Rezdiffra (resmetirom)- NC Standard

Restricted Product(s)

• Rezdiffra (resmetirom)

FDA Approved Use

For the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in conjunction with diet and exercise.

Criteria for Initial Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient has a confirmed diagnosis of NASH fibrosis suggested by the historical data and meets ONE of the following (medical record documentation required); 
   1. Historical biochemical test for fibrosis: PRO-C3 >14 ng/mL or ELF ≥9; OR 
   2. Vibration-controlled transient elastography (e.g., Fibroscan) with kPa greater than or equal to 8.5 AND controlled attenuation parameter (CAP) greater than or equal to 280 dB.m-1; OR 
   3. Liver biopsy within the past 2 years confirming steatosis AND ALL the following: 
      1. NAFLD Activity Score (NAS) greater than or equal to 4; AND 
      2. A score of at least 1 in each NAS component [i.e., steatosis (scored 0 to 3), ballooning degeneration (scored 0 to 2), lobular inflammation (scored 0 to 3)]; AND 
      3. Fibrosis stage 1, 2, or 3; AND 
3. The patient will use the requested medication in combination with lifestyle interventions, including diet and exercise (medical record documentation required); AND 
4. The patient does NOT have ANY of the following: 
   1. Significant alcohol consumption; OR 
   2. Hepatocellular carcinoma (HCC); OR 
   3. Uncontrolled diabetes (HbA1c ≥ 9.0%); OR 
   4. Any other liver disease (e.g., decompensated cirrhosis, Wilson's disease, hepatitis); OR 
   5. MELD score greater than or equal to 12 unless due to therapeutic anticoagulation; OR 
   6. History of bariatric surgery (within the past 5 years); AND
5. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, hepatologist); AND 
6. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Criteria for Continued Approval

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient will continue to use requested medication in combination with lifestyle interventions, including diet and exercise (medical record documentation required); AND 
3. The patient has had clinical benefit with the requested agent (i.e., resolution of steatohepatitis and no worsening of liver fibrosis OR improvement in liver fibrosis and no worsening of steatohepatitis) (medical record documentation required); AND 
4. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
5. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, hepatologist).
   
   Duration of Approval: 365 days (1 year)

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.

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.

May 2024: Criteria update: Remove requirement of MRI-PDFF.
April 2024: Original utilization management criteria issued.