Pharmacy Policy Bulletin
Fexmid (cyclobenzaprine) – Commercial and Healthcare Reform
Number: J-0288 Category: Managed Rx Coverage
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial (1. or 2.):

1.  Rx Mgmt Step Therapy = Preferred

2.  Rx Mgmt Performance = MRXC = Yes

 

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Fexmid (cyclobenzaprine)
FDA-Approved Indications:
  • Adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions


Background:
  • Fexmid relieves muscle spasms through a central action, possibly at the brain stem level, with no direct action on the neuromuscular junction or the muscle involved.
  • Cyclobenzaprine tablets are available in 5 mg, 7.5 mg, and 10 mg strengths. The 5 mg and 10 mg tablets are generics of Flexeril while the 7.5 mg tablets are generics of Fexmid.
  • For most patients, the recommended dose of cyclobenzaprine is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day.
  • Muscle relaxants should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
  • Prescribing Considerations:
    • Safety and effectiveness of cyclobenzaprine tablets in pediatric patients below 15 years of age have not been established.


Approval Criteria

I.      Initial Authorization        

       When a benefit, coverage of Fexmid may be approved when all of the following criteria are met  (A. and B.):

 A.  The member has a diagnosis of muscle spasms associated with an acute, painful musculoskeletal condition.

 B.   The member has experienced therapeutic failure or intolerance to three (3) of the following medications, or contraindication to all four (4) medications (1. through 4.):

1. Generic cyclobenzaprine 5 mg tablets or 10 mg tablets

2. Generic methocarbamol tablets

3. Generic chlorzoxazone 500 mg

4. Generic baclofen tablets

 

II.    Reauthorization

When a benefit, reauthorization of Fexmid may be approved when all of the following criteria are met (A. and B.):

A.    The prescriber attests that the member continues to experience discomfort associated with an acute, painful musculoskeletal condition. 

B.    The prescriber attests that the member has experienced positive clinical response to therapy.

 

III.   An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations. 


Limitations of Coverage

I.      Coverage of Fexmid for disease states outside of its FDA-approved indication(s) should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

II.    For Commercial or HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.


Authorization Duration
  • Commercial and HCR Plans: If approved, up to a 6 month authorization may be granted.


Automatic Approval Criteria

Members who meet the criterion below (A.) will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate on-line, with no prior authorization required.

 

A.    The member has a paid claim for three (3) of the following medications within the past 90 days (1. through 4.):

1.     Generic cyclobenzaprine 5 mg tablets or generic cyclobenzaprine 10 mg tablets

2.     Generic methocarbamol tablets

3.     Generic chlorzoxazone 500 mg

4.     Generic baclofen tablets


Version: J-0288-001
Effective Date Begin: 10/01/2020
Effective End Begin: 03/31/2021
Original Date: 06/03/2020
Review Date: 08/05/2020


References:

  1. Flexeril [package insert]. Washington, PA: McNeil Consumer Healthcare; April 2013.
  2. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2020. Accessed July 13, 2020.
  3. Clinical Pharmacology On-line. Tampa, FL: Elsevier 2020. Accessed July 13, 2020.
  4. Witenko, C, Moorman-Li, R, et al. Consideration for the Appropriate Use of Skeletal Muscle Relaxants for the Management of Acute Low Back Pain. P.T. 2014 Jun; 39(6): 427-435,

 




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.