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Interferons are species specific proteins that possess complex antiviral, antineoplastic and immunomodulatory activity. There are 3 major classes of interferons -- alpha, beta and gamma with overlapping but distinct biologic properties. Though the specific mechanism of action of interferon beta-1a (Avonex®)(Rebif®) and interferon beta-1b (Betaseron®) (Extavia®) are unknown, it is expected to involve their immunoregulatory actions.

An alternative to beta interferons is glatiramer acetate (Copaxone®) formerly known as copolymer-1.  The mechanism by which glatiramer acetate (Copaxone®) exerts its effect in multiple sclerosis is not fully known.  It is thought to act by modifying immune processes that are currently believed to be responsible for the pathogenesis of MS.

Natalizumab (Tysabri®) is a recombinant humanized IgG4K monoclonal antibody. The specific mechanism of action in multiple sclerosis is unknown. It is thought that it prevents the migration of leukocytes across the endothelium into inflamed parenchymal tissues.

Dalfampridine (Amprya®) is a potassium channel blocker which has been found to improve impulse conduction in nerve fibers in which the myelin sheath has been damaged.

Fingolimod (Gilenya®) is a sphingosine 1-phosphate receptor modulator. The mechanism of action in multiple sclerosis is unknown. It is thought that it may involve reduction of lymphocyte migration into the central nervous system.

Teriflunomide (Aubagio®) is an immunomodulatory agent with anti-inflammatory properties. It inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which it exerts its therapeutic effect in MS is unknown but may involve a reduction in the number of activated lymphocytes in CNS.

FDA APPROVED INDICATIONS

Interferon beta-1a (Avonex®) (Rebif®), interferon beta-1b (Betaseron®) (Extavia®) and glatiramer acetate (Copaxone®) are indicated for the treatment of relapsing forms of  multiple sclerosis to decrease the frequency of clinical exacerbations. Interferon beta-1a (Avonex®) (Rebif®) are also indicated to slow the accumulation of physical disability in MS. 

Natalizumab (Tysabri®) is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumlation of physical disability and reduce the frequency of clinical exacerbations. Natalizumab (Tysabri®) is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis therapies.

Dalfampridine (Ampyra®) is indicated as a treatment to improve walking in patients with multiple sclerosis.

Fingolimod (Gilenya®) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Teriflunomide (Aubagio®) is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.

IDENTIFICATION

Generic Name: Interferon beta-1a
Brand Name: Avonex®

Generic Name:  Interferon beta-1a
Brand Name:  Rebif®

Generic Name: Interferon beta-1b
Brand Name: Betaseron®

Generic Name: Interferon beta-1b

Brand Name: Extavia®

Generic Name:  Glatiramer acetate
Brand Name:  Copaxone®

Generic Name: Natalizumab
Brand Name: Tysabri®

Generic Name: Dalfampridine
Brand Name: Ampyra®

Generic Name: Fingolimod
Brand Name: Gilenya®

Generic Name: Teriflunomide
Brand Name: Aubagio®

Effective 10/01/11, failure of Betaseron®, Rebif®, or Copaxone® is required for new starts before receiving Avonex®, Extavia®, Tysabri®, or Gilenya®.

Interferon beta-1a (Avonex®) (Rebif®) are considered medically necessary for early treatment of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis (RRMS).

Interferon beta-1b (Betaseron®) (Extavia®) and glatiramer acetate (Copaxone®) are considered medically necessary for Relapsing Remitting Multiple Sclerosis.

Natalizumab (Tysabri®) is considered medically necessary as monotherapy for Relapsing forms of Multiple Sclerosis after failure of at least one other Multiple Sclerosis therapy (Copaxone®, Rebif®, Avonex®, Betaseron® Extavia®, Gilenya®, or Novantrone®).

Patients and physicians attempting to obtain approval for Natalizumab (Tysabri®) must meet all requirements outlined by the TOUCH^TM program and have registered with the TOUCH^TM prescribing program.

Dalfampridime (Ampyra®) is considered medically necessary to improve walking in patients with Multiple Sclerosis.  Results from a baseline Timed 25-foot Walk (T25FW), creatinine clearance value, and documentation of ambulatory status must be provided for initial approval. After twelve weeks of therapy, documentation of patient's improvement in walking as seen by an increase in walking speed during a follow-up T25FW must be submitted for continuation of treatment.

Fingolimod (Gilenya®) is considered medically necessary for relapsing forms of multiple sclerosis as monotherapy after failure of at least one other Multiple Sclerosis therapy (Copaxone®, Rebif®, Avonex®, Betaseron®, Extavia®, or Tysabri®). A baseline ECG, recent CBC and liver enzyme results, a baseline ophthalmologic evaluation, and exclusion of pregnancy must be documented. It must also be documented that the patient does not have an acute or long term infection, is current with their varicella vaccine, is not being treated with Class Ia or Class III antiarrhythmics, or have a diagnosis of bradycardia, heart block, sick sinus syndrome, ischemic heart disease, prolonged QT interval, congestive heart failure, irregular heartbeat, or history of syncope or stroke. All patients should be observed with a physician on-site for six hours after the first dose for signs and symptoms of bradycardia with hourly pulse and blood pressure measurement and must have a follow-up ECG at the end of this observation period (This is in addition to the pre-observation ECG. The observation is not eligible for reimbursement.) The dosage should not exceed 0.5mg once daily and be prescribed by a board certified neurologist.  Additional safety information is available in the package insert for Gilenya.

Teriflunomide (Aubagio®) is considered medically necessary for the treatment of patients with relapsing forms of multiple sclerosis as monotherapy after documentation of failure with Avonex®, Rebif®, Betaseron®, Copaxone®, Extavia®, or Tysabri®. Prior to initiating therapy, a TB skin test must be performed. Transaminase, bilirubin levels, and a CBC must be obtained within six months before initiation of therapy. Further CBC monitoring should be based on signs and symptoms of infection. ALT levels must be monitored at least monthly for six months after starting treatment. Blood pressure must be checked before the start of therapy and periodically thereafter. Pregnancy must be excluded before the initiation of treatment and prevented thereafter in female patients and female partners of male patients. Dosage should not exceed 14mg/day and must be prescribed by a board certified neurologist.

None

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

2/1999: Reviewed and updated by Pharmacy & Therapeutics Committee

1/30/2002: Prior authorization added

2/14/2002: Investigational definition added

5/1/2002: Type of Service and Place of Service deleted

11/6/2002: Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted.

3/17/2003: Code Reference section updated, HCPCS Q3025, Q3026 added

3/25/2003: FDA Approved Indications and Policy section expanded to include Avonex coverage for early treatment of MS

8/15/2005: Code Reference section updated, CPT code 90782, 99204 deleted

10/27/2005:  Title of policy expanded to include Multiple Sclerosis, Rebif® and Glatiramer acetate (Copaxone®).  Description section updated with information about Multiple Sclerosis (MS), Rebif® and glatiramer acetate (Copaxone®).  FDA approved indications and identification information revised.  "Off-Label" uses deleted.  Policy section updated:  changed preferred provider to Accredo, changed telephone # from 1-866-591-9075 to 1-866-240-3373, changed fax # from 1-866-591-9094 to 1-800-464-2107; added CuraScript as another preferred provider; added Rebif® and glatiramer acetate (Copaxone®); deleted disease states considered investigational.  Sources updated with Rebif®, Avonex®, Betaseron® and Copaxone® added.

11/2005:  Approved by Pharmacy & Therapeutics (P&T) Committee

6/29/2006: CuraScript fax number changed from 1-877-462-6234 to 1-866-239-5502

8/24/2006: Tysabri® added to policy

11/28/2006: Code Reference section updated; added HCPCS Q4079

7/9/2007:  Code Reference section updated; HCPCS J1595 added

12/19/2007: Coding updated per 2008 CPT/HCPCS revisions

01/01/2009: Accredo and CuraScript preferred provider information removed. BCBSMS information added.

10/7/2009: Extavia® Prescribing Information added to policy description and policy statement sections. HCPC code Q4079 deleted from covered table due code was deleted as of 12-31-2007.

02/22/2010:  Policy section updated to add Dalfampridine (Ampyra®). Dalfampridime (Ampyra®) is considered medically necessary to improve walking in patients with Multiple Sclerosis.  After six months of therapy, documentation of patient's improvement in walking must be submitted for continuation of treatment. Added HCPCS Code J8499 to Covered Codes Table for Ampyra®.

07/15/2010:  Policy description unchanged. Policy statement regarding Dalfampridine (Ampyra®) revised to state that a baseline Timed 25-foot Walk (T25FW), creatinine clearance value, and documentation of ambulatory status must be provided for initial approval. The time frame to evaluate for continuation of treatment was changed from six months to twelve weeks, with a follow-up T25FW being required at that time.

02/28/2011: Added new HCPCS code J1826 to the Code Reference section.

09/19/2011:  Policy revised to add coverage criteria for Gilenya®. Added Gilenya® to the HCPCS description of J8499.

09/28/2011: Policy statement revised to state that effective 10/01/11, failure of Betaseron®, Rebif®, or Copaxone® is required for new starts before receiving Avonex®, Extavia®, Tysabri®, or Gilenya®.

03/06/2013:  Policy updated to add coverage criteria for Teriflunomide (Aubagio®), which is considered medically necessary for the treatment of patients with relapsing forms of multiple sclerosis as monotherapy after documentation of failure with Avonex®, Rebif®, Betaseron®, Copaxone®, Extavia®, or Tysabri®. Prior to initiating therapy, a TB skin test must be performed. Transaminase, bilirubin levels, and a CBC must be obtained within six months before initiation of therapy. Further CBC monitoring should be based on signs and symptoms of infection. ALT levels must be monitored at least monthly for six months after starting treatment. Blood pressure must be checked before the start of therapy and periodically thereafter. Pregnancy must be excluded before the initiation of treatment and prevented thereafter in female patients and female partners of male patients. Dosage should not exceed 14mg/day and must be prescribed by a board certified neurologist.

Facts and Comparisons, January 1999

Hayes Medical Technology Directory

Rebif® Prescribing Information (added 10-27-2005)

Avonex® Prescribing Information (added 10-27-2005)

Betaseron® Prescribing Information (added 10-27-2005)

Copaxone® Prescribing Information (added 10-27-2005)

Tysabri® Prescribing Information (added 08-24-2006)

Extavia® Prescribing Information (added 10-7-2009)

Ampyra® Prescribing Information (added 2-22-2010)

Gilenya® Prescribing Information

Aubagio® Prescribing Information

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.  

Covered Codes 

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