'Brakes' on reimbursed drug’s listing process

Settlement of the Pharmaceutical Industry in 2019 by Administration & System by the NHIS & the HIRA

Focus on drug price reorganization

This year, the insurance authorities were able to reorganize their drug price system to the organization of the person in charge of drug prices.

 

Last year, The NHIS　chairman Yong-ik Kim, who designed Moon Jae-in Care, was very active, and this year, there have been a number of institutional improvements that have been carried out by staff in charge of implementing the policy.

 

In the drug sector alone, there were many big and small things happening, including the expansion of screening benefits and RSA drugs, and the creation of contracts that included supply obligations prior to drug price negotiations and patient protection and confidentiality.

 

As the HIRA manages the health insurance finance, it has to focus on the income expansion to support the policy of strengthening security and the task of spending expenditure efficiency.

 

If the focus has been on finding new drug-based follow-up management plans, next year, it will continue to seek ways to improve the 'price-volume agreement' that has been spinning the wheels with research services several years ago.

 

The HIRA reviewed the revised economic evaluation guidelines and reference methods for foreign drug prices until the second half of this year to improve the drug listed system.

 

In August, the RSA target was expanded from cancer and rare diseases to severe and intractable diseases, and the severe atopic dermatitis, Dupixent, will be paid from next January.

 

◆Enhancing Access to Medicines by Moon Jae-In Care= This year, the first case of drug screening benefits was released.

 

In order to strengthen health insurance coverage, six types of anti-cancer drugs, which had no reimbursement standard or remained as 'baseline non reimbursement' at 100% of the copayment rate, were selected as a screening benefit.

 

The protagonists of the first screening benefits include breast cancer treatments ‘Perjeta (Pertuzumab)’, ‘Halaven inj (Eribulin)’, Prostate Cancer Therapeutics, ‘Xtandi soft cap (Enzalutamide)’, and ‘Zytiga (Abiraterone)’.

 

RSA targets for late-release drugs were also expanded.

 

Dupixent, which was not an anticancer drug or a rare disease treatment drug, had difficulty in applying RSA expansion, but the health insurance policy review committee decided to complete the reimbursement registration process on the 23rd.

 

The MOHW applies a special calculation to reduce the incurable cost of medical expenses (20~60% → 10%) for rare and incurable diseases, and expanded the target diseases.

 

In January of this year, The MOHW identified 100 rare diseases and included them in the exception, and added 91 new rare diseases in the second half of this year.

 

In the case of medicines, health insurance coverage is being expanded to focus on the treatment of serious diseases such as anticancer drugs and rare diseases.

 

Compared to 2016, anti-cancer drug spending rose 41% from ₩1.47trillion to ₩1.46trillion in 2018, and rare disease treatment spending increased 81% from ₩235.2 billion to ₩4265 billion.

 

During the same period, the drug cost growth rate exceeded 19%.

 

This year, a new high-priced drug called Spinraza, which costs ₩560 million for the first year and ₩280 million from the next year, will cost ₩92.35 million per vial per patient.

 

It is also a significant year for reimbursement listing under both total contracts system and RSA.

 

◆Reorganization of departments related to drug price in the HIRA=The organizational reform of the department in charge of drug prices in the HIRA, which was in charge of the implementation of Moon’s care, was an issue.

 

The HIRA changed the existing insurance reimbursement division to the reimbursement strategy division from January 1 through amendment of the Order Regulations and the Enforcement Rules of the Order Regulations, and increased the departments related to drug prices from two to three.

 

Dr.

 

Jong-Heon Park, former researcher, was appointed as the head of the reimbursement strategy division.

 

Since the establishment of the Drug Price System Division, it has also lowered the threshold of 'secret drug price negotiations' by opening a foreign drug price inquiry guidelines bulletin board and opening the drug price negotiation drug.

 

In July, the glass ceiling of the 2nd level pharmacy occupation promotion of the HIRA broken.

 

In order to guarantee the opportunity for promotion of pharmacy jobs, which was stopped at Level 3, the HIRA has been reorganizing its personnel and organizational regulations since 2017.

 

As a result, Nam-sun Shin, the head of drug price negotiations, a second-level manager was produced from the pharmaceutical industry.

 

◆The HIRA, fix the drug price system= Last year, the Economic Evaluation System Improvement TFT was operated to revise the economic evaluation guidelines for medicines.

 

TFT focused on the comparative drug, ICER, utility, and discount rate that the pharmaceutical industry has pointed out.

 

Based on the TFT report, the HIRA is publishing commissioned research announcements to develop guidelines and conducting research.

 

The economic evaluation system was created in 2007 following the introduction of a drug screening system.

 

Over the past decade, the Economic Evaluation Subcommittee of the Committee on Drug Benefit Evaluation has reviewed data of approximately 190 ingredients (80 times) based on economic evaluation guidelines.

 

However, since the guidelines used to evaluate the economic feasibility have been applied since the beginning of June 2006 and only one revision was made in December 2011, the pharmaceuticals complain that the reality is not reflected.

 

At the Fifth Health Insurance Policy Review Committee held on April 3rd, there was a brake on the decision to skip negotiations.

Another issue is the decision to delay negotiations to negotiate during the April 3 meeting of the Health Insurance Policy Review Committee.

 

At the time of the face-to-face screening process, 90-100% of the weighted average price of alternative drugs was accepted and drug price negotiations were skipped.

 

Among the drugs envisaged by the Health Insurance Policy Review Committee, there was a brake on reimbursement such as antidepressant Agotine tablet of Whanin, Faslodex of breast cancer treatment of AstraZeneca Korea, and Alunbrig tablet of non-small cell lung cancer treatment of Takeda.

 

This is because members of the Health Insurance Policy and Deliberation Committee have put in place conditions for the drug price agreement.

 

The conditional resolution was foreseen to some extent from the time the Ministry of Health and Welfare switched all the drugs proposed to the Health Policy Review Committee to face to face examination.

 

The MOHW raised the CJ Healthcare's K-cap tablet for gastroesophageal reflux disease to the Health Insurance Policy Review Committee on February 26, and decided on an internal policy to turn the face-to-face examination of drugs that had been settled through price negotiations.

 

From this point on, a subsidiary agreement on 'performance of supply obligations' will be drawn up for all drugs undergoing drug price negotiations with the HIRA, and the 'pre-counseling system' will be actively operated until the Minister of Health and Welfare 's order for drug price negotiations.

 

The HIRA has signed and managed a contract containing the same provisions, including 'Supply Obligations and Patient Protection' on 172 drugs of 59 pharmaceutical companies by October this year.

 

It is necessary to negotiate in advance whether there is a drug that can be replaced by itself and how the supply will proceed in the future.

 

In the research process conducted by the HIRA, the foreign drug price standard referred to in the process of listing domestic drug benefits is added from A7 (USA, UK, Germany, France, Italy, Switzerland, Japan) to A10 (additially Taiwan, Canada, Australia).

 

When the results of the study suggest that they should be expanded.

 

The movement has begun to improve this.

 

Recently, the HIRA also added 'Post-Pharmaceutical Evaluation' and 'Herbal Drugs' to the Subsidy Commission of the Pharmaceutical Benefits Evaluation Committee.

 

The new Sub-Committee on Subsequent Drug Evaluation will conduct post-evaluation of those drugs that have extended their coverage by anticancer drugs, rare drugs, and clinical usefulness, which are expensive drugs.

 

◆Yang-ho Cho ’s issue=n last July, the prosecution filed a warrant for arrest of the chairman of Hanjin Group, Cho, Yang-ho, for fraud, embezzlement, and duties.

 

He also illegally borrowed a pharmacist's license and ran a pharmacy to violate the pharmacist law, and retrieval process begins for ₩100 billion in insurance financing.

 

Six criminal detectives at the Southern District Prosecutors' Office investigated Cho's suspicion of escaping the inheritance tax, and have been accused of running a pharmacy illegally as a nominee for over 20 years.

 

But, on April 8, when President Cho suddenly passed away, the trial proceedings have been disrupted including violations of the Pharmaceutical Affairs Law.

 

At present, Mr.

 

Cho's illegal pharmacy trial continues against Mr.

 

Won, a pharmacist Lee, and his spouse Mrs Ryu , who conspired to commit the crime.

 

Sue was suspected of violating pharmacological law by opening a pharmacy on the first floor of the company's annex under the name of pharmacist Lee, through Mr.

 

Won and Mrs Ryu.

 

◆Field survey=Since this year, the self-check system has been expanded.

 

The autonomous check system was introduced to allow the reviewers to detect and report unfair claims by informing the appropriate nursing institution of the possibility of unfairness of the reimbursement expenses already paid before the on-site investigation.

 

Trial project from December 2017 ▲ Temporary mandibular joint shooting (1st) ▲ Increase of claims after divided use of injection (2nd) ▲ Violation of breast biopsy calculation standard ▲Pharmacy differential index and night addition error claim based on the results of the autonomous inspections in turn, the autonomous inspection system was introduced in earnest from November 1, 2018.

 

The HIRA noted that such a problem was also pointed out by the State Auditor last year.

 

The HIRA feels the necessity of reviewing administrative measures for improvement based on the type and billing amount.

 

On the other hand, the NHIS has argued that employees of the HIRA should have the special judicial police right to eradicate operated hospitals by office manager, not a doctor.

 

◆Bending of the first ₩1 trillion in history= The NHIS announced the average rate of increase in the conversion index for nursing institutions on the 1st of next year at 2.29% (bending ₩1.47 trillion).

 

Although it was determined to be slightly lower than 2019 (2.37%) in consideration of the subscriber's ability, financial integrity, and medical expenses growth rate, it recorded the first ₩1 trillion in sales.

 

Next year's budget is estimated at ₩1.4688 trillion, with ₩434.9 billion for hospitals, ₩93.5 billion for dentistry, ₩66.9 billion for oriental medicine, and ₩114.2 billion for pharmacies.

 

The rate of increase was 3.5% in pharmacies, 3.1% in dentistry, 3% in oriental medicine, and 1.7% in hospital, but the order of the distribution of bending shares was reversed.

 

◆DUR Advancement Pilot Project=The Drug Utilization Review (DUR) Advancement Pilot Project, which has been in progress since August 1st, was completed this month.

 

The HIRA conducted a pilot project for 20 medical institutions (2 senior general hospitals, 2 general hospitals, 1 hospital, 4 clinics, and 11 pharmacies) in the second half of this year.

 

Based on the results of 2018 DUR Research Plan for Advancement of DUR, the pilot project was undertaken to establish a comprehensive management system before and after drug use as well as to establish a compensation system.

 

And there are two types of systems in which pharmacies participate: aftercare, allergy, and adverse event monitoring.

 

◆Drug serial number system= From January 1, the serial number system has been implemented.

 

The average reporting rate for the first half of all distributors released in August was 89.1%, at the time of shipment, 2591 companies (96.4%) had a serial number reporting rate of more than 50%, and 98 companies (3.6%) had less than 50%.

 

The appeals of 18 wholesalers were cited as a result of the request by the HIRA to 98 companies for administrative disposal.

 

80 unappealed or rejected complaints were selected as the final administrative disposal request companies and notified to the public health center.

 

In the second half of this year, the administrative reporting criteria for the distribution number serial number of distributors have been raised from 50% to 55%.

 

From July to December this year, after the first half of this year's accounting period, requests for administrative disposal of manufacturing import companies are applied from the serial number reporting rate in the second half of this year.