(Updated as of 14 March 2023)
On 24 January 2023, the OIC-Secretary of Health (SOH) approved the Health Technology Assessment Council (HTAC) recommendation for the government financing of recombinant Human Erythropoietin (epoetin alfa) 4000 IU/mL solution for injection (IV/SC), 1mL pre-filled syringe, for the management of chemotherapy-induced anemia in patients with non-myeloid disease through its minor inclusion in the Philippine National Formulary (PNF).
Based on the Department Circular No. 2022-0584, otherwise known as Amendment to the Department Circular 2022-0254 dated 05 April 2022 titled, “Updates on the HTAC Processing of Minor Inclusion,” the minor inclusion process is applicable to drugs already listed in the PNF, and therefore eligible for government financing, but are being applied for additional dosage strength, net content, immediate packaging, pack size or volume, and any other change that will not result in significant difference in terms of bioavailability and meaningful clinical outcomes with the PNF-listed health technology.
The HTAC considered the following in developing its recommendation:
- Only the net volume of the pre-filled syringe (PFS) that contains 4,000 IU of epoetin alfa was changed from 0.4mL to 1 mL. Both dosage formulations contain 4,000 IU of epoetin alfa; hence, the number of pre-filled syringes that will be consumed per dose (i.e., 150 units/kg/dose or 40,000 IU/dose) will not differ.
- The unit price of epoetin alfa 4,000 IU/mL solution for injection (IV, SC) 1mL pre-filled syringe (Php 275.00, based on the provided procurement price by Jose B. Lingad Memorial Regional Hospital) is lower than the unit price of epoetin alfa 4,000 IU/0.4 mL, pre-filled syringe (IV, SC) (Php 555.00 based on the 2022 DOH Drug Price Reference Index).
- Since the unit cost of the proposed dosage formulation is lower than the unit cost of the comparator (i.e., the currently listed form in the PNF) and there are no differences in the number of pre-filled syringes that will be consumed per patient per regimen, cost savings are expected with the use of the proposed epoetin alfa, 4000 IU/mL solution for injection (IV, SC), 1mL pre-filled syringe.
- For an average adult patient with anemia due to concurrent myelosuppressive chemotherapy (60 kg* patient), the cost savings (per patient) associated with the use of the new formulation with new net content are the following:
- 150 units/kg/dose, thrice weekly dosing regimen: Php 20,160 for 8 weeks of treatment
- 40,000 units/week once weekly dosing regimen: Php 22,400 for 8 weeks of treatment
- For an average adult patient with anemia due to chronic kidney disease (50 kg* patient), the cost savings (per patient) associated with the use of the new formulation with new net content are the following:
- 50 units/kg/dose, thrice weekly dosing regimen: Php 10,080 for 12 weeks of treatment
- 100 units/kg/dose, thrice weekly dosing regimen: Php 20,160 for 12 weeks of treatment
- For an average adult patient with anemia due to concurrent myelosuppressive chemotherapy (60 kg* patient), the cost savings (per patient) associated with the use of the new formulation with new net content are the following:
*The average weights of patients were based on consultation with medical societies.
- Compared to the unit price of the currently-listed epoetin alfa 4,000 IU/ mL, vial form, the unit price of the proposed epoetin alfa 4,000 IU/mL solution for injection (IV, SC), 1mL pre-filled syringe, is still lower; hence, resulting in cost-savings.
Link to the issuance: DC No. 2023-0060
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