(1266) The Cost-effectiveness of Compounded Semaglutide versus Commercial glp1-ras

Objectives: GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONISTS (GLP-RAS) HAVE PROVEN TO BE EFFECTIVE IN REDUCING BLOOD GLUCOSE LEVELS IN TYPE 2 DIABETICS, STIMULATING WEIGHT LOSS, AND PREVENTING PROGRESSION OF CKD. HOWEVER, GIVEN THEIR COST COUPLED WITH BACKORDERS AND SHORTAGES AFFECTING PATIENTS NATIONWIDE, ALTERNATIVE SOLUTIONS SUCH AS COMPOUNDED SEMAGLUTIDE HAVE EMERGED. PHARMACEUTICAL COMPOUNDING PLAYS A PIVOTAL ROLE IN HEALTHCARE AS IT CAN HELP BRIDGE THE GAP IN INDIVIDUAL THERAPEUTIC NEEDS. FROM DOSE ADJUSTMENTS IN PEDIATRIC CARE, TO REMOVING EXCIPIENTS OR DYES FOR PATIENT ALLERGIES, TO MEETING THE DEMANDS OF MEDICATIONS EXPERIENCING NATIONWIDE SHORTAGES, COMPOUNDING PHARMACIES OFFER SOLUTIONS TO SPECIFIC PATIENT NEEDS. COMPOUNDED MEDICATIONS FALL UNDER STRICT USP < 795> AND REGULATORY OVERSIGHT BY STATE AND FEDERAL JURISDICTIONS; PHARMACIES ARE SUBJECT TO INSPECTIONS TO ENSURE QUALITY, SAFETY, AND PURITY OF COMPOUNDED PRODUCTS. THIS PROJECT STUDIES PATIENTS RECEIVING COMPOUNDED SEMAGLUTIDE SUSPENSION WITH VITAMIN B6, FORMULATED AT FIVE DIFFERENT DOSAGES USING RYBELSUS® TABLETS. OUR PRIMARY OBJECTIVES WILL BE TO DESCRIBE THE CLINICAL EFFECTS OF COMPOUNDED SEMAGLUTIDE AT FIVE DIFFERENT DOSAGES, ESTIMATE ITS COST-EFFECT RELATIONSHIP FOR WEIGHT LOSS AND OBSERVE TOLERABILITY.

Methods: THIS WILL BE A CHART REVIEW STUDY OF CONSENTING PATIENTS OVER THE AGE OF 18 YEARS, WHO HAVE RECEIVED A PRESCRIPTION FOR COMPOUNDED SEMAGLUTIDE, HAVE A BMI >27 WITH AT LEAST ONE HIGH-RISK COMORBIDITY, OR A BMI >30. THE STUDY EXCLUDES PATIENTS WHO HAVE RECENTLY USED COMMERCIALLY AVAILABLE GLP1-RAS IN THE PREVIOUS 90 DAYS. THIS STUDY WILL TAKE PLACE AT AN INDEPENDENT COMMUNITY PHARMACY THAT SERVES PATIENTS ACROSS NORTHERN COLORADO. SEMAGLUTIDE AT THIS PHARMACY IS COMPOUNDED USING RYBELSUS® TABLETS AS AN ORAL SUSPENSION CONTAINING 0.6MG/ML, 0.9 MG/ML, 1.2 MG/ML, 2.4 MG/ML, OR 4.8 MG/ML SEMAGLUTIDE WITH VITAMIN B6 (PYRIDOXINE) TO IMPROVE GI TOLERABILITY. PATIENTS USE AN ORAL SYRINGE TO SELF-ADMINISTER A 1ML DOSE EVERY THREE DAYS. EACH PRESCRIPTION LASTS FOR 45 DAYS AND MAY BE REFILLED. COMPOUNDED PRESCRIPTIONS MEET ALL FDA, USP < 795> AND COLORADO BOARD OF PHARMACY REQUIREMENTS AND RECOMMENDATIONS. WEIGHT CHANGES AND SIDE EFFECTS WILL BE COLLECTED IN A 14-DAY CYCLE USING A PHI-PROTOCOL, PATIENT REPORTED SURVEY. THIS TIMEFRAME ALLOWS FOR SOME EFFECTS TO BE SEEN OF THE COMPOUNDED ORAL SEMAGLUTIDE. REFILLS, COSTS, AS WELL AS STRENGTH OF THE COMPOUND, WILL BE COLLECTED USING COMPUTER PRESCRIPTION SOFTWARE. IDENTITY OF INDIVIDUALS WILL BE PROTECTED VIA ENCRYPTED COMPUTER SOFTWARE. STATISTICAL ANALYSIS WILL BE APPROPRIATELY CONDUCTED FOR ALL VARIABLES COLLECTED. DESCRIPTIVE STATISTICS (MEAN, STANDARD DEVIATION, STANDARD ERROR OF WEIGHT LOSS OF PATIENT) AND CONFIDENCE INTERVALS WILL BE DETERMINED FOR EACH MEASUREMENT. CHANGES IN WEIGHT WILL BE COMPARED OVER TIME TO DETERMINE IF THERE IS A SLOPE SIGNIFICANTLY LESS THAN ZERO (P < 0.05) FOR EACH SEMAGLUTIDE DOSAGE. THIS STUDY IS IRB EXEMPT AS A QUALITY CONTROL STUDY WHICH DOES NOT INFLUENCE PARTICIPANT DRUG THERAPY.

Results: DATA COLLECTION WILL COMMENCE AFTER IRB EXEMPTION IS APPROVED. THE RESULTS WILL BE UTILIZED TO ESTABLISH IF COMPOUNDED SEMAGLUTIDE WITH VITAMIN B6 CAN BE A THERAPEUTIC ALTERNATIVE TO HIGHER DOSE RYBELSUS AND DURING NATIONWIDE MANUFACTURER SHORTAGES.

Conclusions: IF COMPOUNDED ORAL SEMAGLUTIDE WITH VITAMIN B6 IS EFFECTIVE FOR WEIGHT LOSS AND GI TOLERABILITY, THE COST DIFFERENCE AND AVAILABILITY COULD HELP MILLIONS OF AMERICANS STRUGGLING WITH WEIGHT LOSS. THIS COULD POTENTIALLY REDUCE THEIR RISK OF CARDIOVASCULAR EVENTS AND HAVE A PROFOUND ECONOMIC IMPACT ON THE HEALTHCARE SYSTEM.