NSCLC treatment Vizimpro 30 mg KRW 25,684 per tablet

HIPDC clears MOHW’s revised list of reimbursed drugs, Evenity injection priced at KRW 123,700

Sirturo 100 mg tablet priced at KRW 145,676 with expanded indication

From December, Pfizer Pharmaceutical Korea’s non-small cell lung cancer (NSCLC) treatment Vizimpro (dacomitinib) 30 mg tablet would be priced at 25,684 won with the healthcare reimbursement.

 

The insured pricing for Amgen Korea’s osteoporosis treatment Evenity (romososumab) injection prefilled syringe was set at 123,700 won.

 

South Korea’s Ministry of Health and Welfare (MOHW) announced the National Health Insurance Policy Deliberation Committee (HIPDC) convened a 17th general meeting on last Nov.

 

27 and made the said decisions for the revised List of Reimbursed Drugs and Upper Limit Pricing.

 

◆Vizimpro tablet: In the South Korean market, Vizimpro is indicated as a first-line treatment for patients with locally advanced or metastatic NSCLCL with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R substitution on exon 21.

 

About 1,100 patients in South Korea can use the product.

 

The pharmaceutical company earned the Ministry of Food and Drug Safety’s (MFDS) approval on Feb.

 

14 this year and applied for the healthcare reimbursement to the Health Insurance Review and Assessment Service (HIRA) on following Mar.

 

27.

 

HIRA convened a meeting for the Drug Reimbursement Evaluation Committee (DREC) on Oct.

 

12 and evaluated the product’s coverage listing would be feasible if it is priced lower than the weighted average pricing of its alternative drug.

 

DREC assessed the clinical efficacy of Vizimpro is non-inferior to other alternative options like Iressa, Tarceva and Giotrif, as textbooks and clinical guideline recommended the drug as a first-line treatment for the patients with EGFR mutation-positive advanced NSCLC.

 

Among the A7 countries, the health authorities in the U.S., the U.K, Germany, Switzerland and Japan have listed the drug, and the adjusted average pricings of the 15 mg, 30 mg and 45 mg tablets are 164,217 won, 194,948 won and 179,010 won, respectively.

 

The company reached an agreement after negotiating the projected claim cost with the National Health Insurance Service (NHIS) from Oct.

 

20 through Nov.

 

17.

 

The two parties have negotiated that the projected claim cost would reach 6 billion won, considering the alternative treatment options, clinical efficacy and market ratio based on the administration cost.

 

NHIS predicts no additional financial cost as there are alternative options.

 

The product’s insured pricings are set at 16,052 won, 25,684 won and 32,105 won for 15 mg, 30 mg and 45 mg tablets, respectively.

 

◆ Evenity injection prefilled syringe: An osteoporosis treatment for post-menopausal women with high risk of bone fracture, Evenity injection received the MFDS approval as of May 31 last year.

 

The company submitted an application for the NHI coverage to HIRA on Mar.

 

27 this year, and HIRA evaluated the drug would be feasible for the listing if it were to be priced lower than the weighted average pricing of alternative options at a DREC meeting convened on last Sept.

 

9.

 

DREC assessed the drug is clinical effective, compared to an alternative option Forsteo injection, as textbooks and clinical guideline mentions the drug as an option for the indication.

 

Also, academic societies claimed the drug increases patients’ bone density in hip and femoral neck and demonstrates outstanding effect, compared to other treatment options.

 

While the U.S., the U.K.

 

Germany and Japan have listed the drug, the adjusted average pricing is set at 527,302 won.

 

The company then negotiated the projected claim cost with NHIS from Sept.

 

19 through Nov.

 

17.

 

The two parties have agreed on 3.6 billion won, considering the administration cost difference with alternative drugs and clinical efficacy.

 

NHIS predicts no additional financial cost as there are alternative options.

 

The insured drug pricing, effective from December, is set at 123,700 won.

 

Meanwhile, Janssen Korea’s pulmonary multi-drug resistant tuberculosis treatment Sirturo 100 mg tablet, currently covered with NHI when administered according to the label since May 2017, is to expand the indication and also change the insured pricing.

 

The upper limit pricing is set at 145,676 won per tablet.

 

MOHW official said, “The newest revision in the list should come in effect from Dec.

 

1 for expanded NHI benefit.”s