H.P. Acthar Gel (ACTH) is
considered medically necessary to treat infantile spasms in patients under age 2
after a 2-week trial of high-dose prednisolone.
Unless there are medical
contraindications or intolerance to corticosteroids, QualChoice considers the
use of ACTH gel in the following corticosteroid-responsive conditions to not be
medically necessary. Intolerance to
corticosteroids is defined as suffering an adverse reaction to steroids
classified as severe, including, but not limited to, anaphylactic reaction,
angioedema, arrhythmia exacerbation, avascular necrosis, bone fractures,
cardiomyopathy, esophageal ulceration, GI bleeding/perforation, heart failure,
increased intracranial pressure, lupus-like symptoms, ocular hypertension, optic
neuritis or pancreatitis. Approval
for use in any of the conditions below requires submission of two peer-reviewed
prospective clinical trials published with the last 10 years reflecting ACTH
efficacy and safety for the relevant condition as part of current practice
standards. These conditions include, but are not necessarily limited to the
thyroiditis, hypercalcemia associated with cancer)
Nervous System (acute
exacerbations of multiple sclerosis)
Rheumatic Disorders (e.g.
as an adjunctive therapy for short-term administration in psoriatic arthritis,
Collagen Disease (e.g.
during an exacerbation or as maintenance therapy in systemic lupus
(e.g. pemphigus, bullous dermatitis herpetiformis)
Allergic States (e.g.
control of severe allergic conditions)
Ophthalmic diseases (e.g.
(e.g. symptomatic sarcoidosis, Loffler’s Syndrome)
(e.g. acquired autoimmune hemolytic anemia)
Neoplastic diseases (e.g.
palliative treatment of leukemia’s and lymphomas in adults, acute leukemia of
Edematous state (e.g.
(e.g. ulcerative colitis, regional enteritis)
tuberculous meningitis, trichinosis with neurologic or myocardial involvement)