PN injection benefit restriction suddenly halted

Manufacturers of PN ingredient intraarticular injections recently submitted opinions to the HIRA

Re-discussion of the one-time benefit limit over the life cycle and the presentation/notification

Process to the health policy deliberation committee is also expected to be postponed

Intra-articular injection of PN ingredients reduces knee cartilage friction by maintaining physical restoration and high elasticity

With the advent of the reevaluation period for selective coverage of intraarticular injections containing PN (sodium polynucleotide), health authorities are planning to adjust the patient copayment upward.

 

Manufacturers and sellers have recently submitted opinions to HIRA, drawing attention to the future direction.

 

The opinion is based on supporting papers and clinical evaluations, and it is expected that the issue of 'restrictions on reimbursement of related products' will be quickly resolved.

 

According to the industry on the 7th, HIRA held a suitability evaluation committee and treatment material expert evaluation committee from early this year to September with the advent of the selective reimbursement period for PN preparations and agreed to increase the patient copayment from the existing 80 to 90%.

 

The key issue in the selective reimbursement of PN drugs is evaluated as 'restriction of administration after 6 months from the start of treatment,' and if such a measure is actually realized, the related market may be in danger of virtually drying up.

 

Currently, there are approximately 20 pharmaceutical companies manufacturing and selling intra-articular injections containing PN ingredients, and the market size alone amounts to a whopping 80 to 100 billion won.

 

If all went as planned, the measure to restrict coverage of PN drugs around October to December would likely have been submitted to the review committee and then notified, but the brakes were put on hold as pharmaceutical companies' written opinions based on clinical usefulness, feasibility, and cost-effectiveness were delivered.

 

The PN preparation is a new medical technology that has entered insurance coverage and has secured clinical results that are not inferior to the safety and effectiveness of the pharmaceutical collagen/sodium hyaluronate injection.

 

The industry and academic community also believe that ex officio adjustments related to ‘withdrawal of insurance benefits’ are an abuse of administrative power when there is clinical data that is comparatively inferior to alternative drugs, regardless of whether it is a drug or medical device.

 

An industry official said, "PN, collagen, and hyaluronic acid injections are usually administered 1 to 5 times every 6 months, and it is known that there is no significant difference in their effectiveness and safety.

 

However, with the advent of selective coverage, PN injections are now available for life.

 

He pointed out, “Limiting benefits to only one vaccination per cycle is highly problematic.” Regarding the overall situation, the legal profession's position is citing the precedent of Dong-A ST's Styrene Tablet, and it is highly likely that PN preparations and intraarticular injections will also present conditional clinical trials related to securing effectiveness within the next 2 to 3 years.

 

In the case of Stillen, there is a precedent in 2011 of receiving reimbursement for about 2.5 years on the condition of securing an indication for the prevention of gastritis due to the administration of non-steroidal anti-inflammatory drugs (NSAIDs).

 

At the time, the dispute over the reduction of styrene tablets' benefits, although it failed to secure clinical trial data to prove its usefulness, was evaluated as an exemplary case of protecting the authority and pride of an 80 billion won blockbuster domestic natural medicine, including indications for the treatment of acute and chronic gastritis, against the ex officio adjustment of health authorities.

 

there is.

 

The introduction of health insurance coverage for new medical technologies is an active patient consideration policy that limits the upper limit of indiscriminate treatment fees for similar non-covered products and can also be expected to have a savings effect on health insurance finances.

 

In other words, with the development of private actual cost insurance, out-of-pocket expenses can be minimized, and the national health insurance financial loss can be reduced to only 1/4 of the level of registered drugs, killing two birds with one stone.

 

This raises questions about the current benefit restriction measure.

 

PN preparations have been proven to be safe and effective using DNA components, a safe biomaterial extracted from salmonid fish, and are a biomaterial for tissue repair recommended for patients whose knee cartilage is worn out due to aging or overweight by reducing knee joint friction.

 

all.