Handok tops KRW 30 bln PAH treatment market

Traclear (KRW 6.2 bln), Opsumit (KRW 11 bln) and Uptravi (KRW 1.6 bln) make KRW 18.8 bln

Conducting PAH forum for 11 years

Receiving NHI reimbursement for double and triple combination therapies

(From left) PAH treatment Uptravi, Traclear and Opsumit by Handok

Korean pharmaceutical industry is closely paying attention to Handok’s market share constantly growing in pulmonary arterial hypertension (PAH) treatment sector.

 

In 2019, Korean PAH treatment market volume was recorded at 30.7 billion won with 20 percent bump from the previous year.

 

In the market, Handok’s PAH line up—Traclear (6.2 billion won), Opsumit (11 billion won), Uptravi (1.6 billion won)—has taken up 61 percent of the market share generating overall 18.8 billion won together.

 

Opsumit and Traclear are dominating 80 percent of the endothelin receptor antagonists (ERA) PAH treatment market share.

 

And among prostacyclins, Uptravi owns 35 percent of the market share.

 

Products in the general prostacyclin class have soared in the PAH market share.

 

The specific class has grown 56 percent in 2019 from the previous year, where Uptravi’s volume skyrocketed by 128 percent (700 million won to 1.6 billion won).

 

After releasing Traclear in 2006, Handok has launched follow-on drugs, Opsumit and Uptravi in 2016 and 2017, respectively, that are now successfully competing in the PAH treatment market.

 

The company’s effort to raise awareness of PAH since 2010 by organizing a forum and various academic conferences has soundly propelled the business.

 

PAH is a rare disease causing high blood pressure in pulmonary artery, which comes with symptoms of dyspnoea, fainting, anasarca and even the motor nerve could be seriously affected.

 

According to overseas studies, average time of survival after diagnosis has been reported to be around two to three years, and it takes about average of 1.5 years to get diagnosed.

 

PAH treatments are divided into three types—oral, inhalant, and injection.

 

The oral medications are again divided into three types.

 

Traclear (bosentan), Opsumit (macitentan), and Volibris (ambrisentan) are categorized as ERA.

 

Pahtension (sildenafil) and Cialis (tadalafil) are phosphodiesterase type 5 inhibitor (PDE5i).

 

And lastly Uptravi (selexipag) is prostacyclin.

 

Most popularly prescribed PAH treatment, Opsumit has conducted two-year-long trial SERAPHIN, unprecedentedly long for oral PAH medication, and clinically confirmed the lowered risk of mortality and morbidity and reduced hospitalization rate in patients with PAH.

 

According to the study with 742 patients with PAH, an arm administered with 10 mg of Opsumit demonstrated mortality and morbidity 45 percent lower than the placebo arm, and the arm’s death and hospitalization by PAH was reduced by 50 percent.

 

The incidents of side effects, such as increase in hepatoxicity and peripheral edema, were on par with the placebo group, confirming outstanding safety profiled.

 

Unlike other PAH treatment in ERA class, Opsumit has advantages of not requiring monthly hepatoxicity test, and convenience with once-daily administration.

 

And with special case reimbursement for rare disease treatment, the treatment can be provided with various medical aid benefits.

 

Most recently launched Uptravi is the first oral prostacyclin.

 

Unlike other existing options, the medication works selectively on IP receptor that induces vasolidation, and it has been consolidating its position in the PAH treatment market as a combination therapy option since its release.

 

PAH treatment trend in 2008 to 2016 analyzed by Health Insurance Review and Assessment Service (HIRA) found three-year survival in Korea is at 54 percent, which is lower than the U.S.

 

(2006-2007) at 68 percent.

 

As combination therapy rate in Korea is at 18 percent, far lower than 52 percent in the U.S., the figure implies promoted use of combination therapy is needed.

 

In GRPIHON study, extended up to three years with 1,156 patients with PAH, Uptravi has confirmed reduction in mortality and morbidity.

 

Against placebo group (80 percent already administered with ERA or PDE5i), patient group treated with Uptravi combination therapy had 40 percent lower relative risk of mortality and morbidity, showing clinical efficacy in patients who are already in treatment with other options.

 

In Korea, insurance reimbursement is granted on both sequential double and triple combination of PAH treatments.

 

Patients, who used to take either ERA or PDE5i monotherapy or ERA plus PDE5i double combination therapy, could receive reimbursement when combining with Uptravi.

 

As stipulated by PAH treatment’s general reimbursement standard for early combination therapy taken in effect from last June, patients who have been administered with ERA plus PDE5i combination for over three months may receive reimbursement for taking Uptravi as third combination.