Zelboraf - NC Standard

Restricted Product(s)

• Zelboraf® (vemurafenib)

FDA Approved Use

• For the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test 
• For the treatment of patients with Erdheim-Chester disease (ECD) with a BRAF V600 mutation

Criteria for Approval of Restricted Product(s)

Initial Coverage

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. The patient has been diagnosed with Erdheim-Chester Disease (medical record documentation required); AND 
   1. Tumor specimens confirm the presence of BRAF V600 mutation (medical record documentation required); AND 
   2. The patient will be taking Zelboraf as a single agent; OR 
4. The patient has been diagnosed with unresectable or metastatic melanoma (medical record documentation required); AND 
   1. Tumor specimens confirm the presence of BRAF V600E mutation (medical record documentation required); AND 
   2. The patient does not have wild-type BRAF melanoma; AND 
   3. Zelboraf must be used in combination with Cotellic in patients that are BRAF V600E mutation-positive (medical record documentation required); AND 
5. The patient will not be taking Zelboraf in combination with another BRAF kinase inhibitor (e.g. Taflinar), immunotherapy (e.g.nivolumab, ipilimumab, pembrolizumab), or Mekinist; AND 
6. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., oncologist); AND 
7. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; 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

1. The patient has been previously approved for Zelboraf 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 not be taking Zelboraf in combination with another BRAF kinase inhibitor (e.g. Taflinar), immunotherapy (e.g.nivolumab, ipilimumab, pembrolizumab), or Mekinist; AND 
3. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
4. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., oncologist).
   
   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

April 2022: Criteria update: Edited format and added continuation criteria.
September 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).
January 2018: Original utilization management criteria issued.