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

MEASUREMENTS FOR DRUG POLICYMAKERS AND ASSESSMENT TOOLS FOR CLINICIANS  

British Columbia – Alzheimer’s disease Therapy

Initiative (ADTI)

Disclosures (PL)

Honoraria and participation in advisory board meetings (Janssen, Novartis, Pfizer)

Clinical trials sponsored by BMS, Elan, Janssen, Pfizer

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

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

Dementia Education Strategy

Sharing knowledge and experience between physicians and healthcare professionals and public

Conferences, public forums, literatureWorkshopshttp://www.health.gov.bc.ca/pharmacare/adti/careg

iver/cognitive.html

Special Authority

Special authority coverageThree versions of form

Initiation Renewal/switching for lack of efficacy Switching for tolerability

http://www.healthservices.gov.bc.ca/pharme/sa/adti.html

Dr. Oz1234 1st Ave, Anywhere, BC V7X 4H5

12345

604

604

123-4567

123-4568

Renewal or Switching Due to Lack of Effect

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

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?

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?