P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 1

Presbyterian Health Plan and Presbyterian Insurance Company

Pharmacy and Therapeutics Committee Provider Update

FOURTH QUARTER 2019

Pharmacy and Therapeutics (P&T) Committee Decisions Effective January 1, 2020The 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 October 16, 2019, and we would like to share with you the decisions made at the meeting that affect our formularies and pharmacy benefits.

PPC101909

Centennial, Commercial, Metal Formulary UpdatesDrug Name Therapeutic Class Centennial Care Commercial Metal Level Plans

Formulary Additions

Afirmelle™ (levonorgestrel/ethinyl estradiol) 0.1mg/20mcg tablet

Oral Contraception F $0 $0

Ayuna™ (levonorgestrel/ ethinyl estradiol) 0.15mg/30mcg tablet

Oral Contraception F T1 T2

Baqsimi™ (glucagon) 3mg intranasal device

Hypoglycemia Treatment

F T2 T3

Darzalex® (daratumumab) 100mg/5mL and 400mg/20mL single-dose vial

Antineoplastic MB, PA MB, PA MB, PA

Didrex® (benzphetamine HCl) 25mg, 50mg tablets

Anorexant BE T3, PA, QL T4, PA, QL

Dotti™ (estradiol patch) 0.025mg/24hr, 0.0375mg/24hr, 0.05mg/24hr, 0.075mg/24hr, 0.1mg/24hr transdermal patches

Hormone Replacement

F, QL T1, QL T2, QL

Dulera® (mometasone furoate/formoterol fumarate dihydrate) 50mcg/5mcg per actuation

Inhaled Corticosteroid, Long-Acting Beta Agonist

F, PA, QL T3, PA, QL T4, PA, QL

MB = Medical Benefit, ME = Medical Exception, NF = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits Apply, SP = Specialty Pharmacy Mandated, ST = Step Therapy Required, AL = Age Limit, BE = Benefit Exclusion

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 2

Centennial, Commercial, Metal Formulary UpdatesDrug Name Therapeutic Class Centennial Care Commercial Metal Level Plans

Flucelvax® Quadrivalent (influenza virus vaccine (subvirion)) 60mcg/0.5mL

Flu Vaccine $0, QL $0, QL $0, QL

Flumist® (influenza virus vaccine (live)) 0.1mL intranasal suspension

Flu Vaccine $0, QL, AL $0, QL, AL $0, QL, AL

Haegarda® (C1 esterase inhibitor (human)) 2000 unit and 3000 unit vial

C1 Esterase Inhibitor F, PA, SP T4, PA, SP T5, PA, SP

Hailey™ (norethinedrone/ethinyl estradiol) 1.5mg/30mcg tablet

Oral Contraception F T1 T2

Kalbitor® (ecallantide) 10mg vial Kallikrein Inhibitor MB, PA, SP MB, PA, SP MB, PA, SP

Kalliga™ (desogestrel/ethinyl estradiol) 0.15mg/30mcg tablet

Oral Contraception F $0 $0

lidocaine hydrochloride 3mg/mL intravenous infusion

Antiarrhythmic Agent MB MB MB

Lo-Zumandimine™ (drospirenone/ethinyl estradiol) 3/0.02mg tablet

Oral Contraception F T1 T2

methylphenidate (generic for Methylin®) 5mg/5mL, 10mg/5mL oral solution

Stimulant F, PA, QL, AL T3, PA, QL, AL T4, PA, QL, AL

Myxredlin™ (insulin human in sodium chloride) 100 units insulin human in 100 mL of 0.9% sodium chloride

Insulin MB MB MB

Nicotrol® (nicotine) 10mg inhaler

Smoking Cessation Aid

F $0 $0

Nicotrol® (nicotine) 10mg/mL nasal solution

Smoking Cessation Aid

F $0 $0

Nubeqa® (darolutamide) 300mg tablets Antineoplastic F, PA, QL, SP T4, PA, QL, SP T5, PA, QL, SP

phendimetrazine (generic for Bontril®) 105mg extended release and 35mg immediate release tablet

Anorexiant BE T3, PA, QL T4, PA, QL

Piqray® (alpelisib) 5 mg, 150mg, 200mg tablets

Antineoplastic F, PA, QL, SP T4, PA, QL, SP T5, PA, QL, SP

Polivy™ (polatuzumab vedotin-piiq) 140mg single-dose vial

Antineoplastic MB, PA MB, PA MB, PA

Spiriva® Respimat (tiotropium bromide) 1.25mcg/actuation inhaler

Long-Acting Anti-cholinergic Agent

F T2 T3

Symdeko® (tezacaftor/ivacaftor and ivacaftor) 50mg/75mg tezacaftor/ivacaftor with 75mg ivacaftor tablets

Cystic Fibrosis Treatment

F, PA, QL, SP T4, PA, QL, SP T5, PA, QL, SP

Symjepi® (epinephrine) 0.15mg/0.3ml Injection Solution

Alpha-/Beta-Agonist F T1 T2

Takhzyro® (lanadelumab-flyo) 300mg/2mL vial

Kallikrein Inhibitor F, PA, SP T4, PA, SP T5, PA, SP

diethylpropion HCl (generic for Tenuate®) 75mg extended release tablets, 25mg immediate release tablets)

Anorexiant BE T3, PA, QL T4, PA, QL

tranexamic acid (0.7%) 1000mg/100ml intravenous solution

Antihemophilic Agent

MB MB MB

Zumandimine™ (drospirenone/ethinyl estradiol) 3/0.03mg tablet

Oral Contraception F T1 T2

MB = Medical Benefit, ME = Medical Exception, NF = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits Apply, SP = Specialty Pharmacy Mandated, ST = Step Therapy Required, AL = Age Limit, BE = Benefit Exclusion

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 3

Centennial, Commercial, Metal Formulary UpdatesDrug Name Therapeutic Class Centennial Care Commercial Metal Level Plans

New Generics – Unless otherwise noted, when a generic product becomes available, the brand-name product will be removed from the formularies.

febuxostat (generic for Uloric®) 40mg, 80mg tablet

Antigout Agent F, PA, QL T3, PA, QL T4, PA, QL

aminocaproic acid (generic for Amicar®) 0.25gm/mL oral solution

Antihemophilic Agent

PA, QL T4, PA, AL T5, PA, AL

carboprost tromethamine (generic for Hemabate®) 250mcg/mL intramuscular solution

Prostaglandin MB MB MB

Isotretinoin (generic for Amnesteem, Claravis, Myorisan, Zenatane) 20mg, 30mg, 40mg capsules

Acne Product F, PA, QL, AL T3, PA, QL, AL T4, PA, QL, AL

pregabalin (generic for Lyrica®) 25mg, 50mg, 75mg, 100mg, 200mg, 225mg, 300mg capsules

GABA Analog F, PA, QL T3, PA, QL T4, PA, QL

ramelteon (generic for Rozerem®) 8mg tablet

Melatonin Receptor Agonist

F, PA, QL T3, PA, QL T4, PA, QL

ranitidine (generic for Zantac®) 1000mg/40mL vial for intravenous solution

Histamine H2 Antagonist

MB MB MB

halcinonide (generic for Halog®) 0.1% topical cream

Topical Corticosteroid

NF NF T4, ST, QL

fosaprepitant (generic for Emend®) 150mg vial

Antiemetic MB, PA, QL MB, PA, QL MB, PA, QL

Simpesse (generic for Seasonique) 0.15/0.03mg tablets

Oral Contraception F $0 $0

triamterene (generic for Dyrenium) 50mg and 100mg capsules

Potassium Sparing Diuretic

NF T3 T4

Ery-TAB (erythromycin) 250mg, 333mg, 500mg delayed release tablet

Antibiotic F T4 T5

Other Changes

Aloxi® (palonosetron) 0.25mg/2mL, 0.25mg/5mL vials Remove prior authorization criteria.

Antiemetic MB MB MB

Aubagio® (teriflunomide) 7mg, 14mg tablets Remove prior authorization requirement.

Multiple Sclerosis Agent

F, QL, SP T4, QL, SP T5, QL, SP

Avonex® (interferon beta-1A) 30mcg prefilled syringe, 33 mcg vial Remove prior authorization requirement.

Multiple Sclerosis Agent

F, QL, SP T4, QL, SP T5, QL, SP

Berinert® (C1 esterase inhibitor, human)500 unit kit Update prior authorization criteria.

C1 Esterase Inhibitor F, PA, SP T4, PA, SP T5, PA, SP

MB = Medical Benefit, ME = Medical Exception, NF = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits Apply, SP = Specialty Pharmacy Mandated, ST = Step Therapy Required, AL = Age Limit, BE = Benefit Exclusion

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 4

Centennial, Commercial, Metal Formulary UpdatesDrug Name Therapeutic Class Centennial Care Commercial Metal Level Plans

Other Changes (continued)

Cinryze® (C1 esterase inhibitor (human))500 unit vial Update prior authorization criteria.

C1 Esterase Inhibitor F, PA, SP T4, PA, SP T5, PA, SP

budesonide (generic for Enterocort EC®)3mg DR capsuleAdd to Centennial Care formulary and add QL to all formularies.

Systemic Corticosteroid

F, QL T3, QL T4, QL

icatibant (authorized generic for Firazyr®) 30mg/3mL syringeUpdate prior authorization criteria.

Selective Bradykinin B2 Receptor Antagonist

F, PA, SP T4, PA, SP T5, PA, SP

isosorbide dinitrate 30mg tabletIncrease in tier.

Antianginal Agent F T2 T3

Jakafi® (ruxolitinib) 5mg, 10mg, 15mg, 20mg and 25mg tabletsUpdate prior authorization criteria.

JAK Inhibitor F, PA, QL, SP T4, PA, QL, SP T5, PA, QL, SP

Kalydeco® (ivacaftor)150mg tablets; 25mg, 50mg, 75mg packetsUpdate prior authorization criteria.

Cystic Fibrosis Treatment

F, PA, SP, QL T4, PA, SP, QL T5, PA, SP, QL

Kombiglyze XR® (saxagliptin/metformin)2.5/1000 mg, 5/100mg, 5/500 mg tabletsAdd prior authorization criteria.

Antidiabetic PA, QL T3, PA, QL T4, PA, QL

Latuda® (lurasidone)20mg, 40mg, 60mg, 80mg, 120mg tabletsUpdate prior authorization criteria.

Atypical Antipsychotic

F, PA, QL, AL T4, PA, QL, AL T5, PA, QL, AL

Mavyret® (glecarprevir/pibrentasvir)100/40mg tabletsUpdate prior authorization criteria.

Hepatitis C antiviral F, PA, QL, SP T4, PA, QL, SP T5, PA, QL, SP

Nasacort® (triamcinolone acetonide)55 mcg/actuation nasal suspensionAdd to Exchange formulary.

Nasal Steroid F NF T2

Onglyza® (saxagliptin HCl)2.5mg, 5mg tabletsUpdate prior authorization criteria.

Antidiabetic F, PA, QL T3, PA, QL T4, PA, QL

oxazepam 10mg, 15mg, 30mg capsulesIncrease in tier.

Benzodiazepine NF T2, QL T3, QL

Rebif® (interferon beta-1A)22mcg, 44mcg auto-injector or prefilled syringe; titration packRemove prior authorization requirement.

Multiple Sclerosis Agent

F, QL, SP T4, QL, SP T5, QL, SP

Renflexis® (infliximab-abda)100mg/20mL vialUpdate prior authorization criteria.

TNF-inhibitor MB, PA, SP MB, PA, SP MB, PA, SP

Remicade® (infliximab) 100mg/2 mL vialUpdate prior authorization criteria.

TNF-inhibitor MB, PA, SP MB, PA, SP MB, PA, SP

MB = Medical Benefit, ME = Medical Exception, NF = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits Apply, SP = Specialty Pharmacy Mandated, ST = Step Therapy Required, AL = Age Limit, BE = Benefit Exclusion

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 5

Centennial, Commercial, Metal Formulary UpdatesDrug Name Therapeutic Class Centennial Care Commercial Metal Level Plans

Soliris® (eculizumab)300mg/3 mL single-dose vialUpdate prior authorization criteria.

Complement Inhibitor

MB, PA, SP MB, PA, SP MB, PA, SP

Symdeko® (tezacaftor/ivacaftor and ivacaftor) 50mg/75mg tezacaftor/ivacaftor with 75mg ivacaftor tablets; 100mg/150mg with 15mg ivacaftorUpdate prior authorization criteria.

Cystic Fibrosis Treatment

F, PA, QL, SP T4, PA, QL, SP T5, PA, QL, SP

Trelstar® (triptorelin pamoate) 3.75mg, 11.25mg, 22.5mg intramuscular suspensionAdd prior authorization criteria.

Gonadotropin Releasing Hormone Agonist

MB, PA, SP MB, PA, SP MB, PA, SP

Tudorza® (aclidinium bromide)400mcg/actuationDecrease tier on Commercial and Exchange plans and add a quantity limit.

Long-Acting Anticholinergic Agent

NF T2, QL T3, QL

solifenacin succinate (generic for Vesicare®) 5mg, 10mg oral tabletsAdd to Centennial Care formulary, update to preferred drug tier on Commercial and Exchange formularies.

Anticholinergic Agent

F, QL T1, QL T2, QL

MB = Medical Benefit, ME = Medical Exception, NF = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits Apply, SP = Specialty Pharmacy Mandated, ST = Step Therapy Required, AL = Age Limit, BE = Benefit Exclusion

Medicare Formulary UpdatesDrug Name Therapeutic Class Coverage

New Generics

triamterene (generic for Dyrenium)50mg, 100mg oral capsules

Diuretic T3

desogesterol/ethinyl estradiol and estradiol (generic for Simliya) 0.02mg/0.15mg tablets x 21 and 0.01mg x 5 tablets

Oral Contraception T3

Hailey™ (norethinedrone/ethinyl estradiol)1.5mg/30mcg tablet

Oral Contraception T3

erythromycin (generic for Ery-TAB®)250mg, 333mg, 500mg delayed release tablet

Antibiotic T4

Dotti™ (estradiol patch) 0.025mg/24hr, 0.0375mg/24hr, 0.05mg/24hr, 0.075mg/24hr, 0.1mg/24hr transdermal patches

Hormone Replacement T4, PA (high-risk medication)

ramelteon (generic for Rozerem®)8mg tablet

Melatonin Receptor Agonist T4, PA, QL: 1/day

Humalog® (authorized generic insulin lispro)100unit/mL

Insulin T4, QL

febuxostat (generic for Uloric®)40mg, 80mg tablet

Antigout Agent T4

loteprednol etabonate (generic for Lotemax®)5mg/mL ophthalmic suspension

Ophthalmic Corticosteroid T4, ST

mesalamine DR (generic for Delzicol®)400mg DR capsules

5-Aminosalicylic Acid Derivative T4, ST

MB = Medical Benefit, ME = Medical Exception, NF = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits Apply, SP = Specialty Pharmacy Mandated, ST = Step Therapy Required, AL = Age Limit, BE = Benefit Exclusion, mg = milligrams

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 6

Medicare Formulary UpdatesDrug Name Therapeutic Class Coverage

New Generics

cinacalcet (generic for Sensipar®) 30mg, 60mg, 90mg tablet

Calcimimetic T5

penicillamine (generic for Cuprimine®)250mg capsule

Chelating Agent T5

erlotinib (generic for Tarceva®) 25mg, 100mg, 150mg tablet

Antineoplastic T5, PA, QL

bosentan (generic for Tracleer®)62.5mg, 125mg tablets

Endothelin Receptor Antagonist T5, QL, SP

icatibant acetate (generic for Firazyr®)10mg/mL solution

Selective Bradykinin B2 Receptor Antagonist

T5, PA

pregabalin (generic for Lyrica®) 25mg, 50mg, 75mg, 100mg, 200mg, 225mg, 300mg capsules

GABA agonist 300mg, 225mg: T3, QL: 2/day 100mg, 150mg, 200mg, 25mg, 50mg: T3, QL: 3/day

Formulary Additions

Kalydeco® (ivacaftor)25mg packets

Cystic Fibrosis Treatment T5, PA, QL

Symdeko® (tezacaftor/ivacaftor and ivacaftor)50mg/75mg tezacaftor/ivacaftor with 75mg ivacaftor tablets

Cystic Fibrosis Treatment T5, PA, SP, QL

Abilify® MyCite (sensor aripiprazole) 2mg, 5mg, 10mg, 15mg, 20mg, 30mg

Atyical Antipsychotic T5, QL, PA

Piqray® (alpelisib)50mg, 150mg, 200mg tablets

Antineoplastic T5, PA, QL

Xpovio® (selinexor)20mg tablet

Antineoplastic T5, PA, SP, QL

Vyndaqel® (tafamidis)20mg capsule

Transthyretin Stabilizer T5, PA, QL

Zykadia® (ceritinib)150mg capsule

Antineoplastic T5, PA, QL, SP

Turalio® (pexidartinib)200mg capsule

Antineoplastic T5, PA, QL

Nubeqa® (darolutamide)300mg tablet

Antineoplastic T5, QL, SP

MB = Medical Benefit, ME = Medical Exception, NF = Non-Formulary, PA = Prior Authorization Required, QL = Quantity Limits Apply, SP = Specialty Pharmacy Mandated, ST = Step Therapy Required, AL = Age Limit, BE = Benefit Exclusion, mg = milligrams

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 7

ANNOUNCEMENTS

Universal Prior Authorization FormStarting Jan. 1, 2020, New Mexico Senate Bill 188, the Health Insurance Prior Authorization Act, will require providers and their offices to utilize a universal prior authorization form when requesting prior authorization from all health insurers.

This form will be posted to www.phs.org for download and use by Jan. 1, 2020.

Centennial Care Opioid Safety EditsEffective Oct. 15, 2019, Presbyterian implemented a process to calculate the morphine milligram equivalent (MME) cumulative opioid dosage and provide real-time messages to the dispensing pharmacy following the guidelines and language under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act and the New Mexico Human Services Department Medical Assistance Division (HSD MAD). Presbyterian implemented this process In order to comply with the requirements of the SUPPORT Act regarding maximum daily MME safety edits.

MME safety edits include the following: When the cumulative opioid dosage exceeds 90 MME per day, the prescription claim will reject and the prescriber must submit a Drug Prior Authorization. Subsequent requests by a prescriber to increase an MME limit will require the prescriber to submit a new request. The dispensing pharmacist may contact Presbyterian’s Pharmacy Help Desk for an override 1) if they deem the filling of the prescription to be an “emergency” and cannot reach the prescriber or 2) when the Presbyterian Pharmacy Prior Authorization department is closed. For MME cumulative dosages between 50mg and 90mg per day for opioid naïve members (no fill history for and opioid medication in the past 120 days) a soft reject is in place that can be reviewed and overridden by the dispensing pharmacist at the point of sale.

Exceptions will be made for certain members including members receiving hospice or palliative care, treatment for cancer, or who are residents of a long-term care facility.

You can find Presbyterian formularies and updates, including restrictions (e.g., quantity limits, step therapy and prior authorization criteria) and preferences, online at https://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 https://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 by email. Presbyterian eNews registration is located at https://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 Manual are also available online at https://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 Operations relationship executive.

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 8

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 ModificationsUse 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 http://docs.phs.org/idc/groups/public/documents/communication/pel_00251399.pdf.

Presbyterian Health Plan FormulariesPresbyterian Health Plan (Presbyterian) strives to give our providers access to the information and support they need. One way we do this is by providing information on medications that are covered by the health plan. Presbyterian formularies may be accessed in the following ways:

• Searchable formularies will soon be available at www.phs.org/providers/formularies/Pages/default.aspx. You may search for a drug using this tool by viewing an alphabetical list of drugs, searching by drug name or searching by therapeutic class. You may also find out if a covered drug has any restrictions by clicking on the link for the drug.

• Providers can also find PDF versions of Presbyterian formularies and updates, including restrictions (e.g., quantity limits, step therapy and prior authorization criteria) and preferences, online at the webpage noted above.

• Presbyterian formularies may also be accessed using 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 from the App Store or Google Play.

For any questions about the formulary coverage of medications, you may call Presbyterian’s Pharmacy Services Help Desk at (505) 923-5500, or toll-free at 1-888-923-5757. The Help Desk’s business hours are Monday through Friday, from 8 a.m. to 5 p.m. You may also email the ASKRX Email at ASKRX@phs.org. The email box is monitored during regular business hours (Monday through Friday, from 8 a.m. to 5 p.m.) and one of our clinical pharmacists will respond within one business day.

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 9

Food and Drug Administration (FDA) Alerts

July 1, 2019 to September 30, 2019For a full list of FDA alerts and additional information see the FDA website at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts

1. Voluntary recall on Kogenate® FS manufactured by Bayer. [07/15/2019, 07/16/2019] - The recall affects 2000 IU vials. These products are being recalled due to the affected vials containing another antihemophilic factor, Jivi®. Kogenate FS and Jivi are both used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A. While the majority of the mislabeled vials in the affected lots were recovered, approximately 990 of these vials were released in the U.S. Bayer has voluntarily recalled both lots of Kogenate in the interest of patient safety, to ensure that any potentially impacted product is removed from pharmacy shelves, and that patients and their healthcare providers are alerted. Anyone with an existing inventory of the recalled product should stop use and distribution and quarantine the product immediately. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter and contact affected patients directly for notification.

2. Voluntary recall on drospirenone/ethinyl estradiol tablets manufactured by Jubilant Cadista Pharmaceuticals. [07/23/2019] - Recalled due to out-of-specification (OOS) dissolution results at the three-month stability time point and so the product efficacy may be decreased due to incomplete absorption of the active ingredients. To date, Jubilant Cadista Pharmaceuticals has not received any reports of adverse events related to this recall. Anyone with an existing inventory of the recalled product should stop use and distribution, and quarantine the product immediately. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter and send letters to members who had prescription claims for potentially affected lots of medication.

3. Venclexta (venetoclax): New warnings added to prescribing information. [07/25/2019] - The FDA approved an update to the Warnings and Precautions section of the Venclexta (venetoclax) drug label regarding increased mortality in patients with multiple myeloma when Venclexta is added to Velcade® (bortezomib) and dexamethasone. Treatment of patients with multiple myeloma with Venclexta in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

4. Xeljanz, Xeljanz XR (tofacitinib): new boxed warning. [07/26/2019] - A new warning was added to the tofacitinib (Xeljanz, Xeljanz XR) drug label regarding an increased risk of pulmonary embolism and death with the 10mg twice daily dose in patients with ulcerative colitis (UC). Healthcare providers should discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis. Tofacitinib should be reserved to treat UC for patients who have failed or do not tolerate TNF blockers. Tofacitinib should be avoided in patients who may have a higher risk of thrombosis. When treating UC, use tofacitinib at the lowest effective dose and limit the use of the 10mg twice daily dosage to the shortest duration needed. The FDA will reassess these safety issues when the safety trial has completed and final, verified data are available. The FDA will update the public when additional information is available. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

5. Recall on clobazam oral suspension manufactured by Bionpharma. [07/31/2019] - Clobazam oral suspension was recalled at the patient level due to microbial contamination. Anyone with an existing inventory of the recalled product should stop use and distribution, and quarantine the product immediately. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter and send letters to members who had prescription claims for potentially affected lots of medication.

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 10

6. Safety update: entacapone-containing products. [08/13/2019] - The FDA had previously announced in March 2010 that a clinical trial suggested a possible increased risk of prostate cancer with the entacapone component of Stalevo. The FDA subsequently required the Stalevo manufacturer, Novartis, to conduct a study to further evaluate this potential risk. Now the FDA has announced that there is no increased risk of prostate cancer with the use of entacapone [i.e., Comtan® (entacapone) and Stalevo® (carbidopa/levodopa/entacapone)] to treat Parkinson’s disease (PD). The recommendations for using these medicines will remain the same as labeled in the prescribing information. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

7. Voluntary recall on Relpax® (eletriptan) manufactured by Pfizer. [08/14/2019] - Two lots of Relpax (eletriptan) 40mg tablets have been voluntarily recalled because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of genus Pseudomonas and Burkholderia. Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life-threatening infections. In addition, there is risk of temporary gastrointestinal distress without serious infection. For the general population these risks are low; for certain vulnerable patient populations (such as patients with compromised immune systems, cystic fibrosis and chronic granulomatous disease) there may be the potential for serious adverse events including life-threatening infections. Anyone with an existing inventory of the recalled product should stop use and distribution, and quarantine the product immediately. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

8. Safety Update: Mavyret™ (glecaprevir/pibrentasvir), Zepatier® (elbasvir/grazoprevir), and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir). [08/28/2019] - The FDA announced that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C (CHC) in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

9. Voluntary Recall: Natpara (parathyroid hormone) manufactured by Takeda. [09/05/2019] - A voluntary recall was announced for all doses of Natpara (parathyroid hormone) injection due to a potential issue related to rubber particulates originating from the rubber septum of the Natpara cartridge. Takeda is working closely with the FDA to resolve the issue and resume supply as soon as possible. Patients should contact their healthcare provider if they have experienced any problems that may be related to using the recalled Natpara injection. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter and send letters to notify members who had prescription claims for potentially affected lots of medication.

10. Voluntary Recall: Milk of Magnesia manufactured by Plastikon. [09/06/2019] - Plastikon announced a voluntary, patient-level recall of two lots of milk of magnesia 2400mg/30mL oral suspension because these lots did not meet Plastikon’s in-house microbiological specification for total aerobic microbial count. Milk of Magnesia oral suspension is privately labeled by Major and packaged in cartons. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

11. Safety Alert: Ranitidine. [09/13/2019] - The FDA announced that some ranitidine medicines contain the nitrosamine impurity, N-nitrosodimethylamine (NDMA), at low levels. NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. The FDA is not calling for individuals to stop taking ranitidine at this time. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

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12. New Warning: Ibrance® (palbociclib), Kisqali® (ribociclib) and Verzenio® (abemaciclib). [09/13/2019] - The FDA announced that the Warnings and Precautions sections of the Ibrance (palbociclib), Kisqali (ribociclib) and Verzenio (abemaciclib) drug labels were updated with information regarding interstitial lung disease (ILD) and pneumonitis. Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with cyclindependent kinase 4/6 (CDK4/6) inhibitors, including Ibrance, Kisqali and Verzenio when taken in combination with endocrine therapy. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

13. Voluntary Recall: Calcilo XD® manufactured by Abbott Nutrition. [09/16/2019] - Abbott Nutrition announced a voluntary, consumer-level recall of one lot of Calcilo XD powder cans due to an inconsistency in aroma and color in a small number of cans from this specific batch. Calcilo XD is a low-calcium/vitamin D-free infant formula with iron. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Contact Abbott Nutrition for instructions on how to return or replace the product. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter and send letters to members who had prescription claims for potentially affected lots of medication.

14. Voluntary recall (expansion) on losartan and losartan/HCTZ tablets manufactured by Torrent Pharmaceuticals Limited. [01/03/2019, 01/22/2019, 03/01/2019, 04/18/2019, 09/19/2019] - These products are being recalled due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA. To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter and send letters to members who had prescription claims for potentially affected lots of medication.

15. Recall on Ranitidine manufactured by Sandoz. [09/23/2019] - The FDA announced a consumer-level recall of several lots of Sandoz’s ranitidine capsules because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz’s ranitidine capsules. NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Patients are asked to continue taking their medication and speak to their physician or pharmacist about alternative healthcare treatment options. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter and send letters to members who had prescription claims for potentially affected lots of medication.

16. Recall on Ranitidine manufactured by Apotex. [09/26/2019] - The FDA announced a voluntary retail-level recall of several lots of Apotex’s over-the-counter (OTC) ranitidine tablets labeled by Walgreens, Walmart, and Rite-Aid due to potential contamination with low levels of N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Patients are asked to continue taking their medication and speak to their physician or pharmacist about alternative healthcare treatment options. Response by Presbyterian Health Plan: Inform providers in the P&T newsletter.

NOTE: Notification is sent to PHP Members regarding Class I or II drug recalls or market withdrawals due to a drug safety issue. Notification regarding drug recalls that are lot specific is not required as it is not possible for the health plan to identify members who were dispensed a specific lot of a medication.

P&T COMMITTEE PROVIDER UPDATE FOURTH QUARTER 2019 … 12

Presbyterian Health Plan, Inc.Provider Network ManagementP.O. Box 27489Albuquerque, NM 87125-7489www.phs.org

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Contact UsThe 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 questions or concerns, please email the ASK PHP P&T mailbox at askphppt@phs.org.