Japan's Ministry of Health, Labour and Welfare (MHLW) has announced the reimbursement of 19 treatments, including AbbVie (US)'s hepatitis C drug Viekirax (ombitasvir + paritaprevir + ritonavir).
IHS Life Sciences perspective | |
Implications | The National Health Insurance (NHI) price for Viekirax was set at JPY26,801.20 (USD218.25) per tablet, compared with an NHI price of JPY80,171.30 for Gilead Sciences (US)'s chronic hepatitis C (HCV) treatment Harvoni (ledipasvir + sofosbuvir) in April. |
Outlook | The NHI price of both Viekirax and Harvoni was based on the similar efficacy-comparison method, which has come into question after critics pointed out that Harvoni's price was higher than those for the two comparator drugs (which are not combined in clinical settings); similarly, Viekirax's pricing has also been called into question, with pricing policy changes on combination HCV drugs to be expected. |
Japan's Ministry of Health, Labour and Welfare (MHLW) has announced the reimbursement of 19 treatments, including AbbVie (US)'s hepatitis C drug Viekirax (ombitasvir + paritaprevir + ritonavir). See the Japanese-language announcement here.
Major drug approvals (MHLW) (November 2015) | ||||
Drug | Company | Therapeutic category | Price, JPY | Pricing method |
Zoloft (sertraline), 37.5mg / 75mg | Pfizer (US) | Post-traumatic stress disorder (PTSD) | 160.80 / 270.70 | Similar efficacy-comparison method (I) |
Tracleer (bosentan), 32mg | Actelion | Pulmonary arterial hypertension | 4,577.00 | Similar efficacy-comparison method (I) |
P-TOL (sucroferric oxyhydroxide) chewable tablets | Kissei Pharmaceutical (Japan) | Hyperphosphatemia | 214.20 / 314.30 | Similar efficacy-comparison method (I) |
Mulpleta (lusutrombopag), 3mg | Shionogi (Japan) | Thrombocytopenia associated with chronic liver disease in patients undergoing an elective invasive procedure | 16,107.60 | Similar efficacy-comparison method (I) |
Marizev (omarigliptin), 12.5mg, 25mg | MSD (US) | Type 2 diabetes | 559.20 / 1,045.10 | Similar efficacy-comparison method (II) |
EquMet (vildagliptin + metformin), LD, HD | Novartis (Switzerland) | Type 2 diabetes | 87.70 / JPY87.70 | Exceptions to new medical formulation |
Caprelsa (vandetanib), 100mg | AstraZeneca (UK) | Radical unresectable medullary thyroid cancer | 7,836.40 | Similar efficacy-comparison method (I) |
Sublingual allergy immunotherapy (SLIT-tablet), 3,300 / 10,000 JAU | Torii Pharmaceutical (Japan) | Dust mite sublingual tablets | 66.40 / JPY201.20 | Similar efficacy-comparison method (I) |
Viekirax (ombitasvir + paritaprevir + ritonavir) | AbbVie (US) | Hepatitis C (HCV) genotype 1 | 26,801.20 per tablet | Similar efficacy-comparison method (I) |
Keppra (levetiracetam), 500mg | UCB (Belgium) | Anti-epileptic | 1,978 | Similar efficacy-comparison method (I) |
Ryzodeg + Tresiba (insulin degludec/insulin aspart) | Novo Nordisk (Denmark) | Insulin-treated diabetes | 1,551 / JPY2,322 | Exceptions to new medical formulation |
Leuplin PRO (leuprorelin), 22.5mg | Takeda (Japan) | Hormonal agent | 105,039 | Standard between the adjustment |
Copaxone (glatiramer acetate), 20mg | Takeda (Japan) | Metabolism agents not classified elsewhere (relapse prevention for multiple sclerosis) | 5,617 | Similar efficacy-comparison method (I) |
Yondelis (trabectedin), 0.25mg / 1mg | Taiho Pharmaceutical (Japan) | Malignant soft-tissue tumours | 49,307 / 197,698 | Cost accounting system |
Radiopharmaceutical Oct Leo scan intravenous set | Fujifilm Pharma (Japan) | Neuroendocrine tumours | 115,464 | Cost accounting system |
Allergen scratch extract positive control solution "Torii" histamine dihydrochloride, 2ml | Japan Tobacco (Japan) | Histamine allergies | 7,996 | Similar efficacy-comparison method (I) |
Spiriva Respimat (tiotropium bromide) inhalation spray | Boehringer Ingelheim (Germany) | Chronic obstructive pulmonary disease (COPD) | 4,256.90 | Similar efficacy-comparison method (I) |
Zebiax lotion (ozenoxacin) 2%, 1g | Maruho (Japan) | Suppurative skin inflammation, including superficial skin infection and acne | 82.20 | Similar efficacy-comparison method (I) |
Transdermal anti-inflammatory analgesic patch formulation LOQOA tape (S-flurbiprofen) | Taisho Pharmaceutical (Japan) | Osteoarthritis | 45.90 | Listed drugs (special cases) |
Source: MHLW | ||||
Outlook and implications
It is worth noting that the National Health Insurance (NHI) price for AbbVie (US)'s hepatitis C treatment Viekirax (ombitasvir + paritaprevir + ritonavir) is JPY26,801.20 (USD218) per tablet. Based on a 12-week regimen of two tablets per day, the total cost per-treatment course is JPY4,502,601.60, according to IHS calculations. However, treatment regiments can vary depending on patient response, with the duration of the course sometimes lasting 24 weeks.
By comparison, the NHI price granted to Gilead Sciences (US)'s chronic hepatitis C (HCV) treatment Harvoni (ledipasvir + sofosbuvir) in April was JPY80,171.30 (see Japan: 27 August 2015: Japan grants reimbursement to Gilead's Harvoni, forecasts peak sales of USD988 mil.). As Harvoni's regimen is 12 weeks of treatment (for treatment-naïve patients with or without cirrhosis and treatment-experienced patients without cirrhosis; in both cases one tablet daily), each patient in Japan could require more than JPY6.7 million (USD56,000) of government funding, according to IHS calculations.
Both NHI prices were calculated using the similar efficacy-comparison method. However, the pricing of Harvoni was challenged last month, with critics pointing out that the drug received an NHI price higher than the total daily price of two comparator drugs – Daklinza (daclatasvir) and Sovaldi (sofosbuvir) – which are not combined in clinical practice (see Japan: 30 October 2015: Japan to alter rule on treatment cost for combination drugs following Harvoni debate). According to local media reports, Viekirax's NHI pricing has also been called into question, with pricing policy on combination HCV treatments expected – although the exact form the changes will take remains to be seen.