Under some plans, including plans that use an open or closed formulary, Actiq, butorphanol ns, Combunox, Duragesic, fentanyl patch, fentanyl transmucosal lozenge, Fentora,oxycodone/ibu and OxyContin CR, are subject to precertification. If precertification requirements apply Aetna considers Actiq, butorphanol ns, Combunox, Duragesic, fentanyl patch, fentanyl transmucosal lozenge, Fentora, oxycodone/ibu and OxyContin CR, to be medically necessary for those members who meet the following precertification criteria:
(A AND B) AND C For Actiq, fentanyl transmucosal lozenge, Fentora-ONLY
C - For butorphanol ns, Combunox, Duragesic, fentanyl patch, oxycodone/ibu,OxyContin CR
A documented
A. Diagnosis of cancer
AND
B.Concomitant use of long acting opioid therapy*
AND
C. According to the manufacturer and/or clinical literature, Actiq, butorphanol ns, Combunox, Duragesic, fentanyl patch, fentanyl transmucosal lozenge, Fentora, oxycodone/ibu 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
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 Combunox, fentanyl patch, Duragesic, oxycodone/ibu, OxyContin CR,
butorphanol
Member has diagnosis of cancer and prescription is written by an oncologist orpain 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 OR
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 has failed an every-72-hours regimen and requires dosing every 48 hours (Duragesic, fentanyl patch-only)OR
Member requires a regimen of Duragesic with more than one patch every 72 hours (Duragesic, fentanyl patch-only) OR
Member requires a dose every 12 hours(BID) andthetotaldaily dose is <320mg,ANDthe member has prior history of dose titration increasing incrementally (OxyContin CR-only)OR
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’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
Member has current diagnosis of cancer (as the primary cause of the pain) and is currently on long-acting opioid and is being titrated on the long-acting opioid 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. oxycodone, morphine sulfate oral(Roxanol); oxymorphone(Opana); hydromorphone(Dilaudid); oxycodone/ibuprofen(Combunox); oxycodone/apap(Percocet))
Step Therapy Criteria
Alcet, Anexsia, Bancap HC Capital/Codeine, Combunox, Darvocet-N, Darvon, Darvon Compound, Duragesic, Fioricet/Codeine, Fiorinal/Codeine, Fentora, Lorcet/HD/Plus, Lortab, Lortab elixir, Lynox, Magnacet, Maxidone, Norco, Percodan, Percocet, Percocet 2.5/325, Reprexain, Roxicet, Roxicet 5/500, Synalgos DC, Talacen, Tylenol #3, Tylox, Trycet, Ultram, Ultram ER, Vicodin, Vicodin ES, Vicoprofen, Vopac, Xodol, and Zydone are currently listed on the Step-Therapy List.* Therefore, these 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 them to be medically necessary for those members who meet the criteria below:
Contraindication to the preferred generic equivalent alternative OR
Intolerance to the preferred generic equivalent alternative OR
Allergy to the preferred generic equivalent alternative OR
Failure of an adequate clinical trial of two days of the preferred generic equivalent alternative.
For Combunox, Fentora, Lynox, Magnacet, Percocet 2.5/325, Reprexain, Roxicet 5/500, Synalgos DC, Ultram ER, Vopac, Zydone tab, and Xodol
For Combunox A. A documented:
Contraindication to a preferred generic oxycodone combination alternative OR
Intolerance to a preferred generic oxycodone combination alternative OR
Allergy to a preferred generic oxycodone combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic oxycodone combination alternative
For Fentora A. A documented:
Contraindication to the preferred generic fentanyl transmucosal lozenge alternative OR
Intolerance to the preferred generic fentanyl transmucosal lozenge alternative OR
Allergy to the preferred generic fentanyl transmucosal lozenge alternative OR
Failure of an adequate clinical trial of one week of the preferred generic fentanyl transmucosal lozenge alternative
For Lynox, Magnacet, Percocet 2.5/325, Roxicet 5/500
A. A documented:
Contraindication to a preferred generic oxycodone/acetaminophen combination alternative OR
Intolerance to a preferred generic oxycodone/acetaminophen combination alternative OR
Allergy to a preferred generic oxycodone/acetaminophen combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic oxycodone/acetaminophen combination alternative.
For Reprexain
A. A documented:
Contraindication to a preferred generic hydrocodone/ibuprofen combination alternative OR
Intolerance to a preferred generic hydrocodone/ibuprofen combination alternative OR
Allergy to a preferred generic hydrocodone/ibuprofen combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic hydrocodone/ibuprofen combination alternative
For Synalgos DC
A. A documented:
Contraindication to a preferred generic dihydrocodeine combination alternative OR
Intolerance to a preferred generic dihydrocodeine combination alternative OR
Allergy to a preferred generic dihydrocodeine combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic dihydrocodeine combination alternative
For Ultram ER
A. A documented:
Contraindication to a preferred generic tramadol alternative OR
Intolerance to a preferred generic tramadol alternative OR
Allergy to a preferred generic tramadol alternative OR
Failure of an adequate clinical trial of two days of a preferred generic tramadol alternative
For Vopac,
A. A documented:
Contraindication to a preferred generic acetaminophen/codeine combination alternative OR
Intolerance to a preferred generic acetaminophen/codeine combination alternative OR
Allergy to a preferred generic acetaminophen/codeine combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic acetaminophen/codeine combination alternative
For Xodol and Zydone
A. A documented:
Contraindication to a preferred generic hydrocodone/acetaminophen combination alternative OR
Intolerance to a preferred generic hydrocodone/acetaminophen combination alternative OR
Allergy to a preferred generic hydrocodone/acetaminophen combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic hydrocodone/acetaminophen combination alternative
Medical Exception Criteria
Alcet, Anexsia, Bancap HC Capital/Codeine, Combunox, Darvocet-N, Darvon, Darvon Compound, Duragesic, Fioricet/Codeine, Fiorinal/Codeine, Fentora, Lorcet/HD/Plus, Lortab, Lortab elixir, Lynox, Magnacet, Maxidone, Norco, Percodan, Percocet, Percocet 2.5/325, Reprexain, Roxicet, Roxicet 5/500, Synalgos DC, Talacen, Tylenol #3, Tylox, Trycet, Ultram, Ultram ER, Vicodin, Vicodin ES, Vicoprofen, Vopac, Xodol, and Zydone are currently listed on the Step-Therapy List.* Therefore, these 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 them to be medically necessary for those members who meet the criteria below:
Contraindication to the preferred generic equivalent alternative OR
Intolerance to the preferred generic equivalent alternative OR
Allergy to the preferred generic equivalent alternative OR
Failure of an adequate clinical trial of two days of the preferred generic equivalent alternative.
For Combunox, Fentora, Lynox, Magnacet, Percocet 2.5/325, Reprexain, Roxicet 5/500, Synalgos DC, Ultram ER, Vopac, Zydone tab, and Xodol
For Combunox A. A documented:
Contraindication to a preferred generic oxycodone combination alternative OR
Intolerance to a preferred generic oxycodone combination alternative OR
Allergy to a preferred generic oxycodone combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic oxycodone combination alternative
For Fentora A documented
A. Diagnosis of cancer
AND
B. Concomitant use of long acting opioid therapy*
AND C. A documented:
Contraindication to the preferred generic fentanyl transmucosal lozenge alternative OR
Intolerance to the preferred generic fentanyl transmucosal lozenge alternative OR
Allergy to the preferred generic fentanyl transmucosal lozenge alternative OR
Failure of an adequate clinical trial of one week of the preferred generic fentanyl transmucosal lozenge alternative
For Lynox, Magnacet, Percocet 2.5/325, Roxicet 5/500
A. A documented:
Contraindication to a preferred generic oxycodone/acetaminophen combination alternative OR
Intolerance to a preferred generic oxycodone/acetaminophen combination alternative OR
Allergy to a preferred generic oxycodone/acetaminophen combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic oxycodone/acetaminophen combination alternative.
For Reprexain
A. A documented:
Contraindication to a preferred generic hydrocodone/ibuprofen combination alternative OR
Intolerance to a preferred generic hydrocodone/ibuprofen combination alternative OR
Allergy to a preferred generic hydrocodone/ibuprofen combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic hydrocodone/ibuprofen combination alternative
For Synalgos DC
A. A documented:
Contraindication to a preferred generic dihydrocodeine combination alternative OR
Intolerance to a preferred generic dihydrocodeine combination alternative OR
Allergy to a preferred generic dihydrocodeine combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic dihydrocodeine combination alternative
For Ultram ER
A. A documented:
Contraindication to a preferred generic tramadol alternative OR
Intolerance to a preferred generic tramadol alternative OR
Allergy to a preferred generic tramadol alternative OR
Failure of an adequate clinical trial of two days of a preferred generic tramadol alternative
For Vopac,
A. A documented:
Contraindication to a preferred generic acetaminophen/codeine combination alternative OR
Intolerance to a preferred generic acetaminophen/codeine combination alternative OR
Allergy to a preferred generic acetaminophen/codeine combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic acetaminophen/codeine combination alternative
For Xodol and Zydone
A. A documented:
Contraindication to a preferred generic hydrocodone/acetaminophen combination alternative OR
Intolerance to a preferred generic hydrocodone/acetaminophen combination alternative OR
Allergy to a preferred generic hydrocodone/acetaminophen combination alternative OR
Failure of an adequate clinical trial of two days of a preferred generic hydrocodone/acetaminophen combination alternative
Actiq, Alcet, Avinza, Opana, Perlox, Theracodophen Pak and Ultracet are currently listed on the Aetna Formulary Exclusions List.* Therefore, these 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 these to be medically necessary for those members who meet the following criteria:
A AND B AND C For Actiq ONLY C- For Alcet, Avinza, Opana; Perlox, Theracodophen Pak, Ultracet
A. Diagnosis of cancer
AND
B. Concomitant use of long acting opioid therapy*
AND
C. A documented:
Contraindication to two preferred analgesics, either narcotic analgesics (single entity or combination products) OR
Intolerance to two preferred analgesics, either narcotic analgesics (single entity or combination products) OR
Allergy to two preferred analgesics, either narcotic analgesics (single entity or combination products) OR
Failure of an adequate clinical trial of two days each of at least two preferred analgesics, either narcotic analgesics (single entity or combination products).
Approximate Equianalgesic Dosing of Opioid Analgesics in Adults
Drug
Duration
Half-life
Route
Equianalgesic Dosage
Codeine
4–6 h
3 h
IM
120 mg
PO
200 mg
Fentanyl Sublimaze
Duragesic Patch
1–2 h
1.5–6 h
IM
0.1 mg
Transdermal Patch 25mcg/hr (for chronic pain only) roughly equivalent to oral morphine 50mg/24hr. Upward titration of patch no more frequently than every 3 days
Hydrocodone Lorcet
Lortab
Vicodin
4–8 h
3.3–4.5 h
PO
30 mg
Hydromorphone Dilaudid
4–5 h
2–3 h
IM
1.3–1.5 mg
PO
7.5 mg
Levorphanol Levo-Dromora
6–8 h
12–16 h
IM
2 mg
PO
4 mg
Meperidine Demerol
2–4 h
3–4 h
IM
75 mg
PO
300 mg
Methadone Dolophine
4–6 h
15–30 h
IM
10 mg
PO
10–20 mg
Morphine Roxanol
3–7 h
1.5–2 h
IM
10 mg
PO
30–60 mg
Extended-release morphine -Avinza
Q24hr
PO
30
Controlled-release morphine MS Contin
Oramorph SR
Kadian
The above policy is based on the following references:
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 SymptomManagement 2002;23:278-91.
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 20thAnnual Scientific Meeting of the American Pain Society, Phoenix, AZ, April 19-22, 2001.
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.
Richards D, Simmonds M, Shelby S, et al. Once daily, rapid onset extended release morphine in patients with chronic malignant pain. Abstract #1559. Presented at the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.
Anon. Drugs for pain. Med Lett Drugs Ther. 1998;40(1033):79-84.
Quigley C. Hydromorphone for acute and chronic pain. Cochrone Database Syst Rev. 2002;(1):CD003447.
Broomhead A, Kerr R, Tester W, O’Meara P, Maccarrone C, et al. Comparison of a once-a day sustained-release morphine formulation with standard oral morphine treatment for cancer pain.J Pain Symptom Manage 1997; 14 (2): 63-73.
Kerr R, Tester W. A patient preference study comparing two extended-release morphine sulfate formulations (once-daily Kadian versus twice-daily MS Contin) for cancer pain.Clin Drug Invest 2000; 19 (1): 25-32.
Rischitelli DG, Karbowicz SH. Safety and efficacy of controlled-release oxycodone: A systematic literature review. Pharmacotherapy 2002;22(7):898-904.
American Pain Society.Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain 4th ed. Glenview, IL: American Pain Society, 1999.
Kaplan R, Parris WC-V, Citron ML, et al. Comparison on controlled-release and immediate-release oxycodone tablets inpatients with cancer pain.J Clin Oncol. 1998;16(10):3230-3237
Heiskanen T, Kalso E. Controlled-release oxycodone and morphine in cancer related pain.Pain. 1997;73:37-45.
Citron ML, Kaplan R, Parris WC-V, et al. Long-term administration of controlled-release oxycodone tablets for the treatment of cancer pain.Cancer Invest. 1998;16(8):562-571.
Mucci-LoRusso P, Berman BS, Silberstein PT, et al.Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study.Eur J Pain. 1998;2:239-249.
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2006.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2006.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2006.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2006.
Product Information Opana® and OpanaER® accessed at http://opana.com/
Pereira J, Lawlor P, Vigano A, et al. Equianalgesic dose ratios for opioids. a critical review and proposals for long-term dosing. J Pain Symptom Manage 2001;22:672-87.
Anderson R, Saiers JH, Abram S, Schlicht C. Accuracy in equianalgesic dosing. conversion dilemmas. J Pain Symptom Manage 2001;21:397-406
Copyright 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.
*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
*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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