The Philippines may not be in a position to take immediate advantage of any vaccine to be developed in the near future against COVID-19. And this situation seems to require a review of Republic Act No. 11223 or the Universal Healthcare Act of 2018, which appears to pose a “limitation” as to when any new vaccine can be paid for by universal health insurance.
The issue has less to do with Philhealth’s financial viability or its capacity to buy. The concern is over some restriction in RA 11223 with respect to what new medicine, vaccine, or health technology can be bought or reimbursed by Philhealth. And this restriction may hinder Philhealth from urgently accessing newly developed COVID-19 vaccine and drug treatment.
Section 34 of RA 11223 provides for a “Health Technology Assessment” or HTA process for policies, programs, and regulations to be set by the Department of Health and Philhealth for a “range of entitlements such as drugs, medicines, pharmaceutical products, and other devices, procedures and services as provided for” under the universal healthcare law.
And among the criteria of the HTA process is “safety and effectiveness,” which requires that “interventions [drugs or medicines, etc.] must have undergone Phase IV clinical trial,” and that “systematic review and meta-analysis [for these drugs] must be readily available. The interventions must also not pose any harm to the users and healthcare providers.”
Moreover, the “interventions must reduce out-of-pocket expenses” of Philhealth beneficiaries, and their makers must have “economic studies and cost-of-illness studies to satisfy this criterion.” Also, the “interventions,” which include vaccines, “must be affordable and the cost thereof must be viable to the financing agents,” or those paying for them.
If Philhealth is to strictly adhere to these requirements under RA 11223, it is doubtful if newly developed COVID-19 vaccines and drugs can be immediately made available to Philhealth members. Even a vaccine or medicine already approved by the Food and Drug Administration (FDA) may not necessarily comply with these Philhealth requirements.
Cost is one thing. The vaccine must be “affordable,” and its cost “viable to the financing agents.” This is not likely to happen as newly developed medicines tend to be more expensive during introduction. And, given the urgent global demand for a COVID-19 vaccine and medicine, and the effort put into developing them, for sure they will be far from affordable not just to Philhealth but for most people as well.
As for new drugs reducing “out-of-pocket expenses” of Philhealth beneficiaries, and their makers having “economic studies and cost-of-illness studies to satisfy this criterion,” well, good luck with that. It appears doubtful that drug makers will still be concerned with such things as they aim for market advantages in launching new products.
A report in The New York Times dated June 30 detailed how a new drug to treat COVID-19 patients, called Remdesivir, will be sold at $520 per vial, or $3,120 per treatment course, to US hospitals for treatment of patients with private insurance. The drug is available only in the US until September.
The report also noted that the drug’s price will be set at a lower $390 per vial, or $2,340 per treatment course, for patients on government-sponsored insurance and for those in countries with national health care systems. But, even at this lower price, Remdesivir will still be too expensive for Philhealth, and thus for most Filipinos.
But the most difficult hurdle for Philhealth, it seems, is the RA 11223 requirement for “Phase IV clinical trial” for drugs and medicines to be bought or paid for by Philhealth, as well as the availability of “systematic review and meta-analysis [for these drugs]” even before they get to Philhealth’s hands. By the time these two requirements are actually met, it may already be too late for the Philippines.
Phase 4 clinical trial begins only after a drug has already been approved for general use. In short, after Phases 1 to 3. Thus, a new drug or vaccine may already be approved by the FDA after Phase 3, but this doesn’t mean that Philhealth can already buy the new drug for distribution, or that Philhealth will pay for it every time it is dispensed by doctors or hospitals.
In Phase 1, the drug is tested only on a small number of volunteers. In Phase 2, the drug is further tested, and its use and dosing adjusted, to improve its efficacy. Phase 3 is the last phase of testing before drug information and clinical trial results are submitted to regulators for approval of the drug or medicine for use by the general population.
Phase 4 is already post marketing surveillance, and starts only after FDA approval and the drug is already being marketed and made available to the general public. Phase 4 trial checks on the drug’s performance in real life scenarios, to study the long-term risks and benefits of using the drug and to discover side effects. In this line, some Phase 4 trials can actually take years to complete.
But in our case today, how long can we afford to wait? Should Philhealth still require a Phase 4 trial specifically for COVID-19 vaccines and drugs? I support the “Phase 4 clinical trial” requirement in general, since it helps protect people and ensure their safety. It is always best that a drug is fully tested, and enjoys a good record, before it is made widely available at government’s expense. Phase 4 can prevent another Dengvaxia controversy from happening again.
However, the universal healthcare law should also give Philhealth some flexibility in dealing with pandemic situations. COVID-19 is extraordinary. We now find ourselves in a unique but complicated situation. We urgently need drugs and vaccines to deal with a virus that has caused a global health emergency. But, even if the FDA approves any of these vaccines or drugs soon, if Philhealth will not pay for them without Phase 4 trial, then how can most of our people afford them?
Marvin Tort is a former managing editor of BusinessWorld, and a former chairman of the Philippines Press Council