Formulary Additions, Cont.

Transcription

1 u Formulary Additions... 1 u No Initial Fill 2 u standing Orders u criteria Restricted u Quantity Limits u Medicare Formulary... 3 u drug Benefit Update: 2012 Medicare Part D Changes 4 u Floorstock 5 u Clinical Updates u Reviewed At P&T, But Not Added To The Formulary I S S U E 5 V O LU M E 6 D E C E M B E R 2011 Formulary A P U B L I C AT I O N O F T H E G E O R G I A P H A R M A C Y A N D T H E R A P E U T I C S ( P & T ) C O M M I T T E E. 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 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. Testosterone (Androderm) 2 mg/24 hours and 4 mg/24 hours transdermal patches were added to the Commercial Formulary and the Medicare Part D (MPD) Formulary on December 6, Androderm is FDA approved for the treatment of male hypogonadism. Androderm 2.5 mg and 5 mg patches have been discontinued by the manufacturer. Patients can be adequately controlled on lower strengths of Androderm, which reduces the possibility of testosterone blood concentrations outside the upper limit of normal. Androderm 2 mg and 4 mg patches are smaller in size and contain 20% less testosterone than the 2.5 mg and 5 mg patches, respectively. As supplies of Androderm 2.5 mg and 5 mg patches dwindle, patients will need to be converted to the newer strengths. Providers will need to provide a signed Androderm prescription for patients when converting to the 2 mg or 4 mg patches. Update Formulary Additions Calcium acetate (Phoslyra) 667 mg/5 ml oral solution was added to the Commercial and MPD Formularies December 6, Currently, there is a shortage of PhosLo (calcium acetate) tablets. In order to continue to have a calcium acetate product available during the shortage, Phoslyra has been added to the formulary. Phoslyra is available to members for a brand copay. Dasatinib (Sprycel) 100 mg tablet is currently available on the MPD Formulary and will be added to the Commercial Formulary effective December 20, Dasatinib is a tyrosine kinase inhibitor indicated in the treatment of certain types of leukemias. Currently, dasatinib 20 mg, 50 mg, and 70 mg tablets are available on the KPGA Commercial formulary. The addition of dasatinib 100 mg tablets to the Commercial Formulary allows for more dosing flexibility in patients requiring a higher dose of the medication. Page 1

2 Page 2 Formulary Additions, Cont. Olanzapine (generic Zyprexa Zydis) 5 mg, 10 mg, 15 mg and 20 mg orally disintegrating tablets (ODT) are available on the Medicare Part D Formulary will be added to the Commercial Formulary effective December 20, Olanzapine is a thienobenzodiazepine antipsychotic indicated for the treatment of schizophrenia, acute or mixed mania episodes associated with bipolar I disorder (as monotherapy or in combination with lithium or valproate), maintenance treatment of bipolar disorder, and in combination with fluoxetine for treatment-resistant or bipolar depression. Olanzapine and Olanzapine ODT became available generically in October and offers a significant cost savings over the branded products, Zyprexa and Zyprexa Zydis. Olanzapine ODT will be available to members for a generic co-pay. Olanzapine ODT offers an additional dosage from for those patients needing treatment with olanzapine who are unable to swallow tablets. Gabapentin (generic Neurontin) 250 mg/5 ml oral solution is available on the Medicare Part D Formulary and will be added to the Commercial Formulary effective December 20, Gabapentin is a GABA analog indicated for adjunctive therapy for treatment of partial seizures with and without secondary generalized seizures in patients >12 years of age with epilepsy; adjunctive therapy for treatment of partial seizures in pediatric patients 3-12 years of age; and management of postherpetic neuralgia (PHN) in adults. Gabapentin 250 mg/ml oral solution became generically available in May 2011 and has been approved for use in place of Neurontin 250 mg/ml oral solution by the KP National Pharmacy product evaluation process. Gabapentin oral solution offers an additional dosage form for those patients needing treatment with gabapentin who are unable to swallow tablets or capsules. New No Initial Fill No initial fill medications are Commercial non-formulary medications that require review by the Pharmacy Consult Service (PCS) prior to the first fill of the medication under the drug benefit. These Commercial non-formulary medications are not eligible for a thirty day courtesy supply from the pharmacy prior to PCS authorization. No initial fill only applies to Commercial members with a closed formulary benefit. Rivaroxaban (Xarelto) 15 mg and 20 mg tablets: Rivaroxaban 15 mg and 20 mg tablets are an oral factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). Guidelines for the use rivaroxaban 15 mg and 20 mg tablets have been developed and reviewed by the P&T Committee. Rivaroxaban 15 mg and 20 mg tablets will be added to the Criteria Restricted (QRM) list April 1, Sitagliptin and simvastatin (Juvisync) tablets: Sitagliptin and simvastatin (Juvisync ) tablets are FDA approved for use in patients for whom treatment with sitagliptin and simvastatin is appropriate. Sitagliptin is FDA approved as an adjunct to diet and exercise for the treatment of type 2 diabetes mellitus and simvastatin is indicated an as adjunct to diet for the management of lipid disorders. Other sitagliptin containing products, Januvia (sitagliptin) and Janumet (sitagliptin/ metformin) are currently on the QRM list on the Commercial formulary. The guidelines for the use of sitagliptin/simvastatin align with the current guidelines for the other sitagliptin containing products. Sitagliptin/simvastatin will be added to QRM April 1, New Standing Orders Approved 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. Colchicine: Distribution of generic colchicine was discontinued in September Prior to the distribution being stopped, KP was able to obtain supplies. After the existing supplies of generic colchicine are exhausted, only FDA approved brand colchicine (Colcrys) will be available. A standing order has been developed to help promote efficient prescribing of colchicine and to help preserve the existing supplies. Criteria Restricted Criteria restricted medications require review by Quality Resource Management (QRM) prior to coverage. The prior authorization process and criteria apply to the Commercial formulary, not the Medicare Part D formulary. Providers must call QRM to request authorization consideration at (Option 2). A complete listing of prior authorization medications and their corresponding criteria is available on the intranet under Healthcare Delivery/ Guides & Reference/ Formularies/ Criteria Restricted (QRM). The following medications will be added to the list of Criteria Restricted (QRM) effective January 1, 2012: Provenge (sipuleucel-t) Soliris (eculizumab) Tradjenta (linagliptin)

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, BCPS Clinical Pharmacy Gary Beals, RPh Director of Pharmacy Karen Bolden, RN, BSN Clinical Services Deborah Burzotta, PharmD Pharmacy Operations Alyssa Dayton, MD Obstetrics and Gynecology Carole Gardner, MD Elder Care Patrice Gaspard, MD Pediatrics Kelly Degraffenreid, MD Ambulatory Medicine Donald Hanchett, MD Ambulatory Medicine David Jones, MD Pediatrics Felecia Martin, PharmD Pharmacy/Geriatrics Susan Moon, MD Hospitalist Designated Alternates: Jacqueline Anglade, MD Obstetrics and Gynecology Lesia Jackson, RN Clinical Services Margaret Shugart, MD Behavioral Health New Quantity Limits For certain medications, KP establishes quantity limits for Commercial Coverage to help ensure safe and appropriate use or when there is a market place shortage of a medication. Oxycontin (oxycodone controlled release) is FDA approved for every 12 hour dosing. Within our region, 63% to 72% of patients purchase > 60 tablets of Oxycontin per month which is inconsistent with the product labeling. On November 1, 2011, the Centers for Disease Control and Prevention (CDC) published a report on Overdoses of Proscription Opioid Pain Relievers. As part of the report, the CDC recommends insurers identify and take action to reduce both inappropriate and illegal prescribing. The CDC also recommends insurers limit reimbursement in ways that reduce inappropriate prescribing, discourage efforts to obtain opioids from multiple health-care providers, and improve clinical care. Implementation of a quantity limit on Oxycontin aligns with the recent recommendations from the CDC. Beginning January 2nd, a quantity limit will be imposed on Oxycontin so that coverage is limited to no more than 60 Oxycontin tablets, across all strengths, per 30 days. Xarelto (rivaroxaban) 10 mg tablets are FDA approved for prophylaxis of deep vein thrombosis (DVT ) in patients undergoing hip and knee replacement surgery. Rivaroxaban 10 mg tablets are taken once daily for days for DVT prophylaxis following hip replacement surgery and once daily for 35 days following hip replacement surgery. To help ensure the appropriate use of rivaroxaban 10 mg tablets, a quantity limit of up to 35 tablets will be activated beginning January 2nd, Medicare Part D Formulary Kaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T Committee reviews drugs and decides on formulary status. Regional P&T chairs are voting members of an interregional committee that addresses the relatively few drugs for which regional decisions differ. This committee is called MPD Formulary Reconciliation Committee (MPD FoRCe). MPD FoRCe resolves differences in formulary decisions. Regional P&T chairs convey the decision(s) back to their respective regional P&T Committees to finalize the National MPD Formulary decision(s). The following medications were added to the MPD Formulary on the corresponding effective date: Medication Name Brand or Generic? Effective Date Hycet Solution mg Generic 11/1/2011 Hydrocodone/Acetaminophen solution mg Generic 11/1/2011 Hydromorphone Hcl Tablet 8 mg Generic 11/1/2011 Methotrexate Sodium Injection 50 mg/2 ml Generic 11/1/2011 Adcentris Injection 50 mg Brand 12/6/2011 Androderm 2 mg/24 hr & 4 mg/24 hr Brand 12/6/2011 Complera tablet Brand 12/6/2011 Creon Capsule 3000 Unit Brand 12/6/2011 Levofloxacin in D5W Injection 250 mg/50 ml Generic 12/6/2011 Levofloxacin in D5W Injection 500 mg/100 ml Generic 12/6/2011 Levofloxacin in D5W Injection 750 mg/150 ml Generic 12/6/2011 Levofloxacin Injection 25 mg/ml Brand 12/6/2011 Levofloxacin Solution 25 mg/ml Generic 12/6/2011 Phoslyra Solution Brand 12/6/2011 Trospium Chloride Tablet 20 mg Generic 12/6/2011 Xalkori Capsule 200 mg & 250 mg Brand 12/6/2011 Zelboraf Tablet 240 mg Brand 12/6/2011 Page 3

4 Drug Benefit Update: 2012 Medicare Part D Changes This section contains a brief overview of some of the Medicare Part D drug benefit changes that will go into effect January 1, Initial coverage threshold amount in Total Drug Costs (TDC) will increase to $2,930 (from $2,840 in 2011). TDC is the annual accumulation of covered Part D pharmacy charges (what the Part D plan and member pay). Total Out of Pocket (TrOOP) will increase to $4,700 (from $4,550 in 2011) in the Coverage Gap (donut hole). TrOOP is the annual accumulation of copayments, coinsurance, brand discount payments (and deductible, if any) paid by the member or by anyone on his/her behalf. Part D Drug Benefit featuring six drug tiers for Kaiser Permanente Senior Advantage Individual Plan (KPSA DPA) members. Each drug on our Part D formulary is assigned a drug tier that will have a different cost sharing. Our KPSA DPA members pay the cost sharing according the coverage stage they are in (i.e., initial coverage, coverage gap and catastrophic coverage). Tier 1 Preferred generic (Value Generic) drugs new tier that will feature lower generic copays for select chronic condition drugs Tier 2 Non-preferred generic (Generic) drugs new tier for other generics Tier 3 Preferred brand-name (Brand) drugs new tier for current formulary brand-name drugs Tier 4 Non-preferred brand-name drugs new tier for current non-formulary brand drugs that will be available at a higher cost sharing in 2012 (without the need for a formulary exception) Tier 5 Specialty Tier new tier level, no change in cost sharing Tier 6 Injectable Part D vaccines new tier for injectable vaccines, $0 copay (these vaccine costs count toward the Part D TDC accumulation) Group members will continue to have a two-tier generic/brand drug benefit with different coverages and cost sharing. Medicare Part D members may have prescriptions filled at KP pharmacies and SELECT Rite Aid pharmacies. For specific locations, refer to the 2012 Pharmacy Directory located on Knowledge Base (pharmacy, benefits, Medicare). Drug Tier Tier 1 Preferred Generics Tier 2 Non-preferred Generics Tier 3 Preferred Brands Tier 4 Non-preferred Brands Tier 5 Specialty Drugs Tier 6 Part D Injectable Vaccines Page 4 KPSA Individual Part D Cost Sharing* Initial Coverage (to $2,930 TDC) Up to 30-day supply KP: $5-7 copay Rite Aid : $12 copay MOI: $10-14 copay KP: $10 copay Rite Aid : $20 copay MOI: $20 copay KP: $45 copay Rite Aid : $50 copay MOI: $90 copay KP: $65 copay Rite Aid : $75 copay MOI: $130 copay Coverage Gap (up to $4,700 in TrOOP) Up to 30-day supply KP: $5-7 copay Rite Aid : $12 copay MOI: $10-14 copay KP: $10 copay Rite Aid : $20 copay MOI: $20 copay Coverage Gap Brand discount payment** 25% coinsurance Catastrophic Coverage (over $4,700 in TrOOP) Per Prescription $2-5 copay $10-15 copay Medicare Part D members can only have prescriptions filled at SELECT Rite Aid Pharmacies. * Actual copay will depend on whether member has selected the Basic or Enhanced Individual Plan. ** 50% of the drug price less the brand dispensing fee. Abbreviations: MOI = Mail-order incentive - two copays for up to 90-day supply; TDC = Total Drug Costs; TrOOP = Total Out-of-Pocket $0 Additional Clinical Alerts Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults ucm htm Stimulant used in Children with Attention- Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review ucm htm Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn ucm htm Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit ucm htm Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric ucm htm Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric ucm htm

5 Up Coming 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 January 1, 2011 if you wish to comment on any of the medications, class review, 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) Formulary Reviews (February (August 2011): 2012): Formulary status of the Formulary following status medications of the following will be medications reviewed: will Zytiga, be reviewed: Rifapetine, Nuedexta and Estrace and Viibryd The criteria for Prior Authorization medications Medication (QRM) Class will Reviews be reviewed. Antianxiety Agents Antiasthmatics Anticonvulsants Antidepressants Antimyasthenic Antiparkinsons Antipsychotics/Antimanic Agents Genitourinary - Misc. Hematological agents - Misc. Hypnotics Migraine Products Neuromuscular Blockers Psychotherapeutics - Misc. Stimulants/ADHD Urinary Anti-infectives Urinary Antispasmodics Floorstock Additions Department Name Cardiology Endocrinology Oncology/Infusion Medication Added Epinephrine 0.15 mg and 0.3 mg auto injector Novolin R 100 units/ml, 10 ml vial Prevnar 13, 0.5 ml SDV Clinical Updates FDA Drug Safety Communication: Review Update of Trilipix (Fenofibric Acid) and the ACCORD Lipid Trial. FDA notified healthcare professionals the cholesterol-lowering medication Trilipix (fenofibric acid) may not lower a patient s risk of having a heart attack or stroke. FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The ACCORD Lipid trial found no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone. Trilipix was approved by the FDA in 2008 as an adjunct to dietary therapy to lower triglycerides and low-density lipoprotein (LDL) cholesterol, and to increase the high-density lipoprotein cholesterol. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in two large randomized controlled trials. Trilipix is non-formulary at KP. Generic fenofibrate 54 mg and 160 mg strength tablets are available on the Commercial and Medicare Part D Formularies. Directives Healthcare professionals should consider the benefits and risks of Trilipix when deciding to prescribe the drug to patients, and counsel patients about those benefits and risks. FDA MedSafety Alert: Serious Bleeding Events with Dabigatran (Pradaxa). The FDA is evaluating post-marketing reports of serious bleeding evens in patients taking dabigatran (Pradaxa). Dabigatran is an anticoagulant used to reduce the risk of stroke in patients with non-valular atrial fibrillation (AF). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial, (18,000 patients) comparing dabigatran and warfarin, major bleeding events occurred at similar rates between the two groups. FDA is working to determine whether the reports of bleeding in patients taking dabigatran are occurring more commonly than would be expected, based on observations in the large clinical trial that support the approval of dabigatran. Dabigatran is designated as a Criteria Restricted Medication (QRM) on the Commercial formulary. Dabigatran is not on the Medicare Part D Formulary. Guidelines for the use of dabigatran have been developed and approved by the P&T Committee and are available on the intranet under Health Care Delivery, Guides and Reference, Formularies, QRM Guidelines. Directives: At this time, FDA continues to believe that dabigatran provides an important health benefit when used as directed. FDA recommends healthcare professionals who prescribe dabigatran follow the recommendations in the approved drug label. Patients with AF should not stop taking dabigatran without talking to their healthcare professional. Stopping use of blood thinning medications can increase the risk of stroke, which can lead to permanent disability and death. Reviewed at the P&T Meeting, but NOT Added to the Formulary Ticagrelor (Brilinta) 90 mg tablet, decision pending for MPD Gapapentin enacarbil (Horizant) 600 mg extended-release tablet, decision pending for MPD Clonidine (Kapvay) 0.1 mg and 0.2 mg extended-release tablets, decision pending for MPD Incobotulinumtoxin A (Xeomin) 50 unit and 100 unit injection, decision pending for MPD Simvastatin/sitagliptin (Juvisync) tablets Rivaroxaban (Xarelto) 10 mg, 15 mg, and 20 mg tablets Gatifloxicin (Zymaxid) 0.5% opthalmic solution, decision pending for MPD Page 5