For reimbursed drug, efficacy and cost-efficiency come first

HIRA answers questions on listing choline alfoscerate, Avastin and Xarelto

HIRA submits written answer to NA Health and Welfare Committee Audit questioning

On the last day of the 20th National Assembly Annual Audit for the Health Insurance Review and Assessment Service (HIRA), half the questions were dedicated to pharmaceutical affairs.

 

The lawmakers of the NA Health and Welfare Committee questioned HIRA about NHI reimbursement reevaluation on dementia treatment choline alfoscerate, reimbursement expansion on NOAC Xarelto, and reimbursement expansion on the anticancer treatment reflecting its frequent non-reimbursed off-label use as ophthalmic solution.

 

Some lawmakers claimed the General Principle of Healthcare Reimbursement on liquid solutions, like syrup and suspensions, should be revised and expand utilization cap eligible for reimbursement.

 

As always, however, HIRA had a strictly basic answer for the said topics and stated, “The issues addressed would be sufficiently reviewed when clinical efficacy and cost-efficiency are proven”.

 

Below is Daily Pharm’s summary of HIRA’s written answer submitted to the NA on Oct.

 

28.

 

◆Reimbursement reevaluation on choline alfoscerate: The current system does not stipulate a reevaluation for NHI reimbursement based on clinical efficacy, except for special cases of Ministry of Food and Drug Safety (MFDS) revoking an approval.

 

The government's National Health Insurance Comprehensive Plan is to establish a pharmaceutical reevaluation system considering clinical efficacy of listed drug, financial impact and healthcare coverage listing status in foreign countries.

 

HIRA, then, plans to have Drug Post-evaluation Subcommittee under Drug Reimbursement Evaluation Committee (DREC) to conduct NHI reimbursement feasibility reevaluation with the new system.

 

Particularly, HIRA official stressed uncertainty of choline alfoscerate “has been questioned constantly” and that the agency would “establish reevaluation system promptly for it”.

 

The dementia treatment is usually sold as a health functional food in other countries.

 

◆Expanded reimbursement benefit on Xarelto: Medical industry urges the health authority to grant NHI benefit on new oral anticoagulant (NOAC) Xarelto (rivaroxaban) to high-risk patients with coronary artery disease (CAD), specifically for cases of atrial fibrillation (AF) before and after catheter ablation and electrical cardiodiversion, nonvalvular AF with hypertrophic cardiomyopathy, and nonvalvular AF with CHA₂DS₂-VASc score 1.

 

At the moment, Brilinta (ticagrelor) and Xarelto are listed for reimbursement as antiplatelets, and the benefit for Xarelto only covers high-risk patients with nonvalvular AF.

 

HIRA answered, “As medical academic society has requested expanding reimbursement benefit on Xarelto, the agency plans to promptly review additional clinical evidences, such as revised guideline in foreign countries”, and the treatment’s “reimbursement would be expanded depending on clinically proven efficacy”.

 

◆Revising General Principle for syrup and suspensions: The current General Principle on Healthcare Reimbursement Criteria and Method stipulates granting NHI reimbursement benefit on pharmaceutical syrup and suspensions, also available in types of table or capsule with equivalent ingredient, in following cases; prescribed to patients younger than 13; patients with old age, dementia or other dysfunctional esophagus unable to swallow; prescribed with antacid, sucralfate, and sodium alginate under approved indication.

 

The National Assembly pointed out the General Principle regarding pharmaceutical liquid solution should be amended and provide healthcare benefit for all Koreans to consume drug more conveniently.

 

But HIRA official explained, “Liquid solution tends to be more expensive than tablet or capsule drugs”, therefore, “the General Principle, on Oct.

 

1, 2011, stipulated providing benefit to subject drugs meeting cost-efficiency standard under certain medical state and patient condition”.

 

Since 2011, some syrup and suspension with proven cost-efficiency have received reimbursement as an exception to the General Principle.

 

HIRA official added, “The agency would accordingly review the need to amend general reimbursement criteria based on cost-efficiency standard”.

 

◆Listing Avastin for reimbursement: This year’s National Assembly Audit addressed promptly providing reimbursement for non-reimbursed off-label treatment approved to be used.

 

The issue refers to the use of anticancer treatment Avastin in ophthalmology as a non-reimbursed off-label treatment for macular generation.

 

After consulting with Ministry of Food and Drug Safety (MFDS), HIRA allowed request for use of non-reimbursed treatment at clinics without an institutional review board (IRB) by revising ‘Standard and Procedure of Requesting Usage Approval of Non-reimbursed Off-label Drug’ this month.

 

HIRA stated it would consider providing healthcare reimbursement benefit in the future, when the legitimately used off-label drugs meet clinical efficacy and cost-efficiency standards.

 

◆Expanding RSA for follow-on drugs: As the RSA subject regulation for severe disease has been revised in last July, HIRA plans to positively review feasibility of expanding RSA subject for follow-on drugs after collecting public opinions.

 

◆Preventing illegal drug distribution: HIRA has decided to upgrade monitoring system to better manage all drug distribution information and to utilize the collected information properly through the serialization system.

 

HIRA currently requires a serial number to be labeled on minimal drug distribution unit container for the health authority to track individual unit in all phase of distribution, from manufacturing to import, distribution, and consumption.

 

In last May, HIRA cooperated with Seoul city community police to investigate illegal distribution of a weight-loss medicine Saxenda injection.

 

◆Drug pricing standard for the revised Generic Pricing Policy: The latest revision in the Generic Drug Pricing Policy stipulates drug pricing differentiated with compensation for cost, time and investment spent on generic development, and revised weighted pricing system.

 

Nonetheless, the pricing standard for incrementally modified new drug is same as before.

 

As the new weighted pricing policy could bring down prices of some incrementally modified drugs (IMD), HIRA plans to adequately amend the standard with Ministry of Health and Welfare.

 

HIRA official said, “IMDs are mostly developed by Korean pharmaceutical companies, so drug pricing benefit without limitation on IMD could cause international trade discrepancy as unfairly favorable benefit for Korean companies only”, but “the agency would continue to talk to other related ministries and industry about other means to promote development of IMD with better clinical efficacy”.

 

◆Revising PE analysis review process: In Australia and Canada, a company is responsible for submitting pharmaco-economic analysis and a public agency is responsible for reviewing the submitted material.

 

But in Korea, pharmaceutical companies have difficulties editing submitted PE analysis report.

 

Lawmakers claimed Korea should adopt ‘Application Registration System’ to prevent such inconvenience.

 

HIRA official answered, “it would be reviewed in detail, surveying overseas cases and current conditions in Korea”.