2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC20
Submitter : Mr. Robert Gassner Date & Time: 05/11/2004 06:05:45
Organization : National Psoriasis Foundation
Consumer Group
Category :
Issue Areas/Comments
GENERAL
GENERAL
Suggestions for AHRQ FY 2005 Research Priorities.

Psoriasis is a chronic and incurable autoimmune disease in which faulty signals from the immune system lead to inflamed, scaly skin lesions that can itch, crack, bleed and be extremely painful. Psoriasis lesions generally appear on the joints, limbs and scalp but can appear anywhere on the body, covering some people from head to toe. More than 5 million Americans, and therefore in the range of 800,000 people served by Medicare (2% of 40 million), have been diagnosed with psoriasis and/or psoriatic arthritis. Psoriatic arthritis, a degenerative disease of the joints and connective tissues that affects up to 20% or perhaps even more of patients with psoriasis, is often misdiagnosed or diagnosed late.


Psoriasis poses a severe hardship, both in direct economic costs as well as substantial psychological costs [Stern]. Over $2 billion is spent each year to treat the disease [Ellis]. A National Institute of Mental Health-supported study found that psoriasis can cause reductions in physical and mental functioning comparable to that seen in cancer, arthritis, hypertension, diabetes, heart disease, and depression [Rapp]. Ongoing research suggests that patients with psoriasis have a number of significant co-morbidities [Pearce]. Psoriasis patients also face the challenge of seeking and/or needing care from a number of different physicians ? dermatologists, rheumatologists, and general practitioners.


Despite this dramatic impact on people?s lives, the federal government spent less than $5 million on psoriasis research in 2003, or less than $1 per patient [NIAMS]. At the same time, research conducted by pharmaceutical companies focuses primarily on individual current or potential therapies.


AHRQ may want to consider studying: (1) comparative clinical effectiveness of various new biologic medications used to treat psoriasis and/or psoriatic arthritis; (2) comparative utilization, cost, and cost-effectiveness of the various treatments currently used for psoriasis and/or psoriatic arthritis; and/or (3) the appropriateness of dermatology- versus rheumatology-based care for psoriasis and/or psoriatic arthritis patients, and ways to promote effective and efficient collaboration between the two specialties for the benefit of patients.


AHRQ research in these areas could help improve (1) the quality of life for millions of Americans facing psoriasis and psoriatic arthritis, (2) collective understanding of how to manage and treat these and other chronic autoimmune diseases; and (3) the Medicare system overall.


The National Psoriasis Foundation, for over 35 years the voice of the psoriasis community in the United States, would be interested in
collaborating with AHRQ and other organizations on this kind of research.


SOURCES:

--Ellis, CN, et al. Cost of atopic dermatitis and eczema in the United States. Journal of the American Academy of Dermatology 2002; 46: 361- 370.

--National Psoriasis Foundation. www.psoriasis.org and various publications.

--NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases). Personal contacts, 2004.

--Pearce, DJ, et al. (Dept. of Dermatology, Wake Forest University School of Medicine). Retrospective analysis of adverse effects and comorbidities in patients on systemic psoriasis therapy. Poster presented at American Society of Dermatology annual conference, February 2004.

--Rapp, SR, et al. Psoriasis causes as much disability as other major medical diseases. Journal of the American Academy of Dermatology 1999; 41: 401-407.

--Stern, RS, et al. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. Journal of Investigative Dermatology Symposium Proceedings 2004; 9: 136-139.