```

[Federal Register: October 26, 2011 (Volume 76, Number 207)]
[Notices]               
[Page 66307-66308]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc11-59]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

 
Scientific Information Request on Phototherapy for Treatment of 
Chronic Plaque Psoriasis

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from manufacturers of 
Phototherapy medical devices for treatment of chronic plaque psoriasis. 
Scientific information is being solicited to inform our Comparative 
Effectiveness Review of Biologic and Nonbiologic Systemic Agents and 
Phototherapy for Treatment of Chronic Plaque Psoriasis, which is 
currently being conducted by the Evidence-based Practice Centers for 
the AHRQ Effective Health Care Program. Access to published and 
unpublished pertinent scientific information on this device will 
improve the quality of this comparative effectiveness review. AHRQ is 
requesting this scientific information and conducting this comparative 
effectiveness review pursuant to Section 1013 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, Public 
Law 108-173.

DATES: Submission Deadline on or before November 25, 2011.

ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the 
study for which you are submitting information from the list of current 
studies and complete the form to upload your documents.
    E-mail submissions: ehcsrc@ohsu.edu (please do not send zipped 
files--they are automatically deleted for security reasons).
    Print submissions: Robin Paynter, Oregon Health and Science 
University, Oregon Evidence-based Practice Center, 3181 SW. Sam Jackson 
Park Road, Mail Code: BICC, Portland, OR 97239-3098.

FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, 
Telephone: 503-494-0147 or E-mail: ehcsrc@ohsu.edu.

SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
Public Law 108-173, the Agency for Healthcare Research and Quality has 
commissioned the Effective Health Care (EHC) Program Evidence-based 
Practice Centers to complete a comparative effectiveness review of the 
evidence for Biologic and Nonbiologic Systemic Agents and Phototherapy 
for Treatment of Chronic Plaque Psoriasis.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by systematically requesting 
information (e.g., details of studies conducted) from medical device 
industry stakeholders through public information requests, including 
via the Federal Register and direct postal and/or online solicitations. 
We are looking

[[Page 66308]]

for studies that report on phototherapy for treatment of chronic plaque 
psoriasis, including those that describe adverse events, as specified 
in the key questions detailed below. The entire research protocol, 
including the key questions, is also available online at: http://effectivehealthcare.AHRQ.gov/index.cfm/search-forouides-reviews-and-reports/?pageaction=displayproduct&productid=793.
    This notice is a request for industry stakeholders to submit the 
following:
     A current product label, if applicable (preferably an 
electronic PDF file).
     Information identifying published randomized controlled 
trials and observational studies relevant to the clinical outcomes. 
Please provide both a list of citations and reprints if possible.
     Information identifying unpublished randomized controlled 
trials and observational studies relevant to the clinical outcomes. If 
possible, please provide a summary that includes the following 
elements: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to withdrawn/
followup/analyzed, and effectiveness/efficacy and safety results.
     Registered ClinicalTrials.gov studies. Please provide a 
list including the ClinicalTrials.gov identifier, condition, and 
intervention.
    Your contribution is very beneficial to this program. AHRQ is not 
requesting and will not consider marketing material, health economics 
information, or information on other indications. This is a voluntary 
request for information, and all costs for complying with this request 
must be borne by the submitter. In addition to your scientific 
information please submit an index document outlining the relevant 
information in each file along with a statement regarding whether or 
not the submission comprises all of the complete information available.

    Please Note: The contents of all submissions, regardless of 
format, will be available to the public upon request unless 
prohibited by law.

    The draft of this review will be posted on AHRQ's EHC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the e-mail list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.

Key Questions

    Proposed Key Questions (KQs) were posted for public comments and 
were modified with consideration of the comments received. Since 
controversy surrounds the classification of psoriasis as mild or 
moderate-to-severe, moderate-to-severe disease was not included as an 
explicit inclusion criterion in the systematic search of the literature 
or in the comparative effectiveness review. As suggested in the public 
comments, we will consider when evaluating efficacy data whether 
patients were na[iuml]ve to biologics, were treated previously with 
biologics, or were allowed drug holidays. Although a suggestion was 
made to evaluate combination therapy and to compare harms in patients 
without psoriasis or untreated controls with psoriasis, such an 
evaluation falls outside the scope of our review. We have now specified 
the measures that will be used for health-related quality of life in 
KQ.
    1. The Psoriasis Area and Severity Index (PAST) score will be 
considered not only as a binary outcome but as a continuous outcome as 
suggested. Although we had proposed the Psoriasis Scalp Severity Index 
(PSSI) and the Nail Psoriasis Severity Index (NAPSI) scores as 
outcomes, patient-reported improvement in scalp pruritus and scalp pain 
were suggested as additional outcomes in KQ 1; scalp pruritus and scalp 
pain are not as commonly reported in the literature and are less likely 
to add extra value over the body-wide assessments. We have not listed 
specific malignancies (hepatosplenic T-cell lymphoma and other 
lymphomas) and infections (tuberculosis and histoplasmosis) in KQ 2 as 
suggested to be more comprehensive. Weight and impact of neutralizing 
antibodies have been added as characteristics that will be evaluated in 
KQ 3. We did not move major adverse cardiovascular events (MACE) from 
final health outcomes to harms, because this is an outcome of the 
disease process rather than of therapeutic interventions. Subgroup 
analyses based on duration of followup were discussed with the 
Technical Expert Panelists (TEP).
    The acronyms used in the questions below are defined within the 
text and the list under Definitions of Terms.

Question 1

    In patients with chronic plaque psoriasis, what is the comparative 
effectiveness of systemic biologic agents and systemic nonbiologic 
agents (between-class comparisons) or phototherapy when evaluating 
intermediate (plaque BSA measurement, PAST score, Patient's Assessment 
of Global Improvement, PGA, and individual symptom improvement) and 
final health outcomes (mortality, HRQoL [e.g., DLQI, HAQ-DI, EQ-5D] and 
other patient-reported outcomes, MACE, diabetes, and psychological 
comorbidities [e.g., depression, suicide])?

Question 2

    In patients with chronic plaque psoriasis, what is the comparative 
safety of systemic biologic agents and systemic nonbiologic agents 
(between-class comparisons) or phototherapy (hepatotoxicity [e.g., AST, 
ALT], nephrotoxicity [e.g., SCr, GFR], hematologic toxicity [e.g., TCP, 
anemia, neutropenia], hypertension, alteration in metabolic parameters 
[e.g., glucose, lipids, weight, BMI, thyroid function], injection site 
reaction, malignancy, infection, and study withdrawal)?

Question 3

    In patients with chronic plaque psoriasis treated with systemic 
biologic therapy, systemic nonbiologic therapy, or phototherapy, which 
patient or disease characteristics (e.g., age, gender, race, weight, 
smoking status, psoriasis severity, presence or absence of concomitant 
psoriatic arthritis, disease duration, baseline disease severity, 
affected BSA, disease location, number and type of previous treatments, 
failure of previous treatments and presence of neutralizing antibodies) 
affect intermediate and final outcomes?
    Details regarding the specific therapies considered in each class 
of interventions and comparators can be found in Tables 1-5. There are 
no specific requirements in terms of followup period that will be 
evaluated in these key questions. The setting will include inpatient, 
outpatient and home therapy.

    Dated: October 14, 2011.
Carolyn M. Clancy,
 Director, AHRQ.
[FR Doc. 2011-27563 Filed 10-25-11; 8:45 am]
BILLING CODE 4160-90-M
```