Pharmacy Prior Authorization Criteria

Nascobal (cyanocobalamin) Spray- Non Formulary

Indications for Prior Authorization

Nascobal (cyanocobalamin) Spray

• For diagnosis of Pernicious Anemia
  Indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.

• For diagnosis of Vitamin B12 Deficiencies
  Indicated as a supplement for other vitamin B12 deficiencies, including:1)Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare). 2) Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency. 3)Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc. 4)Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind loop syndrome may produce deficiency of vitamin B12 or folate. 5)Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia

Criteria

Nascobal

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Vitamin B12 Deficiency

• Submission of medical records (e.g., chart notes) documenting that the patient is unable to absorb vitamin B12 via the oral route due to ONE of the following:
• strict vegetarian diet
• malabsorption from structural or functional damage to the stomach or ileum
• inadequate secretion of intrinsic factor
• competition of vitamin B12 by intestinal parasites or bacteria (e.g., tapeworm, blind loop syndrome)
• inadequate utilization of vitamin B12 (e.g., antimetabolites are employed in treatment of neoplasia)
AND
• Patient has a documented diagnosis of trypanophobia (ie., needle-phobia)

Nascobal

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Pernicious Anemia

• Diagnosis of pernicious anemia
AND
• Submission of medical records (e.g., chart notes) that the patient has had a previous administration of intramuscular vitamin B-12 therapy
AND
• Justification provided for why the patient can no longer receive intramuscular vitamin B-12 therapy

P & T Revisions

2021-04-05, 2020-11-16, 2020-11-16

References

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Revision History

• 2021-04-05: Added submission of medical records for the vitamin B12 deficiency criteria.
• 2020-11-16: new non formulary program
• 2020-11-16: new non formulary program

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