Published on: February 10, 2022

Health Technology Assessment (HTA) and the inclusion of Drugs in the Philippine National Formulary (PNF)

The Health Technology Assessment Council (HTAC) was created under the Universal Healthcare Act of 2019 (Republic Act No. 11223) to ensure equitable access to quality and affordable health care to Filipinos. The HTAC provides technical guidance on the optimal use of health technologies including drugs that are for inclusion in the essential medicines list. For medications, the HTAC recommends the PNF listing of essential medicines for government financing.

In assessing different health technologies and essential medicines that satisfy the priority healthcare needs of Filipinos, several criteria are used such as, but are not limited to, responsiveness to magnitude and severity; safety and effectiveness; ethical, social, and health systems implications; cost-effectiveness, affordability and viability; and household financial impact. The medicines should have been approved by the Philippine Food and Drug Administration (FDA).

One of the drugs assessed by HTAC is Oral Pre-Exposure Prophylaxis (PrEP) (Emtricitabine [FTC] 200 mg + Tenofovir Disoproxil Fumarate [TDF] 300 mg FDC). Oral PrEP is used to prevent HIV infection among individuals at substantial risk of getting infected. Oral PrEP has a monitored-release Certificate of Product Registration (MR CPR) from the FDA.

What is human immunodeficiency virus (HIV)?

HIV is a viral infection that targets the immune system and gradually weakens people’s defenses against many infections and some types of cancer. If left untreated, the HIV viral infection can progress to a disease called HIV Acquired Immune Deficiency Syndrome (HIV AIDS), wherein the body’s immune system is severely incapacitated due to the virus. HIV can be transmitted via exchange of body fluids from infected people such as blood, breast milk, semen and vagina secretions. 

What is Oral Pre-exposure Prophylaxis (PrEP)?

Oral PrEP is taken as a single pill once daily, as an add-on to other HIV-prevention strategies,  for periods of frequent or unpredictable sex until 2 days after the most recent sexual exposure. It is used to prevent HIV infection in people who are at substantial risk of getting HIV. It is important to not miss a dose, and to take the medicine with food or in between meals. 

The DOH National AIDS and STI Prevention and Control Program (NASPCP) aims to reduce the transmission of HIV and sexually transmitted infections (STI). The Program will facilitate access to oral PrEP. 

What is the recommendation of HTAC for the use of Oral PrEP?

On 18 January 2022, the Secretary of Health approved HTAC’s recommendation to include Oral Pre-Exposure Prohylaxis (PrEP) in the Philippine National Formulary (PNF), to reduce the risk of acquiring sexually transmitted HIV infection. 

What is the basis of the HTAC recommendation?

Based on current available evidence, Oral PrEP can be described as such: 

  • It is safe and efficacious in preventing the transmission of HIV infection;
  • It is highly acceptable among potential users;
  • It will not incur immediate budget impact to the government;
  • It is affordable if the target number of users is based on the enrollment rate of the HIV Program and if additional funds are secured by the Program

The cost effectiveness of Oral PrEP cannot be determined yet due to lack of data in the Philippine context.

The HTAC recommends the following to the DOH and the NASPCP once Oral PrEP use is implemented: 

  • For Program monitoring and evaluation to be put in place to measure the real world effectiveness of Oral PrEP in reducing the risk of sexually acquired HIV infection;
  • For the Program to conduct information dissemination on the limitations of PrEP and implementation of active campaigns for the continuation of other STI-preventive strategies in addition to Oral PrEP;
  • For the DOH to ensure high-quality surveillance following the World Health Organization (WHO) guidelines to enable the conduct of impact monitoring and assessment;
  • For Oral PrEP initiatives to be integrated as part of the existing health system processes to reach communities more efficiently; and,
  • For the Disease Prevention and Control Bureau (DPCB), through the NASPCP, to strengthen the health system domains (e.g., service delivery, interprofessional collaboration, increased rural or Geographically Isolated and Disadvantaged Areas (GIDA) access to oral PrEP, among others) to ensure a safe and consistent supply and equitable distribution through all its treatment hubs across the country.

Important things to know when using Oral PrEP

  • Common side effects include upset stomach, headaches, nausea, vomiting, dizziness, feeling weak, loss of appetite and usual allergic reactions. 
  • Call a physician if any of the following side effects are experienced: deep rapid breathing, back pain, yellow skin or eyes, itching or pain in the abdomen; fever or chills, especially with sore throat, cough, rash and any other signs of infection
  • The drug should not be taken by those who are allergic to any of its ingredients.
  • An individual must be HIV-negative before taking the drug, and should get tested regularly.
  • An individual may still get HIV if they stop the other preventive measures (such as wearing condoms) and use Oral PrEP as the only means of avoiding HIV infection.
  • An individual must tell their healthcare provider if they are currently taking any other medicines or supplements for proper advice on medication interactions.
  • Serum creatinine test is recommended (required if the individual has a history of conditions affecting the kidney, such as diabetes or hypertension) before the initiation of therapy, but should not be a cause of delay for initiating the use of PrEP. Serum creatinine test is required every 6 months or as indicated after initiation of therapy. 
  • Extra precautionary measures should be applied when using the drug for the following situations:
    • Possible pregnancy and if there are plans for breastfeeding
    • Driving and/or operating machines
    • Lactose intolerance (since lactose is one of the ingredients of the medicine)

Link to the Evidence Summary: Emtricitabine + Tenofovir Disoproxil Fumarate fixed-dose combination as Oral Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV infection

Link to the Filipino Version: Gabay ng HTAC: Pagsama ng Oral PrEP sa PNF

References

Center for Disease Control and Prevention. (n.d.). Truvada Medication Information Sheet. Retrieved from https://www.cdc.gov/hiv/pdf/PrEP_GL_Patient_Factsheet_Truvada_English.pdf

Department of Health (n.d.). HIV, AIDS and STI Prevention and Control Program. Retrieved from https://doh.gov.ph/national-hiv/sti-prevention-program

Riddel, J., Amico, K.R., & Mayer, K. (2018). HIV Pre-exposure Prophylaxis: A Review. The Journal of the American Medical Association, 319(12), 1261-1268. 

World Health Organization (2021). Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. https://www.who.int/publications/i/item/9789240031593