Kentucky Department for Medicaid Services Drug Review and Options for Consideration

Transcription

1 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin The fllwing table lists the Agenda items scheduled, as well as the Optins fr Cnsideratin, t be presented and reviewed at the September 21, 2017 meeting f the Pharmacy and Therapeutics Advisry Cmmittee. Single Agent Reviews New Prduct t Market: Arym ER Optins fr Cnsideratin Nn-prefer in the PDL class: Narctics: Lng-Acting (Analgesics, Narctics Lng-Acting) Length f Authrizatin: 6 mnths Arym ER (mrphine sulfate extended-release), an piid agnist with abuse-deterrent prperties, is apprved fr the management f pain severe enugh t require daily, arund-the-clck, lng-term piid treatment in adults fr which alternative treatments are inadequate. It is available as 15 mg, 30 mg, and 60 mg tablets fr ral administratin every 8 r 12 hurs. Criteria fr Apprval: Prescriber is a Pain Management Specialist r prescriber has prf f cnsultatin with a Pain Management specialist; AND Diagnsis f severe pain requiring daily, arund-the-clck, lng-term pain management, defined as: Pain lasting >6 cnsecutive mnths; AND Trial and failure f ne nn-piid analgesic (i.e., NSAIDs, APAP) at maximum tlerated dses withut adequate relief f pain; AND Trial and failure f ne shrt-acting piid analgesic at maximum tlerated dses withut adequate relief f pain; AND Trial and failure f tw preferred lng-acting piids; AND Patient des NOT have a histry f drug r alchl abuse/dependence r addictin (drug and alchl txiclgy screen results dated within the past mnth must be submitted with the PA request); AND If the patient is female between the ages f 18 and 45 years f age, prescriber must attest t the fact that patient has been cunseled regarding the risks f becming pregnant while n this medicatin, including the risk f nenatal abstinence syndrme (NAS); AND Patient des NOT have respiratry depressin, acute r severe brnchial asthma, r hypercarbia; AND Patient des NOT have paralytic ileus. Quantity Limit = 3 tablets per day

2 New Prduct t Market: MrphaBnd Optins fr Cnsideratin Nn-prefer in the PDL class: Narctics: Lng-Acting (Analgesics, Narctics Lng-Acting) Length f Authrizatin: 6 mnths MrphaBnd (mrphine sulfate extended-release), an piid agnist with abuse-deterrent prperties, is apprved fr the management f pain severe enugh t require daily, arund-the-clck, lng-term piid treatment in adults fr which alternative treatments are inadequate. It is available as 15 mg, 30 mg, 60 mg, and 100 mg tablets fr ral administratin. Criteria fr Apprval: Prescriber is a Pain Management Specialist r prescriber has prf f cnsultatin with a Pain Management specialist; AND Diagnsis f severe pain requiring daily, arund-the-clck, lng-term pain management, defined as: Pain lasting >6 cnsecutive mnths; AND Trial and failure f ne nn-piid analgesic (i.e., NSAIDs, APAP) at maximum tlerated dses withut adequate relief f pain; AND Trial and failure f ne shrt-acting piid analgesic at maximum tlerated dses withut adequate relief f pain; AND Trial and failure f tw preferred lng-acting piids; AND Patient des NOT have a histry f drug r alchl abuse/dependence r addictin (drug and alchl txiclgy screen results dated within the past mnth must be submitted with the PA request); AND If the patient is female between the ages f 18 and 45 years f age, prescriber must attest t the fact that patient has been cunseled regarding the risks f becming pregnant while n this medicatin, including the risk f nenatal abstinence syndrme (NAS); AND Patient des NOT have respiratry depressin, acute r severe brnchial asthma, r hypercarbia; AND Patient des NOT have paralytic ileus. Quantity Limit = 2 tablets per day Page 2 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

3 New Prduct t Market: Xadag Optins fr Cnsideratin Nn-prefer in the PDL class: Parkinsn s Disease (Antiparkinsn s Agents) Length f Authrizatin: 1 year Xadag (safinamide) is a mnamine xidase type B (MAO-B) inhibitr indicated as adjunctive treatment t levdpa/carbidpa in patients with Parkinsn s disease experiencing ff episdes. Xadag has nt been shwn t be effective as mntherapy fr the treatment f Parkinsn s disease. It is available as 50 mg and 100 mg tablets fr ral administratin. Criteria fr Apprval: Diagnsis f Parkinsn s disease (PD); AND Receiving PD therapy with carbidpa/levdpa; AND Experiencing ff episdes with carbidpa/levdpa; AND Des nt have severe hepatic impairment (Child-Pugh Scre > 9); AND Nt taking ANY the fllwing medicatins: Dextrmethrphan; OR MAOIs (e.g., r ther drugs that are ptent inhibitrs f mnamine xidase (e.g., linezlid); OR Other sertnergic drugs (e.g., SNRIs, SSRIs, TCAs, St. Jhn s wrt, cyclbenzaprine); OR Opiids (e.g., meperidine, methadne, prpxyphene, tramadl); OR Sympathmimetic medicatins (e.g., methylphenidate, amphetamine). Quantity Limit = 1 tablet per day Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 3

4 New Prducts t Market: Tymls Optins fr Cnsideratin Nn-prefer in the PDL class: Bne Resrptin Suppressin and Related Agents Length f Authrizatin: 1 year Tymls (abalparatide), a parathyrid hrmne (PTH) receptr-1 agnist, is indicated fr the treatment f pstmenpausal wmen with steprsis at high risk fr fracture defined as a histry f steprtic fracture, multiple risk factrs fr fracture, r patients wh have failed r are intlerant t ther available steprsis therapy. In pstmenpausal wmen with steprsis, abalparatide reduces the risk f vertebral fractures and nnvertebral fractures. Cumulative use f Tymls and ther parathyrid hrmne analgs (e.g., teriparatide) fr mre than 2 years during a patient s lifetime is nt recmmended due t a dse-dependent increase in stesarcma bserved in rdents. It is available in a pre-filled pen device cntaining 3120 mcg/1.56 ml (thirty 80 mcg dses) slutin fr subcutaneus injectin. Criteria fr Apprval: Diagnsis f pst-menpausal steprsis; AND Dcumented hip DXA (femral neck r ttal hip) r lumbar spine T-scre 2.5 (standard deviatins); AND Patient is at a high risk fr fractures; AND Patient is nt at increased risk fr stesarcma (e.g., Paget's disease f bne, bne metastases r skeletal malignancies, etc.); AND Patient has nt received therapy with parathyrid hrmne analgs (e.g., teriparatide) in excess f 24 mnths in ttal; AND Dcumented treatment failure, cntraindicatin, r ineffective respnse t a minimum 12 mnth trial (t allw fr repeat DXA) n previus therapy with ral bisphsphnates (e.g., alendrnate, risedrnate, ibandrnate); AND Trial and failure f at least 1 preferred medicatin. Renewal Criteria: Disease respnse (absence f fractures); AND Ttal length f therapy has nt exceeded 24 mnths. Quantity Limit = 1 pen per 30 days Page 4 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

5 New Prducts t Market: Kevzara Optins fr Cnsideratin Nn-prefer in the PDL class: Immunmdulatrs (Cytkine and CAM Antagnists) Length f Authrizatin: 1 year Kevzara (sarilumab) is an interleukin-6 (IL-6) receptr antagnist indicated fr treatment f adults with mderately t severely active rheumatid arthritis wh had an inadequate respnse r intlerance t 1 r mre disease-mdifying antirheumatic drug(s). It is available in pre-filled syringes cntaining 150 mg/1.14 ml r 200 mg/1.14 ml slutin fr subcutaneus injectin; each cartn cntains 2 dses. Criteria fr Apprval: Diagnsis f mderately t severely active rheumatid arthritis (RA); AND Trial and failure (at least 3 mnths) f at least 1 ral disease-mdifying antirheumatic drug (DMARD) such as methtrexate, azathiprine, hydrxychlrquine, leflunmide, etc.; AND Trial and failure f, r cntraindicatin t, a preferred immunmdulatr (i.e., Enbrel r Humira ). Negative tuberculsis (TB) screening prir t initiating treatment; AND Kevzara will nt be used with a TNFα inhibitr (e.g., Enbrel, Humira ) r ther bilgic DMARD (e.g., Actemra, Orencia ) Renewal Criteria: Meet initial apprval criteria; AND Onging mnitring fr TB; AND Disease respnse as indicated by imprvement in signs and symptms cmpared t baseline such as the number f tender and swllen jint cunts. Quantity Limit = 1 cartn per 28 days Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 5

6 New Prduct t Market: Siliq Optins fr Cnsideratin Nn-prefer in the PDL class: Immunmdulatrs (Cytkine and CAM Antagnists) Length f Authrizatin: 6 mnths Siliq (brdalumab) is indicated fr the treatment f mderate t severe plaque psriasis in adults wh are candidates fr systemic therapy r phttherapy and have failed t respnd r have lst respnse t ther systemic therapies. Siliq has a risk evaluatin and mitigatin strategies prgram in place because f suicidality bserved in clinical trials. It is available in a pre-filled syringe cntaining 210 mg/1.5 ml slutin fr subcutaneus injectin; each cartn cntains tw dses. Criteria fr Apprval: Diagnsis f mderate t severe plaque psriasis; AND Symptms persistent fr 6 mnths with at least 1 f the fllwing: Invlvement f at least 10% f bdy surface area (BSA); OR Psriasis Area and Severity Index (PASI) scre f 12 r greater; OR Incapacitatin due t plaque lcatin (i.e., head and neck, palms, sles r genitalia); AND Negative tuberculsis (TB) screening prir t initiating treatment; AND Patient des nt have a histry f Crhn s disease; AND Trial and failure f tw f the fllwing therapies: Methtrexate Cyclsprine Oral retinid (e.g., Amnesteem, istretinin) Tpical crticsterids Phttherapy/UV light Cal tar preparatins; AND Trial and failure f, r cntraindicatin t, a preferred immunmdulatr (i.e., Enbrel r Humira ). Renewal Criteria: Patient cntinues t meet criteria identified abve; AND Onging mnitring fr TB; AND Disease respnse as indicated by imprvement in signs and symptms cmpared t baseline, such as redness, thickness, scaliness, and/r the amunt f surface area invlvement. Quantity Limits: Lading Dse = 2 cartns during the first 28 days Maintenance Dse = 1 cartn every 28 days Page 6 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

7 New Prduct t Market: Trulance New Prduct t Market: AirDu RespiClick Optins fr Cnsideratin Nn-prefer in the PDL class: GI Mtility Agents (GI Mtility, Chrnic) Length f Authrizatin: 1 year Trulance (plecanatide) is a guanylate cyclase-c agnist indicated fr the treatment f chrnic idipathic cnstipatin in adult patients. It is available as a 3 mg tablet fr ral administratin. Criteria fr Apprval: Diagnsis f chrnic idipathic cnstipatin; AND Trial and failure f, r cntraindicatin t, at least 2 preferred agents, ne f which must be Linzess (linacltide). Quantity Limit = 1 tablet per day Nn-prefer in the PDL class: Beta Agnists: Cmbinatin Prducts (Gluccrticids, Inhaled) Length f Authrizatin: 1 year AirDu RespiClick (fluticasne prpinate and salmeterl) is a fixed dse cmbinatin prduct cntaining a crticsterid and a lng-acting beta agnist indicated fr treatment f asthma in patients aged 12 years and lder. It is available in 55 mcg/14 mcg, 113 mcg/14 mcg, and 232 mcg/14 mcg strengths as an inhalatin pwder in the RespiClick device, which cntains 60 actuatins. Criteria fr Apprval: Diagnsis f asthma; AND Trial and failure f at least 2 preferred agents, ne f which must be Advair Diskus. Age Limit = > 12 years Quantity Limit = 1 inhaler per 30 days Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 7

8 New Prduct t Market: Emflaza Optins fr Cnsideratin Nn-prefer in the PDL class: Oral Sterids (Gluccrticids, Oral) Length f Authrizatin: 1 year Emflaza (deflazacrt) is a crticsterid indicated fr the treatment f Duchenne muscular dystrphy in patients 5 years f age and lder. It is available as ral tablets in 6 mg, 18 mg, 30 mg, and 36 mg strengths as well as an ral suspensin cntaining mg/1 ml. Criteria fr Apprval: Diagnsis f Duchenne muscular dystrphy (DMD); AND Patient is currently receiving, r planning t receive, physical therapy; AND Patient has experienced 1 f the fllwing adverse reactins directly attributable t previus therapy with prednisne: Significant behaviral changes negatively impacting functin at schl, hme, day care, etc.; OR Significant weight gain (e.g., crssing 2 percentiles and/r reaching 98 th percentile fr age and sex) Renewal Criteria: Patient cntinues t receive physical therapy; AND Patient has received benefit frm therapy, which may include 1 r mre f the fllwing supprted by dcumentatin (e.g., prgress ntes): Stability, imprvement r slwing f decline in mtr functin; Stability, imprvement r slwing f decline in respiratry functin; Stability, imprvement r slwing f decline in sequelae related t diminished strength f stabilizing musculature (e.g., sclisis, etc.); Stability, imprvement r slwing f decline in quality f life. Administratin: Dse based n weight; 0.9 mg/kg nce daily. Age Limit = > 5 years Page 8 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

9 New Prduct t Market: Dupixent Optins fr Cnsideratin Nn-prefer in the PDL class: Immunmdulatrs, Atpic Dermatitis (Immuntherapy, Atpic Dermatitis) Length f Authrizatin: 1 year Dupixent (dupilumab) is an interleukin-4 receptr (IL-4) α-antagnist indicated fr the treatment f adult patients with mderate t severe Atpic Dermatitis whse disease is nt adequately cntrlled with tpical prescriptin therapies r when thse therapies are nt advisable. Dupixent can be used with r withut tpical crticsterids; it is available as prefilled syringes cntaining 300 mg/2 ml slutin fr subcutaneus injectin; each cartn cntains 2 dses. Criteria fr Apprval: Have a diagnsis f mderate t severe atpic dermatitis (AD) with 1 f the fllwing: Invlvement f at least 10% f bdy surface area (BSA); OR Scring Atpic Dermatitis (SCORAD) scre f 20 r mre; OR Investigatr s Glbal Assessment (IGA) with a scre 3; OR Eczema Area and Severity Index (EASI) scre f 16; OR Incapacitatin due t AD lesin lcatin (e.g., head and neck, palms, sles, r genitalia); AND Have a prir dcumented trial (3 mnth minimum) and failure (r cntraindicatin) f at least 1 agent in each f the fllwing categries: Tpical crticsterid f medium t high ptency (e.g., mmetasne, flucinlne); AND Tpical calcineurin inhibitr (i.e., tacrlimus r pimecrlimus); AND Immunsuppressive systemic agent (e.g., cyclsprine, azathiprine, methtrexate, mycphenlate mfetil, etc.); AND Trial and failure f phttherapy (e.g., psralens with UVA light [PUVA], UVB, etc) prvided patient has reasnable access t this treatment; AND Is nt pregnant. Renewal Criteria: Cntinue t meet abve criteria; AND Dcumented respnse cmpared t baseline as measured by measures used t qualify mderate t severe AD at baseline (e.g., pruritus, BSA invlvement, EASI, IGA, SCORAD). Quantity Limits: Lading Dse = 1 cartn per 14 days Maintenance Dse = 1 cartn per 28 days Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 9

10 New Prduct t Market: Kisqali Optins fr Cnsideratin Prefer with Clinical Criteria in the PDL class: Oral Onclgy Agents, Breast Cancer (Onclgy, Oral Breast) Length f Authrizatin: 6 mnths Kisqali (ribciclib) is an inhibitr f cyclin-dependent kinase (CDK) 4 and 6 indicated in cmbinatin with an armatase inhibitr as initial endcrinebased therapy fr the treatment f pstmenpausal wmen with hrmne receptr psitive, human epidermal grwth factr receptr 2 negative advanced r metastatic breast cancer. Kisqali is available as 200 mg tablets fr ral administratin. Criteria fr Apprval: Patient has a diagnsis f advanced r metastatic breast cancer that is: Hrmne receptr (HR)-psitive; AND Human epidermal grwth factr receptr 2 (HER2)-negative; AND Is being used as first-line therapy in cmbinatin with an armatase inhibitr; AND Female patients must be pstmenpausal. Renewal Criteria: Patient cntinues t meet initial review criteria; AND Lack f disease prgressin r decrease in tumr size. Administratin: Up t 3 tablets daily n days 1-21 f a 28 day cycle. Quantity Limit = 63 tablets per 28 days Page 10 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

11 New Prduct t Market: Rydapt Optins fr Cnsideratin Prefer with Clinical Criteria in the PDL class: Oral Onclgy, Hematlgic Cancer (Onclgy, Oral Hematlgic) Length f Authrizatin: 1 year Rydapt (midstaurin) is an ral tyrsine kinase inhibitr indicated fr the treatment f adult patients with newly diagnsed, FLT3 mutatin-psitive acute myelid leukemia, as detected by an FDA-apprved test, in cmbinatin with standard cytarabine and daunrubicin inductin and cytarabine cnslidatin. Rydapt is als apprved as single-agent therapy fr the treatment f aggressive systemic mastcytsis, systemic mastcytsis with assciated hematlgical neplasm, and mast cell leukemia. Rydapt is available as 25 mg capsules fr ral administratin. Acute Myelid Leukemia (AML) Criteria fr Apprval: Patient must be newly diagnsed with AML (excluding acute prmyelcytic leukemia); AND Patient s is FLT3 mutatin-psitive as detected by an FDA-apprved test (e.g., Leukstrat CDx FLT3 Mutatin Assay); AND Must be used in cmbinatin with standard cytarabine and daunrubicin inductin and cytarabine cnslidatin therapy (may nt be used as a singleagent inductin therapy). Systemic Mastcytsis (SM) Criteria fr Apprval: Patient has a diagnsis f 1 f the fllwing: Aggressive systemic mastcytsis (ASM); OR Systemic mastcytsis with assciated hematlgic neplasm (SM- AHN); OR Mast cell leukemia (MCL). Renewal Criteria: Tumr respnse, stabilizatin f disease r decrease in clinical findings. Administratin: Acute Myelid Leukemia: 2 capsules twice daily n days 8-21 f a 21 day cycle. Systemic Mastcytsis: 4 capsules twice daily cntinuusly. Quantity Limits: Acute Myelid Leukemia = 56 capsules per 21 days Systemic Mastcytsis = 8 capsules per day Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 11

12 New Prduct t Market: Alunbrig New Prduct t Market: Zejula Optins fr Cnsideratin Nn-prefer in the PDL class: Oral Onclgy, Lung Cancer (Onclgy, Oral Lung) Alunbrig (brigatinib) is a kinase inhibitr indicated fr the treatment f patients with anaplastic lymphma kinase (ALK)-psitive metastatic nnsmall cell lung cancer (NSCLC) wh have experienced disease prgressin n, r are therwise intlerant t, treatment with criztinib (Xalkri ). Alunbrig is available as 30mg tablets fr ral administratin. Length f Authrizatin: 1 year Criteria fr Apprval: Diagnsis f nn-small cell lung cancer (NSCLC) that is anaplastic lymphma kinase (ALK) psitive as detected by an FDA-apprved test; AND Histry f trial and failure f, r intlerance t, criztinib (Xalkri ). Quantity Limit = 6 tablets per day Nn-prefer in the PDL class: Oral Onclgy, Other (Onclgy, Oral Other) Length f Authrizatin: 1 year Zejula (niraparib) is an inhibitr f ply (ADP-ribse) plymerase (PARP) enzymes, PARP-1 and PARP-2, and acts t increase the frmatin f PARP- DNA cmplexes resulting in DNA damage, apptsis, and cell death. Zejula is indicated fr the maintenance treatment f adult patients with recurrent epithelial varian, fallpian tube, r primary peritneal cancer wh are in a cmplete r partial respnse t platinum-based chemtherapy. It is available as 100 mg capsules fr ral administratin. Criteria fr Apprval: Diagnsis f recurrent epithelial varian, fallpian tube, r primary peritneal cancer; AND Agent is being used as mntherapy; AND Therapy t begin n later than 8 weeks after the mst recent platinumcntaining regimen; AND Must have had disease imprvement r stabilizatin with platinum-based chemtherapy; AND N diagnsis r histry f Myeldysplastic Syndrme/Acute Myelid Leukemia (MDS/AML). Quantity Limit = 3 capsules per day Page 12 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

13 Criteria Reviews Optins fr Cnsideratin The fllwing drug classes and prduct(s) cntain current and recmmended clinical criteria fr the P&T Cmmittee t review. Criteria Review: Ysprala MAR2017 Current Criteria: Has the patient had a therapeutic trial and treatment failure f at least 1 preferred drug? Dcument the details; OR Is there any reasn that the patient cannt be switched t a preferred medicatin? Dcument the details. Acceptable reasns include: Adverse reactin t preferred drugs; OR Allergy t preferred drugs; OR Cntraindicatin t preferred drugs. Recmmended Changes: Length f Authrizatin: 1 year Patient has 1 f the fllwing: Histry f ischemic strke r transient ischemia f the brain due t fibrin platelet embli; OR Histry f mycardial infarctin (MI); OR Unstable angina pectris; OR Chrnic stable angina pectris; OR Histry f revascularizatin prcedures (CABG r PCA); AND Patient requires aspirin therapy fr 6 mnths; AND Age 55 r lder; OR Histry f gastric r dudenal ulcer within the past 5 years; AND Demnstrated nn-adherence t individual cmpnents (aspirin and meprazle) and/r aspirin and 1 preferred prtn pump inhibitr (PPI). Age Limit = 18 years Quantity Limit = 1 tablet per day Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 13

14 Criteria Reviews Criteria Review: Anxilytics (Antianxiety Agents) Current PDL Criteria: Optins fr Cnsideratin Is there any reasn the patient cannt be changed t a medicatin nt requiring prir apprval? Acceptable reasns include: Allergy t medicatins nt requiring prir apprval; Cntraindicatin t r drug-t-drug interactin with medicatins nt requiring prir apprval; Histry f unacceptable/txic side effects t medicatins nt requiring prir apprval The requested nn-preferred medicatin may be apprved if bth f the fllwing are true: If there has been a therapeutic failure t n less than 2 preferred medicatins; AND The requested medicatin s crrespnding generic (if cvered by the state) has been attempted with multiple manufacturers (if available) and failed r is cntraindicated Current Maximum Duratin (MD) Criteria: All benzdiazepines are available withut a prir authrizatin fr the first 60 days per 365-day perid. Fr therapy beynd 60 days, prir authrizatin is required and may be apprved as fllws: Apprve fr 1 mnth fr the fllwing diagnsis: Acute alchl withdrawal Apprve fr 6 mnths fr the fllwing diagnses / situatins: Agraphbia Anxiety Anxiety disrder Chemtherapy-induced nausea & vmiting Depressin Panic attacks r panic disrder Scial phbia Status epilepticus Apprve fr 1 year fr the fllwing diagnsis: Seizures Fr all ther diagnses: Requests will be reviewed by a Clinical Pharmacist n a case-by-case basis fr apprval cnsideratin. These requests must be accmpanied by medical literature published in a peer reviewed jurnal. N recmmended changes. Page 14 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

15 Criteria Reviews Criteria Review: Sedative Hypntics (Sedative Hypntic Agents) Current PDL Criteria: Optins fr Cnsideratin Is there any reasn the patient cannt be changed t a medicatin nt requiring prir apprval? Acceptable reasns include: Allergy t medicatins nt requiring prir apprval; Cntraindicatin t r drug-t-drug interactin with medicatins nt requiring prir apprval; and Histry f unacceptable/txic side effects t medicatins nt requiring prir apprval The requested nn-preferred medicatin may be apprved if bth f the fllwing are true: If there has been a therapeutic failure t n less than 2 preferred medicatins; AND The requested medicatin s crrespnding generic (if cvered by the state) has been attempted with multiple manufacturers (if available) and failed r is cntraindicated Current Quantity Limits: All agents are subject t a quantity limit f 1 per day; EXCEPT Triazlam 0.25mg is allwed 2 per day. N recmmended changes. Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 15

16 Full Class Reviews Angitensin Mdulatrs (Angitensin Cnverting Enzyme Inhibitrs (ACEI), ACEI + Diuretic Cmbinatins, Angitensin Receptr Blckers (ARB), ARB + Diuretic Cmbinatins, Direct Renin Inhibitrs) Optins fr Cnsideratin Agents in the fllwing Therapeutic Classes are subject t status changes frm what is n the current Preferred Drug List (PDL). Angitensin Cnverting Enzyme Inhibitrs (ACEI) DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and Fr any new chemical entity in the Angitensin Cnverting Enzyme Inhibitrs (ACEI) class require PA until reviewed by the P&T Advisry Cmmittee. ACEI + Diuretic Cmbinatins DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and Fr any new chemical entity in the ACEI + Diuretic Cmbinatins class require PA until reviewed by the P&T Advisry Cmmittee. Angitensin Receptr Blckers (ARB) DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and Fr any new chemical entity in the Angitensin Receptr Blckers (ARB) class require PA until reviewed by the P&T Advisry Cmmittee. ARB + Diuretic Cmbinatins DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and Fr any new chemical entity in the ARB + Diuretic Cmbinatins class require PA until reviewed by the P&T Advisry Cmmittee. Direct Renin Inhibitrs DMS t select preferred agent(s) based n ecnmic evaluatin. Agents nt selected as preferred will be cnsidered nn-preferred and Fr any new chemical entity in the Direct Renin Inhibitrs class require PA until reviewed by the P&T Advisry Cmmittee. Page 16 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

17 Full Class Reviews Antifungals, Tpical (Tpical Antifungal Agents) Beta-Blckers (Alpha/Beta Blckers, Beta Blckers, Beta Blckers + Diuretic Cmbinatins) Optins fr Cnsideratin DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and will Fr any new chemical entity in the Tpical Antifungal Agents class, require PA until reviewed by the P&T Cmmittee. Alpha/Beta Blckers DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and will Fr any new chemical entity in the Alpha/Beta Blckers class, require PA until reviewed by the P&T Cmmittee. Beta Blckers DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and will Fr any new chemical entity in the Beta Blckers class, require PA until reviewed by the P&T Cmmittee. Leuktriene Mdifiers Beta Blckers + Diuretic Cmbinatins DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and will Fr any new chemical entity in the Beta Blckers + Diuretic Cmbinatins class, require PA until reviewed by the P&T Cmmittee. Prpsed Criteria: Mntelukast Granules Age Edit Mntelukast granules fr patients under 6 years f age: n prir authrizatin required. Mntelukast granules fr patients 6 years f age and lder: apprval requires a clinically valid reasn why the tablets OR chewable cannt be used. DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 1 unique chemical entity shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and will Fr any new chemical entity in the Leuktriene Mdifiers class, require PA until reviewed by the P&T Cmmittee. Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 17

18 Full Class Reviews Liptrpics, Statins (Liptrpics: Statins) Optins fr Cnsideratin DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 2 unique chemical entities shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and will Fr any new chemical entity in the Liptrpics: Statins class, require PA until reviewed by the P&T Cmmittee. Rsacea Agents, Tpical (Tpical Rsacea Agents) New additin t class: Rhfade Recmmend nn-prefer in this class. Length f authrizatin: 1 year Rhfade (xymetazline hydrchlride 1% cream), an alpha 1A adrenceptr agnist, is apprved fr the tpical treatment f persistent facial erythema assciated with rsacea in adults. It is available in 30 gram and 60 gram tubes and pumps fr tpical administratin. Criteria fr Apprval: Diagnsis f rsacea r facial erythema; AND Trial and failure f metrnidazle; AND Trial and failure f at least ne f the fllwing: tetracycline, mincycline, dxycycline, erythrmycin, clindamycin, r benzyl perxide. Quantity Limit = 60 grams per 30 days DMS t select preferred agent(s) based n ecnmic evaluatin; hwever, at least 1 unique chemical entity shuld be preferred. Agents nt selected as preferred will be cnsidered nn-preferred and will Fr any new chemical entity in the Tpical Rsacea Agents class, require PA until reviewed by the P&T Cmmittee. Page 18 Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin

19 Cnsent Agenda Optins fr Cnsideratin A. Fr the fllwing therapeutic classes, there are n recmmended changes t the currently psted Preferred Drug List (PDL) status. Alzheimer s Agents Andrgenic Agents Angitensin Mdulatr Cmbinatins Anticnvulsants Antidepressants, SSRIs Antihistamines, Minimally Sedating Antihyperuricemics Antiparasitics, Tpical Antipsriatics, Oral Antivirals, Tpical Bladder Relaxant Preparatins Erythrpiesis Stimulating Prteins Nasal Preparatins Antibitics Otic Antibitics Otics, Anti-Inflammatries PAH Agents Oral and Inhaled Phsphate Binders Ulcerative Clitis Agents Vasdilatrs, Crnary B. Fr the fllwing therapeutic classes, there are n recmmended changes ther than a brand/generic switch. Antidepressants, Other Kentucky Department fr Medicaid Services Drug Review and Optins fr Cnsideratin Page 19