Nexletol & Nexlizet - NC Standard

Restricted Product(s)

• Nexletol (bempedoic acid) 
• Nexlizet (bempedoic acid and ezetimibe)

FDA Approved Use

• As an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia. 
• To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: 
  • established cardiovascular disease (CVD), or 
  • a high risk for a CVD event but without established CVD.

Criteria for Approval of Restricted Product(s)

Initial Coverage Criteria

1. The patient has ONE of the following: 
   1. A diagnosis of primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]); OR 
   2. The patient is using the requested agent to reduce the risk of myocardial infarction and coronary revascularization AND one of the following: 
      1. The patient has established cardiovascular disease (CVD); OR 
      2. The patient has a high risk for a CVD event; AND 
2. ONE of the following: 
   1. The patient is on concomitant statin therapy; OR 
   2. The patient has an intolerance or hypersensitivity to statin therapy; OR 
   3. The patient has an FDA labeled contraindication to ALL statins; AND 
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 1 year (365 days)

Continuation Coverage Criteria

1. The patient was approved through Blue Cross NC initial coverage criteria or would have met initial criteria for approval at the time they started therapy; AND 
2. The patient has had clinical benefit with the requested agent; AND 
3. ONE of the following: 
   1. The patient is on concomitant statin therapy; OR 
   2. The patient has an intolerance or hypersensitivity to statin therapy; OR 
   3. The patient has an FDA labeled contraindication to ALL statins; AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 1 year (365 days)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7)

Nicholls S, Lincoff AM, Bays HE, et al. Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of bempedoic acid on cardiovascular events in patients with statin intolerance. Am Heart J. 2021 May;235:104-112.

Nissen S, Lincoff AM, Brennan D, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Tolerant Patients. NEJM. 2023; 388:1353-1364.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

July 2024: Criteria change: Added criteria for primary hyperlipidemia. Removed diagnostic criteria for HeFH, established ASCVD, and high risk for ASCVD.

April 2024: Criteria change: Added new FDA approved indication. Updated criteria to allow for cardiovascular risk reduction.

Jan 2024: Criteria update: Updated FDA approved indication. Removed “maximally tolerated” qualifier for statin therapy.

April 2023: Criteria change: Addition of continuation coverage criteria. Decreased Dutch Lipid Score requirement to greater than 5 for HeFH diagnosis. Addition of quantity limits. Modified step through statin therapy requirements.

May 2022: Criteria update: Annual criteria review. Duration of approval decreased to 365 days. October 2020: Criteria change: Require diagnosis of HeFH or ASCVD. Require currently on statin therapy or failure of two statin therapies, one of which was at low dose.

May 2020: Criteria update: Added Nexlizet to the policy.

Mar 2020: Original utilization management criteria issued.