№ files_lp_3_process_9_28934
File format: docx
Character count: 76402
File size: 564 KB
Year:
2021
Region / City:
Australia
Topic:
Pharmaceutical Approval
Document Type:
Resubmission Request
Author:
Merck Sharp & Dohme
Target Audience:
Medical Practitioners, Healthcare Professionals
Period of Validity:
Not specified
Approval Date:
8 November 2017
Date of Changes:
November 2017
Treatment Phase:
Initial
Indication:
Clostridium Difficile Infection (CDI)
Restriction Level:
Section 100 – Authority Required
Prescriber Type:
Dental, Medical Practitioners, Nurse Practitioners, Optometrists, Midwives
Clinical Criteria:
Confirmed Toxin B Positive CDI, High Risk of Recurrence
Clinical Claim:
Bezlotoxumab more effective than SoC antibiotics in preventing CDI recurrence
Cost Effectiveness:
Comparison with Standard of Care (SoC)
Background:
TGA approved on 8 November 2017 for prevention of CDI recurrence
Context:
Pharmaceutical resubmission seeking authority for listing bezlotoxumab as an option for preventing Clostridium Difficile Infection recurrence in patients at high risk, emphasizing its cost-effectiveness over standard antibiotic treatments.
Price: 8 / 10 USD
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Year:
2022
Region / City:
Australia
Topic:
Medical treatment approval and submission for pembrolizumab and lenvatinib
Document type:
Submission for drug listing
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC), Therapeutic Goods Administration (TGA)
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Medical professionals, health regulators
Period of validity:
2022 onward
Approval date:
August 10, 2021
Amendment date:
Not specified
Year:
2023
Region / City:
Australia
Theme:
Oncology, Pharmaceutical
Document Type:
Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, policymakers
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Oncology / Colorectal Cancer Treatment
Document Type:
Medical submission
Agency / Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Medical practitioners
Effective Period:
Ongoing
Approval Date:
Not provided
Date of Revision:
Not provided
Year:
2024
Region / City:
Australia
Topic:
Oncology / Cancer Treatment
Document Type:
Pharmaceutical Submission
Organization:
Merck Sharp & Dohme
Author:
Merck Sharp & Dohme
Target Audience:
Healthcare professionals, regulatory bodies, pharmaceutical industry
Effective Period:
From September 2024
Approval Date:
Pending
Date of Changes:
September 2024
Context:
A submission by Merck Sharp & Dohme to request a multi-indication listing for pembrolizumab to treat advanced or metastatic cancers under the Pharmaceutical Benefits Scheme in Australia.
Year:
2022
Region / City:
Australia
Theme:
Oncology, Pharmacology
Document Type:
Addendum
Organ / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Healthcare professionals, regulatory bodies
Period of Validity:
Indication approved on February 7, 2022
Approval Date:
07 February 2022
Change Date:
Not specified
Year:
2022
Region / city:
Australia
Topic:
Early-stage triple negative breast cancer treatment
Document type:
Pharmaceutical submission
Organization / institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target audience:
Medical professionals, healthcare providers
Effective period:
From September 2022
Approval date:
2 September 2022
Modification date:
Not specified
Registration status:
Approved by TGA
Background:
Pembrolizumab was approved by the TGA for the treatment of early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and as monotherapy post-surgery.
Condition:
Triple negative breast cancer
Indication:
Early stage triple negative breast cancer
Restriction:
Section 100 (Efficient funding of chemotherapy), Authority Required – Streamlined
Treatment initiation criteria:
Hormone receptor negative, HER2 negative, preparing for surgery, ECOG status 1 or less, treatment combined with chemotherapy, no previous treatment, not exceeding 24 weeks of therapy
Continuation criteria:
Must have undergone surgery, ECOG status 1 or less, monotherapy for adjuvant phase, no more than 27 weeks of therapy
Grandfathering criteria:
Must have previously received non-PBS subsidised treatment
Price:
$7,881.87 private, $7,733.78 public for neoadjuvant; private and public prices for adjuvant not specified
Number of doses:
7 for neoadjuvant, 8 for adjuvant
Source:
Table 1.1-1, pp12-14
Context description:
A pharmaceutical submission for the approval of pembrolizumab as a treatment for early-stage triple-negative breast cancer, including neoadjuvant and adjuvant therapy details and pricing for PBS listing.
Year:
2021
Region / City:
Australia
Topic:
Pneumococcal vaccine submission
Document type:
Submission for listing on the National Immunisation Program
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Health professionals, regulatory bodies, policy makers
Period of validity:
Ongoing
Approval date:
16 July 2021 (FDA approval), 14 October 2021 (EMA recommendation)
Date of changes:
Not specified
Context:
A clinical submission for the inclusion of a 15-valent pneumococcal conjugate vaccine (PCV15) on the National Immunisation Program for adults at risk of pneumococcal disease.
Year:
2017
Region / city:
Australia
Theme:
Oncology, Immunotherapy
Document type:
Pharmaceutical Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Merck Sharp & Dohme
Target audience:
Healthcare professionals, medical practitioners
Effective period:
Ongoing
Approval date:
March 2017
Changes date:
Not specified
Context:
A pharmaceutical submission for the listing of pembrolizumab for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients, detailing proposed PBS listings, treatment phases, and clinical criteria.
Year:
2023
Region / city:
Australia
Topic:
Pneumococcal vaccination
Document type:
Submission
Agency / organization:
Australian Technical Advisory Group on Immunisation (ATAGI)
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Healthcare professionals involved in immunization
Period of validity:
Not specified
Approval date:
Expected by 30 April 2023
Date of changes:
9 February 2023
Year:
2018
Region / city:
Australia
Subject:
Pharmaceutical application for diabetes treatment
Document type:
Pharmaceutical submission
Organization / institution:
PBAC, TGA
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Medical practitioners, healthcare professionals
Validity period:
Ongoing since 2018
Approval date:
16 April 2018
Revision date:
March 2018
Year:
2019
Region / city:
Australia
Theme:
Oncology, Pharmacology
Document Type:
Pharmaceutical Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target Audience:
Healthcare professionals, regulatory bodies
Period of Validity:
Not specified
Approval Date:
16 October 2019
Date of Revisions:
Not specified
PBS Code:
10424P, 10436G, 10475H, 10493G, 11492W, 11494Y
Requested Dose Regimen:
400 mg Q6W
Indications:
Unresectable Stage III or Stage IV malignant melanoma, metastatic non-small cell lung cancer (NSCLC)
Price:
Private $17,434.92, Public $17,118.12
PBAC Outcome:
March 2020 meeting
Regulatory Status:
TGA approval
Clinical Evidence:
Pharmacokinetic modelling data
Clinical Trials:
Not presented for 400 mg Q6W, PK data used
Economic Analysis:
None provided