IHS Global Insight Perspective | |
Significance | New generic drugs have been listed on the NHI scheme and four new compounds will soon enter the market. The most important new compounds are Takeda's Actos and Mitsubishi Tanabe's Radicut. |
Implications | This listing was delayed for a month due to the earthquake in March. Despite the ban on Actos in some European countries, the MHLW has maintained market approval of the anti-diabetic drug in Japan, which allows generic makers to launch their products. |
Outlook | As Actos has various issues such as patent litigation, a potential risk associated with bladder cancer, as well as a new study result showing a link to blindness, generic makers need to be up-to-date and provide enough information to prescribers to maintain their trust. |
Japan's Ministry of Health, Labour and Welfare (MHLW) announced it would list 330 new generic drug items on the National Health Insurance (NHI) scheme on Friday (24 June). Following four brand new generic drugs entered into the reimbursement scheme; Takeda (Japan)'s anti-diabetic drug, Actos (pioglitazone), Mitsubishi Tanabe (Japan)'s cerebral neuroprotectant, Radicut (edaravone), anti-osteoporotic drug, Ajinomoto (Japan)'s Actonel and Takeda (Japan)'s Benet (both risedronate) and MSD (US)'s hepatitis C virus treatment, Rebetol (ribavirin). The new drugs are included with 7 formulations and 87 items in the NHI list, which are mostly for pioglitazone and edaravone (50 items from 18 companies, 35 items from 22 companies respectively) whereas only 1 item was listed for both risedronate and ribavirin.
Some generic makers gained a series of NHI listings this time such as Kyowa Yakuhin's 25 items, Taiyo Yakuhin's 22 items, Nichi-Iko's 21 items, Towa's 19 items and Nipro Pharma's 18 items. Excluding name changes, the total number of new items has dropped to 296, yet the economic department of the MHLW considers the volume of listing is consistent with recent listings. However the number of application withdrawals was higher than usual, recording 80 items, Yakuji Nippo reported. More than 50 items were linked to patent litigation while approximately 10 items were influenced by the earthquake and tsunami that hit the nation in March.
Among already listed compounds, X-ray contrast agent, iohexol and ophthalmology use of hyaluronic acid both added the largest 13 items from 5 companies, making the market even more crowded. Eisai (Japan)'s anti-ulcer drug Pariet (rabeprazole) and Sanofi (France)'s anti-diabetic drug Amalyl (glimepiride), even exceeded 20 items per formulation in the list, which led to them receiving only 90% of the cheapest listed price.
Outlook and Implications
This listing for generic drugs was delayed by one month due to the prioritisation to the earthquake issues the country has been focusing on since 11 March (see Japan: 20 April 2011: NHI Listing to Be Postponed for Month in Japan Because of Earthquake). It seems that the impact was minimal and progressed under the new timeline. As shown, the majority of new compounds entered into the NHI list on this round were dominated by generic versions of Actos and Radicut, which are both in court for patent litigation. The MHLW was concerned about the potential instability in supply, which would affect patients who take their generic drugs, hence the regulator took a written commitment from generic makers, promising a secured supply despite the result of lawsuits. This action is important for the future of the generic industry in general, because one of the complaints from prescribers who do not use generic drugs is that generic companies tend to withdraw items from the market more often than originator drugs, leading to anxieties and doubts in patients. Some eight generic companies have made a deal with Takeda for Actos' generic launch to avoid such uncertainty (see Japan: 25 May 2011: Generic Company Signs Deal with Takeda to Postpone Launch of Actos Generic for a Year), therefore it is likely that the originator will fight hard to defend its blockbuster's intellectual property against 18 companies launched this time. In addition, Actos faces increasing concern linked to bladder cancer and French and German regulators have withdrawn marketing authorisations. The United States and Japan raised an alert recently (See Japan: 27 June 2011: MHLW Warns Doctors Not to Prescribe Actos to Patients with Bladder Cancer). The MHLW's decision means it will retain marketing authorisation which allows generic makers to launch its products to the market, however as another potential risk to developing diabetic macular edema which could lead to blindness was presented at the American Diabetes Association's annual meeting according to Bloomberg, it is important for generic makers to provide the latest information to doctors, in the same way as originator makers.