№ lp_1_2_37095
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This addendum presents updates related to the approval and listing of pembrolizumab for the treatment of advanced endometrial cancer in combination with lenvatinib and as monotherapy for patients with deficient DNA mismatch repair (dMMR).
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
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
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:
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:
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
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:
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:
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