SOH approves the HTAC recommendation on the minor inclusion of sambong 250mg tablet in PNF

 

The Secretary of Health approved the HTAC recommendation on the minor inclusion of sambong 250mg tablet for anti-urolithiasis (kidney stones) in the Philippine National Formulary (PNF) on 14 January 2022.

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

The herbal preparation is currently listed in the PNF as a 500mg tablet which increases urinary output for patients with edema or other conditions with fluid retention; and for the treatment and prevention of kidney stones.

In reaching its recommendation to include sambong 250mg tablet, the HTAC considered the following:

  • Effectiveness in treating patients with kidney stones
    • The systematic review of Tolosa et al., 2020 shows that sambong tablets remain effective in treating patients with kidney stones by radiographic evidence of a decrease in size and/or number of stones; and, the passage of stone/s and/or disappearance or reduction of signs and symptoms.
      In addition, there were no serious adverse events related to the use of the said herbal product.
  • Dosing requirement of sambong tablets for adult and pediatric populations
    • Either 250mg or 500mg form of sambong tablet can be used for treatment of kidney stones for adult (18 years old and above) and pediatric (7-12 years old) populations.
    • The average dosing for the adult and pediatric populations of the sambong tablet are as follows:
      For the adult population (60 kg patient): 2,400 mg/day in 3 divided doses for 14 days, then 1,200 mg/day in 2-3 divided doses for the next 28 days
      For the pediatric population (30 kg patient): 1,200 mg/day in 3 divided doses for 14 days, then 600 mg/day in 2-3 divided doses for the next 28 days
    • Pediatric patients and patients with kidney stones less than 5mm will require a lower dose preparation of sambong tablets for more accurate dosing, and as a cheaper alternative to surgery. The lower dose of sambong tablet (250mg) will be more advantageous after the third week of the dosing regimen wherein the patient will transition to 600 mg/day divided into 2-3 doses within a day.
    • On the other hand, using the 500 mg tablet will likely require 2 tablets per day (1 tablet in the morning and at noon) since the tablet is not scored. This is equivalent to 1,000 mg per day or 33.33 mg/kg/day which exceeds the recommended daily dose of 20-25 mg/kg/day.
  • Affordability of sambong 250mg tablet compared to 500mg tablet
    • Compared to the 500mg sambong tablet, there will be cost savings in using the 250mg sambong tablet for the treatment course per patient for both the adult and pediatric populations.
    • The lower cost is mainly due to the lower unit cost of the sambong 250 mg tablet (Php 1.80) which is 66% (Php 3.45) cheaper than sambong 500 mg tablet (Php 5.25).

For more information on the current reviews and recommendations of the HTAC, you may also check the HTA Philippines website (hta.doh.gov.ph).