Transcript CSIR Presentation to Minister George Abbott

Case Study:
To substitute or not to substitute?
The GI example
Gail Attara, Executive Director
June 23, 2009
1
Background: Acid Reflux
• 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
• When stomach contents regularly back up into the
esophagus, a chronic condition called gastroesophageal
reflux disease (GERD) occurs
2
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
3
Impact: Acid Reflux
• 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
1.
2.
3.
4.
Aliment Pharmacol Ther 2008;27(3):249-56.
Aliment Pharmacol Ther 2003;18(4):387-93
Am J Med 1998;104:252-8
Can J Gastroenterol 2005;19(1):15-35.
4
Impact: Acid Reflux
• 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
1.
2.
3.
4.
Am J Gastroenterol 2006;101:1900-20.
Can J Gastroenterol 2005;19(1):15-35.
Am J Pharmacogenomics 2003;3(5):303-315
Pract Gastro 2004;28(4):62-69
5
Experience prior to taking Rx
On a scale of 1-5 where 1 is never and 5 is always; top 2 responses (4 & 5)
Felt tired or worn out
43%
Experienced an inability to sleep
41%
Felt worried about my health
38%
Avoided a meal
21%
Experienced a lack of concentration at work
18%
Disturbed the sleep of my partner
16%
Felt embarrassed around others
13%
Avoided sex or intimacy
Avoided a social engagement
Missed work
12%
9%
7%
n=1033
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.
6
Symptom severity before Rx
1.0
1.5
2.0
2.5
3.0
3.5
Acidic taste
3.2
Stomach pain
3.1b
Indigestion
3.1b
Problems sleeping
3.1b
Sore or burning throat
2.9
b
Stomach bloating
2.9
b
Chest pain
2.8b
Feelings of slow digestion
2.8b
Excessive burping
Nausea/sickness
4.5
5.0
3.5b
Heartburn
Flatulence/gas
4.0
b
Symptom severity before
prescription medication
Mean score on scale of 1-5, where 1
is very mild and 5 is severe
80% of patients experienced at least
one somewhat severe or severe
symptom prior to medication
2.7b
2.7
b
Before medication
2.6b
n=1033
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.
7
Treatment: Acid Reflux
• 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
=
8
Symptom severity before & after Rx
1.0
1.5
2.0
Heartburn
1.7
Acidic taste
1.7
Stomach pain
Indigestion
3.0
3.1
Stomach bloating
2.9
1.9
2.8
1.8
Feelings of slow digestion
2.0
Flatulence/gas
2.0
1.7
5.0
Symptom severity before
prescription medication
Mean score on scale of 1-5, where 1
is very mild and 5 is severe
2.9b
1.7
Nausea/sickness
4.5
3.1b
2.2
1.7
b
3.1b
1.7
Excessive burping
4.0
3.2b
1.8
Chest pain
3.5
3.5b
Problems sleeping
Sore or burning throat
2.5
b
2.8b
2.7b
2.6
b
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.
2.7b
Before medication
b
After medication
n=1033
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.
9
Overview
• 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
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Therapeutic Substitution
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)
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Therapeutic Substitution
• 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
12
Study Background
• 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.
13
CSIR Study Conclusions
• 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)
*Includes PharmaCare and non-PharmaCare utilization
14
Population Cohorts
180,000
160,000
140,000
Number of Patients
120,000
100,000
Non-Pariet PPIs
Pariet
Therapeutic Substitution
80,000
60,000
40,000
20,000
0
1
2002
2
2003
3
2004
4
2005
Year
15
TS-Associated Increased Costs
$500
(Individual)
$450
$400
$350
$300
Physician
Hospitals
PPI
$250
$200
$150
$100
Table 5. TS increased health costs: controlling
for age, gender, and utilization in previous year
$50
$0
2003
n= 45,374
2004
n= 24,676
2005
n=17,412
16
Millions
TS-Associated Increased Costs
$10
(Aggregate, Net)
$9
$8
$7
$6
Physicians
$5
Hospitals
Rx (PPIs)
$4
$3
Total 3-Year Increased Costs
$2
Physicians
$1
24,648,265
Hospitals
9,747,423
Rx (PPI)
9,113,527
$
$0
2003
2004
43,509,215
2005
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Socioeconomic Implications
• Not counted in study…
• Personal effect on patients’ quality of life,
presenteeism, potential efficiency losses
• PharmaCare costs
– extra Special Authorities = more staff to handle
• Physician costs - not
billable, to handle workload
• Crowding out others who
needed healthcare services
18
Socioeconomic Implications
• 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
19
The Province Newspaper, 2003
20
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
21
Further Resources
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