Rucalo newly listed, Meqsel+Rafinlar expands reimbursement

Government plans to revise List of Reimbursed Drug and Maximum Reimbursed Price

Healthcare reimbursement would be granted on Yooyoung Pharmaceutical’s chronic constipation treatment Rocalo tablet (prucalopride succinate) soon at a price of 100 won a unit.

 

Used to treat BRAF V600E mutation-confirmed metastatic melanoma, Novartis Korea’s Meqsel (trametinib dimethyl sulfoxide) plus Rafinlar (dabrafenib mesylate) combination therapy would be additionally indicated for treating non-small cell lung cancer (NSCLC).

 

But, only in condition of signing the expenditure cap type risk sharing agreement (RSA) for the financial issues.

 

According to pharmaceutical industry on Feb.

 

5, the Korean government plans to reflect the said changes on ‘List of Reimbursed Drug and Maximum Reimbursed Price.’

◆ Rucalo tablet: A selective serotonin 5-HT4 receptor agonist, Rucalo treats adults with chronic constipation, who does not respond to conventional laxative.

 

After Ministry of Food and Drug Safety (MFDS) approved the drug as of Jan.

 

25 last year, the company immediately applied for reimbursement to Health Insurance Review and Assessment Service (HIRA) on Feb.

 

15 last year.

 

Reimbursement on the drug was granted by Drug Reimbursement Evaluation Committee (DREC) in last October following the review by HIRA.

 

Apparently, Korean Society of Neurogastroenterology and Motility’s claim that the doctors actually consider such prokinetic drug when a patient does not respond to first-line laxative (form-bulking or osmotic laxatives), has influenced the decision.

 

In fact, the drug is listed in some of A7 countries like the U.K., Germany, Italy and Switzerland.

 

Since then, the company successfully reached an agreement during pricing negotiation with National Health Insurance Service (NHIS) conducted from last November to early January, as ordered by MOHW.

 

When the listing is completed, the drug’s maximum reimbursed price is predicted to be set at 127 won per 1 mg unit, and 191 won per 2 mg unit.

 

◆ Meqsel plus Rafinlar combination therapy expands reimbursement: Meqsel plus Rafinlar combination therapy has been indicated for treating metastatic melanoma in patient with confirmed BRAF V600E mutation.

 

The combination has been receiving reimbursement since November 2017 in Korea.

 

BRAF V600E mutation is a particular change in BRAF gene that affects growth and transmission of cancer cell and is frequently found in a number of specific cancers like melanoma.

 

For the reimbursement review procedure, it took the pharmacoeconomic analysis exemption route.

 

After a while, the pharmaceutical company added the therapy an indication to treat NSCLC patient with confirmed BRAF V600E mutation, and applied for expanded reimbursement to HIRA in February last year.

 

HIRA’s Cancer Disease Deliberation Committee and DREC cleared reimbursement for the combination therapy in April and October last year, respectively.

 

The combination therapy used on NSCLC, also recommended by clinical practice guidelines by National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO), was evaluated to have improved clinical efficacy when reviewed by DREC.

 

However, the government and NHIS laid down a condition of signing RSA to cover the financial impact caused by expanding reimbursement on the combination therapy’s NSCLC-treating indication (NHI estimates yearly claim would be approximately 20 billion won).

 

During the negotiation with the company later, the maximum prices of Meqsel and Rafinlar were lowered by 23% and 13%, respectively.

 

When the new reimbursement is finalized, the maximum reimbursed price per unit is expected to be set at 128,344 won and 32,086 won per 2 mg and 0.5 mg of Meqsel, and 24,751 won and 36,336 won per 50 mg and 75 mg of Ranfilar.