Rebamipide eye drops will be reimb next month

...eyes on whether the reimb will reorganize the artificial tears market

2 items from Samil and Kukje Pharma listed for reimbursement... gain attention as an alternative to hyaluronic acid eye drops set to receive reimbursement reevaluations

Mucosta ophathalmic solution (Rebamipide) being currently sold in Japan

Whether the reimbursement of Samil Pharmaceutical and Kukje Pharma’s rebamipide eye drop solutions that were developed as a treatment for dry eye will reorganize the artificial tears market is gaining attention.

 

In particular, with reimbursement reevaluations set to be conducted for hyaluronic acid eye drops that occupy the largest share of the artificial tears market this year, the possibility of changes made in the market share and rank has also been raised.

 

On the 15th, the Ministry of Health and Welfare issued an administrative notice of an amendment to newly establish a reimbursement standard for Rebamifide 0.1/5ml.

 

The drugs subject to the amendment are Samil Phamraceutical’s ‘Reva-K Eye Drops’ and Kukje Pharma’s ‘Reba-eye Eye Drops 2%.’ The Health Insurance Review and Assessment Service decided to approve the drugs for reimbursement within its approved indication, for the ‘improvement of corneal and conjunctival epithelial damage in adult patients with dry eye syndrome.’ However, its combined administration with mucin secretagogue (diquafosol sodium) will not be allowed reimbursement.

 

The reimbursement will be add a rebamipide option to the dry eye treatment market.

 

Rebamipide eye drops have already been released in Japan in 2012 by Otsuka Pharmaceutical as 'Mucosta ophthalmic suspension UD 2%', but Samil and Kukje’s products are the first to be introduced to Korea.

 

Rebamipide is known to stabilize the tear film by increasing ocular mucin secretion and contribute to the improvement of corneal and conjunctival epithelial damage to improve dry eye symptoms.

 

Samil and Kukje demonstrated the drug's improved outcomes through a clinical trial.

 

In a clinical trial that was conducted on a total of 220 patients with dry eye symptoms (74 patients in the 2% Rebamipide ophthalmic suspension arm, 74 patients in the placebo arm), patients were administered the drug or placebo in each eye four times (every 4 hours).

 

At week 12, outcomes in the 2% Rebamipide ophthalmic suspension arm were superior to the placebo arm.

 

With the drug demonstrating an effect in improving dry eye syndrome when administered just 4 times a day, Rebamipide has been evaluated to have an improved convenience compared to existing artificial tear products that require administration 5-6 times per day.

 

Reimbursed eye drop options currently in use for dry eye include hyaluronic acid, diquafosol sodium, and cyclosporine.

 

Among the options, hyaluronic acid boasts the largest share in the market, which is estimated to bring in an annual sales of KRW 230 billion.

 

These hyaluronic acid eye drops will be receiving reevaluation on their adequacy of reimbursement this year.

 

According to HIRA, as of January 2022, reimbursement is being applied to 427 items from 51 companies, and the average annual claims amount of the drugs for the past three years was estimated to be around KRW 231.5 billion.

 

Controversy over the reimbursement adequacy of hyaluronic acid eye drops, which were reimbursed since 1997, has been raised for some time.

 

In 2000, the National Evidence-based healthcare Collaborating Agency (NECA) argued for the need to improve the reimbursement standards for dry eye, saying that it was too early to conclude that hyaluronic acid ophthalmic solutions are clinically significantly different from other treatment alternatives.

 

Hyaluronic acid eye drops are currently used both for specialized and general drugs in Korea, however, most are used with a doctor's prescription, putting pressure on Korea’s national insurance finances.

 

On the other hand reimbursement for hyaluronic acid is not applied in major developed countries and is only reimbursed in Japan.

 

If the reevaluation concludes that hyaluronic acid eye drops are not eligible for reimbursement, the artificial tears market will inevitably be reorganized.

 

The analysis is that the existing diquafosol sodium and cyclosporine products will reap reflective benefit, and the rebamipide eye drops that are reimbursed this time may also serve as an alternative.

 

Recently, Daewoo Pharm is also known to be preparing a same-ingredient drug with Samil Pharmaceutical and Kukje Pharma for approval.

 

An industry official said, “Rebamipide eye drops that will be reimbursed this time, developed by Samil and Kukje, have improved marketability.

 

It offers an improvement in the irritability experienced using the original Japanese product.

 

Therefore, I believe the products will settle as new options in the dry eye syndrome treatment market upon release.