Topic Suggestion Description
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Date submitted: July 01, 2009
Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
- does use of generic medications for seizures result in poorer control (more ER visits and or hospitalizations than the use of brand name medications.
Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)
If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:
- Brand vs generic medications used for seizures
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 with seizures
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
- all but should be divided by seizure type. Evidence that any subpopulation has different outcomes would be of interest.
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
- more cost effective care
Describe any health-related risks, side effects, or harms that you are concerned about.
- Increased seizures with the use of generics.
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.?
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
- 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
- State Children's Health Insurance Program (SCHIP)
Describe why this topic is important.
- For many years most neurologists have insisted that there are issues with generic seizure medications. There is little evidence to support this notion. However their professional society has publically come out against the substitution of "A" rated generics and neurologists use a large amount of brand drugs for treatment of these disorders. In addition many states include these drugs in their narrow therapeutic index laws. This results in a large amount of potentially unnecessary healthcare costs/spending that is not evidence based and may be unnecessary.
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.)
- interest in drug related topics.
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.)
- If yes, please explain:
- see above. In addition there has been debate over FDA "A" rated generic substitution of certain drugs.While the FDA stands behind their methodology and it is supported by payors, the issue remains a public policy dilemma and has resulted in various NTI laws.
How will an answer to your research question be used or help inform decisions for you or your group?
- Hopefully result in the increased use of generics for treatment of these disorders.
Describe the timeframe in which an answer to your question is needed.
- no rush. Whenever it happens.
Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.
- Because of the notion that there is a difference there may be a disparity in how physicians treat underserved and low income populations compared to the insured population.Medicaid may require generic substitution while those with private pay can get the brands. If there is in fact a difference between the therapeutic effect of these drugs then more rational and consistant coverage decisions can be made.
- 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)
- Health Care Industry (Device, Drug, or Other Manufacturer)
- Are you making a suggestion as an individual or on behalf of an organization?