Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    H.P. Acthar Gel (ACTH) requires prior authorization.

2)    ACTH is approved for use to treat infantile spasms.

3)    ACTH is covered under the medical benefit as a specialty drug.

1)    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. 

2)    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 following:

A.   Endocrine (non-supportive thyroiditis, hypercalcemia associated with cancer)

B.   Nervous System (acute exacerbations of multiple sclerosis)

C.   Rheumatic Disorders (e.g. as an adjunctive therapy for short-term administration in psoriatic arthritis, rheumatoid arthritis)

D.   Collagen Disease (e.g. during an exacerbation or as maintenance therapy in systemic lupus erythematosus, dermatomyositis)

E.   Dermatologic Disease (e.g. pemphigus, bullous dermatitis herpetiformis)

F.    Allergic States (e.g. control of severe allergic conditions)

G.   Ophthalmic diseases (e.g. allergic conjunctivitis)

H.   Respiratory Diseases (e.g. symptomatic sarcoidosis, Loffler’s Syndrome)

I.     Hematologic disorders (e.g. acquired autoimmune hemolytic anemia)

J.    Neoplastic diseases (e.g. palliative treatment of leukemia’s and lymphomas in adults, acute leukemia of childhood)

K.   Edematous state (e.g. nephrotic syndrome)

L.    Gastrointestinal diseases (e.g. ulcerative colitis, regional enteritis)

M.  Miscellaneous (e.g. tuberculous meningitis, trichinosis with neurologic or myocardial involvement)

H.P. Acthar Gel is limited to no more than a 30 day supply per fill.

ACTH has been used in a variety of conditions considered to be corticosteroid-responsive.  However, there are limited to no data comparing the efficacy of ACTH to corticosteroids in these conditions.  Additionally, ACTH gel has the potential to cause more adverse effects than corticosteroids.  Given the lack of comparative data and potential for increased risk to the patient, a clinical need for the use of ACTH gel for corticosteroid-responsive conditions has not been demonstrated.

1)    H.P. Acthar Gel Product Information.  Questcor Pharmaceuticals  June 2011

2)    Clinical Pharmacology.  H.P. Acthar Gel.  Accessed online November 2016.

3)    Hussain S, et al “Treatment of infantile spasms with very high dose prednisolone before high dose ACTH” AES 2012; Abstract 1.247.

Addendum:

Effective 01/01/2017: Changed coverage to medical benefit as opposed to pharmacy benefit.  More clearly defined intolerance to corticosteroids.