Protein Convertase Subtilisn/Kexin (PCSK9) Inhibitors Will they live up to the hype? What do I need to know?
|
|
- Wilfred Smith
- 6 years ago
- Views:
Transcription
1 Protein Convertase Subtilisn/Kexin (PCSK9) Inhibitors Will they live up to the hype? What do I need to know? Adley Lemke, Pharm.D. PGY-1 Pharmacy Resident Hennepin County Medical Center April 27, 2018
2 Objectives 1. Describe the current therapies and guideline based recommendations surrounding cholesterol management. 2. Explain the mechanism by which PCSK9 inhibitors lower LDL cholesterol. 3. Name the different PCSK9 inhibitors. 4. Identify patient characteristics that make them good candidates for PCSK9 inhibitor therapy. 5. Demonstrate how these medications are administered and relevant monitoring. 6. State medication education points for patients before receiving PCSK9 inhibitor therapy.
3 Conflict of Interest Statement I, Adley I. Lemke, certify that I have no affiliations with or involvement in any organization or entity with any financial interest (such an honoraria; educational grants; participation in speakers bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this presentation.
4 GUIDELINES AND THERAPIES
5 Boekholdt et al. J Am Coll Cardiol Aug 5;64(5): Dyslipidemia- Why do we care? 50% decrease LDL-C. ~35% decrease risk of CV event. WOW
6 Which Guideline? Does it Matter? Stone et al. J Am Coll Cardiol Jul 1;63(25 Pt B): Jacobson et al. Journal of Clinical Lipidology. 2015;9: Jellinger et al. Endocrine Practice. 2017;23(2):1-87.
7 Guideline Overlap- Staging Risk Very High High ASCVD Diabetes mellitus (type 1 or 2) with 2 other major ASCVD Risk Factor or Evidence of End-Organ Damage 3Major ASCVD Risk Factors Diabetes mellitus (type 1 or 2) with 0-1 other Major ASCVD Risk Factors and no evidence of end organ damage Chronic kidney disease stage 3B or 4 LDL-C 190 mg/dl Quantitative risk score reaching the high-risk threshold ASCVD MAJOR RISK FACTORS - Age - Males 45 years - Females 55 years - Family history of early CHD - Current cigarette smoking - High blood pressure - Low HDL-C Moderate Low 2 Major ASCVD Risk Factors 0-1 Major ASCVD Risk Factors STATIN BENEFIT GROUPS - Clinical ASCVD - LDL-C 190 MG/DL - Diabetes (Type 1 or 2) age years - Estimated 10-year ASCVD Risk >7.5% Stone et al. J Am Coll Cardiol Jul 1;63(25 Pt B): Jacobson et al. Journal of Clinical Lipidology. 2015;9:
8 Guideline Differences: Treatment Goals Risk Group Low Moderate High Very High Extremely High Guideline/ Treatment Goals ACC/AHA 2013 NLA 2015 ACCE 2017 Life Style Changes Moderate-Intensity Statin (30-50% LDL Reduction) High-Intensity Statin (>50% LDL Reduction) LDL <100 mg/dl Non-HDL <130 mg/dl Treat if: LDL 160 mg/dl Non-HDL 190 mg/dl LDL <100 mg/dl Non-HDL <130 mg/dl Treat if: LDL 130 mg/dl Non-HDL 160 mg/dl LDL <100 mg/dl Non-HDL <130 mg/dl Treat if: LDL 100 mg/dl Non-HDL 130 mg/dl LDL <60 mg/dl Non-HDL <100 mg/dl Treat if: LDL 70 mg/dl Non-HDL 100 mg/dl LDL <130 mg/dl Non-HDL <160 mg/dl LDL <100 mg/dl Non-HDL <130 mg/dl Apo B <90 mg/dl LDL <70 mg/dl Non-HDL <100 mg/dl Apo B <80 mg/dl LDL <55 mg/dl Non-HDL <80 mg/dl Apo B <70 mg/dl ACC/AHA: American College of Cardiology; NLA: National Lipid Association; ACCE: American Association of Clinical Endocrinologist and American College of Endocrinology Stone et al. J Am Coll Cardiol Jul 1;63(25 Pt B): Jacobson et al. Journal of Clinical Lipidology. 2015;9: Jellinger et al. Endocrine Practice. 2017;23(2):1-87.
9 Usefulness of Specific Cholesterol Treatment Goals Goal directed therapy has not been tested in randomized controlled clinical trials. Collectively, trials demonstrate lower ontreatment levels are associated with lower risk of ASCVD. PURPOSE OF SPECIFIC CHOLESTEROL GOAL: To assure aggressive treatment. Jacobson et al. Journal of Clinical Lipidology. 2015;9:
10 Lipid/Lipoprotein Effect (% Change) Comparing Treatment Options LDL-C Non-HDL-C HDL-C TG -60 Statins Bile Acid Sequestrants Nicotinic Acid Fibric Acids Cholesterol Absorption Inhibitor Drug Class Long-Chain Omega-3 Fatty Acid Drugs Adapted from Jacobson et al. Journal of Clinical Lipidology. 2015;9:
11 Therapy Strategy Start with a statin Use risk stratification to choose intensity Contraindications: hypersensitivity, active liver disease, pregnancy, and lactation Verify adherence and efficacy Maximize the statin Consider additional agents to achieve goals in high risk patients Stone et al. J Am Coll Cardiol Jul 1;63(25 Pt B): Jacobson et al. Journal of Clinical Lipidology. 2015;9:
12 QUESTION My patient is statin intolerant. Now what?
13 Answer Statin intolerance defined: Adverse symptoms, signs or laboratory abnormalities attributed by the patient or provider to the statin and in most cases perceived by the patient to interfere unacceptably with activities of daily living (such as sleep, work/ housework, leisure-time activity), leading to a decision to stop or reduce statin therapy. -Guyton et al. (2014) Most often intolerance presents as myalgia Some reports of short-term memory impairment Guyton et al. An assessment by the Statin Intolerance Panel: 2014 update. J Clin Lipidol May-Jun;8(3 Suppl):S72-81.
14 Answer cont. Intolerance reported in ~10% of patients Real rates of intolerance unknown Risks for increased adverse effects: Multiple comorbidities History of muscle disorders Unexplained ALT elevations (>3 times the upper limit of normal) Interacting medications >75 years of age Guyton et al. An assessment by the Statin Intolerance Panel: 2014 update. J Clin Lipidol May-Jun;8(3 Suppl):S Stone et al. J Am Coll Cardiol Jul 1;63(25 Pt B):
15 Answer cont. Muscle symptoms: Symptoms include pain, tenderness, stiffness, cramping, weakness, or generalized fatigue Severe: Hold the statin and evaluate Mild Moderate: Consider holding statin Restart or lower dose when symptoms resolve or another cause is identified Stone et al. J Am Coll Cardiol Jul 1;63(25 Pt B):
16 Answer cont. Of note, it is assumed that the failure to achieve an optimal response to statin therapy is largely due to nonadherance with treatment, also know as pseudoresistance. -Ito & Santos (2017) Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
17 PCSK9 Inhibitors- The Hype BIG CHANGE PCSK9 Inhibitors are included in the 2017 AACE Guidelines. these drugs have the potential to revolutionize the treatment of the highest risk individuals, as well as those individuals unable to reach LDL-C goals with maximally tolerated statin dose Jellinger et al. Endocrine Practice. 2017;23(2):1-87.
18 PCSK9 Inhibitors The Hype This drug class meets a large unmet need for more aggressive lipid-lowering therapy beyond statins in a effort to further reduce residual risk in individuals with clinical ASCVD and diabetes, which up to now has not been possible. - Jellinger (2017) Jellinger et al. Endocrine Practice. 2017;23(2):1-87.
19 PCSK9 INHIBITOR MECHANISM
20 Origins of PCSK9 2 French families with high cholesterol genetically tested No link to LDL-R or Apo B genes found 12.5% of members had mutations at the PCSK9 locus There is a link! PCSK9 shown to play a role in cholesterol homeostasis Abifadel et al. Nat Genet Jun;34(2):154-6.
21 Why PCSK9? Familial hypercholesterolemia genetic disorder associated with defects in LDL degradation 60-90% LDL-R mutations 2-10% Apo B mutations <5% PCSK9 mutations million people affected world wide Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
22 Why PCSK9? Heterozygous Familial Hypercholesteremia (HeFH) Total cholesterol: mg/dl Heart disease develops by age 55 in males, 60 in females Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
23 Why PCSK9? Homozygous Familial Hypercholesteremia (HoFH) More severe and rare Total cholesterol: mg/dl Heart disease and aortic stenosis often developing at a young age Death before age 20 or 30 if not treated Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
24 Why PCSK9? Treatment for HeFH or HoFH: Diet Lifestyle modification Statins BUT. Most patients require multiple cholesterol lowering agents Effective management remains low Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
25 Why PCSK9? Statins Cholesterol synthesis PCSK9 Synthesis LDL Degradation RESULT: Statin efficacy plateaus Marais AD, Kim JB, Wasserman SM, Lambert G. Pharmacol Ther Jan;145:58-66.
26 LDL Regulation 1. Package 5. Degradation & removal 4. Trig loss LDL 2. Distribute 3. Repackage & Distribute Marais AD, Kim JB, Wasserman SM, Lambert G. Pharmacol Ther Jan;145:58-66.
27 Mechanism- PCSK9 3. Complex internalized and destroyed in lysosome. 2. PCSK9 binds LDL and LDL-R to form a complex. 1. PCSK9 synthesized and secreted into plasma. Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
28 Mechanism- PCSK9 Inhibitors 2. LDL and LDL-R internalized 3. LDL-R recycled not destroyed 4. More LDL-R available while LDL is destroyed 1. Inhibitor (mab) captures PCSK9 Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
29 Monoclonal Antibodies Antigen Antigen FAB Domain FC Domain Antibody Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32. FAB = Mouse FC = Human Human Monoclonal Antibody
30 Monoclonal Antibodies Antigen Antigen Receptor Lysozome Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32. Macrophage
31 Monoclonal Antibodies Safety and Efficacy Problems Human immune system can react to mouse segment Suboptimal penetration of target site Diminished efficacy with cytokine release Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
32 PCSK9 INHIBITORS: EVIDENCE
33 Alirocumab ODYSSEY LONG TERM Purpose: to establish the safety and efficacy of alirocumab use Primary outcome: change in calculated LDL from baseline to week 24 Robinson et al. New England Journal of Medicine. 2015;372(16):
34 Alirocumab ODYSSEY LONG TERM Baseline 99.9% on a statin 47% on a high intensity statin Average LDL: 122 mg/dl Average HDL: 50 mg/dl Robinson et al. New England Journal of Medicine. 2015;372(16):
35 Alirocumab ODYSSEY LONG TERM Robinson et al. New England Journal of Medicine. 2015;372(16):
36 Alirocumab ODYSSEY LONG TERM Adverse events: Injection site reactions: 5.9% Myalgia: 5.4% Neurocognitive effects: 1.2% Ophthalmologic events: 2.9% Allergic reaction 10% vs 9.5% in placebo? Robinson et al. New England Journal of Medicine. 2015;372(16):
37 Evolocumab OSLER trial Purpose: Establish long term safety and efficacy Primary outcome: change in LDL, adverse effects Extension on phase 2 and 3 studies Sabatine et al. New England Journal of Medicine. 2015;372(16):
38 Evolocumab OSLER trial Baseline 70% taking a statin 27% on a high intensity statin Average LDL-C: 120 mg/dl Average HDL-C: 51 mg/dl Sabatine et al. New England Journal of Medicine. 2015;372(16):
39 Evolocumab OSLER trial Sabatine et al. New England Journal of Medicine. 2015;372(16):
40 Evolocumab OSLER trial Sabatine et al. New England Journal of Medicine. 2015;372(16):
41 Evolocumab OSLER trial Neurocognitive adverse effects <1% but occurred more often in treatment group Injection site reaction (4.3%), not evaluated in placebo Muscle related 6.4% treatment and 6% placebo Sabatine et al. New England Journal of Medicine. 2015;372(16):
42 Evolocumab FOURIER trial Purpose: Investigate long term outcomes Primary outcome: composite for cardiovascular death, myocardial infarction, stroke, hospitalization of unstable angina or coronary revascularization Sabatine et al. New England Journal of Medicine. 2015;372(16):
43 Evolocumab FOURIER trial Baseline Myocardial infarction: 80% 70% on high intensity statin Median LDL: 92 mg/dl Sabatine et al. New England Journal of Medicine. 2015;372(16):
44 Evolocumab FOURIER trial Sabatine et al. New England Journal of Medicine. 2015;372(16):
45 Evolocumab FOURIER trial Sabatine et al. New England Journal of Medicine. 2015;372(16):
46 NLA PCSK9 Recommendations Populations of interest: Stable ASCVD Progressive ASCVD LDL-C 190 mg/dl Very-high risk patients with a statin response Orringer et all. Journal of Clinical Lipidology (11):
47 BOTTOM LINE: Which patients will be prescribed PCSK9- inhibitors? Familial hypercholesterolemia Clinical ASCVD on maximally-tolerated statin with on-treatment LDL 70 mg/dl or non-hdl 100 mg/dl Very high ASCVD risk with statin intolerance Essentially, PCSK9 inhibitor s role is to facilitate the achievement of LDL goals for patients taking the maximum tolerated statin. Orringer et all. Journal of Clinical Lipidology (11):
48 PRODUCT ADMINISTRATION AND INFORMATION
49 Alirocumab (Praluent ) FDA indication: HeFH ASCVD on max tolerated statin Dose: Start- 75 mg SQ every 2 weeks Max- 150 mg every 2 weeks OR 300 mg SQ monthly Praluent- alirocumab injection, solution. Sanofi-Aventis. DailyMed [online]. Updated July 2017.
50 Alirocumab (Praluent ) Dose forms: 75 mg/ml or 150 mg/ml solution in pen or prefilled syringe Praluent- alirocumab injection, solution. Sanofi-Aventis. DailyMed [online]. Updated July 2017.
51 Alirocumab (Praluent ) Adverse Reaction Placebo (N=1,276) Praluent (N=2,476) Nasopharyngitis 11.1% 11.3% Injection site reactions 5.1% 7.2% Influenza 4.6% 5.7% Urinary tract infection 4.6% 4.8% Diarrhea 4.4% 4.7% Bronchitis 3.8% 4.3% Myalgia 3.4% 4.2% Muscle spasms 2.4% 3.1% Sinusitis 2.7% 3.0% Cough 2.3% 2.5% Contusion 1.3% 2.1% Musculoskeletal pain 1.6% 2.1% Praluent- alirocumab injection, solution. Sanofi-Aventis. DailyMed [online]. Updated July 2017.
52 Alirocumab (Praluent ) Monitoring: Lipids at 4-8 weeks Missed dose: Within 7 days give dose and resume schedule >7 days give dose and start new schedule Praluent- alirocumab injection, solution. Sanofi-Aventis. DailyMed [online]. Updated July 2017.
53 Alirocumab (Praluent ) Store: refrigerator or room temp for up to 30 days Inject in thigh, upper arm or abdomen Do not administer to damaged skin Praluent- alirocumab injection, solution. Sanofi-Aventis. DailyMed [online]. Updated July 2017.
54 Alirocumab (Praluent ) 1. Check window is clear. 2. Let pen warm to room temp for mins. 3. Clean injection site. 4. Remove safety cap and press pen into injection site at 90 degree angle until yellow safety cover is no longer visible. 5. Push green button and release immediately. You will hear a click. 6. Remove the pen after the window has turned yellow (up to 20 sec). 7. Discard pen in a sharps container. Praluent- alirocumab injection, solution. Sanofi-Aventis. DailyMed [online]. Updated July 2017.
55 Repatha- evolocumab injection, solution. Amgen. DailyMed [online]. Updated July Evolocumab (Repatha ) FDA indication: HeFH HoFH ASCVD on max tolerated statin Dose: 140mg SQ every 2 weeks 420 mg SQ monthly
56 Repatha- evolocumab injection, solution. Amgen. DailyMed [online]. Updated July Evolocumab (Repatha ) Dosage Forms: 140 mg/ml solution in pen or prefilled syringe 420 mg/3.5 ml Pushtronex system
57 Repatha- evolocumab injection, solution. Amgen. DailyMed [online]. Updated July Evolocumab (Repatha ) Adverse Reaction Placebo (N=302) Repatha (N=599) Nasopharyngitis 9.6% 10.5% Upper respiratory tract infection 6.3% 9.3% Influenza 6.3% 9.3% Back pain 5.6% 6.2% Injection site reactions 5.0% 5.7% Cough 3.6% 4.5% Urinary tract infection 3.6% 4.5% Sinusitis 3.0% 4.2% Headache 3.6% 4.0% Myalgia 3.0% 4.0% Dizziness 2.6% 3.7% Musculoskeletal pain 3.0% 3.3% Hypertension 2.3% 3.0% Diarrhea 2.6% 3.0% Gastroenteritis 2.0% 3.0%
58 Repatha- evolocumab injection, solution. Amgen. DailyMed [online]. Updated July Evolocumab (Repatha ) Store: refrigerated or room temp for 30 days Inject in upper arm, abdomen or thigh
59 Evolocumab (Repatha ) Repatha- evolocumab injection, solution. Amgen. DailyMed [online]. Updated July Check window is clear. 2. Let pen warm to room temp for 30 mins. 3. Clean injection site. 4. Stretch skin over thigh injection site, pinch over stomach or upper arm injection site. 5. Remove safety cap and press pen into injection site at 90 degree angle until skin stops moving. 6. Push gray button and release immediately. You will hear a click. 7. Remove the pen after the window has turned yellow (up to 15 sec). 8. Discard pen in a sharps container.
60 Repatha- evolocumab injection, solution. Amgen. DailyMed [online]. Updated July Evolocumab (Repatha ) 1. Warm infusor for ~45 mins. 2. Clean injection site. 3. Open cartridge door, clean tip of cartridge and insert. 4. Close cartridge door. 5. Peel away green pull tabs. 6. Blue flashing light means it is on. 7. Place infusor on skin (stretched if stomach placement). 8. Press and release start button. 9. May take 9 mins. Solid green light means it is done. 10. Discard infusor in sharps container.
61 Bococizumab Humanized monoclonal antibody Currently in clinical trials Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32.
62 $$$ COST $$$ Product Evolocumab (Repatha) SureClick autoinjector 140 mg/ml; 1 ml Evolocumab (Repatha) Pushtronex system 420 mg/ 3.5mL; 3.5 ml Evolocumab (Repatha) prefilled syringe 140 mg/ml; 1 ml Alirocumab (Praluent) Pen-injector 75 mg/ml; 1 ml Alirocumab (Praluent) Pen-injector 150 mg/ml; 1 ml Cost/Dose $ $1, $ $ $ Source: Lexicomp Pricing.
63 Summary 1. Guidelines recommend statins for the prevention of cardiovascular events for those with clinical ASCVD, diabetes, hyperlipidemia and at increased ASCVD risk. 2. PCSK9 inhibitors can be used in patients who fail to achieve treatments goals on statins, cannot tolerate statins or have familial hyperlipidemia. 3. PCSK9 inhibitors increase LDL receptors on hepatocytes resulting in more LDL degradation. 4. The two PCSK9 inhibitors available on the market are Alirocumab (Praluent) and Evolocumab (Repatha). 5. The dosage forms of these medications are easy to use. 6. Patients should be educated on storage administration, symptoms of allergic reaction and adverse effects of these agents.
64 References Abifadel et al. Nat Genet Jun;34(2): Boekholdt et al. J Am Coll Cardiol Aug 5;64(5): Guyton et al. An assessment by the Statin Intolerance Panel: 2014 update. J Clin Lipidol May-Jun;8(3 Suppl):S Ito MK, Santos RD. J Clin Pharmacol Jan;57(1):7-32. Jacobson et al. Journal of Clinical Lipidology. 2015;9: Jellinger et al. Endocrine Practice. 2017;23(2):1-87. Marais AD, Kim JB, Wasserman SM, Lambert G. Pharmacol Ther Jan;145: Orringer et all. Journal of Clinical Lipidology (11): Praluent- alirocumab injection, solution. Sanofi-Aventis. DailyMed [online]. Updated July Repatha- evolocumab injection, solution. Amgen. DailyMed [online]. Updated July Robinson et al. New England Journal of Medicine. 2015;372(16): Sabatine et al. New England Journal of Medicine. 2015;372(16): Stone et al. J Am Coll Cardiol Jul 1;63(25 Pt B):
Objectives. Conflict of Interest Statement 4/19/2018
Protein Convertase Subtilisn/Kexin (PCSK9) Inhibitors Will they live up to the hype? What do I need to know? Adley Lemke, Pharm.D. PGY-1 Pharmacy Resident Hennepin County Medical Center April 27, 2018
More informationPCSK9 Inhibitors: Promise or Pitfall?
PCSK9 Inhibitors: Promise or Pitfall? Tracy Harlan, PharmD PGY2 Ambulatory Care Resident University of Iowa Hospitals and Clinics tracy harlan@uiowa.edu Tracy Harlan does not have any actual or potential
More information4 th and Goal To Go How Low Should We Go? :
4 th and Goal To Go How Low Should We Go? : Evaluating New Lipid Lowering Therapies Catherine Bourg Rebitch, PharmD, BCACP Clinical Associate Professor Disclosure The presenter has nothing to disclose
More informationGet a Statin or Not? Learning objectives. Presentation overview 4/3/2018. Treatment Strategies in Dyslipidemia Management
Get a Statin or Not? Treatment Strategies in Dyslipidemia Management Michelle Chu, PharmD, BCACP, CDE Assistant Professor of Clinical Pharmacy, USC School of Pharmacy Sahar Dagher, PharmD Virtual Care
More informationProprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary
Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization
More informationPCSK9 Agents Drug Class Prior Authorization Protocol
PCSK9 Agents Drug Class Prior Authorization Protocol Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of medical
More informationEVOLOCUMAB Generic Brand HICL GCN Exception/Other EVOLOCUMAB REPATHA 42378
Generic Brand HICL GCN Exception/Other EVOLOCUMAB REPATHA 42378 This drug requires a written request for prior authorization. All requests for Repatha (evolocumab) require review by a pharmacist prior
More informationClinical Policy: Evolocumab (Repatha) Reference Number: ERX.SPMN.184 Effective Date: 01/2017
Clinical Policy: (Repatha) Reference Number: ERX.SPMN.184 Effective Date: 01/2017 Last Review Date: Revision Log See Important Reminder at the end of this policy for important regulatory and legal information.
More informationPharmacy Policy Bulletin
Pharmacy Policy Bulletin Title: Policy #: PCSK9 inhibitors Rx.01.170 Application of pharmacy policy is determined by benefits and contracts. Benefits may vary based on product line, group, or contract.
More informationMaking War on Cholesterol with New Weapons: How Low Can We/Should We Go? Shaun Goodman
Making War on Cholesterol with New Weapons: How Low Can We/Should We Go? Shaun Goodman Disclosures Research grant support, speaker/consulting honoraria: Sanofi and Regeneron Including ODYSSEY Outcomes
More informationPCSK9 Inhibitors Are They Worth The Money? Michael J. Blaha MD MPH
PCSK9 Inhibitors Are They Worth The Money? Michael J. Blaha MD MPH Presented by: Michael J. Blaha November 16, 2017 1 Financial Disclosures Grants: Amgen Foundation, Aetna Foundation Advisory Boards: Amgen,
More informationCommon Repatha Documentation Requirements for Patients With Primary Hyperlipidemia and Established CVD 1,2
Established CVD Common Repatha Documentation Requirements for Patients With Primary Hyperlipidemia and Established CVD 1,2 Primary and Secondary Diagnosis Codes Primary Diagnosis: Primary hyperlipidemia
More informationDrug Prior Authorization Guideline PCSK9 Inhibitors -
Drug Prior Authorization Guideline PCSK9 Inhibitors - REPATHA (evolocumab) PRALUENT (alirocumab) PA9911 Covered Service: Yes when meets criteria below Prior Authorization Required: Yes-as shown below Additional
More informationDrug Class Monograph
Drug Class Monograph Class: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Drugs: Praluent (alirocumab), Repatha (evolocumab) Line of Business: Medi-Cal Effective Date: February 17, 2016
More informationPharmacy Management Drug Policy
SUBJECT: ; Praluent (alirocumab), Repatha (evolocumab) POLICY NUMBER: Pharmacy-61 EFFECTIVE DATE: 8/15 LAST REVIEW DATE: 9/22/2017 If the member s subscriber contract excludes coverage for a specific service
More information2/23/2018. Management of Hyperlipidemia Update on Guidelines and Novel Therapies. Burden of Heart Disease in U.S.
Management of Hyperlipidemia Update on Guidelines and Novel Therapies SHARATH SUBRAMANIAN, MD, FACC February 24, 2018 Disclosures : None Burden of Heart Disease in U.S. https://www.cdc.gov/nchs/images/databriefs/251
More information2017 Update in Internal Medicine: Clinical Dyslipidemia Update
2017 Update in Internal Medicine: Clinical Dyslipidemia Update Erin E. Kershaw, M.D. Chief, Division of Endocrinology Associate Professor of Medicine Certified in Endocrinology, Diabetes, and Metabolism
More informationClinical Policy: Evolocumab (Repatha) Reference Number: ERX.SPA.169 Effective Date:
Clinical Policy: (Repatha) Reference Number: ERX.SPA.169 Effective Date: 01.11.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2063-8 Program Prior Authorization/Medical Necessity Medication Repatha (evolocumab) P&T Approval Date 5/2015, 9/2015, 11/2015,
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Proprotein Convertase Subtilisin/kexin type 9 Page 1 of 24 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Proprotein Convertase Subtilisin/kexin type 9 (PCSK9)
More informationLipid Management C. Samuel Ledford, MD Interventional Cardiology Chattanooga Heart Institute
Lipid Management 2018 C. Samuel Ledford, MD Interventional Cardiology Chattanooga Heart Institute Disclosures No Financial Disclosures Disclosures I am an Interventional Cardiologist I put STENTS in for
More informationWhat Role do the New PCSK9 Inhibitors Have in Lipid Lowering Treatment?
What Role do the New PCSK9 Inhibitors Have in Lipid Lowering Treatment? Jennifer G. Robinson, MD, MPH Professor, Departments of Epidemiology & Medicine Director, Prevention Intervention Center University
More informationAlirocumab (Praluent): First in the New Class of PCSK9 Inhibitors
DrUG FOrECAST Alirocumab (Praluent): First in the New Class of PCSK9 Inhibitors Marina Manniello, PharmD Candidate; and Michele Pisano, PharmD, CGP INTRODUCTION Hyperlipidemia, also known as hypercholesterolemia,
More informationPatient Lists. Epic ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION. Please see accompanying full Prescribing Information
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient Lists in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject PCSK9 Inhibitors Table of Contents Coverage Policy... 1 General Background... 4 Coding/Billing Information... 9 References... 9 Effective Date... 01/15/2018
More informationClinical Policy: Evolocumab (Repatha) Reference Number: CP.CPA.269 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: (Repatha) Reference Number: CP.CPA.269 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationRequest for Prior Authorization for PCSK9 inhibitor therapy Website Form Submit request via: Fax
Request for Prior Authorization for PCSK9 inhibitor therapy Website Form www.highmarkhealthoptions.com Submit request via: Fax - 1-855-476-4158 PCSK9 is a protein that reduces the hepatic removal of low-density
More informationFULL PRESCRIBING INFORMATION: CONTENTS*
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use REPATHA safely and effectively. See full prescribing information for REPATHA. REPATHA (evolocumab)
More informationPCSK9 Inhibitors: Changing the Landscape of Lipid-Lowering Therapy
PCSK9 Inhibitors: Changing the Landscape of Lipid-Lowering Therapy http://parriscardio.theangelheartcenter.com/wp-content/uploads/2013/03/heart-disease-prevention.jpg Jennifer Jiang, PharmD PGY1 Pharmacy
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2062-8 Program Prior Authorization/Medical Necessity Medication Praluent (alirocumab) P&T Approval Date 5/2015, 8/2015, 9/2015,
More informationHYPERLIPIDEMIA IN THE OLDER POPULATION NICOLE SLATER, PHARMD, BCACP AUBURN UNIVERSITY, HARRISON SCHOOL OF PHARMACY JULY 16, 2016
HYPERLIPIDEMIA IN THE OLDER POPULATION NICOLE SLATER, PHARMD, BCACP AUBURN UNIVERSITY, HARRISON SCHOOL OF PHARMACY JULY 16, 2016 NOTHING TO DISCLOSE I, Nicole Slater, have no actual or potential conflict
More informationClinical Policy: Lomitapide (Juxtapid) Reference Number: ERX.SPA.170 Effective Date:
Clinical Policy: (Juxtapid) Reference Number: ERX.SPA.170 Effective Date: 01.11.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationSubject: Repatha (evolocumab) Original Effective Date: 09/28/2015. Policy Number: MCP-258 Revision Date(s): 5/4/16; 4/17/17
Subject: Repatha (evolocumab) Original Effective Date: 09/28/2015 Policy Number: MCP-258 Revision Date(s): 5/4/16; 4/17/17 Review Date(s): 5/4/2016, 4/17/2017, 7/10/2018 DISCLAIMER This Medical Policy
More informationEvolving Concepts on Lipid Management from Ezetimibe (IMPROVE IT) to PCSK9 Inhibitors
Evolving Concepts on Lipid Management from Ezetimibe (IMPROVE IT) to PCSK9 Inhibitors Sidney C. Smith, Jr. MD, FACC, FAHA, FESC Professor of Medicine/Cardiology University of North Carolina at Chapel Hill
More informationHigh ( 50%) Restrictions mg 20-40mg Simvastatin (Zocor) 10mg 20-40mg $1.66 Pravastatin (Pravachol) mg $6.
MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Cholesterol P&T DATE: 5/8/2018 THERAPEUTIC CLASS: Cardiovascular REVIEW HISTORY: 5/17, 5/16, 5/15, 2/14, LOB AFFECTED: Medi-Cal
More informationQUANTITY LIMIT TARGET DRUGS- RECOMMENDED LIMITS Brand (generic) GPI Multisource Code Quantity Limit
Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Criteria- Through Preferred Agent(s) Program Summary This program applies to Commercial, Netresults
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Repatha) Reference Number: HIM.PA.SP46 Effective Date: 01.01.18 Last Review Date: Line of Business: Health Insurance Marketplace Revision Log See Important Reminder at the end of this
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Proprotein Convertase Subtilisin/kexin type 9 Page 1 of 22 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Proprotein Convertase Subtilisin/kexin type 9 (PCSK9)
More informationREPATHA (PCSK9 INHIBITORS)
REPATHA (PCSK9 INHIBITS) Indications: PCSK9 Inhibitors are indicated for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease as
More informationPatient List Inquiries
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient List Inquiries in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for
More informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 9 Last Review Date: September 15, 2017 Repatha Description Repatha
More informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 9 Last Review Date: November 30, 2018 Repatha Description Repatha (evolocumab)
More informationAsk the Experts: Clinical Case Studies Focusing on Non-statin Therapies for Treating Patients with Hypercholesterolemia
Ask the Experts: Clinical Case Studies Focusing on Non-statin Therapies for Treating Patients with Hypercholesterolemia Presented as a Live Webinar Wednesday, March 1, 2017 1:00 p.m. 2:00 p.m. ET On-demand
More informationPatient Action Sets. Allscripts Touchworks ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient Action Sets in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT
More informationPCSK9 inhibition across a wide spectrum of patients: One size fits all?
PCSK9 inhibition across a wide spectrum of patients: One size fits all? PACE ESC Barcelona 2017 G.K. Hovingh MD PhD MBA dept of vascular medicine Academic Medical Center the Netherlands g.k.hovingh@amc.uva.nl
More informationContemporary management of Dyslipidemia
Contemporary management of Dyslipidemia Todd Anderson Feb 2018 Disclosure Statement Within the past two years: I have not had an affiliation (financial or otherwise) with a commercial organization that
More informationPatient Lists. Allscripts Professional ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient Lists in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT
More informationB. Patient has not reached the percentage reduction goal with statin therapy
Managing Cardiovascular Risk: The Importance of Lowering LDL Cholesterol and Reaching Treatment Goals for LDL Cholesterol The Role of the Pharmacist Learning Objectives 1. Review the role of lipid levels
More informationLipids & Hypertension Update
Lipids & Hypertension Update No financial disclosures Michael W. Cullen, MD, FACC Senior Associate Consultant, Assistant Professor of Medicine Mayo Clinic Department of Cardiovascular Diseases 34 th Annual
More informationPCSK9 Inhibitors and Modulators
PCSK9 Inhibitors and Modulators Pam R. Taub MD, FACC Director of Step Family Cardiac Rehabilitation and Wellness Center Associate Professor of Medicine UC San Diego Health System Disclosures Speaker s
More informationClinical Policy: Mipomersen (Kynamro) Reference Number: ERX.SPMN.186 Effective Date: 01/2017
Clinical Policy: (Kynamro) Reference Number: ERX.SPMN.186 Effective Date: 01/2017 Last Review Date: Revision Log See Important Reminder at the end of this policy for important regulatory and legal information.
More informationPCSK9 antibodies: A new therapeutic option for the treatment of hypercholesterolemia
: 262-267, 2017 Περίληψη Διάλεξης PCSK9 antibodies: A new therapeutic option for the treatment of hypercholesterolemia I. Gouni-Bethold Polyclinic for Endocrinology, Diabetes, and Preventive Medicine University
More informationClinical Policy: Mipomersen (Kynamro) Reference Number: ERX.SPA.171 Effective Date:
Clinical Policy: (Kynamro) Reference Number: ERX.SPA.171 Effective Date: 01.11.17 Last Review Date: 08.18 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationManaging Dyslipidemia and ASCVD Risk: Confusion, Controversy Consensus
Managing Dyslipidemia and ASCVD Risk: Confusion, Controversy Consensus Pamela B. Morris, MD, FACC, FAHA, FASPC, FNLA Chair, ACC Prevention of Cardiovascular Disease Council and Section The Medical University
More informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.16.08 Subject: Repatha Page: 1 of 8 Last Review Date: September 18, 2015 Repatha Description Repatha
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Evolocumab (Repatha) Reference Number: CP.PHAR.123 Effective Date: 10.01.18 Last Review Date: 07.13.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at the end
More informationDrug Therapy Guidelines
Drug Therapy Guidelines PCSK9 Inhibitors: Praluent TM, Repatha TM Applicable Medical Benefit Effective: 5/1/18 Pharmacy- Formulary 1 x Next Review: 3/19 Pharmacy- Formulary 2 x Date of Origin: 10/9/15
More informationADMINISTRATIVE POLICY AND PROCEDURE
ADMINISTRATIVE POLICY PROCEDURE Policy #: Subject: PCSK9 INHIBITS (ex: Repatha) Section: Care Management Effective Date: January 1, 2015 Revision Date(s): NA Review Date(s): NA Responsible Parties: Patryce
More informationLipid Guidelines Who, What, and How Low. Anita Ralstin, MS, CNP Next Step Health Consultant, LLC New Mexico Heart Institute
Lipid Guidelines Who, What, and How Low Anita Ralstin, MS, CNP Next Step Health Consultant, LLC New Mexico Heart Institute Disclosures! None Objectives! List factors used in screening for dyslipidemia
More informationDrug Class Prior Authorization Criteria PCSK9 Inhibitors
Drug Class Prior Authorization Criteria PCSK9 Inhibitors Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of
More informationReducing Cardiovascular Risk Through Non-Statins. Kim K. Birtcher, PharmD Joseph Saseen, PharmD
Reducing Cardiovascular Risk Through Non-Statins Kim K. Birtcher, PharmD Joseph Saseen, PharmD Target Audience: Pharmacists ACPE#: 0202-0000-18-049-L01-P Activity Type: Application-based This activity
More informationDisclosures. Objectives 2/11/2017
Role of Non-Statin Therapy in CV Risk Reduction James A. Underberg, MD, MS, FACPM, FACP, FASH, FNLA,FASPC Clinical Assistant Professor of Medicine NYU School of Medicine NYU Langone Center for Cardiovascular
More information10/24/2016. CPE Information and Disclosures. Managing Dyslipidemia: Evolving Roles of Nonstatins and Newer Drugs. Learning Objectives.
CPE Information and Disclosures Managing Dyslipidemia: Evolving Roles of Nonstatins and Newer Drugs Kathleen A. Lusk, Pharm.D., BCPS Assistant Professor, Pharmacy Practice University of the Incarnate Word
More informationHYPERCHOLESTEROLEMIA
UPDATES ON HYPERCHOLESTEROLEMIA WITH EMPHASIS ON PCSK9 INHIBITORS July, 2018 Chicago by Ernesto L. Chua, MD, FACC, FACP, FPCP Board Certified in Internal Medicine Board Certified in Cardiology COL, USAF,
More informationDavid Y. Gaitonde, MD, FACP Endocrinology DDEAMC, Fort Gordon
David Y. Gaitonde, MD, FACP Endocrinology DDEAMC, Fort Gordon I have no actual or potential conflicts of interest in relation to this program or presentation. Raphael School of Athens, 1509-1511 Apply
More informationPCSK9 INHIBITORS, ARNIS, FUNNY CHANNEL INHIBITORS: ARE YOU SURE THESE ARE REALLY CARDIAC DRUGS?
PCSK9 INHIBITORS, ARNIS, FUNNY CHANNEL INHIBITORS: ARE YOU SURE THESE ARE REALLY CARDIAC DRUGS? ALLORIE SMITH, PHARM.D. CARDIOVASCULAR UPDATE CONFERENCE FEBRUARY 9, 2012 OBJECTIVES Explain the pharmacology
More informationHyperlipidemia: Past and Present. Rebecca Khaimova, PharmD The Brooklyn Hospital Center
Hyperlipidemia: Past and Present Rebecca Khaimova, PharmD The Brooklyn Hospital Center Rkhaimova@tbh.org Conflicts of Interest None to disclose Learning Objectives for Pharmacist Describe the pathophysiology
More informationAlirocumab for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia
Alirocumab for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia Lead author: Stephen Erhorn Regional Drug & Therapeutics Centre (Newcastle) November 2015 2015 Summary Alirocumab (Praluent,
More informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 8 Last Review Date: December 2, 2016 Repatha Description Repatha (evolocumab)
More informationNew Strategies for Lowering LDL - Are They Really Worth It?
New Strategies for Lowering LDL - Are They Really Worth It? Gregg C. Fonarow, MD, FACC, FAHA, FHFSA Eliot Corday Professor of CV Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Director,
More informationPCSK9 Inhibitors Current Status
PCSK9 Inhibitors Current Status Ryan T. Whitney, MD FACC Bryan Heart Fall Conference 2015 Disclosures, Conflicts, and Nefarious Connections I own no stock in the companies mentioned in this talk. I am
More informationNo relevant financial relationships
MANAGEMENT OF LIPID DISORDERS Balancing Benefits and harms Disclosure Robert B. Baron, MD MS Professor and Associate Dean UCSF School of Medicine No relevant financial relationships baron@medicine.ucsf.edu
More informationDyslipidemia and Combination Therapy: A Framework for Clinical Decision Making
Dyslipidemia and Combination Therapy: A Framework for Clinical Decision Making Shashank Sinha, MD Pamela B. Morris, MD, FACC 8 October 2016 Mexico City Introduction: Pamela B. Morris, MD, FACC COMING TO
More informationLearning Objectives. Patient Case
Joseph Saseen, Pharm.D., FASHP, FCCP, BCPS Professor and Vice Chair, Department of Clinical Pharmacy University of Colorado Anschutz Medical Campus Learning Objectives Identify the 4 patient populations
More informationAccumulating Clinical data on PCSK9 Inhibition: Key Lessons and Challenges
ESC 2015 London Accumulating Clinical data on PCSK9 Inhibition: Key Lessons and Challenges Paul M Ridker, MD, MPH Eugene Braunwald Professor of Medicine Harvard Medical School Director, Center for Cardiovascular
More informationModern Lipid Management:
Modern Lipid Management: New Drugs, New Targets, New Hope Kirk U. Knowlton, M.D Director of Cardiovascular Research Co Chief of Cardiology Why lower LDL C in those without evidence of CAD (primary prevention)
More informationReports. NextGen ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION. Please see accompanying full Prescribing Information
ABOUT THIS GUIDE This Guide provides a high-level overview of in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT (alirocumab)
More informationManaging Dyslipidemia in Disclosures. Learning Objectives 03/05/2018. Speaker Disclosures
Managing Dyslipidemia in 2018 Glen J. Pearson, BSc, BScPhm, PharmD, FCSHP, FCCS Professor of Medicine (Cardiology) Co-Director, Cardiac Transplant Clinic; Associate Chair, Health Research Ethics Boards;
More informationPraluent. Praluent (alirocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.06 Subject: Praluent Page: 1 of 10 Last Review Date: September 20, 2018 Praluent Description Praluent
More informationEducational Objectives. Disease Trajectories and CVD Risk Reduction. Hypercholesterolemia Support for LDL-C Causality
Educational Objectives At the conclusion of this activity, participants should be able to: Evaluate the extent of residual CVD risk to which ASCVD patients are exposed, and treat additional CVD risk elements
More information2/26/19. Secondary Cardiovascular Risk Reduction: Incorporating Evolving Data to Individualize Care. Disclosures. Faculty
Secondary Cardiovascular Risk Reduction: Incorporating Evolving Data to Individualize Care Faculty v Karol E. Watson, MD, PhD Professor of Medicine/Cardiology Co-director, UCLA Program in Preventive Cardiology
More informationConfusion about guidelines: How should we treat lipids?
Confusion about guidelines: How should we treat lipids? Anne Carol Goldberg, MD, FACP, FAHA, FNLA Professor of Medicine Washington University School of Medicine American College of Physicians Missouri
More informationPraluent (alirocumab)
Praluent (alirocumab) Policy Number: 5.01.600 Last Review: 06/2018 Origination: 07/2015 Next Review: 06/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Praluent
More informationClass Update PCSK9 Inhibitors
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationRegistry Reports. eclinicalworks ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION
ABOUT THIS GUIDE This Guide provides a high-level overview of Registry Reports in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT
More informationNew Horizons in Dyslipidemia Management in Primary Care
New Horizons in Dyslipidemia Management in Primary Care Copyright 2017 by Sea Courses Inc. All rights reserved. No part of this document may be reproduced, copied, stored, or transmitted in any form or
More informationDYSLIPIDEMIA. Michael Brändle, Stefan Bilz
DYSLIPIDEMIA Michael Brändle, Stefan Bilz Cardiovascular risk in patients with DM Current guidelines with emphasis on patients with DM Familial Hypercholesterolemia PCSK9-inhibitors Primary Prevention
More informationHigh ( 50%) Restrictions mg 20-40mg PA; TS ⱡ 15 ⱡ
MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Cholesterol P&T DATE: 5/9/2017 THERAPEUTIC CLASS: Cardiovascular REVIEW HISTORY: 5/16, 5/15, 2/14, 5/12, LOB AFFECTED: Medi-Cal
More informationPCSK9 Inhibitors Praluent (Alirocumab) and Repatha (Evolocumab) For the Treatment of Familial Hypercholesterolemia
PCSK9 Inhibitors Praluent (Alirocumab) and Repatha (Evolocumab) For the Treatment of Familial Hypercholesterolemia Policy Number: Original Effective Date: MM.04.037 08/01/2016 Line(s) of Business: HMO;
More informationCholesterol, guidelines, targets and new medications
Cholesterol, guidelines, targets and new medications Alexis Baass MD, MSc, FRCPC, DABCL, FNLA Medical Biochemist and Lipidologist MUHC Clinical Researcher and Lipidologist IRCM Disclaimers Grants/Research
More informationPCSK9 Inhibitors Current Status
PCSK9 Inhibitors Current Status Ryan T. Whitney, MD FACC Bryan Heart Spring Conference 2016 Disclosures, Conflicts, and Nefarious Connections I own no stock in the companies mentioned in this talk. I am
More informationCost-effectiveness of evolocumab (Repatha ) for hypercholesterolemia
Cost-effectiveness of evolocumab (Repatha ) for hypercholesterolemia The NCPE has issued a recommendation regarding the cost-effectiveness of evolocumab (Repatha ). Following NCPE assessment of the applicant
More informationRepatha (evolocumab) Policy Number: Last Review: 06/2018 Origination: 07/2015 Next Review: 06/2019
Repatha (evolocumab) Policy Number: 5.01.601 Last Review: 06/2018 Origination: 07/2015 Next Review: 06/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Repatha
More informationJuxtapid (lomitapide)
Juxtapid (lomitapide) Policy Number: 5.01.599 Last Review: 06/2018 Origination: 07/2015 Next Review: 06/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Juxtapid
More informationWhat s our starting point? New Lipid-Lowering Drugs: PCSK9 Inhibitors. Why You Should Care. Outline ATPIII Guidelines 1
New Lipid-Lowering Drugs: Inhibitors Blockbusters or Bust? Jody Mallicoat, BS, PharmD PGY1 Pharmacy Resident OSF Saint Francis Medical Center, Peoria, IL What s our starting point? Had you heard of inhibitors
More informationWhat do the guidelines say about combination therapy?
What do the guidelines say about combination therapy? Christie M. Ballantyne, MD Center for Cardiovascular Disease Prevention Methodist DeBakey Heart & Vascular Center Baylor College of Medicine Houston,
More informationRegistry Processor Reports
ABOUT THIS GUIDE This Guide provides a high-level overview of Registry Processor Reports in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates
More informationConsiderations and Controversies in the Management of Dyslipidemia for ASCVD Risk Reduction
Considerations and Controversies in the Management of Dyslipidemia for ASCVD Risk Reduction Pamela B. Morris, MD, FACC, FAHA, FASCP, FNLA Chair, ACC Prevention of Cardiovascular Disease Council The Medical
More information