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CAR-T and Gene Therapies: Hope Is on the Horizon

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CAR-T and Gene Therapies: Hope Is on the Horizon Magellan Rx Report Fall 2017 Opioid-Induced Osteoporosis in the Star Ratings and Variable Fee Schedule Constipation: Managed Care Setting: Quality Improvement: Reimbursement: Associated Costs of A Rising Challenge with Forecasted Measures Impact on Antiemetic Care and Length of Growing Treatment for 2019 and Program Utilization and Hospitalization Opportunities Successes Quality of Care Magellan Rx Report MEDICAL AND PHARMACY BENEFIT MANAGEMENT Fall 2017 CAR-T and Gene Therapies: Hope Is on the Horizon magellanrx.com See for yourself what it’s like in virtual reality Download the free app at InMyEyesApp.com. Doctor-recommended screening, diagnosis, and potential treatment are important for your members with Wet AMD, Macular Edema following RVO, DME, and DR in Patients with DME.* Otherwise, these members may be facing serious risk of vision loss, which may require ongoing resources.1-3 THERE’S EYLEA—A treatment option that can fit your plan • EYLEA has proven outcomes as demonstrated in phase 3 clinical trials in patients with Wet AMD, Macular Edema following RVO, DME, and DR in Patients with DME4 • With monthly and every-other-month dosing,† EYLEA offers exible dosing options to help meet the needs of your providers and your members4 INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS • EYLEA® (aflibercept) Injection is indicated for the treatment • There is a potential risk of arterial thromboembolic events of patients with Neovascular (Wet) Age-related Macular (ATEs) following intravitreal use of VEGF inhibitors, including Degeneration (AMD), Macular Edema following Retinal Vein EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial Occlusion (RVO), Diabetic Macular Edema (DME), and infarction, or vascular death (including deaths of unknown Diabetic Retinopathy (DR) in Patients with DME. cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) CONTRAINDICATIONS in the combined group of patients treated with EYLEA. The • EYLEA® (aflibercept) Injection is contraindicated in patients with incidence in the DME studies from baseline to week 52 was ocular or periocular infections, active intraocular inflammation, 3.3% (19 out of 578) in the combined group of patients treated or known hypersensitivity to aflibercept or to any of the with EYLEA compared with 2.8% (8 out of 287) in the control excipients in EYLEA. group; from baseline to week 100, the incidence was 6.4% (37 WARNINGS AND PRECAUTIONS out of 578) in the combined group of patients treated with • Intravitreal injections, including those with EYLEA, have been EYLEA compared with 4.2% (12 out of 287) in the control group. associated with endophthalmitis and retinal detachments. There were no reported thromboembolic events in the patients Proper aseptic injection technique must always be used when treated with EYLEA in the first six months of the RVO studies. administering EYLEA. Patients should be instructed to report any ADVERSE REACTIONS symptoms suggestive of endophthalmitis or retinal detachment • Serious adverse reactions related to the injection procedure without delay and should be managed appropriately. Intraocular have occurred in <0.1% of intravitreal injections with EYLEA inflammation has been reported with the use of EYLEA. including endophthalmitis and retinal detachment. • Acute increases in intraocular pressure have been seen • The most common adverse reactions (≥5%) reported in patients within 60 minutes of intravitreal injection, including with EYLEA. receiving EYLEA were conjunctival hemorrhage, eye pain, Sustained increases in intraocular pressure have also been cataract, vitreous floaters, intraocular pressure increased, reported after repeated intravitreal dosing with VEGF inhibitors. and vitreous detachment. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately. * The FDA-approved indications for EYLEA are Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in Patients with DME. †After an initial monthly dosing period for certain indications. References: 1. American Academy of Ophthalmology. Preferred Practice Pattern®: Age-Related Macular Degeneration. http://www.aao.org/preferred-practice-pattern/ age-related-macular-degeneration-ppp-2015. 2. American Academy of Ophthalmology. Preferred Practice Pattern®: Retinal Vein Occlusions. http://www.aao.org/preferred- practice-pattern/retinal-vein-occlusions-ppp-2015. 3. American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy. http://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp- updated-2016. 4. EYLEA® (a ibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. October 2016. Please see brief summary of full Prescribing Information on the following page. EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. © 2017, Regeneron Pharmaceuticals, Inc. All rights reserved. 04/2017 777 Old Saw Mill River Road, Tarrytown, NY 10591 US-LEA-13814 US-LEA-13814-REGEYL213 GOOGLE CARDBOARD Payer Ad-MAGELLAN RX-8_375X10_875_R1.indd 1 5/22/17 10:12 AM Table 2: Most Common Adverse Reactions (≥1%) in RVO Studies CRVO BRVO EYLEA Control EYLEA Control Adverse Reactions (N=218) (N=142) (N=91) (N=92) Eye pain 13% 5% 4% 5% Conjunctival hemorrhage 12% 11% 20% 4% Intraocular pressure increased 8% 6% 2% 0% BRIEF SUMMARY—Please see the EYLEA package insert for full Prescribing Information. Corneal epithelium defect 5% 4% 2% 0% Vitreous floaters 5% 1% 1% 0% 1 INDICATIONS AND USAGE Ocular hyperemia 5% 3% 2% 2% EYLEA is indicated for the treatment of: Foreign body sensation in eyes 3% 5% 3% 0% • Neovascular (Wet) Age-Related Macular Degeneration (AMD) Vitreous detachment 3% 4% 2% 0% • Macular Edema Following Retinal Vein Occlusion (RVO) Lacrimation increased 3% 4% 3% 0% • Diabetic Macular Edema (DME) Injection site pain 3% 1% 1% 0% • Diabetic Retinopathy (DR) in Patients with DME Vision blurred 1% <1% 1% 1% 4 CONTRAINDICATIONS Intraocular inflammation 1% 1% 0% 0% 4.1 Ocular or Periocular Infections Cataract <1% 1% 5% 0% EYLEA is contraindicated in patients with ocular or periocular infections. Eyelid edema <1% 1% 1% 0% 4.2 Active Intraocular Inflammation Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were EYLEA is contraindicated in patients with active intraocular inflammation. corneal edema, retinal tear, hypersensitivity, and endophthalmitis. 4.3 Hypersensitivity Diabetic Macular Edema (DME). The data described below reflect exposure to EYLEA in 578 patients with EYLEA is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in DME treated with the 2-mg dose in 2 double-masked, controlled clinical studies (VIVID and VISTA) from EYLEA. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid baseline to week 52 and from baseline to week 100. reactions, or severe intraocular inflammation. 5 WARNINGS AND PRECAUTIONS Table 3: Most Common Adverse Reactions (≥1%) in DME Studies 5.1 Endophthalmitis and Retinal Detachments. Intravitreal injections, including those with EYLEA, have Baseline to Week 52 Baseline to Week 100 been associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1)]. Proper aseptic Adverse Reactions EYLEA Control EYLEA Control injection technique must always be used when administering EYLEA. Patients should be instructed to report (N=578) (N=287) (N=578) (N=287) any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed Conjunctival hemorrhage 28% 17% 31% 21% appropriately [see Dosage and Administration (2.7) and Patient Counseling Information (17)]. Eye pain 9% 6% 11% 9% 5.2 Increase in Intraocular Pressure. Acute increases in intraocular pressure have been seen within 60 minutes Cataract 8% 9% 19% 17% of intravitreal injection, including with EYLEA [see Adverse Reactions (6.1)]. Sustained increases in intraocular Vitreous floaters 6% 3% 8% 6% pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor Corneal epithelium defect 5% 3% 7% 5% (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately [see Dosage and Administration (2.7)]. Intraocular pressure increased 5% 3% 9% 5% 5.3 Thromboembolic Events. There is a potential risk of arterial thromboembolic events (ATEs) following Ocular hyperemia 5% 6% 5% 6% intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial Vitreous detachment 3% 3% 8% 6% infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic Foreign body sensation in eyes 3% 3% 3% 3% events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients Lacrimation increased 3% 2% 4% 2% treated with EYLEA. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in Vision blurred 2% 2% 3% 4% the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; Intraocular inflammation 2% <1% 3% 1% from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287)
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