Category: Analgesics

Class: Opioid Analgesics

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX	TOC	NSO
Opioid Partial Agonists
C	BUPRENORPHINE HCL inj
C	Buprenorphine HCl SL Tab		X
C	BUTORPHANOL TARTRATE inj
C	BUTORPHANOL TARTRATE (NASAL SOLN ONLY)			X
C	PENTAZOCINE/ACETAMINOPHEN			X	X
C	PENTAZOCINE/NALOXONE HCL			X	X
C	NALBUPHINE HCL inj
C	SUBOXONE  (BUPRENORPHINE HCL-NALOXONE HCL SL)		X
C	SUBUTEX  (BUPRENORPHINE HCL SL)		X
C	TALWIN inj  (PENTAZOCINE LACTATE)				X
NC	BUPRENEX inj  (BUPRENORPHINE HCL)						X
NC	STADOL inj  (BUTORPHANOL TARTRATE)						X
NC	TALACEN  (PENTAZOCINE W/ APAP)			X	X	X	X
NC	TALWIN NX  (PENTAZOCINE W/ NALOXONE)			X	X		X

Policy:

1. Precertification Criteria:

Under some plans, including plans that use an open or closed formulary, precertifcation criteria may apply.  If precertification requirements apply Aetna considers the drugs below to be medically necessary for those members who meet the following precertification criteria:

1. Covered Uses

Aetna considers the drugs below medically necessary for any of the following indications:

For  Suboxone and buprenorphine sl /Subutex:

• Diagnosis of treatment of opioid dependence OR Chronic pain.
  
  
2. Prescriber Restrictions

Aetna considers the following  Prescriber Restrictions medically necessary for the drugs listed below.

For Subuxone and buprenorphine sl /Subutex:

• For treatment of opioid dependence-Physician must have DATA 2000 waiver with a Unique Identification Number and a DEA number.
  
  
3. Age Limitations

According to the manufacturer labeling or dosing safety guidelines Aetna considers the following age criteria medically necessary for the drugs listed below.

For pentazocine/acetaminophen, pentazocine/naloxone HCL, Talacen, Talwin and Talwin NX:

• Covered for members less than 65 years of age
  
  
4. Age Limitations Medical Exceptions

If it is medically necessary for a member to be treated initially with one of these medications subject to age limitation, the member, a person appointed to manage the member’s care, or the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit at 1-800-414-2386 to request coverage as a medical exception. Aetna considers these drugs to be medically necessary for those members who meet the criteria specified below.

For pentazocine/acetaminophen, pentazocine/naloxone HCL, Talacen, Talwin inj and Talwin NX:

• If member is greater than or equal to 65 years of age, they must try and fail an alternative drug to treat the condition  that is appropriate in the elderly such as codeine/APAP, dihydrocodeine/APAP/caffeine, oxycodone, oxycodone/APAP, hydrocodone/acetaminophen, hydromorphone, morphine, morphine SR OR  tramadol OR The physician indicates the drug is medically necessary.
  
  
5. Precertification Coverage Duration

Aetna considers the following Maximum length of approval for the drug(s) that meet any/all precertification criteria that applies.

Through End of Plan Contract Year.



2. Quantity Limits




According to the manufacturer labeling, a quantity of each drug will be considered medically necessary as indicated in the table below:

Drug Name	Dosage Form	Strength	Qty	Day(s)
butorphanol tartrate	NASAL SOLUTION	10 MG/ML	2 spray vials* (*1 vial = 2.5 mls )=50MG	Per 30 days	Max Daily Dose 2 sprays every 3-4 hrs Labeling does not list a maximum dose
pentazocine w/apap; TALACEN	TABLET	25-650 MG	6	Per day	Max Daily Dose 6 tablets /day The maximum number of tablets per 24 hours is limited by a maximum acetaminophen dose of 4 g/day
pentazocine/naloxone; TALWIN NX	TABLET	50-0.5 MG	12	Per day	Max Daily Dose 12 tablets per day The maximum number of tablets per 24 hours is limited by the pentazocine dose of 600mg/day.





Quantity Limit Exceptions

For coverage of additional quantities, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit at 1-800-414-2386. Additional quantities will be considered medically necessary for those members who meet the following criteria.

• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.

Quantity Limit Coverage Duration

Aetna considers the following Maximum length of approval for the drug(s) that meet quantity limits criteria.
 
Through End of Plan Contract Year





3. Step Therapy Criteria




Under some plans, including plans that use an open or closed formulary, step-therapy criteria may apply. If step-therapy requirements apply Aetna considers the drugs below to be medically necessary for those members who meet the following step-therapy criteria.

For Talacen:

• A documented trial of two days of the corresponding  generic equivalent
  
  
1. Step Therapy Medical Exceptions




If it is medically necessary for a member to be treated initially with one of these medications subject to step-therapy, the member, a person appointed to manage the member’s care, or the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit at 1-800-414-2386 to request coverage as a medical exception. Aetna considers these drugs to be medically necessary for those members who meet the criteria specified below.

For Talacen:

• Contraindication or Intolerance or Allergy or Failure  of two days of the corresponding  generic equivalent
  
  
2. Step Therapy Coverage Duration




Aetna considers the following Maximum length of approval for the drug(s) that meet step therapy criteria.

Through End of Plan Contract Year.



4. Not Covered Drug Criteria




Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan  are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers the drugs below to be medically necessary for those members who meet the following criteria.

For ALL Not Covered (NC) Drugs

• Contraindication or Intolerance or Allergy or Failure of two days each of three covered(C) alternatives, at least one of which must be the drug's own generic equivalent if available.
  
  
1. Not Covered Drug Coverage Duration




Aetna considers the following Maximum length of approval for the drug(s) that meet criteria for not covered drugs.

Through End of Plan Contract Year.

Special Notes:

Where can I find out more information about buprenorphine treatment for opioid addiction?
In addition to http://buprenorphine.samhsa.gov/faq.html#A27 Web site, you can visit the FDA's buprenorphine pages at http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm, and the manufacturer's Web site at http://www.suboxone.com/.

Additionally, you can contact the SAMHSA Buprenorphine Information Center by telephone, toll-free at 1-866-BUP-CSAT (1-866-287-2728), or by e-mail at info@buprenorphine.samhsa.gov.

 

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. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
8. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
9. Johnson RE & McCagh JC: Buphenorphine and naloxone for heroin dependence. Curr Psychiatr Rep 2000; 2:519-526.
10. Anon: Department of Health and Human Services; Substance abuse and mental health services administration. 42 CFR Part 8. Opioid drugs in maintenance and detoxification treatment of opiate addiction; addition of buprenorphine and buprenorphine combination to list of approved opioid treatment medications. Federal Register 2003; 68:27937-27939.
11. Raisch DW, Fye C, Boardman KD, et al: Opioid dependence treatment, including buprenorphine/naloxone. Ann Pharmacother 2002; 36:312-321.
12. Mattick RP, Kimber J, Breen C, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2003;(2):CD002207

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.

Original Policy Date: January 01, 2010

Effective Date: January 01, 2010