02/01/2024 PARP inhibitors and bevacizumab for treating advanced ovarian cancer
The Ministry of Health’s Drug Advisory Committee has recommended:
- Olaparib 100 mg and 150 mg ...
02/01/2024 PARP inhibitors and bevacizumab for treating advanced ovarian cancer
The Ministry of Health’s Drug Advisory Committee has recommended:
- Olaparib 100 mg and 150 mg tablets; and
- Niraparib 100 mg tablet
for treating advanced ovarian cancer in line with specific clinical criteria.
Funding status
ROlaparib 100 mg and 150 mg tablets are recommended for inclusion on the Medication Assistance Fund (MAF) with effect from 1 September 2022 for the following indications:
- As maintenance monotherapy for patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Treatment should be continued until disease progression or unacceptable toxicity or for a maximum of 24 months;
- In combination with bevacizumab biosimilar (subsidised brand) as maintenance treatment of patients with advanced homologous recombination deficiency (HRD) positive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab biosimilar. Treatment with olaparib should be continued until disease progression or unacceptable toxicity or for a maximum of 24 months; and
- As maintenance monotherapy for patients with platinum-sensitive relapsed BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Patients must not have received prior treatment with a PARP inhibitor for ovarian cancer. Treatment should be continued until disease progression or unacceptable toxicity.
RNiraparib 100 mg tablet is recommended for inclusion on the MAF with effect from 1 March 2024 for the following indication:
- As maintenance monotherapy for patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with BRCA mutation and/or HRD-positive status. Treatment should be continued until disease progression or unacceptable toxicity or for a maximum of 36 months.
Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.
12/07/2022 Bevacizumab biosimilar for treating different types of cancers
The Ministry of Health’s Drug Advisory Committee has recommended:
- Bevacizumab biosimilar (Mva...
12/07/2022 Bevacizumab biosimilar for treating different types of cancers
The Ministry of Health’s Drug Advisory Committee has recommended:
- Bevacizumab biosimilar (Mvasi) 100 mg/40 mL and 400 mg/16 mL concentrate for solution for infusion in line with its registered indications or local clinical protocols for treating:
- Persistent, recurrent, or metastatic cervical cancer when used with platinum-based chemotherapy plus paclitaxel;
- Metastatic colorectal cancer when used with fluoropyrimidine-based chemotherapy;
- Malignant glioma (WHO Grade III and IV) after relapse or disease progression following prior therapy;
- Previously untreated, unresectable, locally advanced, recurrent or metastatic non-squamous non-small-cell lung cancer when used with carboplatin and paclitaxel;
- Previously untreated, advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have suboptimally debulked Stage III disease with more than 1 cm of residual disease or Stage III unresectable or Stage IV disease;
- Recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer when used with carboplatin and gemcitabine or paclitaxel;
- Recurrent, platinum-resistant, epithelial ovarian, fallopian tube, or primary peritoneal cancer when used with paclitaxel, topotecan or pegylated liposomal doxorubicin; and
- Advanced homologous recombination deficiency (HRD) positive high grade epithelial ovarian, fallopian tube or primary peritoneal cancer as maintenance treatment in combination with olaparib in adults who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab biosimilar.
Subsidy status
RBevacizumab biosimilar (Mvasi) 100 mg/4 mL and 400 mg/16 mL concentrate for solution for infusion are recommended for inclusion on the MOH Standard Drug List (SDL) for the abovementioned indications with effect from 1 April 2022.
NRSDL subsidy does not apply to any formulations or strengths of bevacizumab reference biologic (Avastin) or other brands of bevacizumab biosimilars.
Clinical indications, subsidy class and MediShield Life claim limits are provided in the Annex.
12/07/2022 Aflibercept, bevacizumab and ramucirumab for treating metastatic colorectal cancer
NRThe Ministry of Health’s Drug Advisory Committee has not recommended aflibercept, bevacizuma...
12/07/2022 Aflibercept, bevacizumab and ramucirumab for treating metastatic colorectal cancer
NRThe Ministry of Health’s Drug Advisory Committee has not recommended aflibercept, bevacizumab reference biologic (Avastin) or ramucirumab for subsidy for treating metastatic colorectal cancer.
NRBevacizumab (Avastin) has not been recommended in view of unfavourable cost effectiveness compared with bevacizumab biosimilar (Mvasi) at the price proposed by the manufacturer.
NRAflibercept has not been recommended due to low clinical need and unfavourable cost effectiveness compared with Mvasi.
NRRamucirumab has not been recommended following a request from the manufacturer to not consider it for subsidy.
Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.
12/07/2022 Bevacizumab for treating persistent, recurrent or metastatic cervical cancer
NRThe Ministry of Health’s Drug Advisory Committee has not recommended bevacizumab reference b...
12/07/2022 Bevacizumab for treating persistent, recurrent or metastatic cervical cancer
NRThe Ministry of Health’s Drug Advisory Committee has not recommended bevacizumab reference biologic (Avastin) for subsidy for treating persistent, recurrent or metastatic cervical cancer in view of unfavourable cost effectiveness compared with bevacizumab biosimilar (Mvasi) at the price proposed by the manufacturer.
Clinical indications, subsidy class and MediShield Life claim limits are provided in the Annex.