Global Insight Perspective | |
Significance | This round of Japan’s seasonal listings includes three orphan drugs, headlined by Otsuka’s new hyponatraemia treatment Physuline, which has beaten Astellas’ rival vasopressin V2 antagonist Vaprisol to the Japanese market and has received important first-mover advantage. The other orphan drugs are Kirin’s chemotherapy agent Busulfex and Genzyme’s multiple sclerosis drug Avonex. |
Implications | The listings significantly widen the commercial scope of the drugs in question, but the MHLW has once again been sparing in its pricing premiums—a long-standing issue, and a major thorn in the side of the drug industry |
Outlook | It is notable that only two of the newly listed drugs were developed by Japanese companies; indeed, only one is a truly innovative domestic-produced compound. This is indeed a sign of the times for the drug industry in Japan, where foreign pharmas are imposing their authority at the expense of less R&D-intensive domestic firms. |
Season of Lists and Mellow Fruitfulness
The Japanese Ministry of Health, Labour and Welfare (MHLW) has revealed the latest of its quarterly sets of reimbursement listings on the National Health Insurance (NHI) scheme, which will come into effect tomorrow. The Autumn round includes eight new drugs and three new formulations, and three of the listings are designated as orphan drugs. The treatments had mostly been approved over the June-August period. Most of the drugs were reference-priced according to Japan’s usual P&R regulations, but three were priced through cost-plus methodologies.
From Big Pharma, the major new drugs include hepatitis B treatment Baraclude (entecavir; Bristol-Myers Squibb (BMS, U.S.)), which has received a listed price of ¥1,058.10 (US$9.00) for 0.5 mg tablets. Baraclude was designated under medical usefulness type II premiums, and its Japanese listing is under half of its price in the United States, where it is not listed on Medicare Part D, but has a discounted federal supply schedule (FSS) price of US$19.44 per tablet. We believe this is the second global market that Baraclude has been reimbursed in, after Brazil (where it has been listed at a cost of 600 reais per 15-day course, or roughly US$18.62 per tablet).
Japan: NHI Price Listings, 15 September 2006 | ||||||
Drug | API | Formulation | Disease | Company | Price (¥) | Pricing Mechanism |
Avonex | interferon beta-1a | 30 mcg/0.5 ml | MS | Genzyme | 39,890 | Orphan |
Baraclude | entecavir | 0.5 mg tab | Hepatitis B | BMS | 1,058.10 | Therapeutic reference; Type II |
Busulfex | busulfan | 60 mg I.V. | Chemotherapy agent | Kirin Brewery | 40,447 | Orphan; cost-plus; |
Fosamac / Bonalon Once-weekly | alendronate | 35 mg tab | Osteoporosis | Banyu / Teijin | 847.80 | Price adjustment; Type II |
Gabapen | gabapentin | 200 mg tab | Epilepsy | Pfizer | 39.70 | International + therapeutic reference; Type II |
300 mg tab | 53.00 | |||||
400 mg tab | 65.00 | |||||
Itrizole | itraconazole | 1%/ml oral liquid | Anti-mycological | Janssen / Kyowa Hakko | 113.20 | Therapeutic reference; Type I |
Patanol | olopatadine | 0.1% eye drop | Allergic conjunctivitis | Alcon | 204.30 | International reference price |
Physuline | mozavaptan | 30 mg tab | Hyponatraemia | Otsuka | 8,734.40 | Orphan; cost-plus |
Pulmicort | budesonide | 0.25 mg/2 ml | Paediatric asthma | AstraZeneca | 263.30 | Therapeutic reference: Type II |
0.5 mg/2 ml | 346.80 | |||||
Temodal | temozolimide | 20 mg cap | Brain cancer | Schering-Plough | 3,345.90 | Cost-plus |
100 mg cap | 16,746.50 | |||||
Vigamox | moxifloxacin | 0.5% eye drop | Ocular pathogens | Alcon | 130.70 | Therapeutic reference; Type II |
Source: MHLW / Scrip / Global Insight | ||||||
Elsewhere, epilepsy drug Neurontin/Gabapen (gabapentin; Pfizer (U.S.)), osteoporosis treatment Fosamax/Fosamac (alendronate; Merck & Co (U.S.)) and newly paediatric formulated asthma drug Pulmicort (budesonide; AstraZeneca (U.K.)) were also designated second-class medical usefulness premiums. Gabapen and allergic conjunctivitis treatment Patanol (olopatadine; Alcon (U.S.)) were also reference-priced according to international standards; Gabapen has been referenced to generic Neurontin, and has the precise US$0.55-per tablet cost that is generally seen in the United States.
The Japanese industry experienced a major positive in the listing of Otsuka Pharmaceutical’s innovative vasopressin V2-antagonist Physuline (mozavaptan), which was approved in July. Japan becomes Physuline’s first market, although the MHLW has also called for the speedy prioritised development of rival drug Vaprisol (conivaptan; Astellas (Japan)), which was launched in the United States in April. Physuline, alongside Baraclude and chemotherapy drug Busulfex (busulfan; Kirin Brewery (Japan)), has been designated an orphan drug.
Outlook and Implications
The Autumn round of price listings in Japan was relatively inauspicious, with highlights including the first worldwide approval and reimbursement for Physuline, as well as the listings of Baraclude and Schering-Plough’s glioblastoma agent Temodal (temozolomide). Physuline’s pricing is particularly interesting, as the MHLW has provided a significant pricing premium for this domestically developed drug; it costs US$74.18 per tablet, compared to US$57.74 for injections of Astellas’ rival Vaprisol in the U.S. (Federal Supply Schedule (FSS) price). Elsewhere, however, Japan continues to maintain stringent cost-control mechanisms, through reference-pricing and price-adjustment mechanisms that leave little scope for premiums. Despite promises that pro-generics reforms and price cuts implemented earlier this year would be offset by stronger pricing premiums for innovative compounds, this still does not appear to be the case for foreign operators. This is unlikely to change.