Nivolumab [Opdivo]

[MAF] Nivolumab (Opdivo) Concentrate For Infusion 40 mg/4 mL, 100 mg/10 mL

1. For intermediate- or poor-risk advanced renal cell carcinoma, following induction treatment with nivolumab in combination with ipilimumab. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

2. For previously treated advanced renal cell carcinoma (RCC). Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for advanced RCC. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

3. Nivolumab in combination with ipilimumab for untreated intermediate- or poor-risk advanced renal cell carcinoma. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab and 1mg/kg ipilimumab every 3 weeks for 4 doses.

4. Adjuvant treatment of completely resected malignant melanoma in patients with lymph node involvement. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks. Maximum duration of treatment: 12 months.

5. Monotherapy for advanced unresectable or metastatic malignant melanoma. Patients must not have received prior treatment with a PD-1 inhibitor or ipilimumab for advanced unresectable or metastatic malignant melanoma. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

6. Nivolumab in combination with ipilimumab for the treatment of advanced unresectable or metastatic malignant melanoma. The doses of nivolumab and ipilimumab should not exceed: 1mg/kg nivolumab and 3mg/kg ipilimumab every 3 weeks for 4 doses.

7. Treatment of advanced unresectable or metastatic malignant melanoma, following induction treatment with nivolumab in combination with ipilimumab. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

8. For patients with recurrent or metastatic squamous cell cancer of the head and neck whose disease progressed within six months of starting platinum-based chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the recurrent or metastatic setting. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

9. Treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for metastatic NSCLC. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

10. Treatment of patients with unresectable locally advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma after 2 or more prior systemic therapies. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for unresectable locally advanced or recurrent gastric or GEJ cancer. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

11. Treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after an autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the relapsed or refractory setting. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

12. Adjuvant treatment of completely resected oesophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy. Maximum treatment duration: 12 months.

13. Nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, unresectable advanced or metastatic HER2 negative gastric cancer, gastroesophageal junction cancer or oesophageal adenocarcinoma. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

14. Treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the unresectable advanced, recurrent or metastatic setting.

15. Nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

[MAF] Nivolumab (Opdivo) Concentrate For Infusion 240 mg/24 mL

1. Adjuvant treatment of completely resected oesophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy. Maximum treatment duration: 12 months.

2. Nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, unresectable advanced or metastatic HER2 negative gastric cancer, gastroesophageal junction cancer or oesophageal adenocarcinoma. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

3. Treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the unresectable advanced, recurrent or metastatic setting.

4. Nivolumab in combination with ipilimumab for the treatment of advanced unresectable or metastatic malignant melanoma. The doses of nivolumab and ipilimumab should not exceed: 1mg/kg nivolumab and 3mg/kg ipilimumab every 3 weeks for 4 doses.

5. Treatment of advanced unresectable or metastatic malignant melanoma, following induction treatment with nivolumab in combination with ipilimumab. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

6. Nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

[MSHL] Nivolumab Concentrate For Solution For Infusion 40 mg/4 mL, 100 mg/10 mL

1. Nivolumab in combination with ipilimumab for untreated intermediate- or poor-risk advanced renal cell carcinoma. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab and 1mg/kg ipilimumab every 3 weeks for 4 doses.

2. Nivolumab in combination with ipilimumab for treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for unresectable or metastatic MSI-H or dMMR CRC. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab and 1mg/kg ipilimumab every 3 weeks for 4 doses, followed by nivolumab 240mg every 2 weeks or 480mg every 4 weeks as a single agent.

3. Nivolumab in combination with ipilimumab for treatment of advanced unresectable hepatocellular carcinoma (HCC) in patients with disease progression after 1 or more prior lines of systemic therapy, and who have adequate liver function as assessed by the Child-Pugh scoring system. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for advanced unresectable HCC. The doses of nivolumab and ipilimumab should not exceed: 1mg/kg nivolumab and 3mg/kg ipilimumab every 3 weeks for 4 doses, followed by nivolumab 240mg every 2 weeks or 480mg every 4 weeks as a single agent.

4. Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy, for untreated metastatic or recurrent non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumour mutations. Treatment with nivolumab and ipilimumab should be stopped at 2 years, or earlier if disease progresses.

[MSHL] Nivolumab Concentrate For Solution For Infusion 40 mg/4 mL, 100 mg/10 mL

1. For patients with recurrent or metastatic squamous cell cancer of the head and neck whose disease progressed within six months of starting platinum-based chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the recurrent or metastatic setting. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

2. Treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for metastatic NSCLC. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

3. Treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after an autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the relapsed or refractory setting. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

4. For previously treated advanced renal cell carcinoma (RCC). Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for advanced RCC. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

5. For intermediate- or poor-risk advanced renal cell carcinoma, following induction treatment with nivolumab in combination with ipilimumab. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

6. Adjuvant treatment of completely resected malignant melanoma in patients with lymph node involvement. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks. Maximum duration of treatment: 12 months.

7. Monotherapy for advanced unresectable or metastatic malignant melanoma. Patients must not have received prior treatment with a PD-1 inhibitor or ipilimumab for advanced unresectable or metastatic malignant melanoma. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

8. Treatment of patients with unresectable locally advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma after 2 or more prior systemic therapies. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for unresectable locally advanced or recurrent gastric or GEJ cancer. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

9. Treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) after receiving platinum-containing chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for locally advanced or metastatic UC. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

10. Treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for unresectable or metastatic MSI-H or dMMR CRC.

11. Treatment of advanced unresectable hepatocellular carcinoma (HCC) in patients with disease progression after 1 or more prior lines of systemic therapy, and who have adequate liver function as assessed by the Child-Pugh scoring system. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for advanced unresectable HCC. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

[MSHL] Nivolumab Concentrate For Solution For Infusion 40 mg/4 mL, 100 mg/10 mL, 240 mg/24 mL

1. Nivolumab in combination with ipilimumab for the treatment of advanced unresectable or metastatic malignant melanoma. The doses of nivolumab and ipilimumab should not exceed: 1mg/kg nivolumab and 3mg/kg ipilimumab every 3 weeks for 4 doses.

2. Nivolumab in combination with ipilimumab for unresectable malignant pleural mesothelioma. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab every 2 weeks and 1mg/kg ipilimumab every 6 weeks. Treatment with nivolumab and ipilimumab should be stopped at 2 years, or earlier if disease progresses.

3. Nivolumab in combination with ipilimumab for untreated, unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma. The doses of nivolumab and ipilimumab should not exceed: 3mg/kg nivolumab every 2 weeks and 1mg/kg ipilimumab every 6 weeks. Treatment with nivolumab and ipilimumab should be stopped at 2 years, or earlier if disease progresses.

[MSHL] Nivolumab Concentrate For Solution For Infusion 40 mg/4 mL, 100 mg/10 mL, 240 mg/24 mL

1. Treatment of advanced unresectable or metastatic malignant melanoma, following induction treatment with nivolumab in combination with ipilimumab. Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

2. Adjuvant treatment of completely resected oesophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy. Maximum treatment duration: 12 months.

3. Nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, unresectable advanced or metastatic HER2 negative gastric cancer, gastroesophageal junction cancer or oesophageal adenocarcinoma. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

4. Treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the unresectable advanced, recurrent or metastatic setting.

5. Nivolumab in combination with platinum-doublet chemotherapy for neoadjuvant treatment of resectable (tumours ≥4 cm or node positive) non-small cell lung cancer. Maximum duration of treatment: 3 cycles.

6. Nivolumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

7. Adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC, and only if adjuvant treatment with platinum-based chemotherapy is unsuitable. Maximum duration of treatment: 12 months.

[MSHL] Nivolumab Concentrate For Solution For Infusion 40 mg/4mL, 100 mg/10mL

1. Nivolumab in combination with cabozantinib for untreated advanced renal cell carcinoma. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

Legend

This section shows the following:

• Subsidy Scheme and Clinical Indication (where applicable) of drugs listed in the MOH List of Subsidised Drugs

• Subsidised brands of vaccines recommended in the National Immunisation Schedules listed in the MOH Subsidised Vaccine List

• Cancer Drug and Clinical Indication listed in the MediShield Life Cancer Drug List

As this website is updated monthly, please refer to MOH List of Subsidised Drugs, MOH Subsidised Vaccine List or MediShield Life Cancer Drug List for the most updated information.

13/09/2024 Update of MOH List of Subsidised Drugs to include treatments for various cancer conditions

The Ministry of Health’s Drug Advisory Committee has reviewed all available treatments for cancer to update the MOH List of Subsidised Drugs in line with local clinical practice and medical advancements. As part of this review, Technology Guidances have been prepared which describe the subsidy recommendations for many cancer drugs for specific clinical conditions. The remaining treatments which have been considered by the Committee are included in this document.

[R] Based on the available evidence, the Ministry of Health’s Drug Advisory Committee has recommended:

• Abemaciclib 50 mg, 100 mg and 150 mg tablets;

• Abiraterone acetate 250 mg tablets;

• Afatinib 20 mg, 30 mg and 40 mg tablets;

• Alectinib 150 mg capsule;

• Anagrelide 0.5 mg capsule;

• Atezolizumab 840 mg/14 mL and 1200 mg/20 mL concentrate for solution for infusion;

• Avelumab 200 mg/10 mL concentrate for solution for infusion;

• Axitinib 1 mg and 5 mg tablets;

• Azacitidine 100 mg injection;

• Bendamustine 25 mg and 100 mg concentrate for infusion;

• Bicalutamide 50 mg tablet;

• Bortezomib 3.5 mg injection;

• Brentuximab vedotin 50 mg powder for concentrate for solution for infusion;

• Brigatinib 30 mg, 90 mg and 180 mg tablets;

• Cabozantinib 20 mg, 40 mg and 60 mg tablets;

• Ceritinib 150 mg capsule;

• Cetuximab 100 mg/20 mL solution for infusion;

• Cisplatin 100 mg/100 mL concentrate for infusion;

• Cyproterone 50 mg tablet;

• Dabrafenib 50 mg and 75 mg capsules;

• Dasatinib 20 mg, 50 mg and 70 mg tablets;

• Durvalumab 120 mg/2.4 mL and 500 mg/10 mL concentrate for solution for infusion;

• Epirubicin 50 mg/25 mL injection;

• Eribulin mesylate 1 mg/2 mL solution for injection;

• Erlotinib 100 mg and 150 mg tablets;

• Exemestane 25 mg tablet;

• Fludarabine phosphate 50 mg injection;

• Fulvestrant 250 mg/5 mL solution for injection;

• Gefitinib 250 mg tablet;

• Gilteritinib fumarate 40 mg tablet;

• Goserelin 3.6 mg and 10.8 mg depot injections;

• Imatinib 100 mg and 400 mg tablets;

• Ipilimumab 50 mg/10 mL concentrate for solution for infusion;

• Lapatinib 250 mg tablets;

• Lenalidomide 5 mg, 10 mg, 15 mg and 25 mg capsules;

• Leuprorelin acetate 3.75 mg and 11.25 mg depot injection;

• Lorlatinib 25 mg and 100 mg tablets;

• Megestrol 40 mg and 160 mg capsules;

• Midostaurin 25 mg capsule;

• Nilotinib 50 mg, 150 mg and 200 mg capsules;

• Nivolumab 40 mg/4 mL and 100 mg/10 mL concentrate for solution for infusion;

• Obinutuzumab 1000 mg/40 mL concentrate for solution for infusion;

• Olaparib 100 mg and 150 mg tablets;

• Oxaliplatin 200 mg/40 mL concentrate for infusion;

• Paclitaxel-albumin bound nanoparticles 100 mg injectable suspension;

• Palbociclib 75 mg, 100 mg and 125 mg capsules/tablets;

• Pazopanib 200 mg and 400 mg tablets;

• Pegylated liposomal doxorubicin 20 mg concentrate for infusion;

• Pembrolizumab 100 mg/4 mL solution for infusion;

• Pemetrexed 100 mg and 500 mg injections;

• Ponatinib 15 mg tablet;

• Ribociclib 200 mg tablet;

• Ruxolitinib 5 mg, 15 mg and 20 mg tablets;

• Somatropin 5 mg/1.5 mL and 10 mg/1.5 mL prefilled pens and solution for injection;

• Somatropin 4 mg and 5.3 mg/mL powder and solvent for solution for injection;

• Somatropin 5.83 mg/mL and 8 mg/mL solution for injection;

• Sunitinib 12.5 mg capsules;

• Trametinib 0.5 mg and 2 mg tablets; and

• Vinorelbine 50 mg/5 mL injection

for inclusion on the MOH Standard Drug List (SDL) or Medication Assistance Fund (MAF) in line with their registered indications or specific clinical criteria for treating cancer, in view of clinical need, and acceptable clinical and cost effectiveness.

[NR] Drugs that have not been recommended for subsidy are listed in the Annex.

For all drugs, the clinical indications, subsidy class, subsidy implementation dates (if applicable), and MediShield Life claim limits are provided in the Annex.

02/01/2024 Review of cancer drugs for previously treated advanced hepatocellular carcinoma

The Ministry of Health’s Drug Advisory Committee has recommended:

• Cabozantinib 20 mg, 40 mg and 60 mg tablets; and

• Regorafenib 40 mg tablet

for treating advanced unresectable hepatocellular carcinoma in patients with disease progression after one or more prior lines of systemic therapy, and who have adequate liver function as assessed by the Child-Pugh scoring system.

Funding status

[R] Regorafenib 40 mg tablet is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication with effect from 4 January 2022.

[R] Cabozantinib 20 mg, 40 mg and 60 mg tablets are recommended for inclusion on the MAF for the abovementioned indication with effect from 1 September 2022.

[NR] MAF assistance does not apply to any formulations or strengths of ramucirumab, pembrolizumab, nivolumab and ipilimumab when used for previously treated advanced hepatocellular carcinoma.

Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.

02/01/2024 Cabozantinib in combination with nivolumab for previously untreated advanced renal cell cancer

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended cabozantinib in combination with nivolumab for inclusion on the MOH List of Subsidised Drugs for previously untreated advanced renal cell cancer in view of unfavourable cost-effectiveness compared with alternative treatments.

Clinical indications, subsidy class and MediShield Life claim limits for both drugs are provided in the Annex.

19/12/2022 Review of cancer drugs for previously treated advanced gastric cancer

The Ministry of Health’s Drug Advisory Committee has recommended:

• Nivolumab 40 mg/4 mL and 100 mg/10 mL concentrate for solution for infusion for treating patients with unresectable locally advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma after two or more prior systemic therapies in line with the following criteria:

  • Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for unresectable locally advanced or recurrent gastric or GEJ cancer; and

  • Nivolumab should be given as a weight-based dose up to a maximum of 240 mg every two weeks or 480 mg every four weeks.

Subsidy status

[R] Nivolumab 40 mg/4 mL and 100 mg/10 mL concentrate for solution for infusion are recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication with effect from 1 September 2022.

[NR] MAF assistance does not apply to any formulations or strengths of pembrolizumab, ramucirumab, regorafenib or trifluridine/tipiracil when used for previously treated advanced gastric cancer.

Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.

19/12/2022 Immune checkpoint inhibitors and BRAF/MEK inhibitors for treating advanced malignant melanoma

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 and 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 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.

31/08/2022 Nivolumab for treating gastroesophageal cancers

The Ministry of Health’s Drug Advisory Committee has recommended:

• Nivolumab 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL concentrate for solution for infusion for:

  • Adjuvant treatment of completely resected oesophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy. Maximum treatment duration is 12 months.

  • Untreated, unresectable advanced or metastatic HER2 negative gastric cancer, GEJ cancer or oesophageal adenocarcinoma when used with fluoropyrimidine and platinum-based chemotherapy. Treatment with nivolumab should be stopped at 2 years, or earlier if disease progresses.

  • Treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the unresectable advanced, recurrent or metastatic setting.

Funding status

[R] Nivolumab 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL concentrate for solution for infusion are recommended for inclusion on the Cancer Drug List (Medication Assistance Fund and MediShield Life monthly claim limit of SG$1800) for the abovementioned indications from 1 September 2022.

Legend

This section displays recommendation from the MOH Drug Advisory Committee for subsidy and appropriate use of the drug as extracted from the Agency for Care Effectiveness (ACE) Drug Guidances. As this website is updated monthly, please refer to the ACE website for the most updated information.

Note:

General availability information reflected is based on the Public Healthcare Institutions’ (PHI) formulary on what is commonly used for treating their patient population and may or may not be available for patients not under the care of that institution. It does not reflect the PHI’s actual inventory availability and is subjected to change. Please consult the Public Hospitals or Polyclinics for details on availability and supply restrictions/considerations. General availability is not tied to any brand unless otherwise stated.

Users are to consult the respective PHIs for actual inventory availability and supply restrictions/consideration