Implications of the German HTA-Process on Market-Uptake of Oral Treatments for Type-2-Diabetes (T2DM) Since 2007

OBJECTIVES: Since 2011, all new pharmaceuticals are subject to early benefit assessment in Germany. During 2013 some antidiabetics that were launched before 2011 also had to undergo benefit assessment. We aimed to understand the impact of early benefit assessment on market-uptake (sales in units) of new oral treatments forT2DM during the first 24 months. METHODS: We used IMS Pharmascope® data to analyze the number of packs sold during the first 24 months after launch of oral antidiabetics. We compared substances launched during the four years before and after the introduction of early benefit assessment. In addition, we analyzed the impact of benefit assessment for substances launched before 2011 and all re-assessments. We distinguish between mono substances and combination therapies with the therapy standard metformin. RESULTS: Between 2007 and 2014, twelve new oral antidiabetics - seven mono substances and five combinations with metformin - entered the market. Sitagliptin, vildagliptin, saxagliptin, vildagliptin/metformin and sitagliptin/metformin were launched before 2011. Among these sitagliptin and sitagliptin/metformin were most successful. HTA-assessment acknowledged good efficacy and safety profile of sitagliptin and supported sales. A positive assessment of saxagliptin did not boost sales. Vildagliptin exited the market after a negative assessment. With exception of the re-assessment of empagliflozin, all products got a negative evaluation. However, dapagliflozin and empagliflozin had a market-uptake similar to sitagliptin during the first two years after launch (about 25,000 units sold per month). With the exception of sitagliptin/metformin all combinations with metformin did not reach a relevant market share within two years. CONCLUSIONS: HTA assessment lead to market exits of five out of twelve products due to negative evaluations. Positive assessment might have improved the sales of sitagliptin, sitagliptin/metformin and empagliflozin. Saxagliptin did not gain from a positive evaluation. Despite a negative evaluation, dapagliflozin reached a relevant market share.