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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Analgesics, Narcotics and Narcotic Combinations

Status Drug PR PR-QL PR-AL ST M EX‡
P acetaminophen/codeine          
P aspirin/butalbital/caffeine          
P Balacet (propoxyphene-n 100/APAP 325)          
P butalbital/caffeine/codeine/ASA          
P butorphanol ns   X      
P dihydrocodeine combination          
P fentanyl patches   X      
P fentanyl transmucosal lozenge X X      
P hydrocodone/acetaminophen          
P hydrocodone/ibuprofen          
P hydromorphone          
P levorphanol          
P meperidine/promethazine          
P meperidine          
P methadone          
P methadose          
P morphine, morphine SR          
P Narvox™ (oxycodone w/ acetaminophen)          
P oxycodone          
P oxycodone/acetaminophen          
P oxycodone/aspirin          
P oxycodone/ibu   X      
P OxyFast® (oxycodone)          
P pentazocine/acetaminophen          
P pentazocine/naloxone          
P percolone          
P propoxyphene HCl          
P propoxyphene napsylate/APAP          
P propoxyphene/aspirin/caffeine          
P tramadol          
P tramadol/apap          
P vicodin hp (hydrocodone/apap)          
P Kadian CR®  (morphine CR)          
P Opana ER®  (oxymorphone HCl)          
P Oxycontin CR®  (oxycodone SR)   X      
NP Anexsia®  (hydrocodone/APAP)       X X
NP Bancap-HC®  (hydrocodone/APAP)       X X
NP Capital/Codeine®  (codeine/APAP)       X X
NP Darvocet-N®  (propoxyphene napsylate/APAP)       X X
NP Darvon®  (propoxyphene)       X X
NP Darvon Compound®  (aspirin/propoxyphene/caffeine)       X X
NP Demerol®  (meperidine)          
NP Dilaudid®  (hydromorphone)          
NP Fioricet/Codeine®  (butalbital/APAP/caffeine/codeine)       X X
NP Fiorinal/Codeine®  (butalbital/aspirin/caffeine/codeine)       X X
NP Hycet™  (hydrocodone/APAP)          
NP Liquicet™  (hydrocodone/APAP)       X X
NP Lorcet®/Lorcet HD®/Lorcet Plus®  (hydrocodone/APAP)       X X
NP Lortab®/Lortab elixir  (hydrocodone/APAP)       X X
NP MS Contin®  (morphone sulfate)          
NP Norco®  (hydrocodone/APAP)       X X
NP Oxyir  (oxycodone)          
NP Panlor SS/DC  (APAP/caffeine/dihydrocod)          
NP Percodan®  (oxycodone/aspirin)       X X
NP Percocet®  (oxycodone/APAP)       X X
NP Reprexain®  (hydrocodone/ibuprofen)       X X
NP Roxicet®  (oxycodone/APAP)       X X
NP Roxicodone®  (oxycodone)          
NP Synalgos DC®  (dihydrocodeine compound)       X X
NP Talacen®  (pentazocine/APAP)       X X
NP Tylenol #3®  (codeine/APAP)       X X
NP Tylox®  (oxycodone/APAP)       X X
NP Vicodin/Vicodin ES®/Vicodin HP®  (hydrocodone/APAP)       X X
NP Vicoprofen®  (hydrocodone/ibuprofen)       X X
NP Vopac®  (codeine/APAP)       X X
NP Xodol®  (hydrocodone/APAP)       X X
FE Alcet™  (oxycodone/APAP)       X X
FE Actiq®  (fentanyl transmucosal lozenge) X X     X
FE Avinza®  (morphine SR)         X
FE Combunox®  (oxycodone 5mg/ibuprofen 400mg)   X   X X
FE Duragesic®  (fentanyl transdermal)   X   X X
FE Fentora®  (fentanyl citrate buccal tab) X X   X X
FE Lynox®  (oxycodone/APAP)       X X
FE Magnacet™  (oxycodone/APAP)       X X
FE Maxidone®  (hydrocodone/APAP)       X X
FE Opana®  (oxymorphone HCl)         X
FE Percocet® 2.5/325  (oxycodone/APAP)       X X
FE Perlox™  (oxycodone/APAP)         X
FE Roxicet™ 5/500  (oxycodone/APAP)       X X
FE Theracodophen Pak®  (hydrcododone/apap-nutritional supp)         X
FE Trycet®  (propoxyphene-n 100/APAP 325)       X X
FE Ultracet®  (tramadol/APAP)         X
FE Ultram®  (tramadol)       X X
FE Ultram ER®  (tramadol sr)       X X
FE Zydone®  (hydrocodone/APAP)       X X
Note:

Criteria for Anti-Migraine medications are discussed in the Pharmacy Clinical Policy Bulletin:

Anti-Migraine- /products/rxnonmedicare/data/CNS/migraine_2007.html

 



Policy:

  1. Precertification Criteria
  2. 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

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    fentanyl transmucosal lozenge(lpop) Actiq 1 lpop four times daily 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg Up to 15 lpop in 30 days**
    oxycodone/ibuprofen Combunox 1 tablet four times daily 5 mg/ 40 mg Up to 120 tablets in 30 days
    fentanyl patch Duragesic 1-2 patches every 72 hours 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr Up to 20 patches in 30 days (2 patches per 3 days)
    Fentora 1 buccal tablet four times daily 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, 800 mcg Up to 15 lpop in 30 days**
    OxyContin CR 1-2 tablets every 12 hrs 10 mg, 20 mg, 40 mg, 80 mg Up to 120 tablets in 30 days (320mg/day)
    butorphanol 2-3 times daily Nasal solution 10 mg/ml Up to 2 bottles in 30 days


    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) and the total daily dose is <320mg, AND the 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

    **For fentanyl transmucosal lozenge(lpop), Actiq; Fentora

    • 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))

     



  3. Step Therapy Criteria
  4. 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:

    For Alcet, Anexsia, Bancap HC Capital/Codeine, Darvocet-N, Darvon, Darvon Compound, Duragesic, Fioricet/Codeine, Fiorinal/Codeine, Fentora, Lorcet/HD/Plus, Lortab, Lortab elixir, Maxidone,  Norco, Percodan, Percocet, Roxicet, Talacen, Tylenol #3, Tylox, Trycet, Ultram, Vicodin, Vicodin ES, and Vicoprofen

    A.  A documented:

    • 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
       

     

  5. Medical Exception Criteria
  6. 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:

    For Alcet, Anexsia, Bancap HC Capital/Codeine, Darvocet-N, Darvon, Darvon Compound, Duragesic, Fioricet/Codeine, Fiorinal/Codeine, Fentora, Lorcet/HD/Plus, Lortab, Lortab elixir, Maxidone,  Norco, Percodan, Percocet, Roxicet, Talacen, Tylenol #3, Tylox, Trycet, Ultram, Vicodin, Vicodin ES, and Vicoprofen

    A.  A documented:

    • 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, Ultra