№ lp_1_2_05228
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This document is a template for healthcare professionals to draft an appeal letter for insurance coverage denial of XHANCE® nasal spray in the treatment of chronic rhinosinusitis without nasal polyps.
Year:
2024
Region / City:
United States
Topic:
Medical Appeal Letter
Document Type:
Template
Organization / Institution:
OptiNose, Inc.
Author:
OptiNose, Inc.
Target Audience:
Healthcare providers, medical professionals
Period of Validity:
Indefinite
Approval Date:
05/2024
Date of Changes:
None
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Document type:
Supplementary material
Subject:
Differential DNA methylation analysis
Keywords:
DNA methylation, DMPs, DMRs, CpG island, GO enrichment, KEGG pathway, polyps, normal tissue
Biological context:
Comparison between polyp and control tissue samples
Analytical methods:
Correlation heatmap, box plot normalization, differential methylation analysis, GO and KEGG enrichment analysis
Genes mentioned:
LPA, SVIL, KRT18, MYH13 and others listed in enrichment tables
Statistical measures:
Pearson’s correlation coefficient, T value, pvalue, adjusted pvalue, qvalue
Biological processes highlighted:
Regulation of membrane potential, axon guidance, extracellular matrix organization, ion transmembrane transport
Abbreviations:
TSS (transcription start site), P (polyp), C (control), FEM (Functional epigenetic modules), DMP (differentially methylated position), DMR (differentially methylated region)
Year:
2017-2018
Region / City:
Doncaster
Subject:
Healthcare, Gynaecology
Document Type:
Service Specification
Organisation:
CCG
Author:
Not specified
Target Audience:
Healthcare Providers, GPs
Period of Validity:
1st April 2017 to 31st March 2018
Approval Date:
Not specified
Date of Review:
Annual
Date of Changes:
Not specified
Year:
2025
Region / city:
United Kingdom
Topic:
Immunization, Influenza Vaccine
Document Type:
Addendum
Organization / Institution:
UK Health Security Agency (UKHSA)
Author:
Suki Hunjunt, Alex Allen, Greta Hayward
Target Audience:
Health professionals, Immunization Programs
Effective Period:
1 September 2025 - 1 April 2026
Approval Date:
6 August 2025
Modification Date:
23 July 2025
Background:
Live attenuated influenza vaccine nasal spray suspension (Fluenz®) updated formula
Contextual Description:
Addendum to UKHSA PGD v15.0 detailing updates to the influenza vaccine composition and active strains.
Year:
2025
Region / city:
England
Topic:
Influenza Vaccination
Document Type:
Patient Group Direction (PGD)
Authority / institution:
UK Health Security Agency (UKHSA)
Author:
Suki Hunjunt, Jamie Lopez-Bernal, Greta Hayward
Target Audience:
Healthcare practitioners, immunisation staff
Period of validity:
From 1 September 2025 to 1 April 2026
Approval Date:
1 July 2025
Amendment Date:
25 June 2025
Year:
2024
Region / City:
EMEA
Therapeutic Area:
Allergic rhinitis
Document Type:
Product Information
Organization / Institution:
European Medicines Agency
Author:
Not specified
Target Audience:
Healthcare professionals
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2024-2025
Region / City:
Washington State
Topic:
Medical authorization form
Document Type:
Medical Authorization
Organization:
Washington State School for the Blind
Author:
Licensed Health Professional
Target Audience:
Parents/Guardians, School Staff
Effective Period:
07/01/2024 - 08/31/2025
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Note:
Region / city
Topic:
Nasal valve collapse, radiofrequency treatment
Document type:
Medical Procedure Description
Organization / institution:
HERC
Target audience:
Medical professionals
Approval date:
November 2022
Contextual description:
A medical document outlining the procedure code 30469 for repairing nasal valve collapse using low-energy, temperature-controlled radiofrequency treatment, detailing evidence and payer policies.
Authors:
Ruixin Zhou; Carolyn Jordan; Justin Lygrisse; Adrian Raiche
Organization:
Kindeva Drug Delivery, Lexington, KY, USA
Address:
1513 Bull Lea Road, Lexington, KY 40511, USA
Regulatory Authority Referenced:
U.S. Food and Drug Administration (FDA)
Regulatory Document Referenced:
FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation (July 2002)
Drug Product:
RezenopyTM
Dosage Form:
Nasal spray drug product
Study Type:
Comparative spray characterization and statistical equivalence study
Testing Parameters:
Spray pattern; Droplet size distribution (DV10, DV50, DV90, Span, %Volume < 10 µm); Delivered dose (% of label claim)
Media Compared:
USP Purified Water (USP-PW); Placebo formulation; Drug product formulation
Sample Size:
n=90 per test (30 samples per group)
Statistical Method:
Two-sample equivalence test; 95% confidence interval
Software Used:
Viota® Software; Minitab Statistical Software (version 22.1)
Equipment:
SprayVIEW® measurement system; Spraytec® system
Components Evaluated:
Incoming actuator (pump) lots; Finished combination product
Regulatory Context:
NDA filing; FDA-approved nasal spray product
Year:
2021
Region / City:
Hatfield, United Kingdom
Topic:
Computational Fluid Dynamics, Nasal Delivery Devices, Fluid Mechanics
Document Type:
Research Article
Institution:
University of Hertfordshire, University College London, Bespak
Authors:
Hessam Rasooli Nia, Darragh Murnane, Michael Cook, Adam Gibbons, Sabrina Falloon
Target Audience:
Researchers, Engineers, Pharmaceutical Scientists
Period of Effectiveness:
N/A
Approval Date:
N/A
Modification Date:
N/A
Title:
Supplement to “Broadening the Berlin Definition of ARDS to Patients Receiving High–flow Nasal Oxygen”
Study type:
Observational study
Document type:
Supplement including statistical analysis plan, tables and figures
Study population:
Patients with acute hypoxemic respiratory failure due to COVID–19
Clinical focus:
Acute respiratory distress syndrome according to the Berlin definition
Interventions compared:
High–flow nasal oxygen and invasive ventilation
Severity classification:
Mild, moderate and severe ARDS
Outcomes reported:
ICU discharge, hospital discharge, 28–day mortality, 90–day all–cause mortality
Statistical methods:
Hazard ratios with centre as random effect
Corresponding author:
Fleur–Stefanie L.I.M. van der Ven
Institution:
Department of Intensive Care, Amsterdam University Medical Centers, location ‘AMC’
Country:
The Netherlands
Collaborating group:
PRoAcT–COVID study investigators
Year:
2026
Region / City:
Nottingham, UK
Topic:
Nasal drug delivery, spray drying technology
Document type:
Research paper
Institution:
Upperton Pharma Solutions
Authors:
Lara C. Penn, Shailesh K. Mistry, Richard Johnson
Target Audience:
Pharmaceutical scientists, researchers in drug delivery systems
Date of approval:
2026
Date of amendments:
None
Year:
2026
Region / City:
Not specified
Topic:
Burn Patient Clinical Study
Document Type:
Research Report
Institution:
Not specified
Author:
Not specified
Target Audience:
Medical professionals, researchers
Study Period:
Not specified
Sample Size:
56 participants
Patient Grouping:
Study group and control group
Clinical Intervention:
Inspiratory muscle training
Burn Severity:
Severe (>30% body surface area, 2nd/3rd degree)
Primary Burn Causes:
Fire, hot liquids
Data Analysis Methods:
Descriptive statistics, normality tests, variance tests
Field:
Pharmaceutics and Biopharmaceutics
Topic:
Nasal drug delivery and aerosol particle size assessment
Type of document:
Scientific research article
Authors:
Niklas Baltz; Regina Scherließ
Affiliation:
Department of Pharmaceutics and Biopharmaceutics, Kiel University
Institution:
Kiel University
City:
Kiel
Country:
Germany
Research focus:
Determination of inhalable mass fraction below 10 micron in nasal spray formulations
Studied formulations:
Commercial nasal spray for allergy treatment
Analytical methods discussed:
Impactor analysis; HPLC with UV-Vis detection; comparison with laser diffraction
Tested equipment:
Fast Screening Impactor (FSI); Next Generation Impactor (NGI); reduced NGI (rNGI)
Regulatory context:
EMA and FDA recommendations on nasal product development
Measured parameter:
Mass fraction of droplets or particles less than 10 micron
Application context:
Safety evaluation of intranasal drug administration and potential pulmonary exposure
Related therapeutic area:
Intranasal treatments including therapies targeting the central nervous system
Note:
Year
Organization / Institution:
Centers for Disease Control and Prevention (CDC)
Target Audience:
Research Participants
Lung Function Test Type:
Spirometry
Sample Storage Location:
CDC, Chamblee Campus
Context:
This document provides guidelines for collecting urine samples and performing lung function tests (spirometry) as part of a health study, including sample handling, transportation, and testing protocols.
Year:
2026
Region / city:
Not specified
Topic:
Paediatric respiratory care, bronchiolitis, HFNC therapy
Document Type:
Interview script
Organization / institution:
Not specified
Author:
Not specified
Target Audience:
Clinicians, particularly medical and nursing staff working with infants with bronchiolitis
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2026
Region / City:
Lyon, France
Subject:
Nasal drug delivery, impaction force measurement
Document type:
Research article
Institution:
Nemera la Verpillière
Authors:
Laura Berard, Alain Regard
Target audience:
Pharmaceutical researchers, medical device developers
Methodology:
Experimental testing of nasal jet-based prototypes and commercial nasal sprays
Test parameters:
Impaction force, actuation speed, nozzle distance
Comparison:
Marketed nasal saline products, results from C. Guo publication
Key findings:
Jet-based prototypes’ impaction force comparable to commercial products
Device type:
Nasal spray, nasal jet-based prototypes
Year:
2026
Region / City:
Global
Subject:
Emergency treatment of opioid overdose
Document Type:
Pharmaceutical product monograph
Organization / Institution:
OPVEE™ Pharmaceuticals
Author:
OPVEE™ Research and Development Team
Target Audience:
Healthcare professionals and emergency responders
Dosage Form:
Nasal spray
Active Ingredient:
Nalmefene hydrochloride
Indications:
Treatment of known or suspected opioid overdose in patients 12 years and older
Pharmacokinetics:
Nasal administration, onset 2.5–5 minutes, duration ~6 hours above EC50
Safety Considerations:
Pregnancy, lactation, pediatric and geriatric usage, renal and hepatic impairment
Contraindications:
Hypersensitivity to nalmefene or other components
Adverse Effects:
Possible acute withdrawal in opioid-dependent patients, recurrence of respiratory depression