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Tysabri (natalizumab)

Policy Number: PH-0133

 

(Intravenous)

Document Number: IC-0133

Last Review Date: 10/02/2018

Date of Origin: 11/28/2011

Dates Reviewed: 12/2011, 08/2012, 02/2013, 06/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 01/2015, 02/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018

 

  1. Length of Authorization

Crohn’s Disease:

  • Coverage is eligible for renewal
    • Initial coverage will be provided for 12 weeks
    • Renewal coverage will be provided for 6 months

Multiple Sclerosis:

  • Coverage will be provided for 6 months and is eligible for renewal.
  1. Dosing Limits
  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Tysabri 300 mg/15 mL vial for injection: 1 vial per 28 days
  1. Max Units (per dose and over time) [Medical Benefit]:
  • 300 billable units every 28 days
  1. Initial Approval Criteria
  • Patient is at least 18 years old; AND
  • Prescriber and patient must be enrolled in and meet the conditions of the TOUCH program; AND
  • Documented negative JCV antibody ELISA test within the past 6 months§; AND
  • Not used in combination with antineoplastic, immunosuppressant, or immunomodulating agents; AND
  • Patient must not have a systemic medical condition resulting in significantly compromised immune system function; AND

Multiple Sclerosis †

  • Patient has been diagnosed* with a relapsing form of multiple sclerosis [i.e. relapsing-remitting disease (RRMS) or secondary progressive disease (SPMS) with relapses]; AND
  • Confirmed diagnosis* of MS as documented by laboratory report (i.e. MRI); AND
  • Must be used as single agent therapy

Crohn’s Disease †

  • Patient has moderate to severe active disease; AND
  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
  • Documented trial and failure on ONE oral immunosuppressive therapy for at least 3 months, unless use is contraindicated, such as corticosteroids, methotrexate, azathioprine, and/or 6-mercaptopurine; AND
  • Documented trial and failure on ONE TNF-Inhibitor therapy for at least 3 months, unless contraindicated, such as infliximab, certolizumab, or adalimumab; AND
  • Used as single agent therapy [Not used concurrently with another biologic drug or immunosuppressant (e.g., 6-mercaptopurine, azathioprine, cyclosporine, methotrexate, etc.) used for Crohn’s Disease]

FDA Approved Indication(s)

*Definitive diagnosis of MS with a relapsing-remitting course is based upon BOTH dissemination in time and space. Unless contraindicated, MRI should be obtained (even if criteria are met).

Dissemination in time

(Development/appearance of new CNS lesions over time)

Dissemination in space

(Development of lesions in distinct anatomical locations within the CNS; multifocal)

  • ≥ 2 clinical attacks; OR
  • 1 clinical attack AND one of the following:
    • MRI indicating simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI compared to baseline scan
    • CSF-specific oligoclonal bands
  • ≥ 2 lesions; OR
  • 1 lesion AND one of the following:
    • Clear-cut historical evidence of a previous attack involving a lesion in a distinct anatomical location
    • MRI indicating ≥ 1 T2-hyperintense lesions characteristic of MS in ≥ 2 of 4 areas of the CNS (periventricular, cortical or juxtacortical, infratentorial, or spinal cord)

§ Risk factors for the development of Progressive Multifocal Leukoencephalopathy (PML) 13,14

  • Presence of anti-JCV antibodies
  • Prior treatment with an immunosuppressant
  • Natalizumab treatment, especially beyond 2 years
  • Elevated levels of anti-JCV antibody response index (i.e., index > 0.9)*

*In those using natalizumab for 25–36 months with no prior use of immunosuppressants, the PML risk is 0.2 per 1,000 in those with an index of 0.9 or less, 0.3 per 1,000 in those with an index of 0.9–1.5, and 3 per 1,000 in those with an index greater than 1.5.

  1. Renewal Criteria

Authorizations can be renewed based on the following criteria:

  • Patient continues to meet the criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: hypersensitivity reactions, hepatotoxicity, signs or symptoms of progressive multifocal leukoencephalopathy (PML), development of severe infections (including pneumonias, pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellulare, bronchopulmonary aspergillosis, herpes, urinary tract infections, gastroenteritis, vaginitis, tonsillitis, meningitis), etc.; AND
  • Documented negative JCV antibody ELISA test within the past 6 months; AND

Multiple Sclerosis

  • Continuous monitoring of response to therapy [manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate (ARR), development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by expanded disability status scale (EDSS), timed 25-foot walk (T25-FW), 9-hole peg test (9-HPT)]
    • Inadequate response, in those who have been adherent and receiving therapy for sufficient time to realize the full treatment effect, is defined as ≥ 1 relapse, ≥ 2 unequivocally new MRI-detected lesions, or increased disability on examination over a one-year period
    • Infusion reactions or breakthrough disease activity may indicate neutralizing natalizumab antibodies. Therapy should be discontinued in patients who have  persistent neutralizing antibodies to natalizumab

Crohn’s Disease

  • Initial renewal only:
    • Clinical response and remission of disease is seen by 12 weeks
  • Second renewal only:
    • Patient has been tapered off of oral corticosteroids within six months of starting Tysabri; AND
    • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score.]
  • All subsequent renewals:
    • Patient does not require additional steroid use that exceeds three months in a calendar year to control their Crohn’s disease; AND
    • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, tapering or discontinuation of corticosteroid therapy, use of anti-diarrheal drugs, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score.]
  1. Dosage/Administration

Indication

Dose

All Indications

300 mg intravenously over one hour every four weeks

  1. Billing Code/Availability Information

JCode:

  • J2323 – Injection, natalizumab, 1 mg; 1 billable unit = 1mg

NDC:

  • Tysabri 300 mg/15 mL single-use vial: 64406-0008-xx
  1. References
  1. Tysabri [package Insert]. Cambridge, MA; Biogen Idec, Inc.; April 2018. Accessed August 2018.
  2. Goodin DS, Cohen BA, O'Connor P, et al. Assessment: the use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008; 71:766.
  3. Gawronski KM, Rainka MM, Patel MJ, Gengo FM. Treatment Options for Multiple Sclerosis: Current and Emerging Therapies. Pharmacotherapy. 2010;30(9):916-927.
  4. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan 22;58(2):169-78.
  5. Freedman MS, Selchen D, Arnold DL, et al. Treatment optimization in MS: Canadian MS Working Group updated recommendations. Can J Neurol Sci. 2013 May;40(3):307-23.
  6. Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria. Ann Neurol. 2011 Feb; 69(2): 292–302. doi:  10.1002/ana.22366
  7. Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560
  8. Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009;104(2):465.
  9. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
  10. Best WR, Becktel JM, Singleton JW, Kern F: Development of a Crohn’s Disease Activity Index, National Cooperative Crohn’s Disease Study. Gastroenterology 1976; 70(3): 439-444.
  11. Gomollón F, Dignass A, Annese V, et al. EUROPEAN Evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management. J Crohns Colitis. 2016 Sep 22. pii: jjw168.
  12. National Institute for Health and Care Excellence. NICE 20 Crohn’s Disease: Management. Published 10 October 20 Clinical Guideline [CG152]. https://www.nice.org.uk/guidance/cg152/resources/crohns-disease-management-pdf-35109627942085.
  13. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
  14. Rae-Grant, A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.  Neurology® 2018;90:777-788.
  15. Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2.
  16. Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD): Drugs and Biologics (Non-chemotherapy) (L34741). Centers for Medicare & Medicaid Services, Inc. Updated on 5/242018 with effective date 6/01/2018. Accessed August 2018.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

G35

Multiple Sclerosis

K50.00

Crohn's disease of small intestine without complications

K50.011

Crohn's disease of small intestine with rectal bleeding

K50.012

Crohn's disease of small intestine with intestinal obstruction

K50.013

Crohn's disease of small intestine with fistula

K50.014

Crohn's disease of small intestine with abscess

K50.018

Crohn's disease of small intestine with other complication

K50.019

Crohn's disease of small intestine with unspecified complications

K50.10

Crohn's disease of large intestine without complications

K50.111

Crohn's disease of large intestine with rectal bleeding

K50.112

Crohn's disease of large intestine with intestinal obstruction

K50.113

Crohn's disease of large intestine with fistula

K50.114

Crohn's disease of large intestine with abscess

K50.118

Crohn's disease of large intestine with other complication

K50.119

Crohn's disease of large intestine with unspecified complications

K50.80

Crohn's disease of both small and large intestine without complications

K50.811

Crohn's disease of both small and large intestine with rectal bleeding

K50.812

Crohn's disease of both small and large intestine with intestinal obstruction

K50.813

Crohn's disease of both small and large intestine with fistula

K50.814

Crohn's disease of both small and large intestine with abscess

K50.818

Crohn's disease of both small and large intestine with other complication

K50.819

Crohn's disease of both small and large intestine with unspecified complications

K50.90

Crohn's disease, unspecified, without complications

K50.911

Crohn's disease, unspecified, with rectal bleeding

K50.912

Crohn's disease, unspecified, with intestinal obstruction

K50.913

Crohn's disease, unspecified, with fistula

K50.914

Crohn's disease, unspecified, with abscess

K50.918

Crohn's disease, unspecified, with other complication

K50.919

Crohn's disease, unspecified, with unspecified complications

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto Government Benefit Administrators, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC