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 moderate to severe psoriasis, what is the comparative effectiveness of using etanercept (enbrel) versus methotrexate?

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:

A comparison of etanercept versus methotrexate for treatment of moderate to severe psoriasis. I envision a focus on relative effectivness including adverse side effects but would also like to include a cost-effectiveness component.

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.)

Psoriasis usually effects adults of all ages. It is found among many, if not all ethnic groups. Psoriasis can effect children but more commonly the onset occurs in early adulthood.

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

This comparison applies primarily to those with moderate or severe psoriasis. This is a subgroup of all who have psoriasis.

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

I would like to identify improved health outcomes at lower cost. Or the results may identify the additional cost of improved health outcomes associated with newer drugs for this immunological disorder relative to that of methotrexate.

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

Both drugs have adverse effects. Enbrel is relatively new and not all adverse effects are known. But serious and sometimes fatal infections are a risk. Also possible are serious autoimmune reactions such as pemphigus. The primary risk of methotrexate is liver damage. These risks are fairly well known at this point.

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)

• Arthritis and nontraumatic joint disorders
• Infectious diseases, including HIV/AIDS

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• 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
• Other

Importance

Describe why this topic is important.

Psoriasis is relatively common and can be quite disabling. New treatments with TNF inhibitors are expensive and should be carefully weigned against older, more established treatments such as with generic methotrexate. There is insufficient information in the literature on this issue. More information will help improve the efficiency of treatment.

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.)

I have been interested in this subject for some time and have unsuccessfully sought funding for it. I also believe not enough is understood by patients, pharmacists or physicians about relative effectiveness or cost-effectiveness of drugs for psoriasis.

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:

Physicians as well as other providers such as nurses have not been exposed to enough information about comparative effectiveness on this issue. There has been little interest by pharmaceutical firms, government or even the National Psoriasis Foundation to fund research comparing an inexpensive generic drug with the new much more expensive bio-engineered drugs. I believe there should be better information and guidelines about appropriate use of these drugs.

Potential Impact

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

The answer to this question of comparative effectivess will be of great use of my students, many of whom are PharmD students. They are called upon to provide advice to customers about comparative effectiveness and expect to do more of that kind of work in the future. Of course this would be of interest to all pharmacists and physicians who address patients with psoriasis.

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

I think this could be done relatively quickly, within a year or two if the research relied on secondary data.

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

The most vulnerable population targeted in this study are those diabled by severe psoriasis.

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)

The answer to this question of comparative effectivess will be of great use of my students, many of whom are PharmD students. They are called upon to provide advice to customers about comparative effectiveness and expect to do more of that kind of work in the future. Of course this would be of interest to all pharmacists and physicians who address patients with psoriasis.

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