PHARMACY TIMES BY IEHP PHARMACEUTICAL SERVICES DEPARTMENT August 20, 2014

Transcription

1 PHARMACY TIMES BY IEHP PHARMACEUTICAL SERVICES DEPARTMENT August 20, 2014 We would like to inform you of the following changes to the 2014 IEHP that were approved by the Pharmacy and Therapeutics Subcommittee in August 2014: Drug Name Strength & Dosage Form IEHP FORMULARY ADDITIONS/DELETIONS Classification Medi-Cal/HF/HK DualChoice SNP/CMC Beleodaq 500 mg vial Histone deacetylase Non-formulary (belinostat) Diclofenac 1.50% drops NSAID Non-formulary ; PA (new starts only) Doxycycline Isentress (raltegravir) Isentress (raltegravir) Methoxsalen Nevirapine 10 mg/ml vial 20 mg/ml suspension 100 mg powder packet 10 mg capsule 10 mg/ml suspension Antibiotic Non-formulary Integrase Integrase Medi-Cal: DHCS carve out HF/HK: Nonformulary Medi-Cal: DHCS carve out HF/HK: Nonformulary Photosensitizer Non-formulary ; PA NNRTI Medi-Cal: DHCS carve out Nevirapine ER 400 mg tablet NNRTI HF/HK: Nonformulary Medi-Cal: DHCS carve out HF/HK: Non-

2 Rifabutin 150 mg capsule Antibiotic formulary Nitroglycerin 0.4 Vasodilator Non-formulary mg/spray Omega-3 acid ethyl 1 gm Fatty acid Non-covered ; PA esters capsule benefit Raloxifene 60 mg tablet Selective estrogen Non-formulary receptor modulator Reyataz (atazanavir) 50 mg powder packet Protease Medi-Cal: DHCS carve out HF/HK: Nonformulary Non-formulary; Code 1 Restricted to prevention of disseminated Mycobacterium Avium Complex (MAC) disease in patients with advanced HIV infection Risedronate 150 mg Bisphosphonate Non-formulary capsule Sylvant (siltuximab) 100 mg vial Anti-IL-6 chimeric monoclonal antibody Non-formulary ; PA (new starts only) Zydelig (idelalisib) 100 mg, 150 mg tablet Phosphoinositide 3- kinase Non-formulary ; PA (new starts only) Zykadia (ceritinib) 150 mg capsule Anaplastic lymphoma kinase (ALK) Non-formulary ; PA (new starts only) Please Note: Generics are covered when available. Non-formulary agents may be requested through the Pharmacy Exception Request (PER) process Bolded Items: status change as of August 2014 P&T IEHP PRIOR AUTHORIZATION UPDATES Drug Name Classification Medi-Cal/HF/HK DualChoice SNP/CMC Acticlate (doxycycline hyclate) Antibiotic indication and failure Adcirca (tadalafil) PDE5 Confirmation of diagnosis PAH (NYHA Stage 2-3) and under the care of a cardiologist or pulmonologist Afinitor (everolimus) mtor indication and prescribed by an oncologist Afrezza (insulin human ) Hormone indication with

3 HbA1c > 7, best possible combination of anti-diabetic agents; insulin must be initiated prior Ampyra (dalfampridine) Multiple sclerosis See class monograph See class monograph Aptiom (eslicarbazepine Anticonvulsant FDA-approved indication(s) acetate) and failure alternatives Aranesp (darbopoetin Erythropoiesisstimulating See class monograph alfa) agents Aubagio (teriflunomide) Multiple sclerosis See class monograph Avandia (rosiglitazone) Thiazolidinedione Failure or metformin, sulfonylurea, pioglitazone combination. HbA1c score above 7 after at least 3 months of optimal therapy; if TZD is indicated, must use pioglitazone Failure or metformin, sulfonylurea, pioglitazone combination. HbA1c score above 7 after at least 3 months of optimal therapy; if TZD is indicated, must use pioglitazone Avonex (interferon beta- Multiple sclerosis See class monograph 1a) Azilect (Rasagiline) Anti-parkinson indication and -- failure Beleodaq (belinostat) Histone deacetylase Benlysta (belimumab) Betaseron (Interferon beta-1b) Blood Glucose Meter (glucometer) B-cell activating factor indication and ASCO/NCNN guidelines, prescribed by oncologist Positive for systemic lupus erythematosus autoantibody and failure of at least two standard therapies, including antimalarials, corticosteroids, and immunosuppressive/cytotoxic agents indications not otherwise excluded from Part D Multiple sclerosis See class monograph Medical device TRUE2go is formulary; WeCare Pharmacy will provide DTM program Boniva (ibandronate) Bisphosphonate Alendronate as first line therapy; Osteoporosis criteria of BMD (T-score -3.0); IV bisphosphonate requires failure of at least two oral Part B only --

4 Brintellix (vortioxetine) Atypical antidepressant bisphosphonates or patient is contraindicated to the oral bisphosphonate Depression and failure or two formulary medications (6 week-trial each) from the following: formulary selective serotonin reuptake (SSRI), venlafaxine, duloxetine, mirtazapine, bupropion CellCept (mycophenolate) Antimetabolite Transplant rejection prophylaxis for heart, kidney, or liver; or systemic lupus erythematous (SLE), including lupus nephritis and failure of conventional SLE treatment including at least two of the following: corticosteroids, immunosuppressive/cytoxic agents, and antimalarials Cimzia (certolizumab) Biologic agents See class monograph See class monograph Copaxone (glatiramer) Multiple sclerosis See class monograph Cycloset (bromocriptine) Ergot derivative Failure or formulary antidiabetic treatment (e.g. sulfonylurea, metformin, pioglitazone) and A1C>7 after at least 3 months of optimal therapy Eloctate (Factor VIII Recombinant, F c Fusion Protein ) Blood product indication and failure -- Part B Only Enbrel (etanercept) Biologic agents See class monograph See class monograph Entocort (budesonide) Corticosteroid Crohn's disease and failure of formulary oral steroid (prednisone, methylprednisolone, hydrocortisone) -- Erwinaze (erwinia asparaginase) Enzyme Note: Entocort should not be used as maintenance therapy. Acute lymphocytic leukemia (ALL) in combination with other chemotherapeutic agents, prescribed by an oncologist, and member has developed allergic hypersensitivity to E. coliderived asparaginase

5 Euflexxa Hyaluronans See class monograph See class monograph Exelon Patch Acetylcholinesterase (rivastigmine patch) Extavia (Interferon beta- 1b) Eylea (aflibercept) Failed or contraindicated to Exelon capsules for mild to moderate Parkinson s disease dementia; or failed or contraindicated to Aricept, Aricept ODT, and Exelon capsules for Alzheimer s disease indications and trial/failure of formulary Multiple sclerosis See class monograph See class monograph Signal Transduction Inhibitors indication Fabior (tazarotene) Retinoid Failure or two topical formulary acne medications Fanapt (iloperidone) Atypical antipsychotic Medi-Cal: DHCS Carve out HF/HK: Failure or risperidone and quetiapine. Trial of risperidone and quetiapine should be at least 2 months, or if patient develops abnormal behavior/thinking after the treatment indications not otherwise excluded from Part D Gel-One Hyaluronans See class monograph See class monograph Genotropin (somatropin) Hormone See class monograph -- Geodon (ziprasidone) Atypical antipsychotic Medi-Cal: DHCS Carve out --; for solution HF/HK: Failure or risperidone and quetiapine. Trial of risperidone and quetiapine should be at least 2 months, or if patient develops abnormal behavior/thinking after the treatment Giazo (basalazide) Aminosalicylate Mild to moderate ulcerative colitis for males, must be prescribed by GI specialist, failure of sulfasalazine; if criteria is met, Delzicol is the preferred non-formulary oral 5-ASA product Mild to moderate ulcerative colitis for males, must be prescribed by GI specialist, failure of sulfasalazine; if criteria is met, Delzicol is the

6 preferred nonformulary oral 5-ASA product Gilenya (fingolimod) Multiple sclerosis See class monograph Gilotrif (afatinib) Angiokinase indication Humatrope (somatropin) Hormone See class monograph See class monograph Humira (adalimumab) Biologic agents See class monograph Hyalgan Hyaluronans See class monograph See class monograph Invega (paliperidone) Invokamet (canagliflozin and metformin) Atypical antipsychotic Sodium glucose cotransporter-2 and biguanide Medi-Cal: DHCS Carve out HF/HK: Failure or risperidone and quetiapine. Trial of risperidone and quetiapine should be at least 2 months, or if patient develops abnormal behavior/thinking after the treatment indication with HbA1c > 7, best possible combination of anti-diabetic agents Isentress (raltegravir) Integrase Medi-Cal: DHCS carve out -- IVIG IVIG See class monograph See class monograph Januvia (sitagliptin) DPP-IV s Non-formulary; Step therapy: -- must have tried metformin Jardiance (empagliflozin) Sodium glucose cotransporter-2 indication with HbA1c > 7, best possible combination of anti-diabetic agents Jublia (efinaconazole) Antifungal indication and failure Kerydin (tavaborole) Antifungal indication and failure Latuda (lurasidone) Atypical antipsychotic Medi-Cal: DHCS Carve out HF/HK: Failure or risperidone and quetiapine. Trial of risperidone and quetiapine should be at least 2 months, or if patient develops abnormal behavior/thinking after the

7 treatment Levitra (vardenafil) PDE5 Erectile dysfunction is a noncovered benefit; may be allowed for PAH use Liptruzet (ezetimibe, atorvastatin) Anti-lipidemic Failure or two formulary statins (e.g. simvastatin, pravastatin, lovastatin, atorvastatin); lipid panel is required to determine failure Mepron (atovaquone) Antibiotic Pneumocystis pneumonia prophylaxis and treatment Methadone (methadone) Analgesic Chronic severe pain associated with cancer or intractable pain; and failure of first line therapies such as morphine and fentanyl patch; must submit a treatment plan and pain contract Note: Treatment of opioid dependence is not a covered benefit for Medi-Cal Erectile dysfunction is a non-covered benefit; may be allowed for PAH use Failure or two formulary statins (e.g. simvastatin, pravastatin, lovastatin, atorvastatin); lipid panel is required to determine failure Chronic severe pain associated with cancer or intractable pain; and failure of first line therapies such as morphine and fentanyl patch; must submit a treatment plan and pain contract Mycamine (micafungin) Antifungal indication Nasonex (mometasone) Corticosteroid Failure or formulary nasal corticosteroids (i.e. fluticasone, flunisolide, triamcinolone) and combination use with an oral antihistamine; or for members between age 2-4 years after failing Nasacort Failure or formulary nasal corticosteroids (i.e. fluticasone, flunisolide, triamcinolone) and combination use with an oral Neuac (clindamycin Phosphate and benzoyl perioxide) Nexavar (sorafenib) Topical acne agent Protein kinase indication and failure indication(s) and prescribed by an oncologist or hepatologist antihistamine Norditropin (somatropin) Hormone See class monograph See class monograph Nutropin (somatropin) Hormone See class monograph See class monograph Olysio (simeprevir) Antiviral See class monograph See class monograph

8 Omidria (phenylephrine and ketorolac) Alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase indication and failure Omnitrope (somatropin) Hormone See class monograph -- Onglyza (saxagliptin) DPP-IV s Non-formulary; Step therapy: must have tried metformin Failure or metformin, sulfonylurea, pioglitazone combination. HbA1c score above 7 Orbactiv (oritavancin) Antibiotic indication and failure Orthovisc Hyaluronans See class monograph See class monograph Procrit (epoetin alfa) Provigil (modafinil) Erythropoiesisstimulating agents Sympathomimeticlike agent See class monograph Narcolepsy with sleep study and failure or formulary stimulants; or obstructive sleep apnea with sleep study and failure or using continuous positive airway pressure (CPAP) / oral appliance; or fatigue related to multiple sclerosis Pulmozyme (dornase alfa) Enzyme indication - cystic fibrosis in conjunction with standard therapies (e.g. bronchodilators, corticosteroids); prescribed by pulmonologist -- indication - cystic fibrosis in conjunction with standard therapies (e.g. bronchodilators, corticosteroids); prescribed by pulmonologist Rebif (interferon beta-1a) Multiple sclerosis See class monograph Remicade (infliximab) Biologic agents See class monograph Ruconest (C1 esterase, recombinant ) Protease indication prescribed by a specialist (e.g. immunologist, allergist, hematologist), on concomitant use of prophylactic therapy All indications not otherwise excluded from Part D. Saizen (somatropin) Hormone See class monograph See class monograph Samsca (tolvaptan) Vasopressin Significant hyponatremia with Significant

9 receptor 2 antagonist hypervolemia and/or euvolemia; continuation therapy only and must be started in hospital with baseline sodium levels less than 125 meq/l and response to therapy and not responsive to fluid restriction and loop diuretics; total duration of therapy no more than 30 days including days of therapy in hospital hyponatremia with hypervolemia and/or euvolemia; continuation therapy only and must be started in hospital with baseline sodium levels less than 125 meq/l and response to therapy and not responsive to fluid restriction and loop diuretics; total duration of therapy no more than 30 days including days of therapy in hospital Serostim (somatropin) Hormone See class monograph See class monograph Simponi (golimumab) Biologic agents See class monograph See class monograph Sivextro (tedizolid Antibiotic phosphate) indication and failure Soriatane (acitretin) Retinoid Severe psoriasis and failure of two formulary topical steroids such as mid-to-high potency agents (e.g. betamethasone, clobetasol) and/or high dose low potency (e.g. fluocinonide 0.05% four times daily). The low potency preparations are preferred for the face and intertriginous areas Sovaldi (sofosbuvir) Antiviral See class monograph See class monograph Staxyn (vardenafil) PDE5 Erectile dysfunction is a noncovered benefit; may be allowed for PAH use Erectile dysfunction is a non-covered benefit; may be Striverdi Respimat (olodaterol) Long acting betaadrenoceptor agonist Diagnosis of COPD and trial and failure of one formulary long-acting inhaled anticholinergic (e.g. Tudorza) or one formulary long-acting beta-agonist (e.g. Serevent allowed for PAH use Supartz Hyaluronans See class monograph See class monograph Synagis (palivizumab) Monoclonal See drug monograph See drug monograph antibody Synvisc Hyaluronans See class monograph See class monograph

10 Tarceva (erlotinib) Targiniq ER (oxycodone hydrochloride; naloxone hydrochloride extendedrelease ) Tecfidera (dimethyl fumurate) Protein kinase Analgesic indication with confirmed EGFR mutation indication and failure Multiple sclerosis See class monograph See class monograph Tev-Tropin (somatropin) Hormone See class monograph See class monograph Tobi (tobramycin Antibiotic inhalation) FDA indication(s) and prescribed by pulmonologist or infectious disease specialist Tradjenta (linagliptin) DPP-IV s Non-formulary; Step therapy: must have tried metformin Failure or metformin, sulfonylurea, pioglitazone combination. HbA1c score above 7 Tysabri (natalizumab) Multiple sclerosis See class monograph See class monograph Vibativ (telavancin) Antibiotic Methicillin resistant S. Aureus and failure of vancomycin; or treatment of hospital acquired and ventilator associated nosocomial pneumonia caused by S. Aureus when alternatives are not appropriate Vogelxo (testosterone) Anabolic steroid Diagnosis of hypogonadism confirmed by lab data, normal prostate surface antigen level or negative digital rectal exam if applicable; or diagnosis of HIV-wasting syndrome prescribed by specialist Methicillin resistant S. Aureus and failure of vancomycin; or treatment of hospital acquired and ventilator associated nosocomial pneumonia caused by S. Aureus when alternatives are not appropriate Diagnosis of hypogonadism confirmed by lab data and failure of formulary Xeljanz (tofacitinib) Biologic agents See class monograph See class monograph Xgeva (denosumab) Monoclonal antibody Prevention of skeletal-related events in patients with bone metastases from solid tumors; or Giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity

11 Xolair (omalizumab) Anti-IgE antibody See drug monograph See class monograph Zorbtive (somatropin) Hormone See class monograph See class monograph Zydelig (idelalisib) Phosphoinositide 3- kinase indication and ASCO/NCCN guidelines, prescribed by oncologist indications not otherwise excluded from Part D Zykadia (ceritinib) Protein kinase indication(s) and prescribed by oncologist Full Prior Authorization table available at: CLINICAL PRACTICE GUIDELINE UPDATE Clinical Practice Guideline Academy/Association Comment Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection, August 2014 American Academy of Pediatrics This policy statement reflects new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates. This policy statement replaces the recommendations found in the 2012 Red Book.