Pharmacy Medical Policy Natalizumab (Tysabri )

Transcription

1 Pharmacy Medical Policy Natalizumab (Tysabri ) Table of Contents Policy: Commercial Information Pertaining to All Policies Endnotes Coding Information References Forms Policy History Policy Number: 062 BCBSA Reference Number: None Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Note: All requests for outpatient retail pharmacy for indications listed and not listed on the medical policy guidelines may be submitted to BCBSMA Clinical Pharmacy Operations by completing the Prior Authorization Form on the last page of this document. Physicians may also submit requests for exceptions via the web using Express PA which can be found on the BCBSMA provider portal or directly on the web at This medication is not covered by the pharmacy benefit. It is covered by the Medical Benefit or as a Home Infusion Therapy. We cover Tysabri (Natalizumab) when used as a monotherapy for 1 : Adults (18 years and older) with relapsing forms of Multiple Sclerosis when ALL of the following criteria are met: Treatment failure with or contraindication to one of the following: Avonex, Betaseron, Copaxone or Rebif within the past 6 months, AND The drug is prescribed by a board-certified or board eligible neurologist. Adults (18 years and older) with moderately to severely active Crohn s Disease when ALL of the following criteria are met: Treatment failure with or contraindication to one Tumor Necrosis Factor (TNF) blocking agent (i.e. Cimzia, Enbrel, Humira or Remicade ), AND The drug is prescribed by a board-certified or board gastroenterologist. We do not cover the above drugs for other conditions not listed above. Other Information TYSABRI is only: Prescribed by doctors who are enrolled in the TOUCH Prescribing Program. 1

2 Infused at an infusion center that is enrolled in the TOUCH Prescribing Program. Given to patients who are enrolled in the TOUCH Prescribing Program. CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes There is no specific CPT code for this service. HCPCS Codes HCPCS codes: J2323 ICD-9-CM Diagnosis Codes ICD-9-CM Code Description Injection, natalizumab, 1 mg (Tysabri) diagnosis codes: Code Description 340 Multiple sclerosis Regional enteritis of small intestine Regional enteritis of large intestine Regional enteritis of small intestine with large intestine Regional enteritis of unspecified site ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description G35 Multiple sclerosis K50.00 Crohn's disease of small intestine without complications K Crohn's disease of small intestine with rectal bleeding K Crohn's disease of small intestine with intestinal obstruction K Crohn's disease of small intestine with fistula K Crohn's disease of small intestine with abscess K Crohn's disease of small intestine with other complication K Crohn's disease of small intestine with unspecified complications K50.10 Crohn's disease of large intestine without complications K Crohn's disease of large intestine with rectal bleeding K Crohn's disease of large intestine with intestinal obstruction K Crohn's disease of large intestine with fistula K Crohn's disease of large intestine with abscess K Crohn's disease of large intestine with other complication K Crohn's disease of large intestine with unspecified complications K50.80 Crohn's disease of both small and large intestine without complications K Crohn's disease of both small and large intestine with rectal bleeding 2

3 K Crohn's disease of both small and large intestine with intestinal obstruction K Crohn's disease of both small and large intestine with fistula K Crohn's disease of both small and large intestine with abscess K Crohn's disease of both small and large intestine with other complication K Crohn's disease of both small and large intestine with unspecified complications K50.90 Crohn's disease, unspecified, without complications K Crohn's disease, unspecified, with rectal bleeding K Crohn's disease, unspecified, with intestinal obstruction K Crohn's disease, unspecified, with fistula K Crohn's disease, unspecified, with abscess K Crohn's disease, unspecified, with other complication K Crohn's disease, unspecified, with unspecified complications Individual Consideration All our medical policies are written for the majority of people with a given condition. Each policy is based on medical science. For many of our medical policies, each individual s unique clinical circumstances may be considered in light of current scientific literature. Physicians may send relevant clinical information for individual patients for consideration to: Blue Cross Blue Shield of Massachusetts Clinical Pharmacy Department One Enterprise Drive Quincy, MA Tel: Managed Care Authorization Instructions Prior authorization is required for all out patient sites of service For all outpatient sites of service, physicians may fax or mail the attached form to the address above. For all outpatient sites of service, physicians may also submit authorization requests via the web using Express PAth which can be found on the BCBSMA provider portal or directly on the web at PPO and Indemnity Authorization Instructions Prior authorization is required when this medication is processed under the home infusion therapy benefit. Prior authorization is not required when this medication is purchased by the physician and administered in the office in accordance with this medical policy. Physicians may also fax or mail the attached form to the address above. Physicians may also submit authorization requests via the web using Express PAth which can be found on the BCBSMA provider portal or directly on the web at Policy History Date Action 7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/ /2014 Updated ExpressPAth language. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. 2/2012 Updated to correct employee fax number on Outpatient Medical Prior Authorization Form. 1/2012 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 3

4 10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. 10/2009 Updated to reflect UM requirements. 1/2009 New policy, effective 1/2009, describing covered and non-covered indications. References 1. Tysabri [package insert]. San Diego, CA: Biogen Idec, Inc.; January Natalizumab (marketed as Tysabri) information. U.S. Food and Drug Administration. Updated June 14, Kappos L, Hartung HP, havrdova E,et al. Natalizumab treatment for multiple sclerosis: recommendations for patient selection and monitoring. Lancet Neurol. 2007;6: Polman CH, O Connor, PW, Havrdova E, et al, for the AFFIRM Investigatiors. A randomized placebo controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006;354: Rudick RA, Stuart WH, Calabresi PA et al, for the SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006; 354: Expert Opinion Paper. National Clinical Advisory Board of the National Multiple Sclerosis Society. Disease Management Consensus Statement Accessed on January 16, Available at: Consensus.pdf 7. Goodin DS, Frohman EM, Garmany GP, et al. Disease modifying therapies in multiple sclerosis. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MD council for Clinical Practice Guidelines. Neurology. 2002; 58: Sanborn WJ, Colombel JF, Enns R, et al, for the International Efficacy of Natalizumab as Active Crohn s Therapy (ENACT-1) and the Evolution of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn s Disease. N Engl J Med. 2004; 353: Hanauer SB, Sandborn W; Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn s disease in adults. Am J Gastroenterol. 2001; 96: Endnotes 1. Based on the recommendations of the BCBSMA Pharmacy and Therapeutics Committee meeting on 05/13/

5 For Home Infusion Authorizations: Company Name: Contact: Telephone: Provider #: Patient Name: Patient Address: Patient BCBSMA ID#: Patient DOB: Physician Name: Physician Telephone: Physician Address: Physician For Outpatient Administration: Servicing Provider: Phone: Contact Person: Patient Name: Patient BCBSMA ID#: Name: NPI #: Natalizumab (Tysabri ) Outpatient Medical Prior Authorization Form Please complete and fax to: (888) Please contact Pharmacy Operations with questions at (800) If the patient is a BCBSMA employee, please fax the form to: (617) Requesting Provider Phone: Contact Person: Patient Address: Patient DOB: Name: NPI #: Is this fax number secure for PHI receipt/transmission per HIPAA requirements? (Circle one) Yes No Required Clinical Information Drug: Dose: Frequency: Route of administration: Dates of Service: / / to / / Diagnosis: ICD-9 code: Please indicate treatment failure with or contraindication to one or more of the medications listed below Avonex Betaseron Copaxone Rebif Cimzia Enbrel Humira Remicade Other Please list: Physician Signature: Copy of a signed prescription is required for all Home Infusion requests 5