Kaiser Permanente Georgia 1 u FORMULARY ADDITIONS 1 ISSUE1 VOLUME 7 FEBRUARY 2013 u CLINICAL UPDATES 3 u MEDICATIONS REVIEWED AT P&T, BUT NOT ADDED T O THE FORMULARY 4 Orencia (abatacept) 125 mg/ml injection is currently available on the National Medicare Part D (MPD) Formulary as Tier 5, specialty, and was added to the Commercial Formulary effective February 21, 2013. Orencia is a selective T cell co-stimulation modulator FDA approved for the treatment of moderate to severe rheumatoid arthritis. Orencia was previously only available as an intravenous (IV) infusion, but is not available as a subcutaneous injection for patient self administration. Outpatient administration carries a convenience for patients and can spare infusion clinic visits and related costs. Commercial members will pay their brand co-pay for subcutaneous Orencia. Since Orencia is Tier 5, Specialty, on the National MPD Formulary, MPD members will pay a 25% co-insurance for the subcutaneous Orencia. Complera (rilpivirine/emtricitabine/tenofovir) 25/200/300 mg tablets are currently available on the National MPD Formulary as Tier 5, specialty, and were added to the Commercial Formulary effective February 21, 2013. Complera is a fixed combination antiretroviral agent FDA approved for the treatment of HIV-1 infection in adults. It is a combination of two nucleoside/nucleotide reverse transcriptase inhibitors (emtricitabine & tenofovir) and a non- nuceloside reverse transcriptase inhibitor (rilpivirine). EpiPen & EpiPen Jr (epinephrine) are currently available on the National MPD Formulary as Tier 3, brand, and were added to the Commercial Formulary effective February 21, 2013. EpiPen and Epipen Jr are epinephrine authoinjectors FDA approved for the treatment of Type 1 allergic reactions. In December 2010, EpiPen and EpiPen Jr were removed from the formulary and replaced with epinephrine autoinjector (generic Adrenaclick); however, that product has been discontinued by the manufacturer. EpiPen and EpiPen Jr will be available to members for their brand co-payment. u NATIONAL MEDICARE PART D FORMULARY2 A PUBLICATION OF THE GEORGIA PHARMACY AND THERAPEUTICS (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 FLOOSTOCK ADDITIONS2 u KPGA APPROVED COMPOUNDS 2
Transcript
Kaiser Permanente Georgia 1
u Formulary additions . . . . . .1
ISSUE1 VOLUME 7 FEBRUARY 2013
FormularyUpdate
u CliniCal updates . . . . . . . . 3u mediCations reviewed at p&t, But not added to the
Formulary . . . . . . . . . . . . 4
Orencia (abatacept) 125 mg/ml injection is currently available on the National Medicare Part D (MPD) Formulary as Tier 5, specialty, and was added to the Commercial Formulary effective February 21, 2013. Orencia is a selective T cell co-stimulation modulator FDA approved for the treatment of moderate to severe rheumatoid arthritis. Orencia was previously only available as an intravenous (IV) infusion, but is not available as a subcutaneous injection for patient self administration. Outpatient administration carries a convenience for patients and can spare infusion clinic visits and related costs. Commercial members will pay their brand co-pay for subcutaneous Orencia. Since Orencia is Tier 5, Specialty, on the National MPD Formulary, MPD members will pay a 25% co-insurance for the subcutaneous Orencia.
Complera (rilpivirine/emtricitabine/tenofovir) 25/200/300 mg tablets are currently available on the National MPD Formulary as Tier 5, specialty, and were added to the Commercial Formulary effective February 21, 2013. Complera is a fixed combination antiretroviral agent FDA approved for the treatment of HIV-1 infection in adults. It is a combination of two nucleoside/nucleotide reverse transcriptase inhibitors (emtricitabine & tenofovir) and a non-nuceloside reverse transcriptase inhibitor (rilpivirine).
EpiPen & EpiPen Jr (epinephrine) are currently available on the National MPD Formulary as Tier 3, brand, and were added to the Commercial Formulary effective February 21, 2013. EpiPen and Epipen Jr are epinephrine authoinjectors FDA approved for the treatment of Type 1 allergic reactions. In December 2010, EpiPen and EpiPen Jr were removed from the formulary and replaced with epinephrine autoinjector (generic Adrenaclick); however, that product has been discontinued by the manufacturer. EpiPen and EpiPen Jr will be available to members for their brand co-payment.
u national mediCare part d Formulary . . . . . . . . . . . . . . 2
Formulary Additions
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 FloostoCk additions . . . . . . 2 u kpGa approved Compounds . 2
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upCominG Formulary deCisions
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 March 15, 2013 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 Reviews (April 2013):
•Formulary status of the following medications will be reviewed: Azelastine
mediCation Class reviews
Androgen/Anabolic Agents
Antidiabetic Agents
Antiemetic Agents
Antineoplastic Agents
Corticosteroids
Dietary Management Agents
Digestive Aids
Gastrointestinal Agents, Misc
Gout Agents
Ophthalmic Agents
Pharmaceutical Adjuvants
Thyroid Agents
The medications below will be added to the electronic floorstock ordering forms on the intranet:
department name mediCation added
Pain Management Gentamicin 2 mg/ml vial
Pediatrics MenHibrix
Medical Office Floorstock Additions
National Medicare Part D FormularyKaiser 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 MPD Formulary Tier changes are listed below with their corresponding effective date:
Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine
New KPGA Approved CompoundsOnly 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 medication listed below was added to the List of Approved Compounds:•Testosterone 2% in velvachol topical cream
Formulary Additions, ContinuedCarbamazepine (Tegretol-XR) 200 mg & 400 mg extended-release tablets are currently available on the National MPD Formulary as Tier 2, generic, and were added to the Commercial Formulary effective February 21, 2013. Carbamazine ER (Tegretol XR) tablet is an anticonvulsant FDA approved for partial seizures with complex symptomatology (psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), mixed
seizure patterns, trigeminal neuralgia, glossopharyngeal neuralgia. Due to a contract change, carmabazpine ER tablet is now more cost effective than carbamazpine ER capsule (Carbatrol).
Kaiser Permanente Georgia 3
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 Chair:Daniel Lee, MD, FACS
Physician Program Director of Pharmacy
P&T Committee Members:Seeme Ahmad, MD*
Behavioral Health
Debbi Baker, PharmD, BCPSClinical Pharmacy
Gary Beals, RPhDirector of Pharmacy
Karen Bolden, RN, BSNClinical Services
Deborah Burzotta, PharmDPharmacy Operations
Alyssa Dayton, MDObstetrics and Gynecology
Carole Gardner, MDElder Care
Patrice Gaspard, MDPediatrics
Marcus Griffith, MD*Behavioral Health
Donald Hanchett, MDAmbulatory Medicine
David Jones, MDPediatrics
Felecia Martin, PharmDPharmacy/Geriatrics
Susan Moon, MDHospitalist
LaJune Oliver, MDAmbulatory Medicine
Designated Alternates:Jacqueline Anglade, MD
Obstetrics and Gynecology
Lesia Jackson, RNClinical Services
*Attend alternating meetings
Clinical UpdatesMedSafety Alert: Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses. FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement
focuses on zolpidem products approved for bedtime use, which are marketed as gener-ics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. Zolpidem is a sedative-hypnotic (sleep) medicine used in adults for the treatment of insomnia.
FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a com-mon side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.
For zolpidem products, data show the risk for next-morning impairment is highest for pa-tients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bod-ies more slowly than men. Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose.
FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.
Recommendations: FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.•The recommended dose of zolpidem for women should be lowered from 10 mg to 5
mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).
•For zolpidem and other insomnia drugs, prescribe the lowest dose that treats the pa-tient’s symptoms.
• Inform patients that impairment from sleep drugs can be present despite feeling fully awake.
•The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men.
High Risk Medication Alert: Nonbenzodiazepine Hypnotics in the Elderly. While the new FDA warning applies to zolpidem for all age groups, the American Geri-atrics Society 2012 Beers Criteria Update Expert Panel has recently added ALL non-benzodiazepine sedative hypnotics to the Beers List. This means zolpidem (Ambien), eszopi-clone (Lunesta), and zaleplon (Sonata) are considered High Risk Medications in the Elderly. If a patient age 65 or older
receives any one or combination of these drugs for >90 days per calendar year, HEDIS and CMS quality metrics are negatively affected. All patients seeking treatment for insomnia should be educated on good sleep hygiene practices as well as undergo assessment and treatment for underlying conditions such as anxiety, depression or pain. If medical treat-ment is required, melatonin 3 mg (OTC) or trazodone 25 mg (titrated to 150-200 mg nightly as needed) are considered safer options for elderly patients. Melatonin and trazodone should be administered 1 hour before bedtime. If a non-benzodiazepine sedative hypnotic is required after adequate trials of first line therapies, consider using the lowest possible dose for the shortest possible duration (<10 days). KPHC tools and patient communication tools are currently under development to support prescribers in addressing patients with insomnia.
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•Rotigotine (Neupro) 1 mg, 2 mg, & 3 mg transdermal patch, not added to the Commercial Formulary, decision pending for the National MPD Formulary
•Estradiol valerate & dienogest (Natazia) tablet, not added to the Commercial Formulary, decision pending for the National MPD Formulary
•Mirabegron (Mybetriq) 25 mg & 50 mg extended release tablets, not added to the Commercial Formulary, decision pending for the National MPD Formulary
•Fluticasone & azelastin (Dymista) 0.1%-0.37% nasal suspension, not added to the Commercial Formulary, decision pending for the National MPD Formulary
•Fluorometholone (FML) 0.1% ophthalmic ointment, not added to the Commercial Formulary
•Denosumab (Prolia) 60 mg/ml injection, decision pending for the National MPD formulary•Pregabalin (Lyrica) 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, & 300 mg capsules &
20 mg/ml oral solution, decision pending for the National MPD Formulary
Medications Reviewed, but Not Added to the Formulary
additional CliniCal alerts
Samsca (tolvaptan): Drug Warning - Potential Risk of
Liver Injuryhttp://www.fda.gov/Safety/
MedWatch/SafetyInformation/
MedSafety Alert: Eliquis (apixaban): Drug Warning - Potential Risk of Thrombotic Events. The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of Eliquis outweigh the potential risks in patients with non-valvular atrial fibrillation including: Increased risk of thrombotic events, including stroke, when discontinuing Eliquis without an adequate alternative anticoagulant. Eliquis is non-formulary on the KPGA Com-mercial Formulary and Tier 4, Non-Preferred Brand, on the National MPD Formulary.
Eliquis has an apparent half-life of 12 hours during repeat dosing; therefore, the anticoagu-lant effect of Eliquis is present when the drug is taken and for at least a day after discon-tinuation. Discontinuing Eliquis in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Eliquis to warfarin in clinical trials in patients with nonvalvular atrial fibrilla-tion. If Eliquis must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
When converting from or to Eliquis (per manufacturer package insert)•Switching from warfarin to Eliquis: Warfarin should be discontinued and Eliquis
started when the international normalized ratio (INR) is below 2.0.•Switching from Eliquis to warfarin: Eliquis affects INR, so that INR measurements
during coadministration with warfarin may not be useful for determining the appropri-ate dose of warfarin. If continuous anticoagulation is necessary, discontinue Eliquis and begin both a parenteral anticoagulant and warfarin at the time the next dose of Eliquis would have been taken, discontinuing the parenteral anticoagulant when INR research an acceptable range.
•Switching between Eliquis and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.
Directives from Manufacturer: •Advise patients to take Eliquis only as directed and not to discontinue Eliquis without
first speaking to a health care provider.•To report all suspected adverse events associated with the use of Eliquis, please con-
tact: Bristol-Myers Squibb at 1-800-721-5072 and/or FDA Medwatch Program at 1-800-FDA-1088 or www.fda.gov/medwatch
