Tegsedi - NC Standard

Restricted Product(s)

• Tegsedi™ (inotersen) injection

FDA Approved Use

• For treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND
2. The patient has been diagnosed with hereditary transthyretin-mediated amyloidosis confirmed by genetic testing or biopsy (medical record documentation required); AND 
3. The patient will be using Tegsedi in the management of polyneuropathy with clinical manifestations (e.g., neuropathic pain, altered sensation, numbness, tingling, impaired balance, motor disability) (medical record documentation required); AND
4. The patient has not had a history of acute glomerulonephritis caused by Tegsedi; AND
5. The patient has been assessed for ALL the following prior to therapy initiation: platelet count, serum creatinine, estimated glomerular filtration rate (eGFR), urine protein to creatinine ratio (UPCR), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, and perform urinalysis; AND
6. The patient has a baseline platelet count ≥ 100 x 109 /L (medical record documentation required); AND 
7. The patient has a urine protein creatinine ratio (UPCR) < 1000 mg/g (medical record documentation required); AND 
8. The patient does not have moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment; AND
9. The patient will not be using Tegsedi in combination with Onpattro, Amvuttra or Wainua; AND
10. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND
11. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., geneticist, neurologist); AND 
12. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
    
    Duration of Approval: 365 days (1 year)

Continuation Criteria

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 has experienced clinical benefit since initiation of therapy (e.g., polyneuropathy symptom improvement) (medical record documentation required); AND
3. The patient will not be using Tegsedi in combination with Onpattro, Amvuttra or Wainua; 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., geneticist, neurologist).
   
   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

January 2024: Criteria change: Added requested medication cannot be used in combination with Wainua to initial and continuation criteria.
July 2022 v2: Criteria change: Added requested medication cannot be used in combination with Amvuttra to initial and continuation criteria.
July 2022: Criteria change: Update to include urine protein creatinine ratio (UPCR) and hepatic classification in the initial criteria. Added continuation criteria and required patient be managed by or in consultation with a specialist. Added requested medication cannot be used in combination with Onpattro to initial and continuation criteria.
September 2021: Criteria update. Annual criteria review. No changes to policy.
Nov 2018: Original utilization management criteria issued.