№ lp_1_2_57905
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Summary of PBAC recommendations and submissions for listing galcanezumab and related CGRP inhibitors for chronic migraine, including clinical criteria, treatment phases, and patient access considerations.
Year:
2019–2020
Region / country:
Australia
Subject:
Chronic migraine treatment and drug listing
Document type:
Public Summary Document (PSD)
Organization / authority:
Pharmaceutical Benefits Advisory Committee (PBAC), TGA
Drug:
Galcanezumab (Emgality)
Other drugs referenced:
Fremanezumab, Erenumab, Botox
Target population:
Adults with chronic migraine unresponsive to at least three prophylactic migraine medications
Administration form:
Injection 120 mg/1 mL pre-filled pen
Prescription restrictions:
Streamlined listing, treatment by neurologist required, specific clinical criteria for migraine frequency and prior treatment response
Consumer input:
Included 186 individuals, 2 health professionals, 1 organization
Cost analysis:
Cost-minimisation analysis (CMA) versus Botox
Risk sharing arrangement:
Included, with expenditure cap adjustments
Price: 8 / 10 USD
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Date:
[Date]
Patient:
[Patient’s First and Last Name]
Date of Birth:
[Patient’s Date of Birth]
Insurance Company:
[Insurance Company Name]
Subscriber ID #:
[Insurance Subscriber ID]
Subscriber Group #:
[Insurance Group ID]
Insurance Company Contact:
[Insurance Company Contact]
Insurance Company Address:
[Insurance Company Address]
Insurance Company City, State ZIP:
[Insurance Company City, State ZIP]
Medication:
VYEPTI® (eptinezumab-jjmr) [100 mg/300 mg]
Indication:
Preventive treatment of chronic/episodic migraine
ICD-10 Code:
[ICD-10 code]
Prior Treatments:
[List prior treatments with dates and reasons for discontinuation]
Dose Initiation:
[100 mg/300 mg]
Dose Escalation:
[If applicable, 300 mg]
Treatment Continuation:
[Current VYEPTI dose and response]
Physician:
[Physician’s Name]
Provider Identification Number:
[Provider Identification Number]
Practice Name:
[Name of Practice]
Practice Phone Number:
[Phone Number]
Enclosures:
Original Letter of Medical Necessity, patient clinical/diagnostic notes, relevant lab reports, published clinical references
Category:
Health Condition/ Disease
Subcategory:
Intervention
Last Updated:
2014-03-11
Keywords:
headache, migraine, attack, migrainous head pain, aura, neurological disorder, nervous system
Evidence:
B, C & D
Grade of Evidence:
B, C & D
Context:
A systematic review and critical analysis of dietary components that are self-reported as triggers for migraines, based on cross-sectional, case-control, experimental, and cohort studies.
Year:
2026
Patient Name:
[REDACTED]
Patient DOB:
[REDACTED]
Insurance Company:
[REDACTED]
Policy Number:
[REDACTED]
Group Number:
[REDACTED]
ICD10 Codes:
[REDACTED]
Test Name:
Hemiplegic Migraine Panel
CPT Codes:
81406x1, 81407x1, 81479x1
Laboratory:
GeneDx, Inc.
Laboratory Address:
207 Perry Parkway, Gaithersburg, MD 20877
Laboratory NPI:
1487632998
Laboratory TAXID:
205446298
Laboratory CLIA:
21D0969951
Ordering Provider:
[REDACTED]
Purpose:
Request for insurance coverage for medically necessary genetic testing
Clinical Indications:
Hemiplegic migraine with aura, family and personal medical history, uninformative prior genetic tests
Relevant Genes:
CACNA1A, SCN1A, ATP1A2, PRRT2
Clinical Features:
Aura, hemiplegic attacks, ataxia, intellectual disability, risk of seizures
Inheritance Pattern:
Autosomal dominant for familial hemiplegic migraine
Target Population:
Individuals with hemiplegic migraine symptoms and family history of similar disorders
References:
Albury et al. 2017; Huang et al. 2017; Pelzer et al. 2018; Jen JC 2001/2015; Noebels et al. 2012; Ebrahimi-Fakhari et al. 2015; Riant et al. 2010
Year:
2024
Location:
Tangent Theater, Trinity College Dublin, Ireland
Theme:
Clinical Neurology, Headache Disorders
Document type:
Conference Program
Organizing body:
Trinity College Dublin
Course director:
Dr Anhar Hassan
Speakers:
Prof Anhar Hassan, Ms Helen Cahill, Prof Miriam Galvin, Ms Naomi Thornton, Ms Sharon Moran, Dr Petya Mihaylova, Dr Siobhan Hutchinson, Ms Mary Pilladath, Dr Eddie O’Sullivan, Dr Nicholas Silver, Prof Brian McGuire
Target audience:
Healthcare professionals, neurologists, clinicians
Date:
February 2, 2024
Schedule:
09:00–16:30
Sessions:
Registration, Welcome, Keynote lectures, Panel discussions, Coffee breaks, Lunch, Closing remarks
Context:
Detailed agenda of a professional neurology conference including lectures, discussions, and practical sessions on migraine and other headache disorders
Year:
2023
Region / City:
Global
Topic:
Migraine Treatment and Prophylaxis
Document Type:
Pharmaceutical List
Author:
Not specified
Target Audience:
Healthcare professionals
Period of validity:
Ongoing
Approval Date:
Not specified
Date of modifications:
Not specified
Year:
2023
Region / city:
Australia
Topic:
Oncology, Pharmaceuticals
Document Type:
Resubmission
Institution:
Australian Government, Pharmaceutical Benefits Advisory Committee
Author:
AstraZeneca Pty Ltd.
Target Audience:
Healthcare professionals, regulatory bodies
Effective Period:
Ongoing
Approval Date:
November 2021
Date of Changes:
November 2021
Note:
Year
Document Type:
Assessment Form
Institution:
Pearson
Author:
Pearson
Target Audience:
Students, Assessors
Year:
2022
Country:
Australia
Therapeutic area:
Oncology
Disease:
Endometrial cancer
Biomarker status:
Mismatch repair deficient (dMMR)
Medicine name:
Dostarlimab
Brand name:
Jemperli
Dosage form:
Solution concentrate for intravenous infusion
Sponsor:
GlaxoSmithKline Australia Pty Ltd
Regulatory body:
Pharmaceutical Benefits Advisory Committee
Submission type:
Standard Re-entry submission
Requested listing:
Section 100
Comparator treatments:
Standard of care chemotherapy; pembrolizumab plus lenvatinib; pembrolizumab monotherapy
Clinical trial referenced:
GARNET
Approval status:
Provisional approval
Indication:
Recurrent or advanced endometrial cancer after platinum-containing regimen
Decision context:
PBS listing consideration
Period covered:
Up to November 2022
Drug name:
Apremilast
Brand name:
Otezla
Dosage form:
Tablet
Strength:
30 mg
Pack composition:
4 tablets of 10 mg, 4 tablets of 20 mg, 19 tablets of 30 mg
Sponsor:
Amgen Australia Pty Ltd
Regulatory status:
TGA registered
TGA registration date:
19 March 2015
Indication:
Severe plaque psoriasis
Previous indication:
Psoriatic arthritis and moderate to severe plaque psoriasis
Application type:
Minor resubmission
Requested listing:
PBS General Schedule, Authority Required (STREAMLINED)
Comparator:
Cyclosporin
Clinical population:
Patients with severe plaque psoriasis intolerant of or contraindicated to methotrexate
Primary outcome:
PASI-75 at 16 weeks
Clinical claim:
Non-inferior comparative efficacy and safety versus cyclosporin
Regulatory body:
Pharmaceutical Benefits Advisory Committee
Submission history period:
2015–2018
Geographic scope:
Australia
Source type:
Public summary document excerpt
Year:
2019
Region / city:
Australia
Theme:
Oncology, Chemotherapy
Document type:
Resubmission for PBS listing
Organ / institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Bristol-Myers Squibb Australia Pty Ltd
Target audience:
Medical professionals, PBAC members
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Medicine:
Midazolam oromucosal solution in pre-filled syringe
Brand name:
Zyamis®
Sponsor:
Clinect Pty Ltd
Dosage forms:
2.5 mg/0.25 mL; 5 mg/0.5 mL; 7.5 mg/0.75 mL; 10 mg/1 mL
Indication:
Treatment of generalised convulsive status epilepticus (GCSE) in patients over 6 months of age
Regulatory authority:
Therapeutic Goods Administration (TGA)
ARTG listing date:
22 April 2022
Advisory body:
Pharmaceutical Benefits Advisory Committee (PBAC)
Submission type:
Early re-entry resubmission
Requested listing:
Section 85 Authority Required (telephone/online)
Additional request:
Prescriber Bag Schedule listing for Medical Practitioners
Comparative medicine:
Midazolam hydrochloride injection 5 mg/mL
Proposed maximum quantity:
2 pre-filled syringes per prescription
Estimated financial impact:
$20 million to < $30 million over six years
Previous consideration:
July 2022 PBAC meeting
Source:
Public Summary Document (PSD), July 2022
Year:
2021
Region / City:
Australia
Document Type:
Public Summary Document (PSD)
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Healthcare professionals, Medical Practitioners
Period of Effect:
2021-2022
Approval Date:
15 July 2021
Revision Date:
November 2021
Year:
2026
Region / city:
Colorado
Theme:
Education, Curriculum Design
Document Type:
Guidelines, Course Proposal
Institution:
Colorado State University
Author:
Curriculum & Catalog Unit
Target Audience:
Faculty, Academic Administrators, Curriculum Committees
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Topic:
Diversity, Equity, and Inclusion
Document Type:
Course Proposal
Institution:
Colorado State University
Target Audience:
CSU faculty, curriculum committees, and academic departments
Year:
2023
Region / City:
Australia
Topic:
Oncology, Haematology, Pharmaceutical Submission
Document Type:
Submission Request
Organisation:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Amgen Australian Pty Ltd
Target Audience:
Healthcare professionals, Pharmaceutical industry
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Year:
2021
Region / city:
South Gloucestershire, Kingswood
Topic:
Planning Application
Document Type:
Consultation Response
Organization / Institution:
The Coal Authority
Author:
James Smith
Target Audience:
Case Officer, Local Planning Authorities
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2026
Region / City:
United Kingdom
Subject:
Professional supervision and accreditation
Document type:
Guidance form
Organization / Institution:
British Association for Counselling and Psychotherapy (BACP)
Author:
BACP Accreditation Department
Target audience:
Supervisors and applicants for accreditation
Purpose:
To provide instructions for completing a supervisor statement as part of the accreditation resubmission process
Relevant legislation:
GDPR, Data Protection Act 2018
Sections included:
Applicant details, Supervisor details, Supervision contract, Comments, Signatures
Format:
Digital form for online submission
Year:
2026
Institution:
Orthopaedic outpatient clinic
Document type:
Medical case report
Authors:
Multiple, corresponding author indicated
Patient age:
40
Patient gender:
Male
Patient smoking status:
Smoker
Medical condition:
Recurrent giant-cell tumor of proximal humerus with pulmonary metastasis
Procedures:
Wide excision, hemiarthroplasty using Austin Moore prosthesis
Histopathology results:
Postoperative biopsy showed recurrent giant-cell tumor, no sign of malignancy initially; malignant GCT after shoulder disarticulation
Infection:
S. aureus, treated with specific antibiotics
Consent:
Informed consent obtained from patient
Follow-up outcome:
Patient deceased 2 years post-disarticulation due to loss of follow-up and missed chemotherapy
Imaging:
X-ray, CT scans partially performed, some unavailable
References:
Added discussion and references following JKKI style
Note:
Year
Subject:
Professional Learning
Document Type:
Guideline
Target Audience:
Teachers
Period of Validity:
One calendar year from original submission