№ lp_1_2_19228
File format: docx
Character count: 2243
File size: 45 KB
Year:
[Insert Year]
Region / City:
[Insert City, State ZIP]
Topic:
Medical treatment authorization
Document type:
Request letter
Organization / Institution:
[Insert Organization Name]
Target audience:
Medical Director, Payer (Insurance Company)
Period of validity:
[Insert Start Date] - [Insert End Date]
Approval date:
[Insert Date of Approval]
Amendment date:
[Insert Date of Changes if any]
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
[Insert Year]
Region / City:
[Insert City, State]
Subject:
Authorization request for treatment with STELARA®
Document Type:
Request for prior authorization
Organization:
[Insert Payer Name]
Target Audience:
Medical Director or individual responsible for prior authorization
Treatment Period:
[Insert relevant time period if specified]
Approval Date:
[Insert Date if available]
Amendment Date:
[Insert Date if available]
Document type:
Prior authorization request letter
Medical specialty:
Gastroenterology
Condition:
Ulcerative colitis
Medication:
STELARA® (ustekinumab)
Request type:
Standard or expedited authorization
Intended recipient:
Medical Director of payer organization
Healthcare setting:
Hospital outpatient, outpatient clinic, private practice, or other
Purpose:
Formulary exception and coverage authorization
Supporting materials referenced:
Prescribing information, clinical guidelines, peer-reviewed literature
Source type:
Clinical administrative correspondence
Year:
Not specified
Region / City:
Not specified
Theme:
Pharmaceutical treatment
Document Type:
Product Information
Organization / Institution:
Janssen Biotech, Inc
Author:
Not specified
Target Audience:
Healthcare professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Document type:
Prior authorization request letter
Medical specialty:
Gastroenterology
Condition:
Ulcerative colitis
Medication:
STELARA® (ustekinumab)
Request type:
Standard or expedited authorization
Intended recipient:
Medical Director of payer organization
Healthcare setting:
Hospital outpatient, outpatient clinic, private practice, or other
Purpose:
Formulary exception and coverage authorization
Supporting materials referenced:
Prescribing information, clinical guidelines, peer-reviewed literature
Source type:
Clinical administrative correspondence
Year:
2022
Region / City:
Australia
Topic:
Pharmaceutical submission
Document type:
Submission
Agency / Institution:
PBAC
Author:
Janssen-Cilag Pty Ltd
Target audience:
Healthcare professionals, pharmaceutical regulators
Period of validity:
N/A
Approval date:
May 2020
Date of last update:
March 2022
Context:
This document is a pharmaceutical submission requesting PBS listing for ustekinumab in the treatment of moderate to severe ulcerative colitis.
Year:
Not specified
Region / City:
Not specified
Theme:
Pharmaceutical treatment
Document Type:
Product Information
Organization / Institution:
Janssen Biotech, Inc
Author:
Not specified
Target Audience:
Healthcare professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Not specified
Topic:
Infliximab dose escalation in Crohn’s disease treatment
Document type:
Medical request letter
Institution / Organization:
Not specified
Author:
Not specified
Target audience:
Insurance company
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
Year:
2026
Region / city:
Multiple centers
Topic:
Medical research, Crohn’s disease
Document type:
Research study
Organization / institution:
Various medical institutions
Author:
Not specified
Target audience:
Medical professionals, researchers
Period of validity:
N/A
Approval date:
N/A
Modification date:
N/A
Year:
2024
Region / city:
Tangier, Morocco
Topic:
Inflammatory Bowel Disease, Crohn’s Disease
Document Type:
Research Study
Organization / Institution:
Mohamed VI University Hospital, Hepato-Gastroenterology Department
Authors:
K. Attaqi, F.Z. Bouamama, S. Temsamani, A. Akjay, H. Ouaya, H. Meyiz, I. Mellouki
Target Audience:
Medical professionals, gastroenterologists
Period of Action:
2020-2024
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / City:
Not specified
Document type:
Medical Case Report
Organization / Institution:
Not specified
Author:
Nicole Wiebe, Liena Zhao, Jessica P. Woolfson
Target audience:
Healthcare professionals, pediatric gastroenterologists
Period of action:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2022
Country:
United States
Study name:
Study of a Prospective Adult Research Cohort with IBD (SPARC IBD)
Affiliated organization:
Crohn’s & Colitis Foundation
Study type:
Prospective cohort study
Number of centers:
17
Population:
Adult patients with Crohn’s disease initiating vedolizumab or ustekinumab after anti-TNF therapy
Exposures:
Ustekinumab, Vedolizumab, Anti-TNF inhibitors
Outcomes:
Treatment discontinuation, Crohn’s disease–related surgery, malignancy, cardiac events, thromboembolic events
Data sources:
Commercial claims data, SPARC IBD cohort data
Coding systems:
ICD-10-CM, ICD-10-PCS, HCPCS Level I and II, CPT-4, NDC
Sample size (SPARC IBD subset):
Vedolizumab n=77; Ustekinumab n=227
Primary measures:
Incidence rates per 1000 person-years, hazard ratios with 95% confidence intervals
Citation:
Raffals LE, Saha S, Bewtra M, et al. Inflamm Bowel Dis 2022;28:192–199
Year:
2026
Study Type:
Clinical trial
Phase:
Phase 2
Intervention:
Tesnatilimab, Ustekinumab, Placebo
Primary Endpoint:
Change from baseline in CDAI score at Weeks 8 and 12
Secondary Endpoints:
Clinical remission, clinical response, PRO-2 score, SES-CD, GHAS
Analysis Methods:
ANCOVA, MMRM, Cochran-Mantel-Haenszel chi-square test, Multiple Comparison Procedures
Sample Size:
60 patients per arm (Week 8), 50 patients per arm (Week 12)
Power:
84% (Week 8), 85% (Week 12)
Error Rate:
0.05 (two-sided)
Covariates:
Baseline CDAI score, SNP-positive status, Bio-IR status, study visit, visit-by-treatment interaction
Year:
2017
Region:
International (studies from Europe, Australasia, North America)
Topic:
Paediatric Crohn’s disease, nutrition therapy
Document type:
Review article
Institution:
Southampton Children’s Hospital, University of Southampton
Authors:
James J Ashton, Joan Gavin, R Mark Beattie
Keywords:
Crohn’s disease, nutrition, paediatric, exclusive enteral nutrition
Population:
Children and selected adult patients with Crohn’s disease
Study period:
1980–2017
Evidence sources:
Randomised controlled trials, observational studies, retrospective studies, meta-analyses, review articles, editorials, conference abstracts, case reports
Main focus:
Induction of remission, immune modulation, microbiome changes, growth and nutritional outcomes
Guideline references:
ECCO, ESPGHAN, NASPGHAN, ESPEN