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09-J1000-39

Original Effective Date: 10/01/11

Reviewed: 10/12/16

Revised: 01/01/17

Subject: Multiple Sclerosis Self Injectable Therapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system (CNS). It is characterized by triad of inflammation, demyelination, and scarring of the central nervous system and manifests as pathological (immune-mediated CNS demyelination and axonal injury) and clinical (exacerbations, disability progression) dissemination in time and space. Although the clinical course of the disease is capricious, MS has been categorized into four types: relapsing-remitting (RRMS), secondary progressive (SPMS), primary progressive (PPMS), and progressive-relapsing (PRMS). The most common type is RRMS, which is characterized by acute attacks followed by periods of remission. An initial attack may present as a clinically isolated syndrome (CIS); individuals presenting with this syndrome are high risk for subsequent conversion to clinically definite MS (CDMS).

Although a cure for MS remains elusive, several treatment options slow the progression of the disease and reduce the frequency of relapses. These include dimethyl fumarate (Tecfidera), fingolimod (Gilenya), glatiramer acetate (Copaxone, Glatopa), interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), natalizumab (Tysabri), peg-interferon beta-1a (Plegridy), teriflunomide (Aubagio), alemtuzumab (Lemtrada), and daclizumab (Zinbryta). Clinical practice guidelines set forth by the American Academy of Neurology (AAN) and the Multiple Sclerosis Therapy Consensus Group (MSTCG) recommend IFN beta or glatiramer acetate as initial treatment options for RRMS. Additionally, expert opinion favors early initiation of immunomodulatory therapy.

The exact mechanism by which interferon (IFN) beta therapy exerts its beneficial effects is not clearly delineated; however, multiple clinical studies have demonstrated the ability of IFN beta preparations to reduce the number and severity of relapses and the number of new lesions appearing on magnetic resonance imaging (MRI). IFN beta preparations may also reduce the long-term progression of MS. To date, several head-to-head studies have evaluated differences in the beneficial effects (i.e., clinical, MRI measures of response) between the different types of IFN beta preparations; unfortunately, clinical interpretation of the results is limited by methodologic problems (e.g., short duration, non-blinded design, non-standardized dosages and/or routes of administration). As such, no consensus has been reached as to whether one preparation should be used in favor over the other.

Glatiramer acetate is also considered a first line option for the treatment of individuals with RRMS. Although glatiramer acetate has not demonstrated efficacy in slowing, reversing, or halting the progression of the disease, it has been proven to delay the time to CDMS among patients who have experienced a first clinical episode and have MRI results consistent with MS. While the efficacy of glatiramer acetate relative to IFN beta therapy has not been established, it may be useful in members who do not respond adequately to or who do not tolerate IFN beta therapy.

Of note, neither the IFN beta preparations nor glatiramer acetate have proven benefits in the setting of PPMS. The labeling of IFN beta preparations and glatiramer acetate indicate “relapsing MS” as an FDA-approved indication. Acute exacerbations may occur in the setting of SPMS; as such, treatment of relapsing SPMS with IFN beta product is not typically considered an off-label indication.

The FDA approved daclizumab (Zinbryta®) in May 2016 for the treatment of relapsing forms of MS. The FDA recommends use after failure of two or more medications due to risk of hepatotoxicity and other immune-mediated disorders. Daclizumab (Zenapax®) was initially approved in 1997 for the prevention of renal allograft rejection but was discontinued in 2009. Daclizumab is a monoclonal antibody that interferes with the immune system by binding to the alpha subunit (CD25) of the high-affinity interleukin-2 receptor.

Daclizumab was evaluated in patients with relapsing-remitting MS in a randomized, double-blind, active-controlled trial. Daclizumab 150 mg subcutaneous injection every 4 weeks was compared to interferon beta-1a (Avonex) 30 mcg intramuscular weekly injection. The trial excluded patients with progressive forms of MS or those who had an Expanded Disability Status Scale (EDSS) score of greater than 5. Daclizumab demonstrated a 45% relative reduction in the Annualized Relapse Rate (ARR) when compared to interferon beta-1a (0.216 vs 0.393, p<0.0001) which was evaluated at 144 weeks. Additionally, daclizumab demonstrated a 54% relative reduction in the mean number of new or newly enlarging T2 hyperintense lesions (4.31 vs 9.44, p<.0001) at 96 weeks. There was no statistical difference on the proportion of patients with confirmed disability progression at week 144. The rates of infection, rash and liver-function abnormalities were higher in patients receiving daclizumab.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

NOTE: Aubagio, Avonex, Betaseron, Copaxone, Gilenya, Glatopa, Plegridy, Rebif, and Tecfidera are preferred products for treatment of relapsing forms of multiple sclerosis.

Initiation of Avonex, Rebif, Plegridy or Betaseron meets the definition of medical necessity when ALL of the following criteria are met:

1. The member has a diagnosis of a relapsing form of multiple sclerosis (MS) (i.e., relapsing-remitting MS [RRMS], secondary-progressive MS [SPMS] with relapsing disease, progressive-relapsing MS [PRMS]) or the member has experienced a first clinical episode and has MRI features consistent with MS.

2. The dosage does not exceed FDA approved labeling for the individual agents listed in Table 1.

3. Interferon therapy is NOT used in combination with ANY of the following:

a. Alemtuzumab (Lemtrada)

b. Daclizumab (Zinbryta)

c. Dimethyl fumarate (Tecfidera)

d. Fingolimod (Gilenya)

e. Glatiramer acetate (Copaxone, Glatopa)

f. Interferon beta-1a (Avonex, Rebif)

g. Interferon beta-1b (Betaseron, Extavia)

h. Mitoxantrone (Novantrone)

i. Natalizumab (Tysabri)

j. Peg-interferon beta-1a (Plegridy)

k. Teriflunomide (Aubagio)

Approval duration: 1 year

Initiation of Extavia meets the definition of medical necessity when ALL of the following criteria are met:

1. The member has a diagnosis of a relapsing form of multiple sclerosis (MS) (i.e., relapsing-remitting MS [RRMS], secondary-progressive MS [SPMS] with relapsing disease, progressive-relapsing MS [PRMS]) or the member has experienced a first clinical episode and has MRI features consistent with MS.

2. The member has tried/failed or has a contraindication to ONE of the following:

a. Dimethyl fumarate (Tecfidera)

b. Fingolimod (Gilenya)

c. Glatiramer acetate (Glatopa, Copaxone)

d. Interferon beta-1a (Avonex, Rebif)

e. Interferon beta-1b (Betaseron)

f. Peg-interferon beta-1a (Plegridy)

g. Teriflunomide (Aubagio)

3. The dosage does not exceed FDA approved labeling for the individual agents listed in Table 1.

4. Interferon therapy is NOT used in combination with ANY of the following:

a. Alemtuzumab (Lemtrada)

b. Daclizumab (Zinbryta)

c. Dimethyl fumarate (Tecfidera)

d. Fingolimod (Gilenya)

e. Glatiramer acetate (Copaxone, Glatopa)

f. Interferon beta-1a (Avonex, Rebif)

g. Interferon beta-1b (Betaseron, Extavia)

h. Mitoxantrone (Novantrone)

i. Natalizumab (Tysabri)

j. Peg-interferon beta-1a (Plegridy)

k. Teriflunomide (Aubagio)

Approval duration: 1 year

Initiation of glatiramer acetate (Copaxone, Glatopa) meets the definition of medical necessity when ALL of the following criteria are met

1. The member has a diagnosis of a relapsing form of multiple sclerosis (MS) (i.e., relapsing-remitting MS [RRMS], secondary-progressive MS [SPMS] with relapsing disease, progressive-relapsing MS [PRMS]) or the member has experienced a first clinical episode and has MRI features consistent with MS.

2. The dosage does not exceed FDA-approved labeling listed in Table 1.

3. Glatiramer acetate is NOT used in combination with ANY of the following

a. Alemtuzumab (Lemtrada)

b. Daclizumab (Zinbryta)

c. Dimethyl fumarate (Tecfidera)

d. Fingolimod (Gilenya)

e. Glatiramer acetate (Copaxone, Glatopa)

f. Interferon beta-1a (Avonex, Rebif)

g. Interferon beta-1b (Betaseron, Extavia)

h. Mitoxantrone (Novantrone)

i. Natalizumab (Tysabri)

j. Peg-interferon beta-1a (Plegridy)

k. Teriflunomide (Aubagio)

Approval duration: 1 year

Initiation of daclizumab (Zinbryta) meets the definition of medical necessity when ALL of the following are met:

1. The member is diagnosed with a relapsing form of MS (i.e. relapsing-remitting MS [RRMS], secondary-progressive MS [SPMS] with relapsing disease, progressive-relapsing MS [PRMS])

2. The member has tried/ failed or has a contraindication to two or more of the following:

a. Dimethyl fumarate (Tecfidera)

b. Fingolimod (Gilenya)

c. Glatiramer acetate (Copaxone, Glatopa)

d. Interferon beta-1a (Avonex, Rebif)

e. Interferon beta-1b (Betaseron)

f. Peg-interferon (Plegridy)

g. Teriflunomide (Aubagio)

3. Daclizumab will NOT be used in combination with ANY of the following:

a. Alemtuzumab (Lemtrada)

b. Dimethyl fumarate (Tecfidera)

c. Fingolimod (Gilenya)

d. Glatiramer acetate (Copaxone, Glatopa)

e. Interferon beta-1a (Avonex, Rebif)

f. Interferon beta-1b (Betaseron, Extavia)

g. Mitoxantrone (Novantrone)

h. Natalizumab (Tysabri)

i. Peg-interferon beta-1a (Plegridy)

j. Teriflunomide (Aubagio)

4. Daclizumab will be used as monotherapy

5. The dosage does not exceed FDA-approved labeling listed in Table 1.

Approval duration: 1 year

Continuation of interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), peg-interferon beta-1a (Plegridy), glatiramer acetate (Copaxone, Glatopa), or daclizumab (Zinbryta) meets the definition of medical necessity for the treatment of MS when ALL of the following criteria are met:

1. Member has demonstrated a beneficial response to the requested agent

2. Authorization/reauthorization for the requested agent has been previously approved by Florida Blue or another health plan in the past 2 years, OR the member currently meets all indication-specific initiation criteria

3. The dose does not exceed FDA-approved labeling as outlined in Table 1

4. Use is NOT in combination with any of the following:

a. Alemtuzumab (Lemtrada)

b. Daclizumab (Zinbryta)

c. Dimethyl fumarate (Tecfidera)

d. Fingolimod (Gilenya)

e. Glatiramer acetate (Copaxone, Glatopa)

f. Interferon beta-1a (Avonex, Rebif)

g. Interferon beta-1b (Betaseron, Extavia)

h. Mitoxantrone (Novantrone)

i. Natalizumab (Tysabri)

j. Peg-interferon beta-1a (Plegridy)

k. Teriflunomide (Aubagio)

Approval duration: 1 year

Rebif meets the definition of medical necessity when used as a single agent for the following designated Orphan Drug indication when the maximum FDA-approved dose is not exceeded:

1. Treatment of persons with AIDs including all with CD4 T-cell counts less than 200

Approval duration: 1 year

Copaxone meets the definition of medical necessity when used as a single agent for the following designated Orphan Drug indication when the maximum FDA-approved dose is not exceeded:

1. Treatment of amyotrophic lateral sclerosis (ALS)

Approval Duration: 1 year

Table 1: Maximum Dosage Limits†

Drug

Maximum Dose

Avonex (IFN beta-1a)

30 mcg IM weekly

Rebif (IFN beta-1a)

44 mcg SQ 3 times a week

Betaseron (IFN beta-1b)

0.3 mg SQ every other day

Extavia (IFN beta-1b)

0.3 mg SQ every other day

Plegridy (peg-interferon beta-1a)

125 mcg every 14 days

Copaxone 20 mg (glatiramer acetate)

20 mg SQ daily

Copaxone 40 mg (glatiramer acetate)

40 mg SQ 3 times a week

Glatopa 20 mg (glatiramer acetate)

20 mg SQ daily

Zinbryta (daclizumab)

150 mg SQ every 28 days

Based on FDA-approved labeling

IFN=Interferon; IM=Intramuscularly; SQ=Subcutaneously

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Table 2: FDA-Approved Indications and Recommended Dosing

Drug

FDA-approved indication

Usual Dosage

Comments

Avonex (IFN beta-1a)

Relapsing forms of MS

30 mcg IM once a week

If a dose is missed, it should be given as soon as possible; do not give 2 injections within 2 days of each other

Rebif (IFN beta-1a)

Relapsing forms of MS

22 or 44 mcg SQ three times weekly

Each dose should be given at least 48 hours apart. Refer to the package insert for titration schedule.

Plegridy (pegIFN beta-1a)

Relapsing forms of MS

125 mcg every 14 days

For SQ injection only

Betaseron (IFN beta-1b)

Relapsing forms of MS

0.25 mg SQ every other day

Refer to the package insert for titration schedule.

Extavia (IFN beta-1b)

Relapsing forms of MS

0.25 mg SQ every other day

Copaxone (glatiramer acetate)

Relapsing forms of MS

20 mg SQ daily or 40 mg SQ three times a week

For SQ injection only; allows solution to warm to room temperature.

Glatopa (glatiramer acetate)

Relapsing forms of MS

20 mg SQ daily

For SQ injection only; allows solution to warm to room temperature.

Zinbryta (daclizumab)

Relapsing forms of MS

150 mg SQ once a month

Do not use external heat sources such as hot water to warm daclizumab. Do not place daclizumab back into the refrigerator after allowing it to warm to room temperature.

Also approved for patients who have experience a first clinical episode and have MRI features consistent with MS.

IFN=Interferon; IM=Intramuscularly; SQ=Subcutaneously

Table 3: Recommended Dosage Adjustments†

Avonex (IFN beta-1a)

No dosage adjustments are recommended for either hepatic or renal impairment

Rebif (IFN beta-1a)

Leukopenia and abnormal liver function tests may require a reduction in dose (see “Precautions/Warnings”). No dosage adjustments are recommended for renal impairment.

Plegridy (PegIFN beta-1a)

Dose should be titrated: 63 mcg on day 1, 94 mcg on day 15, and 125 mcg on day 29.

Betaseron (IFN beta-1b)

No dosage adjustments are recommended for either hepatic or renal impairment

Extavia (IFN beta-1b)

Copaxone (glatiramer acetate)

Glatopa (glatiramer acetate)

Zinbryta (daclizumab)

Evaluate transaminase and total bilirubin at periodic intervals to monitor for early signs of serious adverse effects.

Treatment interruption or discontinuation is recommended for the following: ALT or AST greater than 5 times the upper limit of normal (ULN), total bilirubin greater than 2 times the ULN, or ALT or AST greater than or equal to 3 but less than 5 times ULN and total bilirubin greater than 1.5 but less than 2 times ULN.

†Interferon beta and glatiramer pharmacokinetics have not been determined in patients with hepatic or renal impairment; IFN=Interferon

Table 4: Drug Availability

Avonex (IFN beta-1a)

• 30 mcg powder for injection (single-use vial)

• 30 mcg/0.5 mL prefilled syringe

• 30 mcg/0.5 mL auto-injector for injection

Rebif (IFN beta-1a)

• 22 mcg/0.5 mL prefilled syringe

• 44 mcg/0.5 mL prefilled syringe

• Titration pack (contains six 22 mcg/0.5 mL and six 8.8 mcg/0.2 mL prefilled syringes

Plegridy (PegIFN beta-1a)

• 125 mcg/0.5 mL prefilled syringe

• 125 mcg/0.5 mL prefilled syringe

• Starter pack: 63 mcg/0.5 mL prefilled pen, 0.94 mcg/0.5 mL prefilled pen, 125 mcg/0.5 mL prefilled pin

• Starter pack: 63 mcg/0.5 mL prefilled syringe, 0.94 mcg/0.5 mL prefilled syringe, 125 mcg/0.5 mL prefilled syringe

Betaseron (IFN beta-1b)

0.3 mg powder for injection kit (contains a single-use vial and a prefilled single-use syringe containing 1.2 mL of diluent)

Extavia (IFN beta-1b)

0.3 mg powder for injection kit (contains a single-use vial and a prefilled single-use syringe containing 1.2 mL of diluent)

Copaxone (glatiramer acetate)

20 mg/mL or 40 mg/mL prefilled syringe

Glatopa (glatiramer acetate)

20 mg/mL prefilled syringe

Zinbryta (daclizumab)

150 mg/mL solution in a single-dose prefilled syringe.

IFN=Interferon

CONTRAINDICATIONS:

Interferon beta: contraindicated in persons with a history of hypersensitivity to albumin (human)

Glatiramer acetate: contraindicated in persons with a history of hypersensitivity to mannitol

Daclizumab is contraindicated in the following individuals:

Pre-existing hepatic disease or hepatic impairment, including ALT or AST at least 2 times the ULN

History of autoimmune hepatitis or other autoimmune condition involving the liver

History of hypersensitivity to daclizumab or any other component of the formulation

PRECAUTIONS/WARNINGS:

Interferon beta (Avonex, Rebif, Betaseron, Extavia):

Hepatic injury: monitor liver function tests.

Depression and suicide: Use with caution in persons with depression.

Injection site necrosis: Typically, injection site necrosis occurs within the first 4 months of therapy; however, post-marketing reports of injection site necrosis occurring over 1 year after initiation of therapy have been received. Necrosis may occur at single or multiple injection sites. Injection sites should be rotated on a regular basis.

Anaphylaxis: Rare but significant allergic reactions can occur following interferon beta therapy.

Autoimmune disorders: There have been postmarketing reports of autoimmune disorders of multiple target organs, including idiopathic thrombocytopenia and hyper- and hypothyroidism. Rare cases of autoimmune hepatitis have also been reported. Monitor patients for signs of these disorders and implement appropriate treatment when observed.

Seizures: Use with caution in patients with preexisting seizure disorders. A relationship between occurrence of seizures and the use of Avonex® has not been established.

Special risk patients: Leukopenia and new or worsening thyroid abnormalities have developed in some patients treated with interferon beta-1a. Additionally, severe liver injury has been reported rarely. Regular monitoring for these conditions is recommended.

Decreased peripheral blood counts: monitor complete blood counts.

Thrombotic microangiopathy (TMA): cases have been reported. Discontinue if TMA occurs.

Congestive heart failure: monitor with preexisting cardiac disease or worsening cardiac symptoms.

Children: The safety and efficacy of glatiramer have not been established in persons younger than 18 years of age.

Pregnancy and Nursing:

Glatiramer acetate (Copaxone, Glatopa)

Immediate postinjection reaction: a constellation of symptoms immediately after injection that includes at least 2 of the following: anxiety, chest pain, constriction of the throat, dyspnea, flushing, palpitations, and urticaria. In general, it is transient and self-limiting and occurs after the first few months of treatment. This reaction may occur more than once in a given member.

Chest pain: Transient chest pain - without any long-term effects - may occur one or more times, either as part of the post-injection reaction or separately. While some of these episodes occurred in the context of the immediate post-injection reaction previously described, many did not.

Lipoatrophy and skin necrosis: Localized lipoatrophy and, rarely, injection site skin necrosis at injection sites have been reported during postmarketing experience. Careful rotation of injection sites is recommended so no single area is used for injections more than one time per week.

Immunosuppression: Because glatiramer can modify immune response, it may interfere with immune functions. For example, treatment with glatiramer may interfere with the recognition of foreign antigens in a way that would undermine the body's tumor surveillance and its defenses against infection.

Children: The safety and efficacy of glatiramer have not been established in patients younger than 18 years of age.

Pregnancy and Nursing:

Daclizumab (Zinbryta)

Boxed Warning

Life-threatening severe liver injury, including liver failure and autoimmune hepatitis. Prior to starting therapy, obtain serum transaminases (ALT and AST) and bilirubin levels. Test transaminase levels and total bilirubin monthly and assess before the next dose of daclizumab. Follow transaminase levels and total bilirubin monthly for 6 months after the last dose of daclizumab. In case of elevated levels, treatment interruption or discontinuation may be required. Daclizumab is contraindicated in individuals with pre-existing hepatic disease or hepatic impairment.

Other immune mediated disorders. In addition to autoimmune hepatitis, immune-mediated disorders such as skin reactions, lymphadenopathy, and non-infectious colitis can occur. If a patient develops a serious immune-mediated disorder, consider stopping treatment and refer to a specialist to ensure comprehensive diagnostic and appropriate treatment. Some patients required systemic corticosteroids or other immunosuppressive treatment and continued treatment after the last dose of daclizumab.

Risk Evaluation and Mitigation Strategy (REMS) program. Due to risks of hepatic injury, including autoimmune hepatitis and other immune-mediated disorders, daclizumab is only available through a restricted REMS program.

Precautions/Warnings

Hypersensitivity Reactions: Risk of anaphylaxis and angioedema. Discontinue and do not re-start daclizumab if anaphylaxis or other allergic reactions occur

Infections: Increased risk of infections. If serious infection develops, consider withholding daclizumab until infection resolves

Depression and Suicide: Advise patients to immediately report symptoms of depression and/or suicidal ideation to their health care provider. Consider discontinuation if severe depression and/or suicidal ideation occur

BILLING/CODING INFORMATION:

HCPCS Coding:

C9399

Unclassified drugs or biologicals (Plegridy, Zinbryta)

J1595

Injection, glatiramer acetate, 20 mg (Copaxone, Glatopa)

J1826

Injection, interferon beta-1a, 30 mcg (Avonex)

J1830

Injection, interferon beta-1b, 0.25 mg (Betaseron, Extavia)

J3590

Unclassified biologic (Plegridy, Zinbryta)

Q3027

Injection, interferon beta-1a, 1 mcg for subcutaneous use (Avonex)

Q3028

Injection, interferon beta-1a, 1 mcg for subcutaneous use (Rebif)

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

G35

Multiple sclerosis

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) was found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Interferon (L33913) located at fcso.com.

Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline

DEFINITIONS:

Primary-progressive multiple sclerosis (PPMS): Steadily progressive course from onset with no acute attacks; occurs in 10-15% of patients with MS.

Progressive-relapsing multiple sclerosis (PRMS): Steadily progressive course from onset with acute attacks, with or without recovery; occurs in less than 5% of MS patients.

Relapsing-remitting multiple sclerosis (RRMS): Characterized by acute attacks followed by periods of remission; primary form of MS that occurs in approximately 85% of patients.

Secondary-progressive multiple sclerosis (SPMS): An initial period of RRMS, followed by a steadily progressive course, with or without acute relapses; 75-85% of patients diagnosed with RRMS will transition to SPMS.

RELATED GUIDELINES:

Botulinum Toxins, 09-J0000-29
Deep Brain Stimulation, 02-61000-24

Evoked Potentials, Intraoperative Neurophysiologic Testing, and Quantitative Electroencephalography (QEEG), 01-95805-13

Functional Neuromuscular Stimulation, 09-E0000-54

Immune Globulin Therapy, 09-J0000-06

Magnetic Resonance Imaging (MRI) Brain and Head, 04-70540-11

Natalizumab (Tysabri®) IV, 09-J0000-73

Wheelchairs and Wheelchair Accessories, 09-E0000-35

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2016 [cited 2016-09-24].
  2. Bayer. Betaseron (interferon beta-1b) injection. 2016 [cited 2016-09-22].In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66311f74-0472-4fa3-848a-06002ca0def5/.
  3. Biogen. Avonex (interferon beta-1a) injection. 2016 [cited 2016-09-22].In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84d42ba4-6eef-41a7-a1d1-2cc887ef118d/.
  4. Biogen. Plegridy (peginterferon beta-1a) injection. 2016 [cited 2016-09-22.In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08f0ea03-4e6d-195d-aef4-886e32befa95/.
  5. Biogen. Tecfidera (dimethyl fumarate) capsule. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=665d7e74-036c-5f68-5b67-ab84b9b49151/.
  6. Biogen. Tysabri (natalizumab) injection. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5fdde91-1989-4dd2-9129-4f3323ea2962/.
  7. Biogen. Zinbryta (daclizumab) injection. 2016 [cited 2016-09-26]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ced5f68-cb45-44d2-b88a-f5edd2761137.
  8. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016-09-22].Available from: http://www.clinicalpharmacology.com/.
  9. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2015-08-25]. Available from: http://clinicaltrials.gov/.
  10. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically 2016 [cited 2016-09-22]. Available from: http://www.thomsonhc.com/.
  11. EMD Serono. Rebif (interferon beta-1a) injection. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f/.
  12. Freedman MS. Treatment options for patients with multiple sclerosis who have suboptimal response to interferon-β therapy. Eur J Neurol 2014;21:377-87.
  13. Genzyme. Aubagio (teriflunomide) tablet, film coated. 2014 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4650d12c-b9c8-4525-b07f-a2d773eca155/.
  14. Genzyme. Lemtrada (alemtuzumab injection) solution, concentrate. 2014 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6236b0bc-82e9-4447-9a78-f57d94770269/.
  15. Gold R, Giovannoni G, Selmaj K et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomized, double-blind, placebo-controlled trial. Lancet 2013; 381: 2167-75.
  16. Kappos L, Wiendl H, Selmaj K et al. Daclizumab HYP versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2015; 373: 1418-28.
  17. Limmroth V. Treatment of relapsing-remitting multiple sclerosis: current and future algorithms. Eur J Neurol 2014;72:35-8.
  18. Mikol DD, Barkhof F, Chang P, et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs. Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicenter, randomized, parallel, open-label trial. Lancet Neurol 2008;7:903-14.
  19. Multiple Sclerosis Coalition. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. Available at http://www.nationalmssociety.org/getmedia/5ca284d3-fc7c-4ba5-b005-ab537d495c3c/DMT_Consensus_MS_Coalition_color. Accessed 09/26/2016.
  20. National Clinical Advisory Board of the National Multiple Sclerosis Society. Disease management consensus statement. Available at http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/index.aspx Accessed 08/13/2012.
  21. Novartis. Extavia (interferon beta-1b) injection. 2016 [cited 2016-09-22].In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4cfdb571-ec4c-478f-bedc-e0669eeea504/.
  22. Novartis. Gilenya (fingolimod hydrochloride) capsule. 2015 [cited 2015-08-25]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cc9e1c8c-0e2b-44e2-878b-27057f786be9/.
  23. Oliver BJ, Kohli E, Kasper LH. Interferon therapy in relapsing-remitting multiple sclerosis: A systematic review and meta-analysis of the comparative trials. J Neurol Sci 2011;302:96-105.
  24. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016-09-22]]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  25. Sandoz. Glatopa (glatiramer acetate) injection. 2016 [cited 2016-09-22]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f01e40a-b6f6-40fb-b37c-3d06f1428e86/.
  26. Teva. Copaxone (glatiramer acetate) injection. 2016 [cited 2016-09-22]]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa88f583-4f5f-433b-80b4-1f4c9fb28357/.
  27. Wiendl H, Toyka KV, Rieckmann R, et.al. Basic and escalating immunomodulatory treatments in multiple sclerosis: current therapeutic recommendations. J Neurol 2008;255:1449-63.
  28. Wingerchuk DM, Carter JL. Multiple sclerosis: current and emerging disease-modifying therapies and treatment strategies. Mayo Clin Proc 2014;89:225-40.
  29. Zinbryta®(daclizumab)[package insert]. Biogen Inc. Cambridge, Massachusetts; June 2016

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/12/16.

GUIDELINE UPDATE INFORMATION:

10/15/11

New Pharmacy Coverage Guideline.

10/15/12

Review and revision to guideline; consisting of revising description and position statement, updating dosage/administration, precautions/warnings, billing codes, definition, and references, and added contraindication section.

01/15/13

Revision to guideline; consisting of modifying position statement to disallow concurrent use of other MS agents.

04/15/13

Review and revision to guideline; consisting of revising position statement to include continuation criteria.

10/15/13

Review and revision to guideline; consisting of revising position statement to include orphan drug indications and approval duration; updating references and related guidelines.

01/01/14

Revision to guideline; consisting of updating position statement

03/15/14

Revision to guideline; consisting of updating position statement and other sections with newly approved dosing for glatiramer.

10/15/14

Review and revision to guideline; consisting of updating references.

01/01/15

Revision to guideline; consisting of updating position statement.

04/15/15

Revision to guideline; consisting of updating quantity limits for betaseron and extavia.

10/15/15

Review and revision to guideline; consisting of updating position statement, dosage/administration, coding, references.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/17

Review and revision to guideline; consisting of updating position statement, dosage/administration, precautions, coding, and references.

Date Printed: June 26, 2017: 01:23 AM