SOH approves the HTAC recommendation on the minor inclusion of an additional dosage strength of potassium citrate [1620 mg (15mEq)] tablet for severe hypocitraturia and recurrent kidney stones in the Philippine National Formulary (PNF)

The Secretary of Health (SOH) approved the Health Technology Assessment Council (HTAC) recommendation on the minor inclusion of an additional dosage strength of potassium citrate 1620 mg (15mEq) tablet for severe hypocitraturia and recurrent kidney stones in the Philippine National Formulary (PNF) on 11 May 2022. 

Minor inclusions are applicable for drugs that are currently listed in the Philippine National Formulary (PNF), but are being applied for additional strength, immediate packaging, and net content.

Before health technologies are recommended by HTAC for government financing, prior approval from the Philippine Food and Drugs Administration (FDA) in the form of a Certificate of Product Registration (CPR) is needed. The following are the approved formulations that are listed in the PNF:

• Potassium (as citrate), 1080mg (10 mEq) tablet (previously listed)
• Potassium (as citrate), 1620mg (15 mEq) tablet (additional formulation)

In developing  its recommendation for potassium citrate 1620 mg (15mEq) Tablet, the HTAC considered the following:

• Efficacy and safety
  • The FDA issued a CPR for potassium citrate valid until 08 June 2025. 
• Standard of care
  • Potassium citrate is a standard of care for the management of conditions, such as the formation of renal and ureteric stones, and hypocitraturia (low amounts of citrate in urine). Its use is recommended in international Clinical Practice Guidelines, such as UK National Institute for Health and Care Excellence (UK NICE)
• Improved patient compliance
  • While the total treatment cost of shifting from 10 mEq tablet to 15 mEq tablet will incur minimal additional costs (i.e., for severe hypocitraturia the cost increases by Php 14.20 for a 6-month treatment duration or Php 146.00 for a 5-year treatment duration; for recurrent kidney stone, the cost increases by Php 29.20 for a 1-year treatment duration or Php 146.00 for a 5-year duration treatment duration), there is improved patient compliance due to the reduced number of tablets that need to be taken (i.e., 4 tablets per day of the 15 mEq formulation versus 6 tablets per day of the 10 mEq formulation).

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