Table 13: Lipid-Lowering Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Cardiovascular
Medication Class/Individual Agents: Lipid-Lowering Agent
I. Prior-Authorization Requirements
Lipid-Lowering Agents – Bile Acid Sequestrants |
Clinical Notes |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
Available treatment guidelines for the management of hyperlipidemia include:
1. Grundy SM, Cleeman JI, Merz NB, Brewer Jr B, Clark LT, Hunninghake DB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-39. 2.Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PWF. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;00:000–000. DOI: 10.1161/01.cir.0000437738.63853.7a 3. Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS et al. AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary. Circulation. 2018 Nov 10:CIR0000000000000624. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Lipid-Lowering Agents – Cholesterol Absorption Inhibitors |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Lipid-Lowering Agents – Fibric Acids |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Lipid-Lowering Agents – Nicotinic Acids |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Lipid-Lowering Agents – Not Otherwise Classified |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Lipid-Lowering Agents – PCSK9 Inhibitors |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Lipid-Lowering Agents – Statins |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
| # | This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. |
| BP | Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent. |
| * | The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization. |
II. Therapeutic Uses
Fenoglide
FDA-approved, for example:
- hypercholesterolemia
- hypertriglyceridemia
- mixed dyslipidemias
icosapent ethyl
FDA-approved, for example:
- cardiovascular risk reduction (with established cardiovascular disease or diabetes mellitus and risk factors for cardiovascular disease)
- hypertriglyceridemia (not inclusive of those with established cardiovascular disease or diabetes mellitus and cardiovascular risk factors)
Juxtapid
FDA-approved, for example:
- homozygous familial hypercholesterolemia (HoFH)
Nexletol, Nexlizet
FDA-approved, for example:
- atherosclerotic cardiovascular disease
- heterozygous familial hypercholesterolemia (HeFH)
Praluent, Repatha
FDA-approved, for example:
- HeFH in combination with a statin
- HoFH in combination with a statin
- hypercholesterolemia in a member with clinical atherosclerotic cardiovascular disease in combination with a statin
Statins
FDA-approved, for example:
- hypercholesterolemia
Note: The above list may not include all FDA-approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
- All PA requests must include clinical diagnosis, drug name, dose, and frequency.
- A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
- For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
- Additional criteria may apply, depending upon the member's condition and requested medication (see below).
Table 1. Statin Quantity Limits
|
1 unit/day |
1.5 units/day |
2 units/day |
|
Altoprev 60 mg |
Altoprev 20 mg, 40 mg |
fluvastatin 40 mg |
|
amlodipine/atorvastatin |
atorvastatin 10 mg, 20 mg, 40 mg |
lovastatin 40 mg |
|
atorvastatin 80 mg |
Ezallor 5 mg, 10 mg, 20 mg |
|
|
Ezallor 40 mg |
fluvastatin 20 mg |
|
|
ezetimibe/simvastatin |
Livalo 1 mg, 2 mg |
|
|
fluvastatin extended-release 80 mg |
lovastatin 10 mg, 20 mg |
|
|
Livalo 4 mg |
pravastatin 10 mg, 20 mg, 40 mg |
|
|
pravastatin 80 mg |
rosuvastatin 5 mg, 10 mg, 20 mg |
|
|
rosuvastatin 40 mg |
simvastatin 5 mg, 10 mg, 20 mg, 40 mg |
|
|
simvastatin 80 mg |
Zypitamag 1 mg, 2 mg
|
|
|
Zypitamag 4 mg |
|
|
Altoprev, amlodipine/atorvastatin, fluvastatin, fluvastatin extended-release, Livalo, and Zypitamag
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response to ≥ 40 mg/day of rosuvastatin for at least three months, adverse reaction, or contraindication to rosuvastatin; or
- clinical rationale for not using rosuvastatin; and
- one of the following:
- request is within quantity limits; or
- medical necessity for the requested agent above quantity limits.
atorvastatin, ezetimibe/simvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin over quantity limits
- Documentation of the following is required:
- appropriate diagnosis; and
- medical necessity for the requested agent above quantity limits.
cholestyramine resin powder
- Documentation of the following is required:
- appropriate diagnosis; and
- clinical rationale why other commercially available alternatives cannot be used.
Ezallor
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response or adverse reaction to rosuvastatin tablet; or
- medical necessity for the use of a sprinkle capsule formulation; and
- one of the following:
- request is within quantity limits; or
- medical necessity for the requested agent above quantity limits.
fenofibrate 40 mg, 120 mg tablet
- Documentation of the following is required:
- appropriate diagnosis; and
- medical records documenting an inadequate response or adverse reaction to a therapeutically equivalent fenofibrate formulation; and
- one of the following:
- requested quantity is ≤ one unit/day; or
- medical necessity for the requested agent above quantity limits.
icosapent ethyl for cardiovascular risk reduction (with established cardiovascular disease or diabetes mellitus and risk factors for cardiovascular disease)
- Documentation of the following is required:
- diagnosis of cardiovascular risk reduction with one of the following;
- member has established cardiovascular disease (e.g., prior MI, hospitalization for high-risk NSTE-ACS cerebrovascular or carotid disease: prior ischemic stroke, carotid artery disease, PAD); or
- member has diabetes mellitus with at least two risk factors for CVD (e.g., age [women ≥ 65 years, men ≥ 55 years], smoker, HTN, low HDL-C [≤ 40 mg/dL for men and ≤ 50 mg/dL for women], renal dysfunction [CrCl >30 and < 60 mL/min], retinopathy, micro- or macroalbuminuria); and
- triglyceride level ≥ 150 mg/dL; and
- one of the following:
- agent to be used in combination with a statin; or
- clinical rationale why member cannot take a statin; and
- one of the following:
- for icosapent ethyl 1 gm capsule, requested quantity is ≤ four capsules/day; or
- for icosapent ethyl 0.5 gm capsule, requested quantity is ≤ eight capsules/day; or
- medical necessity for the requested agent above quantity limits.
- diagnosis of cardiovascular risk reduction with one of the following;
SmartPA: Claims for icosapent ethyl 1 gm capsule at a quantity of ≤ four units/day will usually process at the pharmacy without a PA request if the member has history of paid MassHealth pharmacy claims for at least 90 days out of the last 120 days of the requested agent.†
icosapent ethyl for hypertriglyceridemia (not inclusive of those with established cardiovascular disease or diabetes mellitus and cardiovascular risk factors)
- Documentation of the following is required:
- diagnosis of hypertriglyceridemia (not inclusive of those with established cardiovascular disease or diabetes mellitus and cardiovascular risk factors); and
- triglyceride level ≥ 500 mg/dL; and
- inadequate response, adverse reaction, or contraindication to omega-3 acid ethyl esters; and
- inadequate response, adverse reaction, or contraindication to a fibric acid derivative (i.e., fenofibrate or gemfibrozil); and
- one of the following:
- for icosapent ethyl 1 gm capsule, requested quantity is ≤ four capsules/day; or
- for icosapent ethyl 0.5 gm capsule, requested quantity is ≤ eight capsules/day; or
- medical necessity for the requested agent above quantity limits.
SmartPA: Claims for icosapent ethyl 1 gm capsule at a quantity of ≤ four units/day will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for at least 90 days out of the last 120 days of the requested agent.†
Juxtapid
- Documentation of the following is required:
- appropriate diagnosis; and
- laboratory test confirming genetic mutation associated with HoFH including low density lipoprotein receptor (LDLR) mutations, PCSK9 mutations and familial defective apoB mutations; and
- age ≥ 18 years; and
- one of the following:
- inadequate response to ≥ 40 mg of rosuvastatin for at least three months, adverse reaction, or contraindication to rosuvastatin; or
- clinical rationale for not using rosuvastatin; and
- one of the following:
- agent to be used as add-on therapy with a high-intensity statin; or
- contraindication to statin therapy; and
- inadequate response, adverse reaction, or contraindication to LDL-C apheresis; and
- one of the following:
- inadequate response or adverse reaction to one additional non-statin lipid-lowering agent (ezetimibe, niacin, fibric acid derivative or bile acid sequestrant); or
- contraindication to all other available lipid-lowering agents.
Nexletol and Nexlizet
- Documentation of the following is required:
- appropriate diagnosis; and
- age ≥ 18 years; and
- one of the following:
- requested agent will be used in combination with a statin; or
- clinical rationale why member cannot take a statin; and
- requested quantity is ≤ one tablet/day; and
- one of the following:
- inadequate response to combination therapy with either atorvastatin at a dose of 80 mg daily or rosuvastatin at a dose of 40 mg daily and ezetimibe for at least three consecutive months;* or
- inadequate response to combination therapy with either atorvastatin at a dose < 80 mg daily or rosuvastatin at a dose < 40 mg daily and ezetimibe for at least three consecutive months* and intolerance to higher doses of atorvastatin or rosuvastatin; or
- for Nexletol, inadequate response to either atorvastatin at a dose of 80 mg daily or rosuvastatin at a dose of 40 mg daily for at least three consecutive months* and adverse reaction or contraindication to the use of ezetimibe; or
- for Nexletol, all of the following:
- inadequate response to either atorvastatin at a dose < 80 mg daily or rosuvastatin at a dose < 40 mg daily for at least three consecutive months;* and
- intolerance to higher doses of atorvastatin or rosuvastatin; and
- adverse reaction or contraindication to the use of ezetimibe.
*Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.
Praluent
- Documentation of the following is required:
- age ≥ 18 years; and
- diagnosis is hypercholesterolemia with one of the following:
- for members with a diagnosis of heterozygous familial hypercholesterolemia, current LDL-C is ≥ 100 mg/dL; or
- for members with a previous history of a cardiovascular event, current LDL-C is ≥ 70 mg/dL; and
- requested agent will be used in combination with a statin;* and
- requested quantity is two pens or syringes/28 days; and
- one of the following:
- prescriber is a specialist (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); or
- prescriber provides consultation notes from a cardiologist regarding the use of the agent (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); and
- one of the following:
- inadequate response to combination therapy with rosuvastatin at a dose of 40 mg daily and ezetimibe for at least the past three months;** or
- inadequate response to combination therapy with rosuvastatin at a dose < 40 mg daily and ezetimibe for at least the past three months** and intolerance to higher doses of rosuvastatin; or
- inadequate response to rosuvastatin at a dose of 40 mg daily for at least the past three months** and adverse reaction or contraindication to the use of ezetimibe; or
- all of the following:
- inadequate response to rosuvastatin at a dose < 40 mg daily for at least the past three months;** and
- intolerance to higher doses of rosuvastatin; and
- adverse reaction or contraindication to the use of ezetimibe.
*Recertification of the requested agent will be contingent upon MassHealth pharmacy claims history or additional documentation addressing adherence to the entire lipid-lowering regimen, as well as positive response to therapy including decrease in LDL-C laboratory values from baseline.
**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.
Repatha
- Documentation of the following is required:
- one of the following:
- diagnosis is homozygous familial hypercholesterolemia and age ≥ 13 years; or
- age ≥ 18 years; and
- diagnosis is hypercholesterolemia with one of the following:
- for members with a diagnosis of heterozygous or homozygous familial hypercholesterolemia, current LDL-C is ≥ 100 mg/dL; or
- for members with a previous history of a cardiovascular event, current LDL-C is ≥ 70 mg/dL; and
- requested agent will be used in combination with a statin;* and
- one of the following:
- prescriber is a specialist (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); or
- prescriber provides consultation notes from a cardiologist regarding the use of the agent (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); and
- one of the following:
- inadequate response to combination therapy with rosuvastatin at a dose of 40 mg daily and ezetimibe for at least the past three months;** or
- all of the following:
- inadequate response to rosuvastatin at a dose < 40 mg daily for at least the past three months;** and
- intolerance to higher doses of rosuvastatin; and
- adverse reaction or contraindication to the use of ezetimibe; or
- inadequate response to combination therapy with rosuvastatin at a dose < 40 mg daily and ezetimibe for at least the past three months** and intolerance to higher doses of rosuvastatin; or
- inadequate response to rosuvastatin at a dose of 40 mg daily for at least the past three months** and adverse reaction or contraindication to the use of ezetimibe; and
- one of the following:
- requested quantity is two autoinjectors or syringes/28 days and one of the following:
- diagnosis is heterozygous familial hypercholesterolemia or hypercholesterolemia in a member with a previous history of any cardiovascular event; or
- diagnosis is homozygous familial hypercholesterolemia and clinical rationale for every-two-week dosing is provided; or
- requested quantity is three autoinjectors or syringes/28 days and all of the following:
- medical necessity for use of three injections given once monthly over the use of the once-monthly on-body infusor system; and
- for members with heterozygous familial hypercholesterolemia or hypercholesterolemia in a member with a previous history of any cardiovascular event, medical necessity for once-monthly dosing is provided; or
- requested quantity is 3.5 mL/28 days of on-body infusor system.
- requested quantity is two autoinjectors or syringes/28 days and one of the following:
- one of the following:
*Recertification of the requested agent will be contingent upon MassHealth pharmacy claims history or additional documentation addressing adherence to the entire lipid-lowering regimen, as well as positive response to therapy including decrease in LDL-C laboratory values from baseline.
**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.
Original Effective Date: 10/2002
Last Revised Date: 12/2020
Clinical Criteria Main Page | Back to top | Previous | Next
Last updated 01/26/21