Fast-track listing of "high-priced new drugs" raises concerns

The Citizens' Coalition for Economic Justice·Korean Pharmacists Associations·Korea Severe Disease Association, demand re-evaluation of fast-track listing

"New drug evaluation results must be disclosed, and a post-marketing evaluation system must be established"

Argued for the reform of the drug pricing system through the establishment of a social discussion body

The Citizens' Coalition for Economic Justice (CCEJ) has urged the government to reconsider the fast-track reimbursement policy for rare disease treatments.

They are citing concerns that health insurance finances could be wasted on high-priced drugs with unverified efficacy.

On the morning of the 9th, the CCEJ, joined by the Korean Pharmacists Associations and the Korea Severe Disease Association raised concerns about the government policy aimed at increasing treatment accessibility for rare diseases. 

On the 9th, the Citizens' Coalition for Economic Justice, joined by the Korean Pharmacists Associations and the Korea Severe Disease Association  held a press conference to demand an immediate halt to the fast-track initiative for ultra-expensive new drugs. 

The groups argued that the government should prioritize establishing post-marketing evaluation measures over the hasty expansion of health insurance coverage for new drugs.

These associations said, ​"The government announced a fast-track policy to reduce the reimbursement listing period from 240 days to 100 days to improve access," adding, "While the previous process required 150 days to review clinical utility and cost-effectiveness, the new plan bypasses these steps, completing the establishment of benefit criteria within a single month."

They pointed out that this effectively eliminates the need to verify a drug’s clinical value. They also condemned the plan to reference the average listed prices of eight major countries (A8) to determine drug costs.

"While prices were previously negotiated over 60 days based on a drug's value, the reform aims to decide prices within a month based on overseas list prices, which are often inflated compared to actual transaction costs," they stated, "This is likely to reflect the high prices desired by pharmaceutical companies." 

Performance Evaluation Results (HIRA) for High-priced Medicines. 1. Evrysdi POS (risdiplam), 2. Spinraza Injection(nusinersen), 3. Luxturna injection (voretigene neparvovec), 4. Kymriah Inj (tisagenlecleucel), 5. Zolgensma injection (onasemnogene abeparvovec).

Furthermore, they also raised concerns about waste of health insurance funds based on the results of survey on the status of the effectiveness of high-priced new drugs.

The organizations based their criticism on HIRA's performance evaluation data for the 5 ingredients of 8 high-priced drugs under the performance-based Risk Sharing Arrangement (RSA).

According to data provided by HIRA to Representative Seo Young-seok's office, even Kymriah, so-called a 'miracle' treatment, showed that 59.1% of treated patients did not achieve the expected therapeutic effect. The organizations estimated that this led to approximately KRW 76.6 billion in unnecessary health insurance drug expenditures.

Additionally, ​Spinraza (nusinersen) and Luxturna (voretigene neparvovec) also recorded a 50% failure rate in meeting performance evaluation standards.

​"Over half of the patients who were treated with Spinraza and Luxturna, despite being subject to a 'prior approval system' that audits patient eligibility before administration," and added, "Based on the results from the French health authorities evaluating ultra-expensive drugs on the Korean market, 54% of the list showed either no or only marginal efficacy improvements compared to existing therapies."

They estimated that if 53 of the 77 rare disease drugs currently awaiting reimbursement are listed under the new 100-day 'fast-track' rule, it would require an additional KRW 1.5 trillion in insurance funding. 

They criticized the government for essentially 'blinding' the evaluation system by skipping clinical and economic feasibility checks and relying on the 'price bubble' of major foreign (A8) listed prices.

To address these issues, the organizations demanded ▲full public disclosure of all new drug efficacy evaluations ▲establishment of a specified post-marketing evaluation measure ▲establishment of financial management for new drugs ▲establishment of a social discussion body.

They stated, "Policies that subject people to potential clinical test subjects with unwarranted efficacy must be halted. We urge the government to secure justification and safety of the policy through social discussions, rather than a closed administrative action. The government must now establish a transparent and fair social discussion body."