1 Gail Attara, Executive Director Case Study: To substitute or not to substitute? The GI example June 23, 2009

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Gail Attara, Executive Director

Case Study:To substitute or not to substitute?

The GI example

June 23, 2009

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• When stomach contents regularly back up into the esophagus, a chronic condition called gastroesophageal reflux disease (GERD) occurs

• Acid reflux occurs when the lower esophageal sphincter is either weak or relaxes inappropriately and allows stomach contents to backflow (reflux) into the esophagus– Stomach contents include digestive fluids

such as hydrochloric acid

Background: Acid Reflux

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More than Heartburn!

• GERD symptoms include:– heartburn

– regurgitation

– bitter or sour taste in the mouth

– persistent sore throat

– chronic coughing

– difficult or painful swallowing

– asthma

– chest pains

– persistent feeling of a lump in the throat

• 1,600 die in Canada each year from acid-related esophageal cancer

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• Heartburn afflicts 24% of Canadians daily1

• GERD has a negative impact on a person’s wellbeing and quality of life that is similar to those who suffered acute coronary events2

• Quality of life for a GERD patient is less than that for a patient with diabetes, hypertension, mild heart failure, or arthritis3

• Alarm Symptoms: vomiting, GI bleeding, choking, persistent coughing, anemia, involuntary weight loss, dysphagia, chest pain, esophageal erosion4

Impact: Acid Reflux

1. Aliment Pharmacol Ther 2008;27(3):249-56.2. Aliment Pharmacol Ther 2003;18(4):387-933. Am J Med 1998;104:252-84. Can J Gastroenterol 2005;19(1):15-35.

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• Population-based studies reveal that GERD is a common condition with a prevalence of 10 to 20% in North America.1

• In Canada, GERD is the most prevalent acid-related disorder & 13% suffer weekly2

• Patients react differently to different PPIs due to many factors – such as other drug interactions, having a slow or rapid metabolism, inappropriate dosage, etc.3

• Incidence of GERD similar across age spectrum BUT complicated GERD increases with increased age4

Impact: Acid Reflux

1. Am J Gastroenterol 2006;101:1900-20.2. Can J Gastroenterol 2005;19(1):15-35.3. Am J Pharmacogenomics 2003;3(5):303-3154. Pract Gastro 2004;28(4):62-69

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On a scale of 1-5 where 1 is never and 5 is always; top 2 responses (4 & 5)

43%

41%

38%

21%

18%

16%

13%

12%

9%

7%

Felt tired or worn out

Experienced an inability to sleep

Felt worried about my health

Avoided a meal

Experienced a lack of concentration at work

Disturbed the sleep of my partner

Felt embarrassed around others

Avoided sex or intimacy

Avoided a social engagement

Missed work

The acid related disease patient experience: Canada. Harris Interactive Research Report, AstraZeneca Canada, Association des maladies gastro-intestinales fonctionnelles, Canadian Digestive Health Foundation, Canadian Society of Intestinal Research, and the Gastrointestinal Society. September 2007.

n=1033

Experience prior to taking Rx

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2.6b

2.7b

2.7b

2.8b

2.8b

2.9b

2.9b

3.1b

3.1b

3.1b

3.2b

3.5b

1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0

Heartburn

Acidic taste

Stomach pain

Indigestion

Problems sleeping

Sore or burning throat

Stomach bloating

Chest pain

Feelings of slow digestion

Flatulence/gas

Excessive burping

Nausea/sickness

Before medication

Symptom severity before prescription medication

Mean score on scale of 1-5, where 1 is very mild and 5 is severe


n=1033

Symptom severity before Rx

80% of patients experienced at least one somewhat severe or

severe symptom prior to medication

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• Most effective medications to treat acid reflux are proton pump inhibitors (Losec®, Pantoloc®, Prevacid®, Nexium®, Pariet™, Tecta ™)

• Although in the same class, they do not work the same in each person

Treatment: Acid Reflux

=

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1.7

1.7

1.8

1.7

2.2

1.7

1.9

1.8

2.0

2.0

1.7

1.72.6b

2.7b

2.7b

2.8b

2.8b

2.9b

2.9b

3.1b

3.1b

3.1b

3.2b

3.5b

1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0

Heartburn

Acidic taste

Stomach pain

Indigestion

Problems sleeping

Sore or burning throat

Stomach bloating

Chest pain

Feelings of slow digestion

Flatulence/gas

Excessive burping

Nausea/sickness

Before medication

After medication


n=1033

Symptom severity before & after Rx

80% of patients experienced at least one somewhat severe or

severe symptom prior to medication

Only 21% of patients did post medication – a significant decline.

Symptom severity before prescription medication

Mean score on scale of 1-5, where 1 is very mild and 5 is severe

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• In 2003, BC Ministry of Health introduced a new proton pump inhibitor Therapeutic Substitution (TS) policy to manage reimbursement under PharmaCare– Proton pump inhibitors (PPIs) suppress stomach acid production

• Stated it would protect $42 million over three years

• Policy introduced with minimal advance warning and no data on potential affect on patients or possible wider effects within healthcare system

Overview

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Cost Savings?• Designed to reduce costs to drug plans by only

covering the cheapest product (different from reference-based models, as it does not allow patient to pay the difference)

• TS based on a false assumption that drugs within the same therapeutic class are medically interchangeable (incorrectly implying that their health effects do not differ significantly, even between drug molecules that are not bio-equivalent)

Therapeutic Substitution

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• Patients had to stop taking PPI that was working and switch to the cheapest PPI (no generic PPIs on the market at that time), to keep PharmaCare coverage

• Many patients reported that either the cheapest PPI did not work and/or that they were experiencing moderate to severe side effects

• Physicians could apply to PharmaCare for SA, to go back to original PPI, if strict criteria were met, including:– Patient had to first ‘fail’ on an older medication (H2RA)

– Treatment failure after an eight week trial of cheapest PPI


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• CSIR asked for linked healthcare data in 2005. Data supplied by BC Ministry of Health Services Aug 2007 comprising individual linked patient records, using unique anonymous numerical identifiers from these databases:– Physician billings (MSP)

– Hospital utilization (Hospital Separations)

– Prescription drugs (PharmaNet)

• Study published in peer-reviewed journal April 2009. – Skinner BJ, Gray JR, Attara GP. Increased health costs from

mandated Therapeutic Substitution of proton pump inhibitors in British Columbia. Alimentary Pharmacology and Therapeutics. 2009;29(8):882-891.

Study Background

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• Study concluded that there were additional net costs of $43.5 million over three years as a result of PPI therapeutic substitution– $24.65 million in additional physician services– $9.75 million for additional hospital services– $9.11 million in increased PPI utilization*

• (Government had stated it would protect $42 million over three years)

CSIR Study Conclusions

*Includes PharmaCare and non-PharmaCare utilization

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Population Cohorts

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

180,000

1 2 3 4

Year

Nu

mb

er

of

Pa

tie

nts

Non-Pariet PPIs

Pariet


2002 2003 2004 2005

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TS-Associated Increased Costs

$0

$50

$100

$150

$200

$250

$300

$350

$400

$450

$500

2003 2004 2005

Physician

Hospitals

PPI

(Individual)

n= 45,374 n= 24,676 n=17,412

Table 5. TS increased health costs: controlling for age, gender, and utilization in previous year

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$0

$1

$2

$3

$4

$5

$6

$7

$8

$9

$10

2003 2004 2005

Mill

ion

s

Physicians

Hospitals

Rx (PPIs)

TS-Associated Increased Costs

(Aggregate, Net)

Total 3-Year Increased Costs

Physicians 24,648,265

Hospitals 9,747,423

Rx (PPI) 9,113,527

$ 43,509,215

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• Not counted in study…• Personal effect on patients’ quality of life,

presenteeism, potential efficiency losses • PharmaCare costs

– extra Special Authorities = more staff to handle

Socioeconomic Implications

• Physician costs - not billable, to handle workload

• Crowding out others who needed healthcare services

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• Not counted in study…• Extra out-of-pocket costs for patients & their families:

– OTC products– travel– time spent away from work & home for visits to physicians,

hospital, pharmacy

Socioeconomic Implications

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The Province Newspaper, 2003

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Change Thought Process

• It does not make economic sense to limit access to a medication that controls a serious disease today, then to pay thousands tomorrow for the consequences of a disease run rampant

• Strive for an open formulary so patients have access to the right medication quickly, so their condition can stabilize and remain under control

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Further Resources

Documents

1 Gail Attara, Executive Director Case Study: To substitute or not to substitute? The GI example June 23, 2009