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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 10 About SOLUTIONS in Health Inc. Our company is a team of licensed bilingual pharmacists with many years of experience in both the community and the hospital setting. SOLUTIONS in Health Inc. designs, organizes and implements a wide range of programs for patients, pharmacists, physicians, employers, pharmaceutical companies, and health benefit providers. Our services include: Prescription drug and medical device compliance programs Follow-up programs with patients to ensure proper compliance, resolve technical issues, dialogue on disease state, manage potential side effects, reduce potential therapeutic failure, reduce medication waste, and of course, offer encouragements. Coordinating employer/employee wellness initiatives On-site wellness programs for employers wishing to improve their employees’ health, thus improving productivity and decreasing absenteeism. Examples of on-site initiatives include smoking cessation, asthma, allergies, cardiovascular health, and diabetes. Health plan review for employers Offer strategies to improve the utilization of medications, to reduce medication wasting, to improve compliance and to control the escalating drug costs. Toll-free information line Provide access to medical and drug information to professionals, to patients, and to pharmaceutical companies through our 1-800 phone line. Health information seminars Public forums on varied health topics, such as diabetes, hormone replacement therapy, incontinence and mental health. 11