The GuangDong Pharmaceutical Association has released the 2023 version of its off-label drug list, marking the 9th edition since its inception in 2015. The list serves as a reference tool rather than a recommendation guide. Contributors to this comprehensive list include Class 3A hospitals from various provinces across China, including Hebei, Shanxi, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Hubei, Hunan, Hainan, Chongqing, Sichuan, Shaanxi, Fujian, and Xinjiang, in addition to Guangdong.
Changes and New Additions to the List
The updated list features 47 new drugs, while 10 products have been removed. Notable new entries include MSD’s PD-1 inhibitor Keytruda (pembrolizumab), Bristol-Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab), and AbbVie’s (NYSE: ABBV) Humira (adalimumab), which are among the pharmaceutical industry’s blockbuster drugs. Keytruda, in particular, is now listed for seven off-label indications.
Classification and Considerations for New Entries
The majority of the new entries are classified as Class IIa, which indicates high-level evidence from randomized controlled studies both domestically and internationally. However, these drugs may have poor accessibility or low potency ratios. For measures that offer significant clinical benefits but come with higher costs, the list suggests considering treatments that patients may benefit from, weighing the balance between efficacy and economic implications.-Fineline Info & Tech
