[Reporter’s Note] Why so cautious with all-comers drug?

Within the pharmaceutical industry, a drug targeting ‘all-comers’ mean it is indicated to treat all patients in non-specific stages of disease.

 

A drug proving treatment efficacy regardless of receptor or genetic mutation sound interesting and appealing.

 

However, the South Korean government is still conservative on the all-comers drug to this date.

 

In some ways, it seems obvious.

 

A wide use of a drug means increase volume of the drug used, which could develop a whole financial issue.

 

But there seems to be more than a financial issue why the government is taking a rather cautious stance, or the careful approach on the all-comers drug.

 

Some say the government is skeptical about the efficacy.

 

A poly ADP-ribose polymerase (PARP) inhibitor Zejular (niraparib) is currently indicated to treat patients with ovarian cancer, and it proved its treatment efficacy in all approved treatment lines regardless of the mutation in targeted BRCA gene.

 

However, the proven efficacy actually shows different levels of efficacy.

 

Zejula improved median progression-free survival (mPFS) by four times in gBRCA-mutated patients, and doubled it in patients without the mutation.

 

And the efficacy gap between the Zejula group and the control group narrowed even more for gBRCA-mutated, homologous recombination deficiency (HRd)-negative patients.

 

Surely, the medicine demonstrated the effect and received Ministry of Food and Drug Safety’s (MFDS) approval, while its levels of efficacy differ in various patient groups.

 

As the mechanism of the medicine has a clearly targeted gene, the government is still limiting the healthcare reimbursement on the ‘BRCA mutation’ indication, although the treatment’s other indications have also proved the efficacy.

 

The government’s stance is understandably cautious and taking more time would not necessarily be bad.

 

Referring to precedents, however, taking more time did not mean better decision.

 

A first immunotherapy to be indicated for all-comers in non-small cell lung cancer (NSCLC) was a PD-1 inhibitor Opdivo (nivolumab).

 

Initially, all specialized doctors agreed ‘PD-L1 expression rate’ was a not a marker, but the government reserved the decision on all-comers coverage and listed the treatment in 2017 on limited indication.

 

More talks followed after then, but the coverage standards remain the same to this date.

 

Although being careful does not hurt, the government should also take patients’ treatment access into account and consider making a compromise.

 

Only about 15 percent of epithelial ovarian cancer patients are known to have BRCA 1/2 mutation.

 

In other words, about 85 percent of the patients do not have BRCA gene mutation.

 

When even doctors are concerned of financial burden and opposing against expanding coverage on a health authority-approved drug, a pharmaceutical company’s reckless demand should not be accepted.

 

But if there is a plausible compromise plan, shouldn’t the government be more open to the discussion?