Outcomes of strategies to improve drug

utilization in British Columbia

James (Jim) Wright Managing Director Therapeutics Initiative

Outline

My journey at the university

The Therapeutics Initiative (TI)

Strategies and outcomes

The Pharmaceutical Task Force and Academic Review of TI

The problem and some potential solutions

Questions.

Warning

Information provided here about prescription drugs that you may be taking could lead to cognitive dissonance and affect your well being.

Viewer discretion is advised.

My journey at UBCFirst Phase

1977 Assistant professor in Pharmacology & Therapeutics and Medicine.

Clinical Pharmacologist – Clinical practice, research and teaching.

1977-1983, MRC funded research into mechanisms of adverse drug effects and drug interactions.

My journey at UBC Second Phase

In 1983 I began doing drug industry funded clinical drug trials.

Between 1983 and 1994, I was principal investigator for 15 trials with 15 different drug companies.

My journey at UBCThird Phase

In 1994 the Therapeutics Initiative was formed and I was appointed the Clinical Managing Director.

I stopped all drug industry funded research.

1994 to present -- main activity, Managing Director of TI and Editor-in-Chief of Therapeutics Letter.

2001, I was appointed Coordinating Editor of the Cochrane Hypertension Review Group.

Therapeutics Initiative, 1994(10 individuals)

Mission: To provide physicians and pharmacists with up-to-date, evidence-based, practical information on prescription drug therapy.

First Task: To become expert in assessing evidence from clinical trials of new drugs in Canada, and to provide the evidence to Pharmacare.

First policy decision: No conflicts of interest were allowed.

What happened?

We became expert in critical appraisal and assessment of evidence from clinical trials.

We got involved in the Cochrane Collaboration and learned their methodology.

We hired experts in Health Technology Assessment and Systematic Review.

Interventions implemented

Therapeutics Letter 6 times per year posted on website and mailed to physicians and pharmacists in BC.

Letters provided the best available evidence about the benefits and harms of drugs and drug classes.

Letters provided drug cost information.

What did the clinicians think about the Letter?Answered by regular surveys

What was the impact on prescribing of the first 20 Letters?Answered using a randomised controlled trial.

Effect of periodic letters on evidence-based drug therapy on prescribing behaviour: a randomized trial

Dormuth CR, Maclure M, Bassett K, Jauca C, Whiteside C, Wright JM (CMAJ 2004; 171(9): 1057-61)

The Therapeutics Initiative is funded by a grant from the Government of British Columbia

Methods

� Physicians:-Study population included 499 physicians from 24 local health areas in British Columbia, Canada

� Communities:-Paired according to the number of physicians. -One in each pair was randomly assigned to the intervention group and the other to the control group

� Source databases:-Physician service records and drug claims records from the British Columbia Ministry of Health

Methods

� Analyses:-Incidence of newly treated patients was measured

-For each drug group studied, patients were classified as being newly treated if none of the drugs in the group were dispensed to them in the previous year.

Results

Table: Characteristics of treatment and control physicians

Treatment ControlCharacteristic Group (n=258) Group (n=241)Physicians:% General Practitioners 89.9 90.4Average age 45.6 46.2% Males/Females 89/11 83/17

Patients:Average age 35.5 (75.2) 35.0 (75.3)% Males/Females/Unknown 46/52/2 (44/52/4) 46/52/2 (44/52/4)Avg. no. visits / MD 6402 (1322) 6660 (1340)

Results in brackets are for subset of patient population 65 and older.

Source: Dormuth CR, Maclure, et al. CMAJ 2004; 171(9): 1057-61

Interpretation

� Printed letters distributed as a series regularly from a trustedsource has a modest desirable impact on prescribing to new patients.

� Further work needs to be done to determine the sustainability ofprescribing changes, and to determine what aspects of printed letters elicit prescribing changes

What policies were implemented?

Outcomes based coverage.

Funding of new drugs was based on the best available evidence.

A new drug only became a full benefit if it represented a therapeutic advantage or a cost advantage over appropriate alternatives.

Examples of drug classes affected by this policy

Non-steroidal anti-inflammatory drugs (Cox-2 selective NSAIDs).

Oral hypoglycemic drugs (glitazones and others).

Cholinesterase inhibitors for Alzheimers Disease.

What was the impact of the outcome based coverage policy?

Canadian Rx atlas 2007Non-steroidal anti-inflammatory

drugs

Canadian Rx atlas 2007Oral diabetes drugs

Canadian Rx Atlas 2007Cholinesterase inhibitors

What other policies were implemented?

Reference based pricing of equivalent drugs within a drug class.

Restricted access based on special authority criteria.

Therapeutic substitution

Reference based pricing

January 1, 1997 least expensive ACE inhibitors fully covered (captopril, quinapril, ramipril).

More expensive ACE inhibitors covered up to a maximum of $27 per month (benazepril, cilazapril, enalapril, fosinopril, lisinopril).

Patients on more expensive ACEI could pay the difference or switch.

Outcomes of reference pricing for angiotensin-

converting-enzyme inhibitorsSchneeweiss S, Walker AM, Glynn RJ, Maclure M, Dormuth C, Soumerai SB.N Engl J Med 2002;346:822-9

No increase in Emergency Hospitalizations due to RP

Schneeweiss et al. N Engl J Med 2002

Pharm

acy savings in prevalent A

CE

I users

$0

$10

$20

$30

$40

$50

$60

Apr-96

May-96

Jun-96

Jul-96

Aug-96

Sep-96

Oct-96

Nov-96

Dec-96

Jan-97

Feb-97

Mar-97

Apr-97

May-97

Jun-97

Jul-97

Aug-97

Sep-97

Oct-97

Nov-97

Dec-97

Jan-98

Feb-98

Mar-98

Apr-98

Mo

nth

Average monthly anti-hypertensives ingredient expenditures per patient

Projected pre-

policy trend

12 mo

nth

saving

s: $6,700,000

Schneew

eisset al. J C

an Med A

ssoc, 2002

Reference pricing for ACEI conclusions

18% of patients switched to lower cost alternative.

Not associated with changes in physician visits, hospitalizations or mortality.

Cost savings to drug funder of approximately $6 million per year.

What policies were implemented?

Reference based pricing of equivalent drugs within a drug class.

Restricted access based on special authority criteria.

Therapeutic substitution

PPI therapeutic substitution

Resu

lts:1) 50%

of PP

I users switched to

preferred PP

I

0 5 10 15 20 25 30 35 40 45Jan-02

Feb-02

Mar-02

Apr-02

May-02

Jun-02

Jul-02

Aug-02

Sep-02

Oct-02

Nov-02

Dec-02

Jan-03

Feb-03

Mar-03

Apr-03

May-03

Jun-03

Jul-03

Aug-03

Sep-03

Oct-03

Nov-03

Dec-03

Jan-04

Feb-04

Mar-04

Apr-04

May-04

Jun-04

Daily doses (* 1000) dispensed per 10,000 seniors .A

ll PP

I

Non-preferred P

PIs

Preferred P

PI: rabeprazole

Esom

eprazole

Fair

Pharm

aCare*

PP

I restrictionE

xtrapolated trend

Rabeprazole

$35/month

$61 -$90

Results: 4) No increase in adverse GI effects 3) Short-term increase in visits

0

2

4

6

8

10

12

14

16

18

Jan-

02

Feb

-02

Mar

-02

Apr

-02

May

-02

Jun-

02

Jul-0

2

Aug

-02

Sep

-02

Oct

-02

Nov

-02

Dec

-02

Jan-

03

Feb

-03

Mar

-03

Apr

-03

May

-03

Jun-

03

Jul-0

3

Aug

-03

Sep

-03

Oct

-03

Nov

-03

Dec

-03

Jan-

04

Feb

-04

Month

Ho

spit

aliz

atio

n r

ate

per

10,

000

.

-10

10

30

50

70

90

110

130

150

Off

ice

visi

t ra

te p

er 1

0,00

0 .

Hospitalization: Complicated PUD

Hospitalization: GI hemorrhage

Office visits (GERD, PUD, gastritis)

PPI restriction Fair PharmaCare†

Cost impactSavings of approximately $3 million in the

first 6 months.

Why were the policies successful?

The TI did not allow any conflicts of interest.

Establishing questions for review was an iterative process.

Drug Assessment Working Group (DAWG) followed Cochrane methodology.

DAWG improved critical appraisal skills and assessing risk of bias over time.

Why were the policies successful?

Researchers were contracted to independently evaluate the impact on drug utilization and health outcomes.

Ministry of Health personnel remained committed to outcomes based coverage despite political pressures.

What did the TI team learn?

All drugs with any effect have both benefits and harms.

Drugs are less effective than what we thought was true.

Drugs are more harmful than what we thought was true.

In many instances we were shocked that Health Canada had approved the drugs for market.

In most instances drugs are marketed without knowing that the benefits outweigh the harms in many if not all the clinical settings where they are used.

What did we discover?

A novel way of measuring the net health effect (benefits minus harms) of drugs in clinical trials.

Total serious adverse events are captured in all clinical trials and represent a measure of total mortality and serious morbidity.

Who were happy about this program?

Ministry of Health

Taxpayers

Most doctors

PATIENTS

Who was unhappy about the program?

The elephants.

Some doctors (specialists) who were friends of the elephants.

What should of happened?

Expansion of the reference based program to new classes of drugs eg. Statins.

Continued development of the international reputation of BC as a drug policy innovator.

Increased funding to the Therapeutics Intiative to increase the expertise and ensure the long-term future.

What Happened?

In October 2007 a Pharmaceutical Task Force was announced by BC Health Minister with the following objectives:

1. Identify and strengthen patient care and choice;

2. Optimize the decision-making process for what drugs are covered under PharmaCare;

3. Improve the effectiveness of the Common Drug Review process;

4. Enhance the effectiveness, transparency and future role of the Therapeutics Initiative.

Nine member Pharmaceutical task force

Chair, Don Avison, President of the University Presidents Council. Board member LifeSciences BC.

Robert Sindelar, Dean, Faculty of Pharmaceutical Sciences, UBC. Board member LifeSciencesBC.

Russell Williams, president of Canada’s Research-based Pharmaceutical Companies (Rx&D).

Susan Paish, Q.C., chief executive officer, Pharmasave Drugs (National) Ltd.

David M. Hall, chief compliance officer and senior vice president of Community Relations, AngiotechPharmaceuticals.

2 Ministry of Health members.

2 others.

PSF recommendations for TIApril 2008

#4 The Ministry of Health should establish a new Drug Review Resource Committee to carry out the drug submission review role currently performed by the Therapeutics Initiative.

#12 Subject to Recommendation #4, if the Therapeutics Initiative is maintained, action must be taken in the following areas: improve the governance, membership and accountability standards; renew and revitalize the panel of expert reviewers;

The Minister of Health accepted all the recommendations of the Pharmaceutical Task Force and set up a mechanism for their implementation.

Academic review of TIhttp://www.pharmacology.ubc.ca/

3 member external panel reviewed the TI over 2 days in October 2008.

Validated the roles and activities of the TI in drug assessment, pharmacoepidemiology and education.

Stable funding must be ensured. The present funding is inadequate.

3 new permanent University F-slots should be established.

What has happened?

The implementation of the Task Force recommendations is nearly complete; it has been costly for the government and extremely disruptive for the TI.

In November 2009, Don Avison confirmed that he was recently appointed as the Canadian representative on Pfizer Global's International Advisory Board. He did not respond to an e-mail asking what he will be paid.

Don Avison received a Leadership award from LifeSciences BC.

What has happened?

The TI’s advisory role to the BC Ministry of Health is unlikely to continue in any meaningful way.

The TI’s funding from the BC Ministry of Health is uncertain.

What is wrong with the prescription drug system?

The elephants (Brand Name drug companies) are too wealthy and powerful.

Recommended reading: “The Corporation: The pathological pursuit of profit and power”“Capitalismo Canibal: La Corporacion, La busqueda patologica de lucro y poder” by Joel Bakan.

It is not the fault of the corporations.

Governments established the system that got us here and must bring in regulations to correct it.

Ways to improve the system.Continue to educate prescribers and patients about the benefits and harms of prescription drugs.

Definition of Advertising

“The science of arresting the human intelligence long enough to get money from it.”

Stephen Leacock

First regulatory step to improve the system.

Ban all advertising, marketing, lobbying and promotion by drug companies.

Ban must include physicians, pharmacists, nurses, government officials, politicians and the public.

This would encourage companies to transfer the huge amounts of money they spend on marketing to research and development.

Second regulatory step to improve the system

Mandate that all Phase III and Phase IV clinical trials be designed, conducted, analysed and reported by independent academic researchers.

The funding for these trials would come from the companies, but they would be prevented from manipulating and biasing the results.

Questions???Thank you for your attention.

www.ti.ubc.ca