Blockbusters face mixed fortunes in drug reassessment

Many major products including Rosuzet and Atozet assigned to second round…their price adjustments delayed until 2030

Of 14,000 products initially identified for first-round reassessment, 1,576 excluded…Cough and Diabex among those spared

The release of the first round of listed drugs subject to reassessment has produced sharply different outcomes, depending on the product.

Products included in Round 1 will face phased price adjustments beginning next year, while key products assigned to the second round or excluded from reassessment will avoid the immediate burden of price cuts.

Reassessment of many major products including Rosuzet and Atozet shifted to second round…easing burden on companies with key brands

According to industry sources on the 10th, the Health Insurance Review & Assessment Service (HIRA) recently released its first-round reassessment list for previously listed drugs. Of the 22,045 products on the reimbursement list as of September this year, 14,013, or 63.6%, were identified as subject to the first round of reassessments.

The government designated product groups in which multiple products with the same route of administration, active ingredient, and dosage form were listed as of Dec. 1, 2012, among others, for the first round, while the remaining products were generally classified for the second round. Price adjustments under the first reassessment will begin in April next year, while those under the second will start in October 2030. Innovative and semi-innovative pharmaceutical companies are eligible for special deferrals, pushing back the timing of their final price adjustments.

Among the most notable products on the list are major drugs with substantial prescription sales that were classified for the second round.

Hanmi Pharmaceutical’s Rosuzet is one prime example. According to pharmaceutical market research firm UBIST, Rosuzet generated KRW 227.9 billion in prescription sales last year, the highest figure in Korea’s outpatient prescription market. Had Rosuzet been included in the first round, its price would have been subject to phased adjustments to 51%, 49%, 47% and 45% beginning next year. Its inclusion in the second round, however, delays its first price adjustment until October 2030, easing the immediate price-cut burden on Hanmi’s flagship product.

In addition to Rosuzet, ▲Organon’s Atozet, ▲JW Pharmaceutical’s Livalozet and ▲Yuhan Corp’ Rosuvamibe, all of which generated more than KRW 100 billion in prescription sales last year, were included in the second round. Daiichi Sankyo’s Lixiana, whose patent is set to expire in November with generic launches expected to follow, is also expected to be subject to second-round price adjustments.

Among products with annual prescription sales of at least KRW 50 billion, ▲JW Pharmaceutical’s Livalo, ▲Boehringer Ingelheim’s Twynsta, ▲Gilead Sciences’ Viread, ▲AstraZeneca’s Crestor, ▲Boehringer Ingelheim’s Jardiance, ▲Novartis’ Exforge, ▲Gilead Sciences’ Vemlidy, ▲BMS’ Baraclude, ▲Boryung’s Kanarb and Dukarb, ▲Daiichi Sankyo’s Sevikar, ▲Hanmi Pharmaceutical’s Esomezol, ▲Daewon Pharmaceutical’s Pelubi and ▲HK inno.N’s Rovazet are also expected to undergo second-round reassessment.

1,576 products excluded from first round…Yuhan’s Cough and Daewoong’s Diabex among them

A substantial number of products were also excluded from the first-round reassessment. The government said exclusions apply to categories including orphan drugs, narcotics, biologics, drugs protected from market withdrawal, low-priced drugs, oxygen, nitrous oxide, radiopharmaceuticals, basic intravenous fluids, artificial perfusion solutions and products for which prices cannot be calculated.

A total of 1,576 products fall into these categories. They include Yuhan Corp’s Cough and Daewoong Pharmaceutical’s Diabex. Based on last year’s prescription sales, Cough generated KRW 38 billion and Diabex KRW 20.9 billion. Seventeen products excluded from the first round recorded prescription sales of at least KRW 10 billion last year.

The exclusions also include key products that have maintained strong prescription performance over many years. By avoiding the price-adjustment burden from this reassessment, these products are also expected to avoid revenue declines stemming from price cuts, assuming prescription volumes remain stable.

By contrast, major blockbuster products including Viatris’ Lipitor, Handok’s Plavix, Daewoong Bio’s Gliatamin and Chong Kun Dang’s Gliatilin were included in the first round. These products will inevitably face pressure on prescription sales and their manufacturers’ performance as price cuts begin next year.

The impact on individual pharmaceutical companies is therefore expected to depend less on how many of their products are subject to reassessment than on which round their key products fall into. For major products generating tens or hundreds of billions of won in annual prescription sales, the reassessment round can significantly alter when the burden of price reductions begins, making the classification of flagship products a key variable in pharmaceutical companies’ future performance.