[FOCUS] Why retrieve the insurance paid for CA?

The tug-of-war between the health authorities and pharmaceutical companies over the negotiation on the restitution of insurance claims paid for the brain function enhancer choline alfoscerate (cholinergic agents) has been now ongoing for 8 months.

 

In December of last year, the Ministry of Health and Welfare (MOHW) ordered the National Health Insurance Service (NHIS) to negotiate with choline alfoscerate companies by February 10th of this year to agree on 'returning the full amount of insurance that was claimed for the drug, from the date the clinical trial protocol was submitted to the Ministry of Food and Drug Safety to the date the indication is removed if the clinical trial fails' to retrieve the claims paid for the drug.

 

8 months had passed since the order was issued, and 6 months had passed from the first deadline that was set for negotiations.

 

However, the only change made to the terms of the negotiation was that the period of insurance retrieval had been pushed back from the 'date the clinical trial protocol was submitted to the 'date the protocol was approved,' and the breakdown of negotiations and deadline extensions have repeated continuously.

 

Some companies have agreed to the 20% retrieval rate proposed by the NHIS.

 

In other words, these companies will be paying back to the NHIS 20% of the amount that was prescribed from the date the clinical trial protocol was approved by MFDS to the date the indication is deleted if their clinical reevaluations for their choline alfoscerate products fail.

 

However, many other pharmaceutical companies, including those that are earning much from choline alfoscerate products, have not been able to reach an agreement with the NHIS even in the several additional negotiation periods that were provided.

 

Even the 20% rate was considered to be too great a risk for these companies.

 

The clinical reevaluations will be completed in 6.5 years at the latest.

 

If companies agree on the 20% rate, and the trial fails after 6.5 years, each company may have to pay out more than 100 billion won each.

 

Due to this burden, many companies are trying to reach an agreement by proposing a lower recollection rate.

 

Some companies are also considering discounting their drug prices in advance while requesting a recollection rate that is lower than 20%.

 

Their opinion is that it may be more efficient to share the risk early on rather than paying out a large sum at once if the clinical trial fails.

 

However, the biggest reason why the negotiations are being indefinitely extended is that there is no justification for the negotiation itself.

 

There had never been a case where the companies had to agree to a restitution rate of the prescribed amount, presuming that the clinical trial would fail even before the trial has begun.

 

There also has been no social consensus made on whether it is reasonable to demand restitution for the failure of a clinical trial that was conducted for reevaluation purposes, for a product that had already been approved and was distributed according to due processes.

 

Clinical reevaluations are conducted to reexamine the safety and efficacy of drugs that are on the market.

 

Selling the drugs that are under clinical reevaluations during the trial period is not illegal because the approval granted by the MFDS stays valid.

 

The MFDS approved the renewal of the product license for choline alfoscerate drugs in 2018.

 

In other words, the authorities in charge of approving drugs acknowledged the safety and efficacy of choline alfoscerate drugs just 3 years ago.

 

Therefore, the legal dispute over whether the attempt to retrieve the claimed insurance benefits is reasonable if the clinical reevaluations fail is deemed inevitable.

 

The health authorities had never once asked the companies to pay back the prescribed amount of a drug that failed reevaluations.

 

The health authorities are also now at a dead-end in this never-ending tug-of-war.

 

With some companies already reaching an agreement with the authorities, the authorities have no choice but to impose sanctions on the pharmaceutical companies that refuses to negotiate and take measures such as removing the company's drugs from the reimbursement list.

 

However, pharmaceutical companies will naturally take legal action if their drug is removed from the reimbursement list.

 

The negotiations on choline alfoscerate products have deepened the confusion across the pharmaceutical industry.

 

One question that lingers is: did the health authorities not expect such fierce resistance when they began negotiations?

 

Did they really not expect the pharmaceutical companies to take legal actions in every direction, filing suits to nullify the negotiation, suspend execution, as well as file constitutional and administrative appeals?

 

Even the period of retrieval that had been modified recently was changed inevitably due to unexpected variables.

 

Choline alfoscerate is approved under 3 indications: to treat ▲ secondary symptoms and degeneration due to cerebrovascular defect or degenerative organic brain syndrome ▲ emotional and behavioral changes ▲ senile pseudo-depression.

 

Of these, only ‘secondary symptoms and degeneration due to cerebrovascular defect or degenerative organic brain syndrome’ is subject to reevaluation, and the remaining two indications will be removed regardless of the clinical trials' success or failure.

 

If the time of retrieval is set to 'the date the clinical trial protocol was approved', pharmaceutical companies will have to pay back insurance for the two indications that had been removed before the clinical reevaluations had begun.

 

This indicates that the retrieval period has not been through from the start.

 

If pharmaceutical companies have to pay back several years' worth of prescriptions due to the failure of their clinical trials, patients could also demand repayment for the drugs that they have taken during those years.

 

The government may also be criticized for allowing the sale of such a problematic drug.

 

A clear explanation seems to be necessary as to why the government is causing more harm than good by pushing ahead with the negotiations for recollection of insurance benefits.