Japan Sales, Volume & Price Analysis - Evaluate · 2 Overview of Japan Sales, Volume, Price ......

Japan Sales, Volume & Price Analysis

Methodology Document & Case Studies

Version 1.1

©Copyright Evaluate Ltd, March 2015 1

1 Contents

2 Overview of Japan Sales, Volume, Price ................................................................................................................... 3

2.1 Overview of New Integrated Japan Datasets .................................................................................................... 4

3 Japan Datasets Structure .......................................................................................................................................... 5

4 Accessing Japan Sales, Volume & Price in EvaluatePharma® ................................................................................... 6

5 Japan Regulatory Approvals PMDA (Pharmaceutical and Medical Devices Agency) ............................................... 7

5.1 Overview of Japan Regulatory Approvals (PMDA) ............................................................................................ 8

5.2 Example of PMDA Record: Lipitor ..................................................................................................................... 9

5.3 Regulatory Approvals (PMDA) Fields .............................................................................................................. 10

6 Japan Drug Pricing: National Health Insurance Drug List........................................................................................ 14

6.1 Overview of National Health Insurance (NHI) Drug List ................................................................................. 14

6.2 Understanding the Japan 12 digit NHI Drug Code Identifier .......................................................................... 15

6.3 Case Study: Lipitor .......................................................................................................................................... 16

6.4 NHI International Price Comparison: Japan vs USA, Germany, UK & France ................................................ 18

Case Study: International Price Comparison on a Product (e.g. Avastin) ............................................... 18 6.4.1

6.5 Japan Price Revisions (Every 2 Years) ............................................................................................................. 19

7 Japan Pricing: Setting of NHI Price .......................................................................................................................... 20

7.1 Overview ......................................................................................................................................................... 20

7.2 NHI Price Reimbursement Fields .................................................................................................................... 21

7.3 Foreign Pricing Comparison Fields .................................................................................................................. 23

7.4 Pricing Methodology Fields ............................................................................................................................. 24

7.5 Price Premium Example: Novartis’s 0.5 mg Gilenya Capsules ....................................................................... 28

7.6 Cost Calculation Example: Ono Pharmaceutical’s 100mg Opdivo IV .............................................................. 29

8 Product Peak Sales Forecast at Launch (Cost per Patient per Year & Number of Patients Treated) ..................... 31

8.1 Overview ......................................................................................................................................................... 31

8.2 Case Study: Avastin Peak Sales Forecast at Launch ........................................................................................ 32


2 Overview of Japan Sales, Volume, Price

EvaluatePharma® is a leading provider of reported annual and quarterly Japan drug product sales. In response to client requests for insight into Japan drug pricing and the volume dynamic behind Japan drug sales, we have integrated into EvaluatePharma®, Japan regulatory approvals, unit drug pricing and peak sales forecasts at launch.

Highlights of Japan Sales, Volume and Price

• Single, Trusted Source for Disclosed Japan Sales, Pricing & Product Peak Sales Forecasts at Launch Japan & English Language; Translation of documents previously only available in Japanese

“No need to go to multiple sources, only provider to integrate reported sales with Japan unit drug pricing: Enhanced insight on Japan/ Time saving”

• Comprehensive Japan Unit Drug Pricing including Primary Care & Biotechnology Products Branded & Generics. Source: National Health Insurance (NHI) Drug Price List Analyze the Pricing Landscape from 2008 (by Therapy Area/ EphMRA/ Pharma Class…) Analyze Japan Price Revisions (occur 1st April every two years). Data present in Yen and US dollars.

“Immediate analysis of Japan unit drug price and two year price revisions over a 7 year horizon”

• Compare Japan Price with USA and International Prices Includes a price comparison of Japan price with major markets (USA, UK, France & Germany) at launch Top Japan products compared to USA price via link to NDC pack number

“Now there is a quick way to analyze the difference in USA price vs. major markets”

• Peak Sales Forecast at Launch; Including Cost per Patient Calculation & No. of Patients Treated Includes all products launched in Japan since December 2004

“No longer need to manually calculate a cost per patient per year” “Insight into company peak sales expectations at launch”

• Analyze the Pricing Adjustments/ Premiums Achieved in Japan Reveals the methodology used by Drug Pricing Organisation (DPO) to set the National Health Insurance (NHI) reimbursement price.

“Now there is an easy way to reveal which products are achieving price premiums in Japan”

• All Regulatory Approvals from PMDA (Pharmaceutical and Medical Devices Agency)


2.1 Overview of New Integrated Japan Datasets

EvaluatePharma® has integrated and standardised 5 disparate data sources for the first time, to simplify Japan product sales, approval and pricing analysis.

List of New Datasets & Insight

Dataset Overview Insight Japan Regulatory Approvals PMDA (Pharmaceutical and Medical Devices Agency)

All products approved in Japan. NHI Pricing and PMDA Approvals datasets have been fully integrated.

The Japan version of Drugs@FDA

Official PMDA Product Approval Lists

Official PDF lists of new approved products in Japan.

Detailed list of all annual approvals and changes and commentary on the detail of the approval or change.

Japan Drug Prices NHI Dataset detailing the reimbursement price of all Japanese approved drugs. 2008+; Published 4 times a year

Reveals all Japan unit prices and revisions since 2008.

Japan Drug Reimbursement Model

NHI Dataset detailing the methodology used to calculate the initial reimbursement price. DEC 2004+

Reveals any pricing premium achieved in Japan. Reveals an international comparison (JP/ USA/ Fr/ Ger/ UK) pricing analysis for the drug at the time of reimbursement.

Japan Product Forecast

A peak sales, cost per patient and number of patients treated forecast made at the time of reimbursement. DEC 2004+

Reveals a company’s expectation of Japan sales, cost per patient per year and the number of patients treated.

Current Dataset

Dataset Overview Insight Annual & Quarterly Disclosed Japan sales

EvaluatePharma® includes company reported Japan drug sales (>500 products covering >$51bn in sales). Released in company financial results / presentations. Coverage is fairly comprehensive within the Top 100 drugs in Japan, with Pfizer being the only major company not to disclose sales. Annual sales for Japan based companies represent sales to the fiscal year end 31 March.

Analyze the sales performance of companies and therapy areas in Japan. Analysis can be presented in Yen or US dollars.


3 Japan Datasets Structure

Product Peak Sales Forecast ~1,000

(1st NHI Drug Code)

Drug Prices 16,000+

(NHI Drug Code)

Approved Drugs (PMDA) (19,000+)

(NHI Drug Code)

Mapped to: - EvaluatePharma® Generic Name - EvaluatePharma® Product Name

Mapped to: - EvaluatePharma® Generic Name (mapped based on first 7 digits of NHI code)

Manufacturers/ Distributors

Mapped to: - EvaluatePharma® Company

New Launch Price Reimbursement 1,000+

(NHI Drug Code)

Mapped to: EvaluatePharma® Products ID

Mapped to: EvaluatePharma® Products ID

Ministry of Health, Labour and Welfare (MHLW)

Pharmaceutical and Medical Devices Agency (PMDA) Regulatory


4 Accessing Japan Sales, Volume & Price in EvaluatePharma® Japan Sales, Volume & Price information can be accessed via EvaluatePharma®’s subscriber site front page & via the searchable summary pages (e.g. Product, Therapy Area, EphMRA, Indication, Pharmacological Class and Company). Access via EvaluatePharma® front page:

Within the Country page for Japan new analyses have been set-up:


Access via EvaluatePharma® Summary Pages: E.g. Use SmartSearch to search for the product “Avastin”:

Within Summary pages all new Japan sales, volume, price information & analysis is available within the “Japan (SVP)” tab:

5 Japan Regulatory Approvals PMDA (Pharmaceutical and Medical Devices Agency)


5.1 Overview of Japan Regulatory Approvals (PMDA) Each product approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese equivalent to Drugs@FDA, receives a unique 13-digit identifier. Once approved a company can seek listing to the National Health Insurance (NHI) drug list to facilitate reimbursement. Overview of module

The PMDA approvals dataset details the products characteristics e.g. Therapeutic category, chemical name/ formula, molecular weight. In addition the manufacturer and distributing companies are also listed.

PMDA Drug Approval Number ~17,000

NHI Drug Code (NDC – 12 digit)

16,000+

Manufacturers/ Distributors


5.2 Example of PMDA Record: Lipitor

Lipitor 5mg was PMDA approved in May 2000 under the application number 21200AMZ00158.


5.3 Regulatory Approvals (PMDA) Fields

Fields Description Package Number

This is a unique number displayed on the PMDA website. (http://www.info.pmda.go.jp/psearch/html/menu_tenpu_kensaku.html). The Package Insert Number consists of the NHI code (the NHI code for the earliest product is used for all versions of the same product) and a major and minor (2 digit) release version each separated by underscores. The highest major and minor numbers denote the most recent release of the package, based on the values of launch extracted. E.g. Meloxicam has the following Package Insert Number for the earliest version launched in July 2008: 1149035F1063_1_04 and the following Package Insert Number for the latest version launched in March 2012: 1149035F1063_3_01.

Drug Index This is used in combination with the package number to create a unique identifier (EVP field)

NHI Drug Code

This is the 12-digit code assigned to a product at price approval by the Japanese Ministry of Health Labour and Welfare. It includes information on the ingredients, formulation and brand, for example the NHI Drug Code for Lipitor is 2189015F1023.

Brand Name ( 販売名)

This is the brand name of the product in Japan in Japanese. Eg: The Japanese brand name for Lipitor: リピトール錠5mg.

Brand Name (Japan)

This is the brand name of the product in Japan stated in English from the PMDA website. Eg: The brand name for Lipitor is: Lipitor Tablets 5mg


Approval Number (承認番号)

The PMDA approval number indicates that the drug has received approval in Japan. This number shows additional information such as, the year of approval, the place of approval and the classification of drug.

E.g. BLOPRESS Tablets 2 = 21100AMZ00262 or 2 11 00 AMZ 00262

Digits 2 11 00 AM Z 00262 Section 1 2 3 4 5 6

Code Name Raw Format Description 1 Number used to show if the

drug is from Showa era or Heisei era.

1 Digit (2) The approval number can only ever start with the digits 1 or 2. Number 1 represents 昭和, which means the drug was from the Showa era (which starts from 25 Dec 1926 to 7 Jan 1989). Number 2 represents 平成, which means the drug was from the Heisei era (which starts from 7 Jan 1989 to the current date).

2 Year of approval 2 Digits (11) The two digits represent the year of approval, for e.g. Blopress 2 is from the 11th year of the Heisei era starting from 7 Jan 1989 onwards to the current date. Therefore the year of approval will be 2000 (1989+11).

3 Place of approval 2 Digits (00) The combinations of 2 letters represent places of approval, for e.g.: -00 means Minister of Health and Welfare approval -01 means Hokkaido -13 means Tokyo

4 Classification of drug 2 Letters (AM) The combinations of 2 letters represent different places of approval, for e.g.: - AM: Ethical pharmaceuticals - AP: OTC drugs - BZ: Medical devices - DZ: Quasi-drugs - CZ: Cosmetics

5 Number used to show if the drug is for Import or Production

1 Digit (Z) This section of the approval number will either have the letter Y or Z. Y means the drug has received approval for import and Z means that the product has received approval for production.

6 Represents the sequence number of the year

Up to 5 Digits (00262)

For e.g.; Blopress tablets 2 will be referred to as the 262nd medical drug of 2000 to have received manufacturing approval.


NHI Listing Date (薬価基

準収載年月)

This is the date the drug was listed in the NHI reimbursement price list.

Launch Date (販売開始年

月)

This is the date the product was launched in Japan.

Additives (添加物)

This gives data about the excipients (ie; ingredients which make up the formulation apart from the active ingredient) in Japanese.

Eg: The additives for Lipitor given by the PMDA website is ‘Lactose hydrate, crystalline cellulose, precipitated calcium carbonate, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, magnesium stearate, hypromellose, macrogol, titanium oxide, talc, iron sesquioxide’ (乳糖水和物

、結晶セルロース、沈降炭酸カルシウム、クロスカルメロースナトリウム、ポリソルベー

ト80、ヒドロキシプロピルセルロース、ステアリン酸マグネシウム、ヒプロメロース、マ

クロゴール、酸化チタン、タルク、三二酸化鉄)

R&D Code (識別コード)

This is a unique code, which is used as a reference for the composition and properties of the drug.

Eg: The R&D code for Crestor 2.5mg is ZD4522:2 ½ and the R&D code for Crestor 5mg is ZD4522 5. Company Code (製薬

会社識別コ

ード)

This is a unique code for each manufacturer; therefore two different drugs can share the same pharmaceutical company identification code

Eg: The company code for both Epipen and Enbrel is 671450 because the manufacturer of both these drugs is Pfizer.

JSCC Number The Japan Standard Commodity Classification number (JSCC), which is composed of 5 or 6 digits, is given to drugs by the Ministry of Internal Affairs and communications. Ethical and Proprietary drugs are given JSCC cumbers which start with the digits ‘87’. The third digit in the JSCC number relates to the therapeutic category.

Eg: Xalkori has a JSCC number starting with 874 which means it affects cellular function.

1st WW Launch Date

This is the date of the first launch of a product anywhere in the world.

Therapeutic Category (薬効分類名)

This is a classification from PMDA according to the therapeutic activity.

Eg: Cymbalta is classified as a Serotonin-noradrenaline reuptake inhibitor (セロトニン・ノルアド

レナリン再取り込み阻害剤).

Generic Name (基準

名)

This details the generic name by which the product is known in Japan in Japanese.

Eg: The generic name for Cymbalta is Duloxetine Hydrochloride Capsules (デュロキセチン塩酸塩

カプセル)


Chemical Name (化学

名)

This details the chemical name by which the product is known.

Eg: The chemical name for Cymbalta is (+)-(S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine monohydrochloride.

Chemical Formulae (分子式)

This is the chemical formulae for the product.

Eg: The chemical formulae for Lipitor is: C66H68CaF2N4O10・3H2O

Molecular Weight (分子量)

This is the molecular weight for the product.

Eg: The molecular weight for Lipitor is 1209.39.

Generic Status (Japan)

This classifies the drugs as either branded or generic (EVP field).

• The initial approach used to classify a drug is by using the data from the PMDA site, if the brand names include the manufacturer name then the drug is classified as a generic, for example, the brand name for Zithromax/Sumamed is Azithromycin Tab.250mg"TEVA", which means it’s a generic product.

• If the brand name doesn’t include the manufacturer name then the Japan drug pricing data is used to determine whether the product is generic or branded. If the raw data provided by the MHLW identifies the product as generic then it is classified as a generic drug, otherwise it’s classified as a branded drug.

Japan Unit Drug Price (¥)

This is the quarterly reimbursed price in Japanese yen for the product at the specified dosage. Eg: The Q2 2014 Japan unit drug price (¥) for Lipitor Tablets 5mg is ¥57.

Japan Unit Drug Price ($)

This is the quarterly reimbursed price in US dollars for the product at the specified dosage. Eg: The Q2 2014 Japan unit drug price ($) for Lipitor Tablets 5mg is $0.55.

Drug Code (Japan)

This is a 9-digit unique code for every dosage of a product. Eg: 610443013 is the drug code for Lipitor Tablets 5mg and 610443014 is the drug code for Lipitor Tablets 10mg.


6 Japan Drug Pricing: National Health Insurance Drug List

6.1 Overview of National Health Insurance (NHI) Drug List All products approved in Japan need to be added to the National Health Insurance (NHI) drug price list. The price gives the reimbursement price to hospitals, pharmacies and clinics.

Each product in the National Health Insurance (NHI) drug list receives a unique 12-digit identifier.

EvaluatePharma® has integrated the National Health Insurance (NHI) drug list so it is linked to the PMDA Approvals List and the EvaluatePharma® products database. The PMDA dataset is required in order to provide a linkage to the company’s manufacturing and distributing. As of Feb 2015 EvaluatePharma®’s NHI drug list contained 16,000+ drug prices, this includes quarterly pricing from 1998. The drug price list is published four times a year.

E.g. Lipitor (Astellas/ Pfizer)

Lipitor was PMDA approved under the application number 21200AMZ00158 (5mg) and 21200AMZ00159 (10mg). On listing to the NHI drug price list Lipitor was given the NHI drug list codes 2189015F1023 and 2189015F2020.

Approval Number (PMDA) ~17,000

NHI Drug Code (NDC – 12 digit)

16,000+

Approval Number (PMDA) NHI Drug Code


6.2 Understanding the Japan 12 digit NHI Drug Code Identifier

E.g. Lipitor 5mg = 2189015F1023 or 2189 015 F 1 02 3

Digits 2189 015 F 1 02 3 Section 1 2 3 4 5 6

Code Name Raw Format Description 1 Japan Standard Commodity

Classification Therapy Classification

4 Digits A two level Japanese therapy classification system. E.g. Lipitor (2189) 218=Hyperlipidemia agents 2189=Hyperlipidemia agents/ Others http://www.genome.jp/kegg-bin/get_htext

2 Ingredient number 3 Digits Oral Medicines: 001-399 Injection drug: 400-699 Topical drug: 700-999

3 Formulation 1 Alphameric Oral Medicines A-E Powders F-L Tablets M-P Capsules Q-S Liquids T –X Other

4 Standard unit number assigned to the classification in section 1-3

1 Digit

5 Number used to differentiate brands with the same classification

2 Digits

6 A number assigned to search for typing input errors

1 Digit

Generic Lipitor (Towa Pharmaceutical 5mg atorvastatin) 2189 015 F 1 07 4

Generic - Towa 2189 015 F 1 07 4 Branded 2189 015 F 1 02 3

Generic Name (first 9 digits) The NHI Code can be used to isolate products with common generic names. This is defined in the first nine digits.

E.g. Atorvastatin Calcium is “2189015F1” Generic Name / Dose / Admin (first 10 digits) The dosage admin is defined by the first 10 digits. Although when more than 10 generics are approved a new price and code is created for the next batch of generics.


http://www.genome.jp/kegg-bin/get_htext

http://www.genome.jp/kegg-bin/get_htext

6.3 Case Study: Lipitor EvaluatePharma® via analysis of the Japan NHI drug price list can analyze Lipitor quarterly drug prices in Japan. Analysis is available in both Yen and US Dollars.

Latest Drug Prices

Lipitor Price Revisions


Unit Level Pricing in Yen and US Dollars


6.4 NHI International Price Comparison: Japan vs USA, Germany, UK & France

Case Study: International Price Comparison on a Product (e.g. Avastin) 6.4.1Avastin was added to the NHI Drug Price List in June 2007. At the time Chugai provided the regulator an analysis of the foreign prices of Avastin. EvaluatePharma® has presented the data in US dollars and expressed them in terms of the USA market being a 100 base.

The price Avastin (100mg/ 4ml) in Japan ($409) in June 2007 was 40% below the USA price listed ($687).

Germany is 15% below USA price. UK is 30% below USA Price.


6.5 Japan Price Revisions (Every 2 Years)

The drug prices listed in the NHI Price List are updated every 2 years (effective from 1st April) and are revised based on actual drug prices achieved (net of discounts) based on a drug price survey.

Detail of the Japan Price Revision: http://www.jpma.or.jp/english/parj/pdf/2013_appendix.pdf

E.g. Lipitor Price Revision The unit drug price for Lipitor 5 & 10 mg has been reduced in each of the last 4 Japan price revisions. In Q2 2008 the price was reduced by 5%, in Q2 2010 by 7%, in Q2 2012 by 11% and in Q2 2014 by 5%.


http://www.jpma.or.jp/english/parj/pdf/2013_appendix.pdf

7 Japan Pricing: Setting of NHI Price

7.1 Overview EvaluatePharma® has processed the MHLW Japanese language documents which detail how the Japan reimbursement price was set.

This content includes what premium(s) a product is/are being given, e.g. Pediatric, Usefulness, Marketability premiums. It also includes foreign pricing comparisons at time of launch, limited to US, Germany, UK and France. It includes product sales forecasts supplied by the company: launch year sales, peak sales, number of patients and cost per patient per year. EvaluatePharma® links to the original Japanese language pricing source documents and price reimbursement approval documents. Content covers approximately 1,200 products since Nov 2004 currently.

For some reformulation and line extensions we derive data from the Japan Pharmaceutical Association (http://www.nichiyaku.or.jp/e/default.html).

Some key benefits

• Analyze what products are achieving price premiums • Can see which drugs have been given a premium so can benchmark and see what to expect for a similar

product • At the time the drug is given pricing, you can see products used for comparator pricing • Can also compare to US SVP and get current US price • Companies gaining product approvals in Japan have to provide peak sales and launch year sales forecasts

and number of patients in Japan – again can compare against peer drugs to get an idea of similar drug’s potential in Japan

• If you launch a new drug for the first time in Japan the MHLW bases the price on estimated cost and then give an adjustment. You can predict how much you can price a drug in Japan.

• We provide real-time information versus static reports

New Launch Price Reimbursement 1,200+

(NHI Drug Code)


7.2 NHI Price Reimbursement Fields

Fields Description NHI Drug Code This is the 12-digit code assigned to a product at price approval by the Japanese Ministry

of Health Labour and Welfare. It includes information on the ingredients, formulation and brand. E.g. Novartis’s 0.5mg Gilenya Capsules was assigned an NHI Drug Code of 3999029M1037.

Brand Name (Japan) - Each Formulation

This is the brand name for the product in Japan along with the strength and formulation information. E.g. Gilenya Capsule 0.5mg

Formulation (Japan) This is information relating to the strength and formulation of the product. E.g. Novartis’s Gilenya is a 0.5mg Capsule

Company Name (Japan)

This is the name of the company receiving price approval.

Approval Classification (Japan)

This is the classification assigned to the product by the Japanese Ministry of Health Labour and Welfare. It can have more than on classification type assigned to it. The different types of classification are:

New Active Ingredient New Combination Drug New Dosage New Efficacy New Formulation New Route of Administration Additional formulation Additional Strength Similar Combination Drug Biosimilar Brand name changed related to (New formulation) Patch Test Drug Others

E.g. Novartis’s 0.5mg Gilenya Capsules is a New Active Ingredient approval type. NHI Price (Japan) (¥) at Reimbursement Date

This is the reimbursed price in Yen, at the initial reimbursement date, for the product at the specified dosage. E.g. The NHI priced Novartis’s 0.5mg Gilenya Capsules at ¥8172 at the initial reimbursement date of 25 Nov 2011.

Therapeutic Category (Japan)

This is the therapeutic category as detailed in the Japanese NHI drug price list. E.g. The therapeutic category as detailed in the Japanese NHI price list for Novartis’s 0.5mg Gilenya Capsules is MS therapies.

NHI Price Reimbursement Date

This is the date at which the drug was given its reimbursement price in Japan. E.g. Novartis’s 0.5mg Gilenya Capsules was given its reimbursement price in Japan on 25 Nov 2011.

Approval Date (Japan) This is the date at which the drug was approved in Japan. E.g. Novartis’s 0.5mg Gilenya Capsules was approved in Japan on 26 Sep 2011


Filing Date (Japan) This is the date at which the drug was filed in Japan. E.g. Novartis’s 0.5mg Gilenya Capsules was filed in Japan on 20 Dec 2010

NHI Price (Japan) (¥) - Latest

This is the latest reimbursed price in Yen, for the product at the specified dosage.

Japanese Price Change Since Reimbursement

This is the percentage change in price between the reimbursement date and the latest price.

Date of Latest Japanese Price

This is the latest date at which the price of the product was given.

Reimbursed Price per Mg at Reimbursement Date (¥)

This is the reimbursed price (¥) per mg at the date of reimbursement in Japan. It is calculated as:

Reimbursed price (¥)

No. of mgs in unit (e.g Tablet)

e.g. Novartis’s 0.5mg Gilenya Capsules The NHI priced Novartis’s 0.5mg Gilenya Capsules at ¥8172 at the initial reimbursement date of 25 Nov 2011. Reimbursed price (¥) per mg = 8172/0.5 = 16344

Reimbursed Price per Mg at Reimbursement Date ($)

This is the reimbursed price ($) per mg at the date of reimbursement in Japan. It is calculated as:

Reimbursed price (¥)/exchange rate at reimbursement date No. of mgs in unit (e.g Tablet)

e.g. Novartis’s 0.5mg Gilenya Capsules The NHI priced Novartis’s 0.5mg Gilenya Capsules at ¥8172 at the initial reimbursement date of 25 Nov 2011. Reimbursed price (¥) per mg = (8172/77.55)/0.5 = 210.77 Exchange rate in November 2011: 77.55

Package NDC (11 Digit)

The Package NDC (11 Digit) a universal product identifier for human drugs. It is an 11-digit code given to each marketed product. It combines the 3 segments of the Package Code (NDC) by removing the hyphens. Labeller code: 4 or 5 digits assigned by the FDA to the firm. E.g. ASTRAZENECA PHARMACEUTICALS LP is assigned 0310 Product code: 3 or 4 digits assigned by the firm. E.g. 0751 Package code: 1 or 2 digits. This distinguishes between the different packages of the same product.

Approval Time (Japan) Months

This is number of months it took to approve the product from the filing date. E.g. Novartis’s 0.5mg Gilenya Capsules was filed on 10 Dec 2010, and approved on 26 Sep 2011. It took 9.2 months for an approval decision to be reached.

Reimbursement Time (Japan) Months

This is the number of months it took for the NHI to give a reimbursement price for the product, from the approval date. E.g. Novartis’s 0.5mg Gilenya Capsules was approved on 26 Sep 2011, and a reimbursement price was given on 25 Nov 2011. It took 2.0 months to determine the reimbursement price.

Link to Approval Document

This link takes you to the approval document for the drug.


Link to NHI Price List Document

This link takes you to the NHI Price List document for the drug. Includes: Reference drug Foreign comparator prices Pricing method Price at reimbursement Sales forecasts in launch and peak year Number of patients treated

7.3 Foreign Pricing Comparison Fields

Fields Description Foreign Comparator Pricing Available

Indicates the presence of foreign comparator pricing used in the NHI Price calculations.

USA Comparator Available

Indicates the presence of USA Comparator pricing used in the NHI Price calculations.

Comparator Price USA ($)

As a comparison, this is the reimbursed price of the same drug in the USA in US dollars, at the date of reimbursement in Japan.

Comparator Price UK (£)

As a comparison, this is the reimbursed price of the same drug in the UK in UK pounds, at the date of reimbursement in Japan.

Comparator Price Germany (€)

As a comparison, this is the reimbursed price of the same drug in Germany in Euros, at the date of reimbursement in Japan.

Comparator Price France (€)

As a comparison, this is the reimbursed price of the same drug in France in Euros, at the date of reimbursement in Japan.

Exchange Rate ($1=¥) The monthly exchange rate between US dollars and Japanese Yen at the reimbursement date.

Exchange Rate (£1=$) The monthly exchange rate between UK pounds and US dollars at the reimbursement date.

Exchange Rate (€1=$) The monthly exchange rate between Euros and US dollars at the reimbursement date. NHI Price (Japan) ($) This is the reimbursement price in US dollars for the product at the specified dosage. Comparator Price UK ($)

As a comparison, this is the reimbursed price of the same drug in the UK in US dollars at the reimbursement date.

Comparator Price Germany ($)

As a comparison, this is the reimbursed price of the same drug in Germany in US dollars at the reimbursement date.

Comparator Price France ($)

As a comparison, this is the reimbursed price of the same drug in France in US dollars at the reimbursement date.

Price USA (USA=100) As a direct comparison to the USA price, the USA price is rebased where the USA price equals 100.

Price Japan (USA=100) As a direct comparison to the USA price, the Japan price is rebased where the USA price equals 100.

Price UK (USA=100) As a direct comparison to the USA price, the UK price is rebased where the USA price equals 100.

Price Germany (USA=100)

As a direct comparison to the USA price, the Germany price is rebased where the USA price equals 100.

Price France (USA=100)

As a direct comparison to the USA price, the France price is rebased where the USA price equals 100.

Price Japan (NHI) (¥) This is the reimbursed price in Yen, at the initial reimbursement date, for the product at the specified dosage. E.g. The NHI priced Novartis’s 0.5mg Gilenya Capsules at ¥8172 at the initial reimbursement date of 25 Nov 2011.


Price Japan (NHI) ($) This is the reimbursed price in US dollars, at the initial reimbursement date, for the product at the specified dosage. E.g. The NHI priced Novartis’s 0.5mg Gilenya Capsules at $105.38 (¥8172) at the initial reimbursement date of 25 Nov 2011.

Price USA ($) This is the reimbursed price of the same drug in the USA in US dollars, at the date of reimbursement in Japan, for the product at the specified dosage.

Price UK (£) This is the reimbursed price of the same drug in the UK in UK pounds, at the date of reimbursement in Japan, for the product at the specified dosage.

Price UK ($) This is the reimbursed price of the same drug in the UK in US dollars at the reimbursement date, for the product at the specified dosage.

Price Germany (€) This is the reimbursed price of the same drug in Germany in Euros, at the date of reimbursement in Japan, for the product at the specified dosage.

Price Germany ($) This is the reimbursed price of the same drug in Germany in US dollars at the reimbursement date, for the product at the specified dosage.

Price France (€) This is the reimbursed price of the same drug in France in Euros, at the date of reimbursement in Japan, for the product at the specified dosage.

Price France ($) This is the reimbursed price of the same drug in France in US dollars at the reimbursement date, for the product at the specified dosage.

7.4 Pricing Methodology Fields

Fields Description Pricing Method

This details the NHI pricing method for new drugs. The different types of pricing methods are: Cost Calculation Method This pricing method is used when no comparator drug is available for comparison. Similar efficacy comparison method (I) This pricing method is used when a comparator drug is available for comparison, and the new product is eligible for premiums. Similar efficacy comparison method (II) This pricing method is used when a comparator drug is available but the new drug is not novel enough for premiums. E.g. The price of Novartis’s 0.5mg Gilenya capsule was determined using the Similar efficacy comparison method (I).


Adjustment: Price Premium

For products whose price has been determined using the similar efficacy comparison (I) method, this item details information relating to any price premiums that may be given. One product may have more than one premium. The different types of price premiums are:

Premium for Innovativeness A premium of 70-120% on the price of the comparator drug is given if all of the below requirements are met: - the drug has a new clinically useful mechanism of action - there is evidence of greater efficacy and safety - the drug improves treatment of indicated diseases and injuries Premium for Usefulness (I) A premium of 35-60% on the price of the comparator drug is given if 2 out of the 3 requirements for the premium for innovativeness are met. Premium for Usefulness (II) A premium of 5-30% on the price of the comparator drug is given if all of the below requirements are met: - the drug has a new clinically useful mechanism of action - there is evidence of greater efficacy and safety - the drug improves therapy of indicated diseases and injuries - the drug offers greater therapeutic usefulness as a result of formulation improvement Premium for Marketability (I) A premium of 10-20% on the price of the comparator drug is given if both of the below requirements are met: - the drug is an orphan drug as defined in the PAL (Pharmaceutical Affairs Law), with the orphan indication being its main indication - the comparator drug has not been given marketability premium (I) Premium for Marketability (II) A premium of 5% on the price of the comparator drug is given if both of the below requirements are met: - the main indications of the drug correspond to separately specified indications for drugs with small markets - the comparator drug has not been given marketability premium (I) or (II) Premium for Paediatric Use This will only apply for drugs which have been studied in Japanese children. A premium of 5-20% on the price of the comparator drug is given if both of the below requirements are met: - the main indications or dosages of the drug are indicated for children (including all infants from birth) - the comparator drug has not been given paediatric use premium If the drug also meets the requirement for the premium for marketability (II), only the premium for paediatric use will be given. Premium for Kit A premium of 5% to the costs of kit parts is given if one of the below requirements are met: - capable of reduction in risk of infections - capable of reduction in dispensing errors - capable of treatment in an emergency setting - capable of improving quality of care Premium for First in Class Drugs A premium of 10% on the price of the comparator drug where Japan represents the first worldwide regulatory approval.

E.g. Novartis’s 0.5mg Gilenya capsule was given a premium for usefulness (I) and a premium for marketability(I) ©Copyright Evaluate Ltd, March 2015 25

Adjustment: Price Premium (%)

For products whose price has been determined using the similar efficacy comparison (I) method, this is the sum of all percentage premiums given to the product. E.g. Novartis’s 0.5mg Gilenya capsule was given a 40% premium for usefulness (I) and 10% marketability (I).

Standard average operating profit rate (%)

For products whose price has been determined using the cost calculation method, this is the average operating profit rate for major manufacturers. This rate is derived from the average taken over the previous 3 years, sourced from the Handbook of Industrial Financial Data (Development Bank of Japan). E.g. At the time of reimbursement, Opdivo did not have a comparator drug available. The price of Opdivo IV 20 mg has been determined using the cost calculation method. The average operating profit rate at reimbursement was 16.9%.

Adjustment: Novelty, Efficacy and Safety (%)

For products whose price has been determined using the cost calculation method, this is the adjustment added to the standard average operating profit rate. The adjustments can be from -50% to +100% depending on innovativeness, efficacy and safety. E.g. An adjustment for novelty, efficacy or safety was made for Opdivo at the time of reimbursement, for 160%.

Final Operating Profit rate (%)

For products whose price has been determined using the cost calculation method, this is the standard average operating profit rate plus the adjustment related to innovativeness, efficacy and safety. E.g. The final operating profit rate of Opdivo IV 20 mg is determined by the standard operating rate of 16.9% and the adjustment related to novelty, efficacy or safety of 160%: 16.9% x 160% = 27%

Adjustment: Foreign Price

For products which are already marketed in markets other than Japan, the price may be adjusted up or down compared to the foreign prices. A maximum 2-fold price increase is allowed. For products whose price has been determined using either of the similar efficacy comparison methods or cost calculation method, if after premiums have been given (for the similar efficacy comparison (I) method), the calculated price is 1.25 times higher than the average foreign price (mean of US, UK, German and French prices), the calculated price is then reduced: ┌ ┐ ⅓ x calculated price + 1 x Average foreign price Average foreign price └ ┘ For products whose price has been determined using the similar efficacy comparison (I) method or cost calculation method, if after premiums have been given (for the similar efficacy comparison (I) method), the calculated price is 0.75 times lower than the average foreign price, the calculated price is then increased: ┌ ┐ ⅓ x calculated price + 0.5 x Average foreign price Average foreign price └ ┘ For products whose price has been determined using the similar efficacy comparison (II) method, price increases are not permitted. E.g. An upward adjustment was made to Xtandi based on average foreign prices.


Adjustment: Specification

For products whose price has been determined using either of the similar efficacy comparison methods, this details any strength or dose-based price adjustments given. E.g. AstraZeneca’s Crestor 5 mg Tablets was given a specification adjustment.

Adjustment: Specification (%)

For products whose price has been determined using either of the similar efficacy comparison methods, this details the percentage strength or dosed based price adjustments.

E.g. AstraZeneca’s Crestor 5 mg Tablets was given a specification adjustment of 94.02%.

Pricing comment

This item is a summary of relevant pricing information related to the product. It includes any premiums (with percentages where available), adjustments from Standard Operating Profit Rate or adjustments from average foreign pricing. E.g. The price of Astellas’s 40mg Xtandi Capsules was determined using an adjustment of 110% to the Standard Operating Profit Rate as well as an upward adjustment based on average foreign price.


7.5 Price Premium Example: Novartis’s 0.5 mg Gilenya Capsules

Novartis’s 0.5 mg Gilenya Capsules Approved: 26th Sep 2011 Listed on NHI drug list: 25th Nov 2011 Pricing Method: Similar efficacy comparison method (I)

Comparator Product

Name Avonex (Biogen Idec), 30µg/0.5mL syringe

Dosing Regimen Weekly

Price ¥39,096 (per syringe)

Equivalent daily cost ¥5,448

0.5 mg Gilenya Capsules are taken daily. The cost will therefore be determined from the equivalent daily cost of Avonex.

Product seeking pricing

Name 0.5 mg Gilenya Capsules

Equivalent daily cost of comparator product

¥5,448

Premiums and reason Premium for usefulness (I): 40%

• Novel mechanism of action of suppression invasion of central nervous tissue shown to reduce recurrence rate

• Improved treatment of disease due to reduced burden on the patient as formulation is changed from syringe to capsule

Premium for Marketability (I): 10% Product is an orphan drug, and comparator drugs were not given a premium for marketability (I).

Total premium: 50%

Price Calculation 5,448 x 1.5 = 8,172


7.6 Cost Calculation Example: Ono Pharmaceutical’s 100mg Opdivo IV

Ono Pharmaceutical’s 100mg Opdivo IV: No similar drug

Product seeking pricing

Name 100mg Opdivo IV

Total Production cost ¥459,778

Operating Income The operating income is calculated as a percentage of the total price of the product excluding distribution costs and consumption tax. The operating income rate is determined based on the average of the previous 3 years as detailed in the Handbook of Industrial Financial Data (Development Bank of Japan). This standard rate can then be adjusted depending on novelty, efficacy and safety compared to existing drugs

At the time of reimbursement (2 Sep 2014), the standard operating income rate used was 16.9%. Opdivo was awarded a premium of 60% above the standard rate due to its clinical significance in the treatment of unresectable malignant melanoma, bringing the total operating income rate to 27%:

16.9% x 160% = 27% Total Price: ¥729,849 Distribution costs: ¥45,953 Consumption tax: ¥54,063

729,849-45,953-54,063 = 629,833 629,833 x 0.27 = 170,055

Therefore, the operating costs is: ¥170,055

Distribution Cost The distribution cost is calculated as a percentage of the total price of the product excluding consumption tax. The rate is determined based on the Survey of the Prescription Pharmaceutical Industry of Japan conducted by the MHLW’s Health Policy Bureau, and is a mean value over the last 3 years. (NB prior to 2012, one-year averages were used).

At the time of reimbursement (2 Sep 2014), the distribution rate used was 6.8% of the total price of the product excluding consumption tax.

Total Price: ¥729,849 Consumption tax: ¥54,063

729,849-54,063 = 675,786 675,786 x 0.068 = 45,953

Therefore, the distribution cost is: ¥45,953

Consumption Tax ¥54,063


Total Price Total Production Cost + Operating Income + Distribution Costs + Consumption Tax

459,778 + 170,055 + 45,953 + 54,063 = ¥729,849

To calculate the total price from the total production cost:

Total Price (T) Total Production Cost (P)

Operating Income (O)

Distribution Costs (D)

Consumption Tax (C)

O = (T - D - C)RO

= TRO - DRO - CRO

= TRO - (TRd - CRd)RO -CRO

= TRO – TRdRO + CRdRO - CRO

D = (T - C)Rd

= TRd - CRd

T = P + TRO - T RdRO + CRdRO - CRO + TRd - CRd + C

T = P + T(RO – RdRO + Rd) + C(RdRO - RO - Rd + 1)

T - T(RO - RdRO + Rd) = P + C(RdRO - RO - Rd + 1)

T(1 - RO + RdRO - Rd) = P + C(RdRO - RO - Rd + 1)

T = P + C(RdRO - RO - Rd + 1)

1 - RO + RdRO - Rd

RO = Operating Income Rate

Rd = Standard Distribution Rate

Total Price = P + C

(1 - RO + RdRO - Rd)


8 Product Peak Sales Forecast at Launch (Cost per Patient per Year & Number of Patients Treated)

8.1 Overview Companies are required to submit forecast of product sales in the Japanese market.

It includes product sales forecasts supplied by the company: launch year sales, peak sales, number of patients and cost per patient per year. EvaluatePharma® links to the original Japanese language pricing source documents and price reimbursement approval documents. Content covers approximately 1,200 products since Nov 2004 currently.

Overview of New Product Launches (last 12 Months) and Peak Sales Expectation (March 2015)

Product Peak Sales Forecast ~1,000

(1st NHI Drug Code)

New SGLT2 Inhibitor diabetes treatment Suglat (Astellas) is forecast to be the most successful product launch based on company peak sales expectations.


8.2 Case Study: Avastin Peak Sales Forecast at Launch

Avastin First Year & Peak Year Sales Forecast vs. Actual Sales

The original company forecast was for peak sales of 30,100 Yen ($245m) in 2017. Actual sales in 2013 were 75,000 Yen.

The original company forecast stated the cost per patient per year to be $13,332 and expected 18,400 patients to be treated in the peak year of 2017.


Product Forecast at Reimbursement

Field Description Brand Name (Japan) - All Dosages

This is the brand name for the product forecast in Japan along with information on all the different dosages associated with the approval. E.g. Crestor Tablet 2.5mg, 5mg, 10mg

No. of Patients Treated - First Year

This is the number of patients to be treated with the product in the first year after launch in Japan, estimated by the company applying for price approval. Forecast is made prior to price approval date. E.g. AstraZeneca has estimated 14,700 patients will take Crestor in the first year after launch.

No. of Patients Treated - Peak Year

This is the number of patients to be treated with the product in the peak year of sales in Japan, estimated by the company applying for price approval. Forecast is made prior to price approval date. E.g. AstraZeneca has estimated 938,000 patients will take Crestor in the peak sales year.

Sales Forecast (¥m) - First Year

This is the sales forecast in Japanese yen in the first year after launch in Japan, estimated by the company applying for price approval. Forecast is made prior to price approval date. E.g. AstraZeneca has forecasted ¥600m sales of Crestor in the first year after launch.

Sales Forecast (¥m) - Peak Year

This is the sales forecast in Japanese yen in the peak year of sales in Japan, estimated by the company applying for price approval. Forecast is made prior to price approval date. E.g. AstraZeneca has forecasted ¥47,700m sales of Crestor in the peak sales year.

Peak Year (after launch)

This is the number of years after launch in which the peak year of sales will occur as estimated by the company applying for price approval. Forecast is made prior to price approval date. E.g. AstraZeneca has estimated that it will take 9 years from launch to reach peak sales.

Sales Forecast ($m) - First Year

This is the sales forecast in US dollars in the first year after launch in Japan, estimated by the company applying for price approval. Forecast is made prior to price approval date. The exchange rate used is the exchange rate in the month and year the price reimbursement was made. E.g. AstraZeneca has forecasted $5.7m sales of Crestor in the first year after launch. Sales Forecast ($m) - First Year = ¥600/105.23 = $5.7m The price reimbursement date for Crestor: 18 March 2005. The exchange rate in March 2005: 105.23

Sales Forecast ($m) - Peak Year

This is the sales forecast in US dollars in the peak year of sales estimated by the company applying for price approval. Forecast is made prior to price approval date. E.g. AstraZeneca has forecasted $453.29m sales of Crestor in the peak sales year. The forecast was made prior to the price approval in June 2005. Sales Forecast ($m) – Peak Sales Year = ¥47,700/105.23 = $453.29m The price reimbursement date for Crestor: 18 March 2005. The exchange rate in March 2005: 105.23

Price Reimbursement Date

This is the date at which the drug was given its NHI reimbursement price in Japan. E.g. The price reimbursement date for 2.5mg, 5mg, and 10mg Crestor tablets is 18 March 2005.

Exchange Rate ($1=¥)

This is the exchange rate between US dollars and Japanese Yen on the price approval date.

First Year This is the first year of sales as estimated by the company applying for price approval.


Peak Year This is the peak year of sales as estimated by the company applying for price approval. No. of Patients Treated (Japan) - First/ Peak Year

This is the number of patients to be treated with the product estimated by the company applying for price approval. Forecast is made prior to price approval date. The field displays both the first year figure (from launch) and/or the peak sales year figure in an annual field format. E.g. AstraZeneca has estimated 14,700 patients will take Crestor in the first year after launch, and 938,000 patients will take Crestor in the peak sales year.

Sales Forecast (¥) - First/ Peak Year

This is the sales forecast in Japanese yen by the company applying for price approval. Forecast is made prior to price approval date. The field displays both the first year figure (from launch) and/or the peak sales year figure in an annual field format. E.g. AstraZeneca has forecasted ¥600m sales of Crestor in the first year after launch, and ¥47,700m sales of Crestor in the peak sales year.

Sales Forecast ($m) - First/ Peak Year

This is the sales forecast in US dollars by the company applying for price approval. Forecast is made prior to price approval date. The field displays both the first year figure (from launch) and/or the peak sales year figure in an annual field format. E.g. AstraZeneca has forecasted $5.7m sales of Crestor in the first year after launch, and $453.29m sales of Crestor in the peak sales year. Sales Forecast ($m) - First Year = ¥600/105.23 = $5.7m Sales Forecast ($m) – Peak Sales Year = ¥47,700/105.23 = $453.29m The price reimbursement date for Crestor: 18 March 2005. The exchange rate in March 2005: 105.23

Annual Sales Japan (¥m)

This is the company disclosed net Japanese sales for the product in Japanese yen (¥) millions.


Field Description Cost Per Unit (mg) (¥)

This is the average cost per mg from all doses and formulations of the same product, in Japanese yen. The cost per mg for each formulation is calculated by:

Price of one unit (e.g. Tablet) No. of mgs in one unit (e.g. Tablet)

E.g. Crestor Reimbursement prices are provided for 2 approved Crestor products in Japan: 2.5mg and 5 mg tablets. Price per tablet (¥) at reimbursement date: 2.5 mg: 91.00 cost per mg = 36.4 5 mg: 174.60 cost per mg = 34.92 Average cost per mg (cost per unit (mg) (¥)) = 35.66

Cost Per Unit (mg) ($)

This is the average cost per mg from all doses and formulations of the same product, in US dollars. The cost per mg in US dollars for each formulation is calculated by:

Price of one unit (¥) e.g. Tablet / exchange rate at reimbursement date No. of mgs in one unit e.g. Tablet

E.g. Crestor Reimbursement prices are provided for 2 approved Crestor products in Japan: 2.5mg and 5 mg tablets. Price per tablet ($) at reimbursement date: 2.5 mg: 91.00 / 105.23 (exchange rate in March 2005) = 0.86 cost per mg = 0.35 5 mg: 174.60 / 105.23 = 1.66 cost per mg = 0.33 Average cost per mg (cost per unit (mg) ($)) = 0.34

Cost Per Patient (¥)

This is the annual sales in Japanese yen, the company is receiving per patient, based on forecasted figures in the peak sales year. The cost per patient in Japanese yen for each formulation is calculated by:

Forecasted peak sales Estimated no. of patients in peak sales year

E.g. Crestor Forecasted sales in peak sales year: ¥47,700m Estimated number of patients in peak sales year: 938,000 Cost per patient (¥) = 47,700,000,000/938,000 = 50,852.88


Cost Per Patient ($)

This is the annual sales in US dollars, the company is receiving per patient, based on forecasted figures in the peak sales year. The cost per mg in US dollars for each formulation is calculated by:

Forecasted peak sales (¥)/ Estimated no. of patients in peak sales year Exchange rate at reimbursement date

E.g. Crestor Forecasted sales in peak sales year: ¥47,700m Estimated number of patients in peak sales year: 938,000 Cost per patient (¥) = 47,700,000,000/938,000 = 50,852.88 Cost per patient ($) = 50,852.88/105.23 = 483.25 Exchange rate in March 2005: 105.23

Units (mg) Per Patient [Coefficient]

This is the number of mgs of the product each patient is estimated to consume in one year, based on forecasted figures in the peak sales year. The units (mg) per patient is calculated by:

Cost per patient (¥) Average cost per unit (mg) (¥)

= Forecasted peak sales (¥)/ Estimated no. of patients in peak sales year

Average of (Price of one unit e.g. Tablet/No. of mgs in one unit e.g. Tablet) for all doses or formulations

E.g. Crestor Forecasted sales in peak sales year: ¥47,700m Estimated number of patients in peak sales year: 938,000 Cost per patient (¥) = 47,700,000,000/938,000 = 50,852.88 Reimbursement prices are provided for 2 approved Crestor products in Japan: 2.5mg and 5 mg tablets. Price per tablet (¥) at reimbursement date: 2.5 mg: 91.00 cost per mg = 36.4 5 mg: 174.60 cost per mg = 34.92 Average cost per mg (cost per unit (mg) (¥)) = 35.66 Units (mg) per patient: 50,852.88/35.66 = 1426

Volume (kg) This is the annual amount in kg that will be sold, based on forecasted figures in the peak sales year. The volume (kg) is calculated by:

Forecasted peak sales (¥m) Average Cost per unit (mg) (¥)

E.g. Crestor Forecasted sales in peak sales year: ¥47,700m Reimbursement prices are provided for 2 approved Crestor products in Japan: 2.5mg and 5 mg tablets.


Price per tablet (¥) at reimbursement date: 2.5 mg: 91.00 cost per mg = 36.4 5 mg: 174.60 cost per mg = 34.92 Average cost per mg (cost per unit (mg) (¥)) = 35.66 Volume (kg): 47,700/35.66 = 1338


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