Kaiser Permanente Georgia 1

u Formulary additions . . . . . .1

ISSUE 2 VOLUME 9 APRIL 2015

FormularyUpdateu medications reviewed at P&t, But not added to the Formulary . . . . . . . . . . . . . . 4

Apremilast (Otezla) tablets will be added to the Commercial Formulary effective May 15, 2015. Apremilast is an orally available phosphodiesterase 4 inhibitor for the treatment

of adult patients with active psoriatic arthritis and patients with moderate to severe plaque psoriasis. Apremilast offers an alternative therapy for patients with moderate to severe plaque psoriasis who have had an inadequate response to topical and other systemic (non-biologic) agents. For the treatment of psoriatic arthritis, current available evidence does not support apremilast’s use first-line in patients who have not previously been tried on conventional non-biologic therapies (e.g., methotrexate). Instead, apremilast may be best suited for patients who have inadequate response, contraindications, or intolerance to non-biologic disease modifying anti-rheumatic drugs (DMARDs). In clinical trials, gastrointestinal effects (nausea, vomiting, and diarrhea) were most commonly reported, generally within the first two weeks of therapy. Apremilast appears to be safer compared to biologic DMARDs and biologics for psoriasis, particularly in regard to the risk of developing serious infections. Apremilast has the advantage of an oral treatment, less severe adverse events and lower cost compared to the formulary biologic drugs, Humira and Enbrel.

u national medicare Part d Formulary . . . . . . . . . . . . . . 4

A PUBL ICAT ION OF THE GEORGIA PHARMACY AND THERAPEUT ICS (P&T) COMMITTEE . The Formulary Update contains information regarding formulary additions, deletions, exclusions, brief descriptions of products, and current drug related news. It also lists items to be discussed at upcoming P&T meetings. Please refer to the web site http://kpnet.kp.org:81/ga/healthcare/formularies.html or providers.kp.org for the full KP GA Drug Formulary. If you have Lexi-Comp PDA access to the KPGA Online Formulary, remember to sync your device for the most current information.

u clinical uPdate . . . . . . . . . 5

u Formulary deletions . . . . . .2

u aPPendix a: Floorstock additions . . . . . . . . . . . . . . .6

Formulary Additions

u new standing order . . . . . . .3u aPProved comPound . . . . . . .3

At A Glance

unew criteria restricted medications . . . . . . . . . . . . . 3

u non-Formulary cost considerations . . . . . . . . . . 5

u Quantity limits . . . . . . . . .3

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uPcoming Formulary items

An important aspect of the formulary process is the involvement of all practitioners. So that each of you has an opportunity to participate in the process, upcoming P&T agenda items are listed below. Please contact your P&T Committee representative or your clinical service chief by May 23, 2015 if you wish to comment on any of the medications, class reviews, or other agenda items under consideration. To make formulary addition requests, you must submit a Formulary Additions/Deletions Form and Conflict of Interest Form to Drug Information Services or call (404) 949-5331.

Formulary DeletionsClobetasol propionate (generic Temovate E) 0.05% emollient cream will be removed from the Commercial Formulary effective May 15, 2015. The other topical dosage forms on the KPGA’s Commercial Formulary are the clobetasol cream, ointment, gel and solution. As above, lotion and spray will be added.

Ketorolac (generic Acular LS) 0.4% ophthalmic solution will be removed from the Commercial Formulary effective May 29, 2015. Ketorolac ophthalmic solution is a nonsteroidal anti-inflammatory (NSAID) ophthalmic agent used for the treatment of post-operative pain and/or inflammation in patients who have undergone cataract extraction or reduction of ocular pain, burning and stinging in patients following corneal refractive surgery. Ketorolac 0.5%, the preferred formulary alternative, contains the same preservative and inactive ingredients as ketorolac 0.4%, they are both dosed the same way, and they both have similar safety and efficacy profiles. Ketorolac 0.4% is significantly more expensive than ketorolac 0.5%. For the cost of treating 1 patient with ketorolac 0.4%, 11 patients can be treated with ketorolac 0.5%.

Clobetasol propionate (Clobex) 0.05% topical lotion and clobetasol propionate (Clobex) 0.05% spray will be added to the Commercial Formulary effective May 15, 2015. Clobetasol is a topical corticosteroid with ultra high potency. It is indicated in the treatment of short-term relief of inflammation and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses. The other topical dosage forms on the KPGA’s Commercial Formulary are the clobetasol cream, ointment, gel and solution.

Formulary Addition, Continued

Restasis (Cyclosporine) 0.05% ophthalmic emulsion will be removed from the Commercial Formulary effective May 29, 2015. Cyclosporine ophthalmic emulsion (Restasis) is indicated to increase tear production in patients whose tear production is presumed

to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (KCS), also known as chronic dye eye disease. KCS results from a T-cell mediated inflammatory process, which then suppresses tear production. First line treatment for dry eyes include non-pharmacologic options such as environmental modifications, elimination of offending topical and/or systemic medications, and eyelid therapy (warm compress/eyelid scrubs) and pharmacologic options such as artificial tear substitutes, gels and/or ointments. For patients with moderate to severe dry eyes, anti-inflammatory therapies, such as cyclosporine or corticosteroids, can be considered after failure of first line agents. Cyclosporine has been shown to have short-term clinical benefits in the treatment of dry eye; however, data is lacking on the long-term effectiveness for treatment of dry eyes. Reducing the use of Restasis has been adopted as an ICPSS (inter-regional clinical pharmacy services subcommittee) initiative. KPGA has the second highest utilization of Restasis per member per month of all KP regions.

Lidocaine 5% ointment will be removed from the Commercial Formulary effective May 15, 2015. Lidocaine 5% ointment, a topical, local anesthetic, is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. The cost of lidocaine 5% ointment has significantly increased. Over-the-counter (OTC) AneCream (lidocaine cream) 5% is conveniently available without a prescription at Kaiser Permanente pharmacies. When a topical anesthetic is needed for localized pain, consider OTC lidocaine cream 5% (AneCream) instead of prescription lidocaine 5% ointment.

Calcium acetate (generic PhosLo) 667 mg capsules were removed from the Commercial Formulary effective March 20, 2015. Calcium acetate is indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption. Calcium acetate capsules and calcium acetate (Eliphos) tablets contain the same amount of the same active ingredient (calcium acetate 667 mg). Calcium acetate (Eliphos) 667 mg tablets are preferred formulary alternative available at a generic copay.

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Questions and concerns?

If you have any questions or concerns, please contact any of the following P&T Committee members and designated alternates:

P&T interim Chair:Carole Gardner, MD

P&T Committee Members:Debbi Baker, PharmD, BCPS

Clinical Pharmacy

Gary Beals, RPhDirector of Pharmacy

Karen Bolden, RN, BSNClinical Services

Alyssa Dayton, MDObstetrics and Gynecology

Carole Gardner, MDElder Care

Patrice Gaspard, MDPediatrics

Marcus Griffith, MD*Behavioral Health

David Jones, MDPediatrics

Craig Kaplan, MDAmbulatory Medicine

Felecia Martin, PharmDPharmacy/Geriatrics

Shayne Mixon, PharmDPharmacy Operations

Rachel Robins, MDHospitalist

Jennifer Rodriguez, MD*Behavioral Health

Ivorique Turner, MDAmbulatory Medicine

Designated Alternates:Jacqueline Anglade, MD

Obstetrics and Gynecology

Lesia Jackson, RNClinical Services

*Attend alternating meetings

New Criteria Restricted MedicationsCriteria restricted medications require review by Quality Resource Management (QRM) prior to coverage. The prior authorization process and criteria apply to all formularies except the Medicare Part D Formulary. Providers must call QRM to request authorization consideration at 404-364-7320. A complete listing of prior authorization medications and their corresponding criteria is available on the intranet under Healthcare Delivery/Guides & References/Formularies/Criteria Restricted (QRM) Medications. The following medications will be added to the list of Criteria Restricted Medications (QRM).

•Empagliflozin (Jardiance)•Albiglutide (Tanzeum)

DPP-IV inhibitors are no longer restricted to be prescribed by Endocrinologists only. The criteria for these medications will still apply for all prescribers.

Quantity LimitsIn order to encourage appropriate drug utilization and contain medication cost, quantity limits are implemented on certain medications. The quantity limit defines the maximum quantity of a medication that can be dispensed over a specific period of time at the applicable benefit co-pay for the patient.

The medication below will be added to the quantity limit list effective May 29, 2015.

Medication Name Quantity Limit

Cyclosporine (Restasis) 0.05% ophthalmic emulsion

30-day supply

KPGA Approved CompoundOnly medications on the list of Approved Compounds may be prepared at Kaiser Permanente pharmacies. The approved list of compounds and recipes are posted on the intranet under Healthcare Delivery/Pharmaceutical Services/Compounds.

The compound below will be added to the List of Approved Compounds. •Ophthalmiclidocainejellycompoundforproceduraluse(outsourcedtoanapprovedvendor)

New Standing OrderApproved standing orders are written instructions issued by medical practitioners, in accordance with the regulations, authorizing pharmacy personnel at pharmacies owned or operated by Kaiser Foundation Health Plan to supply and administer specified medications under circumstances specified in the order.

Lidocaine 5% ointment/patches will be changed to Over-the-counter (OTC) lidocaine 5% (AneCream 5) via standing order. OTC AneCream (lidocaine cream) 5% is conveniently available without a prescription at Kaiser Permanente pharmacies.

Colchicine 0.6 mg tablets (generic Colcrys) will be changed to colchicine 0.6 mg cap-sules (generic Mitigare) via standing order. Colchicine (generic Mitigare) capsules are the preferred, non-formulary dosage form. Colcrys tablets and colchicine capsules contain the same active ingredient, colchicine, in the same amount and work the same way to help manage gout.

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Formulary Reviews (June 2015):

Medication class Reviews

Dermatological

Penicillins

Cephalosporins

Macrolids

Tetracyclines

Fluoroquinolones

Aminoglycosides

Sulfonamides

Antimycobacterial

Antifungals

Antivirals

Antimalarials

Amebicides

Antihelmintics

Anti-infectives -- Misc

class review

•Lenvatinib (Lenvima) capsules, decision pending for the National MPD Formulary•Palbociclib (Ibrance) 75 mg, 100 mg, 125 mg capsules, decision pending for the

National MPD Formulary•Human papillomavirus 9-valent vaccine (Gardasil 9), decision pending for National

MPD formulary•C1 inhibitor (recombinant) (Ruconest) vial solution was not added to the Commercial

Formulary, decision pending for National MPD formulary•Vorapaxar (Zontivity) 2.08 mg tablets were not added to the Commercial Formulary,

decision pending for National MPD formulary•Efinaconazole (Jublia) 10% topical solution was not added to the Commercial

Formulary, decision pending for National MPD formulary•Luliconazole (Luzu) 1% cream was not added to the Commercial Formulary, decision

pending for National MPD formulary•Tavaborole (Kerydin) 5% topical solution was not added to the Commercial

Formulary, decision pending for National MPD formulary•Tasimelteon (Hetlioz) 20 mg capsules were not added to the Commercial Formulary,

decision pending for National MPD formulary•Tedizolid (Sivextro) 200 mg IV solution and tablets were not added to the

Commercial Formulary, decision pending for National MPD formulary•Suvorexant (Belsomra) 5 mg, 10 mg, 15 mg, 20 mg tablets were not added to the

Commercial Formulary, decision pending for National MPD formulary•Nintedanib (Ofev) 100 mg, 150 mg capsules were not added to the Commercial

Formulary, decision pending for National MPD formulary•Pirfenidone (Esbriet) 267 mg capsules were not added to the Commercial Formulary,

decision pending for National MPD formulary

Medications Reviewed, but Not Added to the Formulary

National MPD Formulary initial tier placements are listed below with the corresponding effective date:

Medication Name TierEffective

Date

suvorexant (Belsomra) 5 mg, 10 mg, 15 mg, 20 mg tablets Tier 4 2/3/2015

meningococcal group B (Trumenba) vaccine inj susp Tier 6 2/3/2015

alemtuzumab (Lemtrada) 12 mg/1.2 mL injection Tier 5 2/3/2015

human papillomavirus 9-valent vaccine (Gardasil 9) Tier 6 2/3/2015

Edoxaban (Savaysa) 15 mg, 30 mg, 60 mg tablets Tier 4 2/3/2015

miltefosine (Impavido) 50 mg capsules Tier 4 Pending

naloxegol (Movantik) 12 mg, 15 mg tablets Tier 4 Pending

elvitegravir (Vitekta) 85 mg, 150 mg tablets Tier 5 Pending

finafloxacin (Xtoro) 0.30% suspension Tier 4 Pending

Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine

Kaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T Committee reviews drugs and decides on tier status. The National Medicare Part D Pharmacy and Therapeutics Committee is charged with reconciling regional differences in MPD Formulary recommendations through consensus building in order to maintain one National MPD Formulary for Kaiser Permanente.

National Medicare Part D Formulary

Medical Office Floorstock AdditionsP&T Committee annually reviews all of the department floorstock lists. Approved medi-cations will be added to the electronic floorstock ordering forms on the intranet.APPENDIX A CONTAINS A DETAILED LIST OF ADDITIONS TO DEPARTMENT FLOORSTOCK LISTS.

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Clinical UpdatesTestosterone Products: Drug Safety Communication - FDA Cautions About Using Tes-tosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And StrokeThe U.S. Food and Drug Administration (FDA) is requiring that the manu-facturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testos-terone levels due to aging, even if a man’s symptoms seem related to low testosterone.

Based on the available evidence from studies and expert input from an FDA Advisory Com-mittee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testoster-one. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.

Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of the possible increased cardiovas-cular risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breath-ing, weakness in one part or one side of the body, or slurred speech.

additional clinical alerts

Chantix (varenicline): Drug Safety Communication - FDA Updates Label to

Include Potential Alcohol Interactionhttp://www.fda.gov/Safety/

MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/

ucm437415.htm

Non-Formulary Cost ConsiderationsClass Non-formulary Medications Formulary Alternatives Clinical/Cost Pearls

Gout Agents•Colchicinetabsandcaps•Febuxostat(Uloric)

Gout Prophylaxis: allopurinol and probenecid

Gout Treatment: naproxen*, ibu-profen*, indomethacin*, predni-sone

*NSAIDs should be avoided in renal/liver dysfunction, current anticoagula-tion, patients >65 years & transplant patients. Particularly, indomethacin should be reserved for patients <64 years.

•For the cost of every 1 patient being treated with Uloric, 131 patients can be treated with allopurinol or 7 patients can be treated with probenecid. •For the cost of every 1 patient being treated with colchicine caps, 37 patients can be treated with allopurinol or 63 pa-tients can be treated with indomethacin.

Irritable bowel syndrome with constipation agents

•Lubiprostone(Amitizia)•Linaclotide(Linzess)

OTC Miralax and lactulose oral-solution

•For the cost of every 1 patient being treated with Amitizia, 65 patients can be treated with lactulose. •For the cost of every 1 patient being treated with Linzess, 35 patients can be treated with lactulose.

Over-the-Counter Asthma Products La-beled as Homeopathic: FDA Statement - Consumer Warning About Potential

Health Riskshttp://www.fda.gov/Safety/MedWatch/

SafetyInformation/SafetyAlertsforHuman-MedicalProducts/ucm439014.htm

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Appendix AKPGA Medical Office Floorstock Additions Department Name Medication Added

Cardiology Dexamethasone Sodium Phosphate 4mg/mL

Hydralazine HCl inj 20mg/mL vial

Proair HFA 90mcg inh w/ dose counter 8.5gm

Podiatry Gentamicin 0.1% oint 15gm

Endocrinology Lupron Depot 22.5mg syg 3mo kit

OB GYN

Hurricaine 20% spray w/ extension tube

Monsels paste 8mL

Petrolatum foil UD jelly 5gm

Normal saline 0.9% 10mL in 12mL syg

Skyla DS IUD

Orthopedics Triple antibiotic oint 0.9gm UD packet

Gastroenterology Prevnar 13 prefilled syg 0.5mL

Nephrology Prevnar 13 prefilled syg 0.5mL

Cosmetic Dermatology Aquaphor ointment skin healing 1.75oz

Cetaphil gentle skin cleanser 16oz

Cetaphil lotion 16oz

Vitrase 200 unit/mL

Plastic Surgery Aquaphor ointment 50gm

Ophthalmology Ketorolac tromethamine 0.5% oph 5mL

Pulmonology Prevnar 13 prefilled syg 0.5mL

Xopenex HFA inh 15gm

Dermatology Aquaphor ointment skin healing 1.75oz

Drysol sol 37.5mL

BD Ultrafine 8mm 31gx1cc

Jessner’s solution 120mL

Bleomycin sulfate 15 IU

KOH10% in water 60mL

Levulan kerastick 20% top solution

LMX5 5% cream15gm

Sodium bicarbonate 8.4% SDV 50mL

Sodium chloride 23.4% SDV 30mL

Water for inj, SDV 10mL