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Nebraska Supplemental PDL June 2018

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Nebraska Supplemental PDL June 2018 Applies to: Nebraska Supplemental PDL Albenza (albendazole) Albenza (albendazole) Covered uses All medically accepted indications Exclusion Criteria See age restrictions Required Medical Enterobiasis, ascariasis: Medical documentation indicating use Information for treatment for enterobiasis and previous trial and failure to ivermectin and Pin-X Intestinal strongyloidiasis, cutaneous larva migrans, or infection by loa loa: Medical documentation indicating use for treatment for intestinal strongyloidiasis, cutaneous larva migrans, or infection by loa loa and previous trial and failure to ivermectin. Approve for use as empiric treatment for presumptive strongyloides infection in Sub-Saharan Africa refugees from LoaLoa endemic countries, regardless of previous ivermectin use.2 Echinococcosis (Hydatid disease), neurocysticercosis: Medical documentation indicating the use for treatment of echinococcosis or neurocysticercosis. Age restrictions 1 year of age or older Prescriber None Restrictions Coverage Duration 6 months (Hytadid) 1 month for other indications Other Criteria None Reference 1. Albenza [package insert]. Amedra Pharmaceuticals. Horsham, PA. February, 2013 2. Centers for Disease Control and Prevention. Guidelines for Overseas Presumptive Treatment of Strongyloidiasis, Schistosomiasis, and Soil-Transmitted Helminth Infections. http://www.cdc.gov/immigrantrefugeehealth/guidelines/overseas/intestinalparasites- overseas.html. Accessed August 20, 2014. Updated 01/2017 Page 1 of 1 Applies to: Aristada (aripiprazole lauroxil) Nebraska Supplemental PDL Aristada (aripiprazole lauroxil, extended release) Covered uses All medically accepted indications Exclusion Criteria Aristada should be avoided in populations with dementia-related psychosis. (Black Box warning) Required Medical 1. Medical diagnosis of schizophrenia Information 2. Must have failed at least 2 weeks of 2 oral atypical antipsychotics (aripiprazole, risperidone, paliperidone, ziprasidone, quetiapine, olanzapine, etc.) OR provide documentation of non-compliance, inability to swallow oral medications, or contraindication to oral atypical antipsychotics. 3. Requested dose is administered once monthly (442mg, 662mg, or 882mg), every 6 weeks (882 mg only), or every 8 weeks (1064 mg only). Age re strictions 18 years or older Pre scribe r N/A Restrictions Coverage Duration 1 year Othe r Crite ria Members currently taking this medication at the time of enrollment will not be required to meet prerequisites for authorization References: 1) Aristada [package insert]. Alkermes, Inc. Waltham, MA. July 2016 Updated 03/2018 Page 1 of 1 Applies to: Aripiprazole ER Susp (Abilify Maintena) Nebraska Supplemental PDL Abilify Maintena (aripiprazole extended release suspension) Covered uses All medically accepted indications Exclusion Criteria Abilify Maintena should be avoided in populations with dementia-related psychosis. (Black Box warning) Required Medical 1. Medical diagnosis of Schizophrenia or Bipolar I disorder Information 2. Must have failed at least 2 weeks of 2 oral atypical antipsychotics (aripiprazole, risperidone, paliperidone, ziprasidone, quetiapine, olanzapine, etc.) OR provide documentation of non-compliance, inability to swallow oral medications, or contraindication to oral atypical antipsychotics. 3. Requested maintenance dose is administered once monthly Age restrictions 18 years of age and older Prescriber N/A Restrictions Coverage Duration 1 year Other Criteria Members currently taking this medication at the time of enrollment will not be required to meet prerequisites for authorization The recommended starting and maintenance dose of Abilify Maintena is 400 mg monthly (no sooner than 26 days after the previous injection). References: • Abilify Maintena (Aripiprazole). National Library of Medicine and National Institutes of Health. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee49f3b1-1650-47ff- 9fb1-ea53fe0b92b6#S2.5. Updated February 23, 2017. Accessed August 8, 2017. Created 08/2017 Page 1 of 1 Applies to: Nebraska Supplemental PDL Mepron (atovaquone7mg/ 5 mL) Mepron (atovaquone 750 mg/ 5 mL) Covered uses All FDA approved indications Exclusion Criteria N/A Required Medical Pneumocystis jirovecii pneumonia (PCP) Information 1. Atovaquone 750 mg/ 5 mL will be approved based on all of the following criteria: a. The patient has a diagnosis (i.e. HIV) warranting PCP infection prophylaxis. -AND- b. The patient has a documented intolerance to TMP-SMX and dapsone. -OR 2. Atovaquone 750 mg/ 5 mL will be approved based on all of the following criteria: a. The patient has a diagnosis of acute mild to moderate pneumonia caused by P. jirovecii. -AND b. The patient has a documented intolerance to TMP-SMX. Age restrictions N/A Prescriber N/A Restrictions Coverage 6 months Duration Other Criteria N/A REFERENCES 1 Mepron® Prescribing Information. GlaxoSmithKline, March 2014 2 Centers for Disease Control and Prevention. Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents. MMWR 2009;58 (No. RR4): 6-10. 3 Atovaquone. Facts and Comparisons. Web. 26 July 2011. Updated 01/2017 Page 1 of 2 Applies to: Nebraska Supplemental PDL Mepron (atovaquone7mg/ 5 mL) 4 El-Sadr WM, Murphy RL, Yurik TM, et al. Atovaquone compared with dapsone for the prevention of Pneumocystis carinii pneumonia in patients with HIV infection who cannot tolerate trimethoprim, sulfonamides, or both. N Engl J Med 1998;339:1889-1895. Updated 01/2017 Page 2 of 2 Applies to: Nebraska Supplemental PDL Topical Santyl (collagenase) Topical Santyl (collagenase) Covered uses All medically accepted indications Exclusion Criteria Stage 1 ulcers Wounds with healthy, non-necrotic tissue Required Medical Use for treatment of: Information a) Burns- severe partial or full thickness wounds b) Decubitus ulcer c) Diabetic ulcer d) Varicose ulcer Age restrictions 18 years of age and older Prescriber N/A Restrictions Coverage Duration 3 months Other Criteria Dosing: Apply once daily (or more frequently if the dressing becomes soiled). References: 1. Product Information: COLLAGENASE SANTYL(R) topical ointment, collagenase topical ointment. Healthpoint Ltd. Fort Worth, TX 76107, 2013 Updated 01/2017 Page 1 of 1 Applies to: Nebraska Supplemental PDL Compounded Products Covered uses All medically accepted indications Exclusion Criteria Compounded products ≥ $140 Certain cream, ointment, gel, and foam bases with GPI 98 Required Medical All individual ingredients within a compound, regardless of Information RX/OTC status, are covered if the aggregate cost of the compound is < $140 Age restrictions N/A Prescriber N/A Restrictions Coverage Duration Based on submitted request Other Criteria N/A Created 02/2017 Page 1 of 1 Applies to: Jadenu (deferasirox) Nebraska Supplemental PDL Jadenu (deferasirox) Covered uses All FDA approved indications Exclusion Criteria Serum creatinine greater than 2 times the age-appropriate upper limit of normal (ULN) OR CrCl less than 40 ml/min Poor performance status High-risk myelodysplastic syndromes or advanced malignancies Platelet count less than 50 x 109/L Required Medical 1) Documentation of chronic iron overload due to blood transfusions Information (transfusional hemosiderosis) with: • Documentation of red blood cells transfusion of at least 100 mL/kg of packed red blood cells • Baseline serum ferritin level of 1,000 mcg/L prior to therapy • Baseline iron levels prior to therapy • Current serum ferritin levels greater 500 mcg/L • Current iron levels • Current weight • Initial dose: 14 mg/kg/day with dosage adjustments based on response 2) Documentation of chronic iron overload resulting from a genetic blood disorder called nontransfusion-dependent thalassemia. • Current serum ferritin levels greater 300 mcg/L • Liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) • Current weight • Initial dose: 7 mg/kg/day with dosage adjustments based on response Age restrictions Age 2 or greater with chronic iron overload due to blood transfusions. Age 10 or greater with chronic iron overload resulting from a genetic blood disorder called non-transfusion dependent thalassemia. Prescriber Restrictions Hematologist Coverage Duration 6 months Other Criteria Max dose 28 mg/kg/day Reference: Jadenu [package insert]. Novartis Pharmaceuticals. East Hanover, NJ. October 2015 Last updated 11/2015 Applies to: Nebraska Supplemental PDL Pulmozyme (dornase alfa) Pulmozyme (dornase alfa) Covered uses All medically accepted indications Exclusion Criteria Required Medical Stated diagnosis from a pulmonologist of Cystic Fibrosis Information Stated diagnosis of atelectasis and/or pulmonary mucus plugging in non-cystic fibrosis disease states with trial and failure of preferred alternative Age restrictions Prescriber Pulmonologist Restrictions Coverage Duration 1 year Other Criteria Safety and efficacy of daily administration have not been demonstrated in patients for longer than 12 months. Preferred Alternative CF: approve Atelectasis and/or mucus plugging: acetylcysteine References: 1. Product Information: Pulmozyme(R) inhalation solution, dornase alfa inhalation solution. Genentech, Inc., South San Francisco, CA, 2010. Updated 01/2017 Page 1 of 1 Applies to: Nebraska Supplemental PDL Multaq (dronedarone) Multaq (dronedarone) Covered uses All FDA approved indications Exclusion Criteria • Patients with PERMANENT atrial fibrillation who will not or cannot be cardioverted to normal sinus rhythm • Symptomatic heart failure
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