№ lp_1_2_37085
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Regulatory submission and reimbursement assessment record detailing the evaluation of dapagliflozin for public listing for chronic kidney disease within the Australian Pharmaceutical Benefits Scheme based on clinical and economic evidence.
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
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Year:
2014
Region / city:
Australia
Topic:
Pharmaceutical product submission
Document type:
Application for listing
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target audience:
Health professionals, regulatory authorities
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
1 April 2014
Year:
2023
Region / city:
United Kingdom
Topic:
Medicines Optimisation, SGLT2 inhibitors
Document Type:
Protocol
Author:
NHS England
Target Audience:
Healthcare professionals, clinicians, systems involved in diabetes and heart failure treatment
Period of Validity:
Ongoing
Approval Date:
September 25, 2023
Date of Changes:
Not specified
Clinical Area:
Type 2 diabetes, heart failure, chronic kidney disease
Inclusion Criteria:
Patients aged 18 years and older prescribed empagliflozin, canagliflozin, ertugliflozin, or branded dapagliflozin for T2DM and/or HF
Exclusion Criteria:
Severe renal impairment, diabetic ketoacidosis, and other contraindications as per SPC
Background:
Dapagliflozin is now the first-line SGLT2i in England due to cost reduction following patent expiry.
Implementation Date:
Not specified
Post-switch:
No need for additional eGFR monitoring unless clinical concerns arise
Description:
Protocol outlining the process for switching eligible patients from other SGLT2 inhibitors to dapagliflozin for the management of Type 2 diabetes and heart failure in primary care.
Year:
2023
Region / city:
United Kingdom
Topic:
Medicines optimisation, SGLT2 inhibitors, diabetes, heart failure
Document type:
Protocol
Organ / institution:
NHS England
Author:
NHS
Target audience:
Clinicians, healthcare providers
Period of validity:
Ongoing
Approval date:
Not specified
Modification date:
Not specified
Country:
England
Healthcare system:
National Health Service (NHS)
Issuing body:
NHS England
Medicines mentioned:
Dapagliflozin; Forxiga; Empagliflozin; Canagliflozin; Ertugliflozin
Therapeutic class:
SGLT2 inhibitors
Indications:
Heart failure; Diabetes mellitus
Document type:
Patient information leaflet
Subject:
Change of prescribed SGLT2 inhibitor medication
Dosage information:
10mg once daily; 5mg starting dose in patients with liver problems
Target audience:
Patients prescribed SGLT2 inhibitors for heart failure and/or diabetes
Geographical scope:
England
Year:
2023
Region / city:
United Kingdom
Topic:
Medicine optimisation, diabetes, heart failure, chronic kidney disease
Document type:
Protocol
Organisation:
NHS England
Author:
Not specified
Target audience:
Healthcare professionals
Period of validity:
Ongoing
Approval date:
September 25, 2023
Modification date:
Not specified
Clinical condition:
Type 2 diabetes mellitus, heart failure, chronic kidney disease
Medication:
Dapagliflozin, Empagliflozin, Canagliflozin, Ertugliflozin
Intended use:
Generic dapagliflozin
Switch criteria:
Based on patient needs and clinical appropriateness
Inclusion criteria:
Patients aged 18 years and older currently prescribed certain SGLT2 inhibitors
Exclusion criteria:
History of adverse reactions or specific clinical conditions
Recommended dosage:
10mg once daily, with adjustments for hepatic or renal impairment
Monitoring:
HbA1c, blood tests, signs of infections or DKA
Drug interactions:
Fewer interactions compared to other SGLT2 inhibitors
Patient communication:
Information leaflets, SMS, letters
Post-switch monitoring:
Routine HbA1c checks, watch for DKA
Clinical recommendation:
Consider shared decision-making and patient discussions
References:
NICE guidelines, NHS guidance, formulary recommendations
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:
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