What are the comparative levels of evidence for use of intravenous immunoglobulin (IVIG) in unlabeled indications?

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.: What are the comparative levels of evidence for use of intravenous immunoglobulin (IVIG) in unlabeled indications?
Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.): yes
If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:: IVIG, corticosteroids, routine antimicrobial treatment (disease-specific, as IVIG is used in a large amount of unlabeled indications)
What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.): all patients
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.): Medicare and Medicaid patients
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.): Improvement in subjective quality of life measurements, as this drug is frequently given for neurologic dysfunction
Describe any health-related risks, side effects, or harms that you are concerned about.: risk is minimal, though cost is extensive

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

AHRQ Priority Populations

Low income groups
Minority groups
Women
Children
Elderly
Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

Describe why this topic is important.: This drug is used extensively, particularly safety net hospitals, in unlabeled indications. Insurance payers may not always cover its cost, although level of evidence may support its use. For patients whose treatment course is primarily for the IVIG-related indication, a disproportionate share of cost is borne by the pharmacy department.
What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.): Working with institutional policy
Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.): yes
If yes, please explain:: Low quantity and quality of evidence for many unlabeled indications

How will an answer to your research question be used or help inform decisions for you or your group?: May help institute criteria for appropriate use
Describe the timeframe in which an answer to your question is needed.: Two years
Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.: Patients who should receive treatment on an outpatient basis but cannot afford coinsurance

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate): May help institute criteria for appropriate use

Are you making a suggestion as an individual or on behalf of an organization?: Individual

Please tell us how you heard about the Effective Health Care Program: internet

Effective Health Care Program