer drug prices were higher in other countries (index range: 1.05–2.78) compared to Korea. The prices in Korea were similar to countries with the lowest prices. When the PPP was applied, prices were higher in the US, Germany, Italy, and Japan than in Korea (range: 1.10–2.13); however, the prices were lower in the UK, France, and Switzerland than in Korea (range: 0.72–0.99). The financial burden of implementing the pre-listing and post-evaluation scheme was calculated at 0.83% of the total anticancer drug sales value in Korea from 2013–2017. Conclusions: The prices of anticancer drugs in Korea were similar to the lowest prices among the seven other study countries. A pre-listing and post-evaluation scheme should be considered to improve patient access to novel anticancer drugs by reducing the reimbursement review time and uncertainties.

Objectives: Sildenafil, a phosphodiesterase-5 inhibitor is mainly used in the treatment of erectile dysfunction and pulmonary hypertension. Malignant melanoma associated with the use of sildenafil is a safety signal established in the past. However, the time of onset of this event is not well explored. The purpose of this study was to examine the onset profiles of Sildenafil associated Malignant Melanoma using FAERS database. Methods: A systematic data mining was performed in FAERS Database (1998Q2 to 2019Q4) using a pharmacovigilance analytical tool (OpenVigil 2.0) in order to access the FAERS data. Reporting Odds Ratio (ROR) was used to compute the signal strength of Sildenafil induced Malignant Melanoma. A value ROR-1.96SE ,1 was obtained and considered as a positive signal. The time-to-onset was computed by subtracting the date of the event with start date of the drug (date of eventstart date of drug) and the profile was analyzed using the Weibull shape parameter (WSP) test. Shape and scale parameters were used to define the time to onset profile. Results: FAERS database had a total of 6274 reports for Malignant Melanoma. Total number of reports for Sildenafil associated Malignant Melanoma was 1539 (24.5%). The signal strength of Sildenafil associated Malignant Melanoma was 37.33 (37.22-39.56) which is well above the threshold. The median time-to-onset of Sildenafil associated Malignant Melanoma was 1461 (range: 657-2588) days. WSP test indicated wear-off failure-type profile with shape parameter: 1.30 (95% C.I 1.23-1.38) and scale: 1884.60 (95% C.I 1777. 74-1996.52). Conclusions: Sildenafil followed wear-off failure-type profile, suggesting that attention should be given in later stages of treatment. The risk of malignant melanoma increases as the duration of treatment increases. Thus, it is advisable to avoid long treatment, especially more than 650 days. However, due to the widely distributed data, patients should be monitored throughout the course of therapy.