Denosumab

[MAF] Denosumab (Prolia) Prefilled Syringe 60 mg/mL

1. Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for non-metastatic breast cancer.

2. Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

3. Treatment of patients with osteoporosis (T-score ≤ -2.

4. at high risk for fracture.

[MAF] Denosumab (Xgeva) Injection 120 mg/1.7 mL

1. Prevention of skeletal-related events in patients with bone metastases from breast cancer, castration-resistant prostate cancer, lung cancer, and all other solid tumours.

2. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

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01/04/2023 Review of cancer supportive care medicines>

[R] The Ministry of Health’s Drug Advisory Committee has reviewed the available clinical evidence for cancer supportive care medicines routinely used in public healthcare institutions to update the MOH List of Subsidised Drugs in line with local clinical practice. The following medicines have been recommended 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 cancer supportive care, in view of clinical need and acceptable clinical and cost-effectiveness:

• Aprepitant 125 mg and 80 mg tri-pack capsules;

• Cetirizine 10 mg tablet;

• Denosumab 60 mg/mL prefilled syringe;

• Denosumab 120 mg/1.7 mL solution for injection;

• Epoetin alfa 10,000 international units/mL and 40,000 international units/mL prefilled syringes;

• Epoetin beta 10,000 international units/0.6 mL and 30,000 international units/0.6 mL prefilled syringes;

• Folic acid 400 mcg tablet;

• Granisetron 1 mg tablet;

• Granisetron 1 mg/mL and 3 mg/3 mL solution for injection;

• Ketamine 500 mg/10 mL solution for injection;

• Montelukast 10 mg tablet;

• Oxycodone 5 mg and 10 mg capsules;

• Posaconazole 100 mg delayed-release tablet;

• Pegfilgrastim (Neulastim) 6 mg/0.6 mL prefilled syringe;

• Pegfilgrastim biosimilar (Fulphila) 6 mg/0.6 mL prefilled syringe;

• Pregabalin 25 mg, 50 mg, 75 mg, 100 mg, 150 mg and 300 mg capsules;

• Ranitidine 150 mg tablet; and

• Voriconazole 50 mg and 200 mg tablets.

[NR] Medicines that have not been recommended for subsidy due to unacceptable cost-effectiveness are listed in the Annex.

The clinical indications, subsidy class and subsidy implementation dates (if applicable) for all medicines included in the review are provided in the Annex.

01/07/2022 Denosumab for treating osteoporosis and glucocorticoid-associated bone loss

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

• Denosumab 60 mg/mL prefilled syringe for treating patients with osteoporosis (T-score ≤ -2.5) at high risk of fracture.

Patients must also receive adequate calcium and vitamin D supplementation whilst undergoing treatment.

Subsidy status

[R] Denosumab 60 mg/mL prefilled syringe is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication with effect from 1 July 2022.

[NR] MAF assistance does not apply to denosumab 60 mg/mL prefilled syringe when used for treating glucocorticoid-associated bone loss.

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DHCPL 21/07/2017 XGEVA® (denosumab) Solution for Injection 120mg/vial – Risk of Multiple Vertebral Fractures (MVF) following treatment discontinuation

DHCPL 14/08/2015 Prolia® (denosumab 60mg) and Xgeva® (denosumab 120mg) – Clinically significant cases of hypercalcaemia after cessation of treatment with denosumab in paediatric patients

DHCPL 02/10/2014 Xgeva® (denosumab 120mg) – Updated recommendations for calcium monitoring related to the risk of severe symptomatic hypocalcaemia (SSH)

DHCPL 08/04/2013 Xgeva® (denosumab 120 mg) – Risk of atypical femoral fracture

DHCPL 18/03/2013 Prolia® (denosumab 60 mg) – Risk of anaphylactic reaction and new contraindication in patients with clinically significant hypersensitivity to Prolia®

DHCPL 05/10/2012 Risk of atypical fracture with Prolia® (denosumab)

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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