№ lp_1_26179
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This is a medical letter requesting insurance approval for a dose increase of infliximab for a patient with Crohn’s disease.
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
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Year:
2021
Region / City:
Australia
Topic:
Pharmaceutical Submission
Document Type:
Regulatory Submission
Agency / Institution:
PBAC
Author:
CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Target Audience:
Healthcare professionals, regulatory authorities
Effective Period:
2021 and ongoing
Approval Date:
25 August 2021
Date of Changes:
March 2022
Year:
2022
Region / city:
Australia
Theme:
Rheumatoid Arthritis, Pharmaceutical submission
Document type:
Submission for PBS listing
Organization / institution:
Celltrion Healthcare Australia Pty Ltd
Author:
Celltrion Healthcare Australia Pty Ltd
Target audience:
Health professionals, regulators
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Document Type:
Prior Authorization Request Letter
Subject:
Authorization for intravenous Infliximab treatment
Medication:
Infliximab
Request Type:
Standard or Expedited
Addressee:
Medical Director or Prior Authorization Reviewer
Author:
Healthcare Provider
Related Information:
Diagnosis, ICD Code, Dose and Frequency
Supporting Documentation:
Prescribing Information, Peer-Reviewed Articles, Clinical Guidelines
Purpose:
Coverage and Reimbursement Approval
Clinical Content:
Patient Diagnosis, Treatment History, Prognosis, Rationale for Treatment
Site of Service:
Inpatient or Outpatient Medical Facility
Year:
2020
Region / City:
Naas, Ireland
Topic:
Healthcare, Medical Protocol
Document Type:
Protocol
Organization:
Naas General Hospital
Author:
Joanna Rea
Target Audience:
Gastroenterology team, Clinical Nurse Manager, Nursing staff, IBD Clinical Nurse Specialist
Period of Validity:
January 2023
Approval Date:
14th of January 2020
Date of Revision:
January 2023
Date of Update:
Not specified
Keywords:
Infliximab, infusion, protocol, healthcare, patient safety, staff training, adverse events, gastroenterology
Year:
2015
Region / city:
Australia
Subject:
Pharmaceutical Submissions, Biosimilars
Document Type:
Application for PBS Listing
Organization / Institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Hospira
Target Audience:
Healthcare professionals, regulatory authorities, pharmaceutical industry
Period of validity:
Ongoing
Approval Date:
N/A
Date of changes:
N/A
Year:
2022
Region / City:
USA
Topic:
Kawasaki Disease Treatment
Document Type:
Research Article
Organization / Institution:
Multiple Medical Centers
Author:
Kaitlyn Krebushevski
Target Audience:
Pediatricians, Researchers
Period of Action:
Ongoing
Approval Date:
January 2022
Modification Date:
Not specified
Methodology:
Literature Review, Meta-Analysis, Randomized Control Trials
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:
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
Year:
2006
Region / City:
Australia
Topic:
Medication management, disability services
Document Type:
Legal / Regulatory
Organization:
Disability Services
Author:
Not specified
Target Audience:
Healthcare providers, professionals in disability services
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Chronic migraine, medicinal product submission
Document type:
Submission for PBS listing
Organization:
Novartis Pharmaceuticals Australia Pty. Limited
Author:
Not specified
Target audience:
Health professionals, pharmaceutical regulatory bodies
Period of validity:
Not specified
Date of approval:
2 July 2018
Date of amendments:
November 2023
Year:
2024
Regulatory authority:
Therapeutic Goods Administration (TGA)
Medicine:
MACITENTAN 10 mg with TADALAFIL 40 mg (Opsynvi®)
Indication:
Pulmonary arterial hypertension (PAH), WHO Group 1, functional class II and III
Therapy type:
Dual or triple combination therapy
Dosage form:
Tablet, fixed dose combination (FDC)
Prescriber type:
Medical practitioners
Restriction type:
Authority Required (Written, Complex Authority Required)
Clinical criteria:
Treatment as dual therapy (MAC+TAD) or triple therapy with prostanoid
Population:
Adult patients with stable PAH on separate doses of macitentan and tadalafil
Previous considerations:
PBAC recommendations for macitentan and tadalafil since 2011–2014
Approval date:
16 September 2024
Source documents:
TGA registration, PBAC meeting minutes, ACM minutes August 2024, FDA, EMA, CDA references
Note:
Year
Subject:
High Dose Antipsychotic Monitoring
Document Type:
Medical Form
Institution:
Oxford Health
Target Audience:
Healthcare professionals
Year:
2024
Region / city:
United Kingdom
Subject:
Radiological Protection, Transport of Radioactive Materials
Document Type:
Technical Assessment Guide
Organization:
Office for Nuclear Regulation (ONR)
Author:
Inspector - Nuclear Safety
Target Audience:
ONR safety inspectors
Validity Period:
October 2024 - October 2029
Approval Date:
October 2024
Revision Date:
Not applicable
Document Reference:
NS-TAST-GD-100
Record Reference:
2020/281169
Issue:
2.1
Purpose:
Guidance for assessing shielding designs and dose rates of transport packages for radioactive materials.
Scope:
Focuses on shielding and dose rate assessments in accordance with IAEA regulations for transport safety.
Related Legislation:
IAEA SSR-6 (2018), UK regulations for radioactive materials transport
Note:
Contextual Description
Note:
Year
Topic:
Lung disease, steroid treatment
Document type:
Information sheet
Organization / institution:
Sheffield Teaching Hospitals NHS Foundation Trust
Author:
Respiratory and endocrinology teams
Target audience:
People with lung disease on high dose inhaled steroids
Year:
2023
Region / city:
Canberra, Australia
Topic:
Obstetrics, Pre-eclampsia, Pregnancy Care
Document type:
Guideline
Organization / institution:
Canberra Health Services
Author:
Society of Obstetric Medicine Australia and New Zealand (SOMANZ)
Target audience:
Medical Officers, Registered Nurses, Registered Midwives, Students, Pharmacists
Period of validity:
Not specified
Approval date:
2023
Date of amendments:
Not specified