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Barriers to Implementation of Preventative Therapies in CV Disease Risk in Patients With Type 2 Diabetes Kim Birtcher, MS, PharmD, AACC Managing CV Disease Risk in Diabetes Heart House Roundtable June 20, 2017
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Access to Care SGLT2 Inhibitors & GLP-1 receptor agonists
Prescription drug coverage Brand only Preferred versus non-preferred versus non-formulary Higher out-of-pocket costs, donut hole, assistance programs Quantity limits Step therapy Prior authorization $600/month Liraglutide $430/month empagliflozin
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Prescription Drug Coverage* (… can be confusing) Empagliflozin
Insurance 1 Insurance 2 Insurance 3 HMO Medicaid Medicare Part D** Preferred brand Yes Non-preferred brand Quantity limits Step therapy Prior authorization * 30 day supply ** SGLT2 inhibitors not on plan
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Prescription Drug Coverage* (… can be confusing) Liraglutide
Insurance 1 Insurance 2 Insurance 3 HMO Medicaid Medicare Part D Preferred brand Yes Non-preferred brand Quantity limits Step therapy Prior authorization Cigna Aetna Student plan HMO Texas Medicaid Medicare Part D * 30 day supply
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Things to Consider Clinician Patient selection Patient education
Baseline and subsequent monitoring Drug initiation, titration Managing side effects
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SGLT2 Inhibitors – Things to Consider
Contraindications Severe Renal impairment, ESRD, dialysis Renal function – check at baseline and periodically Canagliflozin Dose limits for GFR 45 – 60 mL/min/1.73 m2 Do not use if GFR < 45 mL/min/1.73 m2 Dapagliflozin Do not initiate if GFR < 45 mL/min/1.73 m2 Not recommended if GFR consistently 30 - < 60 mL/min/1.73 m2 Empagliflozin
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SGLT2 Inhibitors – Things to Consider
Warnings/precautions Hypotension Assess & correct volume depletion Urosepsis & pyelonephritis Genital mycotic infection Hypoglycemia Before initiation, lower dose of secretagogue or insulin Ketoacidosis
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SGLT2 Inhibitors – Things to Consider
Warnings/precautions Bone fracture ↑ potassium Monitor w/ impaired renal function ↑ LDL-C Black box warning Canagliflozin - amputations
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SGLT2 inhibitors– Things to Consider
Patient teaching Reason prescribed What to expect – ex. lab monitoring What s/s to report Hypersensitivity reactions Breathing problems Dizziness, feeling faint or lightheaded, falls Fast or irregular heartbeat Muscle weakness, unusual tiredness Nausea, vomiting, unusual stomach pain/upset s/s of low blood sugar, UTI, mycotic infections T3 (preferred brand on 5 tier plan) for Medicare Advantage; Tier 2 or 3(on 3 tier plan) Medicare Advantage: Zetia & Vytorin Tier 3 (preferred brand on 5 tier plan) Zetia & Vytorin Tier 3 (on 3 tier plan) – UHC Zetia Tier 2, Vytorin tier 3 – ERS
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Liraglutide – Things to Consider
Black box warning/contraindications Personal or family history of medullary thyroid carcinoma Patients w/ Multiple Endocrine Neoplasia syndrome type 2 Warnings/precautions Thyroid C-cell tumors in animals Pancreatitis
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Liraglutide – Things to Consider
Risk Evaluation and Monitoring Strategy (REMS) Inform providers/patients of serious risks Medullary Thyroid Carcinoma Pancreatitis Medication guide w/ initial & refill prescriptions Tell patients to read each time
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Liraglutide – Things to Consider
Warnings/precautions Serious hypoglycemia w/ insulin or secretagogue Potential drug interactions Slows GI motility May impact absorption of oral meds
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Liraglutide – Things to Consider
Patient teaching Reason prescribed Start at low dose X 1 week, then increase dose GI side effects usually resolve Injectible Teach patient how to use pen device Prime Dial dose Leave needle in skin 6 seconds after injecting Pen storage, discard pen after 30 days
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Liraglutide – Things to Consider
Patient teaching What to expect – ex. lab monitoring What s/s to report to clinician Hypersensitivity reactions Breathing problems Nausea, vomiting, unusual stomach pain/upset s/s of low blood sugar Trouble passing urine/change in urine amount
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Clinician to Clinician Communication
Potential for treatment gap Who will initiate and monitor therapy? Efficacy and safety Who will change therapy if there are safety concerns? Who will manage drug side effects?
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Things to Consider? How can we promote screening and treatment initiation? What can be done to facilitate communication among clinicians? How can we eliminate/minimize the gaps in care?
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