Study On The Pricing Of A New Anti-tumor Drug

Objective:To provide the basis for pricinga new anti-tumor drugby cost analysis and pricing study,meanwhile providing reference for pricing of other new drugs.The influencing factors of new drug pricing is also discussed.Methods:The evaluation method of research and develop(R&D)cost of new drugs at home and abroad were determined by the "literature review".At the same time,the calculation method of R&D cost of new drugs considering time value was further confirmed,providing the data basis for the projected sales expense and annual sales volume in new drug pricing.The total cost of a new anti-tumor drug during pre-clinical and clinical phase was calculated,and the development cost of the new drug was also analyzed by "cost analysis method".The financial,testing,processing,material,labor and other costs that incurringduringthe development of the new drug was calculated.The pricing of new drugs and the key factors was determined by using the method of"interview with key insiders"."Free pricing method”was used for new drug pricing.Results:Cost analysis:The total cost of new drug development was about 217 million RMB.The cost of new drug development increased year by year from project initiation,especially from the start of clinical trials in 2012.Of all the costs,the proportion of test processing fees is the highest,with a share of over 50%from 2012 onwards(from 2012-1017,53.90%,72.61%,54.91%,71.45%,66.99%,57.50%share,respectively).The cost of test processing mainly includes commissioned research,commissioned production and inspection services.New drug pricing:The patent for the new drug expires in 2029 with 10 years from its listing to its expiration(2019-2029).It is assumed that the cost of the new drug will be recovered within 3 years(2019～2021)and the profit period will be 7 years after.The total cost of the three years after the listing,taking into account the time value and sales cost,is about RMB 692 million.Assuming that the "consultation rate*diagnostic rate" is 20%,30%and 40%,the estimated sales volume is 61431,92146 and 122862 bottles,and the price is RMB 11257,RMB 7505 and RMB 5629 respectively.It is estimated that the market price of this product is about 6500 yuan～13000 yuan.Conclusions:The major factors affecting new drugs pricing include the high cost of developent,the high cost of sell,the different morbidity and mortality of tumors,clinical demand and competitive product.Other factors leading to the high cost of new drug development include the scale and quantity of clinical trials,the complexity of product development,and the policy and regulatory environment.The price of the another anti-tumor drug is USD 10000/month in the United States and RMB 37000/month in China.Based on the scientific pricing process and the comparison of the price of a listed drug,the market price of this new drug is relatively reasonable.Enterprises should not only conduct scientific and rigorous new drug research and development,but also should comply with thepolicies and regulations,improving the probability of success of the research,developing good original Chinese new drugs,meanwhile conducting reasonable cost analysis and pricing to truly benefit the people and the society!...