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glutamine (sickle cell) — Blue Cross Blue Shield of Montana

sickle cell disease

Preferred products

  • L-glutamine

Initial criteria

  • The patient has a diagnosis of sickle cell disease AND
  • The patient is using the requested agent to reduce the acute complications of sickle cell disease AND
  • If the patient has an FDA approved indication, then ONE of the following: (A) The patient's age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for using the requested agent for the patient's age for the requested indication AND
  • ONE of the following: (A) The patient has tried and had an inadequate response after at least 6 months duration of therapy with maximally tolerated hydroxyurea [medical records including chart notes are required] OR (B) The patient has an intolerance or hypersensitivity to hydroxyurea OR (C) The patient has an FDA labeled contraindication to hydroxyurea AND
  • ONE of the following: (A) The patient will NOT be using the requested agent in combination with Adakveo (crizanlizumab-tmca) OR (B) There is support for use of the requested agent in combination with Adakveo (crizanlizumab-tmca) AND
  • If the request is for ENDARI with an available generic equivalent (L-glutamine), then ONE of the following: (A) The request is for a BCBS IL Fully Insured, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR (B) The patient is currently being treated with the requested agent and is currently stable on the requested agent [chart notes required] OR (C) The patient has tried and had an inadequate response to the generic equivalent [chart notes required] OR (D) The generic equivalent was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR (E) The patient has an intolerance or hypersensitivity to the generic equivalent that is NOT expected to occur with the brand agent [chart notes required] OR (F) The patient has an FDA labeled contraindication to the generic equivalent that is NOT expected to occur with the brand agent [chart notes required] OR (G) The generic equivalent is expected to be ineffective based on known clinical characteristics of the patient and drug, cause a significant barrier to adherence, worsen a comorbid condition, decrease functional ability, or cause adverse reaction/physical or mental harm [chart notes required] OR (H) The generic equivalent is not in the best interest of the patient based on medical necessity [chart notes required] OR (I) The patient has tried another prescription drug in the same pharmacologic class or mechanism that was discontinued due to lack of efficacy or adverse event [chart notes required] OR (J) There is support for the use of the requested brand agent over the generic equivalent AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • The patient has had clinical benefit with the requested agent (e.g., reduction in acute complications of sickle cell disease since initiating therapy) AND
  • ONE of the following: (A) The patient will NOT be using the requested agent in combination with Adakveo (crizanlizumab-tmca) OR (B) There is support for use of the requested agent in combination with Adakveo (crizanlizumab-tmca) AND
  • If the request is for ENDARI with an available generic equivalent (L-glutamine), then ONE of the following: (A) The request is for a BCBS IL Fully Insured, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR (B) The patient is currently being treated with the requested agent and stable [chart notes required] OR (C) The patient has tried and had an inadequate response to the generic equivalent [chart notes required] OR (D) The generic equivalent was discontinued due to lack of efficacy or adverse event [chart notes required] OR (E) The patient has an intolerance or hypersensitivity to the generic equivalent not expected with the brand agent [chart notes required] OR (F) The patient has an FDA labeled contraindication to the generic equivalent not expected with the brand agent [chart notes required] OR (G) The generic equivalent is expected to be ineffective, cause adherence barrier, worsen comorbid condition, decrease function, cause harm [chart notes required] OR (H) The generic equivalent is not in the best interest of the patient based on medical necessity [chart notes required] OR (I) The patient has tried another agent in the same class/mechanism discontinued due to inefficacy or adverse event [chart notes required] OR (J) There is support for the use of the requested brand agent over the generic equivalent AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • The requested quantity (dose) does NOT exceed maximum FDA labeled dose

Approval duration

12 months