Note: Criteria for fentanyl and Duragesic is discussed in the Pharmacy Clinical Policy Bulletin: Duragesic; and Criteria for OxyContin CR is discussed in the Pharmacy Clinical Policy Bulletin: OxyContin CR
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, Balacet, butorphanolnasal spray, Combunox, Darvocet-N, Darvon-N, Demerol, meperidine, Opana, oxycodone/ibuprofen, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCL, propoxyphene/aspirin/caffeine, propoxyphene napsylate/acetaminophen, Talacen, Talwin NX and Trycet are subject to precertification. If precertification requirements apply Aetna considers Balacet, butorphanol nasal spray, Combunox, Darvocet-N-100, Darvon-N, Demerol, meperidine, Opana, oxycodone/ibuprofen, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCL, propoxyphene/aspirin/caffeine, propoxyphene napsylate/acetaminophen, Talacen, Talwin NX and Trycet to be medically necessary for those members who meet the following precertification criterion:
A. Quantity limits:
For Butorphanol nasal spray
A. Quantity limits: 2 vials/30 day supply increments
For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of butorphanol nasal spray will be considered medically necessary for those members who meet the following criterion:
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
For Combunox and oxycodone/ibuprofen
A. Quantity limits: 5 mg/400 mg - 120 tablets per 30 days
For coverage of additional tablets, member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of Combunox will be considered medically necessary for those members who meet the following criterion:
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
For Opana*
A. Quantity limits: Opana - 180 tablets per 30 days
For coverage of additional tablets, member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of Opana will be considered medically necessary for those members who meet the following criterion:
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
*For a diagnosis of cancer, the quantity limits on Opana do not apply.
B. For Balacet, Darvocet-N, Darvon-N, Demerol, meperidine, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCL, propoxyphene/aspirin/caffeine, propoxyphene napsylate/acetaminophen, Talacen, Talwin NX and Trycet
Age limit for members equal to or greater than 65 years of age:
A. Member has tried and failed alternative drugs that are appropriate in the elderly
to treat the condition. OR B. Member has been stabilized on the drug for an extended period of time OR
C. Discontinuation of the drug or change in drug therapy might result in physical and/or
mental impairment OR
D. Member is in a critical or terminal state and disruption of therapy would be
inappropriate OR E. It is medically necessary that the member receive the drug AND Member is being monitored AND Member has no known history of emergency department visits and/or hospital admissions
from use of the drug OR F. Member received a prescription for the drug from an emergency room physician or from a
physician in an acute care setting and will only be using the drug for a short duration of time.
Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Alcet, Bancap HC,Capital/Codeine, Combunox, Darvocet-N, Darvon-N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Lynox, Magnacet, Norco, Opana, Percocet, Percodan, Primalev, Reprexain, Talacen, Trycet, Tylenol #3/#4, Tylox, Ultracet, Ultram, Vicodin, Vicodin ES, Vicoprofen, Xodol, and Zydone are subject to step-therapy. Aetna considers, Alcet, Bancap HC, Capital/Codeine, Combunox, Darvocet-N, Darvon-N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Lynox, Magnacet, Norco, Opana, Percocet, Percodan, Primalev, Reprexain, Talacen, Trycet, Tylenol #3, Tylox, Ultracet, Ultram, Vicodin, Vicodin ES, Vicoprofen, Xodol and Zydone to be medically necessary for those members who meet the following step-therapy criterion:
For Alcet, Bancap HC,Capital/Codeine, Combunox, Darvocet-N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Norco, Percocet, Percodan, Talacen, Trycet, Tylenol #3/#4, Tylox, Ultracet, Ultram, Vicodin, Vicodin ES and Vicoprofen
A documented trial of two days of the corresponding covered generic equivalent
For Darvon-N, Reprexain, Xodol and Zydone
A documented trial of two days of a covered generic alternative
For Lynox, Magnacet and Primalev
A documented trial of two days of any covered generic oxycodone/acetaminophen product
For Opana
A documented trial of two days of any covered generic oxycodone product
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
Alcet, Bancap HC, Capital/Codeine, Combunox, Darvocet N, Darvon-N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Lynox, Magnacet, Norco, Opana, Percocet, Percodan, Primalev, Reprexain, Talacen, Trycet, Tylenol #3/#4, Tylox, Ultracet, Ultram, Vicodin, Vicodin ES, Vicoprofen, 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:
For Alcet, Bancap HC, Capital/Codeine, Combunox, Darvocet N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet Plus, Lortab, Norco, Percocet, Percodan, Talacen, Trycet, Tylenol #3/#4, Tylox, Ultracet, Ultram, Vicodin, Vicodin ES and Vicoprofen
A. A documented:
Contraindication to the corresponding covered generic equivalent OR
Intolerance to the corresponding covered generic equivalent OR
Allergy to the corresponding covered generic equivalent OR
Failure of an adequate trial of two days of the corresponding covered generic equivalent
For Darvon-N, Reprexain, Xodol and Zydone
A. A documented:
Contraindication to one covered generic alternative indicated for the member's condition OR
Intolerance to one covered generic alternative indicated for the member's condition OR
Allergy to one covered generic alternative indicated for the member's condition OR
Failure of an adequate trial of two days of one covered generic alternative indicated for the member's condition
For Lynox, Magnacet and 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 product indicated for the member's condition OR
Intolerance to one preferred generic oxycodone product indicated for the member's condition OR
Allergy to one preferred generic oxycodone product indicated for the member's condition OR
Failure of an adequate trial of two days of one preferred generic oxycodone product indicated for the member's condition
Avinza, Dazidox, Demerol, Dilaudid, Dolophine, Duragesic, Liquicet, Maxidone, MS Contin, Opana inj, Oramorph SR, OxyIR, Panlor DC, Panlor SS, Roxanol, Roxicet solution and 5/500 tablet, Roxicodone, Synalgos DC, Talwin NX, Ultram ER 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, Liquicet, Maxidone, MS Contin, Opana inj, Oramorph SR, OxyIR, Panlor DC, Panlor SS, Roxicet solution and 5/500 tablet, Roxanol, Roxicodone, Synalgos DC, Talwin NX, Ultram ER 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 covered generic hydrocodone/APAP liquid due to the higher strength of APAP in the covered generic alternative (Liquicet ONLY)
Place of Service:
Outpatient
The above policy is based on the following references:
DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
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.
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.
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.
Eliot L, Geiser R, Loewen G. Steady-state pharmacokinetic comparison of a new, once-daily, extended-release morphine formulation (Morphelan) and OxyContin twice daily.
Rischitelli DG, Karbowicz SH. Safety and efficacy of controlled-release oxycodone: A systematic literature review. Pharmacotherapy 2002;22(7):898-904.
Quigley C. Hydromorphone for acute and chronic pain. Cochrone Database Syst Rev. 2002;(1):CD003447.
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.
Medve RA, Wang J, Karim R, et al.Tramadol and acetaminophen tablets for dental pain. Anesth Prog. 2001 Summer;48(3):79-81.
LattaKS, Ginsberg B, Barkin RL. Meperidine: a critical review. Am J Ther. 2002;9(1):53-68.
Berde CB and Sethna NF. Analgesics for the treatment of pain in children. N Engl J Med. 2002;347:1094-1103.
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.
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.
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.
McClellan K, Scott LJ. Tramadol/paracetamol. Drugs. 2003;63(11):1079-86; discussion 1087-8.
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
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
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
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
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
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
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
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
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.