Cholinesterase Inhibitors in a real-world coverage study Revised outline

1. Cholinesterase Inhibitors in a real-world coverage studyRevised outline • Introduction: measurement for drug policymakers and assessment tools for clinicians • What caregivers think of cholinesterase inhibitors (KAREN KOBAYASHI) • Trends in utilization and costs of services associated with introduction of drug coverage for cholinesterase inhibitors (MALCOLM MACLURE) • Clinical epidemiology: Who benefits? How do we know? (LYNN BEATTIE) • Alzheimer’s Drug Therapy Initiative: Seniors Medication Study (GING-YUEK ROBIN HSIUNG) • The ADTI CLIMAT (Clinical Meaningfulness in Alzheimer Disease Treatment) study (CLAUDIA JACOVA) • ADTI: Current view and future directions

2. British Columbia – Alzheimer’s disease Therapy Initiative (ADTI) MEASUREMENTS FOR DRUG POLICYMAKERS AND ASSESSMENT TOOLS FOR CLINICIANS

4. Disclosures (PL) • Honoraria and participation in advisory board meetings (Janssen, Novartis, Pfizer) • Clinical trials sponsored by BMS, Elan, Janssen, Pfizer

5. Alzheimer’s Disease Therapy Initiative • July 2006 – Meeting with key stakeholders • Community members • Clinicians • Government representatives • Coverage for cholinesterase inhibitors provided for B.C. residents who are in mild to moderate stages of Alzheimer’s disease • Concurrently, gathering evidence on “effectiveness” of medications and the program itself

6. Alzheimer’s Disease Therapy Initiative • Over the following year, development of educational and medication program • BC PharmaCare launched ADTI program in October 2007 • 4-phase project, now in third & fourth phase • PharmaCare providing funding for ADTI until March 2012

7. Dementia Education Strategy • Sharing knowledge and experience between physicians and healthcare professionals and public • Conferences, public forums, literature • Workshops • http://www.health.gov.bc.ca/pharmacare/adti/caregiver/cognitive.html

8. Special Authority • Special authority coverage • Three versions of form • Initiation • Renewal/switching for lack of efficacy • Switching for tolerability http://www.healthservices.gov.bc.ca/pharme/sa/adti.html

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12. Renewal or Switching Due to Lack of Effect

14. Patient Assessment • Four areas – cognition, function (basic and instrumental activities) and behaviour • Clinicians are asked to assess the change in a patient’s ability over six months • Assigning a score of + 1, 0 or - 1 for each area • Clinicians are asked to make a judgment of improvement or decline, taking into account clinical factors (OPAR) • Very much, much or minimal improved, no change or minimal, much or very much worse

15. ADTI Ongoing Studies • The Caregiver Study • What are the benefits, if any, of ChEI from perspective of family caregivers for patients and for themselves and how do they compare with clinical assessments of these medications? • Utilization and Cost Study • Trends of ChEIs and health services use before and during ADTI, with aim of estimating cost-effectiveness • Clinical Epidemiology • Who benefits from ChEI including effectiveness of switching, tolerability and treatment trajectories?

16. ADTI Studies • The Senior’s Medication Study • Who benefits from continued treatment and consequences of treatment termination? • The CLIMAT • How can a positive response to ChEIs be characterized on a scale of clinically meaningful change? Can its items be used in situations of clinical equipoise?