Criteria for Medical Benefit Drugs Requiring Clinical Review

Transcription

1 Note: Authorization of a service based on the clinical information provided does not guarantee payment. The claim must be properly submitted and the member must be eligible on the date of service for the claim to be payable. Coverage will be authorized for uses as described in Chapter 15 of the Medicare Benefit Policy Manual, National Coverage Determinations, or Local Coverage Determinations. Please visit cms.gov or med.noridianmedicare.com to view these documents. Requests may be submitted by calling Care Management at or by faxing the Medical Benefit Drug Request Form along with supporting documentation to To facilitate the process, consult this guide and follow the required clinical criteria and information guidelines outlined here when submitting your request. Adagen (J2504) pegademase bovine Aldurazyme (J1931) laronidase Bendeka (J9034) bendamustine hydrochloride Bivigam (J1556) Botox (J0585) onabotulinumtoxina Diagnosis of adenosine deaminase (ADA) deficiency with severe combined immunodeficiency disease (SCID) Documentation of SCID AND absence of thymus and other lymphoid tissues History of bone marrow transplantation or explanation of patient s ineligibility No evidence of severe thrombocytopenia Diagnosis of Hurler or Hurler-Scheie mucopolysaccharidosis (MPS) Type I with moderate to severe symptoms Serum assays confirming alpha-l-iduronidase enzyme deficiency AND either of the urinary glucosaminoglycans (GAGs): dermatan sulfate or heparin sulfate o Chronic lymphoid leukemia (CLL) o Indolent B-cell non-hodgkin s lymphoma (NHL) AND ment history including rituximab-containing regimens o Metastatic breast cancer, multiple myeloma, non-hodgkin s lymphoma, or another diagnosis not listed AND clinical documentation supporting use Chart notes including history of present illness and previous ments Clinical documentation supporting the diagnosis will be used to o Previous o Bladder muscle dysfunction with or without neuromuscular condition AND ment history including anticholinergics o Blepharospasm with dystonia, cervical dystonia, spasticity o Chronic migraines ( 15 migraines per month) o Another diagnosis not listed AND clinical documentation supporting use Chart notes including history of present illness and previous ments

2 Carimune NF (J1566) Carticel (J7330) chondrocytes, autologous cultured Cerezyme (J1786) imiglucerase Cinqair (J2786) reslizumab Cuvitru (J1555) Immune globulin Cyramza (J9308) ramucirumab Clinical documentation supporting diagnosis will be used to o Previous Diagnosis of articular cartilage defect at the knee requiring autologous chondrocyte implantation Chart notes including history of present illness and prior procedures or ments Diagnosis of symptomatic non-neuropathic Gaucher s disease confirmed by: o Biochemical assay of glucocerebrosidase activity in WBCs or skin fibroblasts less than or equal to 30 percent normal activity o Genotyping revealing two pathogenic mutations of glucocerebrosidase gene Evidence of symptomatic manifestations such as: anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly Chart notes including patient s weight history of present illness and previous Diagnosis of severe uncontrolled eosinophillic asthma confirmed by either: o Blood eosinophils > 150 cells/mcl at ment initiation o Blood eosinophils > 300 cells/mcl within past 12 months Concurrent ment with which Cinqair will be used for add-on maintenance Chart notes including history of present illness and previous ments Clinical documentation supporting the diagnosis will be used to Previous o Metastatic gastric cancer, gastroesophageal junction adenocarcinoma, or cardio-esophageal junction of stomach AND prior fluoropyrimidine- or platinum-containing chemotherapy o Metastatic colorectal cancer AND ment history including bevacizumab, oxaliplatin, and fluoropyrimidine-containing chemotherapy AND concurrent FOLFIRI ment o Metastatic non-small cell lung cancer (NSCLC) AND prior platinum-containing chemotherapy AND concurrent docetaxel ment Documentation of any EGFR or ALK genomic tumor aberrations Chart notes including patient s weight and history of present illness

3 Darzalex (J9145) daratumumab Dysport (J0586) abobotulinumtoxina Elaprase (J1743) idursulfase Elelyso (J3060) taliglucerase alfa Empliciti (J9176) elotuzumab Euflexxa (J7323) Exondys 51 (J1428) eteplirsen Diagnosis of multiple myeloma Documentation of ment history with any of the following: o 1 prior therapy AND concurrent ment with dexamethasone with either bortezomib or lenalidomide o 2 prior therapies including lenalidomide and a proteasome inhibitor AND concurrent ment with pomalidomide and dexamethasone o Double refractory to both a proteasome inhibitor and immunomodulatory agent to be used as monotherapy Chart notes including patient s weight and history of present illness o Cervical dystonia or spasticity o Hemifacial spasm, blepharospasm, or another diagnosis not listed AND clinical documentation supporting use Chart notes including history of present illness and previous ments Diagnosis of Hunter syndrome (mucopolysaccharidosis (MPS) Type II) Serum assays confirming iduronate sulfatase enzyme deficiency AND either of the urinary glucosaminoglycans (GAGs): dermatan sulfate or heparin sulfate Diagnosis of Type 1 Gaucher s disease confirmed by: o Biochemical assay of glucocerebrosidase activity in WBCs or skin fibroblasts less than or equal to 30 percent normal activity o Genotyping revealing two pathogenic mutations of glucocerebrosidase gene Diagnosis of multiple myeloma Documentation of ment history with 1 to 3 prior therapies (medication names, dosages, dates of therapy, and response) Concurrent therapy of lenalidomide and dexamethasone Chart notes including patient s weight and history of present illness Diagnosis of Duchenne muscular dystrophy with confirmed mutation of Duchenne muscular dystrophy gene amenable to exon 51 skipping

4 Eylea (J0178) aflibercept Fabrazyme (J0180) agalsidase beta Flebogamma (J1572) Gammagard (J1569) Gammagard S/D (J1566) Gammaked (J1561) o Diabetic macular edema (DME) with or without diabetic retinopathy o Exudative age-related macular degeneration (AMD) o Macular retinal edema following retinal vein thrombosis Chart notes including patient s weight, history of present illness, and previous ments such as Lucentis or Avastin (dosages, dates of therapy, response) Diagnosis of Fabry s disease supported by: o Males: GLA mutation AND α-galactosidase deficiency in plasma and/or leukocytes o Females: GLA mutation Clinical documentation eliminating possibility of other conditions, such as cardioembolic stroke or dissection syndromes Clinical documentation supporting diagnosis will be used to o Previous Clinical documentation supporting the diagnosis will be used to o Previous Clinical documentation supporting the diagnosis will be used to o Previous Clinical documentation supporting the diagnosis will be used to o Previous

5 Gammaplex (J1557) Gamunex-C (J1561) Gel-one (J7326) Gelsyn-3 (J7328) Genvisc 850 (J7320) Hyalgan (J7321) Hymovis (J7321) HyQvia (J1575) / hyaluronidase Imlygic (J9325) talimogene laherparepvec Clinical documentation supporting the diagnosis will be used to o Previous Clinical documentation supporting the diagnosis will be used to o Previous Clinical documentation supporting the diagnosis will be used to Previous Diagnosis of unresectable malignant melanoma with cutaneous, subcutaneous, or nodal lesions following initial surgery Chart notes including history of present illness and previous surgeries, procedures and ments (medication names, dosages, dates of therapy, response)

6 Jetrea (J7316) ocriplasmin Kanuma (J2840) sebelipase alfa Keytruda (J9271) pembrolizumab Kyprolis (J9047) carfilzomib Lartruvo (J9285) olaratumab Diagnosis of symptomatic vitreomacular adhesion Chart notes including history of present illness and previous procedures and Diagnosis of Wolman s disease confirmed by genetic testing OR lysosomal acid lipase deficiency (LAL-d) by blood test o Unresectable or metastatic melanoma o Melanoma with disease progression following ipilimumab o Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression following platinum-containing chemotherapy o Metastatic non-small cell lung cancer (NSCLC) with one of the following: PD-L1 expression 50% AND no prior systemic chemotherapy PD-L1 expression AND prior platinum-based chemotherapy Non-squamous AND concurrent ment with carboplatin and pemetrexed o Refractory classical Hodgkin lymphoma (chl) or relapsed after 3 therapies o Another diagnosis not listed AND clinical documentation supporting use Any BRAF V600 mutations or EGFR or ALK genomic tumor abberations o Relapsed or refractory multiple myeloma following at least 1 line of therapy o Waldenström macroglobulinemia Diagnosis of soft tissue sarcoma (STS) with histologic subtype that would typically be ed with an anthracycline-containing regimen Confirmation that patient is not candidate for radiotherapy or surgery Concurrent ment with doxorubicin

7 Lucentis (J2778) ranibizumab Lumizyme (J0221) alglucosidase alfa Macugen (J2503) pegaptanib octasodium Monovisc (J7327) Myobloc (J0587) rimabotulinumtoxinb Naglazyme (J1458) galsulfase Nucala (J2182) mepolizumab o Diabetic macular edema (DME) with or without diabetic retinopathy o Diabetic retinopathy o Exudative age-related macular degeneration (AMD) o Macular retinal edema following retinal vein thrombosis o Myopic choroidal neovascularization ments such as Eylea or Avastin (dosages, dates of therapy, response) Diagnosis of Pompe disease documented by: o Absence of acid alpha glucosidase (GAA) activity confirmed by GAA mutation testing OR GAA activity testing in fibroblasts or muscle o Screening tests including chest X-ray, electrocardiogram (ECG), electromyogram (EMG) AND/OR creatine kinase (CK) Evidence that all other possible conditions have been ruled out ments (dosages, dates of therapy, response) Diagnosis of neovascular (wet) age related macular degeneration (AMD) ments such as Avastin (dosages, dates of therapy, response) Diagnosis of spasmodic torticollis Chart notes including history of present illness and previous ments Diagnosis of mucopolysaccharidosis (MPS) Type IV Serum assays confirming enzyme deficiency of N-acetylgalactosamine-6- sulfatase AND urinary glucosaminoglycan (GAG) dermatan sulfate Diagnosis of severe uncontrolled eosinophillic asthma confirmed by either: o Blood eosinophils > 150 cells/mcl at ment initiation o Blood eosinophils > 300 cells/mcl within past 12 months Concurrent ment with which Nucala will be used for add-on maintenance Chart notes including history of present illness and previous ments

8 Octagam (J1568) Onivyde (J9205) irinotecan liposome Opdivo (J9299) nivolumab Orthovisc (J7324) Portrazza (J9295) necitumumab Privigen (J1459) Probuphine (J0570) buprenorphine Clinical documentation supporting the diagnosis will be used to o Previous Diagnosis of metastatic adenocarcinoma of the pancreas following gemcitabinebased therapy Concurrent ment of leucovorin AND fluorouracil Chart notes including history of present illness and previous ments o Unresectable or metastatic malignant melanoma o Metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), or metastatic urothelial carcinoma AND prior platinumbased chemotherapy o Advanced renal cell carcinoma (RCC) AND prior antiangiogenic therapy o Relapsed or progressive classical Hodgkin s disease AND autologous hematopoietic stem cell transplantation (auto-hsct) AND either prior brentuximab vedotin transplantation or 2 additional lines of systemic therapy o Another diagnosis not listed AND clinical documentation supporting use Evidence of BRAF V600 mutations or EGFR or ALK genomic tumor abberations ments or procedures (dosages, dates of therapy, response) Diagnosis of metastatic squamous non-small cell lung cancer (NSCLC) Clinical documentation supporting the diagnosis will be used to o Previous Diagnosis of opioid dependence

9 Supartz FX (J7321) Synvisc (J7325) Vimizim (J1322) elosulfase alfa VPRIV (J3385) velaglucerase alfa Xeomin (J0588) incobotulinumtoxina Xolair (J2357) omalizumab Yervoy (J9228) ipilimumab Yondelis (J9352) trabectedin Diagnosis of mucopolysaccharidosis (MPS) Type IV-A (Morquio A syndrome) Confirmation of diagnosis with clinical examination AND skeletal radiographs AND urinary glucosaminoglycans (GAGs) AND enzymatic activity of GALNS in blood cells or fibroblasts Diagnosis of Type 1 Gaucher s disease confirmed by: o Biochemical assay of glucocerebrosidase activity in WBCs or skin fibroblasts less than or equal to 30 percent normal activity o Genotyping showing two pathogenic mutations of glucocerebrosidase gene Diagnosis of blepharospasm, cervical dystonia or spasticity Chart notes including history of present illness and previous ments o Chronic idiopathic urticaria AND previous ment with H1 antihistamine o IgE-mediated allergic asthma AND documentation of recent IgE serum levels AND previous ment with inhaled corticosteroids o Malignant cutaneous melanoma with regional lymph node involvement following complete resection as adjuvant therapy o Unresectable or metastatic melanoma procedure and ments (medication names, dosages, dates of therapy, response) Unresectable or metastatic leiomyosarcoma or liposarcoma Documentation of prior anthracycline-containing regimen Chart notes including history of present illness and previous procedure and Visiant conducts organization determinations and reconsiderations on behalf of Premera Blue Cross.