Download Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors

REVIEW REQUEST FOR
Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors
(Praluent®/Repatha®)
Provider Data Collection Tool Based on Medical Policy DRUG.00078
Policy Last Review Date:
02/02/2017
Request Date:
/
Initial Request
Buy and bill
/
Policy Effective Date:
03/29/2017
Provider Tool Effective Date:
Subsequent Request
Individual’s Name:
Date of Birth:
/
/
Individual’s Phone Number:
Insurance Identification Number:
Primary Diagnosis:
10/01/2016
Diagnosis Code(s) (if known):
Ordering Provider Name & Specialty:
Individual’s Weight
(lbs) (kg)
Provider ID Number (if known):
Office Address:
Contact Name and Office Phone Number:
Office Fax Number:
Servicing Provider Name & Specialty (If different than Ordering Provider):
Provider ID Number (if known):
Office Address:
Contact Name and Office Phone Number:
Office Fax Number:
Place of Service:
Home
Office
Dialysis Center
Outpatient Hospital
Ambulatory Infusion
Ambulatory Infusion Center
Other:
Drug Name/HCPCS Code (if known)
Dose to be administered:
Alirocumab (Praluent®)
J3490
J3590
Evolocumab (Repatha®)
J3490
J3590
Other:
When did the individual first start this drug?
Frequency (Days, Wks, Months)
/
/
Duration:
Start Date For This Request:
(Weeks)
/
/
mg/ml
(other)
This medical policy based data collection tool is for a provider medical necessity review request for the initial and
continued use of PCSK9 inhibitors, Alirocumab (Praluent®) or Evolocumab (Repatha®), to reduce serum low-density
lipoprotein cholesterol (LDL-C) levels in individuals with primary hypercholesterolemia who cannot tolerate or
have not had an adequate response to the currently available lipid lowering therapies.
Please check all of the following that apply to the individual.
Request is for initial use of Alirocumab (Praluent®) or Evolocumab (Repatha®)
(If checked, complete Sections 1-4 below)
Request is for continued use of Alirocumab (Praluent®) or Evolocumab (Repatha®)
(If checked, complete Sections 1-5 below)
REVIEW REQUEST FOR
Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors
(Praluent®)
Provider Data Collection Tool Based on Medical Policy DRUG.00078
Policy Last Review Date: 02/02/2017
Policy Effective Date: 03/29/2017
Provider Tool Effective Date: 10/01/2016
Alirocumab (Praluent®)/ Evolocumab (Repatha®)
Section 1.
Individual is age 18 years or older and is at high risk for Acute Coronary Syndrome (ACS)
Individual is age 13 years or older and is at high risk for Acute Coronary Syndrome (ACS)
(If EITHER of the above is checked, identify how the individual’s high risk was determined by marking
the following, as is appropriate for the individual)
Individual has Homozygous Familial Hypercholesterolemia (HoFH) confirmed by:
Presence of 2 mutant alleles at the LDLR, apoB, PCSK9 or ARH adaptor gene locus
An untreated LDL-C concentration greater than 500 mg/dL (13 mmol/L) or treated LDL-C greater than
or equal to 300 mg/dL (7.76 mmol/L) and one of the following:
Cutaneous or tendonous xanthoma before age of 10 years
Untreated LDL-C levels consistent with heterozygous familial hypercholesterolemia in both parents
(greater than 190 mg/dL)
Individual has Heterozygous Familial Hypercholesterolemia (HeFH) confirmed by:
Presence of a mutation in LDLR, apolipoprotein B (ApoB), PCSK9 or ARH adaptor protein (LDLRAP1)
gene
A World Health Organization (WHO)/Dutch Lipid Network Criteria score greater than 8 points
Individual has a history of clinical Atherosclerotic Cardiovascular Disease (ASCVD)
(If checked, mark all of the following that apply to the individual)
a history of Acute Coronary Syndromes
a history of Myocardial Infarction (MI)
a history of stable or unstable angina
a history of coronary or other arterial revascularization
a history of Stroke
a history of Transient ischemic attack (TIA)
a history of Peripheral arterial disease presumed to be of atherosclerotic origin
Section 2.
Individual is on high intensity statin therapy, or statin therapy at the maximum tolerated dose where
high intensity statin is defined as atorvastatin 40 mg or higher OR rosuvastatin 20 mg or higher
Individual is statin intolerant, as defined by the National Lipid Association Statin Intolerance Panel
(If checked, mark all of the following that apply)
Individual is not able to tolerate at least 2 statins, with at least 1 started at the lowest starting daily dose
Statin dose reduction is attempted for symptom and biomarker abnormality resolution, rather than
discontinuation of statin therapy altogether
Intolerable symptoms or abnormal biomarker changes are reversible upon statin discontinuation,
but reproducible by re-challenge**of statins, [**Statin re-challenge may be appropriate for individuals who are
symptomatic, and whose creatine kinase is less than 4 times the upper limit of normal, and for individuals whose
AST/ALT is less than 3 times the upper limit of normal, per laboratory reference ranges]
A statin re-challenge** is not clinically appropriate for this individual
Symptoms or biomarker abnormalities are not attributable to established predispositions or conditions
recognized to increase the risk of statin intolerance, such as:
Individual does not have hypothyroidism
Individual has not had drug interactions
Individual has not had concurrent illness
Individual has not had significant changes in physical activity/exercise
Individual does not have underlying muscle disease
Individual has a condition that is a contraindication for statin therapy, including active liver disease,
unexplained persistent elevation of serum transaminases or pregnancy
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REVIEW REQUEST FOR
Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors
(Praluent®)
Provider Data Collection Tool Based on Medical Policy DRUG.00078
Policy Last Review Date: 02/02/2017
Policy Effective Date: 03/29/2017
Provider Tool Effective Date: 10/01/2016
Section 3.
Individual is on ezetimibe (ZETIA®) in addition to statin therapy (applies to individuals on statin therapy only)
Individual is high risk and has achieved suboptimal lipid lowering response, despite at least 3 months of compliant lipid
lowering therapy and lifestyle modifications, where suboptimal response is defined as:
Individual’s initial LDL-C is known and there has been less than 50% reduction in the LDL-C
Individual’s initial LDL-C is unknown and the documented CVD and LDL-C remains greater than or
equal to 70mg/dl
Individual’s initial LDL-C is unknown and there is NO documented history of CVD and LDL-C remains
greater than or equal to 100mg/dl
Section 4
Alirocumab (Praluent®/Repatha®) will NOT be used concurrently with omitapide
Alirocumab (Praluent®/Repatha®) will NOT be used concurrently with mipomersen
Section 5. Continued Use
Request is for continued use of Alirocumab (Praluent®) Section
Request is for continued use of Evolocumab (Repatha®)
Please list the clinical evidence of LDL reduction with dates:
Initial Level: _________________________
Subsequent Levels:________________________________________________________
This request is being submitted:
Pre-Claim
Post–Claim. If checked, please attach the claim or indicate the claim number
I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its
designees may perform a routine audit and request the medical documentation to verify the accuracy of the information
reported on this form.
/
/
Name & Title of Provider or Provider Representative Completing Form
Date
& attestation (Please Print)*
*The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted
Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization
management services on behalf of your health benefit plan or the administrator of your health benefit plan.
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