** Fee-For-Service Pharmacy Provider Notice #229 May 2018 PDL Changes **

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** Fee-For-Service Pharmacy Provider Notice #229 May 2018 PDL Changes ** August 03, 2018 Please be advised that the Department for Medicaid Services (DMS) is making changes to the Kentucky Medicaid Fee-For-Service (FFS) Pharmacy Preferred Drug List (PDL) based on recommendations and guidance as adopted by the Commissioner of the Department for Medicaid Services of the Cabinet for Health and Family Services by order dated May 25, 2018. The Kentucky Medicaid FFS Pharmacy and Therapeutics Advisory Committee (Committee) met on May 17, 2018. The Committee did not attain the necessary quorum; the expertise, vote, and recommendations of the Committee members in attendance were captured within the Committee s official recommendations delivered for review. DMS, through its Commissioner, reviewed the recommendations and in consultation rendered its final decisions. In addition to the changes noted below; the Commissioner also approved updates to the FFS Pharmacy Program s clinical criteria for opioid medications. Please refer to FFS Pharmacy Provider Notices #227 and #230 for additional information regarding new limitations and prior authorization criteria. On September 4, 2018, the following changes will be effective: New Drug Classes Drug Class will become preferred products: will become nonpreferred products and require prior authorization (PA): Antineoplastics Agents, Topical fluorouracil 5% cream fluorouracil topical solution Colony Stimulating Factors Neupogen Granix QL Carac diclofenac 3% gel Efudex fluorouracil 0.5% cream Panretin Picato Targretin Tolak Valchlor Opiate Dependence Treatments Suboxone film Bunavail QL Fulphila QL Leukine QL Neulasta QL Nivestym QL Zarxio QL grandfathering allowed buprenorphine buprenorphine/naloxone tablet QL Probuphine Sublocade Zubsolv QL

Existing Drug Classes Drug Class will remain preferred products: Narcotics: Long-Acting fentanyl transdermal 12, 25, 50, 75, 100 mcg morphine sulfate ER (generic MS Contin ) Narcotic Agonist/ N/A Antagonists Narcotics: Short-Acting butalbital/apap/caffeine CC codeine/apap CC, hydrocodone/apap CC, hydrocodone/ibuprofen CC, hydromorphone tablets CC, meperidine solutioncc, morphine concentrate, solution, tablets CC, oxycodone solution, tablets CC, oxycodone/apap CC, tramadol CC, will become preferred products: Embeda Arymo will become nonpreferred products and require prior authorization (PA): will remain non-preferred products and require prior authorization (PA): ER QL Belbuca QL buprenorphine patch Butrans ConZip QL Duragesic Exalgo QL fentanyl transdermal 37.5, 62.5, 87.5 mcg hydromorphone ER QL Hysingla ER QL Kadian QL Morphabond ER QL morphine sulfate SA (generic Kadian, Avinza ) QL MS Contin QL Nucynta ER CC,QL oxycodone ER QL OxyContin QL oxymorphone ER QL tramadol ER QL Xtampza ER QL Zohydro ER QL butorphanol NS QL pentazocine/naloxone Ascomp with codeine butalbital/apap/caffeine/codeine butalbital compound/codeine Capital with codeine carisoprodol compound codeine Demerol dihydrocodeine bitartrate/apap/caffeine dihydrocodeine bitartrate/asa/caffeine Dilaudid Fiorinal with codeine hydromorphone liquid, suppositories Ibudone levorphanol meperidine tablets morphine suppository Lorcet Lorcet HD Lorcet Plus Lortab Norco

Drug Class Narcotics: Fentanyl Buccal Products Non-Steroidal Anti- Inflammatory Drugs will remain preferred products: N/A celecoxib QL diclofenac sodium DR tablets diclofenac sodium ER ibuprofen indomethacin ketorolac tromethamine QL meloxicam tablets naproxen tablets sulindac will become preferred products: Voltaren gel will become nonpreferred products and require prior authorization (PA): will remain non-preferred products and require prior authorization (PA): Nucynta Opana Oxaydo oxycodone capsules, concentrate oxycodone/asa oxycodone/ibuprofen oxymorphone IR Panlor Percocet Primlev (brand and generic) Repraxain Roxicodone Synalgos-DC tramadol/apap Tylenol with codeine Ultracet Ultram Vanatol CC Verdrocet Vicodin Vicodin ES Vicodin HP Xartemis XR Xodol Xylon Zamicet Abstral Actiq fentanyl citrate lollipop Fentora Lazanda Subsys CC Anaprox DS Arthrotec Celebrex QL Daypro DermacinRX Lexitral PharmaPak diclofenac/misoprostol diclofenac potassium diclofenac topical gel (1%), solution diflunisal Duexis CC EC-Naprosyn etodolac etodolac SR Feldene fenoprofen Flector CC flurbiprofen Indocin indomethacin ER

Drug Class Oral Oncology Agents, Breast Cancer Oral Oncology, Prostate Cancer Oral Oncology, Skin Cancer will remain preferred products: anastrozole exemestane Ibrance Kisqali letrozole tamoxifen citrate Tykerb QL Verzenio Xeloda bicalutamide QL Emcyt CC flutamide QL Xtandi QL Zytiga QL Erivedge Mekinist Tafinlar will become preferred products: Erleada Nilandron QL Odomzo Cotellic will become nonpreferred products and require prior authorization (PA): will remain non-preferred products and require prior authorization (PA): ketoprofen ketoprofen ER meclofenamate mefenamic acid meloxicam suspension Mobic nabumetone Nalfon Naprelan EC Naprosyn naproxen CR naproxen EC naproxen suspension oxaprozin Pennsaid CC piroxicam Ponstel Sprix CC Tivorbex tolmetin Vimovo Vivlodex QL Vopac MDS Xrylix CC Zipsor Zorvolex Arimidex Aromasin capacetabine cyclophosphamide Fareston Faslodex Femara. Nerlynx Casodex QL nilutamide QL Zelboraf

Consent Agenda The therapeutic classes in the table below were reviewed; no changes were made to the currently posted status for agents in these classes. Androgenic Agents Antihyperuricemics Bone Resorption Suppression and Related Erythropoiesis Stimulating Proteins Glucocorticoids, Oral Growth Hormone Oncology, Oral Hematologic Cancers Oncology, Oral Lung Cancer Oncology, Oral Other Oncology, Oral Renal Cell Carcinoma Pancreatic Enzymes Phosphate Binders Progestins for Cachexia Thrombopoiesis Stimulating Proteins

New Products to Market Drugs Requiring PA Lonhala Magnair Solosec Criteria Non-prefer in the PDL class: COPD Agents Length of Authorization: 1 year Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. It is available as a solution for inhalation in a unit-dose, single-use 1 ml vial (each vial contains 25 mcg of glycopyrrolate) in either a Starter Kit, which contains 60 unit-dose vials and 1 Magnair nebulizer system, or a Refill Kit, which contains 60 unit-dose vials and a Magnair handset refill. Criteria for Approval: Diagnosis of chronic obstructive pulmonary disease (COPD); AND Demonstrate treatment failure with 1 other long-acting muscarinic antagonist (LAMA) agents due to technique/delivery mechanism. Age Limit: > 18 years Quantity Limit: 2 vials per day Non-prefer in the PDL class: Antibiotics, GI Length of Authorization: Date of Service (1 day) Solosec (secnidazole) is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in adult women. It is available as granules for oral administration in a 2-gram unit-of-use foil packet. Criteria for Approval: Female patient with diagnosis of bacterial vaginosis (BV); AND No in vitro resistance to nitroimidazole derivatives (metronidazole, tinidazole, secnidazole) or prior failure of metronidazole or tinidazole for the current course of infection; AND No hypersensitivity to nitroimidazole derivatives; AND Trail and failure of, or contraindication to, at least 1 preferred nonnitroimidazole (e.g., clindamycin). Age Limit: > 18 years Quantity Limit: 1 packet per fill

Drugs Requiring PA Steglatro and Segluromet Criteria Non-prefer in the PDL class: Diabetes: SGLT2 Inhibitors Length of Authorization: 1 year Steglatro (ertugliflozin), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). It is available as 5 mg and 15 mg tablets. Its fixed-dose combination with metformin, Segluromet (ertugliflozin/metformin), is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. It is available as 2.5/500, 2.5/1000, 7.5/500, and 7.5/1000 mg tablets. Criteria for Approval: Diagnosis of type 2 diabetes; AND 3-month trial and failure of 1 preferred SGLT2 inhibitor; OR Contraindication to all preferred SGLT2 inhibitor products. Age Limit: > 18 years Quantity Limit: Steglatro : 1 tablet per day Segluromet : 2 tablets per day Steglujan Non-prefer in the PDL class: Diabetes: DPP-4 Inhibitors (Hypoglycemics, Incretin Mimetics/Enhancers) Length of Authorization: 1 year Steglujan (ertugliflozin/sitagliptin) is a fixed-dose combination of ertugliflozin with DPP-4 inhibitor sitagliptin. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM when treatment with both ertugliflozin and sitagliptin is appropriate. Steglujan is available in 5/100 and 15/100 mg tablets. Criteria for Approval: Diagnosis of type 2 diabetes; AND 3-month trial and failure of 1 preferred DPP-4 inhibitor AND 1 preferred SGLT2 inhibitor (taken separately or together); OR 3-month trial and failure of a preferred DPP-4/SGLT2 combination product. Age Limit: > 18 years Quantity Limit: 1 tablet per day

To review the complete summary of the final PDL selections and new products to market updates and changes, please refer to the Commissioner s Final Decisions from May 17, 2018 posted on the provider web portal at: https://kyportal.magellanhealth.com (by clicking the Resources/Documents/Committees/P&T tabs). Thank you for helping Kentucky Medicaid members maintain access to prescription coverage by selecting drugs on the preferred drug list whenever possible. Please contact Magellan Medicaid Administration at kyproviders@magellanhealth.com for any additional information or questions you may have. Sincerely, Jade Range, CPhT Jade Range, CPhT Contracts Manager kyproviders@magellanhealth.com Kentucky Medicaid Fee-for-Service Pharmacy Program s Contact Information Clinical Support Center 1-800-477-3071 Sunday Saturday 24 hours a day Pharmacy Support Center 1-800-432-7005 Sunday Saturday 24 hours a day Provider Services 1-877-838-5085 Monday Friday 8:00 a.m. 4:30 p.m. Please contact the Clinical Support Center to request a prior authorization (PA) or to check the status of a request. NOTE: The only drugs that are now required to be submitted via fax are Brand Medically Necessary, Buprenorphine products, Synagis, and Zyvox. Please contact the Pharmacy Support Center when claims assistance is required. Timely filing, lock-in, and early refill (ER) overrides can be obtained through this Call Center. Please contact Provider Services if you have questions about enrollment or when updating your license or bank information. Member Services 1-800-635-2570 Monday Friday Please contact Member Services if you are a member or if you as the provider have questions regarding the member s benefits or eligibility 8:00 a.m. 5:00 p.m. coverage dates.