Medical Injectable Prior Authorization Criteria Last updated: 07/10/2014

Transcription

1 Medical Injectable Prior Authorization Criteria Last updated: 07/10/2014

2 A Abatacept... 6 Abobotublinumtoxin A... 8 Abraxane Actemra Acthar Actimmune Adagen Adalimumab Adcetris Ado-trastuzumab emtansine Afinitor Aflibercept Agalsidase beta Aldurazyme Alefacept Alemtuzumab Alferon N Alglucerase Alimta Alkeran Alpha 1-Proteinase Inhibitor Human Amevive Anakinra Antithymocyte Gloulin Equine Aralast Aranesp Arcalyst Arranon Arzerra Atgam Avastin B Belatacept Belimumab Benlysta Bevacizumab Bivigam, Bortezomib Botox... 8 Brentuximab C C1 inhibitor (human) Cabazitaxel Caldolor Campath Camptosar Canakinumab Capsaicin Carboplatin Carimune NF Ceredase Cerezyme Certolizumab pegol Cetuximab Cimzia Cinryze Collagenase clostridium histolyticum Copegus Corticotropin Cyramza Cytogam Cytomegalovirus Immune Globulin D Dacogen Darbepoetin Decitabine Degarelix Denosumab Docetaxel Doxil Doxorubicin E Eculizumab Elaprase Elelyso Eligard Elosulfase alfa Eloxatin Enbrel Epoetin alfa Epogen Epoprostenol Erbitux Eribulin Etanercept Euflexxa Everolimus Eylea F Fabrazyme Faslodex Firmagon Flebogamma Flolan Fludara Fludarabine Fluocinolone Implant... 75

3 Folotyn Forteo Fulvestrant Fusilev G Galsulfase Gamimune N 10% Gammagard Liquid Gammagard S/D Gammaplex Gammar IV Gammar-P IV Gamunex-C Gazyva Gemcitabine Gemzar Genotropin Glassia Golimimab Goserelin H Halaven Herceptin Histrelin... 82, 83 Hizentra Humatrope Humira Hyalgan Hyaluronate Sodium Hydroxyprogesterone Caproate Ibuprofen (IV Idursulfase Ilaris Iloprost Imiglucerase Immune Globulin, subcutaneous IncobotulinumtoxinA... 8 Infergen Infliximab Interferon Alfa-2b Interferon alfacon Interferon Alfa-N Interferon gamma-1b Intravenous Immune Globulin (IVIG Intron A Invega Sustenna Ipilimumab Irinotecan Istodax Iveegam I Jetrea Jevtana J K Kadcyla Kineret Krystexxa L Laronidase Leuprolide Leuprolide/norethindrone Levoleucovorin Levulan Kerastick Lincocin Lincomycin Linezolid, Oral Lipodox Lucentis Lupaneta Kit Lupron M Macugen Makena Marqibo Melphalan Methyl Aminolevulinate Methylnaltrexone Metvixia Mometasone Furoate Sinus Implant Mozobil Myobloc... 8 Myozyme N Naglazyme Naltrexone Extended-Release Natalizumab Nelarabine NeoProfen Neumega Norditropin Nplate Nulojix Nutropin

4 O Obinutuzumab Ocriplasmin Octagam Ofatumumab Omacetaxine mepesuccinate Omalizumab Omnitrope OnabotulinumtoxinA... 8 Oncaspar Oprelvekin Orencia... 6 Orthovisc Oxaliplatin P Paclitaxel , 135 Palipridone Pamitate Palivizumab Panglobulin Panitumumab Paraplatin Pegademase Pegaptanib Pegasparginase Pegasys Peg-Intron Pegloticase Pegylated Interferon Pemetrexed Perjeta Pertuzumab Plerixafor Polygam S/D Pralatrexate Privigen Procrit Prolastin Prolia Propel Protropin Provenge Q Qutenza R Radium Ra 223 dichloride Ramucirumab Ranibizumab Rebetol Rebetron Relistor Remicade Remodulin Retisert Ribavirin Ribavirin/Interferon A-2b Rilonacept RimabotulinumtoxinB... 8 Rituxan Rituximab Romidepsin Romiplostim S Saizen Serostim Simponi Aria Sipuleucel Soliris Somatrem Somatropin Somatropins Stelara Supartz Supprelin LA Sylatron Synagis Synribo Synvisc Synvisc-One T Taliglucerase alfa Taxol Taxotere Temodar Temozolomide Temsirolimus Teriparatide Tev-Tropin Tigecycline Toclizumab Torisel Trastuzumab Trelstar Treprostinil Triptorelin Tygacil Tysabri Tyvaso U Ustekinumab

5 V Vantas Varicella zoster immune globulin Varizig Vectibix Velaglucerase alfa Velcade Ventavis Vimizim Vincristine sulfate liposome Vivitrol Vpriv X Xeomin... 8 Xgeva Xiaflex Xofigo Xolair Y Yervoy Z Zaltrap Zemaira Ziv-aflibercept Zoladex Zorbtive Zyvox

6 : : Abatacept Orencia Created: 09/12/2013 Rheumatoid Arthritis: Initial Criteria: 1. Has the treatment been prescribed by or is it currently being supervised by a rheumatologist? 2. Does the member have moderately to severely active rheumatoid arthritis? 3. Does the member have a history of COPD? If yes, do not approve. If no, continue to #4. 4. Has the member failed a 4 month trial of ALL of the following biologic DMARDs: Enbrel, and Humira? If yes, continue to #5. 5. Is Orencia being prescribed along with methotrexate or another non-biologic DMARD (leflunomide, hydroxychloroquine, minocycline, penicillamine, sulfasalazine, aurothioglucose, or auranofin)? If yes, approve x 6 months: If no, do not approve max of 12 vials x 1 month, then max 4 vials/month x 5 months. Rheumatoid Arthritis: Renewal Criteria: 1. Has the member experienced 20% or greater improvement in tender joint count and swollen joint count or increase in function? 2. Approve x 12 months. Juvenile Idiopathic Arthritis (JIA) Initial Criteria: 1. Is the member 6 years or older? 2. Has the treatment been prescribed by or is it currently being supervised by a rheumatologist?

7 3. Does the member have moderately to severely active juvenile idiopathic arthritis? If yes, continue to #4. 4. Has the member failed at least a 4 month trial of Enbrel and Humira? If yes, continue to #5. If no, do not approve 5. Approve x 12 months. Maximum of 12 vials x 1 month then maximum of 4 vials per month x 11 months. JIA: Renewal Criteria: 1. Has the member experienced a 20% or greater improvement in tender joint count and swollen joint count or has there been an improvement in functional ability? 2. Approve x 12 months. Maximum of 4 vials/month. Does not meet PA criteria.

8 Abobotublinumtoxin A OnabotulinumtoxinA IncobotulinumtoxinA RimabotulinumtoxinB Dysport Botox Xeomin Myobloc Created: 11/15/13 Initial Criteria: 1. Does the member have functional impairment related to one of the following diagnoses: a. Torsion dystonia,, or b. Spasmodic torticollis,, or c. Blepharospasm,, or d. Strabismus,, or e. Congential sternocleidomastoid torticollis,, or f. Laryngeal dysphonia, or g. Hemifacial spasm,, or h. Pediatric limb spasticity associated with cerebral palsy. If yes, continue to #12. If no, continue to #2. 2. Does the member have functional impairment related to limb spasticity from one of the following diagnoses? a. Multiple sclerosis, or b. Other dymyelinating diseases of the central nervous system,, or c. Stroke (CVA), or d. Brain Injury, or e. Spinal cord injury with resultant paraplegia, hemiplegia, or quadrapelgia. If yes, continue to #4. If no, continue to #3 3. Does the member have chronic migraine (defined as 15 days per month with headache lasting 4 hours per day or longer) requesting Botox? If yes, continue to #5 If no, continue to # Has the member tried and failed or have contraindications to conventional therapy including all of the following? a. Non-pharmacologic therapy including physical therapy, splinting, bracing, biofeedback which has been ineffective or cannot be maximized secondary to significant contracture AND b. Oral agents, such as baclofen (MS), dantrolene, tizanidine, diazepam, clonazepam, and gabapentin are proven ineffective, would not be as effective, or are contraindicated.

9 If yes, continue to # Is the request from a neurologist or pain specialist? If yes, continue to #6. 6. Do we have baseline information on member s narcotic usage, ED visits based on pharmacy claims and medical claims in QNXT? If yes, continue to #7. If no, request from provider. 7. Are headaches the result of medication overuse/rebound defined as using narcotics, triptans, butalbital or ergotamine > 12 days a month (check Rx claims)? If yes, do not approve. If no, continue to #8 8. Has the member had adequate trial of or contraindications to at least three of the following drug classes? a. Triptans such as sumatriptan, naratriptan b. Ergot alkaloids such as D.H.E, ergotamine c. Analgesics (ASA, APAP) d. NSAIDs If yes, continue to #9. 9. Has the member had adequate trial of or contraindications to at least one medication from the following drug classes? a. Anticonvulsants such as divalproex, topiramate, gabapentin b. Beta Blockers such as atenolol, nadolol, propranolol c. Calcium Channel Blockers such as verapamil d. Tricyclic Antidepressants such as amitriptyline, nortriptyline, desipramine If yes, approve x 6 months with 200 units Botox /fill. 10. Does the member have a diagnosis of urinary incontinence associated with a neurologic condition (spinal cord injury or multiple sclerosis) and has failed at least 2 anticholinergic medications (such as oxybutynin, Detrol) and would otherwise proceed with augmentation cystoplasty? If yes, continue to #12. If no, continue to # Does the member have a diagnosis of overactive bladder with symptoms of urge incontinence, urgency and frequency and has failed at least 2 anticholinergics? If yes, approve x 3 months. 12. Approve for 12 months with the following quantity limits: Botox: maximum of 200 units per count for migraine indication Xeomin: # 4 counts of a maximum of 70 units per count for blepharospasm Renewal Criteria:

10 Spasticity: 1. Has the member met treatment goals, including but not limited to the following? a. Decrease in severity of dystonia, e.g., abnormal head positioning, improved range of motion, and b. Decrease in pain, and c. Decrease in disability, e.g., enhanced motor ability and functional skills, improved execution of tasks, ADLs. If yes, approve 12 months with quantity limit defined above. Migraine: 1. Has the member showed decreased number of migraine days or less migraine episodes or decreased narcotics usage and/or ED visits? If yes, approve 12 months with quantity limit defined above. Overactive Bladder: 1. Has there been documentation of benefit, such as decreased incontinence episodes or frequency? If yes, approve x 12 months.

11 Adalimumab Humira Created: 09/12/2013 Crohn s Disease Initial Criteria 1. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #2. 2. Does the member have a diagnosis of severe fistulizing Crohn s disease? If yes, continue to #5. If no, continue to #3. 3. Does the member have moderate to severe Crohn s disease? If yes, continue to #4. (Note: Moderate and Severe Disease: failed treatment for mild to moderate disease or has more prominent symptoms including fevers, significant weight loss, abdominal pain or tenderness, intermittent nausea or vomiting (without obstructive findings), or significant anemia, evidence of intestinal obstruction, cachexia, or evidence of abscess.) 4. Has the member failed conventional therapy with at least one agent from ALL of the following drug classes? a. Corticosteroids: prednisone or hydrocortisone b. Aminosalicylic acid derivatives: Sulfasalazine or mesalamine c. Immunosuppressants: Azathioprine or methotrexate If yes, continue to #4. If no, do not approve 5. Approve x 6 months and#6 syringes/vials x 1 month. Approved dosing: 160mg at week 0, 80mg at week 2, followed by a maintenance dose of 40mg every other week beginning at week 4. Note: The combined use of Humira and a tumor necrosis factor (TNF) inhibitor, such as Enbrel, Remicade or combined use of Humira with Orencia is considered investigational. Combination therapy is not authorized. Renewal Criteria: Crohn s Disease 1. Has the member experienced a decrease in symptoms, reduction in enterocutaneous fistulas or clinical remission? If yes, approve x 1 year. Approved dosing: 40mg every other week.

12 Ulcerative Colitis Initial Criteria: 1. Does the member have an active infection or a history of recurring infections? If yes, do not approve.. If no, continue to #2. 2. Does the member have a diagnosis of moderate to severe Ulcerative Colitis defined by the following criteria: Moderate = greater than or equal to 4 stools daily. Severe = greater than or equal to 6 bloody stools daily and evidence of toxicity such as fever, anemia, elevated ESR, or tachycardia. 3. Does the member have contraindications to or combined symptoms despite treatment for at least 12 weeks with a combination of topical therapy (hydrocortisone, sulfasalazine, mesalamine) and the following oral therapies at maximally tolerated doses: a. Oral Aminosalicylates i. Sulfasalazine 4-6gm/day ii. Mesalamine 2-4.8gm/day iii. Olsalazine 1.5-3gm/day iv. Basalazide 6.75gm/day b. Oral predisone 20-40mg/day. c. Azathioprine mg/kg/day or Purinethol mg/day If yes, continue to #4. 4. Approve x 6 months. Approved dosing: 160mg at week 0, 80mg at week 2, followed by a maintenance dose of 40mg every other week beginning at week 4. Renewal Criteria: Ulcerative colitis 1. Has the member demonstrated a significant response including the following: Decrease in bloody stools per day and/or Elimination of signs of toxicity If yes, approve for 1 year. Approved dosing: 40mg every other week. Rheumatoid Arthritis Initial Criteria: 1. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #2. 2. Does the member have moderately to severely active rheumatoid arthritis?

13 3. Has the treatment been prescribed or is a rheumatologist currently supervising it? If yes, continue to #4. 4. Has the member tried and failed or have contraindications to methotrexate 20mg per week for at least 8 weeks? If yes, continue to #5. 5. Has the member tried and failed or have contraindications to the following: leflunomide, hydroxychloroquine, or sulfasalazine? If yes, continue to #6 If no, do not approve 6. Is Humira being prescribed along with at least one of the following DMARDs: methotrexate, leflunomide, hydroxychloroquine, minocycline, penicillamine, sulfasalazine, aurothioglucose, or auranofin? If yes, continue to #7. 7. Is the dose of Humira 40mg every other week? If yes, continue to #8. 8. Approve for 6 months. Approved dosing: 40mg every other week. Note: The combined use of Humira and a tumor necrosis factor (TNF) inhibitor, such as Enbrel, Remicade or combined use of Humira with Orencia is considered investigational. Combination therapy is not authorized. Renewal Criteria: Rheumatoid Arthritis: 1. Has the member experienced 20% or greater improvement in tender joint count and swollen joint count? 2. Is the dose of Humira 40mg every other week? If no, forward to the plan for review. 3. Approve for 1 year. Approved dosing: 40mg every other week. Psoriatic Arthritis Initial Criteria: 1. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #2. 2. Does the member have psoriatic arthritis? 3. Is the diagnosis based on the following?

14 a. Clinical presentation of active, inflammatory arthritis, e.g. +/- elevated sed rate or CRP, swollen joint count, and b. Radiographic findings consistent with joint erosion. If yes, continue to #4. 4. Has the member failed or have contraindications to conventional management with all of the following? a. NSAIDs, and b. Methotrexate (or other DMARD such as leflunomide or sulfasalazine). If yes, continue to #5. If no, do not approve 5. Is the dose of Humira 40mg every other week? If yes, continue to #6. 6. Approve for 6 months. Approved dosing: 40mg every other week. Note: The combined use of Humira and a tumor necrosis factor (TNF) inhibitor, such as Enbrel, Remicade or combined use of Humira with Orencia is considered investigational. Combination therapy is not authorized. Renewal Criteria: Psoriatic Arthritis: 1. Has the member experienced 20% or greater improvement in tender joint count and swollen joint count? 2. Is the dose of Humira 40mg every other week? If no, forward to the plan for review. 3. Approve x 12 months. Approved dosing: 40mg every other week. Ankylosing Spondylitis Initial Criteria: 1. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #2. 2. Does the member have ankylosing spondylitis? 3. Does the member have moderate to severe active disease, evidenced by a Bath AS Disease Activity Index (BASDAI) score of 4 or Physician Global Assessment of 2 or greater on Likert scale (0 = none, 1 = mild, 2 = moderage, 3 = severe, 4 = very severe)? If yes, continue to #4.

15 4. Has the member tried and failed conventional therapy with all of the following At least 2 NSAIDs for 3 months, and Physical therapy/exercise program, and Sulfasalazine in members with peripheral disease, not required for axial disease and If yes, continue to #5. If no, do not approve 5. Is the dose of Humira 40mg every other week? If yes, continue to #6. 6. Approve for 6 months. Approved dosing: 40mg every other week. Note: The combined use of Humira and a tumor necrosis factor (TNF) inhibitor, such as Enbrel, Remicade or combined use of Humira with Orencia is considered investigational. Combination therapy is not authorized. Renewal Criteria: Ankylosing Spondylitis: 1. Does the member have significant improvement in signs and symptoms of AS and/or functioning (such as 50% or 2-point improvement in BASDAI or Physician Global of > 1)? If yes, approve for 1 year. Approved dosing: 40mg every other week. Juvenile Idiopathic Arthritis (JIA) Initial Criteria: 1. Is the member 4 years or older? 2. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #3. 3. Does the member have moderately to severely active juvenile idiopathic arthritis? If yes, continue to #4. Has the treatment been prescribed by a rheumatologist or is one currently supervising it? If yes, continue to #5. Has the member had a trial of glucocorticoid injections if fewer than 4 joints affected? If yes, continue to #6. 4. Has the member tried and failed or have contraindications to methotrexate for at least 3 months?

16 If yes, continue to #7. Is the dose of Humira 20mg or 40mg every other week? If yes, continue to #8. Approve for 6 months. Approved dosing: 40mg every other week. Note: The combined use of Humira and a tumor necrosis factor (TNF) inhibitor, such as Enbrel, Remicade or combined use of Humira with Orencia is considered investigational. Combination therapy is not authorized. Renewal Criteria: Juvenile Idiopathic Arthritis: 1. Has the member experienced 20% or greater improvement in tender joint count and swollen joint count or has there been an improvement in functional ability? Is the dose of Humira 20mg or 40mg every other week? If no, forward to the plan for review. 2. Approve x12 months. Approved dosing: 40mg every other week. Plaque Psoriasis Initial Criteria: 1. Is the member 18 years of age? If yes, continue to #2 2. Does the member have chronic, moderate to severe Plaque Psoriasis with functional impairment and one or more of the following: a. At least 10% body surface area involved b. Hand, foot or mucous membrane involvement 3. Has the treatment been prescribed or is it currently being supervised by a dermatologist? If yes, continue to #4. 4. Has the member tried and failed or have contraindications to ALL of the following: High-potency topical corticosteroids (betamethasone dipropionate, clobetasol, fluocinonide) At least one other topical agent: calcipotriene, tazarotene, anthralin PUVA or UVB Phototherapy At least one systemic agent: methotrexate, cyclosporine, acitretin. If yes, continue to #5. If no, do not approve

17 5. Approve for 6 months.. Renewal Criteria: Plaque Psoriasis 1. Has the member experienced a 50% reduction in plaques and/or is there evidence of functional improvement? If yes, approve x12 months. Approved dosing: 40mg every other week. Note: The combined use of Humira and a tumor necrosis factor (TNF) inhibitor, such as Enrel, Remicade or combined use of Enbrel with Orencia is considered investigational. Combination therapy is not authorized. Quantity Exception Criteria: 1. Member has RA, PsA, ankylosing spondylitis, Crohn s disease or plaque psoriasis and is started and stabilized on 40 mg once weekly dosing: approve up to 5 syringes for a 34-day supply. 2. For induction dosing consisting of 80 mg once followed in one week by 40 mg EOW dosing in members with plaque psoriasis: approve a one-time override up to 4 syringes for a 34 day supply. 3. Member has plaque psoriasis and the Humira Psoriasis Starter Package kit is being prescribed for induction dosing: may approve a one-time override for 4 syringes/1 kit. 4. Member has Crohn s disease and induction therapy with Humira is being initiated (consisting of 160 mg at week 0 followed by 80 mg at week 2, then 40 mg EOW beginning at week 4): approve a one-time override up to 7 syringes for a 34 day supply. 5. Member has Crohn s disease and the Humira Crohn s Disease Starter Package kit is being prescribed for induction dosing: may approve a one-time override for 6 syringes/1 kit. 6. Member has Crohn s disease and the dose of Humira is being increased to 40 mg once weekly or 80 mg EOW. Approve up to 5 syringes for a 34-day supply if the member has been taking Humira dosed 40 mg EOW for at least 4 weeks. 7. Member has RA and the dose of Humira is being increased to 40 mg once weekly. Approve up to 5 syringes for a 34-day supply if the member has taken MTX in combination with Humira dosed 40 mg EOW for at least 2 months. 8. Member has RA and the dose of Humira is being increased to 40 mg once weekly. Approve up to 5 syringes for a 34-day supply if the member is currently receiving Humira dosed 40 mg EOW and is either unable to tolerate MTX or MTX is contraindicated. 9. Member has PsA, ankylosing spondylitis, or plaque psoriasis and the dose of Humira is being increased to 40 mg once weekly. Approve up to 5 syringes for

18 a 34-day supply if the member has taken Humira dosed 40 mg EOW for at least 2 months. 10. A quantity override for other indications is not recommended. No information is currently available on using once weekly dosing in JIA.

19 Ado-trastuzumab emtansine Kadcyla Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** Initial Criteria: 1. Is the member age 18 or older? 2. Is Kadcyla being prescribed by an oncologist? 3. Does the member have a diagnosis of HER-2 positive metastatic breast cancer? If yes, continue to #4. 4. Has the member previously received treatment with Herceptin and a taxane, separately or in combination? If yes, approve x 12 months. Renewal Criteria: 1. Has there been clinical and radiological evidence of tumor regression? If yes, approve x 12 months.

20 Aflibercept Eylea Created: 11/14/13 1. Does the member have a diagnosis of Exudative (Wet) Age-Related Macular Degeneration (AMD) or Macular Edema following Retinal Vein Occlusion (RVO)? If yes, continue to #2 2. Has the member tried and failed Avastin? If yes, approve for life. If no, do not approve and recommend Avastin.

21 Agalsidase beta Fabrazyme Created: 09/12/2013 Initial Criteria: 1. Does the member have a diagnosis of Fabry disease? 2. Is there medical record documentation of For males: diagnostic confirmation of α galactosidase levels (α- GAL) of less than 1.5 nmol/hr/ml on plasma or less than 4nmol/hr/mg in leukocytes. For females: diagnostic confirmation based on low leukocyte α- GAL A or family history of genetic mutation analysis of the α- GAL A gene or characteristic findings e.g., angiokeratomas, telangiectasias, severe neuropathic pain and organ involvement 3. Is the member at least age 8? If yes, continue to #4. 4. Has the provider outlined objective, measurable treatment goals? If yes, continue to #5. If no, request from provider. 5. Approve x 6 months. 1mg/kg IV every 2 weeks. Renewal Criteria: 1. Is there medical record documentation of stabilization or slowing of disease progression? If yes, approve x 6 months.

22 Alefacept Amevive Created: 09/12/2013 Initial Criteria: 1. Is the drug prescribed by a dermatologist? 2. Is the member 18 years? 3. Does the member have a diagnosis of chronic ( 6 months), severe plaque psoriasis? If yes, continue to #4. 4. Does the member meet one of the following? a. Functional hand, foot or mucous membrane involvement b. More than 10% of body surface area involved If yes, continue to #5 5. Does the member have documented, inadequate response or contraindication to Enbrel and Humira? If yes, continue to #6. 6. Does the member have the following contraindication: HIV infection? If yes, do not approve. If no, continue to #7. 7. Approve for 3 months with quantity limit of #4 vials/30 days. Renewal Criteria: 1. Has a minimum of 12 weeks elapsed since the initial 12-week course of treatment? 2. Does the member have a documented 50% improvement in affected body surface area, a significant reduction in plaque severity, and/or improvement in functioning after one 12- week course? If yes, approve x 3 months with quantity limit of # 4 vials/30 days.

23 : : Alemtuzumab Campath Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** Initial Criteria: 1. Is the member age 18 or older? 2. Does the member have a diagnosis of B-cell chronic lymphocytic leukemia (B- CLL)? 3. Is the request from an oncologist or hematologist? If yes, approve x 12 months. Renewal Criteria: 1. Is there documentation of response to treatment? If yes, approve x 12 months.

24 : : Anakinra Kineret Created: 09/12/2013 Initial Criteria: 1. Is the request for the treatment of NOMID: neonatal onset multi-system inflammatory disease? If yes, approve x 12 months. If no, continue to RA below. Rheumatoid Arthritis: 1. Has the treatment been prescribed or is it currently being supervised by a rheumatologist? 2. Does the member have a diagnosis of active rheumatoid arthritis? 3. Has the member tried and failed or have contraindications to methotrexate monotherapy at a dose 20mg per week for at least 8 weeks? If yes, continue to #4. 4. Is the member intolerant to or has the member failed at least one other DMARD: leflunomide, hydroxychloroquine, or sulfasalazine? If yes, continue to #5. 5. Approve x 6 months. Renewal Criteria: Rheumatoid Arthritis: 1. Has the member experienced 20% or greater improvement in tender joint count and swollen joint count? If yes, approve x 12 months.

25 Alglucerase Imiglucerase Taliglucerase alfa Cerezyme Elelyso Ceredase Created: 09/12/2013 Initial Criteria: 1. Does the member have diagnosis of type 1 Gaucher disease? 2. Has the diagnosis been confirmed by one of the following: biochemical assay of glucocerebrosidase activity in WBCs or skin fibroblasts is less than or equal to 30% of normal activity genotyping revealing 2 pathogenic mutations of the glucocerebrosidase gene 3. Does the severity of disease result in one or more of the following conditions: Moderate-to-severe anemia Thrombocytopenia with bleeding tendency Bone disease Significant hepatomegaly or splenomegaly If yes, continue to #4. If no, do not approve 4. Has the provider documented objective, measurable treatment goals? If yes, approve 6 months. If no, request from rovider. 60 units/kg every other week. Renewal criteria: 1. Is there medical record documentation of stabilization of disease progression, such as: Improvement in hematologic markers, such as increased Hgb/Hct and/or platelet counts Reduction in spleen or liver volume Reduction in biochemical markers, such as chitotrisidase, ACE, acid phosphatase tartrate resistant (TRAP) Reduction in skeletal markers, such as DEXA scan, bone pain, bone age (for member age 14 years or less). If yes, approve x 6 months.

26 Alglucosidase alfa Lumizyme Myozyme Created: 09/12/2013 Initial Criteria: 1. Does the member have a diagnosis of late-onset (non-infantile) Pompe disease and has not shown evidence of cardiac hypertrophy, or a diagnosis of infantile-onset Pompe disease? 2. Is there medical record documentation of clinical symptoms and biochemical testing indicates alpha-1,4-glucosidate deficiency consistent with infantile- or late-onset Pompe disease? 3. Is the member at least 8 years old? If yes, continue to #4. 4. Has the provider outlined objective, measurable treatment goals? If yes, continue to #4. 5. Approve x 6 months. Approved dosing: 20mg/kg IV every 2 weeks. Approve Myozyme for infantile-onset and Lumizyme for late-onset over the age of 8. Renewal Criteria: 1. Is there medical record documentation of improvement in disease progression? If yes, approve x 6 months.

27 Alpha 1-Proteinase Inhibitor Human Prolastin, Aralast, Zemaira Glassia Created: 09/12/2013 Initial Criteria: 1. Is the member a current smoker? If no, continue to #3. 2. Is the member enrolled in a smoking cessation program and abstinent for at least 6 months? If yes, continue to #4. If no, do not Approve Is the request from a pulmonologist? 3. Does the member have ZZ or Z/null AAT deficiency? If yes, continue to #5. 4. Does the member have an AAT serum level 11μM or 50mg/dL? If yes, continue to# Does the member have a diagnosis of moderate emphysema and/or an FEV 1 between 30-65%? If yes, continue to #7. 6. Is the member currently undergoing or has undergone? a. Pulmonary rehabilitation, and b. Weight loss and nutritional support, if indicated. If yes, continue to #8. 7. Has the provider outlined specific, measurable treatment goals such as? a. Slowing of FEV1 decline, and b. Lack of disease progression. If yes, approve for 12 weeks. Renewal Criteria: 2. Is the member meeting treatment goals? If yes, approve for 12 months

28 Alprostadil injection Alprostadil urethral suppository Caverject, Edex Muse Note: The treatment of ED is benefit exclusion.

29 Antithymocyte Globulin Equine (Lymphocyte Immune Globulin) Atgam Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** 1. Does the member have a diagnosis of moderate to severe aplastic anemia and is not a suitable candidate for bone marrow transplant? If yes, approve x 14 days. If no, continue to #2. 2. Does the member have a kidney transplant rejection and has there been a lack of response after pulse corticosteroids? If yes, approve x 14 days. If no, continue to #3. 3. Is the request for kidney transplant rejection prophylaxis? If yes, approve x 1 month.

30 Asparaginase Erwinia chrysanthemi Erwinaze Created: 11/14/13 1. Does the member have a diagnosis of acute lymphoblastic leukemia? 2. Has the member experienced a hypersensitivity reaction to E.coli-derived Elspar or Oncaspar? If yes, approve x 12 months.

31 Autologous cultured chrondrocytes Carticel Created: 11/14/13 1. Does the member have a diagnosis of defect of articular cartilage, Femoral condyle of the knee? If yes, review with Medical Director If no, do not approve

32 Belatacept Nulojix Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** 1. Is the request from a nephrologist or transplant specialist? 2. Is the request for prophylaxis of organ transplant in a member who had a kidney transplant? 3. Has the member failed (acute rejection, side effects, or inability to comply with oral therapy) or has contraindications to tacrolimus and cyclosporine? If yes, continue to #4. 4. Is the member Epstein-Barr virus positive? If yes, continue to #5. 5. Will Nulojix be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids? If yes, continue to #6. 6. Approve for life.

33 Belimumab Benlysta Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** Initial Criteria: 1. Is Benlysta being prescribed by or in consultation with a rheumatologist? 2. Does the member have a diagnosis of active, autoantibody-positive systemic lupus erythematosus (SLE) and is currently receiving standard therapy? 3. Does the member have a Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) score of 6? If yes, continue to #4. 4. Does the member have severe active lupus nephritis or severe active central nervous system lupus? If yes, do not approve. If no, continue to #5. 5. Has the member failed all of the following (alone or in combination)? NSAIDs Corticosteroids Antimalarials (primarily hydroxychloroquine) Immunosuppressives (e.g. cyclophosphamide, cyclosporine, tacrolimus, leflunomide, azathioprine, mycophenolate, and methotrexate) If yes, continue to #6. 6. Is the member currently on another biologic and/or IV cyclophosphamide? If yes, do not approve. If no, continue to #7. 7. Has the prescriber outlined specific and measurable treatment goals to assess a 6 month trial? If yes, approve for 6 months. Approve If no, request treatment 10mg/kg every 2 weeks for the first plan. 3 doses then 10mg/kg every 4 weeks. Total fill of 7.

34 Renewal Criteria: 1. Is there medical record documentation of any of the following? SELENA-SLEDAI score point reduction of 4 or more. Provider has indicated that there is no worsening of disease from baseline after treatment with belimumab. Bristish Isles Lupus Assessment Group (BILAG) Classic Index that measures organ specific changes in disease activity in the past 28 days that indicates no new BILAG A score and no more than one new BILAG B score compared with baseline. No worsening of disease activity requiring intensification of therapy with high-dose steroids or immunosuppressants. Experienced a dose reduction of steroid therapy. If yes, approve for 6 months. Approve 10mg/kg every 4 weeks. Total fill of 7.

35 : : Bendamustine Treanda Created: 11/14/ Does the member have a diagnosis of chronic lymphocytic leukemia or non- Hodgkin's lymphoma? 2. Approve x 12 months.

36 : : Bevacizumab Avastin Created: 9/12/13 ** Criteria apply to New Starts Only ** 1. Is Avastin being prescribed by an oncologist or ophthalmologist? 2. Is the member at least 18 years of age? 3. Is the diagnosis one of the following: a. Metastatic colorectal cancer i. First- or second-line therapy, in combination with IV 5-fluorouracilbased chemotherapy ii. Second-line therapy, in combination with fluoropyrimidine/irinotecan- or fluoropyrimidine/oxaliplatin-based chemotherapy, in patients who have progressed on a first-line bevacizumab-containing regimen iii. Not indicated for adjuvant treatment for stage II or III disease b. Advanced nonsquamous, nonsmall cell lung cancer i. Recurrent or metastatic, unresectable, locally advanced, first-line treatment in combination with paclitaxel and carboplatin c. Metastatic HER-2 negative breast cancer who have not received chemotherapy for metastatic disease d. Glioblastoma multiforme of brain, Recurrent, progressive disease following prior therapy e. Metastatic renal cell cancer in combination with interferon alfa If yes, continue to #5. If no, continue to #4. 4. Is the diagnosis diabetic retinopathy AND they have failed laser photocoagulation? If yes, continue to #5. 5. Approve for 12 months.

37 Bortezomib Velcade Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** Initial Criteria: 1. Is the member age 18 or older? 2. Does the member have a diagnosis of multiple myeloma or relapsed or refractory mantle cell lymphoma? 3. Is the request from an oncologist? If yes, approve x 6 months. Renewal Criteria: 1. Is there documentation of response to treatment? If yes, approve x 6 months.

38 Brentuximab Vedotin Adcetris Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** Initial Criteria: 1. Is the member age 18 or older? 2. Is Adcetris being prescribed by a hematologist or oncologist? 3. Is Adcetris being used with bleomycin? If yes, do not approve. If no, continue to #4. 4. Does the member have Hodgkin s Lymphoma? If yes, continue to #5. If no, continue to #6. 5. Has the member failed 2 prior chemotherapy regimens (i.e. ABVD, Stanford V, BEACOPP) if not an autologous stem cell transplant candidate, OR failed an autologous stem cell transplant? If yes, approve x 12 months. 6. Does the member have a diagnosis of Anaplastic Large Cell Lymphoma and has failed at least 1 multi-agent chemotherapy regimen? If yes, approve x 12 months. Renewal Criteria: 1. Has there been clinical and radiographical evidence of tumor response? If yes, approve x 12 months.

39 C1 inhibitor (human) Cinryze Created: 09/12/2013 Initial criteria: 1. Does the member have a diagnosis of hereditary angioedema (HAE) confirmed by genetic testing or normal C1q lab levels with levels below the lab s normal reference range for both C4 and C1INH? 2. Does the member have a history of at least two attacks per month which are considered severe with swelling of the face, throat or gastrointestinal tract that significantly interrupts usual daily activity despite short-term symptomatic treatment? 3. Has the member been evaluated for triggers of HAE attacks and is maximally managed for avoidance of those triggers (such as stress, hormonal changes, dental surgery, trauma, medications including ACE inhibitors and estrogen)? If yes, continue to #4. 4. Has the member failed treatment with androgen therapy (i.e. danazol)? If yes, continue to #5. If no, do not approve and recommend a trial of danazol. 6. Is treatment with acute, abortive therapy an option for this member (Firazyr, Berinert)? If yes, do not approve If no, continue to # Review case with medical director for consideration of approval. Long-term prevention: 1000 units IV q 3-4 days. Short-term prevention: 1000 units per procedure. Renewal criteria: 1. Has there been at least a 50% reduction in the number of angioedema attacks, significant improvement in the severity and duration of attacks, and clinical documentation of functional improvement? If yes, approve previous qty as above If no, do not approve x 1 month.

40 Cabazitaxel Jevtana Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** Initial Criteria: 1. Is the member male and age 18 or older? 2. Is Jevtana being prescribed by an oncologist? 3. Does the member have a diagnosis of hormone-refractory metastatic prostate cancer? If yes, continue to #4. 4. Has the member been previously treated with a docetaxel-containing regimen? If yes, approve x 12 months. Renewal Criteria: 1. Has there been evidence of tumor response? If yes, approve x 12 months.

41 Canakinumab Ilaris Created: 09/12/ Is requested by a rheumatologist? If yes, continue to #2 If no do not approve. 2. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #3 3. Does the member have a diagnosis of cryopyrin-associated periodic syndromes (CAPS)? If yes, continue to #4 If no, continue to #8. 4. Is member 4 years or older? If yes, continue to #5 5. Is there documentation of a generic mutation in the Cold-Induced Auto inflammatory Syndrome 1 (CIAS1 sometimes referred to as the NLRP3)? If yes, continue to #6 6. Does the member experience one of the following classic symptoms of CAPS: a. Familiar cold urticaria: recurrent intermittent episodes of fever and rash that primarily followed cold exposure. b. Muckle-Wells Syndrome: chronic fever and rash that may wax and wane in intensity. If yes, continue to #7 7. Is there documented significant functional impairment leading to limitation in activities of daily living (ADLs)? If yes, approve x 1 dose 8. Does the member have a diagnosis of systemic onset juvenile chronic arthritis? If yes, continue to #8 9. Is member 2 years of age or older? If yes, continue to #9 10. Has the member had a trial of glucocorticoid injections if fewer than 4 joints affected? If yes, continue to # Has the member tried and failed or have contraindications to methotrexate for at least 3 months? If yes, continue to # Has the member tried and failed or contraindication to a. Humira or Enbrel and Orencia for at least 6 months: for member age 6 and older b. Humira or Enbrel for at least 6 months: for age under 6 years of age If yes, approved x 6 months

42 : : Capsaicin Qutenza Created: 11/15/13 1. Does the member have a diagnosis of postherpetic neuralgia? 2. Has the member failed ALL of the following? a. Capsaicin cream b. Tricyclic antidepressant (amitriptyline, nortriptyline, desipramine) c. Gabapentin d. Lyrica 3. Approve up to 4 patches x 3 months. Must be administered by a healthcare professional.

43 : : Carboplatin Paraplatin (generic available) Created: 11/14/13 **Criteria Apply to New Starts Only** 1. Does the member have a diagnosis of ovarian cancer? 2. Approve x 12 months.

44 Carfilzomib Kyprolis Created: 11/14/13 **Criteria Apply to New Starts Only** 1. Does the member have a diagnosis of multiple myeloma? 2. Has the member failed (such as experiencing disease progression) ALL of the following? a) Velcade (bortezomib) b) Thalomid (thalidomide) OR Revlimid (Lenalidomide)** 3. Approve for 1 year.

45 Ceftaroline fosamil Teflaro Created: 11/14/13 Review request with Medial Director on case-by-case basis.

46 : : Cimzia Certolizumab pegol Created: 09/12/2013 Updated: 01/09/2014 Crohn s Disease Initial Criteria: 1. Does the member have a diagnosis of moderate to severe Crohn s Disease or (see note for definition)? Note: Moderate and Severe Disease: failed treatment for mild to moderate disease or has more prominent symptoms including fevers, significant weight loss, abdominal pain or tenderness, intermittent nausea or vomiting (without obstructive findings), or significant anemia, evidence of intestinal obstruction, cachexia, or evidence of abscess. 2. Is the member age 18 or older? 3. Has the member failed Humira? If yes, continue to #4. If no, do not approve and recommend untried agents. 4. Is certolizumab being initiated or supervised by a gastroenterologist? If yes, approve x 6 months. Note: The combined use of certolizumab and a tumor necrosis factor (TNF) inhibitor, such as infliximab, or etanercept, or adalimumab, is considered investigational. Combination therapy is not authorized. Renewal Criteria: 1. Is the member currently on certolizumab and has a documented response such as a decrease in symptoms, reduction in enterocutaneous fistulas or clinical remission? If yes, approve x 12 months. Rheumatoid Arthritis Initial Criteria:

47 1. Does the member have a diagnosis of moderately- to severely-active rheumatoid arthritis? 2. Has the treatment been prescribed or is a rheumatologist currently supervising it? 3. Is the member age 18 or older? If yes, continue to #4. 4. Has the member tried and failed or have contraindications to Enbrel or Humira If yes, continue to #5. If no, do not approve 5. Approve for #6 vials x 1 month then #2 vials per month x 5 months. Dose is 400mg SC x 1 then at 2 and 4 weeks. Maintenance: 200mg q 2 weeks or 400mg q 4 weeks. Renewal Criteria: 1. Has the member experienced 20% or greater improvement in tender joint count and/or swollen joint count? 2. Approve #2 vials per month for 12 months. Psoriatic Arthritis Initial Criteria: 1. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #2. 2. Does the member have psoriatic arthritis? 3. Is the diagnosis based on the following? c. Clinical presentation of active, inflammatory arthritis, e.g. +/- elevated sed rate or CRP, swollen joint count, and d. Radiographic findings consistent with joint erosion. If yes, continue to #4. 4. Has the member failed or have contraindications to conventional management with all of the following? c. NSAIDs, and d. Methotrexate (or other DMARD such as leflunomide or sulfasalazine). If yes, approve x6 months. Note: The combined use of Cimzia and a tumor necrosis factor (TNF) inhibitor, such as Humira, Enbrel, Remicade or combined use of Cimzia with Orencia is considered investigational. Combination therapy is not authorized.

48 Renewal Criteria: 1. Has the member experienced 20% or greater improvement in tender joint count and swollen joint count? If yes, approve x 12 months. Ankylosing Spondylitis Initial Criteria: 1. Does the member have an active infection or a history of recurring infections? If yes, do not approve. If no, continue to #2. 2. Does the member have ankylosing spondylitis? 3. Does the member have moderate to severe active disease, evidenced by a Bath AS Disease Activity Index (BASDAI) score of 4 or Physician Global Assessment of 2 or greater on Likert scale (0 = none, 1 = mild, 2 = moderage, 3 = severe, 4 = very severe)? If yes, continue to #4. 4. Has the member tried and failed conventional therapy with all of the following At least 2 NSAIDs for 3 months, and Physical therapy/exercise program, and Sulfasalazine in members with peripheral disease, not required for axial disease If yes, approve x 6 months. If no, do not approve Note: The combined use of Cimzia and a tumor necrosis factor (TNF) inhibitor, such as Humira, Enbrel, Remicade or combined use of Cimzia with Orencia is considered investigational. Combination therapy is not authorized. Renewal Criteria: 1. Does the member have significant improvement in signs and symptoms of AS and/or functioning (such as 50% or 2-point improvement in BASDAI or Physician Global of > 1)? If yes, approve for 1 year.

49 : : Cetuximab Erbitux Created: 9/12/13 ** Initial Criteria apply to New Starts Only ** Initial Criteria: 1. Is the member age 18 or older? 2. Is Erbitux being prescribed by an oncologist? 3. Does the member have a diagnosis of one of the following? Metastatic colorectal cancer: o K-Ras mutation negative, EGFR-expressing, as monotherapy in patients intolerant to irinotecan-based chemotherapy o K-Ras mutation negative, EGFR-expressing, as monotherapy in patients who failed irinotecan- and oxaliplatin-based chemotherapy o K-Ras mutation negative, EGFR-expressing, first-line therapy in combination with FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin) o K-Ras mutation-negative, EGFR-expressing, in combination with irinotecan in patients refractory to irinotecan-based chemotherapy Head and neck cancer: o locally or regionally advanced squamous cell in combination with radiation o Metastatic or recurrent squamous cell as monotherapy after failure of prior platinum-based therapy o Metastatic or recurrent squamous cell as first-line therapy in combination with platinum-based chemotherapy and 5- fluorouracil If yes, continue to #4. 4. Approve x 12 months. Renewal Criteria: 1. Has there been evidence of tumor response? If yes, approve x 12 months.

50 Collagenase clostridium histolyticum Xiaflex Created: 11/15/13 Last Updated: 05/08/14 Initial Criteria 1. Does the member have a diagnosis of Dupuytren s contracture? If no, continue to #4. 2. Is there medical record documentation that indicates the member would be unable to tolerate a surgical form of treatment? 3. Approve up to 3 injections at 4 week intervals (maximum 12 weeks). 4. Does the member have a diagnosis of Peyronie s disease with palpable plaque and severity of curvature 30 degrees? If yes, continue to #5 If no do not approve. 5. Is it requested by urologist? If yes, continue to #6 6. Has member tried or had contraindication to pentoxifylline? If yes, continue to #7 7. Approve x2 injections with 6 weeks approval duration. Renewal Criteria (For Peyronie s disease indication only) 1. Is there documented improvement of degrees of curvature from previous injection but remain greater than 15 degree? If yes, continue to #2 2. Approve x2 injections with 6 weeks approval duration.

51 Corticotropin Acthar gel Created: 11/14/13 Review request with Medial Director on case-by-case basis.

52 Cytomegalovirus Immune Globulin Cytogam Created: 09/12/ Is request for CMV prophylaxis in member with solid organ transplant including: heart, liver, pancreas, kidney and lung with high risk CMV infection? If yes, continue to #2 If not, do not approve. 2. Is the requested in conjunction with ganciclovir or Valcyte? If yes, approve x 16 weeks

53 Degarelix Firmagon Created: 9/12/13 1. Is the member age 18 or older and male? 2. Is Firmagon being prescribed by an oncologist? 3. Does the member have a diagnosis of advanced prostate cancer? If yes, approve x life.

54 Epoetin alfa Darbepoetin Epogen Procrit Aranesp Created: 09/12/2013 Initial Criteria: 1. Does the member have anemia associated with ONE of the following conditions? a. Chronic renal failure (CRF), or b. Solid tumors or multiple myeloma or lymphoma or lymphocytic leukemia who is currently undergoing myelosuppressive chemotherapy. If yes, continue to #4. If no, continue to #2. 2. Does the member have anemia associated with HIV/AIDS Zidovudine therapy? If yes, continue to #5. If no, continue to #3. 3. Does the member have anemia associated with interferon-ribavirin treatment (Pegasys, Peg-Intron, ribavirin, Ribasphere, Copegus)? If yes, forward to PLAN for review. 4. Does the member meet ALL of the following criteria? a. Hgb < 10 g/dl or Hct < 30%, and b. transferrin saturation > 20% and/or ferritin > 100 ng/ml If yes, continue to #6. 5. Does the member meet ALL of the following criteria? a. Hgb < 10 g/dl or Hct < 30%, and b. transferrin saturation 20%, and c. Endogenous erythropoietin 500 IU/L, and d. Zidovudine doses 4200mg per week If yes, continue to #6. 6. Approve for 3 months. Renewal Criteria: 1. Is the member currently on epoetin (Procrit, Epogen) or darbepoetin (Aranesp) therapy and has maintained adequate iron stores (transferring saturation > 20%)?