Pembrolizumab [Keytruda]

[MAF] Pembrolizumab (Keytruda) Infusion 100 mg/4 mL

1. For untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumours express PD-L1 with a tumour proportion score ≥50%, with no EGFR or ALK genomic tumour aberrations. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

2. Pembrolizumab in combination with platinum-doublet chemotherapy, for untreated metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumour aberrations. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

3. Pembrolizumab in combination with platinum-doublet chemotherapy for untreated metastatic squamous non-small cell lung cancer (NSCLC). Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

4. Treatment of patients with metastatic non-small cell lung cancer (NSCLC), whose tumours express PD-L1 with a tumour proportion score ≥1% and had 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. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

5. Adjuvant treatment of completely resected malignant melanoma in patients with lymph node involvement. Maximum duration of treatment: 12 months.

6. Treatment of advanced unresectable or metastatic malignant melanoma. Patients must not have received a PD-1 inhibitor or ipilimumab for advanced unresectable or metastatic malignant melanoma.

7. Monotherapy for untreated unresectable, recurrent or metastatic squamous cell cancer of the head and neck (RMSCCHN) with PD-L1 CPS≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

8. Pembrolizumab in combination with platinum-based chemotherapy, for untreated unresectable, recurrent or metastatic squamous cell cancer of the head and neck (RMSCCHN) with PD-L1 CPS≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

9. Treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL), who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the relapsed or refractory setting. Treatment with pembrolizumab should be stopped at 2 years, or earlier if the person has a stem cell transplant or the disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

10. 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. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

11. Pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥

12. and who have not received prior chemotherapy for metastatic disease. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

13. For untreated metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

14. Pembrolizumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, locally advanced unresectable or metastatic carcinoma of the oesophagus or HER2 negative gastroesophageal junction (GEJ) adenocarcinoma (tumours with epicenter 1 to 5 cm above the GEJ) that is not amenable to surgical resection or definitive chemoradiation. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses.

[MSHL] Pembrolizumab Solution For Infusion 100 mg/4 mL

1. 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. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

2. Pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥

3. and who have not received prior chemotherapy for metastatic disease. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

4. For untreated metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

5. Monotherapy for untreated unresectable, recurrent or metastatic squamous cell cancer of the head and neck (RMSCCHN) with PD-L1 CPS≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

6. Pembrolizumab in combination with platinum-based chemotherapy, for untreated unresectable, recurrent or metastatic squamous cell cancer of the head and neck (RMSCCHN) with PD-L1 CPS≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

7. For untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumours express PD-L1 with a tumour proportion score ≥50%, with no EGFR or ALK genomic tumour aberrations. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

8. Pembrolizumab in combination with platinum-doublet chemotherapy for untreated metastatic squamous non-small cell lung cancer (NSCLC). Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

9. Pembrolizumab in combination with platinum-doublet chemotherapy, for untreated metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumour aberrations. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

10. Treatment of patients with metastatic non-small cell lung cancer (NSCLC), whose tumours express PD-L1 with a tumour proportion score ≥1% and had 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. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

11. Treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL), who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for this condition in the relapsed or refractory setting. Treatment with pembrolizumab should be stopped at 2 years, or earlier if the person has a stem cell transplant or the disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

12. Adjuvant treatment of completely resected malignant melanoma in patients with lymph node involvement. Maximum duration of treatment: 12 months.

13. Treatment of advanced unresectable or metastatic malignant melanoma. Patients must not have received a PD-1 inhibitor or ipilimumab for advanced unresectable or metastatic malignant melanoma.

14. Pembrolizumab in combination with fluoropyrimidine and platinum-based chemotherapy for untreated, locally advanced unresectable or metastatic carcinoma of the oesophagus or HER2 negative gastroesophageal junction (GEJ) adenocarcinoma (tumours with epicenter 1 to 5 cm above the GEJ) that is not amenable to surgical resection or definitive chemoradiation. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses.

15. Treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

16. Treatment of patients with locally advanced or metastatic urothelial carcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥10, and who are not eligible for cisplatin-containing chemotherapy. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

17. 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. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

18. Treatment of patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for PMBCL. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression

19. Treatment of metastatic Merkel cell carcinoma. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

20. Treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for the same MSI-H or dMMR solid tumour in the unresectable or metastatic setting. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

21. Pembrolizumab in combination with chemotherapy as neoadjuvant treatment, and then continued as adjuvant monotherapy after surgery, for previously untreated high-risk, early-stage triple-negative breast cancer. Treatment with pembrolizumab should be stopped after a maximum duration of 1 year across neoadjuvant and adjuvant phases, or earlier if disease progresses or recurs.

22. Pembrolizumab, in combination with chemotherapy, for treating patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 with a CPS ≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

23. Pembrolizumab, in combination with chemotherapy and bevacizumab, for treating patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 with a CPS ≥1. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

24. Adjuvant treatment of patients with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Maximum duration of treatment: 12 months

[MSHL] Pembrolizumab Solution For Infusion 100 mg/4 mL

1. Pembrolizumab in combination with axitinib for untreated advanced renal cell carcinoma. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

2. Pembrolizumab in combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma (EC) that is not microsatellite instability-high (non-MSI-H) or mismatch repair deficient (non-dMMR), who have disease progression following prior platinum chemotherapy and are not candidates for curative surgery or radiation. Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for advanced EC. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment, with or without lenvatinib, is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

3. Pembrolizumab in combination with lenvatinib for untreated advanced renal cell carcinoma. Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment, with or without lenvatinib, is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

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.

17/02/2025 Pembrolizumab for treating locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended pembrolizumab for inclusion on the MOH List of Subsidised Drugs, when used in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for patients with untreated locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma, whose tumours express programmed death-ligand 1 with a combined positive score greater than or equal to 1. The decision was based on the unfavourable cost-effectiveness of pembrolizumab and an unacceptable pricing proposal from the company.

Clinical indication, subsidy class and MediShield Life claim limit for pembrolizumab are provided in the Annex.

17/02/2025 Pembrolizumab for treating resectable Stage II, IIIA, or IIIB (T3-4N2) non-small-cell lung cancer

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended pembrolizumab for inclusion on the MOH List of Subsidised Drugs, when used in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for treating resectable Stage II, IIIA, or IIIB (T3-4N2) non-small-cell lung cancer. The decision was based on the unfavourable cost-effectiveness of pembrolizumab compared with nivolumab, and an unacceptable pricing proposal from the company.

Clinical indication, subsidy class and MediShield Life claim limit for pembrolizumab are provided in the Annex.

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 Review of cancer drugs for treating advanced urothelial carcinoma

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

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

• Pembrolizumab 100 mg/4 mL solution for infusion

for treating advanced urothelial carcinoma (UC) in line with specific clinical criteria.

Funding status

[R] Avelumab 200 mg/10 mL concentrate for solution for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for maintenance treatment of locally advanced or metastatic UC that has not progressed with first-line platinum-based chemotherapy when used in line with the treatment regimen outlined in the Annex.

[R] Pembrolizumab 100 mg/4 mL solution for infusion is recommended for inclusion on the MAF for treating patients with locally advanced or metastatic UC after receiving platinum-based chemotherapy in line with the following criteria:

• Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for locally advanced or metastatic UC; and

• Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

[R] MAF assistance for the abovementioned treatments will be implemented from 1 September 2022.

[NR] MAF assistance does not apply to pembrolizumab when used for patients with untreated PD-L1-positive UC who are unable to receive cisplatin-based chemotherapy, or erdafitinib when used for treating UC with FGFR3 genetic alterations.

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

02/01/2024 Pembrolizumab for treating persistent, recurrent, or metastatic cervical cancer

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended pembrolizumab for inclusion on the MOH List of Subsidised Drugs, when used in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in patients whose tumours express programmed death-ligand 1 with a combined positive score greater than or equal to 1. The decision was based on the uncertain extent of clinical benefit and unfavourable cost-effectiveness of pembrolizumab at the price proposed by the company.

Clinical indication, subsidy class and MediShield Life claim limit for pembrolizumab are provided in the Annex.

02/01/2024 Pembrolizumab for treating high-risk early-stage triple-negative breast cancer

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended pembrolizumab for inclusion on the MOH List of Subsidised Drugs, when used in combination with chemotherapy as neoadjuvant treatment and then continued as adjuvant monotherapy after surgery, for treating high-risk, early-stage, triple-negative breast cancer. The decision was based on the uncertain extent of clinical benefit and unfavourable cost-effectiveness of pembrolizumab at the price proposed by the company.

Clinical indication, subsidy class and MediShield Life claim limit for pembrolizumab are provided in the Annex.

02/01/2024 Pembrolizumab for the adjuvant treatment of renal cell carcinoma

[NR] The Ministry of Health’s Drug Advisory Committee has not recommended pembrolizumab for inclusion on the MOH List of Subsidised Drugs for the adjuvant treatment of renal cell carcinoma in patients who are at increased risk of recurrence following nephrectomy or nephrectomy with resection of metastatic lesions. The decision was based on the uncertain extent of clinical benefit and unfavourable cost-effectiveness of pembrolizumab at the price proposed by the company.

Clinical indication, subsidy class and MediShield Life claim limit for pembrolizumab 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.

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.

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