№ files_lp_3_process_9_44234
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The document is a public consultation survey seeking feedback on medicines for the PBAC March 2024 meeting.
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
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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
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
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
) and join the S1NET. For guides with in depth examinations of performance measure definitions, go to:
https://www.milsuite.mil/book/docs/DOC-129783
Table of Contents (Hyperlinks to Sections):
Developing ‘Significant Duties and Responsibilities’ OER Narratives: Notes, Rules, and Instructions OER Narrative Prohibited Techniques, Inconsistencies, No-Go’s: Negative Comment Rules Referred OERs Narrative Comment Examples Block a. APFT and HT/WT Block b. Overall Performance Block c. Character (to include SHARP comments) Block d. Presence Block e. Intellect Block f. Leads Block g. Develops Block h. Achieves Senior Rater Potential Senior Rater Narrative Examples Senior Rater Narrative Comment Examples (for potential, promotion, school, etc.) Successive Assignments Other SR Comments (explanations of anything unusual about OER) Effective Words for Evaluations JUNIOR OFFICER PLATE (DA FORM 67-10-1) NOTE: 2LTs who have NOT completed BOLC, will not receive an OER until they complete BOLC (AC and ARNG; USAR officers can receive an OER before completing BOLC). The FROM date will be their commissioning date. All time until their BOLC graduation will be NONRATED on their first OER. OER PROFILING: OERs: Rater and Senior Rater Profiles are CONSTRAINED, meaning Officers are only allowed to grant 49% of each rank they rate with either an “EXCELS” (as Rater) or “MOST QUALIFIED” (as Senior Rater). HOWEVER, if you have an immature profile, and have only just begun rating/senior rating Officers of a certain rank, you are allowed a ONE TIME option of giving one of the first two evaluations you make at a particular grade, an “EXCELS” (as Rater) or “MOST QUALIFIED” (as Senior Rater). OER (OER SUPPORT FORM) PART III: Developing ‘Significant Duties and Responsibilities’ (blocks a., b., and c.): Refer to DA PAM 611-21 (https://www.milsuite.mil/book/groups/smartbookdapam611-21
) and DA PAM 600-3 (Commissioned Officer Professional Development and Career Management), to assist in the development of PART III, block d. As a minimum, the duty description will include pr:
- Number of personnel supervised, - Amount of resources under the rated officer’s control, - Scope of responsibilities. 3) Descriptions must be clear and concise with emphasis on specific functions required. 4) Note conditions unique to the assignment; e.g. RA officers assigned to FT support duties with RC units or USAR officers assigned to RA units OER NARRATIVES: Notes, Rules, and Instructions Rater and Senior Rater Narratives: - Requires candor and courage; frank and accurate assessment. - Quantify officer’s value relative to peers and do so in concert with rater/senior rater box check. - Are short; tell a simple story about the quality of officer being evaluated. - Are interesting and compelling. - Are looked at by selection board members when they are looking for in-depth information about a rated officer’s performance and potential. - Numbers; 1-10, write them out (e.g. one, two, ten). 11 or higher, write the number; e.g. 11, 15, 105. Exception, when a 1-10 is WITH an 11 or higher; e.g. “5 tool kits with 20 tools each.” - Fashion the narrative to the officer; double check use of “he/his” vs. “she/hers.” - Awards: Awards and/or special recognition received during the rating period may be cited in evaluation comments (for example, “received the Humanitarian Service Medal” or “named the Instructor of the Year”). - Raters and SR CAN use the officer’s name in the narrative; e.g. “1LT Joe was ….” Rater and Rater Narratives: - Focus on PERFORMANCE; explaining what the rated officer did and how well he/she did it. - Focus on specifics to quantify and qualify performance. - Raters should advocate the rated officer to the SR. - When there is no SR (due to lack of qualifications), rater’s narrative provides the input on both performance and potential. Senior Rater (SR) and SR Narrative (see SR Rater Narrative section for examples): - Focus on POTENTIAL, 3-5 years out (promotions, command, school, & assignments). - Can amplify box checks by using the narrative to clearly send the appropriate message to selection boards. - CANNOT mention Box Check. - Additional information for when SR is also Rater can be found in DA PAM 623-3, pg. 26, “DA Form 67–10–1, part VI: block c—Senior Rater Narrative.” OER Narrative Prohibited Techniques, Inconsistencies, No-Go’s: - School/Course Comments: Bullets about how a Soldier did in a school or course are ONLY allowed if that school did not produce an AER/DA Form 1059. - Narratives are not a laundry list of superlatives – more is not necessarily better. - Brief, unqualified superlatives or phrases, particularly if they may be considered trite. - Excessive use of technical acronyms, or phrases not commonly recognized. - Techniques aimed at making specific words, phrases, or sentences stand out from the rest of the narrative; e.g. excessive use of capital letters; unnecessary quotation marks; repeated use of exclamation points; wide spacing between selected words, phrases, or sentences to include double spacing within a paragraph or between paragraphs. - Inappropriate references to box checks; e.g “Would be TOP BLOCK if profile allowed” or “absolutely far exceeded the standard”. - Trying to quantify (e.g. “top 2% of my captains”) with a small population. - Stay in your lane/level; avoid comments like “Best 1LT in the Army” unless you’re the Army CoS. - Stating “the best ever”; having 10 in the population, 50 in the profile. - Using overused phrases and clichés that are counterproductive or overused; e.g. stellar, historic, “delivered a dazzling performance,” “hit the ground running,” consummate professional, and unlimited potential. - Using specific selection board-type language. Examples of this include, “definitely a 6+ Soldier”. - Don’t exaggerate; “If I could prove it, CPT X is an LTC disguised as a CPT.” - Be mindful of what IS NOT said; it can have the same impact as what is said; e.g. NOT having numbers, or quantifiable points. - Don’t say the sa
Note:
en
Topic:
Officer Evaluation, Narrative Guidelines
Document Type:
Guide
Target Audience:
Raters, Senior Raters
Year:
2024
Region / city:
International
Topic:
Safety transport of radioactive materials
Document type:
Report
Organization / institution:
International Atomic Energy Agency (IAEA)
Author:
IAEA Secretariat
Target audience:
IAEA members, safety committees, regulators
Period of validity:
Not specified
Date of approval:
Not specified
Date of amendments:
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
Year:
2023
Region / City:
Geneva
Topic:
Design Law Treaty
Document Type:
Draft
Organ / Institution:
WIPO
Author:
Secretariat
Target Audience:
Diplomatic Conference Participants, WIPO Member States
Period of Effectiveness:
2023-2024
Approval Date:
N/A
Date of Changes:
N/A