Pricing, reimbursement and market access (PRMA) in JAPAN
Order Description
PLEASE SEE UPLOADED DOCUMENT for questions to be answered and notes to complete this project on pricing, reimbursement and market access (PRMA) in JAPAN. There are three main tasks to be completed that are highlighted n the document. Please reference everything. Please be very detailed.
EVERYTHING IN YELLOW HIGHLIGHT IS WHAT NEEDS TO BE ANSWERED, THERE ARE 3 MAIN TASKS – please include references, there are additional notes at the end for your review, but much more additional research needs to be done, fact checked, and referenced.
Task 1: Pricing, reimbursement and market access (PRMA) in JAPAN
Please detail in writing the following in 1 page:
A. The flow chart (below) of pricing, reimbursement and market access (PRMA) decision-making bodies in JAPAN. We need to know the following:
? who they are
? what they do
? and most importantly, how they influence each other in JAPAN
B. A description of health technology assessment (HTA) protocols in JAPAN
SOME NOTES ABOUT WHAT WE ARE LOOKING FOR IN THIS TASK: In Japan, price and reimbursement is determined by clinical innovation compared to available therapies.
Manufacturer:
? Files new product application with PMDA (PMDA covers entire process from clinical trial consultations to approval reviews)
? Submits clinical dossier to NHI
? Pharmacoeconomic data are optional, but being used more readily by the NHI
Decision makers influence each other as this flow chart depicts:
FLOW CHART:

MHLW = Ministry of Health, Labour and Welfare
PMDA = Pharmaceutical and Medical Devices Agency
DPO = Drug Pricing Association
NHI (KKN) = National Health Insurance
EHI (KN) = Employee Health Insurance

Task 2: The drug called Linagliptin – Pricing, reimbursement and market access (PRMA) in JAPAN
Boehringer Ingelheim has manufactured linagliptin. As a local affiliate for Boehringer Ingelheim, you are in charge of the PRMA for linagliptin in JAPAN.

The product profile of linagliptin is available at: https://www.medicines.org.uk/emc/medicine/25000/SPC/Trajenta+5+mg+film-coated+tablets/
Pay particular attention to the following attributes: Indication, safety and tolerability, mechanism of action, efficacy, administration.

A. How successful was your pricing, reimbursement and market access (PRMA) strategy in JAPAN? Please complete the following table:
Attribute Linagliptin
Price This answer will be in yen and dollars
Reimbursement status This answer will be a percentage, we need to know where the remainder of the percentage the money will come from
Main competitors This answer will be a list of drug names

B. How did the HTA body/payer arrive at their decision made? Please prepare up to 1 page which explains the reimbursement recommendation made by JAPAN?s HTA body/payer (You can look at things like reimbursement status and HTA assessment)
Indication
C. How important were linagliptin?s various attributes to the HTA body/payer in JAPAN?
D. Please score the product attributes of linagliptin from 1 = not impactful; 5 = very impactful
Attribute
Please score the product attributes of linagliptin from 1 = not impactful; 5 = very impactful and note in 1 -3 sentences your reasons why
Indication
Mechanism of action
Efficacy
Safety & tolerability
Administration
Economic benefit
Task 3: Loss of exclusivity (drug patent) in JAPAN
This year, Symbicort for asthma and COPD loses patent protection
As the HTA body/payer in JAPAN:
A. What are the generic pricing rules that you will consider when the loss of patent protection occurs in JAPAN? Please prepare about 1 page on generic pricing rules in JAPAN
B. Based on these rules, how will you price Symbicort and any future generic therapies using the table below for JAPAN?

Attribute
Symbicort

2014 list price for Symbicort
This answer will be in yen, please also convert to US dollars
An estimate of the 2015 list price for Symbicort
This answer will be in yen, please also convert to US dollars
An estimate of the 2015 list price for a generic budesonide/formoterol competitor
This answer will be in yen, please also convert to US dollars

Notes to consider:
The generic pricing rules that you will consider when the loss of patent protection in JAPAN
Generic uptake
Price of generics versus originator (drug brand)
Generic pricing rules
How generics work in Japan
What is the uptake (prescribing numbers) in JAPAN
Percentage of generics in JAPAN
These next pages are just some additional notes for all tasks, if needed. There are no tasks here below.
?
These next pages are just some additional notes for all tasks, if needed. There are no tasks here below.
Two calculation methods are used to determine drug prices: comparator or cost-plus
Comparator method whereby product is priced based on relative innovation / usefulness, as well as other factors
Reimbursement price for new drugs is determined by comparison with existing drugs
Entry of drugs into the price list occurs 4 times per year; process generally takes 60 days, but up to 90 days at a maximum
The comparator method can result in premiums up to 160% above reference country prices
There are six premium rates for reimbursement prices for new drugs

Reference: Pharmaceutical Administration and Regulations of JAPAN
www.jpma.or.jp/english/parj/1003.html
Once price is established, it is very difficult to increase and often decreases over time
Price cuts occur in Japan every 6 months
? Historically, rates have been around 6-9%
2010 price cut resulted in an average 6.5% decrease across all drugs
Products deemed ?innovative? are exempt from price cuts
? Includes those with an innovative comparison rating or a drug with no alternative treatments, competitors or generic equivalents
? However, the manufacturer must also fulfil certain obligations
There is a common reimbursement price for hospital and non-hospital use
Expansion into paediatric / novel indications is a method of countering continuing price decreases

Generics are typically priced at 70% of the cost of the identical branded product
The first entry generic is priced at 70% of the identical branded product
? In the case of an oral generic for which there are greater than 10 branded drugs already on the market, the price of the generic is 60% of the branded price
When branded and generic forms are already on the market, a later entering generic is priced at the same price as the lowest identical generic
When there more than twenty branded products are available, the generic price is 90% of the lowest branded price
All drugs are reimbursed nationally with varying out-of-pocket costs (OOP) to the patient
Exact OOP amount is an extremely complicated calculation involving the determination of net assets, net income, and medical expenditure of each individual
? On average, around 30% co-payment
Due to its very calculated system, stakeholder research is often with clinicians