[Federal Register Volume 76, Number 207 (Wednesday, October 26, 2011)]
[Notices]
[Pages 66307-66308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27563]
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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.
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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unpublished pertinent scientific information on this device will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: [email protected] (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: [email protected].
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