№ lp_1_2_66532
File format: docx
Character count: 57319
File size: 318 KB
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.
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
Cancer treatment
Document Type:
Clinical submission
Organization:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of Validity:
Ongoing (TGA approval received September 28, 2021)
Approval Date:
September 28, 2021
Date of Changes:
None specified
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
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:
Cancer treatment
Document Type:
Clinical submission
Organization:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of Validity:
Ongoing (TGA approval received September 28, 2021)
Approval Date:
September 28, 2021
Date of Changes:
None specified
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
Year:
2017
Country:
Australia
Region:
Australia
Subject:
Oncology; Pharmaceutical reimbursement policy
Document type:
Pharmaceutical reimbursement submission summary
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Program:
Pharmaceutical Benefits Scheme (PBS) Section 100 Efficient Funding of Chemotherapy
Medication:
Pembrolizumab (Keytruda®)
Manufacturer:
Merck Sharp & Dohme (Australia) Pty Ltd
Medical condition:
Urothelial cancer
Disease stage:
Locally advanced (Stage III) or metastatic (Stage IV)
Target population:
Patients with urothelial cancer after failure of a platinum-containing regimen
Comparator treatments:
Paclitaxel; Docetaxel
Clinical trial referenced:
KEYNOTE-045 (KN045)
Primary outcomes:
Overall survival; Progression-free survival
Secondary outcomes:
Objective response rate; Duration of response; Health-related quality of life; Safety
Treatment regimen:
Pembrolizumab 200 mg intravenous infusion every 3 weeks
Requested listing category:
Authority Required listing under PBS
Pricing context:
Published PBS dispensed price for maximum amount provided for public and private hospitals
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