Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

For patients with allergic disease, what is the comparative effectiveness of improving health outcomes and lowering healthcare utilization by treating their disease with sublingual immunotherapy (allergy drops taken under the tongue) as opposed to not receiving any kind of disease modifying immunotherapy, or relying only on allergen avoidance, environmental controls and pharmacotherapy.

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:

Currently the vast majority of allergy suffers (~95%) address their conditions by employing allergen avoidance and environmental control measures along with symptom reducing pharmacotherapy, none of which address the underlying cause of the disease nor have they been proven to be significantly beneficial. Less than 5% of allergy sufferers are under disease modifying immunotherapy, the current standard approach used in the U.S. is subcutaneous allergy shots. The utilization of allergy shots, for many reasons, is extremely low (less than 5%) in the U.S., allergy drops delivered sublingually has been proven as safe and effective, and used in other parts of the World. It is increasingly being used in the U.S. as an “off-label” delivery of the antigens that are injected. While there are still outstanding questions being researched, there is a growing body of knowledge and existing research (rated level 1A by WHO for some conditions) that in some way eclipses what is know about allergy injections. Drops offer a patient-friendly, viable immunotherapy alternative. It is important to understand the comparison we are recommending is not drops to shots, rather the much bigger issue of disease modifying treatment for the vast population of allergic disease sufferers receiving no immunotherapy.

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.)

Allergies are found to be prevalent in virtually all age groups and genders. Allergies are strongly linked to asthma, sinusitis, urtucaria, eczema, migraine headaches, depression, GERD, otitis media and other conditions.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Minorities, inner-city populations, Autism Spectrum Disorder (ASD) patients.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

In children, addressing allergies early in life can prevent the onset of asthma and additional sensitivities. For those already suffering with chronic conditions, such as asthma and sinusitis it can mean a significant reductions in symptoms, medication use and unplanned health utilization, while significantly improving their quality of life. For anyone with severe anaphylactic levels of allergic disease, it can mean a life saving opportunity by reducing sensitivies from dangerous levels.

Describe any health-related risks, side effects, or harms that you are concerned about.

Leaving the cause of allergic disease unaddressed can be dangerous for a significant percentage of allergy suffers. Avoiding an allergen, for instance a food, can actually increase the level of sensitivity, creating a heightened level of severe reactions due to an inadvertent exposure. The risk of not treating the cause of an allergy means that symptoms persist, typically leading to acute illnesses and prolonged use of medications which can result in negative side effects. The type of treatment being recommended has a strong safety profile in terms of a treatment, superior to doing nothing to address the cause of their disease, even superior to injection immunotherapy.

Appropriateness for EHC Program

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)

• Depression and other mental health disorders
• Developmental delays, attention-deficit hyperactivity disorder, and autism
• Infectious diseases, including HIV/AIDS
• Pulmonary disease/asthma

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

• Medicaid
• Medicare
• State Children's Health Insurance Program (SCHIP)
• Other

Importance

Describe why this topic is important.

Allergic disease is one of the most prevalent diseases in the United States. It affects 1 in 5 Americans.

It’s the predominant cause/trigger of two highly prevalent chronic conditions: Sinusitis and Asthma. It is a leading cause of productivity loss for organizations and it’s incidence is on the rise. Yet less then 5% of the allergic population in the United States is in disease modifying treatment, immunotherapy.

The positive economic impact is very large, thousands of dollars of reduced utilization costs per patient over the course of treatment, yielding significant cost savings to employers and health care programs. The personal Quality of Life improvement and associated in-direct impacts are even larger.

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.)

Our medical group has developed and has treated well over 100,000 patients with a route of delivery for immunotherapy that works well, is very safe, has high patient compliance and represents a logical extension to current therapies. Several hundred other doctors around the U.S. use our method or protocol as well.

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:

The Medicare program has an NCO written in 1996 with respect to the use of sublingual antigens (Supplies: 45-28), stating sublingual antigens (allergy drops) are not safe or effective. This rule impacts all insurers that look to the Medicare policies regarding coverage. Allergy associations and Universities are conducting research on this route of delivery and hundreds of studies have already been performed world-wide. The delay in U.S. research and the view by the allergy associations that this form of therapy is “new” has slowed the adoption of sublingual for reasons that are not consistent with past immunotherapy policies of using natural extensions (new routes) of existing treatments.

The current recommended route of delivery for FDA approved antigens immunotherapy is subcutaneous injections. Delivery of the same antigens via the sublingual mucosa is widely practiced internationally and by allergists, especially ENT allergists in the United States. However, the United States Medicare program and the allergy societies still consider it investigative despite mounting evidence. Sublingual is a logical extension of current immunotherapy approaches using the same FDA regulated antigens.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

It will allow us to continue on with our practice and continue to train other doctors with our techniques and not to have to consume our resources to address the questions that invariably come up when people hear “investigative or experimental” associated with this form of treatment, and eventually for insurance companies to cover the costs of the allergy treatment sets (drops).

Describe the timeframe in which an answer to your question is needed.

As soon as possible, the potential benefits to patients, employers, organizations and society at large in terms of health improvement, quality of life, productivity and disease reductions in health care costs (economics) is enormous, and it will provide a tool with children to prevent the onset of diseases such as asthma and future allergy sensitivities.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Allergies and the chronic disease associated with them disproportionately affect low income, minorities, inner-city residence and children. Allergies are 2-3 times more prevalent in Autism Spectrum Disorder (ASD) patients, but virtually all populations are impacted to some degree.

Nominator Information

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)

It will allow us to continue on with our practice and continue to train other doctors with our techniques and not to have to consume our resources to address the questions that invariably come up when people hear “investigative or experimental” associated with this form of treatment, and eventually for insurance companies to cover the costs of the allergy treatment sets (drops).

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

Organization

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