Marc S. Sabatine, MD, MPH, Michelle O'Donoghue, MD, MPH, Robert S. Rosenson, MD, and James A. Underberg, MD, MS, FACPM, FACP, FNYAM, FASPC, FNLA, prepared useful Practice Aids pertaining to LDL-C lowering for this CME activity titled "Following the Evidence: LDL-C as a Path to Reducing Cardiovascular Events—How Low Do We Go?" For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2RgYhWr. CME credit will be available until December 16, 2019.

1. This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Reducing Cardiovascular Events
With LDL-C: A Patient CaseBook
for Physicians
PRACTICE AID
Case 1: Henry
50-Year-Old African American MaleWith Prior MI and
LDL-C of 72 mg/dLWith High-Intensity Statin
Past Medical History
• MI (2 y ago)
Medications
• Rosuvastatin 40 mg/d
• Acetaminophen 500 mg
as needed
• Multivitamin daily
PatientInformation
 LDL-C: 72 mg/dL
 HDL-C: 63 mg/dL
 TC: 151 mg/dL
 TG: 81 mg/dL
 Lp(a): 75 nmol/L
 Fasting blood glucose:
84 mg/dL
MetabolicPanel
For
Refill times
Date
Treatment Recommendations
 Consider ezetimibe to further reduce Henry’s LDL-C
 PCSK9 inhibitor or other lipid-lowering therapy
may be considered if LDL-C is ≥70 mg/dL despite
statin + ezetimibe
Access the activity, “Following the Evidence: LDL-C as a Path to Reducing
Cardiovascular Events—How Low Do We Go?” at www.peerview.com/JCD40.

2. Reducing Cardiovascular Events
With LDL-C: A Patient CaseBook
for Physicians
PRACTICE AID
Case 2: Jane
47-Year-OldWomanWithVery High LDL-C
PatientExam
 Untreated LDL-C:
254 mg/dL
 TC: 335 mg/dL
 HDL-C: 67 mg/dL
 TG: 51 mg/dL
 Lp(a): 212 nmol/L
 Apo B: 168 mg/dL
FHScreening
FH Screening Heterozygous FH
Personal/FamilyHistory
• Mother: Hypercholesterolemia, treated with
statin; experienced stroke at age 60 y
• Father: Hypercholesterolemia, treated
with statin; MI at age 59 y
• Sister: 51 y, untreated LDL-C of 242 mg/dL;
7 coronary stents placed for unstable angina
beginning at age 37 y
• Jane: Became a vegan after sister’s MI;
reluctant to begin statin due to fear
of dementia
Consider familial hypercholesterolemia (FH) diagnosis if patient meets the following criteria1-4
:
• Family history of premature CHD (age <55 y in men, <65 y in women)
• High LDL-C while off treatment
– Age <20 y: ≥160 mg/dL
– Age ≥20 y: ≥190 mg/dL
The presence of xanthomas, corneal arcus, and xanthelasmas before the age of 60 are highly suggestive of FH, more specifically
homozygous FH (HoFH), although sitosterolemia should be ruled out as a cause.5
F + H = FH
Family history of early cardiac events + High cholesterol
Access the activity, “Following the Evidence: LDL-C as a Path to Reducing
Cardiovascular Events—How Low Do We Go?” at www.peerview.com/JCD40.

3. Reducing Cardiovascular Events
With LDL-C: A Patient CaseBook
for Physicians
PRACTICE AID
For
Refill times
Date
 Add PCSK9 inhibitor to further reduce Jane’s LDL-C
Treatment Recommendations
Case 2: Jane
47-Year-OldWomanWithVery High LDL-C
After initiation of atorvastatin 40 mg/d and ezetimibe 10 mg/d,
she has a repeat metabolic panel
 LDL-C: 110 mg/dL
 HDL-C: 57 mg/dL
 TC: 182 mg/dL
 TG: 76 mg/dL
 Lp(a): 218 nmol/L
 Fasting blood glucose:
76 mg/dL
 Serum creatinine:
0.82 mg/dL
 ALT: 23 U/L
 AST: 26 U/L
Repeat
MetabolicPanel
Access the activity, “Following the Evidence: LDL-C as a Path to Reducing
Cardiovascular Events—How Low Do We Go?” at www.peerview.com/JCD40.

4. Reducing Cardiovascular Events
With LDL-C: A Patient CaseBook
for Physicians
PRACTICE AID
For
Refill times
Date
 Consider ezetimibe to further reduce Carol’s LDL-C
 PCSK9 inhibitor or other lipid-lowering therapy may be
considered if LDL-C is ≥70 mg/dL despite statin + ezetimibe
Treatment Recommendations
Case 3: Carol
60-Year-Old FemaleWith PAD and LDL-C of 105 mg/dL
Despite High-Dose StatinTherapy
Past Medical History
• Left leg pain with ambulation
• Symptoms occur with prolonged
walking; described as cramping
in calf and thigh
• Hyperlipidemia
• Type 2 diabetes
Medications
• Atorvastatin 80 mg/d
• Clopidogrel 75 mg/d
• Metformin 1,000 mg 2x/d
• Saxagliptin 5 mg/d
• Multivitamin daily
PatientInformation
 LDL-C: 105 mg/dL
 HDL-C: 45 mg/dL
 TC: 210 mg/dL
 TG: 298 mg/dL
 Lp(a): 82 nmol/L
 Fasting blood glucose:
125 mg/dL
 HbA1c: 7.2
MetabolicPanel
Access the activity, “Following the Evidence: LDL-C as a Path to Reducing
Cardiovascular Events—How Low Do We Go?” at www.peerview.com/JCD40.

5. ACC: American College of Cardiology; AHA: American Heart Association; CHD: coronary heart disease; Lp(a): lipoprotein(a); PAD: peripheral artery disease; TC: total cholesterol; TG: triglycerides.
1. Gonzalez-Santos L, Underberg J. J Clin Lipidol. 2011;5:229. 2. Stone NJ et al. Circulation. 2014;129(Suppl.2):S1-S45. 3. O’Brien E et al. Am Heart Journal. 2014;167:342-349. 4. Hopkins PN et al. J Clin Lipidol.
2011;5:S9-S17. 5. Hopkins PN et al. J Clin Lipidol. 2011;5:S9-S17.
Reducing Cardiovascular Events
With LDL-C: A Patient CaseBook
for Physicians
PRACTICE AID
For
Refill times
Date
 Since Linda is statin intolerant, consider PCSK9 inhibitor
or other lipid-lowering therapy if LDL-C is ≥70 mg/dL
despite ezetimibe
Treatment Recommendations
Case 4: Linda
65-Year-Old FemaleWho Had an Ischemic Stroke
6 Months Ago and Is Statin Intolerant
Past Medical History
• Stroke 6 mo ago
• Former smoker
(quit following stroke)
• Unable to tolerate statin therapy
(muscle aches)
Medications
• Aspirin 81 mg/d
• Ezetimibe 10 mg/d
• Valsartan 160 mg/d
PatientInformation
 LDL-C: 120 mg/dL
 HDL-C: 53 mg/dL
 TC: 205 mg/dL
 TG: 160 mg/dL
 Lp(a): 102 nmol/L
 BP: 132/78 mmHg
 Fasting blood glucose:
80 mg/dL
MetabolicPanel
Access the activity, “Following the Evidence: LDL-C as a Path to Reducing
Cardiovascular Events—How Low Do We Go?” at www.peerview.com/JCD40.

6. Access the activity, “Following the Evidence: LDL-C as a Path to Reducing
Cardiovascular Events—How Low Do We Go?” at www.peerview.com/JCD40.
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Apo B: apolipoprotein B100; ASCVD: atherosclerotic cardiovascular disease; ASPC: American Society for Preventive Cardiology; FH: familial hypercholesterolemia; HeFH: heterozygous familial
hypercholesterolemia; HoFH: homozygous familial hypercholesterolemia; ICD: International Classification of Diseases; LDL-R: low-density lipoprotein receptor; LLM: lipid-lowering medication; NLA: National
Lipid Association; NPI: National Provider Identifier; PAD: peripheral artery disease; PCSK9: proprotein convertase subtilisin/kexin type 9.
1. Baum SJ et al. Clin Cardiol. 2017;40:243-254. 2. Cohen JD et al. J Clin Lipidol. 2017;11:891-900. 3. https://www.lipid.org/node/2289. Accessed October 26, 2018. 4. https://www.aspconline.org/aspc-mobile-app/.
Accessed October 28, 2018. 5. https://www.prnewswire.com/news-releases/american-society-for-preventive-cardiology-aspc-to-introduce-innovative-mobile-app-to-access-pcsk9-inhibitors-at-a-town-hall-
during-the-acc18-the-american-college-of-cardiologys-annual-scientific-session--expo-300605789.html. Accessed October 28, 2018.
PCSK9 Inhibitor Access:
NLA Checklist, Prior Authorization
Form, and Approval Letter Template1-5
PRACTICE AID
NLA Information Checklist
for PCSK9 Inhibitor Approval Applications
Get the ASPC Mobile App
Indication and documentation of medical conditions (ASCVD or FH)

A recent lipid panel (<30 days old)

Statin use history

Failure to achieve LDL-C goal despite maximally tolerated statin therapy

Documentation of adjunctive lipid-lowing therapy
Simplifies the
process for clinicians
and their office
staff to gain patients
access to PCSK9
inhibitors


7. PRACTICE AID
PCSK9 Inhibitor Prior Authorization Form
(to be completed by prescriber)
Prescriber Information Patient Information
Prescriber’s NPI: Patient’s medical ID #:
Prescriber name: Patient name:
Phone #: ( ) Patient DOB:
Fax #: ( ) Primary ICD diagnosis code:
Prescription Information
Drug requested: Frequency of dosing:
 New therapy  Continuation Quantity requested:
Clinical Information
Patient age 18 years or older:  yes  no Patient pregnant:  yes  no
Is there a diagnosis of clinical ASCVD, heterozygous familial hypercholesterolemia (HeFH),
or homozygous hypercholesterolemia (HoFH)? Circle all that apply.
 yes
 no
Is taking his/her maximally tolerated statin dose?
Maximally tolerated statin therapy is defined as the highest tolerated intensity and frequency of a statin, even if the
dose is zero. This is preferably the guideline-recommended intensity of statin, but may of necessity be a lower-
intensity dose or reduced frequency of statin dosing, or even no statin at all. Statin intolerance can be defined as
unacceptable adverse effects that resolve with discontinuation of therapy and recur with rechallenge of two to
three statins, preferably ones that use different metabolic pathways with one of which being prescribed at the
lowest approved dose.
 yes
 no
Has HeFH.
HeFH is defined as untreated LDL-C ≥160 mg/dL for children and ≥190 mg/dL for adults and with one first-degree
relative similarly affected or with premature coronary artery disease or with positive genetic testing for an
LDL-C–raising gene defect (LDL-R, Apo B, or PCSK9).
 yes
 no
Has HoFH.
HoFH is defined as LDL-C ≥400 mg/dL and one or more parent with clinically diagnosed FH, positive genetic testing
for two LDL-C–raising gene defects (LDL-R, Apo B, or PCSK9), or autosomal-recessive FH.
 yes
 no
Has Clinical ASCVD.
Clinical ASCVD includes acute coronary syndromes, history of MI, stable or unstable angina, coronary or other arterial
revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin, as well as other
forms of atherosclerotic vascular disease including significant atherosclerosis of the coronary, carotid, iliofemoral
circulations, and the aorta. Documentation of ASCVD requiring additional lipid lowering.
 yes
 no
Requires additional LDL lowering.
Patients with clinical ASCVD, HeFH, or HoFH who may require additional lowering of LDL-C, including those with less than expected
percent reduction in LDL-C or residual absolute levels of LDL-C, non–HDL-C, or Apo B that exceed goals for atherogenic lipoproteins as
specifically defined in any of the current guidelines for these very high-risk and “extreme risk” populations.
Baseline LDL: Current LDL:
Current lipid lowering medication and amount
In my professional opinion, this patient requires the medication prescribed. The information provided supports this opinion.
Prescriber's signature: Date:
Check all that apply:
 Acute coronary syndrome  History of MI  Stable or unstable angina  Coronary revascularization
 Other arterial revascularization  Stroke  TIA  PAD
Extensive subclinical atherosclerosis:
• Coronary circulation • Carotid circulation
• Iliofemoral circulation • Atherosclerosis of the aorta
 Statin:  Dose:  Ezetimibe:
 Other LLMs:  Dose: LDL apheresis  yes  no
Baum SJ et al. Clin Cardiol. 2017;40:243-254.

8. To whom it may concern:
This letter provides the necessary information supporting the request to treat
with . Our mutual patient:
Is taking his/her maximally tolerated statin dose.
Maximally tolerated statin therapy is defined as the highest tolerated intensity and frequency of a statin, even if the dose is zero.
This is preferably the guideline-recommended intensity of statin but may of necessity be a lower-intensity dose, or reduced
frequency of statin dosing, or even no statin at all. Statin intolerance can be defined as unacceptable adverse effects that
resolve with discontinuation of therapy and recur with rechallenge of two to three statins, preferably ones that use different
metabolic pathways with one of which being prescribed at the lowest approved dose.
Has HeFH.
HeFH is defined as untreated LDL-C ≥160 mg/dL for children and ≥190 mg/dL for adults and with one first-degree relative
similarly affected or with premature coronary artery disease or with positive genetic testing for an LDL-C–raising gene defect
(LDL-R, Apo B, or PCSK9).
Has HoFH.
HoFH is defined as LDL-C ≥400 mg/dL and one or more parent with clinically diagnosed FH, positive genetic testing for two
LDL-C–raising gene defects (LDL-R, Apo B, or PCSK9), or autosomal-recessive FH.
Has Clinical ASCVD.
Clinical ASCVD includes acute coronary syndromes, history of MI, stable or unstable angina, coronary or other arterial
revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin, as well as other forms of
atherosclerotic vascular disease including significant atherosclerosis of the coronary, carotid, iliofemoral circulations, and the
aorta.
Requires additional LDL lowering.
Patients with clinical ASCVD, HeFH, or HoFH who may require additional lowering of LDL-C include those with less than
expected percent reduction in LDL-C or residual absolute levels of LDL-C, non–HDL-C, or Apo B that exceed goals for
atherogenic lipoproteins as specifically defined in any of the current guidelines for these very high-risk and “extreme risk”
populations.
I look forward to your timely approval for our mutual patient. I am available to provide more information if you desire. Time is
of the essence; our patient and I appreciate your alacrity.
NB: supportive medical records provided.
PRACTICE AID
Patient name:
Insurance ID #:
Address:
City, State, Zip:
In my professional opinion, this patient requires the medication prescribed.
The information provided supports this opinion.
Prescriber’s signature:
Date:
Date:
Baum SJ et al. Clin Cardiol. 2017;40:243-254.