№ lp_1_2_18833
File format: docx
Character count: 22212
File size: 104 KB
Year:
2022
Region / City:
Australia
Subject:
Pharmacology, Pharmaceutical Benefits Scheme (PBS)
Document Type:
Submission
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of validity:
Not specified
Approval Date:
3 June 2022
Date of Changes:
Not specified
Contextual Description:
A regulatory submission detailing the request for listing of dupilumab in new forms for treating severe atopic dermatitis and uncontrolled severe asthma in pediatric patients under the PBS.
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Field:
Gastroenterology
Topic:
Metabolic endoscopy and type 2 diabetes treatment
Type of document:
Clinical study report
Study design:
First in-human extension study
Intervention:
Proximal Intestinal Mucosal Ablation (PIMA)
Preceding study registration:
NCT05887635
Medical condition:
Type 2 diabetes (T2D)
Primary outcomes:
Safety, tolerability, feasibility, efficacy
Sample size:
8 patients
Patient characteristics:
Uncontrolled T2D (HbA1c 7.5–10.0%) despite ≥1 glucose lowering agent
Procedure details:
Up to 75 cm post-ampullary mucosal ablation using second-generation through-the-scope RFVA catheter
Anaesthesia:
General anaesthesia
Follow-up period:
3 months
Key measurements:
HbA1c, HOMA-IR, BMI, adverse events, VAS pain score
Year:
2023
Region / City:
Multiple countries
Topic:
Medical / Asthma Treatment
Document Type:
Research Study
Organization / Institution:
Various research centers and universities
Authors:
Jonathan Corren, David J. Jackson, Thomas B. Casale, Larry Borish, Klaus F. Rabe, William W. Busse, Jorge F. Maspero, Daniel J. Jackson, Nadia Daizadeh, Arman Altincatal, Amr Radwan, Angela Khodzhayev, Michel Djandji, Juby A. Jacob-Nara, Paul J. Rowe, Yamo Deniz
Target Audience:
Medical professionals, researchers
Period of Validity:
Ongoing study
Date of Approval:
N/A
Date of Amendments:
N/A
Year:
2026
Region / city:
Edinburgh, UK
Topic:
Knee osteoarthritis, gait analysis, motor control
Document type:
Research article
Institution:
Royal Infirmary of Edinburgh
Author:
Not specified
Study population:
50 adults with end-stage knee osteoarthritis
Gender distribution:
25 males, 25 females
Age range:
61–79 years
Methodology:
Uncontrolled manifold (UCM) analysis, motion capture, treadmill walking
Data collection period:
Not specified
Ethics approval:
REC reference 15/SS/0058
Keywords:
gait variability, uncontrolled manifold, knee, osteoarthritis, postural stability
Year:
2015
Region / City:
Texas
Topic:
Atopic dermatitis, skin allergies in pets
Document type:
Medical article
Organization / Institution:
Derm Delivered PLLC
Author:
Jacqueline Gimmler, DVM, MS, DACVDBoard-certified Veterinary Dermatologist
Target audience:
Pet owners, veterinarians
Period of validity:
N/A
Approval date:
9/3/15
Modification date:
5/13/22
Document Type:
Template letter
Purpose:
Appeal of prior authorization denial
Product Name:
OPZELURA (ruxolitinib) cream 1.5%
Indication:
Mild to Moderate Atopic Dermatitis
Intended Author:
Prescriber
Intended Recipient:
Health Plan or Payer
Target Population:
Non-immunocompromised adult and pediatric patients 12 years of age and older
Subject Matter:
Coverage appeal and prescribing information
Included Sections:
Sample appeal letter, Indication, Limitations of Use, Important Safety Information
Medical Context:
Prior authorization denial and coverage review process
Document type:
Delphi survey questionnaire
Research method:
Delphi method
Medical field:
Dermatology
Disease focus:
Atopic dermatitis
Purpose:
Development of a simplified severity assessment scale and simplified criteria for initiating systemic treatment
Target respondents:
Medical doctors and clinical experts in atopic dermatitis
Survey structure:
Three sections including indicator screening, treatment initiation criteria agreement, and respondent familiarity and judgment basis
Assessment domains:
Pruritus, skin lesion characteristics, quality of life, and additional clinical factors
Indicator levels:
First-level, second-level, and third-level indicators
Treatment types referenced:
Immunosuppressants, glucocorticoids, biologics, and molecularly targeted therapy
Clinical factors referenced:
Itch duration and intensity, body surface involvement, lesion characteristics, quality-of-life impact, treatment response history, relapse history, and comorbid allergic diseases
Evaluation scale:
Five-point importance and agreement rating scales
Year:
2026
Region / City:
Not specified
Topic:
Dermatology, Atopic Dermatitis
Document Type:
Clinical Note
Institution:
Healthcare Facility
Author:
Not specified
Patient Age / Demographics:
Not specified
Assessment Date:
2026-03-09
Treatment Recommendations:
Topical corticosteroids, emollients, possible calcineurin inhibitors
Follow-up:
4-6 weeks
Potential Referral:
Dermatologist if symptoms persist
Context:
Clinical record detailing assessment, differential diagnosis, and stepwise treatment plan for a patient with atopic dermatitis, including follow-up instructions and precautions.
Year:
2015
Region / City:
Texas
Topic:
Atopic dermatitis, skin allergies in pets
Document type:
Medical article
Organization / Institution:
Derm Delivered PLLC
Author:
Jacqueline Gimmler, DVM, MS, DACVDBoard-certified Veterinary Dermatologist
Target audience:
Pet owners, veterinarians
Period of validity:
N/A
Approval date:
9/3/15
Modification date:
5/13/22
Document Type:
Template letter
Purpose:
Appeal of prior authorization denial
Product Name:
OPZELURA (ruxolitinib) cream 1.5%
Indication:
Mild to Moderate Atopic Dermatitis
Intended Author:
Prescriber
Intended Recipient:
Health Plan or Payer
Target Population:
Non-immunocompromised adult and pediatric patients 12 years of age and older
Subject Matter:
Coverage appeal and prescribing information
Included Sections:
Sample appeal letter, Indication, Limitations of Use, Important Safety Information
Medical Context:
Prior authorization denial and coverage review process
Document type:
Delphi survey questionnaire
Research method:
Delphi method
Medical field:
Dermatology
Disease focus:
Atopic dermatitis
Purpose:
Development of a simplified severity assessment scale and simplified criteria for initiating systemic treatment
Target respondents:
Medical doctors and clinical experts in atopic dermatitis
Survey structure:
Three sections including indicator screening, treatment initiation criteria agreement, and respondent familiarity and judgment basis
Assessment domains:
Pruritus, skin lesion characteristics, quality of life, and additional clinical factors
Indicator levels:
First-level, second-level, and third-level indicators
Treatment types referenced:
Immunosuppressants, glucocorticoids, biologics, and molecularly targeted therapy
Clinical factors referenced:
Itch duration and intensity, body surface involvement, lesion characteristics, quality-of-life impact, treatment response history, relapse history, and comorbid allergic diseases
Evaluation scale:
Five-point importance and agreement rating scales
Year:
2026
Region / City:
Not specified
Topic:
Dermatology, Atopic Dermatitis
Document Type:
Clinical Note
Institution:
Healthcare Facility
Author:
Not specified
Patient Age / Demographics:
Not specified
Assessment Date:
2026-03-09
Treatment Recommendations:
Topical corticosteroids, emollients, possible calcineurin inhibitors
Follow-up:
4-6 weeks
Potential Referral:
Dermatologist if symptoms persist
Context:
Clinical record detailing assessment, differential diagnosis, and stepwise treatment plan for a patient with atopic dermatitis, including follow-up instructions and precautions.
Year:
Not specified
Region / City:
Not specified
Topic:
Clinical trial design, sample size estimation
Document type:
Educational material, study design guide
Author:
Not specified
Target audience:
Clinical researchers, study designers
Effective period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified