Published on 01 October 2024

As of 23 September 2024, the Health Technology Assessment (HTA) Council has completed the evidence appraisal on the assessment of Reteplase (10 units lyophilized powder for IV injection) for ST-Elevation Myocardial Infarction (STEMI) Patients for possible inclusion in the Philippine National Formulary (PNF). As such, the HTA Council hereby makes public its preliminary recommendation on the non-inclusion in the PNF and thus the non-government financing of reteplase, for stakeholder feedback/comments.

The HTA Council’s preliminary recommendation on the non-inclusion in the PNF and thus the non-government financing of reteplase was based on the following reasons:

• Reteplase vs streptokinase: In terms of efficacy, the evidence comparing reteplase + PAC vs streptokinase + PAC showed inconclusive results. However, in terms of safety, while there is a decreased risk of serious allergic reaction (high certainty of evidence), the increased risk of hemorrhagic stroke compared to streptokinase + PAC is twice as high (moderate certainty of evidence). The HTA Council gave higher value to the outcome of hemorrhagic stroke over serious allergic reactions, albeit both being critical outcomes. 
• Reteplase vs alteplase: In terms of efficacy and safety, the evidence comparing reteplase + PAC versus accelerated or non-accelerated + PAC showed inconclusive results.
• There are no guidelines that recommend the use of reteplase preferentially over other fibrinolytic agents, such as streptokinase and alteplase, in the management of STEMI. Further, reteplase is not listed in the WHO Essential Medicines List.

Supporting evidence and discussions  that informed the recommendation of the HTA Council, as well as the advisory for this recommendation can be found below. All comments, inputs, and/or appeals on the above preliminary recommendation may be submitted until 15 October 2024 (Tuesday), for the consideration of the HTA Council, through email at hta@dost.gov.ph.

Please use the prescribed form for appeals indicated in the official HTA Philippines website [https://hta.dost.gov.ph/appeals-2/]. Appeals not following the prescribed format, and those submitted beyond the deadline shall not be entertained.

Should you have any questions or concerns regarding the preliminary recommendation, please do not hesitate to contact us through the same email address or via telephone call via (02) 8651-7800 local 2410.