Corticotropin Therapy
Does not apply to Medicare Advantage.
DESCRIPTION
Corticotropin is a highly purified sterile preparation of adrenocorticotropic hormone (ACTH). It is currently only commercially available in gelatin to provide a prolonged release in tissues after subcutaneous or intramuscular injection. ACTH stimulates the adrenal cortex to produce multiple hormones, including cortisol, corticosterone and aldosterone.
An example of a preparation of corticotropin is H. P. ActharŽ Gel.
REFER TO DECISION SUPPORT TREE
POLICY
Corticotropin for the treatment of infantile spasms (West syndrome) is considered medically necessary.
Corticotropin for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Multiple sclerosis
Rheumatic disorders
Collagen disease
Dermatologic disease
Allergic state
Ophthalmic disease
Respiratory disease
Edematous state
Corticotropin for diagnostic testing of adrenocortical function is considered not medically necessary.
Corticotropin for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Corticotropin for the treatment of the following conditions is considered medically appropriate if ALL of the following criteria are met:
The individual shows ANY ONE of the following:
Unresponsiveness to corticosteroid treatment
Contraindication to corticosteroid therapy
The condition is ANY ONE of the following:
Multiple sclerosis if treatment is for acute exacerbations
Rheumatic disorders if ALL of the following:
Therapy is adjunctive
Treatment is short term to tide over an acute episode/exacerbation
Specific diagnosis is ANY ONE of the following:
Psoriatic arthritis
Rheumatoid arthritis
Juvenile arthritis
Ankylosing spondylitis
Collagen disease if ALL of the following:
Use is ANY ONE of the following:
During exacerbation
Maintenance therapy
Specific diagnosis is ANY ONE of the following:
Systemic lupus erythematosus
Systemic dermatomyositis (e.g., polymyositis)
Dermatologic diseases if specific diagnosis is ANY ONE of the following:
Severe erythema multiforme
Stevens-Johnson syndrome
Allergic state if specific diagnosis of serum sickness
Ophthalmic disease if ALL of the following:
Disease is ANY ONE of the following:
Severe acute allergic and inflammatory
Chronic allergic and inflammatory
Disease involves the eye and its adnexa (e.g., keratitis, iritis, iridocyclitis, diffuse posterior uveitis, diffuse posterior choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation)
Respiratory disease if diagnosed as symptomatic sarcoidosis
Edematous state if treatment is to induce ANY ONE of the following:
A diuresis
A remission of proteinuria
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
This policy does not apply to Medicare Advantage.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
The published literature was reviewed and no controlled studies were found to validate the use of corticotropin therapy in the treatment/prevention of any other conditions/diseases.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2011). Repository corticotropin injection (5.01.17). Retrieved June 28, 2011 from BlueWeb.
Lexi-Comp Online. (2011, May). AHFS DI. Corticotropin (diagnostic). Retrieved June 27, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, February). Corticotropin. Retrieved June 27, 2011 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2010, October). Center for Drug Evaluation and Research. H. P. actharŽ gel (corticotropin). Retrieved June 27, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/14/2008
MOST RECENT REVIEW DATE: 2/22/2012
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Corticotropin Therapy (H.P. ActharŽ Gel)
Is the requested medication being used for diagnostic testing of adrenocortical function?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual show evidence of infantile spasms with a diagnosis of West syndrome?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Does the individual show evidence of unresponsiveness to or contraindication to corticosteroid therapy?
If yes, go to question #4
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of multiple sclerosis with acute exacerbation?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual show evidence of an acute episode or exacerbation of ANY ONE of the following and therapy will be adjunctive?
Psoriatic arthritis
Rheumatoid arthritis
Juvenile arthritis
Ankylosing spondylitis
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #6
Does the individual have systemic lupus erythematosus or systemic dermatomyositis (e.g., polymyositis) that is exacerbated or requires maintenance therapy?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #7
Does the individual have a diagnosis of ANY ONE of the following?
Severe erythema multiforme
Stevens-Johnson syndrome
Serum sickness (allergic state)
Symptomatic sarcoidosis (respiratory disease)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #8
Does the individual have an ophthalmic disease involving the eye and its adnexa (e.g., keratitis, iritis, iridocyclitis, diffuse posterior uveitis, diffuse posterior choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation) that is ANY ONE of the following?
Severe acute allergic and inflammatory
Chronic acute and inflammatory
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #9
Does the individual show evidence of an edematous state requiring a diuresis or a remission of proteinuria?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.