FDA APPROVAL AND PRICE ANALYSIS FOR GLUCAGON-LIKE PEPTIDE- RECEPTOR AGONIST (GLP-1 RA) FOR T2DM AND OBESITY- A DESCRIPTIVE STUDY (DURING THE PERIOD OF 2005-2016).
Author(s)
Alzarea AI1, Simonetti J2, Zaghloul I3, Tyrrell B1, Mekary RA1
1MCPHS University, Boston, MA, USA, 2Harvard Vanguard Medical Associates, Boston, MA, USA, 3MCPHS university, Boston, MA, USA
OBJECTIVES: To describe trends in the Average Wholesale Price (AWP) per Define daily dose (DDD) and year of therapy at the market entry of all U.S. Food and Drug Administration (FDA)-approved GLP-1RA drugs. METHODS: The FDA-approved GLP-1RA drugs were collected from the Drugs@FDA database. Their DDD was extracted using the WHO anatomical therapeutic chemical classification and their AWP/unit price and market status from the RED BOOK Online(R)RESULTS: There were 15 dosage forms and strengths of approved GLP-1RA medications including 5 active ingredients(86.7%) and two combinations with insulin(13.3%). Exenatide(40.0%), Liraglutide(13.3% ), Lixisenatide(13.3% ), Albiglutide(6.7%), and Dulaglutide(13.3%) were the approved active ingredients. Exenatide was the first approved in 2005. The combination of each of Liraglutide and Lixisenatide with insulin was the last approved (late 2016). About half (53.3%) of these drugs included a box warning about thyroid C-cell tumor in animals. GLP-1RA drugs’ indications were T2DM (93.3%) and chronic weight management (6.7%) for adults only. Their route of administration was subcutaneous. Their usage frequency was once daily (40.0%), twice daily (26.7%), and once weekly (33.3%). No generics were found for GLP-1RAs with 4.2% being repackaged. Their collected AWP prices ranged from $216.35 to $1609.71 and their effective dates ranged from 05/23/2005 to 01/01/2017. The median price/30 DDD was $476.69 (range=$216.35-$1609.71). A significant direct association was found between drugs’ prices/30DDD and their effective dates after inflation adjustment (slope =0.17; 95%CI=0.12-0.22). Similar associations were found for Exenatide, Liraglutide, Albiglutide, and Dulaglutide (All P-values<0.05). CONCLUSIONS: Five active ingredients and two combinations with insulin were approved by the USFDA. Their indications were T2DM and chronic weight management for adults only. GLP-1RAs prices/DDD were directly associated with the progress of time owing to the lack of generics.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PDB34
Topic
Economic Evaluation
Topic Subcategory
Cost-comparison, Effectiveness, Utility, Benefit Analysis
Disease
Diabetes/Endocrine/Metabolic Disorders