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What Managed Care Needs to Know About Novel Therapies in the Evolving Management of Type 2 Diabetes For Audio Please call 866‐206‐0240, Participant Code 64953949# If you are having difficulties logging in or calling in, please contact Jeremy at [email protected].
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Faculty Disclosure: Dr. Reid serves as a consultant and on an advisory board for Boehringer Ingelheim, Janssen, Lilly USA, Novo Nordisk and Sanofi. His presentation has been peer reviewed.
Planning Committee Disclosure: Bill Williams, MD has no real or perceived financial relationships to disclose. Jacquelyn Smith, RN, BSN, MA, CMCN has no real or perceived financial relationships to disclose. Katie Eads has no real or perceived financial relationships to disclose. Will Williams has no real or perceived financial relationships to disclose.
Accreditation: The National Association of Managed Care Physicians (NAMCP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. NAMCP designates this enduring material for a maximum of 1 AMA PRA Category I creditsTM. Each physician should claim credit commensurate with the extent of their participation in the activity.
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This activity is supported by an educational grant from Lilly USA, LLC
What Managed Care Needs to Know About Novel Therapies in the Evolving Management of Type 2 Diabetes
TIMOTHY S. REID, M.D. MERCY DIABETES CENTER JANESVILLE, WI
1 3/29/2017
The Cost of Diabetes
29.6 Million Americans with Diabetes
$245 Billion Spent for Diabetes
1 in 5 Health Care Dollars spent on patients with diabetes
1 in 3 Medicare Dollars spent on patients with Diabetes
Diabetes Medical Expenditures are 2.3x higher
3835 People will be diagnosed with
diabetes today http://www.diabetes.org/diabetes-basics/statistics/infographics/adv- staggering-cost-of-diabetes.html (Accessed 4 March 2017) http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html
Rank Cause of Death US Total Cost 1 Heart Disease $190 Billion 2 Cancer $227 Billion 3 Chronic Lung Disease $65 Billion 4 Stroke $34 Billion Accidents 5 $308 Billion
6 Alzheimer’s Dse $70 Billion 7 Diabetes $112 Billion 8 Renal Disease $61 Billion 9Pneumonia and Flu $40 Billion 10 Suicide $34 Billion Total Cost: $1.1 Trillion
http://247wallst.com/special-report/2012/01/18/1-1-trillion-what-the-10-leading-causes-of-death-cost-the-u-s-economy/3/
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Objectives:
1. Discuss methods to enable optimal cost management of novel therapies to be realized by multiple T2DM stakeholders including managed care organizations 2. Analyze strategies used by managed care organizations to facilitate high quality care for members with T2DM, and how newer therapies affect those strategies 3. Discuss how newer therapies have affected managed care professionals in the T2DM arena 4. Role of medical directors and payers in Type 2 Diabetes management
Two of the Major Diabetes Management Guidelines:
1. American Diabetes Association:1 1. Widely distributed 2. Primary Care Aware 3. Referenced by many organizations 2. Am. Association of Clinical Endocrinologists:2 1. Well Know to Diabetes Specialists 2. Comprehensive 3. Detailed Strength of Recommendations 1. Effectiveness 2. Side Effects
1. http://professional.diabetes.org/content/clinical-practice-recommendations 2. https://www.aace.com/publications/algorithm
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Start with Monotherapy unless:
A1c is greater than or equal to 9%, consider Dual Therapy
A1c is greater than or equal to 10%, blood glucose is greater than or equal to 300 mg/dl, or patient is markedly symptomatic, consider Combination Injectable Therapy. (See Figure 8.2) Monotherapy Metformin Lifestyle Management Efficacy* high Hypo Risk low risk Weight neutral/loss Side Effects GI/lactic acidosis Costs* low If A1c target not achieved after approximately 3 months of monotherapy, proceed to 2‐drug combination (order not meant to denote any specific preference –choice dependent on a variety of patient ‐ & disease‐specific factors): Dual Therapy Metformin + Lifestyle Management
Sulfonylurea Thiazolidinedione DPP‐4 Inhibitor SGLT‐2 Inhibitor GLP‐1 receptor agonist Insulin (basal) Efficacy* high high intermediate intermediate high highest Hypo Risk moderate risk low risk low risk low risk low high risk Weight gain gain neutral loss loss gain Side Effects hypoglycemia edema, HF, fxs rare GU, dehydration, fxs GI hypoglycemia Costs* low low high high high high
If A1c target not achieved after approximately 3 months of monotherapy, proceed to 3‐drug combination (order not meant to denote any specific preference –choice dependent on a variety of patient ‐ & disease‐specific factors):
Triple Therapy Metformin + Lifestyle Management Sulfonylurea Thiazolidinedione DPP‐4 Inhibitor SGLT‐2 Inhibitor GLP‐1 receptor agonist Insulin (basal)
TZD SU SU SU SU TZD
or DPP‐4 ‐i or DPP‐4 ‐i or TZD or TZD or TZD or DPP‐4 ‐i or SGLT‐2‐i or SGLT‐2‐i or SGLT‐2‐i or DPP‐4 ‐i or SGLT‐2‐i or SGLT‐2‐i
or or or or GLP‐1‐RA or GLP‐1‐RA Insulin or GLP‐1‐RA Insulin GLP‐1‐RA or Insulin or Insulin or Insulin
Combination Injectable Therapy (See Figure 8.2) Copyright ©2017 American Diabetes Association Diabetes Care2017 Jan; 40(Supplement 1): S64‐S774
Reprinted with permission from American Association of Clinical Endocrinologists © 2016 AACE. Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE/ACE comprehensive type 2 diabetes management algorithm 2016. Endocr Pract.2016;22: 84‐113
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Two Diabetes Management Guidelines:
1. They both speak to the comprehensive nature of diabetes management 1. Lifestyle modifications 2. Dietary recommendations 3. Medication initiation and combinations 4. Referrals and Screenings
1. http://professional.diabetes.org/content/clinical-practice-recommendations 2. https://www.aace.com/publications/algorithm
Two Diabetes Management Guidelines:
1. Implementation: 1. Used Largely as Medication Roadmap 2. Many times not encultured into the actual point of care experience 3. Can lead to poly-pharmacy
1. http://professional.diabetes.org/content/clinical-practice-recommendations 2. https://www.aace.com/publications/algorithm
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What Does This Mean For Managed Care?
Large Population with Diabetes Chronic and Progressive Disease State Best Practices requires a hands on approach for both provider and Care organizations Expensive to treat effectively Expensive to ignore
Federal/Medicare/CMS
Diabetes is one of the significant focus areas: Value-Based Programs Better Health Care for Individuals Better Health for Populations Lower Cost Quality Payment Program Advanced Alternative Payment Models Merit-based Incentive Payment System 8 Diabetes Specific Measures
https://qpp.cms.gov/measures/quality
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Managed Care Approach
Case Management Chronic Care Model
Physician Education and Incentives P4P Education Formulary Management Primarily Managing High Cost Medications Drug:Drug Issues
Managed Care Approach
Case Management Chronic Care Model Self-Management Support Decision Support Delivery System Design Clinical Information Systems Organization of Health Care Community
E.H. Wagner, C. Davis, J. Schaefer, M. Von Korff, B. Austin, “A survey of leading chronic disease management programs: are they consistent with the literature,: Managed Care Quarterly 7(1999):(3)56-66.
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Managed Care Approach
Case Management
Patient Heroism Persistent Determination
A Hero or Heroine is a person or main character of a literary work who, in the face of danger, combats adversity through impressive feats of ingenuity, bravery or strength, often sacrificing his or her own personal concerns for some greater good.1
1. Wikipedia, Hero Definition
Managed Care Approach
Case Management
Patient Heroism Persistent Determination
Are we there to support their heroism in a meaningful way?
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Managed Care Approach
Case Management Government Workplace Community
Social Patient Workers Family
Care Managers Providers
Managed Care Approach
Case Management
http://professional.diabetes.org/sites/professional.diabetes.org/files/media/dc_40_s1_final.pdf p. S53 Copyright ©2017 American Diabetes Association Diabetes Care2017 Jan; 40(Supplement 1): S11-S24”
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Managed Care Approach
Case Management: Adherence – How well a patient’s behavior corresponds to a health care provider’s recommendation1 Compliance - The proportion of administered doses/prescribed doses over a period to time1 Concordance – involvement of patients in decision-making to improve patient compliance with medical advice2
1. Garcia-Perez L, Alvarez M, et. Al. Adherence to Therapies in Patients with Type 2 Diabetes. Diabetes Therapy 2013 4:175-194. 2. Wikipedia: Concordance
Managed Care Approach
Case Management: Adherence – How well a patient’s behavior corresponds to a health care provider’s recommendation Medications/Therapy Lifestyle Exercise Dietary Many Factors Age Information Perception and Duration of Disease Dosing Complexity Poly-therapy Psychological factors Safety Tolerability Cost
Garcia-Perez L, Alvarez M, et. Al. Adherence to Therapies in Patients with Type 2 Diabetes. Diabetes Therapy 2013 4:175- 194.
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Managed Care Approach
Case Management: Adherence – How well a patient’s behavior corresponds to a health care provider’s recommendation Medications/Therapy Lifestyle Exercise Dietary Many Factors Age Information Perception and Duration of Disease Dosing Complexity Poly-therapy Psychological factors Safety Tolerability Cost
Garcia-Perez L, Alvarez M, et. Al. Adherence to Therapies in Patients with Type 2 Diabetes. Diabetes Therapy 2013 4:175- 194.
Managed Care Approach
Case Management: Adherence Oral Agents: 1966-2003 Patients on therapy for 6-24 months, 90% adherence was noted at 36-93% EMR Data: 61-85% adherence with 39.6% persistence at 24 months and 4% never filled script Insulin: Retrospective studies • 62% long term • 64% new starts • 4.5% never filled • 25.5% never refilled
Garcia-Perez L, Alvarez M, et. Al. Adherence to Therapies in Patients with Type 2 Diabetes. Diabetes Therapy 2013 4:175- 194.
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Managed Care Approach
Physician Education and Incentives P4P Educational Pieces Contact with Case Managers
Managed Care Approach
Formulary Management Primarily Managing High Cost Medications Adherence Drug:Drug Issues Communication
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HTN and Diabetes Drug Classes in the US over the past 90 Years
12 SGLT-2 Renin Inhibitors Inhibitors
11 Angiotensin II Dopamine Agonists Receptor Blockers 10 Bile Acid Sequestrants ACE Inhibitors 9 DPP-4 Receptor Antagonists 8 Amylinomimetics Calcium Channel Peripheral -1 Blockers 7 GLP-1 Receptor Blockers Agonists -blockers 6 Meglitinides
5 Thiazolidinediones Diuretics Central -2 Adrenergic Agonists 4 -glucosidase Inhibitors neuronal blockers (Phenformin) 3 Withdrawn Biguanides
Number of Medication Classes Number of Medication 1978 2 Insulin Sulfonylureas 1 Vasodialators
1920’s 1950’s 1960’s 1970’s 1980’s 1990’s 2000’s 2010’s
Where Diabetes Medications Work
GLP‐1 GLP‐1 Insulin Insulin
GLP‐1 Insulin Insulin
GLP‐1 GLP‐1 Insulin Insulin Insulin
DeFronzo RA. Diabetes. 2009;58 (4): 773-795.
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Medications for Diabetes:
Tried and True: Newer Choices: Biguanides (metformin) DPP-4i (sitagliptin,others) Sulfonylureas (glipizide, GLP-1RA glimepiride, others) (liraglutide,lixisenatide, Thiazolididiones exenatide, other) (pioglitazone) SGLT-2i (canagliflozin, Α-glucosidase inhibitors dapagliflozin, others) (acarbose, others) U-100 Human & Analogue Insulin(rDNA) (various) U-500 Human Insulin
The Insulins
Tried and True: Newer Choices: Long Acting: Long Acting: U-100 (glargine, detemir) U-100 glargine (follow-along)1 Intermediate: U-100 (degludec) Neutral Protamine Hagedorn (NPH) U-200 (degludec) U-300 (glargine) Short Acting: Short Acting: (Human Regular Insulin) U-200 (lispro) U-100 Analogues (lispro, aspart, (U-100 lispro (follow-along)) glulisine) (Ultra-Short Acting:2) Concentrated: (FIAsp NN-1218) U-500 Human Regular Insulin (70/30 combination of insulin degludec and FIAsp NN-1218)
1. https://www.diabetesdaily.com/learn-about-diabetes/insulin-101/biosimilar-insulin/ 2. http://blog.diabeteslab.org/2016/01/the-future-of-insulin-new-insulin-formulations-under-development/
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The Insulins
The New Insulins In General Similar A1c and BGM reductions to existing insulin products Concentrating insulin results in smaller volume infused with changing pharmacokinetic and pharmacodynamics properties Flatter action curves Longer Durations of Action For the Patient Typically more predictable insulin May allow more dosing flexibility May require more total units of insulin for similar results 10% more glargine U-300 vs U-1003-4 1.08:1 more degludec U-100 vs glargine U-1005
1. https://www.diabetesdaily.com/learn-about-diabetes/insulin-101/biosimilar-insulin/ 2. http://blog.diabeteslab.org/2016/01/the-future-of-insulin-new-insulin-formulations-under-development/ 3. Riddle M. et al. New Insulin Glargine 300 Units/mL vs. Gargine 100 Units/mL in People with Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia in a 6-month Randomized Controlled Trial (EDITION-1). Diabetes Care 2014; 37:2755-2762. 4. Yki-Jarvinen H, et. Al. New Insulin Glargine 300 Units/mL vs. Glargine 100 Units/mL in People with Type 2 Diabetes Using Oral Agents and Basal Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION-2) Diabetes Care 2014;37:3235-3243. 5. Garber A, et. Al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomized, open-label, treat-to-target non-inferiority trial Lancet 2012;379:1498-1507.
The Insulins
The New Insulins In General Similar A1c and BGM reductions to existing insulin products Concentrating insulin results in smaller volume infused with changing pharmacokinetic and pharmacodynamics properties Flatter action curves Longer Durations of Action For the Patient Typically more predictable insulin May allow more dosing flexibility May require more total units of insulin for similar results 10% more glargine U-300 vs U-1003-4 1.08:1 more degludec U-100 vs glargine U-1005
1. https://www.diabetesdaily.com/learn-about-diabetes/insulin-101/biosimilar-insulin/ 2. http://blog.diabeteslab.org/2016/01/the-future-of-insulin-new-insulin-formulations-under-development/ 3. Riddle M. et al. New Insulin Glargine 300 Units/mL vs. Gargine 100 Units/mL in People with Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia in a 6-month Randomized Controlled Trial (EDITION-1). Diabetes Care 2014; 37:2755-2762. 4. Yki-Jarvinen H, et. Al. New Insulin Glargine 300 Units/mL vs. Glargine 100 Units/mL in People with Type 2 Diabetes Using Oral Agents and Basal Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION-2) Diabetes Care 2014;37:3235-3243. 5. Garber A, et. Al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomized, open-label, treat-to-target non-inferiority trial Lancet 2012;379:1498-1507.
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Medications for Diabetes:
Newer Choices: GLP-1RA (liraglutide,lixisenatide, exenatide, dulaglutide, albiglutide) Five Important Actions: Upregulates Beta-Cell activity (insulin) Down-regulates α-cell activity (glucagon) Slows Liver Production of glucose Slows gastric emptying Central hypothalamic satiety action A1c Reduction of 0.6 to 1.6% Fasting and Post-prandial activity Different Preparations: Twice Daily Once Daily Once Weekly Oral investigational (semaglutide) Inplantable investigational (various)
Medications for Diabetes:
Newer Choices: GLP-1RA (liraglutide,lixisenatide, exenatide, dulaglutide, albiglutide) Safety: Early nausea, vomiting, diarrhea possible (usually mild, usually attenuates) Hypersensitivity Renal Impairment Pancreatitis Risk Medullary Thyroid Carcinoma (MTC) – nodules seen in rat and mice studies Multiple Endocrine Neoplasia Type-2 (MEN-2) Weight Loss is Common
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Medications for Diabetes:
Newer Choices: GLP-1RA (liraglutide,lixisenatide, exenatide, dulaglutide, albiglutide) Patient Experience: Choose Patient Wisely Some experience with the oral medications Not at goal Side Effect Profile appropriate for patient Capable of Managing Appropriate Device
Medications for Diabetes:
Newer Choices: SGLT-2i (canagliflozin, dapagliflozin, empagliflozin) Removes excess glucose from circulation by blocking the re-uptake of glucose at the nephron Can remove up to 100 gm of glucose daily from circulation Compatible with other oral agents and insulins
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Medications for Diabetes:
Newer Choices: SGLT-2i (canagliflozin, dapagliflozin, empagliflozin) Safety Bladder infections Yeast infections Dehydration/volume depletion Impairment of Renal Function Euglycemic Diabetic Ketoacidosis Long Bone Fractures Hypersensitivity
Medications for Diabetes:
Newer Choices: SGLT-2i (canagliflozin, dapagliflozin, empagliflozin) Patient Experience: Choose Patient Wisely Not the first oral medication to reach for Encourage increased water intake Recommend good genital hygiene Use care with CKD patients Caution with volume-fragile patients Weight loss is possible Elderly
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The Combinations:
Insulin/GLP-1RA: Lixisenatide/glargine (approved and on market)1 Liraglutide/degludec (approved, not yet on market)2
1. https://www.drugs.com/history/soliqua.html 2. https://www.drugs.com/newdrugs/novo-nordisk-receives-fda-approval-xultophy-100-3-6-insulin-degludec-liraglutide-type-2- diabetes-4458.html
The Combinations:
Insulin/GLP-1RA: Liraglutide/degludec (approved, not yet on market)2 Dual V RCT: Type 2 not controlled with glargine and metformin Degludec/Lira vs glargine (baseline A1c 8.4 and 8.2) • A1c at wk 26 6.6 and 7.1% (non-inferior and superior) • Body Wt. -1.4 vs. +1.8 kg (superior) • Hypoglycemia 2.23 vs 5.05 events per PYE (superior)
1. Lingvay I, et.al. Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients with Uncontrolled Type 2 Diabetes, The DUAL V Randomized Clinical Trial JAMA 2016;315(9):898-907.
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The Combinations:
Insulin/GLP-1RA: Lixisenatide/glargine (approved and on market)1 LixiLan-L RCT (30 week trial) Baseline A1c 8.5 8.1 iGlarLixi vs. iGlar A1c6.9% (-1.1%) vs. 7.5% (-0.6%) Mean Body Weight iGlarLixi vs. iGlar -0.7kg vs. +0.7kg Hypoglycemia iGlar Lixi vs. iGlar 3.03 vs. 4.22 events/pt. yr. Severe Hypoglycemia iGlarLixi 4 patients experienced 5 events vs iGlar 1Pt. 1 event. 1. Aroda V, et. Al. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lisixenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial Diabetes Care 2016;39:1972- 1980.
The Combinations:
Insulin/GLP-1RA: The overnight and fasting control of basal insulin combined with the GLP-1RA benefits previously described Safety: Early nausea, vomiting, diarrhea possible (usually mild, usually attenuates) Hypersensitivity Renal Impairment Pancreatitis Risk Medullary Thyroid Carcinoma (MTC) – nodules seen in rat and mice studies Multiple Endocrine Neoplasia Type-2 (MEN-2) Weight Loss is Common
1. https://www.drugs.com/history/soliqua.html 2. https://www.drugs.com/newdrugs/novo-nordisk-receives-fda-approval-xultophy-100-3-6-insulin-degludec-liraglutide-type-2- diabetes-4458.html
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The Combinations:
Insulin/GLP-1RA: Patient Experience: Limited: as this is a new combination therapy Individual components work well together Consider for patients not at goal with either GLP-1RA or basal insulin therapy Benefit vs. individual components would be adherence (1 vs. 2 or more injections) Watch for transitioning basal insulin patients on larger insulin doses Recommend reducing or deleting secretogogues when making this transition.
Managed Care Approach
Formulary Management
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Managed Care Approach
Formulary Management Cost In General Complications and Hospitalizations Medications and Expense Medication that is purchased and never used Medication that is used sub-therapeutically Medication used for the wrong patient type Medication that is not given to a patient that needs it Inattention Unfamiliarity Prior Authorization or Non-Formulary
Managed Care Approach
Formulary Management Prior Authorization or Non-Formulary Restricts access to higher cost medication Possibly cost saving for health plan Potentially re-directs patients to less costly alternatives
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Managed Care Approach
Formulary Management Prior Authorization or Non-Formulary Interferes with patients receiving necessary medication Fosters distrust in the patient:physician relationship Contributes to physician stress/burnout Added burden to patient care staff Can lead to physician not choosing appropriate medication because of administrative burden
Managed Care Approach
Recommendations: Understand the wisdom of the Clinical Practice Guidelines/Recommendations Understand the wisdom of the treating physician Keep the patient’s well being central to your decision making Use your Data
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Managed Care Approach
Recommendations: Use your Data Physicians Are they meeting recommended process goals How frequently are at risk patients being seen/encountered What medications are being used Are appropriate referrals being made Outcomes? Share this information with physicians. Don’t do a report card….annoying Do present opportunities for improvement Do recommend some behavioral cues that can be effective.
Managed Care Approach
Recommendations: Use your Data Patients Are they meeting recommended process goals Duration of Diabetes If at risk, are they being seen regularly What important co-morbid conditions are present • CHF, Renal, GI, Pancreatitis, etc. What medications are being used • Are the medications that are being used effective • Do the medications make sense with identified co-morbid conditions Are appropriate referrals being made • Diabetes Education, Eyes, Dentist, Renal, etc Outcomes?
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The Good, The Bad, and the Ugly of Diabetes Care
The Good: There is no better time in Human History to have the diagnosis of Diabetes Mellitus
The Bad: There are a lot more people with diabetes and it is expensive to treat
The Ugly: No treatment/under-treatment Complications
With apologies to Clint Eastwood……
Managed Care Plays a Role in Diabetes Management: 1. Larger portion of the population is involved in some form of Managed Care 2. Managed Care has access to data (claims/pharmacy/etc.) that can help all parties understand better how diabetes care is being delivered 3. Managed Care can also help us identify when care is not being delivered 4. Managed Care also has a responsibility in helping understand the longer term implications in the delivery of diabetes care
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Thank you
What Managed Care Needs to Know About Novel Therapies in the Evolving Management of Type 2 Diabetes
TIMOTHY S. REID, M.D. MERCY DIABETES CENTER JANESVILLE, WI [email protected]
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