Will Koselugo, a new neurofibroma drug be reimbursed next ye

Recently, the existing application was withdrawn and re-applied

Expect to shorten the registration period

"Koselugo (Selumetinib, AstraZeneca), the first drug used for childhood neurofibromatosis, a rare disease, is stepping up its challenge." Although he had a hard time at the HIRA in March, efforts to register health insurance have continued since then, such as supplementing data and reapplying for benefits.

 

Starting next year, expectations for the registration are growing as the drug price negotiation period for drugs designated as drugs subject to rapid screening, such as Koselugo, is shortened.

 

According to the industry on the 30th, Koselugo has continued its efforts to register benefits by submitting supplementary data since it was non-reimbursement in March.

 

Since then, the HIRA has also conducted a review by listening to related academic opinions and reviewing standards.

 

It is known that Koselugo's existing drug decision application was recently withdrawn and a new drug decision application was submitted.

 

Koselugo is interpreted as a willingness to continue its efforts to register benefits next year.

 

Starting next year, drugs designated by the Ministry of Food and Drug Safety as life-threatening or critical treatments such as Koselugo will speed up benefit screening and negotiations.

 

The HIRA and the NHIS recently revised related guidelines to provide data to the NHIS in advance for drugs used for life-threatening diseases from next year, moving the negotiations forward by about 30 days.

 

As a result, if Koselugo retries and passes the drug evaluation committee, the pace of registration is expected to accelerate.

 

Patients' opinions on Koselugo are also greater than ever.

 

Neurofibroma has relied on symptomatic treatment without proper treatment.

 

About half of Type 1 patients experience PN, which can occur anywhere in the body along the nerves, and the range of motion is limited depending on the location and size of the nerve or causes pain and appearance problems.

 

If a tumor develops inside, it compresses the internal organs, and most of the tumors are positive and grow slowly, but some are malignant or are likely to lead to breast cancer in women.

 

The prevalence is around one in 3,000 people.

 

Koselugo achieved the primary evaluation index ORR by reducing tumor size by more than 20% in 68% of administered patients in clinical trials.

 

In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months.

 

Half of the patients who did not receive treatment suffer from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to 3 years ago.

 

As the drug approaches 200 million won a year, it is urgent to register health insurance benefits to reduce the economic burden on patients.

 

Insurance authorities are cautious about analyzing cost effects as high drug prices have a significant impact on their finances.