NB Drug Plans Formulary Update

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Bulletin # 995 March 27, 2019 NB Drug Plans Formulary Update This update to the New Brunswick Drug Plans Formulary is effective March 27, 2019. Included in this bulletin: Special Authorization Benefit Additions Changes to Existing Special Authorization Benefits Drugs Reviewed and Not Listed If you have any questions, please contact our office at 1-800-332-3691. The Formulary Updates are available online: http://www.gnb.ca/0212/benefitupdates-e.asp. To unsubscribe from the NB Drug Plans email announcements, please send a message to info@nbdrugs-medicamentsnb.ca. Administered by Medavie Blue Cross on behalf of the Government of New Brunswick

Special Authorization Benefit Additions Product Strength DIN MFR Plans Cost Base Levofloxacin (Quinsair ) 240 mg / 2.4 ml solution for inhalation 02442302 HRZ (SA) MLP For the treatment of chronic pulmonary Pseudomonas aeruginosa infections, when used as a cyclic treatment, in adult patients with cystic fibrosis who have experienced treatment failure with inhaled tobramycin. Clinical Note: Cyclic treatment measured in 28-day cycles is defined as 28 days of treatment, followed by 28 days without treatment. Combined use of inhaled levofloxacin, either concurrently or for antibiotic cycling during off-treatment periods, with other inhaled antibiotics (e.g. tobramycin, aztreonam) will not be reimbursed. Requests will be considered for individuals in Plans ADEFGV. Taliglucerase alfa (Elelyso ) 200 unit/vial powder for injection 02425637 PFI (SA) MLP For the treatment of patients with symptomatic Gaucher disease type 1 (GD1) for whom treatment with velaglucerase alfa is not tolerated or contraindicated. Clinical Notes: 1. Velaglucerase alfa is the preferred reimbursed enzyme replacement therapy for GD1. Requests for patients currently using taliglucerase alfa who do not have a contraindication or intolerance to velaglucerase alfa will be considered for coverage of velaglucerase alfa only. 2. Requests for coverage must meet the criteria for diagnosis of GD1, indication for therapy and expected response to enzyme replacement therapy. These criteria are consistent with the Ontario Guidelines for the Treatment of Gaucher Disease. Please contact the NB Drug Plans at 1-800-332-3691 for the criteria. Approvals will be for a maximum of 60 units/kg every 2 weeks. Initial Approval: 6 months. Renewal Approval: 1 year. Claims that exceed the maximum claim amount of $9,999.99 must be divided and submitted as separate transactions as outlined here. New Brunswick Drug Plans 2 March 2019

Changes to Existing Special Authorization Benefits Product Strength DIN MFR Plans Cost Base Biologic Disease-Modifying Antirheumatic Drugs for Plaque Psoriasis Adalimumab (Humira ) 40 mg / 0.8 ml pen and prefilled syringe 02258595 ABV (SA) MLP Etanercept (Enbrel ) 25 mg/ml vial 02242903 50 mg/ml autoinjector and prefilled syringe 02274728 AGA (SA) MLP Infliximab (Inflectra ) 100 mg vial 02419475 PFI (SA) MLP Infliximab (Remicade ) 100 mg vial 02244016 JAN (SA) MLP Infliximab (Renflexis TM ) 100 mg vial 02470373 FRS (SA) MLP Ixekizumab (Taltz TM ) 80 mg/ml autoinjector 02455102 80 mg/ml prefilled syringe 02455110 LIL (SA) MLP Secukinumab (Cosentyx ) 150 mg/ml prefilled syringe and SensoReady pen 02438070 NVR (SA) MLP Ustekinumab (Stelara ) 45 mg / 0.5 ml prefilled syringe 02320673 90 mg/ml prefilled syringe 02320681 JAN (SA) MLP For the treatment of patients with chronic moderate to severe plaque psoriasis who meet all of the following criteria: Psoriasis Area Severity Index (PASI) > 10 and Dermatology Life Quality Index (DLQI) > 10, or major involvement of visible areas, scalp, genitals, or nails Refractory, intolerant or unable to access phototherapy Refractory, intolerant or have contraindications to one of the following: Methotrexate (oral or parenteral) at a dose of 20 mg weekly ( 15 mg if patient is 65 years of age) for a minimum of 12 weeks Cyclosporine for a minimum of 6 weeks Clinical Notes: 1. For patients who do not demonstrate a clinical response to oral methotrexate, or who experience gastrointestinal intolerance, a trial of parenteral methotrexate must be considered. 2. Refractory is defined as lack of effect at the recommended doses and for duration of treatments specified above. 3. Intolerant is defined as demonstrating serious adverse effects to treatments. The nature of intolerance(s) must be clearly documented. Must be prescribed by a dermatologist. Combined use of more than one biologic DMARD will not be reimbursed. New Brunswick Drug Plans 3 March 2019

All new requests for coverage of infliximab will be approved for the biosimilar versions only. Maximum approved dosages as per existing criteria on the NB Drug Plans Formulary. Initial approval period: 12 weeks for secukinumab and ixekizumab, 16 weeks for others. Renewal approval period: 1 year. Confirmation of continued response is required. Linagliptin / Metformin (Jentadueto ) 2.5 mg / 500 mg tablet 02403250 2.5 mg / 850 mg tablet 02403269 2.5 mg / 1000 mg tablet 02403277 BOE (SA) MLP therapy with linagliptin and metformin, to replace the individual components of linagliptin Saxagliptin / Metformin (Komboglyze ) 2.5 mg / 500 mg tablet 02389169 2.5 mg / 850 mg tablet 02389177 2.5 mg / 1000 mg tablet 02389185 AZE (SA) MLP therapy with saxagliptin and metformin, to replace the individual components of saxagliptin Sitagliptin / Metformin (Janumet ) 50 mg / 500 mg tablet 02333856 50 mg / 850 mg tablet 02333864 50 mg / 1000 mg tablet 02333872 FRS (SA) MLP Sitagliptin / Metformin (Janumet XR ) 50 mg / 1000 mg extended release tablet 02416794 FRS (SA) MLP therapy with sitagliptin and metformin, to replace the individual components of sitagliptin New Brunswick Drug Plans 4 March 2019

Drugs Reviewed and Not Listed The review of the following products found that they did not offer a significant therapeutic and/or cost advantage over existing therapies. Requests for special authorization will not be considered. Product Strength DIN MFR Indication Tapentadol (Nucynta ER ) 50 mg extended release tablet 02415577 100 mg extended release tablet 02415585 150 mg extended release tablet 02415593 200 mg extended release tablet 02415607 250 mg extended release tablet 02415615 PAL For management of pain severe enough to require daily, continuous, long-term opioid treatment. New Brunswick Drug Plans 5 March 2019