it " it at tiiis Pfizer Inc E; 235 East 42nd Street New York, NY 10017 Testimony of Pfizer, Inc., LD 919 to Opioid Analgesics with Abuse-Deterrent Properties An Act to Provide Access Senator Whittemore, Representative Beck and members of the Insurance and Financial Services Committee, thank you for the opportunity to testify in support of LD 919. My name is Tom Brownlie and Pfizer is I am here today on behalf of Pfizer in full support of this legislation. company dedicated a research-based global pharmaceutical development of innovative medicines and treatments around the world. that the bill and improve the quality of life for people We recognize that opioid misuse and abuse is a growing problem with far~ reaching effects on individuals, families, and communities, and support this to the discovery which would simply provide patients access to we encourage the committee to opioids with new technologies FDA has determined can help reduce their abuse. a significant unmet medical need, affecting over 100 million Americans Chronic pain is than the total number of people affected by heart Chronic pain can result in higher health care Institute of utilization Medicine estimated cost the U.S. as much With growing recognition of the need frequently in the U.S, which opioids. disease, cancer, is more and diabetes combined.i and lower work productivity, which the as $635 billion per year.“ to treat pain, prescription opioids are being used more associated with an increase in nonmedical use of prescription The misuse and abuse of prescription significant health, economic, — opioids is now considered at epidemic levels, with and societal consequences. Approximately 4.9 million people age 12 and older were using prescription opioids for number of poisoning deaths — prescription and nonsurpassed motor vehicle deaths in 2008.“ The rate of opioid nonmedical purposes in 2012.“i The prescription drug poisonings — total poisoning deaths nearly quadrupled from 1999 to 2013, with approximately 46 people dying from prescription painkillers every day.v'vi The economic impact of prescription opioid abuse is also striking. Direct medical costs alone are estimated to cost insurance companies $72.5 billion annually.“ Researchers investigating costs of opioid-related medical services estimated that it costs: v $13,398 for each opioid abuse related hospitalization; 6 $5,745 for each substance abuse treatment service; = $5,400 for each complication associated with injection drug-use, such as hepatitis and HIV; v $1,175 for each opioid substance abuse treatment service; 1 / Pfizer Inc 235 E<15t"2“d Street New York, NY 10017 central nervous system, or other novel effects. Prodrugs with abuse-deterrent properties could provide a chemical barrier to the in vitro conversion to the parent opioid, which may deter the abuse of the parent opioid. New molecular entities and prodrugs are subject abuse potential for purposes of the Controlled Substances Act (CSA). to evaluation of Two or more of the above methods could be combined to deter abuse. This category encompasses novel approaches or technologies that are not captured in the Combination Novel Approaches revious categories. Since release of the draft guidance in 2013, companies have submitted study data to the human abuse liability FDA and based on findings from those studies four drugs have received labeling indicating that they are expected to “result in a meaningful reduction in abuse.”‘ Three on the market (EmbedaTM Hysinglam OxyContinTM), and one now has three authorized generic versions also now on the market (OxyContinTM).“i“"X are currently , , Currently, both generic and innovator pharmaceutical manufacturers with different types of deterrent technologies have drugs in late stages of development, and the deterrent opioids in the market is expected to steadily increase, adding both more market competition and more options for addressing specific types of abuse. currently working 0 number of abuse- on such products Some of the companies include: Egalet Corporation which has five abuse~deterrent opioids in development, including an extended~release abuse~deterrent morphine that will start phase III clinical trials in early 2015?“ 0 Teva Pharmaceuticals Industries Ltd. which has (NDA) o filed a rolling New Drug Application for an abuse-deterrent extended-release hydrocodone;X"fi Elite Pharmaceuticals, Inc. which has at least three abuse-deterrent opioids in development, with one scheduled for commercial product launch in 0 Q4 2015; and Collegium Pharmaceutical, Inc. which has two abuse-deterrent opioids in development, including an extended-release oxycodone in late phase clinical development.“iii Of course, what is most critical is the may therefore, the potential benefit they Opponents of this bill will likely unproven. impact these technologies have on misuse and abuse, and confer to individuals, families, and communities. claim that abuse-deterrent drugs are too FDA is the national authority technologies is reviewed the issue, the technologies, new and on drug efficacy and that the safety. They have and the human abuse data extensively, and determined that they are sufficient to warrant labeling claims that indicate abuse-deterrent opioids will likely result in a meaningful reduction directly contradict the 1 FDA. Refonnulated OxyContinQ (Purdue Pharma labeling by the FDA in abuse of the drug. Claims that these drugs do not work in L.P.), which is an extended-release oxycodone and was the July 2013. Targinig® (Purdue Pharma L.P.) product has not been launched). Embeda® is also an extended~release (Pfizer, lnc.) is an extended-release market Q1 2015. Hysingla® (Purdue Pharma L.P.) is opioid to obtain abuse-deterrent morphine approved October 2014 and an extendedwelease hydrocodone that was approved 4 first oxycodone approved July 2014 (Note: This is scheduled to enter the November 2014 (Launch TBD). Pfizer In¢ 235 East 42nd Street New York, NY 10017 FDA’s The introduction of a reformulated now the only version of extendedversion of OxyContin® with abuse-deterrent properties release oxycodone available on the market since the previous version has been removed and Furthermore, real-world data support the generics were not allowed to enter the market — technologies affect abuse in real-world settings. conclusions. allowed researchers And to assess how these the results have been extremely promising. After introduction of the reformulated abuse-deterrent version of OxyContin® into the market, researchers found that abuse rates dropped across a range of patient types and insurers, including: decrease in abuse among a subset of opioid abusers (23.69% to 12.12%, p<0.0001); decrease in abuse among all ¢ 49% 41% 22% decrease in abuse among commercially v 18% decrease in abuse among Medicaid ~ Q The individuals (4.06% to 2.41%, p<0.0001); patients (6.2% to 5.1%, p=0.034). other argument that will likely be put forward considering costs, it is as well as the direct While the results essential that insured (3.6% to 2.8%; p<0.001); and is that these medicines are too costly. When any such discussion account for both the cost of the solution, and indirect savings that result from reductions in misuse and abuse. cannot be directly extrapolated to savings for future abuse-deterrent opioids, researchers tracking the impact of the re~introduction of OxyContin® as an abuse-deterrent version found that health care costs decreased by $9,456 and $11,501 per patient for diagnosed abusers insured by commercial carriers and Medicaid, respectively, and health care costs decreased by $7,565 and$6,856 per patient for undiagnosed abusers insured by commercial carriers and by Medicaid, respectively.Xxiv Overall, the introduction of the reformulated abusedeterrent extended—re1ease (ER) health care More oxycodone is estimated to have saved $430 million in annual costs.“ recently, an economic analysis of the impact of extended-release opioids estimated that, after shifting to abuse-deterrent versions of all accounting for differences in drug cost, the net health care savings would range between $1,757 per patient and $4,033 per patient, depending upon price and insurance coverage assumptions. Arguments suggesting we that should not invest in potentially safer pain therapies, such as abuse-deterrent opioids, fail to recognize that the $72 billion insurers are spending on opioidrelated medical services opioid abuse, whether is we already being incorporated into their premiums. see it directly, or whether we feel it when we We are all paying for write our check to pay our monthly premiums. Maine is not the only state seeking to enhance access to abuse-deterrent opioids. Last year, Massachusetts passed a bill requiring patients be switched to abuse-deterrent opioids in certain 5 W ~: Pfizer Inc _ 235 East l¢2nd f ‘tea as hit Street New York, NY 10017 circumstances, and currently many ensure access to these technologies. In summary, country are consider legislation which would states across the xxvi LD 919 ensures that: v Abuse-deterrent opioids are on a health plan’s formulary; ¢ Cost-sharing for the patient 0 Utilization opioid LD 919 does management is at barriers parity with non-abuse deterrent opioids; do not require a patient fail first. M 0 Require a doctor to prescribe an abuse-deterrent opioid; 0 Prevent a patient from getting a non-abuse deterrent opioid; v Promote the use or prescribing of more opioids. Pfizer recognizes that solving the opioid crisis bullet. on a non-abuse deterrent is extremely difficult Abuse-deterrent opioids will not be the sole solution, but and that there we believe is no magic they can play an important role as part of a comprehensive approach that addresses misuse and abuse from prevention to treatment to overdose rescue. Mainers are paying for opioid abuse directly or indirectly. The state is also paying for opioid abuse through higher medical costs, criminal costs, and losses in productivity. Maintaining the status quo means we will all continue to pay these costs. We believe this bill is a positive step forward for tackling the opioid abuse issue in Maine. We encourage you to vote Ought to Pass on LD 919. Thank you again for the opportunity to speak today. Tom Brownlie Senior Manager U.S. Policy, Pfizer, Inc. IOM (Institute of Medicine). 20] I. Relieving Pain Washington, DC: The National Academies Press. i “ in America: A Blueprint for Transforming Prevention, Care, Education, and Research. lbid. in US Human Services, Addressing Prescription Drug Abuse in the United States: Current Activities and Future DC: Behavioral Health Coordinating Committee and Prescription Drug Abuse Committee; 2013. Warner M, Chen LH, Makuc DM, Anderson RN, Minifio AM. Drug poisoning deaths in the United States, l980—2008. NCHS data brief, no Department of Health and Opportunities. Washington, iv Hyattsville, V CDC, MD: National Center for Health Statistics. 201 Injury Prevention & Control: Prescription 1. Drug Overdose---Data Overview. Available at http://wwW.cdc.gov/drugoverdose/data/index.html. Last accessed April l4, 2015. Vi CDC, Vital Signs, Opioid Painkiller Prescribing»-Where You Live httpI//ww\v.cdc.gov/vitalsigns/opioid~prescribing/. Makes a Dz_f)‘et'eiice. Last accessed April 14, 2015. 6 July 4, 2014. Available at 81 _' =2fs:~s=as;=.=:. Pfizer Inc 235 East 42nd Street New York, NY V“ 10017 how Coalition Against Insurance Fraud. Prescription for peril: insurance fraud finances theft and abuse of addictive prescription drugs. Washington, DC: Coalition Against Insurance Fraud; 2007. Available PDF fileExternal Web Site Icon. Accessed September 26, 20l at http://www.insurancefraud.org/downloads/drugDiversion.pclf Adobe l. Vi" Ibid. ix X Birnbaum H.G., CDC, et al., Pain Medicine. 2011;12:657-667. Morbidity and Mortality Weekly Benzodiazepines — (MMWR), Uni!edS1ale.r. 2012. Available at Among States in Prescribing of Opioid Pain Relievers and http://www.cdc.gov/mmwr/preview/mmwrhtmllmm6326a2.htm?s cid=mm6326a2 w. Last Vital Signs: Variation accessed April 14,2015. Xi Maine, Title 22, Chapter I603: Controlled Substances Prescription Monitoring. X“ The White House, Office of National Drug Control Prevent Youth Substance Abuse. October 9, Policy, White 2014. Available at House Drug Policy Of/ice Announces Grants/or 680 Local Communities to https://www.whitehouse.g0v/ondcp/news~releasesfDFC-nationalwelease-20l4. Last accessed April I4, 2015. "iii Results from the (SMA) xiv "V FDA, Guidance FDA. 2012 National Survey on Drug Use and Health: Summary of National Findings, MD: SAM]-ISA; 2013. NSDUH Series H-46, to Industry: Abuse-Deterrent Opioids FDA approves abuse-deterrent — Evaluation and Labeling. labeling for reformulated Ox}/Contin. The White House. The Administration's Response to the Prescription Press Release. April 16, 2013. Available Drug Epidemic: Action http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/action Last accessed xvii Items. Available 4, at: 2014. at: items response to the prescription drug epidemiepdf. November 4, 2014. FDA, Guidance "Vi" Publication No. April 2015. FDA News http:_//www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ncm3482S2.htm. Last accessed November xvi HHS 13-4795.Rockville, to Industry: Abuse-Deterrent Opioids — and Labeling. Evaluation April 2015. FDA News Release, Food and Drug Administration. FDA approves abuse-deterrent labeling for reformulated OxyContin: Agency will not approve generics to original 0xyContin. April 16, 2013. htttg//www.fda.gov/NewsEvents/Newsroon1_/PressAnnouncements/ucm34825Z.htm xix FDA News Release, Food and Drug Administration. FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic. http_:[/ www.fda.gov / NewsEvents/ Newsroom _/ P1‘essAnnouncements_/ ucm419 2 88.htm XX FDA News Release, Food and Drug Administration. FDA approves extended-release, single-entity hydrocodone product with abuse- deterrent properties. httQ;[/www.fda.go\;/ NewsEvents / Newsroom / PressAnn0uncements / ucm423977.l1tm X“ Abuse Deterrent Opioids: Pipeline. http://www.egalet.c0m/index.igtiproducts~and~;gpeline/;jpeline/ Teva Pharmaceutical Industries Ltd. Teva Announces Initiation 0_fNew Drug Application and Positive Resultsfi'om Second Human Abuse Liability Study for CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets. October 8, 2014. Egalet Corporation. Developing “ii http://www.tevapham1.com/Media/News/Pages/20 l 4/l 975 252.as;g Collegium Pharmaceutical. Products/Pipeline. http://wWw.colleginmpharma.com/productslgpeline "mi “W White et al. 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