Project Grant F31AG104221

TREATMENT PATHWAYS AND ACCESS TO NOVEL AMYLOID-TARGETING ALZHEIMER'S THERAPIES: EXAMINING MULTI-LEVEL INFLUENCES - PROJECT SUMMARY ALZHEIMER'S DISEASE AFFECTS NEARLY 7 MILLION AMERICANS, A NUMBER PROJECTED TO DOUBLE BY 2060, DRIVING ANNUAL COSTS EXCEEDING $755 BILLION. AFTER TWO DECADES WITHOUT NEW TREATMENT OPTIONS, MEDICARE BEGAN COVERING AMYLOID-TARGETING THERAPIES LEQEMBI AND KISUNLA IN 2023-2024, REPRESENTING THE FIRST DISEASE-MODIFYING TREATMENTS THAT GO BEYOND SYMPTOM MANAGEMENT ALONE. THESE THERAPIES SHOW MODEST CLINICAL BENEFITS (27- 29% REDUCTION IN COGNITIVE DECLINE OVER 18 MONTHS), HAVE SIGNIFICANT SIDE EFFECTS, AND COST OVER $25,000 ANNUALLY. WITH RECENT MEDICARE COVERAGE, UPTAKE IS RAPIDLY INCREASING WITH OVER 10,000 PATIENTS ON TREATMENT. IT REMAINS UNCLEAR WHICH PATIENTS ARE ACCESSING THESE THERAPIES AND WHETHER TRADITIONAL BARRIERS TO HEALTHCARE ACCESS EXTEND TO THIS NEW TREATMENT PATHWAY. THIS RESEARCH WILL PROVIDE THE FIRST COMPREHENSIVE ANALYSIS OF ACCESS PATTERNS AND CLINICAL ROLLOUT PATTERNS FOR THESE BREAKTHROUGH ALZHEIMER'S THERAPIES. THE STUDY USES 100% MEDICARE FEE-FOR-SERVICE CLAIMS DATA LINKED TO PATIENT DEMOGRAPHIC AND GEOGRAPHIC INFORMATION TO EXAMINE THREE SPECIFIC AIMS: (AIM 1) EVALUATE WHO SEES A NEUROLOGIST WITHIN ONE YEAR OF AN ALZHEIMER'S OR MILD COGNITIVE IMPAIRMENT DIAGNOSIS, (AIM 2) EVALUATE WHICH PATIENTS THEN UNDERGO BIOMARKER TESTING (REQUIRED FOR TREATMENT ELIGIBILITY) AND WHICH TESTED PATIENTS INITIATE TREATMENT, AND (AIM 3) EVALUATE WHICH PATIENTS DISCONTINUE TREATMENT USING CLAIMS DATA AND WHAT FACTORS CLINICIANS AND PATIENTS IDENTIFY AS IMPORTANT IN MAKING SUCH DECISIONS USING SEMI-STRUCTURED INTERVIEWS WITH PATIENTS AND NEUROLOGISTS TO CONTEXTUALIZE QUANTITATIVE FINDINGS. MR. JANUSZEWICZ WILL CONDUCT THIS RESEARCH UNDER THE MENTORSHIP OF DR. KAREN SCHIFFERDECKER (MIXED- METHODS EXPERTISE), CO-SPONSOR DR. EMMA DEAN (MEDICARE CLAIMS ANALYSIS), AND CONSULTANTS DRS. ELLIOTT FISHER (HEALTHCARE UTILIZATION), NICOLE FOWLER (ADRD CARE PATHWAYS), AND GUANBO WANG (CAUSAL INFERENCE METHODS). THE TRAINING PLAN INCLUDES FOUR SHORT-TERM GOALS: (1) DEVELOPING PROFICIENCY IN MEDICARE CLAIMS DATA ANALYSIS, (2) DEVELOPING QUALITATIVE INTERVIEW AND MIXED-METHODS INTEGRATION SKILLS, (3) TRAINING IN ADVANCED CAUSAL INFERENCE METHODS FOR OBSERVATIONAL HEALTHCARE DATA, AND (4) PROFESSIONAL DEVELOPMENT IN SCIENTIFIC DISSEMINATION AND POLICY COMMUNICATION. TRAINING WILL BE CONDUCTED IN THE DARTMOUTH INSTITUTE'S NATIONALLY RECOGNIZED HEALTH POLICY RESEARCH ENVIRONMENT, WHICH PROVIDES DEDICATED COURSEWORK IN RESEARCH METHODS, REGULAR SEMINARS FEATURING LEADING RESEARCHERS, EXTENSIVE COLLABORATION OPPORTUNITIES WITH CLINICAL AND POLICY EXPERTS, AND ACCESS TO MEDICARE DATA INFRASTRUCTURE. THIS RESEARCH ADDRESSES NIA'S MISSION TO EXTEND HEALTHY YEARS OF LIFE FOR OLDER ADULTS BY GENERATING CRITICAL EVIDENCE ABOUT ACCESS TO NOVEL ALZHEIMER'S TREATMENTS, THEREBY INFORMING MEDICARE POLICY DECISIONS FOR CURRENT AND FUTURE HIGH-COST, LIMITED-BENEFIT THERAPIES. THIS WORK SUPPORTS MR. JANUSZEWICZ'S LONG-TERM GOAL OF BECOMING AN INDEPENDENT NIH-FUNDED INVESTIGATOR EXAMINING PHARMACEUTICAL ACCESS, COST, AND HEALTH IMPLICATIONS FOR AGING POPULATIONS.