[Reporter’s View] At least a guideline for ‘class effect’

‘Recognizing expected efficacy of drugs with same mechanism of action.’ It is definitely an unresolved conundrum.

 

Experts have clashing opinions and each pharmaceutical company has different interests.

 

In the end, what it comes down to is ‘case by case.’ Not that it needs an answer key, but obviously the prescribing doctor’s decision based on experience and medical knowledge is important.

 

The problem is consistency in applying healthcare insurance reimbursement.

 

For some classes, the effects are recognized regardless of the approved label and equivalent reimbursement criteria are applied, but some other classes have different scope of labels approved.

 

Reimbursement expansion on combination therapy of sodium-glucose cotransporter-2 (SGLT-2) inhibitor, currently pending without much of progress from 2018, would be a good example.

 

As Korean Diabetes Association (KDA) failed to settle a dispute over expanding reimbursement on off-label anti-diabetic combination therapies including SGLT-2 inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione (TZD), the government that initially had intention to expand reimbursement on the off-label use, is now hesitant to take a further step.

 

An odd phenomenon of the doctors opposing on expanding reimbursement is happening because of the dispute over class effect.

 

Originally, it was the medical industry that started the discussion of providing reimbursement on anti-diabetic combination therapy.

 

Apparently, doctors had experiences of confusion in prescribing as each drug in same class had different indications, and eventually had reduced reimbursement.

 

In 2013, expanding reimbursement on combination therapy with DPP-4 inhibitor and TZD went through the same ordeal.

 

However, the results were different.

 

The medical industry valuing clinical evidence and expert’s judgment over approved label and financial impact was unprecedented as well.

 

Class effects of DPP-4 inhibitor and SGLT-2 inhibitor, as stated by Korea’s reimbursement standard on orally taken anti-diabetic treatment, have been polarized so far.

 

However, the possibility is still out there.

 

Some expects positive outcome of a former professor at Seoul St.

 

Mary’s Hospital, Yoon Kun-ho, elected as the president of KDA.

 

The former professor used to actively demand for reimbursement on the combination therapy in 2013.

 

We are talking about prescription drug.

 

It doesn’t hurt to be careful.

 

Some might say it better be rather careful.

 

But, if their agenda is to recognize the class effect, then they should set a guideline on ‘required time for properly building up prescription experience, or prescription volume.’ There may be an expectation in the current situation, but there is no promise.

 

If properties of disease are different, then a manual on class effect by each disease is essential.

 

There is no need for the government to worry about the industry getting too confident about class effect and lazy on clinical trial.

 

They know very well that abundant academic data is more powerful in the field than qualifying for reimbursement criteria.