C
Cobimetinib
Availability of ACE Drug Guidance
Yes
Biologics Drug Information Overview
No
Post-marketing information
Dear Healthcare Professional Letters
Subsidy Information and Financing Scheme
No
Active ingredient: Cobimetinib
General information
Subsidy Information and Financing Scheme
Not Applicable
Drug Guidance for Subsidy
The Ministry of Health’s Drug Advisory Committee has recommended:
Dabrafenib 50 mg and 75 mg capsules and trametinib 0.5 mg and 2 mg tablets;
Nivolumab 40 mg/4 mL, 100 mg/10 mL concentrate for solution for infusion;
Nivolumab 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL concentrate for solution for infusion used in combination with ipilimumab 50 mg/10 mL concentrate for solution for infusion; and
Pembrolizumab 100 mg/4 mL solution for infusion
for treating advanced malignant melanoma in line with specific clinical criteria.
Subsidy status
[R] Dabrafenib 50 mg and 75 mg capsules used in combination with trametinib 0.5 mg and 2 mg tablets are recommended for inclusion on the Medication Assistance Fund (MAF) for treating advanced unresectable or metastatic malignant melanoma in patients with a BRAF V600 mutation with effect from 4 January 2022.
[R] Nivolumab 40 mg/4 mL and 100 mg/10 mL concentrate for solution for infusion and pembrolizumab 100 mg/4 mL solution for infusion are recommended for inclusion on MAF for:
adjuvant treatment of completely resected malignant melanoma with lymph node involvement; and
treating advanced unresectable or metastatic malignant melanoma.
[R] Nivolumab 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL concentrate for solution for infusion used in combination with ipilimumab 50 mg/10 mL concentrate for solution for infusion are recommended for inclusion on the MAF for treating advanced unresectable or metastatic malignant melanoma.
[R] MAF assistance for nivolumab, ipilimumab and pembrolizumab will be implemented from 1 September 2022. Treatments should be given in line with the dosing regimens outlined in the Annex.
[NR] MAF assistance does not apply to:
dabrafenib 50 mg and 75 mg capsules used in combination with trametinib 0.5 mg and 2 mg tablets for adjuvant treatment of completely resected BRAF V600 mutation positive malignant melanoma with lymph node involvement; and
cobimetinib 20 mg and vemurafenib 240 mg tablets.
Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.
Post Marketing Information
Registered Product(s) Information
Clinical and product info
Clinical info | Product Info |
|---|---|
Information under the Indication, Dosage and Contraindication sections are extracted from the relevant Package Insert/Patient Information Leaflet of the product available on HSA Infosearch. For more information, please refer to the product's Package Insert/ Patient Information Leaflet available on HSA Infosearch. The information provided is for informational purposes only, and is not exhaustive. The information provided is not a substitute for professional medical advice. Please consult a qualified healthcare provider for any medical advice. | Information available here are product details as registered with the HSA. As this website is updated monthly, please refer to HSA Infosearch for the most updated product information. |
Oral
* Clinical information is available for this product.