What criteria does the Pharmaceutical Committee judge?

12 new drugs listed last year

12 of 24 new drugs were successful in listed drugs, Unfortunately, there are four drugs that have failed the reimbursement challenge.

 

The HIRA evaluates the adequacy of a drug through a review by the Pharmaceutical Benefits Evaluation Committee in accordance with Article 11 (2) of the Rules on National Health Insurance Benefits.

 

Dailypharm analyzed new drugs that passsed by the HIRA's Pharmaceutical Benefit Committee from January to December last year.

 

Of the 24 drugs, only 11 received reimbursed.

 

The remaining 10 drugs were non-reimbursed, and 3 drugs were managed-entry.

 

.Non-reimbursed drugs include 'Duodopa intestinal gel' (levodopa)' by Korea's AbbVie, 'Neuronata-R(autologous bone marrow-derived mesenchymal stem cells)' by Corestem, and 'Zerbaxa' (Ceftolozane/Tazobactam) by MSD Korea

 

.Radicut(Edaravone), the treatment of amyotrophic lateral sclerosisby Mitsubishi Danabe, chose to withdraw its reimbursement during the drug price negotiations with the HIRA

 

.

◆Duodopa intestinal gel=This drug is Progressive Parkinson's disease drug with severe motor ups and downs despite Parkinson's drug treatment,and it was approved on April 6 2015, went through the Pharmaceutical Benefits Subcommittee on July 23 2015 and it was put on the Pharmaceutical Benefit Committee on March 21, 2019, four years later

 

.However, the clinical data submitted by the pharmaceutical did not qualify as 'medical drugs deemed necessary for medical treatment' because clinically meaningful improvements such as prolonged period of survival have not been proved

 

.As a result, it was concluded that ICER was impossible due to insufficient evidence, and drug prices suggested by the company were difficult to accept due to uncertainty

 

.On the other hand, the related academics said that patients who are not controlled by existing Parkinson's disease drugs because they do not have adequate treatment in Korea are necessary for patients suffering from mental and physical pain and severe diseases due to exposure to medical blind spots

 

.This drug is listed in the US, Germany, France, Italy, the UK, and Japan excluding Switzerland among A7 countries

◆Neuronata-R= This drug is used in combination with Riluzole to slow the progression of the disease in amyotrophic lateral sclerosis, went through the Pharmaceutical Benefits Subcommittee on March 21 2018, and it was put on the Pharmaceutical Benefit Committee on last April 25

 

.In patients with amyotrophic lateral sclerosis, clinical necessity was acknowledged by slowing functional decline than without Neuronata-R, The cost was higher than that of the alternative, and the corresponding cost effectiveness was unclear, and A non-reimbursement decision was made

 

.The domestic neurology textbook mentions the approval of rare drugs in the applied products, and the stem cell treatment is introduced as a treatment under study in the ALS in clinical guidelines

 

.However, Yakyeong said, “Riluzole is being given to Amyotrophic lateral sclerosis, and considering the possibility of substitution, it is hard to say that it is an essential drug for medical treatment”

 

.The related academics also suggested that it would be advisable to review the Neuronata-R strains after the results of phase II and III studies have been reported

 

.

◆Zerbaxa=this drug received an item permit on April 7 2017 for complex intraperitoneal infections (with Metroidazole) and complex urinary tract infections (including Pyelonephritis)

 

.The deliberation was conducted on November 21 2018, through the Pharmaceutical Benefits Subcommittee, and the deliberation was conducted by the committee on last June 20

 

.As a result of the deliberation, the clinical necessity is hardly considered inferior to the clinical treatment rate, but it was concluded by non-reimbursement due to the higher cost than the alternative drug

 

.The relevant academics suggested that the introduction of an inferior therapeutic agent compared to Carbapenem has a clinical significance in the case of limited antibiotics against MDR-infected Gram-negative bacterial infections

 

.Among A7 countries, Zerbaxa is registered in the US, Italy, the UK, and Japan

 

.

◆Radicut=This drug failed the reimbursement threshold in the 2018 but was reevaluated by the Third Committee in 2019 and was recognized for its adequacy

 

.Radicut was approved as a drug that could slow the progression of dysfunction caused by amyotrophic lateral sclerosis, but the clinical necessity was recognized, but the cost was high

 

.However, there are no drugs or treatments with the same therapeutic position, and it has passed the severity and social impact of the disease according to the risk sharing plan and the policy to strengthen health insurance coverage as a rare disease treatment drug

 

.The problem was that Mitsubishi Danabe Pharma had been discussing reimbursement in Canada at the same time as Korea

 

.However, Canada decided to refer to Korean drug prices, and withdrew Korea's reimbursement entry to enter Canada's reimbursement

 

.At that time, Radicut was listed in the US and Japan among A7 countries

 

.On the other hand, in order to be reimbursed again, submissions of new cost-effectiveness data should be evaluated and submitted to the Pharmaceutical Benefit Committee

 

.