New Exception Status Benefits

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1 FEBRUARY 2019 Nva Sctia Frmulary Updates New Exceptin Status Benefits Prcysbi (cysteamine bitartrate) Nucala (meplizumab) Ocaliva (betichlic acid) Ravicti (glycerl phenylbutyrate) Taltz (ixekizumab) Criteria Update: Psriatic Arthritis Cimzia (certlizumab pegl) Enbrel (etanercept) Humira (adalimumab) Inflectra and Remicade (infliximab) Simpni (glimumab) Prescriber Identificatin n Exceptin Status Drug Request Nva Sctia Frmulary Updates New Exceptin Status Benefits The fllwing prducts have been listed with the fllwing criteria, effective February 1, Prcysbi (cysteamine bitartrate) 25mg Cap 75mg Cap HRZ HRZ Criteria Fr the treatment f infantile nephrpathic cystinsis with dcumented cystinsin (lyssmal cystine transprter) gene mutatin. Must be prescribed by, r in cnsultatin with, a prescriber with experience in the diagnsis and management f cystinsis Claims fr Prcysbi 75mg capsule that exceed the maximum claim amunt f $9, must be divided and submitted as separate transactins using the fllwing PINs:

2 PAGE 2 OF 6 Nucala (meplizumab) 144mg/Vial Pws Inj (100mg/mL when recnstituted) GSK Criteria Fr the adjunctive treatment f severe esinphilic asthma in adult patients wh are inadequately cntrlled with high-dse inhaled crticsterids and ne r mre additinal asthma cntrller(s) (e.g., a lng-acting beta-agnist), and have a bld esinphil cunt f 0.15 x 10 9 /L at initiatin f treatment with meplizumab r 0.3 x 10 9 /L in the past 12 mnths, if ne f the fllwing clinical criteria are met: Patients wh have experienced tw r mre clinically significant asthma exacerbatins in the past 12 mnths and wh shw reversibility (at least 12% and 200 ml) n spirmetry, r Are treated with daily ral crticsterids (OCS). Stpping Criteria: Failure t achieve a decrease in any clinically significant exacerbatins at 12 mnths; r Failure t achieve a decrease in the daily maintenance OCS dse at 12 mnths. Clinical Ntes: Significant clinical exacerbatin is defined as wrsening f asthma such that the treating physician elected t administer systemic gluccrticids fr at least 3 days r the patient visited an emergency department r was hspitalized. A decrease in the daily maintenance OCS dse is defined as a decrease f at least 25%. Must be prescribed by a respirlgist, clinical immunlgist r allergist. Apprvals will be fr a maximum f 100mg every fur weeks. Initial apprval: 1 year. Renewal apprval: 1 year.

3 PAGE 3 OF 6 Ocaliva (betichlic acid) Criteria 5mg Tab 10mg Tab Initiatin Criteria: Fr the treatment f primary biliary chlangitis (PBC) in cmbinatin with ursdexychlic acid (UDCA) in adults with an inadequate respnse t UDCA, r as mntherapy in adults unable t tlerate UDCA, where the fllwing criteria are met: A cnfirmed diagnsis f PBC, defined as: Psitive antimitchndrial antibdies (AMA); r Liver bipsy results cnsistent with PBC. The patient is under the care f a gastrenterlgist r hepatlgist r ther prescriber with a specialty in gastrenterlgy r hepatlgy. AND The patient has received UDCA fr a minimum f 12 mnths and has experienced an inadequate respnse t UDCA and can benefit frm the additin f betichlic acid. An inadequate respnse is defined as: OR alkaline phsphatase (ALP) 1.67 x upper limit f nrmal (ULN) and/r bilirubin > ULN and < 2 x ULN and/r evidence f cmpensated cirrhsis The patient has experienced dcumented and unmanageable intlerance t UDCA and can benefit frm switching therapy t betichlic acid. INT INT Renewal Criteria: The patient cntinues t benefit frm treatment with betichlic acid as evidenced by: A reductin in the ALP level t less than 1.67 x ULN; r A 15% reductin in the ALP level cmpared with values befre beginning treatment with betichlic acid. Claim Nte: Duratin f apprval: 12 mnths

4 PAGE 4 OF 6 Ravicti (glycerl phenylbutyrate) 1.1g/mL Oral Liquid HRZ Criteria Fr the chrnic management f patients with urea cycle disrders (UCDs). Clinical Nte: Diagnsis must be cnfirmed by bld, enzymatic, bichemical r genetic testing. Must be prescribed by, r in cnsultatin with, a prescriber experienced in the treatment f UCDs. Claims that exceed the maximum claim amunt f $9, must be divided and submitted as separate transactins using the fllwing PINs: Taltz 80mg/mL Autinjectr (ixekizumab) 80mg/mL Prefilled Syringe Criteria Psriasis Fr patients with severe, debilitating chrnic plaque psriasis wh meet all f the fllwing: Bdy surface area (BSA) invlvement f >10% and/r significant invlvement f the face, hands, feet r genitals; Failure t, cntraindicatin t r intlerant f methtrexate and cyclsprine; Failure t, intlerant f r unable t access phttherapy; Written request f a dermatlgist r prescriber with a specialty in dermatlgy. Cntinued cverage is dependent n evidence f imprvement, specifically: A >75% reductin in the Psriasis Area and Severity Index (PASI) scre; r A >50% reductin in PASI with a >5-pint imprvement in DLQI (Dermatlgy Life Quality Index); r Significant reductin in BSA invlved, with cnsideratin f imprtant regins such as the face, hands, feet r genitals.

5 PAGE 5 OF 6 Taltz (ixekizumab) Criteria 80mg/mL Autinjectr 80mg/mL Prefilled Syringe Clinical Ntes: Treatment shuld be discntinued if a respnse has nt been demnstrated after 12 weeks. Cncurrent use f bilgics nt apprved. Initial apprval fr a maximum f 12 weeks. Renewal apprval: 1 year. Apprvals will be fr 160 mg at week 0, fllwed by 80 mg at weeks 2, 4, 6, 8, 10, and 12 then 80 mg every fur weeks. Psriatic Arthritis Fr the treatment f patients with predminantly axial psriatic arthritis wh are refractry, intlerant r have cntraindicatins t the sequential use f at least tw NSAIDs at maximal tlerated dse fr a minimum f tw weeks each. Fr the treatment f patients with predminantly peripheral psriatic arthritis wh are refractry, intlerant r have cntraindicatins t: Clinical Ntes: The sequential use f at least tw NSAIDs at maximal tlerated dse fr a minimum f tw weeks each; and Methtrexate (ral r parenteral) at a dse f 20mg weekly ( 15mg if patient is 65 years f age) fr a minimum f 8 weeks; and Leflunmide fr a minimum f 10 weeks r sulfasalazine fr a minimum f 3 mnths Fr patients wh d nt demnstrate a clinical respnse t ral methtrexate, r wh experience gastrintestinal intlerance, a trial f parenteral methtrexate must be cnsidered. Refractry is defined as lack f effect at the recmmended dses and fr duratin f treatments specified abve. Intlerant is defined as demnstrating serius adverse effects t treatments. The nature f intlerance(s) must be clearly dcumented. Must be prescribed by a rheumatlgist. Cmbined use f mre than ne bilgic DMARD will nt be reimbursed. Initial apprval fr a maximum f 12 weeks. Apprvals will be fr 160mg at week 0, fllwed by 80mg every 4 weeks. Renewal Apprval: 1 year. Cnfirmatin f cntinued respnse is required.

6 PAGE 6 OF 6 Criteria Update: Psriatic Arthritis The psriatic arthritis criteria fr the fllwing prducts has been updated effective February 1, 2019: Cimzia (certlizumab pegl) Enbrel (etanercept) Humira (adalimumab) Inflectra and Remicade (infliximab) Simpni (glimumab) Please see the full criteria fr psriatic arthritis under the ixekizumab (Taltz) listing n Page 5. Prescriber Identificatin n Exceptin Status Request Please ensure the prescriber infrmatin sectin is cmplete when submitting exceptin status drug request frms. The fllwing infrmatin must be included: Prescriber name License number Signature If the abve infrmatin is nt included and clearly legible, respnses may be prevented r delayed. Legend PRESCRIBER CODES MANUFACTURER CODES D - Physician / Dentist S - Senirs Pharmacare GSK GlaxSmithKline Inc. N - Nurse Practitiner F - Cmmunity Services Pharmacare HRZ HZNP Canada Limited P M O - Pharmacist - Midwife - Optmetrist C D E - Family Pharmacare - Drug Assistance fr Cancer Patients - Diabetes Assistance Prgram - Exceptin status applies INT Intercept Pharma Canada Inc. Eli Lilly Canada Inc.