Net societal economic impact in Canada from withholding regulatory approval for generic OxyContin®

Full Article

Net societal economic impact in Canada from withholding regulatory approval for generic OxyContin®

Author(s)
Brett J. Skinner, Ph.D. Canadian Health Policy Institute (CHPI)

Publication Date
September 12, 2012

Citation
Skinner BJ (2012). Net societal economic impact in Canada from withholding regulatory approval for generic OxyContin®. Canadian Health Policy, September 12, 2012. Toronto: Canadian Health Policy Institute.

Copyright
All rights reserved. Unauthorized reproduction of this article in whole or in part is strictly prohibited.

SUMMARY
Introduction

Available evidence suggests non-medical abuse of OxyContin is significant. The Canadian patent for OxyContin is set to expire in November 2012. The manufacturer stopped selling the drug before patent expiry, replacing it with a recently approved abuse-deterrent formulation called OxyNEO. Other drug companies are seeking Health Canada’s approval to sell generic versions of OxyContin once the patent expires. Ontario’s Minister of Health wrote to the Federal Health Minister requesting that generic OxyContin not be approved for sale, stating “Ontario believes that the costs to society of the reintroduction of the more-easily abused version far outweigh the financial benefits that would accrue from the reduced price”.

 

Objective

To estimate the potential net societal economic impact of permanently replacing OxyContin with OxyNEO, an innovative tamper-resistant formulation that could deter abuse of the product, while preserving normal availability for legitimate medical-use by patients.

 

Methods

Expected savings from generic OxyContin were estimated by applying the observed post-generic discounts of two drugs recently affected by patent expiry, to the sales and volumes data for OxyContin. Data from published studies on the prevalence and societal costs of prescription opioid abuse that could be attributed to OxyContin were proportionally extrapolated to Canada to estimate the potential societal economic costs of OxyContin abuse in Canada.

 

Results

In 2011, potential total annual societal economic costs from OxyContin abuse were estimated at $504m in Canada and $318m in Ontario. Total annual savings expected from generic discounts on OxyContin across Canada range between $89m and $152m including all payers and between $45m and $77m for public payers only. In Ontario, corresponding generic savings range between $52m and $106m for all payers and between $29m and $59m for public payers.

 

Conclusion

Permanent replacement of OxyContin with OxyNEO could potentially reduce the societal economic costs of prescription opioid abuse, without causing the loss of health benefits accruing to legitimate users of the drug. Potential savings from the abuse-deterrent impact of OxyNEO substitution exceed the expected savings from generic supply of OxyContin by a net difference of between 232% and 467% for Canada and between 199% and 516% for Ontario. OxyNEO substitution need reduce abuse by as little 18% to 30% for the trade-off to be economically neutral.



INTRODUCTION

 

It is well documented that abuse of prescription opioid pain relievers is a significant and economically costly social problem in America.[1] There is growing evidence that Canada is also experiencing problems with abuse of prescription opioid drugs.[2] OxyContin® is a controlled-release version of the opioid drug oxycodone that has attracted a significant amount of media attention in regard to the problem of prescription drug abuse. OxyContin contains higher dosage strengths of the active opioid ingredient oxycodone compared to the strengths available in other competing products. When taken as prescribed, the controlled-release properties of the drug allow doses to be administered safely to users over longer periods of time, providing extended pain relief. These unique properties have made OxyContin a popular choice for pain management by prescribers. However, abusers have learned to modify the product by chewing, crushing tablets for inhaling or dissolving tablets in fluid for injecting, which defeats the time-release property that moderates the dosage and causes higher doses of the active ingredient to be released immediately. This has resulted in OxyContin becoming a popular drug among abusers, and the drug has been increasingly diverted from the legitimate prescription supply to the street as a result.

The Canadian patent for OxyContin is set to expire on November 25, 2012. The manufacturer of OxyContin has acted early (as of February 2012) to voluntarily withdraw the drug from the market, replacing OxyContin with an innovative patented formulation called OxyNEO®, which is designed to be resistant to crushing and dissolving and which was recently approved for sale by Health Canada. Despite the availability of a new tamper-resistant version of OxyContin (i.e. OxyNEO), Health Canada is set to approve generic versions of the formerly abuse-prone version of OxyContin which was withdrawn from the market by the manufacturer.

Ontario’s Minister of Health Deb Matthews wrote to Federal Health Minister Leona Aglukkaq in a letter dated June 6, 2012 to “request that generic oxycodone controlled-release tablets not be approved for sale in Canada”.[3]

In a news release dated July 11, 2012 the Ontario Association of Chiefs of Police (OACP) publicly endorsed the letter sent by Minister Matthews.[4] According to the media announcement issued by the OACP, “Ontario’s police leaders are backing the Government of Ontario’s call for the federal government to put public safety first by blocking the introduction of cheaper generic versions of the controlled-release painkiller oxycodone into Canada once Purdue Pharmaceuticals’ OxyContin patent expires on November 25… The OACP supports efforts by our provincial government to tighten rules on access to painkillers and by the manufacturer to counter tampering with the drug. We need the federal government to help us protect public safety by stopping the introduction of generic versions of OxyContin into Canada.”

The social and economic rationale offered by Minister Matthews for her request was that, “given the potential for widespread abuse and the susceptibility to diversion and trafficking of this product, we believe that approving the generic oxycodone CR tablets for sale in Canada would further exacerbate the incidences of addiction and death in Canada and contribute to a growing public health crisis.” The Minister concluded that, “Ontario believes that the costs to society of the reintroduction of the more-easily abused version far outweigh the financial benefits that would accrue from the reduced price”.

In March 2012, Ontario’s Ministry of Health also declared that OxyNEO would only be reimbursed under the provincial public drug plan on a restricted access basis requiring special case-by-case approval of the Ministry.

OBJECTIVE

 

The purpose of this study is to estimate the potential net societal economic impact of permanently replacing OxyContin with OxyNEO, an innovative tamper-resistant formulation that could deter abuse of the product, while preserving normal availability for legitimate medical-use by patients.

METHOD

Literature Review

A systematic literature review was conducted to identify published research on: the prevalence of OxyContin (oxycodone) abuse in Canada and the USA; the societal economic costs of abuse of OxyContin (oxycodone) in Canada and the USA; clinical or socio-economic evaluations of abuse-deterrent formulations of OxyContin (oxycodone) on patterns of use by abusers; and the effect of price on patterns of drug abuse.

Published English-language articles were identified by keyword search using the PubMed database. The bibliographies of identified articles were also searched manually for relevant studies. Keyword searches included the following terms: “OxyContin abuse United States”, “OxyContin abuse Canada”, “prescription opioid abuse Canada”, “prescription opioid abuse United States”, “economic cost OxyContin abuse”, “economic cost oxycodone abuse”, “economic cost prescription opioid abuse”, “prescription opioid abuse deterrent formulation”, “prescription opioid abuse resistant formulation” and “price elasticity drug abuse”. The search returned a total of 1,021 titles. After scanning abstracts and eliminating duplicates from separate keyword searches, 37 titles were retained as being relevant and useful to this study.

The literature search identified some studies that examined various aspects of OxyContin, oxycodone and prescription opioid abuse in Canada, however the literature search did not identify any studies estimating Canadian societal economic costs attributable specifically to OxyContin, oxycodone, prescription opioids or prescription drug abuse. There were also no studies that quantified or estimated the overall prevalence of OxyContin or oxycodone abuse in Canada.

The one Canadian study cited by Ontario’s Minister of Health in her letter to the federal Health Minister, examined the relationship between OxyContin abuse and mortality statistics in Ontario. The study examined trends in the prescribing of opioid analgesics from 1991 to 2007 and reviewed all deaths related to opioid use between 1991 and 2004. Researchers used time-series analysis to determine whether the addition of controlled-release oxycodone (OxyContin) to the provincial drug formulary in January 2000 was associated with an increase in opioid-related mortality. The study found that “from 1991 to 2007, annual prescriptions for opioids increased from 458 to 591 per 1000 individuals. Opioid-related deaths doubled, from 13.7 per million in 1991 to 27.2 per million in 2004. Prescriptions of oxycodone increased by 850% between 1991 and 2007. The addition of long-acting oxycodone to the drug formulary was associated with a 5-fold increase in oxycodone-related mortality (p < 0.01) and a 41% increase in overall opioid-related mortality (p = 0.02).”[5] However, the authors did not calculate associated economic costs.

In order to estimate total potential societal economic costs from OxyContin abuse in Canada it was necessary to extrapolate findings from American studies that have produced societal estimates for the United States. The literature review identified only three studies that had estimated total societal economic costs of OxyContin, oxycodone or prescription opioid abuse.[6]

Conceptual model

Based on methods found in the literature and accounting for additional factors, a model for calculating the net impact of a hypothetical policy decision to permanently withdraw OxyContin and replace it with OxyNEO while preserving normal access for legitimate users could conceptually include the following avoidable societal costs:

  • the cost of treating OxyContin-related drug abuse
  • the cost of treating medical complications related to OxyContin abuse
  • the cost of administering criminal justice associated with OxyContin abuse
  • the cost of lost productivity attributable to OxyContin abuse
  • expected increases in illicit demand for OxyContin in response to price reductions from a policy allowing generic supply
  • foregone health benefits of OxyNEO/OxyContin (net of available substitutes) from restricted reimbursement policies

Mitigating factors include:

  • the effectiveness of OxyNEO to reduce prescription drug abuse

Societal economic savings expected from generic supply and provincial restricted reimbursement policies could conceptually include:

  • expected price reductions
  • decreased abuse rates resulting from restricted reimbursement

Data

Data were abstracted (Table 3, Table 4) from the two most recently published estimates of the societal economic costs of OxyContin abuse in the USA.[7] The data were extrapolated to Canada proportionally based on the relative size of the Canadian and American markets for OxyContin in 2011 (Table 5). Data on Canadian market sales and volumes for OxyContin were sourced from IMS Brogan Inc. USA market sales and volumes data for OxyContin were sourced from IMS Health Inc.

The expected total annual direct savings from price reductions associated with generic supply of OxyContin were estimated by applying the observed discounts for post-generic prices of two drugs that recently were affected by patent expiry. In 2010, Ontario made changes to its public reimbursement policy reducing the price paid by the province for generics. Reductions were also adopted in other provinces at various rates. These changes made it important to gather price data from drugs recently affected by patent expiry. The two drugs used for comparison were Lipitor (atorvastatin), which went generic in May 2010 and Actonel (risedronate), which went generic in February 2010 (Table 2).

Data on Canadian market sales and volumes for OxyContin and for Lipitor and Actonel were sourced from IMS Brogan Inc. Upper and lower range estimates were calculated using the different post-generic discount experiences of the two comparator drugs. Data were available to calculate the pre-generic prices of both drugs for one full year before patent expiry (2009) and post-generic prices one full-year following patent expiry (2011). Discounts were calculated by stating post-generic prices as a percentage of the pre-generic price for each drug, and applying the percentage to the sales and volumes data for OxyContin in 2011 (Table 1).

For all of the drugs included in this analysis annual total sales and volumes data covered the entire Canadian market for hospital and drug store sales at the final retail price level, and allowed separate analyses by extended units (e.g. tablets) dispensed, by dosage units (e.g. milligrams) dispensed, by public or private payer, and by jurisdiction (national and provincial). Prices were calculated at the dosage unit level to ensure accurate comparability across varying prescription sizes and dosage strengths. Prices were also averaged across all suppliers of the drug.

RESULTS

 

Estimated annual direct savings on post-generic sales of OxyContin in Canada

Total annual pre-generic sales for OxyContin in 2011 were approximately $234 million across Canada, of which $113 million was accounted for by public payers (Table 1). In Ontario, total annual pre-generic sales of OxyContin in 2011 amounted to approximately $148 million, of which $78 million was paid for publicly.

The analysis (Table 2) shows that the average 2011 post-generic price (per dosage unit dispensed) paid for Lipitor across the entire Canadian market, including both public and private payers was 35% of the 2009 pre-generic price. The corresponding figure was 28% for the Ontario market. The average post-generic price paid for Lipitor by public payers only was 32% of the pre-generic price across Canada and 24% in Ontario. By comparison the post-generic price for Actonel, including public and private payers was 62% of the pre-generic price across Canada and 65% in Ontario. The post-generic price for Actonel for public payers only was 60% of the pre-generic price across Canada and 63% in Ontario.

Applying the post-generic price experiences of two drugs recently affected by patent expiry to the pre-generic 2011 sales and volumes data for OxyContin (Table 1), the expected post-generic total annual cost for OxyContin across the Canadian market is expected to range between $82 million and $145 million including all (public + private) payers, and between $36 million and $68 million including public payers only. In Ontario, the post-generic total annual cost for OxyContin is expected to range between $41 million and $96 million including all payers, and between $19 million and $49 million including public payers only.

By subtracting the post-generic sales estimates for OxyContin from the actual pre-generic 2011 sales data for OxyContin an estimate was produced (Table 1) for the maximum expected net post-generic savings for sales of OxyContin.  The estimate of savings across Canada ranges between $89 million and $152 million including all payers and between $45 million and $77 million for public payers only. In Ontario, the corresponding maximum savings range between $52 million and $106 million for all payers and between $29 million and $59 million for public payers only.

 

Estimated annual potential societal economic cost of OxyContin abuse in Canada

Using the most recent American estimates stated in 2011 Canadian dollars, the total societal cost attributable to OxyContin abuse in the USA in 2011 amounted to approximately $8.0 billion (Table 5). Adjusted for currency equivalence, the value of the Canadian market for OxyContin was approximately 8.0% of the American market in 2011. Applying this percentage to the American estimates for the cost of OxyContin abuse in 2011 produces a proportional estimate of the potential societal economic cost of OxyContin abuse in Canada amounting to $638 million, assuming that OxyContin abuse in Canada reaches American proportions.

One American study separately reported estimates of total, rehabilitation, health, criminal justice and productivity costs attributable to prescription opioid, oxycodone and OxyContin abuse. These categorical percentages were applied to the most recent study of the total cost of prescription opioid abuse in the United States to get updated estimates of the categorical costs.

Extrapolating American cost estimates to Canada requires an adjustment for cross-national differences in health costs. As shown in Table 5, per capita total health spending in Canada in 2011 was 66.4% of per capita total health spending in the USA in the same year, adjusted for currency equivalency. Proportionally reducing the health component of costs attributed to OxyContin abuse in Canada reduces the total potential societal economic cost of OxyContin abuse in Canada in 2011 to $504 million. Applying Ontario’s portion of the 2011 Canadian market for OxyContin (63.1%, calculated from Table 1 data) produces an estimate of the total potential societal economic cost of OxyContin abuse in Ontario in 2011 amounting to approximately $318 million.

Potential of OxyNEO to deter abuse

The potential of OxyNEO to avoid the societal costs of abuse depends on the new drug’s effectiveness at deterring abuse. Two recent studies of the effectiveness of abuse-deterrent formulations for prescription opioid drugs suggest a promising potential for these innovative technologies to reduce abuse.

In one experimental study abusers were tested on their ability to tamper with an abuse-deterrent formulation of oxymorphone and interviewed about the results. According to the study, “Most participants were not willing to snort (92%) or inject (84%) the tampered products.”[8]

A second study surveyed a sample of opioid abusers in the United States, to collect survey respondents’ assessments of OxyNEO’s abuse-deterrent effectiveness. The study found that, “…the selection of OxyContin as a primary drug of abuse decreased from 35.6% of respondents before the release of the abuse-deterrent formulation to just 12.8% 21 months later… Of all opioids used to “get high in the past 30 days at least once”, OxyContin fell from 47.4% of respondents to 30.0% (P<0.001)… Interviews with patients who abused both formulations of OxyContin indicated a unanimous preference for the older version… 66% indicated a switch to another opioid…”[9]

 

In an earlier study, researchers conducted a hypothetical analysis of the expected budgetary savings to private insurers from market adoption of abuse-deterrent formulations of prescription opioid drugs (ADO). Stated in 2006 US dollars, the study estimated, “Potential cost savings to third-party payers from introducing an ADO for the US (assuming a privately insured cost structure) could range from approximately $US0.6 billion to $US1.6 billion per year”.[10]

Relative prevalence of OxyContin abuse in Canada and the United States

There are no official sources of national data that allow a generalizable estimate of the prevalence of OxyContin or oxycodone drug abuse in Canada. Statistics Canada’s Canadian Alcohol and Drug Use Monitoring Survey (CADUMS) asks categorical questions to respondents about prescription opioid abuse, but does not ask specific questions about oxycodone or OxyContin abuse.[11]

Sources of national data on OxyContin and oxycodone abuse in the United States are more readily available. In the US, the most recent edition of the National Survey of Drug Use and Health (NSDUH) reports the number of new initiates to the non-medical use of OxyContin.[12] The Drug Abuse Warning Network (DAWN) is a source of administrative data, which reports on emergency department (ED) visits to American hospitals and allows identification of admissions related to oxycodone abuse. There are no sources of Canadian data comparable to these proxy measures for prevalence of abuse.

The literature search identified one American and two Canadian studies utilizing survey samples of drug abusers that are directly comparable. The American study utilized a national sample of admissions to 157 addiction treatment programs and included 27,816 subjects over the period 2001 to 2004. The study found that, “Approximately 5% of all subjects who were admitted to the 157 addiction treatment programs reported prior use of OxyContin.  Of those subjects, 4.5% reported using the drug on a regular basis for at least 1 year, and 2% reported use of the drug during the 30 days prior to admission.”[13]

The results of the American study can be compared to two more limited Canadian studies. One study was based on a national sample of admissions to 7 urban addiction treatment centres and included 585 subjects during 2005. Like the American study, it surveyed self-reported use of opioids including OxyContin during 30 days before assessment. The study found that use of OxyContin (oxycodone) was reported by 22.4% of respondents.[14] Another Canadian study used a convenience sample of admissions to a single addiction treatment centre (Toronto CAMH) including 571 admissions in total over the period 2000 to 2004. The study found that, “the number of admissions related to controlled-release oxycodone increased substantially (3.8%, 8.3%, 20.8%, 30.6%, and 55.4% of the total opioid admissions in 2000 to 2004, respectively).”[15]

DISCUSSION

 

Conclusions

The savings expected from approving generic versions of OxyContin can be weighed against the potential societal economic costs from undeterred OxyContin abuse. The potential undeterred total annual societal economic costs (C$ 2011) of OxyContin abuse in Canada (approx. $504 million) outweigh the expected direct economic savings from generic supply of OxyContin (approx. $89 million to $152 million) by a net difference of between 232% and 467%. For Ontario, the potential undeterred total annual societal economic costs (C$ 2011) of OxyContin abuse (approx. $318 million) exceed the expected direct economic savings from generic supply of OxyContin (approx. $52 million to $106 million) by a net difference of between 199% and 516%.[16]

A wholesale shift of market demand to OxyNEO (which could be achieved by permanent withdrawal of previous formulations of OxyContin from the market), has the potential to reduce the societal costs of OxyContin abuse, without causing the loss of health benefits accruing to legitimate users of the drug. The potential to reduce the societal economic costs of abuse is proportional to the effectiveness of the deterrent properties of OxyNEO. OxyNEO need not reduce abuse by very much in order to produce net societal economic benefit. The estimates calculated in this study suggest that the maximum expected post-generic savings on sales of OxyContin across Canada are cancelled out once OxyNEO reduces abuse by only 30%. Lower end estimates of post-generic savings are cancelled out once OxyNEO reduces abuse by as little as 18%. For Ontario the corresponding thresholds are 33% and 16%.

In addition, the success of a policy that encourages the substitution of OxyNEO could be expected to encourage a proliferation of abuse-deterrent formulations for other drugs. The proliferation of abuse-deterrent technologies could multiply the societal economic savings estimated from the impact of OxyNEO substitution for OxyContin.

 

Cautions and Limitations

  1. This analysis assumes that a person who is deterred from abusing OxyContin by the new OxyNEO formulation will not substitute other drugs for abuse. It is unlikely that all of the societal economic costs attributable to OxyContin abuse will be eliminated to exactly the same degree that OxyNEO deters abuse. However, as this study has shown, OxyNEO need only eliminate a small percentage of overall drug abuse to outweigh expected post-generic savings on OxyContin sales.
  2. This study assumes that the potential, if not the actual prevalence of OxyContin abuse is proportionally similar in Canada and the United States. The available evidence supports this assumption. The findings of the studies reviewed in this paper show that self-reported use of OxyContin (oxycodone) among abusers being admitted to Canadian treatment centres are very probably as high, or higher than the rates of self-reported use among comparable populations of abusers being admitted to American treatment centres. Even if the current level of abuse in Canada is lower than is observed in the USA, the data suggest the potential for abuse is at least as great in Canada. Importantly, as it pertains to the potential for abuse, the deterrent properties of OxyNEO could have a dramatic effect in preventing new initiates to OxyContin abuse, which would have a significant impact on the growth of total potential OxyContin abuse and thereby prevent the costs estimated in this paper from occurring. Data from the US NSDUH suggests that in 2010 the annual number of new non-medical American users of OxyContin aged 12 or older was 598,000.
  3. The extrapolated health costs attributable to OxyContin abuse have been adjusted for differences in per capita health costs between Canada and the USA. However, extrapolations of other societal economic costs have not been adjusted for potential cross-national differences in the costs of OxyContin abuse related criminal justice, productivity losses and rehabilitation treatment.
  4. Assumptions about the effects of price changes on abuse-related demand following the introduction of cheaper generic versions of OxyContin have not been included in this analysis. The evidence on the effect that generic price reductions would have on abuse rates is mixed and is shown in Table 9. There is strong evidence that as price decreases, illicit demand for drugs increases. At the same time, there is direct evidence in three studies that FDA approval of generic OxyContin in the USA did not lead to immediate increase in the diversion of generic versions of OxyContin prescription drugs found by police in the street supply, and was not followed by immediate increases in the abuse of oxycodone overall. The researchers in these studies caution that longer-term research is necessary to draw definitive conclusions. A review of media stories on OxyContin abuse in the USA suggest that police and government agencies have consistently expressed concerns about the effect of the reduction in price caused by generic OxyContin as a factor that could be linked to the increasing abuse of the drug. The concerns of US authorities about the effect of generic price reductions on illicit demand for OxyContin are echoed by the concerns expressed this year by the Ontario Association of Chiefs of Police cited in the introduction to this paper.
  5. Before OxyNEO was introduced to the market, OxyContin had previously been eligible for normal public reimbursement. Following the manufacturer’s replacement of OxyContin with OxyNEO, Ontario restricted reimbursement for OxyNEO to specially approved cases. Using restricted access policies to reduce the costs of OxyContin abuse must be weighed against the socio-economic costs resulting from the loss of health benefits to the vast majority of the user population that makes legitimate medical use of OxyContin. The net health benefit of OxyContin versus alternatives has not been estimated here, and so the potential loss of health benefits caused by restricted access is not part of the analysis.
  6. The manufacturer of OxyNEO has instituted several socially responsible abuse-reduction strategies that might reduce societal costs of abuse further. These strategies include improvements in supply chain security, assisting law enforcement with prescription drug diversion issues, education of health professionals about opioid abuse and prescription drug diversion, working with government and community groups to raise public awareness about prescription drug abuse, and supporting research on the nature and scope of prescription drug abuse. Any potential additional societal cost savings resulting from these programmes is not included in the calculations presented in this study.

 

ACKNOWLEDGEMENTS

Purdue Pharma Canada supported this study through an unrestricted grant and supplied the data sourced from IMS Brogan Inc. The research was designed and conducted independently by the author. No one other than the author, the peer reviewers and the editors of the journal had access to this article prior to its publication.

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White, Alan G., Howard G. Birnbaum, Milena N. Mareva, Maham Daher, Susan Vallow, Jeff Schein, Nathaniel Katz (2005). Direct Costs of Opioid Abuse in an Insured Population in the United States. Journal of Managed Care Pharmacy (JMCP), Vol. 11, No. 6, July/August 2005.

 

 

 

 

Summary Table. Main Findings.

 

Estimates Canada Ontario
Total sales OxyContin, 2011 $233,917,895 $147,559,947
Maximum expected post-generic savings, lower range estimate, $2011 $88,888,800 $51,645,981
Maximum expected post-generic savings, upper range estimate, $2011 $152,046,632 $106,243,162
Estimated total potential societal economic costs of undeterred OxyContin abuse, $2011 $504,299,196 $318,121,718
Maximum net potential societal economic savings from withdrawing OxyContin and replacing with OxyNEO, lower range estimate, $2011 $352,252,565 $211,878,556
Maximum net potential societal economic savings from withdrawing OxyContin and replacing with OxyNEO, upper range estimate, $2011 $415,410,396 $266,475,737
Net % difference between maximum potential societal economic savings from full substitution of OxyNEO v. direct savings generic OxyContin, lower range estimate 232% 199%
Net % difference between maximum potential societal economic savings from full substitution of OxyNEO v. direct savings generic OxyContin, upper range estimate 467% 516%

 

Table 1. Estimated annual savings from generic OxyContin, Ontario and Canada, C$2011.

 

All Payers (Public and Private), 2011
  Extended Units (e.g. tablets) Dispensed Dosage Units (e.g. milligrams) Dispensed Total Hospital and Drug Store Retail Sales $ Final Retail Price per mg Dispensed
Dosage Units (mg) per Extended Unit Ontario Canada Ontario Canada Ontario Canada Ontario Canada
5 934,120 4,222,480 4,670,600 21,112,400 $616,618 $2,783,188 $0.132 $0.132
10 14,544,220 25,752,880 145,442,200 257,528,800 $13,385,765 $23,772,208 $0.092 $0.092
15 167,880 737,400 2,518,200 11,061,000 $189,337 $836,409 $0.075 $0.076
20 23,005,670 36,814,790 460,113,400 736,295,800 $31,784,108 $51,196,196 $0.069 $0.070
30 302,330 1,205,750 9,069,900 36,172,500 $560,132 $2,259,181 $0.062 $0.062
40 19,440,310 29,107,690 777,612,400 1,164,307,600 $46,627,087 $70,274,228 $0.060 $0.060
60 300,790 887,570 18,047,400 53,254,200 $1,003,220 $2,980,337 $0.056 $0.056
80 12,059,580 17,904,510 964,766,400 1,432,360,800 $53,393,680 $79,816,148 $0.055 $0.056
Totals 70,754,900 116,633,070 2,382,240,500 3,712,093,100 $147,559,947 $233,917,895 $0.062 $0.063
Public Payers, 2011
  Extended Units (e.g. tablets) Dispensed Dosage Units (e.g. milligrams) Dispensed Total Hospital and Drug Store Retail Sales $ Final Retail Price per mg Dispensed
Dosage Units (mg) per Extended Unit Ontario Canada Ontario Canada Ontario Canada Ontario Canada
5 na 1,790,565 na 8,952,825 na $1,190,484 na $0.133
10 7,282,976 12,543,056 72,829,760 125,430,560 $6,874,284 $11,783,110 $0.094 $0.094
15 na 265,684 na 3,985,260 na $302,723 na $0.076
20 11,279,829 17,107,828 225,596,580 342,156,560 $15,980,590 $24,195,360 $0.071 $0.071
30 na 384,819 na 11,544,570 na $725,117 na $0.063
40 10,006,710 13,789,411 400,268,400 551,576,440 $24,605,910 $33,866,210 $0.061 $0.061
60 na 258,129 na 15,487,740 na $885,068 na $0.057
80 6,640,726 8,951,447 531,258,080 716,115,760 $30,076,180 $40,490,520 $0.057 $0.057
Totals 35,210,241 55,090,939 1,229,952,820 1,775,249,715 $77,536,964 $113,438,592 $0.063 $0.064
Expected direct savings post-generic OxyContin (brand and generic versions), applying observed average post-generic discounts for Actonel and Lipitor (brand and generic versions for both) to actual 2011 national market sales of OxyContin
Estimates Payer Range Ontario Canada
Actual total hospital and drug store retail sales of OxyContin $2011 All $147,559,947 $233,917,895
Public $77,536,964 $113,438,592
Observed average 2011 average market price per mg as a percentage of the observed 2009 pre-generic average market price per mg Actonel (upper) and Lipitor (lower) All upper 65% 62%
lower 28% 35%
Public upper 63% 60%
lower 24% 32%
Range of expected total sales of OxyContin (oxycodone hydrochloride) at estimated range of post-generic average market prices All upper $95,913,966 $145,029,095
lower $41,316,785 $81,871,263
Public upper $48,848,287 $68,063,155
lower $18,608,871 $36,300,349
Range of expected direct savings from generic OxyContin All upper* $106,243,162 $152,046,632
lower** $51,645,981 $88,888,800
Public upper*** $58,928,093 $77,138,243
lower**** $28,688,677 $45,375,437
*$147,559,947 – $41,316,785; **$147,559,947 – $95,913,966; ***$77,536,964 – $18,608,871; ****$77,536,964 – $48,848,287

 

 

Table 2. Pre-generic (2009) v. post-generic (2011) price experience, Lipitor (atorvastatin) – generic may 2010 and Actonel (risedronate) – generic February 2010, average market price per dosage unit dispensed, public and private payers, Canada and Ontario.

Total Private Sales Total Public Sales Total mg Dispensed, Private Total mg Dispensed, Public PRIVATE COST per mg Dispensed PUBLIC COST per mg Dispensed
Jurisdiction Market, Drug, Generic/Brand 2009 2011 2009 2011 2009 2011 2009 2011 2009 2011 2011 % 2009 2009 2011 2011 % 2009
CANADA GENERIC $0 $104,759,628 $0 $216,656,657 0 2,971,591,430 0 8,737,345,750 na $0.035 36.18% na $0.025 27%
LIPITOR $310,149,418 $39,126,104 $821,259,952 $58,112,811 3,183,259,740 404,068,020 9,046,523,100 731,209,030 $0.097 $0.097 99.38% $0.091 $0.079 88%
Generic+Lipitor $310,149,418 $143,885,732 $821,259,952 $274,769,468 3,183,259,740 3,375,659,450 9,046,523,100 9,468,554,780 $0.097 $0.043 43.75% $0.091 $0.029 32%
Total Generic+Lipitor, Public+Private 2009 2011 2009 2011 2009 2011 2011 % 2009
$1,131,409,370 $418,655,200 12,229,782,840 12,844,214,230 $0.093 $0.033 35%
ONTARIO GENERIC $0 $42,530,908 $0 $86,059,457 0 1,267,166,190 0 3,989,312,940 na $0.034 35.21% na $0.022 24%
LIPITOR $131,683,095 $6,877,730 $339,636,740 $2,258,638 1,381,253,370 79,825,060 3,727,428,250 67,452,360 $0.095 $0.086 90.38% $0.091 $0.033 37%
Generic+Lipitor $131,683,095 $49,408,638 $339,636,740 $88,318,095 1,381,253,370 1,346,991,250 3,727,428,250 4,056,765,300 $0.095 $0.037 38.48% $0.091 $0.022 24%
Total Generic+Lipitor, Public+Private 2009 2011 2009 2011 2009 2011 2011 % 2009
$471,319,835 $137,726,732 5,108,681,620 5,403,756,550 $0.092 $0.025 28%
CANADA GENERIC $0 $6,336,699 $0 $23,462,783 0 45,774,140 0 267,334,205 na $0.138 43.11% na $0.088 30%
ACTONEL $31,363,401 $16,055,444 $126,821,614 $57,787,091 97,674,095 47,609,615 427,888,265 190,963,230 $0.321 $0.337 105.02% $0.296 $0.303 102%
Generic+Actonel $31,363,401 $22,392,143 $126,821,614 $81,249,874 97,674,095 93,383,755 427,888,265 458,297,435 $0.321 $0.240 74.68% $0.296 $0.177 60%
Total Generic+Actonel, Public+Private 2009 2011 2009 2011 2009 2011 2011 % 2009
$158,185,015 $103,642,017 525,562,360 551,681,190 $0.301 $0.188 62%
ONTARIO GENERIC $0 $2,456,011 $0 $10,959,433 0 19,494,665 0 137,305,705 na $0.126 39.66% na $0.080 26%
ACTONEL $15,396,552 $8,792,406 $69,625,826 $39,499,254 48,463,205 27,282,615 230,571,610 128,361,760 $0.318 $0.322 101.44% $0.302 $0.308 102%
Generic+Actonel $15,396,552 $11,248,417 $69,625,826 $50,458,687 48,463,205 46,777,280 230,571,610 265,667,465 $0.318 $0.240 75.69% $0.302 $0.190 63%
Total Generic+Actonel, Public+Private 2009 2011 2009 2011 2009 2011 2011 % 2009
$85,022,378 $61,707,104 279,034,815 312,444,745 $0.305 $0.197 65%

 

 

 

Table 3. Published estimates of societal economic cost of OxyContin, oxycodone and prescription opioid abuse, USA.


Source
Total Rehabilitation Healthcare Criminal Justice Productivity Drug Specificity
Birnbaum et al 2005

(stated in US$2001)

$8,600,000,000 na $2,600,000,000 $1,400,000,000 $4,600,000,000 Rx opioids
Hansen et al 2011

(stated in US$2006)

$53,400,000,000 $2,200,000,000 $944,000,000 $8,200,000,000 $42,000,000,000 Rx opioids
$7,241,130,000 $427,010,000 $166,460,000 $835,430,000 $5,812,230,000 OxyContin
$6,035,150,000 $254,410,000 $26,060,000 $1,129,210,000 $4,625,470,000 Other oxycodone
Birnbaum et al 2011

(2007 data, stated in US$2009)

$55,700,000,000 na $25,000,000,000 $5,100,000,000 $25,600,000,000 Rx opioids

 

 

 

Table 4. Estimate of annual societal economic cost of OxyContin and total oxycodone abuse, USA, proportionally derived from most recent published estimates, author’s calculations shown.

Source Total Rehabilitation Healthcare Criminal Justice Productivity Drug Specificity
Hansen et al 2011

(2006 data, stated in US$2006)

$53,400,000,000 $2,200,000,000 $944,000,000 $8,200,000,000 $42,000,000,000 Rx opioids
$3,144,000,000 Rehab + Health*
$7,241,130,000 $427,010,000 $166,460,000 $835,430,000 $5,812,230,000 OxyContin
$593,470,000 Rehab + Health*
13.6% 18.9% 10.2% 13.8% OxyContin % Total Rx Opioid Abuse
$6,035,150,000 $254,410,000 $26,060,000 $1,129,210,000 $4,625,470,000 Other oxycodone
$13,276,280,000 $681,420,000 $192,520,000 $1,964,640,000 $10,437,700,000 Total oxycodone*
$873,940,000     Rehab + Health*
24.9% 27.8% 24.0% 24.9% Oxycodone % Total Rx Opioid Abuse*
Birnbaum et al 2011

(2007 data, stated in US$2009)

$55,700,000,000 na $25,000,000,000 $5,100,000,000 $25,600,000,000 Rx opioids
$7,553,013,876 na $4,719,068,066 $519,596,707 $3,542,692,571 OxyContin portion**
$13,848,104,794 na $6,949,268,448 $1,221,910,244 $6,362,026,667 Oxycodone portion**
* author’s calculations; ** author’s calculation applying 2006 ($2006) percentages to 2007 ($2009) data

(category totals do not sum to grand total exactly due to sub-totaling rehabilitation and healthcare costs)

 

Table 5. Estimated Potential Annual Total Societal Economic Cost of OxyContin Abuse to Canada in the Absence of an Abuse-Deterrent Formulation, Assuming Equivalent Proportion of Abuse in Canada and USA.

 

Percentage change in USA CPI from 2009 to 2011 4.8%
Average 2011 Bank of Canada exchange rate, 1US$:C$ 1.011
Most recent estimated cost of OxyContin abuse in the USA, US$2009 $7,553,013,876
Above inflated to US$2011 by percentage change in USA CPI 2009 to 2011 $7,915,558,542
Above stated in C$2011 at average 2011 Bank of Canada exchange rate $8,002,629,686
USA total 2011 sales OxyContin, US$2011 $2,900,000,000
Above stated in C$2011 at average 2011 Bank of Canada exchange rate $2,931,900,000
Canada total 2011 sales OxyContin, C$2011 $233,917,895
Total Canadian sales OxyContin 2011 stated as a percentage of USA sales 8.0%
Estimated total potential cost of Canadian OxyContin abuse at 8.0% of USA cost of OxyContin abuse,  stated in C$2011 $638,479,583
Canada, per capita health spending, public plus private, 2011, C$2011 $5,811
USA, per capita health spending, public plus private, 2011, US$2011 $8,661
Above stated in C$2011 at average 2011 Bank of Canada exchange rate $8,756
Per capita health spending, Canada stated as a percentage of USA, C$2011 66.4%
USA, rehab+health costs of OxyContin abuse, US$2009 $4,719,068,066
Above inflated to US$2011 by percentage change in USA CPI 2009 to 2011 $4,945,583,333
Above stated in C$2011 at average 2011 Bank of Canada exchange rate $4,999,984,750
Estimated proportional Canadian rehab+health costs at 8.0% of USA, OxyContin, C$2011 $398,917,394
Adjusted estimate of proportional Canadian rehab+health costs at 66.4% of USA, C$2011 $264,737,007
Difference between unadjusted and adjusted estimates of Canadian rehab+health costs above $134,180,387
Total potential cost of Canadian OxyContin abuse adjusting for difference in Canada-USA per capita health costs, stated in C$2011 $504,299,196

Table 6. Estimates of economic costs attributable to OxyContin, oxycodone or prescription opioid abuse.

Author(s) Jurisdiction Publication Year Level of Analysis Drug Specificity Findings ( extracts) Data Date Range Monetary Date
Birnbaum et al USA 2005 total population-wide annual societal costs Rx opioids ·       lower bound estimate of the costs of RxO abuse in the United States was $8.6 billion in 2001 (or $9.5 billion in 2005 dollars)

·       $2.6 billion were healthcare costs, $1.4 billion were criminal justice costs, and $4.6 billion were workplace costs

2001 2001 $
White et al USA 2005 mean per capita direct total healthcare costs for a privately insured population Rx and non-Rx opioids ·       Mean annual direct health care costs for opioid abusers were more than 8 times higher than for non-abusers ($15,884 versus $1,830)

·       Hospital inpatient and physician-outpatient costs accounted for 46% ($7,239) and 31% ($5,000) of opioid abusers’ health care costs, compared with 17% ($310) and 50% ($906) for non-abusers

·       Mean drug costs for opioid abusers were more than 5 times higher than costs for non-abusers ($2,034 vs. $386), driven by higher drug utilization

1998 to 2002 2003 $
Hansen et al USA 2011 total population-wide annual societal costs Rx opioids total and by drug incl., OxyContin and oxycodone ·       In 2006, the estimated total cost in the United States of nonmedical use of prescription opioids was $53.4 billion

·       $42 billion (79%) was attributable to lost productivity, $8.2 billion (15%) to criminal justice costs, $2.2 billion (4%) to drug abuse treatment, and $944 million to medical complications (2%)

·       Costs specific to OxyContin (Total $7241.13m, 13.61%; drug abuse treatment $427.01m, 19.24%; medical $166.46m, 22.14%; productivity $5812.23m, 13.83%; criminal justice $835.43m, 10.16%)

·       Costs specific to other oxycodone (Total $6035.15m, 11.34%; drug abuse treatment $254.41m, 11.46%; medical $26.06m, 3.47%; productivity $4625.47m, 11.01%; criminal justice $1129.21m, 13.74%)

2006 2006 $
Birnbaum et al USA 2011 total population-wide annual societal costs Rx opioids ·       Total US societal costs of prescription opioid abuse were estimated at $55.7 billion in 2007 (USD in 2009)

·       Workplace costs accounted for $25.6 billion (46%), health care costs accounted for $25.0 billion (45%), and criminal justice costs accounted for $5.1 billion (9%)

2007 2009 $

Table 7. Prevalence of OxyContin, oxycodone or prescription opioid abuse.

Author(s) Jurisdiction Publication Year Level of Analysis Drug Specificity Findings (extracts) Data Date Range
Carise et al USA 2007 national sample of admissions to 157 addiction treatment programs, 27,816 subjects OxyContin ·       5% of all subjects who were admitted to the 157 addiction treatment programs reported prior use of OxyContin

·       Of those subjects, 4.5% reported using the drug on a regular basis for at least 1 year, and 2% reported use of the drug during the 30 days prior to admission

·       78% of subjects who reported OxyContin use also reported that the drug had not been prescribed to them for any medical reason

2001 to 2004
NSDUH USA 2011 population-wide rates of initiation among non-medical users all substances, Rx and non-Rx opioids, oxycodone, OxyContin ·       In 2010, the number of new non-medical users of OxyContin aged 12 or older was 598,000 up from 584,000 in 2009 2010
DAWN USA 2012 population-wide rates of ED visits Rx and non-Rx opioids, oxycodone, OxyContin ·       Oxycodone ED Visits 59.1 per 100,000 population in 2010

·       Oxycodone ED Visits, 2004 – 51,418; 2010 – 182,748; percent change, 2004 to 2010 255%.

2010
Fischer et al Canada 2006 national sample of admissions to 7 urban addiction treatment centres, 585 subjects Rx and non-Rx opioids, oxycodone, OxyContin ·       Self-reported use of OxyContin during 30 days before assessment: 131 (22.4%). 2005
Sproule et al Canada 2009 convenience sample of admissions to a single addiction treatment centre (Toronto CAMH), 571 admissions Rx and non-Rx opioids, oxycodone, OxyContin ·       571 opioid detoxification admissions during the 5-year study period

·       number of admissions related to controlled-release oxycodone (OxyContin) increased substantially – 3.8%, 8.3%, 20.8%, 30.6%, and 55.4% of the total opioid admissions in 2000 to 2004

2000 to 2004
Dhalla et al Canada 2009 Regional (Ontario) census of opioid-related deaths using provincially administered data oxycodone, OxyContin ·       1991 to 2007, annual prescriptions for opioids increased from 458 to 591 per 1000 individuals

·       Opioid-related deaths doubled, from 13.7 per million in 1991 to 27.2 per million in 2004

·       Prescriptions of oxycodone increased by 850% between 1991 and 2007

·       The addition of long-acting oxycodone to the drug formulary was associated with a 5-fold increase in oxycodone-related mortality and a 41% increase in overall opioid-related mortality

1991 to 2007

 

Table 8. Assessments of abuse deterrent formulations of OxyContin or other prescription opioids.

Author(s) Publication Year Level of Analysis Drug Specificity Findings ( extracts) Data Date Range Monetary Date
White et al 2009 Hypothetical national annual cost savings among privately insured population modelled on abuse-deterrent formulation of OxyContin ·       potential cost savings to USA private-sector third-party payers from introducing an abuse-deterrrent formulation range from $US0.6 billion to $US1.6 billion per year 2002 to 2005 2006 $
Cicero and Surratt 2012 Empirical self-administered survey data from participants entering treatment programs around the USA, annual cohorts of 2566 patients,  percentage of respondents reporting non-medical use of OxyContin v. other opioids in previous 30 days. OxyNEO ·       selection of OxyContin as a primary drug of abuse decreased from 35.6% of respondents before the release of the abuse-deterrent formulation to just 12.8% 21 months later

·       of all opioids used to get high in the past 30 days at least once, OxyContin fell from 47.4% of respondents to 30.0%

·       Interviews with patients who abused both formulations of OxyContin indicated a unanimous preference for the older version

·       24% found a way to defeat the tamper-resistant properties of the abuse-deterrent formulation and 66% indicated a switch to another opioid

2009 to 2012 n/a
Vosburg et al 2012 Empirical experiment testing of potential for product tampering by groups of abusers oxymorphone DCR ·       most participants were not willing to snort (92%) or inject (84%) the tamper-resistant formulation products unreported n/a

Table 9. Effect of price changes and generic entry on drug abuse.

Author(s) Publication Year Level of Analysis Drug Specificity Findings ( extracts) Data Date Range
Hyatt and Rhodes 1995 national administrative data on ED visits, medical examiners records, arrestee reports cocaine ·       as the price of cocaine decreases, the Emergency Room (ER) mentions, medical examiner reports, and positive urinalysis among arrestees related to cocaine increase

·       as the price of cocaine increases, ER mentions, medical examiner reports, and the percentage of arrestees testing positive for cocaine decline

1986 to 1991
Caulkins 2001 national administrative data on ED visits cocaine and heroin ·       negative correlation between prices and Emergency Department (ED) mentions

·       price changes can explain 97.5% of the variation in ED mentions for cocaine and 95% of the variation for heroin

1978 to 1996
Bailey et al 2006 data from eight poison control centers (PCC) oxycodone, hydrocodone, methadone and morphine ·       evaluated the effect of FDA approval of generic CR oxycodone (OxyContin) on the misuse/abuse of oxycodone, hydrocodone, methadone and morphine

·       PCC intentional exposure (IE) reason codes were used as measures of abuse

·       opioid-specific quarterly IE rates (per 100,000 population and per 10,000 patients) were calculated for 1 year before and after approval

·       changes in regression slopes and in IE rates were analyzed; the regression slopes for oxycodone, methadone and morphine did not change after approval but decreased significantly for hydrocodone

·       none of the prescription opioids’ IE rates significantly increased after generic approval

·       PCC data indicate that approval of generic CR oxycodone was not followed by an immediate unfavorable effect on the misuse/abuse of oxycodone

2003 to 2005
Cicero et al 2007 interviews with 351 drug abuse experts and treatment specialists located in 217 ZIP codes…corresponding prescription data for each of the ZIP codes OxyContin and Fentanyl ·       introduction of generic extended release (ER) oxycodone (OxyContin) and fentanyl patch did not significantly change the total prescriptions written for these products

·       branded sales dropped over a very short time and this was compensated for by a corresponding increase in sales of generics

·       introduction of generic products did not increase the abuse of ER oxycodone or fentanyl products

·       data suggest that drug costs alone do not increase the overall likelihood that a prescription opioid analgesic will be used therapeutically or abused

2003 to 2006
Inciardi et al 2009 data were collected through a post-marketing surveillance initiative supported by the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS) System risk management program, gathered on a quarterly basis from a national sample of police and regulatory agencies. OxyContin and Fentanyl ·       examined the impact of the introduction of generic forms of selected opioids on their diversion to the illicit marketplace

·       with both oxycodone ER (OxyContin) and the fentanyl patch, the diversion of generics has been limited – at least during the time period covered by this analysis

·       diversion did not increase in the short-term, but the need for longer term monitoring appears warranted

2004 to 2008
Chalmers et al 2010 sample of 101 Australian methamphetamine users was surveyed using a behavioural economics approach. methamphetamine and heroin ·       demand for both methamphetamine and heroin was found to be price elastic

·       cross-price elasticity analysis showed limited substitution into other drugs as the price of methamphetamine increased

·       for heroin, there was significant substitution into pharmaceutical opioids

·       for the most part, the decreases in methamphetamine or heroin consumption outweighed any substitution into other drugs

·       reduction in overall drug consumption and expenditure in response to price increases in heroin and methamphetamine observed in this sample lend support to supply-side enforcement strategies that aim to increase retail drug price

·       studies have consistently found that consumption of illicit drugs such as heroin and cocaine is responsive to changes in their own price…

2008

[1] (NIDA) US National Institute on Drug Abuse (2011). Prescription Drugs: Abuse and Addiction. National Institute of Health. US Department of Health and Human Services. URL: http://www.drugabuse.gov/publications/research-reports/prescription-drugs.

[2] In addition to the other evidence reviewed in this study, one of the best sources of information on the prevalence of prescription drug abuse in Canada is the Canadian Centre on Substance Abuse (CCSA). URL: http://www.ccsa.ca/Eng/Priorities/Prescription-Drug-Misuse/Pages/default.aspx.

[3] Minister Matthews’ letter was posted online by the Globe and Mail, July 6, 2012. URL:  http://www.theglobeandmail.com/incoming/ontarios-letter-to-federal-health-minister-leona-aglukkaq/article4396784/

[4] OACP (2012). Media Release. Ontario’s Police Leaders Call on the Federal Government to Keep “Generic” Oxycodone out of Canada: Police Chiefs Warn of Threat to Community Safety. Toronto. July 11, 2012. URL:

http://www.oacp.ca/content/news/article.html?ID=1231

[5] Dhalla et al 2009.

[6] Birnbaum et al 2006; Birnbaum et al 2011; Hansen et al 2011

[7] Hansen et al 2011; Birnbaum et al 2011

[8] Vosburg et al 2012

[9] Cicero and Surratt 2012

[10] White et al 2009

[11] CADUMS 2012

[12] NSDUH 2011

[13] Carise et al 2007

[14] Fischer et al 2006

[15] Sproule et al 2009

[16] Percentages reflect actual figures not the approximations presented in this paragraph.