ISSUE 6 VOLUME 12 DECEMBER 2018 u Formulary Additions . 1 - 2 u Formulary Removals . 3 u Interregional Practice Recommendations . 3 u Prior Authorization (QRM) Additions & Changes . 3 - 4 u New Standing Order . .4 u 2019 Formulary Changes. 4 u National Medicare Part D Formulary . 5 u Introducing Alvesco HFA . 6 u Appendix A: 2019 Step Therapy Changes. 7 Formulary At A GlanceUpdate Formulary Additions The following medications will be added to the Commercial Formulary effective January 1, 2019: • Doxazosin (generic Cardura) 1 mg, 2 mg, 4 mg & 8 mg tablets: Doxazosin is a non-selective alpha1-adrenergic antagonist indicated for the treatment of benign prostatic hyperplasia (BPH) and treatment of hypertension. All alpha1-adrenergic antagonists have similar efficacy for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Due A PUBLICATION OF THE GEORGIA PHARMACY to recent price changes, doxazosin is now more than 3 times less than the cost of terazosin. AND THERAPEUTICS (P&T) COMMITTEE. The Formulary Update contains information regarding formulary Addition of doxazosin to the formulary will provide an additional option for the treatment additions, deletions, exclusions, brief descriptions of of BPH. products, and current drug related news. It also lists • Alfuzosin (generic Uroaxtral) 10 mg tablet: Alfuzosin is a uroselective alpha -adrenergic items to be discussed at upcoming P&T meetings. Please 1 refer to the web site http://kpnet.kp.org:81/ga/healthcare/ antagonist indicated for the treatment of benign prostatic hyperplasia (BPH). Current formularies.html or providers.kp.org for the full KP GA Drug medications for the treatment of BPH on the KPGA Commercial Formulary are tamsulosin Formulary. If you have Lexi-Comp PDA access to the KPGA and terazosin. All alpha -adrenergic antagonists have similar efficacy for the treatment Online Formulary, remember to sync your device for the 1 most current information. of lower urinary tract symptoms (LUTS) secondary to BPH. Due to recent price changes, alfuzosin is now two times less costly than terazosin and is similar in cost to tamsulosin. Kaiser Permanente Georgia 1 Formulary Additions, Continued Upcoming Additionally, alfuzosin offers a cost savings for patients requiring the maximum dose of tamsulosin (0.8 mg daily) for BPH treatment. Addition of alfuzosin to the formulary provides an additional treatment Formulary Items option for BPH for patients who require the maximum tamsulosin dose or who are intolerant to tamsulosin. • Darifenacin (generic Enablex) 7.5 mg & 15 mg tablets: Darifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. Current OAB agents on the KPGA Commercial Formulary include oxybutynin IR/ER and trospium IR/XR. Pharmacotherapy is the second-line treatment option for OAB in patients who fail non-pharmacological behavior therapy. In general, antimuscarinics used for OAB treatment have a modest benefit over placebo. Due to their similar efficacy, guidelines recommend medication selection based on patient-specific characteristics and history of trial/intolerance to antimuscarinics. Due to recent contract changes, the cost of darifenacin has decreased and is now 4 times less than trospium ER and at least 13 times less than branded OAB agents. Addition of darifenacin to the formulary provides a lower cost alterative to generic and brand non-preferred OAB agents. An important aspect of the • Vancomycin (generic Vancocin) 125 mg & 250 mg capsules: Oral vancomycin is a glycopeptide formulary process is the involvement antibiotic used for the treatment of Clostridioides (formerly Clostridium) difficile infection (CDI) of all practitioners. Please contact and treatment of enterocolitis caused by Staphylococcus aureus. Orally administered vancomycin your P&T Committee representative is not effective for treatment of other types of infections that are susceptible to the intravenous or your clinical service chief by formulation. Updated CDI treatment guidelines were published by the Infectious Disease Society January 25th, 2019 if you wish to of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) in 2018. Based on comment on any of the medications, these guidelines, vancomycin is now considered a first line option for initial CDI episodes in adult class reviews, or other agenda items under consideration. To make and pediatric patients and is now preferred over metronidazole for adult patients. Additionally, formulary addition requests, you vancomycin may be considered for treatment of recurrent CDI episodes. Due to contract changes, must submit a Formulary Additions/ the cost of vancomycin oral capsules has decreased and is now more cost effective than the cost of Deletions Form and Conflict of vancomycin oral solution (brand Firvanq). Interest Form to Drug Information • Glatiramer acetate (generic Copaxone) 40 mg/ml syringe: Glatiramer acetate (GA) is a disease Services or call (404) 949-5331. modifying therapy (DMT) indicated for relapsing forms of multiple sclerosis (MS). It is typically used as a first-line agent for patients with moderate disease activity. Currently, Extavia (interferon beta-1b) and Glatopa (glatiramer acetate) 20 mg are the first line, preferred DMTs on the KPGA Commercial Formulary. GA is favored over interferon beta in patients who have a relative contraindication or intolerance to interferon beta such as uncontrolled mood disorder, elevated transaminases or severe flu-like symptoms. GA 40 mg is injected three times a week, compared to the daily injection dosing regimen of GA 20 mg. Due to recent contract changes and availability of generic GA 40 mg, the cost of GA 40 mg is now comparable to current formulary DMTs for MS. Addition of generic GA 40 mg to the Commercial Formulary provides an additional DMT option for management of MS. Brand Copaxone will continue to require prior authorization. • Lugol’s solution: Potassium iodide 10% and iodine 5% (Lugol’s 5%) oral solution is an antithyroid agent used in preparation for thyroidectomy surgery. In patients with Grave’s disease, preoperative potassium iodide, saturated solution of potassium iodide (SSKI), or inorganic iodine is recommended to decrease thyroid blood flow, vascularity, and intraoperative blood loss during the thyroidectomy. Over the counter (OTC) SSKI was previously utilized for this indications, but the cost has increased significantly. Lugol’s solution provides a cost effective prescription option with standardized dosing for this indication. • Cosentyx (secukinumab) 150 mg injection: Cosentyx is a fully human immunoglobulin G1 (IgG1) monoclonal antibody antagonist of interleukin-17A (IL-17A) indicated for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, and adults with active ankylosing spondylitis. A recent network meta-analysis found the interleukin-17A inhibitors (brodalumab, ixekizumab, and secukinumab) were more effective than ustekinumab and generally more effective than etanercept, adalimumab, and apremilast. Overall safety was comparable between the biologics. Due to contract change, Cosentyx is now comparable in cost to first line biologics for the treatment of plaque psoriasis. Addition of Cosentyx to the formulary provides an additional treatment option for patients with plaque psoriasis. • Dalfampridine (generic Ampyra) 10 mg tablet: Dalfampridine is a symptomatic treatment indicated to improve walking speed in patients with relapsing and progressive forms of multiple sclerosis. It is not an immunomodulatory drug and thus it is not a disease modifying therapy. Physical therapy is the only treatment alternative to dalfampridine and it is recommended before exposure to dalfampridine and concomitantly if possible. Addition of dalfampridine to the formulary provides a symptomatic treatment option for multiple sclerosis. The following medication was added to the Commercial Formulary effective November 1, 2018: • Alvesco (generic ciclesonide) 80 mcg & 160 mg MDI: Alvesco was approved for addition to the formulary at the August P&T meeting. See page 6, Introducing Alvesco, for additional information. 2 Kaiser Permanente Georgia Questions and Formulary Removals The following medication will removed from the Commercial Formulary effective January 1, 2019: Concerns? • Atripla (efavirenz, tenofovir disoproxil fumarate, and emtricitabine) tablet: Atripla is a single fixed- dose antiretroviral combination medication used for the treatment of human immunodeficiency virus (HIV). It consists of a non-nucleoside reverse transcriptase inhibitor (efavirenz) and two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC)). A new formulation of tenofovir, tenofovir alafenamide (TAF), has been shown to decrease the risk of kidney and bone toxicities, compared to TDF, while maintaining efficacy against the HIV virus. The TAF/FTC backbone is available in fixed dose combination with other medications, including bictegravir (Biktarvy), elvitegravir/cobicistat (Genvyoa) which are available on the Commercial Formulary. For patients who wish to remain on Atripla, Symfi (efavirenz/tenofovir/lamivudine) is available at a generic copayment and is similar to Atripla. There is an ongoing interregional initiative to convert patients on Atripla to Biktarvy or Symfi for safety and cost savings. Removal of Atripla