Formulary. Update. Formulary Additions. Page 1 I S S U E 3 V O LU M E 6 J U N E 2012

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1 I S S U E 3 V O LU M E 6 J U N E 2012 u Additions... 1 u Deletions.. 2 u Medicare... 3 u Clinical Updates u Medications Reviewed At P&T, But Not Added To The 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 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. If you have Lexi-Comp PDA access to the KPGA Online, remember to sync your device for the most current information. Update Additions Atorvastatin 10 mg, 20 mg, and 40 mg tablets are currently available on the National MPD as Tier 2, generic, and was added to the Commercial effective June 20, Atorvastatin became generically available in November Atorvastatin 80 mg tablet was added to the Commercial in April 2012, but all other dosage forms of atorvastatin remained non-formulary due to their increased cost when compared to equipotent formulary statins. Since the 6 month exclusivity of generic atorvastatin has expired, new pricing is available for all atorvastatin strengths that provide comparable pricing to our current formulary statins. Pegasys (pegylated interferon alpha-2a) ProClick 130 mg and 180 mg autoinjector is currently available on the National MPD as Tier 5, specialty, and was added to the Commercial effective June 20, Pegasys (pegylated interferon alpha-2a) is FDA approved for the treatment of chronic hepatitis C, alone or in combination with ribavirin, and for the treatment of chronic hepatitis B. Pegasys ProClick is a self-contained administration device that delivers a set dosage of the medication. Prednisone 5 mg dose pack is currently available on the National MPD as Tier 2, generic, and was added to the Commercial effective June 20, Methylprednisolone and prednisone are systemic glucocorticosteroids used to treat a variety of disorders including those of hematologic, allergic, inflammatory, neoplastic and autoimmune origin. Steroid dose packs are prepackaged with specific instructions providing a convenient tracking mechanism to assist in patient adherence. The cost of methylprednisolone 4 mg dose packs and 4 mg tablets has risen significantly. Prednisone 5 mg dose packs provide an equivalent steroid dosage to patients as the methylprednisolone dose packs at a fraction of the cost. Page 1

2 Additions, Cont. Hydrocodone/acetaminophen mg tablet, mg tablet, and mg/15 ml suspension is currently available on the National MPD as Tier 2, generic, and was added to the Commercial effective June 20, Hydrocodone/aceatminophen products are FDA approved for the relief of moderate-tosevere pain. On January 1, 2014 the FDA will begin limiting the amount of acetaminophen in combination prescription products to 325 mg. The products listed above are being added to the formulary so they maybe utilized in place of hyrdocodone/acetaminophen combination products which contain >325 mg acetaminophen. Criteria Restricted Medications Deletions ALL opioid/acetaminophen combination products containing >325 mg acetaminophen will be removed from the Commercial effective January 1, 2013 (please see the list of affected products in the table below). Food and Drug Administration (FDA) is requesting manufacturers of oral prescription acetaminophen (APAP) combination products limit the maximum amount of APAP in these products to 325 mg per tablet, capsule, or other dosage unit by January 14, FDA believes that limiting the amount of APAP will reduce the risk of severe liver injury from APAP overdosing, an adverse event that can lead to liver failure, liver transplant, and death. To comply with the regulation, manufacturers will need to limit the amount of APAP per dosage unit to 325 mg or with draw the drug product from the market. Currently, multiple opioid/apap products containing >325 mg APAP are available on the Commercial. To comply with the regulations, opioid/ APAP products containing >325 mg APAP will be removed from the Commercial and replace the products with formulations that contain 325 mg APAP. The addition of the lower opioid/apap dosage strength formulations listed on the previous page will take place June 20th, 2012, but the removal of the combination products with >325 mg APAP would be delayed until January 2013 to allow time to change prescribing patterns and to educate providers on the formulary change. Hydrocodone/APAP and Oxycodone/APAP products to be removed from the Commercial January 1, 2013: Hydrocodone/APAP mg Hydrocodone/APAP mg Hydrocodone/APAP mg Hydrocodone/APAP mg Hydrocodone/APAP mg Hydrocodone/APAP mg Hydrocodone/APAP mg Hydrocodone/APAP mg/ml Page 2 Oxycodone/APAP mg caplet Oxycodone/APAP mg capsule Vancomycin (generic Vancocin) 125 mg and 250 mg capsules were removed from the Commercial effective June 20, Vancomycin is a glycopeptide antibiotic indicated for treatment of Staph aureus, methicillin-resistant S. aureus, meningitis, pneumonia and endocarditis by intravenous administration and Clostridium difficileassociated diarrhea (CDAD) by oral administration. Vancomycin is considered second line for treatment of CDAD, but due to a more virulent strain of C. diff potentially more patients may require treatment with oral vancomycin. Both vancomycin capsules and oral solution contain the same active medication and therefore should have the same efficacy. Vancomycin compounded oral solution is prepared from injectable vancomycin. Vancomycin 125 and 250 mg capsules cost $1000-$2000 more per prescription than the compounded solution. 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) Medications. The following medications will be added to the list of Criteria Restricted Medications (QRM) effective July : Dysport (abobotulinumtoxin A) and Xeomin (incobotulinum toxina) are FDA approved for treatment of cervical dystonia in both toxin-naive and previously treated patients. Cosmetic use of botulinum toxins is excluded from coverage under the medical benefit. Bydureon (exenatide ER) is FDA approved for the Treatment of type 2 diabetes mellitus to improve glycemic control. Firazyr (icatibant) is FDA approved for the Treatment of acute attacks of hereditary angioedema (HAE) Juvisync (janumet/simvastatin) is FDA approved for use in patients for whom treatment with sitagliptin and simvastatin is appropriate. Kalydeco (ivacaftor) is FDA approved for treatment of cystic fibrosis in patients who have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

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 LaJune Oliver, 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 Deletions, Cont. Pancreaze (pancrelipase) capsules will be removed from the Commercial effective July 18, Pancrelipase 5,000 and Zenpep (pancrelipase) 10,000, 15,000 and 20,000, delayedrelease, enteric-coated capsules are Kaiser Permanente s preferred contracted pancreatic enzyme products (PEPs) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Pancrelipase (5,000 lipase units) is the preferred product for patients requiring lower doses. The deletion of Pancreaze from the Commercial allows for streamlined utilization to the contracted products. Product Pancreatic Enzyme Comparison Chart USP Units (Lipase/Protease/Amylase) National Medicare Part D Kaiser Permanente has a National Medicare Part D (MPD). Each regional P&T Committee reviews drugs and decides on tier 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 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 decision(s). National MPD Tier changes are listed below with their corresponding effective date: Medication Name Tier Effective Date Avonex Pen Kit 30 mcg Tier 5 05/01/2012 Korlym tab 300 mg Tier 5 05/01/2012 Lupron Depot inj 45 mg Tier 3 05/01/2012 Lupron Depot-Ped inj 30 mg Tier 3 05/01/2012 Viread pow 40 mg/gm Tier 4 05/01/2012 Viread tab 150 mg, 200 mg, & 250 mg Tier 4 05/01/2012 Vyvanse cap 20 mg, 30 mg, 40 mg, 50 mg, 60 mg & 70 mg Status COM Tier 3 05/01/2012 Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine MPD Pancrelipase capsule 5,000 / 17,000 / 27,000 F Tier 2 Zenpep capsule 10,000 / 34,000 / 55,000 15,000 / 51,000 / 82,000 20,000 / 68,000 / 109,000 Creon capsule 6,000 / 19,000 / 30,000 12,000 / 38,000 / 60,000 24,000 / 76,000 / 120,000 Pancreaze capsule 4,200 / 10,000 / 17,500 10,500 / 25,000 / 43,750 16,800 / 40,000 / 70,000 21,000 / 37,000 / 61,000 F Tier 3 NF Tier 3 NF Tier 4 COM = Commercial MPD = National MPD Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine Page 3

4 National Medicare Part D, Cont. Conditional Part B or D Policy for Boniva and EMLA Effective April 1, 2012, prior authorization will be required for Boniva and EMLA. Prior authorization drugs may be covered by Medicare Part D or Part B depending on how and where they are administered and for what medical condition (dialysis). The affected medications include: Boniva Injection 3 mg/3ml Boniva tab 150 mg (ibandronate sodium tablets) Boniva tab 2.5 mg (ibandronate sodium tablets) EMLA cream (Lidocaine/Prilocaine cream %) EMLA/Tegaderm kit It is important that pharmacy claims for these oral ESRD drugs are processed correctly: HealthTrans will return the appropriate Medicare Part B or Part D cost sharing. Conditional PIMS flags have been added. The billing indications are ESRD ON DIALYSIS or OTHER. Pharmacy staff should enter the correct billing indication for the claim to process accordingly (Do not override the cost share to $0). Members should pay the correct Medicare Part B or Part D cost sharing according to their drug benefit. Clinical Updates Safety Advisory for Merck Vaccines and Diluents. The Information SuperHighway workgroup (part of the Interregional Medication Adherence, Reconciliation, and Safety (IMARS) group) has identified some issue regarding vaccines. Background: Through and evaluation of medication related events, some medication errors related to vaccines have been reported from various KP regions: Patients received flu vaccine which was ineffective due to improper shipment method by vendor. Examination of boxes showed that the temperature strip indicated a drop below the appropriate temperature to stay active. During a Saturday flu clinic, 1/2 doses of Fluzone were being administered to children under the age of three, rather than the thimerosal free injections. Members under 18 years of age received FluLaval, adult influenza vaccine. Staff failed to follow policy/procedures requiring that a morning communication huddle be held. Assessment: The recent vaccine issues identified by the Information SuperHighway workgroup that could result in potential patient harm are the following: Vaccines not being mixed with the appropriate diluents (e.g., using diluents other than the sterile diluent supplied by Merck for their vaccines (such as MMR II, Varivax, and Zostavax) can cause inactivation of these live vaccines and reduce their effectiveness in preventing disease. Act-Hib and Manomumne are packaged in the same box with their diluents and there is the potential for mismatches in quantities. Pentacel packages include two vials, with a vaccine in each vial (HIB component power and the Dtp/IPV liquid). The vials must by mixed just prior to administration. Potential to administer the diluent alone, resulting in the patient not actually receiving a complete vaccination. Rotarix vaccine and storage conditions of the different diluents (refrigerator versus room temperature). Recommendations: Pay close attention when reconstituting vaccines to ensure the correct diluent is being used. Prior to mixing and administering vaccines, review the vaccine package insert to ensure appropriate use. Vaccines should be stored at the appropriate temperatures. Page 4 Additional Clinical Alerts Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication ucm htm Victrelis (boceprevir) and Ritonavir- Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions ucm htm Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies ucm htm Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume ucm htm Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose ucm htm Teva s Adderall 30 mg Tablets: Counterfeit Product - Contains Wrong Active Ingredients ucm htm

5 Upcoming 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 July 15, 2012 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 Additions/Deletions Form and Conflict of Interest Form to Drug Information Services or call (404) Reviews (August 2012): status of the following medications will be reviewed: Medication Class Reviews Vitamins MVI Minerals & Electrolytes Hematopoetic Agents Anticoagulants Hemostatic Agents Otic Agents Mouth/Throat/Dental Antiseptics & Disinfectants Diagnostic Products Skeletal Muscle Relaxants Endocrine and Metabolic Agents - Misc. Non-narcotic Analgesics Opioid Analgesics Anti-Inflammatory Analgesics Clinical Updates, Cont. REMINDER - Use the proper age-appropriate formulation when prescribing and/or administering hepatitis B vaccine (Engerix-B). Single-antigen hepatitis B vaccine (Engerix- B), manufactured by GSK, is the preferred brand for hepatitis B immunizations in the Georgia Region (except in situations where a combination vaccine containing hepatitis B antigen is recommended or desired). It is available in two different strengths: 0.5-mL (10 mcg) single-dose vials and prefilled syringes labeled for use in pediatrics & adolescents 1-mL (20 mcg) single-dose vials and prefilled syringes labeled for use in adults Recent recommendations from the Advisory Committee on Immunization Practices (ACIP), published in December 2011, now emphasize the vaccination of adult patients with Diabetes Mellitus with Hepatitis B vaccines. In anticipation of increased use of Hepatitis B vaccines in this population, it is important to remind Health Care professionals that the age-appropriate formulation should be used. Recommendations: Use the different formulations of Engerix-B only in the age-appropriate groups (i.e., formulation labeled for pediatrics/adolescents should be used in persons aged <20 years, formulation labeled for adults should be used in persons aged 20 years and older). The adult Engerix-B is not approved for infants and children. Use of the adult Engerix-B in the year old age group is discouraged due to the expense of the vaccine, but if it is used it should count as a valid dose. Using the inappropriate formulation in an unlabeled age group may lead to medication errors including insufficient protection, or a higher risk of adverse effects. Please review the table below for dose and administration schedules for Engerix-B vaccines. In alignment with ACIP general immunization practice recommendations, any variation from the recommended route, site, volume, or number of doses of any vaccine is discouraged. In situations where there are shortages or unavailability of age-appropriate vaccines, alternative methods for immunization may be recommended. Engerix-B Dosing Table Age Dose (mcg) Volume (ml) Recommended Schedule Alternate Schedule Infants <1 yr , 1-2, and 6 months* 0, 1, 2, and 12 months Children 1-10 yrs , 1, and 6 months Adolescents 0, 1, 2, and 12 months -OR- 0, 12, and 24 months yrs , 1, and 6 months 0, 12, and 24 months Adults 20 yrs , 1, and 6 months 0, 1, 2, and 12 mos Hemodialysis and Immunocompromised Patients <20 yrs , 1, 2 and 6 months - 20 yrs , 1, 2 and 6 months - Booster Vaccinations 10 yrs When indicated Not applicable 11 yrs 20 1 When indicated Not applicable * Four doses total of Hepatitis B vaccine is permissible when a combination vaccine containing Hepatitis B antigen (e.g., Pediarix) is used after the birth dose A four-dose schedule may be used in infants born of HBsAg-positive mothers for prolonged maintenance of protective titers; these infants should also receive hepatitis B immune globulin (HBIG) An alternative extended administration schedule may be considered for children aged 5-10 years and adolescents; assess the risk for hepatitis B exposure Use of the adult Engerix-B formulation in this age group is not preferred; however, if administered then it will count as a valid dose Higher doses may be more immunogenic but no specific recommendations have been made May be administered as two 1-mL doses of adult Engerix-B administered at one site. A dialysis formulation of Recombivax HB (40 mcg/1 ml) is available. Medications Reviewed, but Not Added to the Denosumab (Prolia) 60 mg/ml injection, decision pending for the National MPD Tocilizumab (Actemra) single use vials, decision pending for the National MPD Ivacaftor (Kalydeco) 150 mg tablets, not added to the Commercial, decision pending for the National MPD Ezogabine (Potiga) tablets, decision pending for the National MPD Page 5