Lybalvi- NC Standard

Restricted Product(s):

• Lybalvi (olanzapine and samidorphan)

FDA Approved Use:

• For the treatment of schizophrenia in adults 
• For the treatment of acute mania or acute episodes with mixed features of bipolar I disorder (as monotherapy or in combination with lithium or valproate), and maintenance monotherapy treatment

Criteria for Approval of Restricted Product(s):

Initial Coverage Criteria

1. The patient is 18 years of age or older; AND 
2. The patient has been diagnosed with schizophrenia or bipolar 1 disorder; AND 
3. The patient is currently on a stable dose of an olanzapine product; AND 
4. The patient has gained ≥5% of baseline body weight since the start of olanzapine therapy; AND 
5. The patient has failed to mitigate weight gain through non-pharmacologic means such as: 
   1. Calorie restriction 
   2. Increased exercise 
   3. Cognitive behavioral therapy 
   4. Psychoeducational interventions; AND 
6. The patient has tried and failed or has a clinical contraindication/intolerance to metformin; AND 
7. The patient is not taking opioids or undergoing acute opioid withdrawal; AND 
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies

Duration of Approval: 365 days (1 year)

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 a positive clinical response to therapy; AND
3. The patient is not taking opioids or undergoing acute opioid withdrawal; AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

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.

Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes Diabetes Care Feb 2004, 27 (2) 596-601; DOI: 10.2337/diacare.27.2.596

Dixon, Lisa & Perkins, Christine & Calmes,. (2009). Guideline Watch (September 2009): Practice Guideline for the Treatment of Patients with Schizophrenia. American Psychiatric Association. 10.1176/appi.books.9780890423929.501001.

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 Q4 annually.

Jan 2025: Criteria change: Policy changed from NC Standard to Enhanced and Essential only

Feb 2023: Criteria update: Continuation coverage criteria added.

Oct 2021: Original utilization management criteria issued.