Under some plans, including plans that use an open or closed formulary, Actiq, Balacet 325, butorphanol nasal spray, Combunox, Darvon, Darvon-N, Darvocet-N, Demerol, Duragesic, Embeda, fentanyl transmucosal lozenges, Fentora, meperidine, Nucynta, Onsolis, Opana, oxycodone/ibuprofen, Oxycontin CR, oxycodone er, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCl, propoxyphene HCl/acetaminophen, propoxyphene napsylate, propoxyphene napsylate/acetaminophen, Talacen, Talwin, and Talwin NX are subject to precertification. If precertification requirements apply Aetna considers Actiq, Balacet 325, butorphanol nasal spray, Combunox, Darvon, Darvocet-N-100, Demerol, Duragesic, Embeda, fentanyl transmucosal lozenges, Fentora, meperidine, Nucynta, Onsolis, Opana, Oxycontin CR, oxycodone er, oxycodone/ibuprofen, propoxyphene napsylate, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCL, propoxyphene napsylate/acetaminophen, Talacen, Talwin, and Talwin NX to be medically necessary for those members who meet the following precertification criterion:
Actiq, fentanyl transmucosal lozenge, Fentora ONLY - A AND C AND D
For Onsolis - B AND C AND D
For butorphanol ns, Combunox, Duragesic, fentanyl patch, Nucynta, Opana,oxycodone/ibuprofen, Oxycontin CR, oxycodone er -- D ONLY
A. A documented current diagnosis of cancer
AND
B. A documented current diagnosis of cancer pain and breakthrough pain in opioid-tolerant patients
AND
C. Concomitant use of long acting opioid therapy (such as, controlled-release morphine (MS Contin, Oramorph SR, Kadian CR), extended-release morphine (Avinza), controlled release oxycodone (Oxycontin CR), extended-release oxymorphone (Opana ER), fentanyl transdermal (Duragesic), methadone (Dolophine, Methadose)
AND
D. Quantity limits:
According to the manufacturer and/or clinical literature, Actiq, butorphanol ns, Cocet, Combunox, Duragesic, fentanyl patch, fentanyl transmucosal lozenge, Fentora, Nucynta, Onsolis, Opana, oxycodone/ibuprofen, oxycodone er, and Oxycontin CR, can be dosed at the interval(s) indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below:
Up to 20 patches in 30 days (2 patches per 3 days)
Fentora
1 buccal tablet up to four times daily
100 mcg,
200 mcg,
400 mcg,
600 mcg,
800 mcg
Up to 240 buccal tablets for all strengths combined per 30 days*
Nucynta
700 mg the first day and 600mg/day thereafter/ 1 tablet every 4 to 6 hours
50 mg,
75 mg,
100 mg
Up to 180 tablets per 30 days
Onsolis
4800 mcg/up to 4 times a day
200 mcg
Up to 240 films per 30 days
Onsolis
4800 mcg/up to 4 times a day
400 mcg, 600 mcg, 800 mcg, 1200 mcg
Up to 120 films per 30 days
Opana
20 mg every 4 to 6 hours
5 mg, 10 mg
180 tablets per 30 days
oxycodone er,
Oxycontin CR
1-2 tablets every 12 hours
10 mg,
15 mg,
20 mg,
30 mg,
40 mg,
60 mg,
80 mg
Up to 120 tablets in 30 days (320mg/day)
For coverage of additional quantities, member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of the above medications will be considered medically necessary for those members who meet the following criterion:
For fentanyl transmucosal lozenge, Actiq; Fentora; Onsolis
Member is experiencing breakthrough pain secondary to current diagnosis of cancer AND
Member is currently on a long-acting opioid and member's dose of the long-acting opioid is being titrated upward by physician AND
Member has tried and failed an adequate trial of two weeks of a single entity or combination pain medication containing an immediate release acting opioid [ex. morphine sulfate oral; oxymorphone(Opana); hydromorphone(Dilaudid); oxycodone/ibuprofen(Combunox); oxycodone/apap (Percocet)]
For OxyContin CR and oxycodone er
Member has diagnosis of cancer and prescription is written by an oncologist or pain specialist OR
Member is enrolled in a hospice program or meets hospice criteria OR
Member has a diagnosis of moderate to severe chronic pain AND
A formal pain evaluation has been documented AND
Other pain management regimens have been inadequate AND
Member is documented to have failed dosing every 12 hours along with a prescription for immediate-release (IR) medication AND
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a more frequent dosing interval (OxyContin CR-only) OR
Member requires a dose every 12 hours(BID) and the total daily dose is <320mg, AND the member has prior history of dose titration increasing incrementally OR
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
For Combunox, oxycodone/ibuprofen, Opana, and butorphanol nasal solution
Member has diagnosis of cancer and prescription is written by an oncologist or pain specialist OR
Member is enrolled in a hospice program or meets hospice criteria OR
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
For Duragesic and fentanyl transdermal patch
Member has diagnosis of cancer and prescription is written by an oncologist or pain specialist OR
Member is enrolled in a hospice program or meets hospice criteria OR
Member has failed an every-72-hours regimen and requires dosing every 48 hours OR
Member requires a regimen of Duragesic with more than one patch every 72 hours OR
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
For Cocet, Embeda and Nucynta
Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
Age limit for members greater than or equal to 65 years of age:
A. Member has tried and failed any two of the following preferred alternative drugs -- codeine/APAP, dihydrocodeine/APAP/caffeine, oxycodone/APAP, hydrocodone/acetaminophen, hydromorphone, morphine, morphine SR, and tramadol -- that are appropriate in the elderly to treat the condition.
OR
B. The physician indicates the drug is medically necessary.
Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary Capital/Codeine, Combunox, Darvocet-N, Darvon, Darvon-N, Embeda, Fentora, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Magnacet, Norco, Nucynta, Onsolis, Opana, Percocet, Percodan, Primalev, Ryzolt, Talacen, Tylenol #3/#4, Tylox, Ultracet, Ultram, Ultram ER, Vicodin, Vicodin ES, Vicoprofen, Vopac, Xodol, and Zydone are subject to step-therapy. Aetna considers Capital/Codeine, Combunox, Darvocet-N, Darvon, Darvon-N, Embeda, Fentora, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Norco, Nucynta, Onsolis, Opana, Percocet, Percodan, Primalev, Ryzolt, Talacen, Trycet, Tylenol #3, Tylox, Ultracet, Ultram, Ultram ER, Vicodin, Vicodin ES, Vicoprofen, Vopac, Xodol and Zydone to be medically necessary for those members who meet the following step-therapy criterion:
A documented trial of two days of the corresponding preferred generic equivalent
For Darvon-N, Ryzolt, Ultram ER, Xodol and Zydone
A documented trial of two days of a preferred generic narcotic analgesic alternative
For Embeda
A documented trial of two days of morphine er
For Primalev and Magnacet
A documented trial of two days of any preferred generic oxycodone/acetaminophen product
For Opana
A documented trial of two days of any preferred generic oxycodone ir tab/sr alternative
For Fentora and Onsolis
A documented trial of two days of fentanyl transmucosal lozenges - a generic alternative on the Aetna Medicare Preferred Drug List.
For Nucynta
A documented trial of two days of any preferred generic morphine or oxycodone immediate release
If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)
Medical Exception Criteria
Balacet 325, Capital/Codeine, Combunox, Darvocet N, Darvon, Darvon-N, Embeda, Fentora, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Norco, Nucynta, Onsolis, Opana, Percocet, Percodan, Primalev, Ryzolt, Talacen, Tylenol #3/#4, Tylox, Ultracet, Ultram, Ultram ER, Vicodin, Vicodin ES, Vicoprofen, Vopac, Xodol, Zamicet, and Zydone are Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan* and are on the Aetna Step-Therapy List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step therapy criteria, unless a medical exception is granted. Aetna considers these to be medically necessary for those members who meet the following criteria:
Contraindication to the corresponding preferred generic equivalent OR
Intolerance to the corresponding preferred generic equivalent OR
Allergy to the corresponding preferred generic equivalent OR
Failure of an adequate trial of two days of the corresponding preferred generic equivalent
For Balacet 325, Darvon-N, Ryzolt, Ultram ER, Xodol and Zydone
A. A documented:
Contraindication to one preferred generic narcotic analgesic alternative OR
Intolerance to one preferred generic narcotic analgesic alternative OR
Allergy to one preferred generic narcotic analgesic alternative OR
Failure of an adequate trial of two days of one preferred generic narcotic analgesic alternative
For Embeda
A. A documented:
Contraindication to morphine erOR
Intolerance to morphine erOR
Allergy to morphine erOR
Failure of an adequate trial of two days of morphine er
For Primalev
A. A documented:
Contraindication to one preferred generic oxycodone/acetaminophen product indicated for the member's condition OR
Intolerance to one preferred generic oxycodone/acetaminophen product indicated for the member's condition OR
Allergy to one preferred generic oxycodone/acetaminophen product indicated for the member's condition OR
Failure of an adequate trial of two days of one preferred generic oxycodone/acetaminophen product indicated for the member's condition
For Opana
A. A documented:
Contraindication to one preferred generic oxycodone ir tab/sr alternative OR
Intolerance to one preferred generic oxycodone ir tab/sr alternative OR
Allergy to one preferred generic oxycodone ir tab/sr alternative OR
Failure of an adequate trial of two days of one preferred generic oxycodone ir tab/sr alternative
For Fentora and Onsolis
A. A documented current diagnosis of cancer
AND
B. Concomitant use of long acting opioid therapy (such as, controlled-release morphine (MS Contin, Oramorph SR, Kadian CR), extended-release morphine (Avinza), controlled-release oxycodone (Oxycontin CR), extended-release oxymorphone (Opana ER), fentanyl transdermal (Duragesic), methadone (Dolophine, Methadose)
AND
C. A documented:
Contraindication to the preferred generic alternative, fentanyl transmucosal lozengesOR,
Intolerance to the preferred generic alternative, fentanyl transmucosal lozengesOR,
Allergy to the preferred generic alternative, fentanyl transmucosal lozengesOR,
Failure of an adequate clinical trial of two days of the preferred generic alternative, fentanyl transmucosal lozenges.
For Nucynta
A. A documented:
Contraindication to any preferred generic morphine or oxycodone immediate release OR
Intolerance to any preferred generic morphine or oxycodone immediate releaseOR
Allergy to any preferred generic morphine or oxycodone immediate release OR
Failure of an adequate trial of two days of any preferred generic morphine or oxycodone immediate release
Avinza, Dazidox, Demerol, Dilaudid, Dolophine, Duragesic, Hycet, Liquicet, Magnacet, Maxidone, MS Contin, Opana inj, Oramorph SR, Panlor DC, Panlor SS, Percocet 2.5/325, Roxicet, Roxicodone, Stadol inj, Synalgos DC,Talwin, Talwin NX, Vopac and Zamicet are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Avinza, Dazidox, Demerol, Dilaudid, Dolophine, Duragesic, Hycet, Liquicet, Magnacet, Maxidone, MS Contin, Opana inj, Oramorph SR, Panlor DC, Panlor SS, Percocet 2.5/325, Roxicet, Roxicodone, Synalgos DC, Talwin, Talwin NX, Vopac and Zamicet to be medically necessary for those members who meet the following criteria:
A. A documented:
Contraindication to two preferred alternative narcotic analgesics (single entity or combination products) OR
Intolerance to two preferred alternative narcotic analgesics (single entity or combination products) OR
Allergy to two preferred alternative narcotic analgesics (single entity or combination products) OR
Failure of an adequate clinical trial of two days each of at least two preferred alternative narcotic analgesics (single entity or combination products) OR
Member is unable to use a preferred generic hydrocodone/APAP liquid (7.5-500mg/15ml) due to the higher concentration of acetaminophen in the preferred generic alternative (Liquicet, Hycet, and Zamicet ONLY)
Place of Service:
Outpatient
The above policy is based on the following references:
1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Caldwell JR, Rapoport RJ, Davis JC, et al. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open label extension trial. J Pain Symptom Management 2002;23:278-91.
8. Douglas MD, Garland WT, Kelly JB, et al. Efficacy of a new, once-daily, rapid-onset, extended-release morphine formulation (Morphelan) and a twice-daily morphine sulfate controlled-release formulation (MS Contin) in patients with chronic, moderate-to-severe pain [abstract #780]. Presented at the 20th Annual Scientific Meeting of the American Pain Society, Phoenix, AZ, April 19-22, 2001.
9. Portenoy RK, Sciberras A, Eliot L, et al. Steady-state pharmacokinetic comparison of a new, extended-release, once-daily morphine formulation, Avinza, and a twice-daily controlled-release morphine formulation in patients with chronic moderate-to-severe pain. J Pain Symptom Management 2002;23:292-300.
10. Eliot L, Geiser R, Loewen G. Steady-state pharmacokinetic comparison of a new, once-daily, extended-release morphine formulation (Morphelan) and OxyContin twice daily.
11. Rischitelli DG, Karbowicz SH. Safety and efficacy of controlled-release oxycodone: A systematic literature review. Pharmacotherapy 2002;22(7):898-904.
12. Quigley C. Hydromorphone for acute and chronic pain. Cochrone Database Syst Rev. 2002;(1):CD003447.
13. Amato L, Davoli M, Ferri M, Ali R. Methadone at tapered doses for the management of opioid withdrawal. Cochrane Database Syst Rev. 2002;(1):CD003409.
14. Medve RA, Wang J, Karim R, et al. Tramadol and acetaminophen tablets for dental pain. Anesth Prog. 2001 Summer;48(3):79-81.
15. Latta KS, Ginsberg B, Barkin RL. Meperidine: a critical review. Am J Ther. 2002;9(1):53-68.
16. Berde CB and Sethna NF. Analgesics for the treatment of pain in children. N Engl J Med. 2002;347:1094-1103.
17. Mystakidou K, Befon S, Tsilika E, Dardoufas K, et al. Use of TTS fentanyl as a single opioid for cancer pain relief: a safety and efficacy clinical trial in patients naïve to mild or strong opioids. Oncology. 2002;62(1):9-16.
18. Palangio M, Morris E, Doyle RT Jr, et al. Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of moderate or severe acute low back pain. Clin Ther. 2002;24(1):87-99.
19. Fricke JR Jr, Karim R, Jordan D, Rosenthal N. A double-blind, single-dose comparison of the analgesic efficacy of tramadol/acetaminophen combination tablets, hydrocodone/acetaminophen combination tablets, and placebo after oral surgery. Clin Ther. 2002;24(6):953-68.
20. McClellan K, Scott LJ. Tramadol/paracetamol. Drugs. 2003;63(11):1079-86; discussion 1087-8.
21. Institute for Clinical Systems Improvement (ICSI). Assessment and management of acute pain. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2006 Mar. 68 p. [118 references]
22. Babul N, Noveck R, Chipman H, Roth S, Gana T, and Albert K. Efficacy and safety of Extended-Release Once -Daily Tramadol in chronic pain. Journal of Pain & Symptom Mgmt. 2004; 28(1): 59-71
23. Darwish M, Kirby M, Robertson P JR, Hellriegel, E and Jiang J. Comparison of equivalent doses of fentanyl buccal tablets and arteriovenous differences in fentayl pharmacokinetics. Clin Pharamacokinet 2006; 45(8): 843-850
24. Kivits A, Ma C, Ahdieh H, Galer BS. A 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, Phase III trial comparing the efficacy of oxymorphone ER and placebo in adults with pain associated with osteoarthritis of the hip or knee. Clinical Therapeutics 2006; 28(3): 352-364
25. Hale M, Dvergsten, and Gimbel J. Efficacy and safety of oxymorphone ER in chronic low back pain. Journal of Pain 2005; 6(1): 21-28
26. McIlwain H, and Ahdieh H. Safety, tolerability, and effectiveness of oxymorphone ER for moderate to severe osteoarthritis pain. Amer J of Therapeutics 2005; 12: 106-112
27. Adams M and Ahdieh H. Single and multiple dose pharmacokinetic and dose-proportionality study of oxymorphone IR tablets. Drugs R D 2005; 6(2): 91-99
28. Matsumoto A, Babul N, and Ahdlieh H. Oxymorphone ER tablets relieve moderate to severe pain and improve physical function in osteoarthritis. Pain Medicine 2005; 6(5): 357-366
29. Gimbel JS, Walker D, Ma t, and Ahdieh H. Efficacy and safety of oxymorphone IR for the treatment of mild to moderate pain after ambulatory orthopedic surgery. Arch Phys Med Rehabil 2005; 86: 2284-2289
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*C = Covered, copay amount depends on benefits plan
CS = Covered under Specialty Tier
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
M EX = Medical Exception
TOC = Transition of Coverage
NSO = New Starts Only
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.
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