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L.5.01.578
Gastrocrom (cromolyn sodium)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Mastocytosis is a rare condition characterized by abnormal accumulations of mast cells in the skin, bone marrow, and internal organs (liver, spleen, gastrointestinal tract, and lymph nodes). These mast cells release substances that cause the symptoms of the disease, such as abdominal pain, nausea, vomiting, diarrhea, headache, flushing or itching of the skin, or hives.
Cromolyn sodium is a synthetic mast cell stabilizer indicated in the management of patients with mastocytosis. Cromolyn sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Evaluation
Cromolyn sodium oral solution may be considered medically necessary when ALL of the following criteria are met:
The individual is ≥2 years of age;
The individual has ONE of the following diagnoses:
Cutaneous mastocytosis as evidenced by typical skin lesions AND skin biopsy demonstrating characteristic clusters of mast cells; OR
Systemic mastocytosis as evidenced by a bone marrow biopsy revealing an abnormally high number of mast cells with an abnormal appearance;
The individual has tried and failed (see Policy Guidelines) treatment with chlorpheniramine (4mg QID) plus cimetidine (300mg QID); AND
The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage.
Length of Approval:6 months
Renewal Evaluation
Cromolyn sodium oral solution may be approved for RENEWAL when ALL of the following criteria are met:
The individual has been previously approved for the requested agent through the BCBSMS PA process;
The individual has documented clinical improvement (i.e., decrease in symptom severity and/or frequency); AND
The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage.
Length of Approval: 12 months
Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
appropriate with regard to standards of good medical practice; and
not solely for the convenience of the Member, his or her Provider; and
the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
Medication Failure
Medication failure is defined as disease progression at generally accepted doses (for >1 month use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.
BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
01/22/2021: New policy added.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
06/27/2024: Policy updated to extend Length of Approval to 6 months.
03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria updated regarding treatment failure. Sources updated.
Gastrocrom prescribing information. Meda Pharmaceuticals. June 2024. Last accessed January 2025.
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