A new drug for optic shylomyelitis is necessary

Kim Ji-eun, insurance director of the Korean Society of Neuroimology

Soliris, there are many patients with urgent prescription

Professor Kim, Ji-eun

Off labels refer to the act of prescribing a medicine for an indication other than a use approved by the Ministry of Food and Drug Safety.

 

In general, the use of the drug has been determined by the health authorities, and the question may arise as to why it is necessary.

 

However, there is an area of disease where this Off label prescription is covered by insurance benefits.

 

It is NMOSD.

 

Currently, the immunosuppressant Azathioprine is used for primary maintenance treatment for optic vesical schomyelitis, and Mycophenolate or Mapthera are prescribed as the second treatment after the failure of Azachioprine treatment.

 

Mycophenolate and Rituximab Offlabel drugs that do not have indications for optic nerve lingualism.

 

The cause is simple.These drugs did not formally obtain indications through clinical studies of optic severe, but were confirmed to be effective through presumed efficacy and long-term accumulated prescription experience.

 

However, there is a more bizarre situation in the area of optic sever.

 

Immediately through phase 3 clinical trials, its effectiveness is confirmed, and officially approved new drugs are not eligible.

 

Dailypharm met with Kim Ji-eun, the insurance director of the Korean Neurological Society (Professor of Neurology at Eo University Seoul Hospital), and heard about the current treatment environment of optic scurveitis and the need for new drugs.

 

The drug used in the treatment of the optic sbellomyelitis category is known as an off label drug.

 

I wonder if there are any side effects to the use of these drugs, and what their characteristics are.

 

Of course, it must be the necessary medicines.

 

However, as it is not a drug that has been proven to be effective and safe in the disease based on systematic clinical research, there are concerns in terms of side effects and effects.

 

In particular, there are many reports that the primary treatment, Azathioprine, is low compared to other drugs, along with the risk of side effects such as bone marrow suppression, elevated liver levels, and increased cancer incidence during long-term use.

 

In fact, about 50% of patients who used Azathioprine stopped treatment due to side effects within 18 months of treatment, of which 15% were due to lack of effects such as recurrence, and 62% were due to side effects of the drug.

 

When following the current domestic benefit standards, Rituximab is used as a tertiary drug if there is a recurrence in the primary and secondary drugs.

 

In the case of Rituximab, it is off label, but compared to other drugs, it has a better recurrence effect, and it is excellent in terms of effectiveness and safety, so in some patients with severe severity, it is increasingly skipping the first and second drug and administering it right away.

 

In some countries abroad, Rituximab can be used as a primary treatment.

 

The effect of Rituximab is not bad, but do we still need a new drug? It's excellent compared to existing drugs.

 

There are patients who still have a relapse even after using Rituximab, so a new drug is needed for them.

 

It is reported that about 10% of patients experience recurrence even after using Rituximab and as the accessibility of new drugs is reduced, these patients have no choice but to maintain their existing treatment even after recurrence.

 

New drugs include monoclonal antibodies that directly act on the main inflammatory immune response targets of optic spondylomyelitis pathology, such as Soliris, Enspring and Uprizuna.

 

Some of them are currently in the process of applying their benefit.

 

Eculizumab is a prote suppressant, and Enspryngg is an interleukin-6 resuppressant with other mechanisms, so that patients who have recurrent in existing drugs can have the opportunity for treatment without being marginalized.

 

In particular, these new drugs are very effective against conventional drugs, and in the case of ekulizumab, it has been found to reduce the risk of recurrence by 94%.

 

- Among the drugs to be said, Soliris and Enspryngg are going through the process.

 

However, there is a disagreement between the pharmaceutical company and the government over the standard, so I know it is not easy to discuss.

 

After prescribing all the drugs that can be used now, it is the direction to recognize the benefit only at the back end (4th or more).

 

The desperate thing for the medical staff is to first offer a new treatment option to patients who don't have a treatment option, and then the best treatment option to prevent irreversible recurrence.

 

However, new drugs are somewhat expensive, and considering the social costs, I think that even patients who have failed to treat ritukshimab need urgent benefits.

 

-As the drug price is high and the non-reimbursed status continues, the expiration date of the drug's PMS is getting closer.

 

If the PMS is not completed under the regulations, the permit will be withdrawn. These new drugs are not enough to come in or not to come in.

 

It was a disease that had not been diagnosed before, but it became possible to diagnose it through anti-quaporin-4 antibody tests, etc., and treatment that can reduce the disorder through drugs became possible.

 

I hope that access to drugs will improve as soon as possible so that patients in need can receive treatment.

 

Have you ever given an opinion to the government at the society level?

 

The conference has also submitted several submissions of opinions on new drugs so that alternative options can be quickly arranged, and it continues to be of interest.

 

I hope the benefit will be made quickly so that even a small number of patients can provide treatment options to those who really need it.

 

Also, the disease itself has a very big impact on the patient's life.

 

In addition, we hope that various new drugs targeting various mechanisms will be available in clinical practice as soon as possible so that an environment where customized treatment can be created for patients can be created.