Japan's Central Social Insurance Medical Council (Chuikyo) has granted reimbursement coverage to 16 active pharmaceutical ingredients (APIs), as well as awarding a 45% pricing premium to Novartis (Switzerland) combination treatment Tafinlar (dabrafenib mesylate) and Mekinist (trametinib dimethyl sulfoxide) for BRAF mutation-positive unresectable malignant melanoma.
Implications | Chuikyo's recommendation of the combination closely follows that of the United Kingdom's National Institute for Health and Care Excellence (NICE), as well as a positive decision by the health technology assessment (HTA) authorities in Germany. |
Outlook | The pricing premiums in particular are a significant positive for Novartis and Janssen Pharmaceutica (Johnson & Johnson, US) drug Imbruvica (ibrutinib), particularly given Japan's focus on reining in pharmaceutical prices amid the National Health Insurance fiscal year 2016 reform. |
Drug | Sponsor | Indication | NHI* reimbursement price (JPY) | Calculation method | Premium |
|---|---|---|---|---|---|
Sabril (vigabatrin) | Sanofi (France) | Infantile spasms | 1,487 | Similar efficacy comparison method (I) | |
Fycompa (perampanel hydrate) | Eisai (Japan) | Adjunctive therapy in epilepsy patients who inadequately respond to other antiepileptic drugs | 189.70 (2 mg) / 310.20 (4 mg) | Similar efficacy comparison method (I) | Upward adjustment based on average foreign price |
Sycrest (asenapine maleate) | Meiji Seika Pharma (Japan) | Schizophrenia | 274.00 (5 mg) / 411.00 (10 mg) | Similar efficacy comparison method (II) | |
Imbruvica (ibrutinib) | Janssen | Relapsed or refractory chronic lymphocytic leukaemia | 9,367 | Similar efficacy comparison method (I) | Premium for usefulness (I) (35%) |
Zykadia (ceritinib) | Novartis | ALK-positive, unresectable advanced or relapsed NSCLC** resistant or intolerant to crizotinib | 6,297 | Similar efficacy comparison method (I) | Upward adjustment based on average foreign price |
Tagrisso (osimertinib mesylate) | AstraZeneca (UK) | EGFR T790M mutation-positive, inoperable or relapsed NSCLC resistant or intolerant to EGFR tyrosine kinase inhibitors | 12,482.50 (40 mg) / 23,932.60 (80 mg) | Similar efficacy comparison method (I) | Premium for usefulness (II) (5%) + upward adjustment based on average foreign price |
Tafinlar (dabrafenib mesylate) | Novartis | BRAF mutation-positive unresectable malignant melanoma | 4,860.60 (50 mg) / 7,156.50 (75 mg) | Similar efficacy comparison method (I) | Premium for usefulness (I) (45%) |
Mekinist (trametinib dimethyl sulfoxide) | Novartis | BRAF mutation-positive, unresectable malignant melanoma | 7,731.70 (0.5 mg) / 29,021.00 (2 mg) | Similar efficacy comparison method (I) | Premium for usefulness (I) (45%) + upward adjustment based on average foreign price |
Primaquine (primaquine phosphate) | Sanofi | Tertian malaria and ovale malaria | 2,211.8 | Cost-calculation method | |
Malarone (atovaquone + proguanil HCl) | GlaxoSmithKline (UK) | Malaria | 161.5 | Inter-strength price adjustment | |
Nucala (mepolizumab, recombinant) | GlaxoSmithKline | Bronchial asthma (only in refractory patients whose asthma symptoms cannot be controlled with existing drugs) | 175,684 | Similar efficacy comparison method (I) | Upward adjustment based on average foreign price |
Kanuma (sebelipase alfa, recombinant) | Alexion (US) | Lysosomal acid lipase deficiency | 1,277,853 | Cost-calculation method | |
Xofigo (radium Ra 223 dichloride) | Bayer (Germany) | Castration-resistant prostate cancer with bone metastases | 684,930 | Cost-calculation method | |
Adynovate (rurioctocog alfa pegol, recombinant) | Baxalta (US) | Control of bleeding tendency in patients with blood coagulation factor VIII deficiency | 59,372 (500 IU/vial) / 110,104 (1000 IU/vial) / 204,184 (2000 IU/vial) | Similar efficacy comparison method (II) | |
Kovaltry (octocog beta, recombinant) | Bayer | Control of bleeding tendency in patients with blood coagulation factor VIII deficiency | 26,680 (250 IU/vial) / 49,477 (500 IU/vial) / 91,753 (1000 IU/vial) / 170,154 (2000 IU/vial) / 244,197 (3000 IU/vial) | Similar efficacy comparison method (II) | |
Mardoux (maxacalcitol + betamethasone butyrate propionate) | Chugai (Japan) | Psoriasis vulgaris | 231 | Special pricing rule for new ethical combination drug | |
* National Health Insurance ** Non-small cell lung cancer | |||||
Source: MHLW, Pharma Japan, 2016© 2016 IHS | |||||
Peak sales forecasts for the new drugs were also released. The treatments will be listed on Japan's National Health Insurance (NHI) list on 25 May.
Drug | Sponsor | Number patients treated | Sales forecast (JPY) | Years after launch |
|---|---|---|---|---|
Sabril (vigabatrin) | Sanofi | 140 | 230 mil. | 9 |
Fycompa (perampanel hydrate) | Eisai | 75,000 | 13.1 bil. | 5 |
Sycrest (asenapine maleate) | Meiji Seika Pharma | 310,000 | 38.5 bil. | 10 |
Imbruvica (ibrutinib) | Janssen | 470 | 4.4 bil. | 4 |
Zykadia (ceritinib) | Novartis | 530 | 1.6 bil. | 10 |
Tagrisso (osimertinib mesylate) | AstraZeneca | 2,400 | 13.5 bil. | 10 |
Tafinlar (dabrafenib mesylate) | Novartis | 80 | 500 mil. | 3 |
Mekinist (trametinib dimethyl sulfoxide) | Novartis | 70 | 510 mil. | 3 |
Primaquine (primaquine phosphate) | Sanofi | 33 | 2.04 mil. | 2 |
Malarone (atovaquone + proguanil HCl) | GlaxoSmithKline | 2 | 2,400 | 1 |
Nucala (mepolizumab, recombinant) | GlaxoSmithKline | 7,300 | 14.3 bil. | 9 |
Kanuma (sebelipase alfa, recombinant) | Alexion | 14 | 1 bil. | 10 |
Xofigo (radium Ra 223 dichloride) | Bayer | 3,000 | 9.4 bil. | 7 |
Adynovate (rurioctocog alfa pegol, recombinant) | Baxalta | 1,700 | 21.3 bil. | 4 |
Kovaltry (octocog beta, recombinant) | Bayer | 1,100 | 13.3 bil. | 3 |
Mardoux (maxacalcitol + betamethasone butyrate propionate) | Chugai | 93,000 | 3.6 bil. | 7 |
* National Health Insurance | ||||
Source: MHLW, Pharma Japan, 2016© 2016 IHS | ||||
Outlook and implications
The pricing premiums in particular are a significant positive for Novartis and Janssen's joint product Imbruvica, particularly given Japan's focus on reining in pharmaceutical prices amid the NHI fiscal year 2016 reform.
Novartis's Tafinlar and Mekinist combination treatment was assessed using the similar efficacy comparison method, and received the 45% pricing premium for usefulness as the combination demonstrated significantly extended overall survival compared with comparator Zelboraf (vemurafenib; Chugai). Chuikyo's approval closely follows that of the United Kingdom's National Institute for Health and Care Excellence (NICE) for the combination, as well as a positive decision by the health technology assessment (HTA) authorities in Germany (see United Kingdom: 2 May 2016: NICE recommends Tafinlar–Mekinist combination in BRAF-V600-positive melanoma).
Janssen's Imbruvica also received a 35% pricing premium for usefulness. This is a significant positive for the firm, and follows the US FDA's decision in March to approve Imbruvica as a first-line treatment for chronic lymphocytic leukaemia (CLL), as well as positive endorsement from the European Medicines Agency (EMA) for the drug earlier this month (see Europe: 3 May 2016: CHMP issues positive recommendation for six new drugs including MS drug Zinbryta). Chuikyo's decision consolidates the prevailing global tendency to reimburse the drug, in contrast with NICE's decision not to do so (see United Kingdom: 3 March 2016: Janssen expresses disappointment at NICE's draft recommendation not to provide funding for Imbruvica).