Download Proposal to study the impact of meloxicam`s expenditure in drug

The impact of meloxicam in drug
plans with restricted access to
celecoxib and rofecoxib
(July 28, 2003)
Prepared for:
Sophie Rochon
Pfizer Canada Inc.
SOLUTIONS in Health Inc.
252 Pelissier Street
Windsor, Ontario N9A 4K2
Tel (519) 252-9555 Fax (519) 252-9585
www.solutionsinhealth.com
Background
The action of nonsteroidal anti-inflammatory drugs (NSAIDs) is mediated through the inhibition of
the enzyme cyclooxygenase (COX). The inhibition of COX has a cascading effect. The release of
prostaglandins (PGs) and other mediators of physiologic homeostasis (including inflammation and
platelet aggregation) is inhibited.
Two COX isozymes have been identified. COX-1 is expressed in high concentrations in various
tissues including the gastrointestinal (GI) tract, kidneys, brain and lungs. Since COX-1 provides
cytoprotection in the GI tract, its inhibition may lead to GI disturbances ranging from dyspepsia to
bleeding. The inhibition of COX-1 also causes the inhibition of PGs which can, in turn, inhibit
platelet aggregation. The COX-2 isozyme is found in greater concentrations in inflamed tissue.
Selectively inhibiting this isozyme results in effective reduction of inflammation without
compromising GI integrity. Traditional NSAIDs such as naproxen are generally non-selective and
inhibit both COX-1 and COX-2.
In recent years, the advent of COX-2 specific inhibitors (coxibs) has revolutionized NSAIDs.
Coxibs include Celebrex® (celecoxib) and Vioxx® (rofecoxib). Their mark of distinction came
mainly from an improved GI safety profile due to COX-2 selective inhibition. When compared to
traditional NSAIDs, coxibs provide similar efficacy and safer GI side effect profiles. Their lack of
affinity for COX-1 not only minimizes impact on the GI tract but may prevent effects on platelet
aggregation.
The introduction of Mobicox® (meloxicam) to the Canadian market shifted this dynamic yet again.
Meloxicam inhibits COX-2. However, as the dose of meloxicam increases so does its inhibition of
COX-1. When compared to diclofenac, fewer GI side effects were reported with meloxicam
however more patients discontinued the drug due to a lack of efficacy1. When compared with
celecoxib however, celecoxib demonstrated a reduced risk of GI events.2
The introduction of new molecules such as the coxibs or meloxicam to a well established
therapeutic class, NSAIDs, resulted in changes to third payer insurer and government formularies.
The coxibs were given restricted access and meloxicam was listed as a general, unrestricted
benefit on both the Ontario Drug Benefit Program (ODBP) and the private payer plan reviewed
here. The effect of these drugs and their listing status is examined.
Objectives
To analyze NSAID utilization data from the ODBP and a private payer of a major employer for the
years 2000-2002. Changes measured include number of prescriptions, market share, cost and
contribution of each molecule (or group) to overall NSAID cost.
To investigate trends that may have resulted from the unrestricted listing of meloxicam within the
NSAID class.
To compare the NSAID utilization patterns between ODBP and a private payer.
To forecast NSAID utilization based on any identified trends.
2
Results
NSAID utilization and expenditure in ODBP Table 1
Claims
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
Total
plus Mobicox®
2002
786,861
871,663
458,496
1,330,159
2,117,020
2001
2000
818,359
955,873
235,423
1,191,296
2,009,655
467,313
1,148,700
0
1,148,700
1,616,013
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
2002
37.17%
41.17%
21.66%
62.83%
2001
40.72%
47.56%
11.71%
59.28%
2000
28.92%
71.08%
0.00%
71.08%
Percent change in market share
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
Percentage of total claims
plus Mobicox®
(decrease = -)
plus Mobicox®
2001-2002
-8.72%
-13.44%
2000-2001
40.80%
-33.09%
Coxibs
Traditional NSAIDs
Cost
84.97%
5.99%
-16.60%
Mobicox®
Traditional NSAIDs
Total
plus Mobicox®
2002
$52,837,243
$23,595,958
$17,660,801
$41,256,759
$94,094,002
2001
$56,234,188
$27,425,444
$8,811,226
$36,236,670
$92,470,858
2000
$31,293,426
$33,344,938
$0
$33,344,938
$64,638,364
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
2002
56.15%
25.08%
18.77%
43.85%
2001
60.81%
29.66%
9.53%
39.19%
2000
48.41%
51.59%
0.00%
51.59%
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
Percentage of total cost
plus Mobicox®
Percent change in cost
(decrease = -)
Total
plus Mobicox®
2001-2002
-6.04%
-13.96%
2000-2001
79.70%
-17.75%
Coxibs
Traditional NSAIDs
Mobicox®
2002
$67.15
$27.07
$38.52
$31.02
$44.45
2001
$68.72
$28.69
$37.43
$30.42
$46.01
2000
$66.96
$29.03
$29.03
$40.00
Cost/claim
100.44%
13.85%
1.76%
8.67%
43.06%
Traditional NSAIDs
Total
plus Mobicox®
Effect of Mobicox on traditional NSAID expenditure in ODBP
Cost of Mobicox as a % of total cost of traditional NSAIDs Table 2
2002
2001
2000
42.8%
24.3%
0%
3
NSAID utilization and expenditure in Private Payer plan Table 3
Claims
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
Total
plus Mobicox®
2002
9,270
21,428
6,956
28,384
37,654
2001
11,354
25,064
4,199
29,263
40,617
2000
11,056
27,546
0
27,546
38,602
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
Percentage of total claims
plus Mobicox®
2002
24.62%
56.91%
18.47%
75.38%
2001
27.95%
61.71%
10.34%
72.05%
2000
28.64%
71.36%
0.00%
71.36%
Percent change in market share
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
2001-2002
-11.91%
-7.78%
78.63%
2000-2001
-2.41%
-13.52%
Coxibs
Traditional NSAIDs
Mobicox®
2002
$678,986
$700,424
$265,880
$966,304
$1,645,290
2001
$884,237
$782,996
$154,566
$937,562
$1,821,799
2000
$896,678
$891,738
$0
$891,738
$1,788,417
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
2002
41.27%
42.57%
16.16%
58.73%
2001
48.54%
42.98%
8.48%
51.46%
2000
50.14%
49.86%
0.00%
49.86%
Coxibs
Traditional NSAIDs
Mobicox®
Traditional NSAIDs
(decrease = -)
Cost
plus Mobicox®
4.62%
0.97%
Traditional NSAIDs
Total
plus Mobicox®
Percentage of total cost
plus Mobicox®
Percent change in cost
(decrease = -)
2001-2002
-23.21%
-10.55%
2000-2001
-1.39%
-12.19%
Coxibs
Traditional NSAIDs
Cost/claim
Total
plus Mobicox®
72.02%
Mobicox®
3.07%
-9.69%
5.14%
1.87%
Traditional NSAIDs
Total
plus Mobicox®
2002
$73.25
$32.69
$38.22
$34.04
$43.69
2001
$77.88
$31.24
$36.81
$32.04
$44.85
2000
$81.10
$32.37
$0.00
$32.37
$46.33
Effect of Mobicox on traditional NSAID expenditure in Private Payer plan
Cost of Mobicox as a % of total cost of traditional NSAIDs Table 4
2002
2001
2000
27.5%
16.5%
0%
4
Summary of overall trends from 2000 to 2002 Table 5
(increase = +, decrease = -)
# of claims
# of traditional claims
# of traditional claims plus Mobicox
# of coxib claims
% claims traditional
% claims traditional plus Mobicox
% claims coxib
total cost
traditional cost
traditional plus Mobicox cost
coxib cost
% cost traditional
% cost traditional plus Mobicox
% cost coxib
cost/claim total
cost/claim traditional
cost/claim traditional plus Mobicox
cost/claim coxib
ODBP
Private Payer
+ 31.00%
- 2.46%
- 24.12%
- 22.21%
+ 15.80%
+ 3.04%
+ 68.38%
- 16.15%
- 42.08%
- 20.25%
- 11.61%
+ 5.63%
+ 28.53%
- 14.04%
+ 45.57%
- 8.00%
- 29.24%
- 21.45%
+ 23.73%
+ 8.36%
+ 68.84%
- 24.28%
- 51.39%
- 14.62%
- 15.00%
+ 17.79%
+ 15.99%
- 17.69%
+ 11.13%
- 5.70%
- 6.75%
+ 0.99%
+ 6.85%
+ 5.16%
+ 0.29
- 9.68%
5
Discussion
Due to their superior safety, proven efficacy and tolerability, coxibs have greatly influenced the
overall use of NSAIDs over the last few years. Coxibs have provided an effective therapy for
patients, including those with previous intolerance to NSAIDs and those on concurrent therapies
affecting platelets.
As with the coxibs, the introduction of meloxicam to the Canadian market has had a significant
impact on NSAID utilization. Meloxicam was introduced to physicians, governments and private
payers as an alternative to Celebrex® and Vioxx® offering similar efficacy and safety at a better
price. The ODBP formulary accepted meloxicam without restrictions. Following suit, many private
payers mirrored their actions making meloxicam fully accessible. While physicians still have
restricted access to either Celebrex® or Vioxx®, their prescription requires significant
administrative work to satisfy the requirements of the ODBP and the private payer.
It is important to note that the process of filling out the Limited Use Form (LUF) for the ODBP is
somewhat simpler than that of the private payer’s Special Authorization (SA) form. The LUFs are
supplied to physicians by the Ministry of Health and Long Term Care of Ontario, and resemble a
prescription pad with a carbon copy. A physician desiring to prescribe a LU product such as
celecoxib or rofecoxib needs simply to ensure that the following information is documented on this
form:
•
•
•
•
•
•
Patient’s name
Name of the LU product
Date the document is initiated
The appropriate LU code
The physician’s signature
The physician’s College of Physician and Surgeons of Ontario (CPSO) number.
The SA forms, in comparison, are not supplied to physicians or pharmacies. Rather, they must be
obtained from the insurance provider directly and presented to the physician for completion.
Greater detail is often required for third party insurers including patient and physician information,
past therapeutic interventions, reasons for treatment failure and relevant diagnostic tests. In some
circumstances, a Specialist alone can fill out the intervention form as a General Practitioner is not
deemed appropriate. Unrestricted agents such as traditional NSAIDs and meloxicam become
increasingly more attractive as therapeutic options that do not entail a delay in initiation of therapy.
After a few years and many therapeutic successes with coxibs, physicians were introduced to
meloxicam. Meloxicam is more expensive (cost/claim) than traditional NSAIDs as a group but has
not consistently proven to have a better safety profile. Data regarding its safety and efficacy as
compared to the coxibs and older traditional NSAIDs is inconsistent. Since a prescription for
meloxicam does not require any extra documentation for coverage, physicians have been
prescribing meloxicam at a disproportionate rate.
The utilization of coxibs and older traditional agents has decreased from 2001 to 2002 while that of
meloxicam has surged for both the ODBP and the private payer. The ODBP experienced an
increase of 94.75% meloxicam claims from 2001 to 2002. While all individual groups (coxibs and
older traditional NSAIDs) were declining in growth and cost, the total growth and cost of traditional
NSAIDs plus meloxicam grew. Meloxicam is clearly the driving force behind the growth and cost
increases seen in the traditional NSAID share of the market. This is illustrated in Table 2 and Table
4.
There is no doubt that coxibs have had a tremendous impact on the cost of NSAIDs primarily
because they demonstrate a safer GI side effect profile. The initial surge in claims for coxibs is
likely due to their arrival on the Canadian market. Data shows that the use of both coxibs has
steadied (2001-2002), as seen in the ODBP, and actually decreased over the last three years in
6
the private payer. Had meloxicam been added as a restricted product to or remained unlisted on
both the government and third party insurer formularies, the overall trends would have certainly
been different than what occurred over the last three years.
It is difficult to estimate what impact restricted access to or no listing of Mobicox would have had
on the total cost of NSAIDs for the ODBP and the private payer. Certain postulates can be
considered:
•
•
•
•
The increase in meloxicam claims would have been much less in part due to the required
documentation.
Many beneficiaries (patients) would not have qualified for coverage for meloxicam due to
criteria for use.
The utilization of the older traditional NSAIDs would not have decreased at the same rate.
It is likely physicians would have prescribed these unrestricted agents more frequently.
Since their average cost per claim is much less than the coxibs or meloxicam, the
reduction in the overall cost of NSAIDs would have been greater.
Result:
o fewer number of claims and corresponding cost for celecoxib and rofecoxib
o number of Mobicox claims would have been significantly lower
o number of older NSAID claims would have been much higher
o average cost per claim reduced
o total utilization would have remained relatively unchanged but with a total
expenditure certainly below what was actually reported.
Under current listing status, it is expected that traditional NSAID claims will continue to decrease
and that meloxicam will represent an even greater percentage of all NSAID claims. Future trends
can be extrapolated only if certain factors affecting utilization patterns are considered.
To forecast NSAID utilization over the next three years, some assumptions need to be taken into
account.
•
•
•
•
•
The status of all products is to remain the same.
No new agent is to be introduced to the market or to the formulary that would cause a
dramatic change in prescribing habits.
There is to be no significant change in price of the agents in the NSAID class (cost/claim
for 2002 used in forecasting).
No current agent becomes generic and available at a lower price.
The processes of Limited Use and Special Authorization are to remain in place and
unchanged.
There is one factor that will likely change patterns of utilization for 2003. Earlier this year, the
ODBP instituted a trial program for its beneficiaries. A prescription for a medication that the
beneficiary had never previously received would be limited to a 30 days supply. Subsequently, the
standard 100 days supply is authorized. This new policy will certainly cause the average cost per
claim to decrease (the cost of a 30 day supply of an agent is clearly less than that of a standard
100 day supply of a chronic medication). It is difficult however to estimate the impact this change
will have on the total number of claims and associated expenditure. Though the private payer has
yet to introduce a similar trial prescription process, the possibility exists it will observe the impact
and implement a similar process to its drug plan if savings are realized for ODBP.
Extrapolation of current trends can be considered to help determine the direction of utilization of
NSAIDs. The following can be considered:
•
•
Meloxicam will grow to represent a larger percentage of all NSAID claims.
Utilization of older traditional NSAIDs will continue to decrease.
7
•
•
The number of claims of combined celecoxib and rofecoxib will continue to decrease as a
percentage of total NSAIDs, as seen in 2001 to 2002.
The number of beneficiaries will likely remain constant, as well as the total number of
NSAID claims (2002 total number of claims used in forecasting).
The following predictions are based on the understanding of past and current trends. This also
addresses only direct NSAID costs and not the costs of disease management such as
hospitalization, absenteeism, or adjunctive medications.
Estimate of future utilization & cost of NSAIDs in ODBP Table 6
Claims
Coxibs
Traditional NSAIDs
Mobicox Traditional NSAIDs
Total
plus Mobicox
e2005
659,869
490,509
966,622
1,457,131
2,117,000
e2004
681,039
617,529
818,432
1,435,961
2,117,000
e2003
723,379
744,549
649072
1,393,621
2,117,000
Coxibs
Traditional NSAIDs
Mobicox
Traditional NSAIDs
% of Total claims
plus Mobicox
e2005
31.17%
23.17%
45.66%
68.83%
e2004
32.17%
29.17%
38.66%
67.83%
e2003
34.17%
35.17%
30.66%
65.83%
Coxibs
Traditional NSAIDs
Mobicox
Traditional NSAIDs
Cost
Total
plus Mobicox
e2005
$44,310,203
$13,278,079
$37,234,279
$50,512,358
$94,822,561
e2004
$45,731,769
$16,716,510
$31,526,001
$48,242,511
$93,974,280
e2003
$48,574,900
$20,154,941
$25,002,253
$45,157,194
$93,732,094
Estimate of future utilization & cost of NSAIDs in Private Payer plan Table 7
Claims
Coxibs
Traditional NSAIDs
Mobicox Traditional NSAIDs
Total
plus Mobicox
e2005
8,216
15,925
13,859
29,784
38,000
e2004
8,216
17,825
11,959
29,784
38,000
e2003
8,596
19,725
9679
29,404
38,000
Coxibs
Traditional NSAIDs
Mobicox
Traditional NSAIDs
e2005
21.62%
41.91%
36.47%
78.38%
e2004
21.62%
46.91%
31.47%
78.38%
e2003
22.62%
51.91%
25.47%
77.38%
Coxibs
Traditional NSAIDs
Mobicox
Traditional NSAIDs
e2005
$601,822
$520,588
$529,691
$1,050,279
$1,652,101
e2004
$601,822
$582,699
$457,073
$1,039,772
$1,641,594
e2003
$629,657
$644,810
$369,931
$1,014,741
$1,644,398
% of Total claims
plus Mobicox
Cost
Total
plus Mobicox
8
The addition of Mobicox® to the ODBP formulary may have been a factor in the deceleration or
stabilization of growth of the coxibs. Even with the reduction in growth of coxibs, with highest
cost/claim, overall NSAID costs may continue to increase with Mobicox® being selected over less
expensive, traditional NSAIDs.
Interestingly, if meloxicam had been placed in the restricted access category in both formularies,
trends may have reflected higher utilization of older traditional NSAIDs with a corresponding drop in
total realized cost.
Conclusion
With their COX-2 affinity, celecoxib and rofecoxib have proven to be safer, equally effective and
more tolerable alternatives to traditional NSAIDs. The coxibs have become the new standard
where anti-inflammatory therapy is necessary. Coxibs offer an alternative for patients intolerable of
the GI effects of traditional NSAIDs as well as patients with concomitant platelet therapy.
Conversely, while offering similar efficacy, traditional NSAIDs (including diclofenac, naproxen, and
ibuprofen) and meloxicam inhibit the COX-1 and COX-2 isozymes at therapeutic doses, thereby
compromising the integrity of the GI tract.
It can be postulated that decision makers for the ODBP and private payer formularies expected the
unrestricted addition of meloxicam to drive costs down at the expense of the coxibs. The growth of
meloxicam has been at the expense of older traditional NSAIDs. Individually, the costs of older
traditional NSAIDs and coxibs (2001-2002) are decreasing.
It can also be postulated that if meloxicam had been given restricted access, physicians would
have continued to prescribe older traditional NSAIDs and these plans would have realized lower
costs than actual.
All NSAIDs, old and new, have a place in therapy. Selection should be based on appropriateness
and not on listing status.
9
REFERENCES
1. Hawkey C, et al. Gastrointestinal Tolerability of Meloxicam Compared to Diclofenac in
Osteoarthritis Patients. Br J Rheumatol 1998;37:937-945.
2. Rheumatology 2003;42:1-10
doi:10.1093/rheumatology/keg376, available online at www.rheumatology.oupjournals.org
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