№ lp_1_25468
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A report on the Pharmaceutical Benefits Scheme (PBS) outcomes for the treatment of chronic conditions, including the update on maximum dispensed quantities (MDQ) and PBS listings of medicines.
Year:
2022
Region / City:
Australia
Topic:
Pharmaceutical Benefits Scheme, Chronic Conditions Treatment, Medicine Listing
Document Type:
Government Report
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Pharmaceutical Benefits Advisory Committee
Target Audience:
Healthcare Professionals, Policymakers, Government Agencies
Period of validity:
Ongoing updates
Approval Date:
December 2022
Date of Amendments:
Ongoing updates
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024
Region / City:
Australia
Subject:
Blinatumomab, B-ALL, MRD-negative, PBS listing, chemotherapy
Document Type:
Addendum
Organization / Institution:
PBAC, TGA
Author:
PBAC Secretariat
Target Audience:
Medical practitioners, healthcare professionals
Validity Period:
Not specified
Approval Date:
November 2024
Amendment Date:
Not specified
Year:
2021
Country:
Australia
Drug:
Dapagliflozin
Brand name:
Forxiga
Dosage form and strength:
Tablet, 10 mg
Sponsor:
AstraZeneca Pty Ltd
Indication:
Chronic kidney disease
Submission type:
Category 1 submission
Requested listing:
Authority Required (Streamlined), General Schedule
Regulatory bodies:
Pharmaceutical Benefits Advisory Committee; Therapeutic Goods Administration
Target population:
Adults with chronic kidney disease with specified eGFR and UACR ranges
Comparator:
Placebo plus standard of care
Intervention:
Dapagliflozin plus standard of care
Clinical claims:
Superior efficacy and non-inferior safety versus standard of care alone
Related indications:
Type 2 diabetes mellitus; heart failure with reduced ejection fraction
Regulatory status date:
Priority review granted 13 November 2020
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
Medicine:
Aciclovir eye ointment 3% (3 mg/g), 4.5 g
Brand name:
Xorox
Sponsor:
Clinect Pty Ltd
ARTG listing date:
6 November 2020
Country:
Australia
Indication:
Herpes simplex keratitis
Regulatory authority:
Therapeutic Goods Administration
Reimbursement scheme:
Pharmaceutical Benefits Scheme
PBAC status:
Not previously considered prior to this submission
Comparator products:
AciVision, Zovirax
Submission type:
Minor submission
Listing type requested:
Restricted benefit, General Schedule
Prescriber types:
Medical practitioners, nurse practitioners, optometrists
Legal framework:
Therapeutic Goods Act 1989, Section 19A
Period discussed:
2014–2021
Source type:
Public Summary Document
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
Medicine:
Ciclosporin 1 mg/mL (0.1%) eye drops
Brand name:
Ikervis®
Sponsor:
Seqirus (Australia) Pty Ltd
Regulatory authority:
Therapeutic Goods Administration (TGA)
Registration date:
11 December 2020
Program:
Pharmaceutical Benefits Scheme (PBS)
Restriction type:
Authority Required (Streamlined)
Schedule category:
GENERAL – General Schedule (Code GE)
Indication:
Treatment of severe keratitis in adult patients with dry eye disease not improved despite tear substitutes
Population:
Patients aged 18 years or older with severe keratitis and dry eye disease
Comparators:
Best supportive care including preservative free artificial tears
Clinical criteria (initiation):
Corneal fluorescein staining grade 4 (modified Oxford scale or equivalent) and OSDI ≥ 23; failure of optimised preservative free tear substitutes
Clinical criteria (continuation):
Demonstrated adequate response at 6 months
Definition of adequate response:
Improvement in CFS ≥ 3 grades and ≥ 30% improvement in OSDI from baseline
Prescriber restrictions:
Ophthalmologist or optometrist
Economic basis:
Cost-utility analysis versus best supportive care
Proposed treatment phases:
Initiation; continuation; continuation after assessment of response
Year:
2024
Region / city:
Australia
Document Type:
Medical Submission
Organization / Institution:
PBAC
Author:
Not specified
Target audience:
Medical practitioners, pharmaceutical authorities
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
November 2024
Note:
Context
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:
N/A
Region / City:
N/A
Subject:
Positive PBAC recommendations, review process, and applicant responses
Document Type:
Guidelines
Author:
N/A
Target Audience:
PBAC applicants, clinicians, stakeholders
Effective Period:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2020
Country:
Australia
Therapeutic Area:
Ophthalmology
Indication:
Diabetic macular oedema (DMO)
Active Substance:
Fluocinolone acetonide 190 microgram intravitreal implant
Brand Name:
Iluvien®
Sponsor:
Specialised Therapeutics Alim Pty Ltd
Regulatory Authority:
Pharmaceutical Benefits Advisory Committee (PBAC)
Registration Status:
TGA registered on 29 July 2019
Type of Submission:
Minor resubmission
Type of Analysis:
Cost-minimisation analysis (CMA)
Comparator:
Dexamethasone intravitreal implant
Restriction Level:
Authority Required – In Writing Only
Treatment Phase:
Initial treatment
Prescriber Type:
Medical practitioners, nurse practitioners, optometrists, midwives, dental practitioners
Program Category:
General Schedule (Code GE)
Clinical Criteria:
Visual impairment due to DMO with specified visual acuity range and prior corticosteroid treatment without significant intraocular pressure rise
Population Criteria:
Patients post-cataract surgery or scheduled for cataract surgery in the treated eye
Document Type:
Public Summary Document extract
Year:
2023
Region / City:
Australia
Topic:
Public Consultation on PBAC Medicine Submissions
Document Type:
Survey
Organization:
Department of Health, Australia
Author:
Department of Health
Target Audience:
Patients, carers, health professionals, consumer groups, public
Period of validity:
Until 31 January 2024
Approval Date:
Not specified
Date of changes:
Not specified
Medicinal Product:
Hydrocortisone granules in capsules 0.5 mg, 1 mg, 2 mg, 5 mg (Alkindi®)
Sponsor:
Chiesi Australia
Regulatory Status:
Registered in the ARTG by the TGA on 18 August 2020
Orphan Drug Status:
Granted by the TGA
Submission Type:
Category 3 submission
Requested Listing:
Authority Required (STREAMLINED), General Schedule (Code GE)
Indication:
Replacement therapy of adrenal insufficiency
Population Criteria:
Patients diagnosed and initiated on treatment at 6 years of age or less; or patients 6 years of age or older with difficulty swallowing hydrocortisone tablets resulting in poor treatment compliance
Comparator:
Hydrocortisone 4 mg and 20 mg tablets (Hydrocortisone Mylan 4®, Hysone 4®, Hydrocortisone Mylan 20®, Hysone 20®)
Legislative Framework:
Section 101(3B) of the National Health Act 1953
Clinical Studies:
Infacort 001; Infacort 003; Infacort 004
Hearing:
No sponsor hearing conducted
Consumer Input:
Comments received from individuals, health care professionals and organisations via the PBS website
Economic Analysis:
Not presented
Year:
2020
Country:
Australia
Medicine:
Rabeprazole sodium 20 mg enteric coated tablets
Brand:
Pariet®
Sponsor:
Janssen-Cilag Pty Ltd
Regulatory register:
Australian Register of Therapeutic Goods (ARTG)
ARTG registration date:
22 June 2020
Type of submission:
General Schedule Authority Required (STREAMLINED) PBS/RPBS listing request
Committee:
Pharmaceutical Benefits Advisory Committee (PBAC)
Legislation referenced:
National Health Act 1953 (section 85D)
Existing listing comparison:
Rabeprazole 20 mg 30-tablet pack
Requested maximum quantity:
28 tablets
Proposed repeats:
Up to 5 repeats depending on item code
Approved ex-manufacturer price proposed:
$2.83
Adjusted proportional AEMP:
$2.64
Indications:
Gastro-oesophageal reflux disease (GORD); prevention of relapse of GORD; symptomatic treatment of GORD; active duodenal ulcer; gastric ulcer
Target population:
Adult patients requiring short-term treatment (4–8 weeks)
Financial impact period:
2022–2027
Estimated net financial impact:
$0 to < $10 million over six years
Hearing:
No sponsor hearing conducted
Consumer comments:
None received
Year:
2019
Region / Country:
Australia
Subject:
Pulmonary arterial hypertension medicines and subsidy policy
Document Type:
Policy review agenda item and briefing
Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Program:
Pharmaceutical Benefits Scheme (PBS)
Topic:
Post-Market Review (PMR) of PAH medicines
Medicines Mentioned:
bosentan, ambrisentan, macitentan, sildenafil, tadalafil, iloprost, riociguat, epoprostenol
Medical Classification Referenced:
WHO Functional Class II–IV pulmonary arterial hypertension
Guidelines Referenced:
2015 European Society of Cardiology / European Respiratory Society Guidelines for the diagnosis and treatment of pulmonary hypertension
Stakeholders:
PAH Reference Group, medicine sponsors including Actelion, GlaxoSmithKline, and Pfizer
Regulatory Focus:
Revision of PBS prescribing restrictions and subsidy conditions
Key Policy Changes Considered:
Extension of subsidised monotherapy to WHO Functional Class II patients, updated PAH definition, inclusion of additional WHO Group 1 PAH subtypes, removal of calcium channel blocker trial requirement, strengthened diagnostic role of right heart catheterisation
Consultation Process:
Pre-PBAC consultation with sponsors and reference group
Associated Meetings:
PBAC meetings in November 2018, March 2019, and planned July 2019 review discussion
Related Policy Activity:
Planned stakeholder meeting on PAH combination therapy scheduled for May 2019
Year:
2018
Region:
Australia
Subject:
PD-1 and PD-L1 checkpoint inhibitor immunotherapies
Document Type:
Submission Template
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Intended Audience:
Patients, healthcare providers, researchers, pharmaceutical industry, government bodies
Submission Deadline:
29 June 2018
Contact Information Required:
Yes
Confidentiality Note:
Commercial-in-confidence or personal information to be redacted before publication
Format:
Electronic submission in Microsoft Word or text-based format
Questions Covered:
Advantages, disadvantages, unmet clinical need, evidence requirements, cost-effectiveness, subsidy pricing, biomarker considerations, extrapolation across medicines and cancer types, rare cancers, follow-up actions, clinical trials, international models
Year:
Not provided
Region / City:
Not specified
Topic:
Research ethics, manuscript submission
Document type:
Template
Author:
Not specified
Target audience:
Authors submitting research articles
Period of validity:
Not provided
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Geneva
Subject:
Human Resources, Workplace Conduct, Sexual Harassment
Document Type:
Decision Draft
Organ / Institution:
World Meteorological Organization (WMO)
Author:
Secretary-General
Target Audience:
Executive Council, WMO staff
Period of Validity:
Ongoing
Approval Date:
2.III.2023
Date of Amendments:
N/A
Year:
2024
Region / City:
East Gippsland
Topic:
Planning permits
Document Type:
Planning Scheme
Authority:
East Gippsland Council
Target Audience:
Applicants for planning permits
Period of validity:
From 1 December 2024
Approval Date:
1 December 2024
Amendment Date:
24 January 2025
Year:
2024
Region / City:
Gauteng / Pretoria / Johannesburg
Subject:
Legal Procedure
Document Type:
Trial Practice Note Template
Organization / Institution:
High Court of South Africa
Author:
Not specified
Target Audience:
Legal professionals, Plaintiffs, Defendants
Period of validity:
N/A
Approval Date:
N/A
Date of amendments:
N/A
Year:
2021
Country:
England
Education framework:
Early Years Foundation Stage
Age range:
3–4 years; Reception
Key areas:
Communication and Language; Personal, Social and Emotional Development; Physical Development
Document type:
Curriculum guidance
Issuing body:
Department for Education
Learning stage:
Early years
Focus:
Developmental expectations and outcomes
Related standards:
Early Learning Goals
Non-statutory status:
Development Matters guidance