Pharmacy and Therapeutics (P&T) Committee Provider Update THIRD QUARTER 2018 P&T Committee Decisions Effective September 1, 2018 Dear Healthcare Practitioner: The Presbyterian Health Plan, Inc., and Presbyterian Insurance Company, Inc., (Presbyterian) P&T Committee meets quarterly to promote the appropriate use of drugs, to maintain the Presbyterian formularies and to support our network of practitioners. The P&T Committee met on July 18, 2018, and we would like to share with you the decisions made at the meeting that affect our formularies and pharmacy benefits. Formulary Additions Drug Name Centennial Care Commercial Metal Level Plans Medicare* Basaglar (insulin glargine injection), 100 U/mL Effective Jan. 1, 2019, Basaglar will be added to the Commercial and Metal Level Plans as the preferred insulin glargine product. Braftovi (encorafenib) 50 mg and 75 mg capsules Cimduo (lamivudine and tenofovir disoproxil fumurate) 300 mg/300 mg tablets Crysvita (burosumab-twza) 10 mg/ml, 20 mg/ml and 30 mg/ml in a single-dose vial Glatopa 40 mg (glatiramer acetate) 40 mg/ ml prefilled syringe QL, QL (Note: Change will go into effect 01/01/2019) 2017:, QL 2018: Tier 3, QL (Note: Change will go into effect 01/01/2019) Tier 4, 2017: Tier 4, QL Tier 4, QL 2017: Tier 4, QL QL MB, PA MB, PA 2017: MB, PA 2018: MB, PA Tier 4, 2017: Tier 4, Tier 3, QL Tier 5, PA (New Starts), QL Tier 5 Tier 5, Tier 5, QL MB = Medical Benefit, ME = Medical Exception, = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits PPC071813 P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 1
Drug Name Centennial Care Commercial Metal Level Plans Medicare* Formulary Additions (continued) Invokamet and Invokamet XR (canagliflozin and metformin) 50/500 mg, 50/1000 mg, 150/500 mg and 150/1000 mg tablets; 50/500 mg, 50/1000 mg, 150/500 mg and 150/1000 mg extended-release tablets Added to the Metal Level Plan formularies with a ST requirement. 2017: Tier 3, ST, QL 2018: Tier 4, ST, QL Mektovi (binimetinib) 15 mg tablets Tier 4, 2017: Tier 4, Palynziq (pegvaliase-pqpz) 2.5 mg/0.5 ml, 10 mg/0.5 ml and 20 mg/ml in a singledose syringe Priftin (rifapentene) 150 mg tablets Added to the Centennial Care formulary. Tier 4, 2017: Tier 4, Formulary Tier 3 2017: Tier 3 2018: Tier 4 Tier 4, ST, QL Tier 5, Tier 3 repaglinide (generic for Prandin ) Added to the Centennial Care formulary. Retacrit (epoetin alfa-epbx) 2000 U/mL, 3000 U/mL, 4000 U/mL, 10000 U/mL and 40000 U/mL in single-dose vials Note: Retacrit will be preferred for use over Epogen or Procrit. ST, QL Tier 3 2017: Tier 3 2018: Tier 4, SP MB or 2000, 3000, & 4000 U/mL: Tier 3*,, SP 10000 & 40000 U/ ml: Tier 4*, PA, 2017: MB or 2000, 3000, & 4000 U/mL: Tier 3*,, SP 10000 & 40000 U/ ml: Tier 4*, PA, Tier 4 2000, 3000, & 4000 U/mL: Tier 3*, 10000 U/mL: Tier 3*, PA 40000 U/mL: Tier 5*, PA Tagrisso (osimertinib) 40 mg and 80 mg tablets *Tier applies if patient is to selfadminister and receive through pharmacy benefit. No PA required if billed under the MB with the following diagnosis codes: C00.0 D49.9 and Z51.89. 2018: MB or 2000, 3000, & 4000 U/mL: Tier 4*,, SP 10000 & 40000 U/ ml: Tier 5*, PA, *Tier applies if patient is to selfadminister and receive through pharmacy benefit. No PA required if billed under the MB with the following diagnosis codes: C00.0 D49.9 and Z51.89. Tier 4, 2017: Tier 4, *Tier applies if patient is to selfadminister and receive through pharmacy benefit. No PA required if billed under the MB with the following diagnosis codes: C00.0 D49.9 and Z51.89. Tier 5, PA (New Starts), Thiola (tiopronin) 100 mg tablets Tier 4, 2017: Tier 4, MB = Medical Benefit, ME = Medical Exception, = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 2
Drug Name Centennial Care Commercial Metal Level Plans Medicare* Formulary Additions (continued) Tymlos (abaloparatide) 3210 mcg/1.56 ml injection Venclexta (venetoclax) 10 mg, 50 mg and 100 mg tablets PA, SP Tier 4, PA, SP 2017: Tier 4, PA, SP PA, SP Tier 4, 2017: Tier 4, Tier 5, PA 10 mg & 50 mg: Tier 4, PA (New Starts), QL Starter Pack & 100 mg tablets: Tier 5, PA (New Starts), QL Yonsa (abiraterone acetate) Tier 5, PA, SP, QL Xeljanz (tofacitinib) 10 mg tablets, SP Tier 4,, SP 2017: Tier 4, PA, PA, Tier 5, New Generics Unless otherwise noted, when a generic product becomes available, the brand-name product will be removed from the formularies. buprenorphine/naloxone (generic for Suboxone ) 8/2 mg film Brand name Suboxone 8/2 mg film will continue to be covered on the formularies until further notice. colesevelam (generic for Welchol ), 625 mg tablets Brand name Welchol will continue to be covered on the Commercial, Metal Level and Medicare formularies until further notice. miglustat (generic for Zavesca ), 100 mg capsules Formulary Tier 5 phytonadione (generic for Mephyton ), 5 mg tablets Other Formulary Changes Formulary Tier 4 2017: Tier 4 2018: Tier 5 Tier 5 Botox (aonabotulinumtoxina) 100 units and 200 units Prior authorization criteria for hyperhidrosis indication updated. MB, PA MB, PA MB, PA Part B, ME chlorzoxazone 500 mg tablet Tier increased on Commercial and Metal Level Plan. Cuprimine (penicillamine) 250 mg capsules Removed from Centennial Care and Commercial Formularies. Tier increased on Metal Level formularies, prior authorization requirement and quantity limits added. Depen Titratabs (penicillamine) 250 mg tablets PA and QL added to Centennial Care, Commercial and Metal Tier increased on Commercial and Metal Level Plan Formularies. Formulary 2017: 2018: Tier 3 2017: Tier 4, Tier 4, 2017: Tier 4, Tier 3 MB = Medical Benefit, ME = Medical Exception, = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 3
Drug Name Centennial Care Commercial Metal Level Plans Medicare* Other Formulary Changes (continued) donepezil ODT (generic for Aricept ODT) 5 mg and 10 mg tablets Prior authorization requirement added to Centennial Care, Commercial and Metal Level Plan formularies. PA Tier 1, PA 2017: Tier 1, PA 2018:, PA Ery-Tab (erythromycin delayed release), 250 mg, 333 mg and 500 mg tablets Tier increased on Commercial and Metal Eryped and E.E.S. Granules for suspension (erythromycin ethylsuccinate) 200 mg/5 ml (generic) and 400 mg/5 ml PA added for patients 12 years of age. Tier increased on Commercial and Metal felbamate (generic for Felbatol ) 400 mg and 600 mg tablets, 600 mg/5 ml oral suspension Tier increased and quantity limits added to Commercial and Metal flunisolide nasal solution 25 mcg/actuation Tier increased on Commercial and Metal Forteo (teriparitide) 600 mcg/2.4 ml pen Requirement for an inadequate response to or intolerance to Tymlos added to Centennial Care, Commercial and Metal Level Plan PA criteria. Formulary Tier 4 2017: Tier 4 2018: Tier 5 AL Tier 4, AL 2017: Tier 4, AL AL Tier 4, QL 2017: Tier 4, QL QL 2017: 2018: Tier 3 PA, SP Tier 4, PA, SP 2017: Tier 4, PA, SP PA, SP Tier 4 Generic erythromycin ethylsuccinate 200 mg/5 ml oral suspension: Tier 3 Tier 5, PA glatiramer acetate 40 mg (Mylan s generic formulation of Copaxone 40 mg), 40 mg/ml prefilled syringe Removed from Centennial Care, Commercial and Metal Level Plan formularies. Glatopa 40 mg will be the preferred glatiramer 40 mg product. Tier 5, QL Invega Sustenna (paliperidone), 39 mg, 78 mg, 117 mg, 156 mg and 234 mg once-monthly extended-release injection suspension Invega Trinza (paliperidone), 273 mg, 410 mg, 546 mg and 819 mg once every 3 months extended-release injection suspension - PA and ST requirements removed. SP Tier 4, SP 2017: Tier 4, SP SP Sustenna 39 mg, 78 mg: Tier 4 Sustenna 156 mg, 234 mg and Trinza: Tier 5, Part B Drug Lantus (insulin glargine) 100 U/mL Lantus will be removed from Commercial and Metal Level Plan formularies effective Jan. 1, 2019. lidocaine 5% topical ointment Removed from the Centennial Care formulary. Tier increased and QL added on the Commercial and Metal Level Plan formularies. (Note: Change will go into effect 01/01/2019) (Note: Change will go into effect 01/01/2019) Tier 3, QL 2017: Tier 3, QL 2018: Tier 4, QL MB = Medical Benefit, ME = Medical Exception, = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 4
Drug Name Centennial Care Commercial Metal Level Plans Medicare* Other Formulary Changes (continued) methotrexate sodium 250 mg/10 ml and 1 gram/40 ml preservative free injection Added to the Centennial Care and Commercial formularies. Renagel (sevelamer) 800 mg tablet Removed from Commercial and Metal Level Plan formularies. Formulary Tier 1 2017: Tier 1 2018: sevelamer (generic for Renvela ) Tier increased on Commercial and Metal terconazole 0.8% cream Tier increased on Commercial and Metal Level Plan formularies. verapamil ER 24 HR 360mg capsules (Verelan ) Removed from Centennial Care formulary. Tier increased on Commercial and Metal Level Plan formularies. Formulary Tier 4 2017: Tier 4 2018: Tier 5 Formulary 2017: 2018: Tier 3 2017: 2018: Tier 3 Tier 3 voriconazole tablets (generic for Vfend ) 50 mg and 200 mg tablets Tier decreased on Commercial and Metal vitamin D oral tablet 400 units Removed from the formularies. This is available for purchase over-the-counter. Tier 3, 2017: Tier 3, 2018: Tier 4, 50 mg: 200 mg: Tier 5, MB = Medical Benefit, ME = Medical Exception, = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits You can find Presbyterian formularies and updates, including restrictions (e.g., quantity limits, step therapy and prior authorization criteria) and preferences online at: www.phs.org/providers/formularies/pages/default.aspx Current and past issues of the Pharmacy & Therapeutics (P&T) Committee Provider Updates are available online at: www.phs.org/providers/contact-us/news-and-communications/pages/default.aspx Providers must register with Presbyterian to receive the Pharmacy & Therapeutics (P&T) Committee Provider Update via email. Presbyterian enews registration is located at: www.phs.org/providers/contact-us/news-and-communications/pages/default.aspx The Universal Practitioner and Provider Manual and the Centennial Care Practitioner and Provider Manuals are also available online at www.phs.org/providers/resources/training-education/pages/outreach.aspx and include information about pharmacy benefits, the prior authorization process, generic substitution and requesting non-formulary medications based on medical necessity. A printed copy of the Centennial Care Practitioner and Provider Manual is available at no cost from Presbyterian by contacting your Provider Network Management relationship executive. P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 5
Formulary Search App As a reminder, Presbyterian formularies are also accessible through the Managed Markets Insights & Technology, LLC (MMIT) Formulary Search App. No registration, username or passwords are required. Search from your desktop at www.formularylookup.com or download the free app today. Requests for Formulary Additions, Deletions or Modifications Use the Formulary Addition Request form to request medication additions, deletions or other changes to the Presbyterian formularies. Complete and submit the form to the ASK PHP P&T mailbox at askphppt@phs.org. The form can be accessed at: docs.phs.org/idc/groups/public/documents/communication/pel_00251399.pdf REMINDER Coverage of Flu Vaccines Flu season is just around the corner and we would like to remind our providers that coverage of flu vaccines for Presbyterian members will start Sept. 1, 2018. FluMist and the High-Dose influenza vaccine will not be covered. Please refer to Presbyterian formularies for a complete listing of covered flu vaccines. Food and Drug Administration (FDA) Alerts from April 2018 to July 2018. For a full list of FDA alerts and additional information, see the FDA website at www.fda.gov/safety/medwatch/ SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590808.htm Lamictal (lamotrigine) - Drug Safety Communication (March 25, 2018) The FDA issued a warning that lamotrigine can cause hemophagocytic lymphohistiocytosis (HLG), a rare reaction that excessively activates the body s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. The FDA is requiring that a new warning about this risk be added to the prescribing information in lamotrigine drug labels. Juluca, Tivicay, Triumeq (dolutegravir) The FDA Is Evaluating Potential Risk of Neural Tube Birth Defects (May 18, 2018) An ongoing observational study in Botswana found that women who received dolutegravir at the time of conception or early in the first trimester of pregnancy may be at higher risk for neural tube birth defects. There are no reported cases of babies born with neural tube defects for women who start dolutegravir later in pregnancy. Healthcare professionals are encouraged to inform women of childbearing age about the potential risk. It there are adverse events or side effects, healthcare professionals and patients are encouraged to report to the FDA s MedWatch at www.fda.gov/medwatch/report P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 6
Keytruda (pembrolizumab) or Tecentriq (atezolizumab) - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy (May 18, 2018) The FDA is alerting healthcare professionals, oncology clinical investigators and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1). The enrolled populations are different from the patients enrolled in the trials that led to the accelerated approvals of Keytruda and Tecentriq to treat locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatincontaining chemotherapy. The FDA recommends providers select patients for the treatment of locally advanced or metastatic urothelial cancer by using the criteria described in Section 14 of each label. These criteria supported the approvals for Keytruda and Tecentriq for initial monotherapy in cisplatin-ineligible patients. Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan - Recall Due to Out of Sequence Capsules (May 29, 2018) Allergan recently identified that four placebo capsules were placed out of order in a sample pack of Taytulla and the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. The lot number 5620706 with the expiration date of May 2019 was recalled. Fluticasone Propionate Nasal Spray by Apotex Corp. - Recall Due to Potential for Small Glass Particles (May 31, 2018) The Fluticasone Propionate Nasal Spray 50 mcg per spray 120 Metered Sprays was found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The affected products are lot number NJ4501 and have an expiration date of July 2020. Fluoroquinolone Antibiotics The FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects (July 20, 2018) The FDA is strengthening the current warnings in the prescription information to indicate that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. The new label changes will add that hypoglycemia can lead to coma, disturbances in attention, disorientation, agitation, nervousness, memory impairment or delirium. Healthcare professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients. Valsartan Containing Products The FDA Announces Voluntary Recall of Several Medicines Containing Valsartan (July 13, 2018) The FDA alerted healthcare professionals and patients of a voluntary recall of several drug products that contain the active ingredient valsartan. This recall is due to an impurity, N-nitrosodimethylamine (NMDA), which was found in the recalled products. Not all products that contain valsartan are being recalled. A list of the recalled products and corresponding manufacturers can be found at www.fda.gov/newsevents/newsroom/pressannouncements/ucm613532.htm P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 7
Presbyterian Health Plan, Inc. Provider Network Management P.O. Box 27489 Albuquerque, NM 87125-7489 www.phs.org PRESRT STD U.S. Postage PAID Albuquerque, NM Permit No. 1971 Contact Us The changes to our formularies are based on requests from our practitioners and by the recommendations of the P&T Committee. We value your input. If you have any concerns, please contact the director of Pharmacy Services, Chad Valdez, RPh, at cvaldez4@phs.org or (505) 923-5530. You may also contact the author of this newsletter, Kendra Ward, PharmD, at kward2@phs.org or (505) 923-6967, Monday through Friday from 8 a.m. to 5 p.m., or email the ASK PHP P&T mailbox at askphppt@phs.org. P&T COMMITTEE PROVIDER UPDATE THIRD QUARTER 2018 8