№ lp_1_2_19222
File format: docx
Character count: 2337
File size: 46 KB
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]
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Theme:
Rheumatology, Methotrexate Therapy, Drug Interaction
Document Type:
Medical Guidelines
Target Audience:
Healthcare Professionals, Specialists
Research field:
Genetic epidemiology
Topic:
Genetic association analysis of psoriasis and psoriatic arthritis
Document type:
Research methods and supplementary materials description
Dataset:
Immunochip dataset
Genotyping centres:
Wellcome Trust Sanger Institute; Centre for Public Health Genomics at the University of Virginia; Arthritis Research UK Centre for Genetics and Genomics at the University of Manchester; University of Queensland Diamantina Institute; Trinity Translational Medicine at the University of Dublin
Genotyping software:
GenomeStudio Data Analysis Software Platform (Genotyping Module v1.8.4)
Quality control tools:
PLINK v1.07; EIGENSOFT v4.2; flashpca
Statistical methods:
Identity-by-descent analysis; principal component analysis; logistic regression; Hardy–Weinberg equilibrium filtering
Genetic markers:
SNPs from Immunochip array
Genomic region of interest:
Major Histocompatibility Complex (MHC)
Genes analyzed:
HLA-C; HLA-B; HLA-A
Phenotypes studied:
Psoriasis; Psoriatic arthritis
Population reference datasets:
HapMap3 CEU; CHB; JPT; YRI
Variables analyzed:
Allele frequency; genotype call rate; heterozygosity; age of disease onset
Associated amino acid position:
Position 45 of HLA-B
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:
[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]
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
Note:
Year
Theme:
Rheumatology, Methotrexate Therapy, Drug Interaction
Document Type:
Medical Guidelines
Target Audience:
Healthcare Professionals, Specialists
Note:
Date Completed/Last Revised
Best Way to Reach:
Text, Phone, Email
Takes medications independently:
yes no
Performs own injections if applicable:
yes no
Can obtain refills independently:
yes no
Year:
2020
Note:
Region / City
Topic:
Clinical Research
Document Type:
Guideline
Organization / Institution:
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Target Audience:
Researchers, Clinical Trial Coordinators, Investigators
Year:
2021
Region / city:
London, UK
Theme:
Refractory Disease, Rheumatoid Arthritis, Juvenile Idiopathic Arthritis
Document type:
Systematic review
Organization / institution:
King’s College London
Authors:
Hema Chaplin, Lewis Carpenter, Anni Raz, Elena Nikiphorou, Heidi Lempp, Sam Norton
Target audience:
Medical professionals, researchers in rheumatology
Period of validity:
Not applicable
Date of approval:
Not stated
Date of amendments:
25.01.2021
Note:
Year
Year:
2017
Region / City:
United States
Topic:
Clinical Research, Multi-Site Clinical Trials
Document Type:
Manual, Guidelines
Organization / Institution:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Author:
NIAMS
Target Audience:
Researchers, Clinical Trial Coordinators
Period of Action:
October 2017 and onwards
Approval Date:
October 2017
Date of Modifications:
Not specified
Year:
2014
Region / City:
Australia
Therapeutic Area:
Systemic juvenile idiopathic arthritis
Document Type:
PBS Submission / Regulatory Application
Organization / Institution:
Novartis Pharmaceuticals Pty Ltd
Medication:
Canakinumab (Ilaris®)
Treatment Phases:
Initial 1, Initial 2, Continuing Treatment
Administration:
Subcutaneous injection, 150 mg/1 mL vial
Prescriber Requirements:
Rheumatologist or supervision under rheumatology treatment centre
Clinical Criteria:
Failure to respond to methotrexate or intolerance/toxicity; refractory symptoms; prior PBS-subsidised treatment
PBS Category:
Authority Required (Written Only)
Comparator:
Tocilizumab, Etanercept, Adalimumab
Approval Body:
TGA (Therapeutic Goods Administration)
Target Patients:
Children and adults with systemic phenotype sJIA, excluding polyarticular presentation
Trial Design:
Randomized, double-blind, placebo-controlled withdrawal study
Year:
2025
Month of Revision:
February 2025
Country:
United Kingdom
Healthcare System:
NHS
Service:
Rheumatology Early Inflammatory Arthritis (EIA) Service
Type of Document:
Medical referral form
Target Group:
Patients aged 18 years or above
Referral Priority:
Urgent (3 week wait)
Required Referral Method:
e-RS
Clinical Criteria:
Persistent joint inflammation ≥ 6 weeks in 2 or more joints with specified clinical features
Required Investigations:
FBC, E&C, LFT, ESR, CRP, RhF, ANA, Anti-CCP, X-rays hands/feet if symptomatic
Treatment Pathway Reference:
DMARD therapy within 6 weeks if diagnosis confirmed
Follow-up Sites:
WRH, KTC, ALX
Year:
2023
Region / City:
N/A
Theme:
Rheumatology, Clinical Research
Document Type:
Research Supplementary Material
Institution:
N/A
Author:
N/A
Target Audience:
Researchers, Healthcare Professionals
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2025
Region / City:
Nationwide / USA
Theme:
Arthritis Awareness
Document Type:
Press Release
Organization:
Arthritis Foundation
Author:
Julie Thomas, Jill Konopka
Target Audience:
General Public, Arthritis Community
Period of Action:
May 2025
Approval Date:
April 15, 2025
Modification Date:
None
Event Locations:
Boston, Houston, Kansas City, New York City, Los Angeles, Chicago, Seattle, San Francisco, San Antonio, Phoenix, Washington DC
Key Artists:
Jonathan Paul Jackson, Rene Clairin, Andrea Cira, Stevie Shao, Viviana Matsuda, Katrina Romulo, Lucinda Hinojos, Lulu Yueming Qu, Alannah Tiller, Karen Anderson Singer, Vanessa Garza, Robin Davisson, Laurel Greenfield
Social Media Hashtags:
#GreenHeartFridays, #ArthritisAwarenessMonth
Year:
2016
Region / city:
Normandy Park, Washington
Subject:
Rheumatoid Arthritis, Medical Technology
Document type:
Company Overview
Organization:
Inmedix
Author:
Andrew J Holman, MD
Target audience:
Healthcare professionals, pharmaceutical companies, investors
Period of action:
2016 and beyond
Approval date:
October 2015
Date of changes:
May 4, 2016
Year:
2021
Region / City:
United Kingdom
Topic:
Musculoskeletal Conditions, Healthcare, Public Health, Employment, Research
Document Type:
Representation
Organization / Institution:
Versus Arthritis
Author:
Versus Arthritis
Target Audience:
Government bodies, healthcare professionals, policymakers
Period of validity:
2021
Approval Date:
September 2021
Date of changes:
None
Year:
2026
Region / City:
Australia
Theme:
Pharmaceutical
Document Type:
Submission for approval
Organization:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Roche Products Pty Ltd
Target Audience:
Medical Practitioners
Effective Period:
Ongoing
Approval Date:
November 2018
Date of Last Revision:
2026
Category / Program:
GENERAL – General Schedule (Code GE)
Prescriber type:
Medical Practitioners
Condition:
Severe active juvenile idiopathic arthritis
PBS Indication:
Severe active juvenile idiopathic arthritis
Treatment phase:
Initial treatment, Continuing treatment
Restriction Level / Method:
Restricted benefit, Authority Required
Clinical criteria:
No more than 16 weeks of treatment allowed under restriction
Prescriber Instructions:
Specific dosage requirements based on patient weight
Comparator:
IV tocilizumab, etanercept, adalimumab
Sponsor hearing:
None
Consumer comments:
None
Clinical trials:
JIGSAW 117 trial
Year:
2011
Region / City:
Wilhelmina Children’s Hospital
Subject:
Juvenile idiopathic arthritis treatment and medication
Document Type:
Research Supplementary Material
Organization / Institution:
Wilhelmina Children’s Hospital
Author:
Not specified
Target Audience:
Medical professionals, researchers
Period of validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Research field:
Genetic epidemiology
Topic:
Genetic association analysis of psoriasis and psoriatic arthritis
Document type:
Research methods and supplementary materials description
Dataset:
Immunochip dataset
Genotyping centres:
Wellcome Trust Sanger Institute; Centre for Public Health Genomics at the University of Virginia; Arthritis Research UK Centre for Genetics and Genomics at the University of Manchester; University of Queensland Diamantina Institute; Trinity Translational Medicine at the University of Dublin
Genotyping software:
GenomeStudio Data Analysis Software Platform (Genotyping Module v1.8.4)
Quality control tools:
PLINK v1.07; EIGENSOFT v4.2; flashpca
Statistical methods:
Identity-by-descent analysis; principal component analysis; logistic regression; Hardy–Weinberg equilibrium filtering
Genetic markers:
SNPs from Immunochip array
Genomic region of interest:
Major Histocompatibility Complex (MHC)
Genes analyzed:
HLA-C; HLA-B; HLA-A
Phenotypes studied:
Psoriasis; Psoriatic arthritis
Population reference datasets:
HapMap3 CEU; CHB; JPT; YRI
Variables analyzed:
Allele frequency; genotype call rate; heterozygosity; age of disease onset
Associated amino acid position:
Position 45 of HLA-B