Oxbryta – NC Standard

Restricted Product(s):

• Oxbryta™ (voxelotor) tablets
• Oxbryta™ (voxelotor) tablets for oral suspension

FDA Approved Use:

• For the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older.

Criteria for Approval of Restricted Product(s):

Initial Coverage:

1. The patient has been diagnosed with sickle cell disease (medical record documentation required); AND
2. The patient is 4 years of age or older; AND
3. If the request is for tablets for oral suspension:
   1. The patient is 11 years of age or younger; AND
   2. The patient is not taking any other medication in a solid dosage form, AND
4. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., hematologist); AND
5. The patient has had at least one vaso-occlusive crisis (VOC) event (requiring healthcare resources) documented in the last 12 months (medical record documentation required); AND
6. The patient’s baseline hemoglobin (Hb) level is ≥5.5 to ≤10.5 g/dL (medical record documentation required); AND
7. The patient has not received a red blood cell (RBC) transfusion within 60 days or erythropoietin within 28 days of starting Oxbryta; AND
8. The patient will not be taking Oxbryta concomitantly with Adakveo (crizanlizumab); AND
9. The patient is currently taking hydroxyurea or has clinical contraindication/intolerance to hydroxyurea; AND
10. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 180 days (6 months)

Continuation Coverage:

1. The patient has been previously approved for Oxbryta (voxelotor) 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 continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., hematologist); AND
3. If the request is for tablets for oral suspension:
   1. The patient is 11 years of age or younger; AND
   2. The patient is not taking any other medication in a solid dosage form, AND
4. The patient has not received a red blood cell (RBC) transfusion or erythropoietin while taking Oxbryta; AND
5. The patient will not be taking Oxbryta concomitantly with Adakveo (crizanlizumab); AND
6. The therapy has been effective for the patient shown through at least ONE of the following (medical record documentation required).:
   1. A decrease in vaso-occlusive crisis (VOC) events (requiring healthcare resources); OR
   2. An increase in hemoglobin (Hb) level by at least 1 g/dL from baseline.

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.

Policy Implementation/Update Information:

January 2023: Criteria update: Addition of new formulation of Oxbryta 300 mg (NOT for oral suspension) to the policy.

July 2022: Criteria change: Decreased duration of initial approval to 6 months. Added limitations to tablets for oral suspension regarding ability to take solid dosage form of medications. Added specialist (e.g., hematologist) must be involved in initial and continuation therapy.

Added to continuation criteria that patient cannot receive RBC transfusion or erythropoietin. Added to continuation criteria that Oxbryta cannot be given concomitantly with Adakyeo.

April 2022: Criteria change: Duration of approval changed to 1 year. Quantity limits added.

January 2022: Criteria update: Decreased duration of approval to 365 days. Added new to market Oxbryta tablet for oral suspension and updated age for expanded indication.

January 2020: Criteria change: Decreased number of VOC events to at least one in the last 12 months on initial coverage. Added increase in Hb level to clinical effectiveness in continuation coverage.

December 2019 Original utilization management criteria issued.