RITUXAN (rituximab and hyaluronidase human)

Transcription

1 Drug Prior Authorization Guideline RITUXIMAB products J9310 RITUXAN (rituximab and hyaluronidase human) PA9847 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below Must be prescribed by Rheumatology, Transplant, Hematology, Neurology, or Oncology specialists with prior authorization through Navitus Prevea360 Health Plan Approved Criteria for RITUXAN: 1.0 Moderate to severe active rheumatoid arthritis in combination with methotrexate (unless intolerant or contraindicated) in adult (18 years of age or older) patients with an inadequate response to one or more TNF antagonist therapies 1.1 Prescribed by a rheumatology specialist 2.0 CD20-Positive, B-cell, non-hodgkins lymphoma (NHL) 2.1 Prescribed by an oncology specialist 3.0 CD20-Positive Chronic Lymphocytic Leukemia (CLL) in combination with fludarabine and cyclophosphamide or bendamustine 3.1 Prescribed by an oncology specialist 4.0 Granulomatosis with Polyangiitis (GPA) (Wegener s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult (18 years of age or older) patients in combination with glucocorticoids 4.1 Prescribed by rheumatology specialist 5.0 Chronic Graft versus host disease as a last-resort treatment 5.1 Prescribed by a transplant specialist 6.0 Neuromyelitis optica, where at least one immunotherapy was ineffective 6.1 Prescribed by a neurology specialist 7.0 Post-transplant lymphoproliferative disorder 7.1 Prescribed by a transplant specialist 8.0 Thrombotic thrombocytopenic purpura or immune or idiopathic thrombocytopenic purpura 1 of 5

2 8.1 Prescribed by a hematology specialist 9.0 Autoimmune hemolytic anemia 9.1 Prescribed by a hematology specialist 10.0 NCCN category 1, 2a, or 2b recommendations for off-label uses 10.1 Prescribed by an oncology specialist Prevea360 Health Plan Approved Criteria for RITUXAN HYCELA (Subcutaneous use, administered by a healthcare professional): 1.0 A full intravenous dose of a rituximab product has been successfully administered; AND 2.0 Prescribed by an oncology specialist; AND 3.0 At least one of the conditions and corresponding criteria below are met: 3.1 Follicular lymphoma (FL): Previously untreated FL Must be used in combination with first line chemotherapy; OR In patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; Relapsed or refractory FL Use as a single agent Non-progressing (including stable disease) Use as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy 3.2 Previously untreated diffuse large B-cell lymphoma (DLBCL) In combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens 3.3 Chronic Lymphocytic Leukemia (CLL) In combination with fludarabine and cyclophosphamide (FC) 3.4 NCCN category 1, 2a, or 2b recommendations for off-label uses Comment(s): 1.0 Initial approval duration is 12 months (subject to formulary changes). 2.0 Renewal criteria (additional 12 months) includes no progression of disease and no unacceptable toxicity and is subject to formulary changes. 2 of 5

3 3.0 Diagnoses not listed under FDA approved indications or NCCN recommendations, or an NCCN recommendation grade of 3 are considered experimental/investigational and are not approvable 4.0 Quantity limits for rituximab are based on prescribing information recommendations 4.1 NHL: 375 mg/m CLL: 375 mg/m 2 in the first cycle and 500 mg/m 2 in cycles 2-6, in combination with FC, administered every 28 days 4.3 RA: In combination with methotrexate two-1000mg IV infusions separated by 2 weeks every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. 4.4 GPA, MPA: In combination with glucocorticoids 375 mg/m 2 once weekly for 4 weeks. 5.0 Quantity limits for RITUXAN HYCELA are based on prescribing information recommendations. 6.0 Documentation is expected to be maintained in the patient s medical record and to be available to Prevea360 Health Plan. Every page of the record is expected to be legible and include both the appropriate patient identification information (e.g., complete name dates of service(s)), and information identifying the physician or non-physician practitioner responsible for and providing the care of the patient. The patient's medical record must contain documentation that fully supports the medical necessity for services. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. 6.1 The medical record must include the following information: A physician's order The name of the drug or biological administered The route of administration The dosage (e.g., mgs, mcgs, cc's or IU's) 6.2 When a portion of the drug or biological is discarded, the medical record must clearly document the amount administered and the amount wasted or discarded. 7.0 Codes and descriptors listed below are provided for informational purposes only and may not be all inclusive or current. Listing of a code in this drug policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member s policy of health coverage with Prevea360 Health Plan, Inc. Inclusion of a code in the table below does not imply any right to reimbursement or guarantee claim payment. Other drug or medical policies may also apply. 3 of 5

4 Medication Name How Supplied National Drug Brand Generic Code (NDC) HCPCS code RITUXAN rituximab 100 mg/10 ml, 500 mg/10 ml single-use vials RITUXAN HYCELA rituximab and hyaluronidase 1400 mg/23400 units, 1600 mg/26800 units rituximab/hyaluronidase single-dose vials J9310 J NOTE: The use of physician samples or manufacturer discounts does not guarantee later coverage under the provisions of the medical certificate and/or pharmacy benefit. All criteria must be met in order to obtain coverage of the listed drug product. 4 of 5

5 Committee/Source Originated: Utilization Management Committee/ Medical Affairs/ Navitus P&T Committee Revised: Utilization Management Committee/ Medical Affairs Pharmacy Practice Leader Medical Director Committee/Quality and Care Management Division/ Reviewed: Utilization Management Committee/Medical Affairs/Pharmacy Practice Leader Pharmacy Practice Leader Medical Director Committee/Quality and Care Management Division Date(s) July 12, 2006 December 10, 2008 May 16, 2012 December 30, 2013 March 16, 2016 March 15, 2017 December 20, 2017 February 21, 2018 December 28, 2011 May 16, 2012 November 19, 2014 March 18, 2015 March 16, 2015 March 15, 2017 December 20, 2017 February 21, 2018 Effective: 03/01/2018 Published: 03/01/ of 5