Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E

12

2.95

11 (2021)

Eisai Co, Ltd
Stock exchange: TSE • Ticker: ESALY • HQ: Tokyo, Japan • Employees: ~10,000

PERFORMANCE IN THE 2022 INDEX
12th place. Eisai has an average performance. The company
has an average performance in access strategies for productson the market. Eisai engages in R&D for priority diseases, but
the majority of late-stage pipeline projects do not have an

How score was achieved
4.14

Governance of Access
2.03

Research & Development

3.13

Product Delivery

access plan. It performs well by having processes in place to0

1

ensure the continuous supply of medicines in LMICs.

2

3

Average

Leader4

5

Governance of Access: 10th place. Eisai has an average performance in this area. It has a clear access-to-medicine strategy
that is integrated into its overall corporate strategy, althoughlate-stage candidates. It has an average performance in R&D

the strategy does not fully extend across its pipeline and port-

capacity building.

folio. It also has a robust set of compliance controls to mitigate the risk of non-compliance in countries in scope of the

Product Delivery: 13th place. Eisai has an average perfor-

Index, but it shares the outcomes of its access-to-medicine

mance in this area. It has access strategies in place for mostactivities for only a subset of initiatives.

of its products in upper-middle and lower-middle income
countries. The company engages in high-quality supply chain

Research & Development: 14th place. Eisai has a below aver-capacity building but has a comparatively poor performanceage performance in this area. It has an average-sized prior-in terms of health systems strengthening and manufacturing

ity pipeline, but only applies access plans to a small number ofcapacity building.

OPPORTUNITIES FOR EISAICHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans. Eisai has a• Established a pharmaceutical sales subsidiary in Vietnam.

structured process in place for R&D access planning that encompasses some projects• Signed the Kigali Declaration, the successor to the London

in the pipeline. The company has access plans in place for 14% of late-stage projects

Declaration, in June 2022, positioning neglected tropicalanalysed. These plans are for projects developed in partnership with DNDi. Eisai canapply access plans to all projects in the pipeline from Phase II onwards, for example,
lecanemab for Alzheimer’s disease.

diseases as an important area of focus.
• Participated in the AMR Action Fund, which was establishedto support the clinical development of new antimicrobial
agents and to achieve a sustainable antimicrobial market,

Expand registration of epilepsy medicines. Eisai has one of the largest portfolios
of on-patent antiepileptic products among the companies in scope. Its antiepileptic
perampanel (Fycompa®) is currently not registered in any of the ten countries in scopein collaboration with more than 20 leading pharmaceuticalcompanies.
• Supported a project led by CA Medlynks which aims towith the highest burden of epilepsy. The company can register this product in thosebuild a new structure for the efficient testing framework

countries, including Guyana and Haiti.

for COVID-19 in Kenya through the setup of PCR testinglaboratories, along with procurement of equipment

Expand access strategies to reach populations in low-income countries. For its breast
cancer treatment eribulin (Halaven®), Eisai deploys equitable access strategies andnecessary for testing and training of screening technicians.
• Expanded the long-term donation programme ofpatient assistance programmes in at least two lower-middle income countries. The

diethylcarbamazine tablets to combat lymphatic filariasis

company can expand such strategies to low-income countries and other countries within Nepal.

a high burden of breast cancer, such as Armenia, Papua New Guinea and Morocco.
Expand supply chain capacity building to more disease areas. Eisai has one existing
supply chain capacity building initiative that meets all Good Practice Standards, focusing
on neglected tropical diseases. The company can work with local partners to expand its
capacity building efforts to more diseases the company focuses on, such as epilepsy, incountries that have a high burden of disease, including Uganda.

29

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical business

Eisai's products are sold in 33 out of 108

and other business.

countries in scope of the Index. Eisai has sales

Revenue by segment (2021) – in JPY

Therapeutic areas: Oncology and neurology.

offices in 8 countries, and sells via suppliers

Pharmaceutical business626.28 bn

Product categories: Innovative medicines.

and/or pooled procurement in an additional 25

Other business

129.95 bn

M&A news: Eisai acquired Arteryex Inc. in April

countries.

		

2022.

Total

756.23 bn

Sales in countries in scope

Sales by geographic region
Pharma revenue (Bn JPY)

700
600
500
400
300
200
100
0

In scope, has sales offices
In scope, any sales

2017
EMEA

In scope, no sales

Americas

Not in scope

2018

2019

2020

Asia/Latin America
Japan

2021
China

OTC and others

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Eisai has a total of 49 R&D projects in scope with 23 of these projects tar-

Eisai has 11 medicines in scope, six of which are on patent. 18% of the med-

geting priority diseases. The other 26 R&D projects target other diseases

icines (2) are on the WHO EML. The off-patent medicines (5) mainly target

in scope. Of the projects targeting priority diseases, the focus is on malaria

mental health (2). One product targets the neglected tropical disease lym-

(13 projects). Of the projects targeting other diseases, the focus is on

phatic filariasis and one further product is for cardiovascular diseases. The

Alzheimer's disease (6) and oncology (18).

on-patent medicines mainly target epilepsy (3) and oncology (2). In addi-

Fourteen R&D projects are in late-stage development that target either ation, one product is for Alzheimer’s disease.

priority disease (3) or address a public health need in LMICs (11).* Evidenceof access planning was in place for 14% of these projects: one targeting apriority disease and one addressing a public health need in LMICs.

49 projects in the pipeline

11 products as selected for analysis by the Index†
17

Communicable**Communicable** 0

6Maternal and neonatal 0

Maternal and neonatal 026

Non-communicableMultiple categories 0
0

20
30
40
50
projects in the pipeline

20
30
40
50
products on the market

Registration/approval

Other***

2

0

0 23

6

2

3

5

Vaccines000Contraceptives

00Addresses needs of LMICs*

3

3

4

4

1

15

Diagnostics

Other projects in scope

8

3

0

0

0

11

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

Phase III10

off patent

Other

Phase II

1

Medicines on patent

WHO EDL

Phase I

10 9

Total

Pre-clinical

Breakdown of products

Discovery

Targets established R&D priorities

10

Non-EML

10

Breakdown of projects

3010Non-communicableMultiple categories 001

Neglected tropical

WHO EML

Neglected tropical

6

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Eisai Co, Ltd

GOVERNANCE OF ACCESSRANK 10SCORE 4.14

Has an access-to-medicine strategy with meas-

medicine in countries in scope of the Index. It

system to monitor activities, audits (both inter-urable objectives. Eisai has an above average

shares the outcomes of its access-to-medi-

nal and external, covering third parties and in all

performance. Its strategy is fully integrated withincine activities for a subset of initiatives, althoughcountries where it operates), formal processes

the overall corporate strategy and states a com-it does so in a centralised manner in its Valueto ensure third-party compliance with company

mitment to long-term sustainability solutions,

Creation Report and directly on its website,

standards and country risk-based assessments.

including affordable pricing. It covers some ofincluding outcomes of activities supporting theNo breaches in countries in scope of the Index

the therapeutic areas in which the company iselimination of NTDs such as lymphatic filariasis.

were publicly found in the period of analysis.

cer. The highest responsibility lies directly with

Performs above average in responsible pro-

Publicly supports the Doha Declaration on

the board.

motional practices. Eisai’s sales agents are

TRIPS and Public Health. Eisai publicly shares

not solely incentivised on sales volume targets.

support of the Doha Declaration on TRIPS andProvides evidence of financial and non-financial

Sales agent incentives are set at the individual,

Public Health, highlighting that Article 31b (cov-access-related incentives at the executive level.

team and country levels. It does not publicly dis-ering the use of compulsory licences) provides

Eisai performs well. It incentivises its in-coun-close information related to transfers of values tobalance between the protection of both IP andtry managers, including country-level corporate

healthcare professionals in countries in scope of

public health under appropriate circumstances.

officers or regional managers, to take action on

the Index (e.g. payments for attending events or

There is evidence of industry association lobbying

access to medicine with financial and non-finan-

promotional activities), unless required by local

on IP and the usage of TRIPS flexibilities, namely

cial rewards. The CEO also has access-related

regulations. The company has a country-specificof compulsory licensing, by national governments

incentives, linked, for example, to initiatives aim-

policy limiting transfers of values to healthcare

in some countries in scope of the Index. As a

ing at eliminating neglected tropical diseases

professionals.

member of the industry association, Eisai, like all

involved, including Alzheimer’s disease and can-(NTDs).

other member companies in scope of the Index, is
Has a robust set of compliance controls to

Publicly discloses outcomes of a subset of its

ensure that governance efforts are not under-access-to-medicine activities. Eisai performs

mined by non-compliant or corrupt activities.

average in transparency of access activities. It

Eisai performs strongly, demonstrating evi-

discloses its commitments, measurable goals,

dence of all components looked for by the Index:

objectives and targets for improving access tofraud-specific risk assessment, a continuous

RESEARCH & DEVELOPMENTRANK 14SCORE 2.03

Access planning processes encompass someMany projects address a public health need in

Eisai does disclose fully disaggregated R&D

projects in the pipeline. Eisai has a structured

LMICs,* with 9% (1/11) of late-stage candidates

investment data to Policy Cures Research.

process in place to develop access plans during

covered by access plans. In this analysis, Eisai

R&D. The process is intended to be applied to ahas 11 late-stage R&D projects that target a dis-

One of the two R&D capacity building ini-

subset of R&D projects (both in-house and col-ease and/or product gap not yet established as atiatives included meets all Good Practicelaborative) for diseases in scope of the Index.

priority by global health stakeholders. These pro-Standards. Eisai's performance is average in thisjects are all deemed by the Index to offer a clear

area. The number of initiatives meeting all inclu-

An average-sized priority R&D pipeline com-public health benefit for people living in LMICs.*sion criteria is lower than average and fewer

pared to peers, with 33% (1/3) of late-stage

Primarily, these projects concern clinical trials in

initiatives meet all Good Practice Standards

candidates supported by access plans. Eisai has

countries in scope of the Index and/or are first-(GPS) than what is average for this indicator.

23 projects including three late-stage candidates

in-class molecules. The projects mainly focus on

Notably, Eisai partners with Seeding Labs toin its pipeline that target a priority product gap.

cancer and Alzheimer's disease. Eisai provides

improve access to laboratory equipment for the

The company's priority pipeline focuses mostly

evidence of an access plan for one of the late-scientific community in countries in scope of theon malaria. Of Eisai's three late-stage candidates

stage candidates. This plan concerns registration

Index. This initiative meets all GPS.

targeting a priority product gap, there is evidence

preparation in countries in scope of the Index.

of an access plan for one. This access plan for31

by default connected to this activity.

fosravuconazole as a treatment for patients with

Does not publicly disclose R&D investment

eumycetoma is in partnership with the Drugs fordata disaggregated by disease category, prod-

Neglected Diseases initiative (DNDi).

uct type or phase of development. However,*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 13SCORE 3.13

Public commitment not to enforce patentsa patient assistance programme to reach addi-

what is average for this indicator. One exam-

in countries in scope. Eisai publicly pledges totional patients. In India, Eisai company has aple of an initiative included for evaluation is theneither file for nor enforce patents in all Least

licensing agreement with Viatris to allow second

partnership with CA Medlynks Kenya and the gov-

Developed Countries and LICs. This commitment

brand manufacturing and increase access in theernment of Meru County to construct a screening

applies to infectious diseases, neglected tropicalcountry. The company provides evidence of how

framework for COVID-19 in Kenya.

diseases and maternal and neonatal diseases.

patient reach has been increased through theseapproaches in India.

Publicly discloses information on patent status.

ness model but has not shown evidence of its

Like most of its peers, Eisai publicly discloses theHas access strategies for its self-adminis-

involvement in scaling up any existing inclusive

patent statuses for small molecules in scope via

tered products for some countries in scope forbusiness models that meet all inclusion crite-

the Pat-INFORMED database. Eisai discloses pat-this analysis. Eisai has an average performanceria. Eisai performs below average in the use ofent information such as filing date, grant number,in this area. The company provides examples ofinclusive business models aimed at meeting the

grant date and jurisdiction.

access strategies in UMICs and LMICs for all threeaccess needs of populations at the base of the

products assessed, including efforts to reach

income pyramid (including other underserved

Is an average-performing company in terms ofadditional patients using pricing strategies that

populations) in LMICs. The One-stop Online

sharing intellectual property assets with third-

consider relevant payers’ ability to pay. For exam-

Service Platform: Yin Fa Tong in partnership withparty researchers. Eisai engaged in one newple, Eisai implemented the lenvatinib (Lenvima®)

JD Health is a joint venture that aims to create a

IP-sharing agreement with third-party research

Easy Access Program (LEAP) in the Philippines,

new solution that provides medical, health, andinstitutions or drug discovery initiatives estab-

which offers two free boxes for every purchase oflifestyle services specifically for the elderly, espe-

lished during the current analysis period thatone box (of the same dose) to all patients regard-cially those with dementia and their families.

meets all inclusion criteria for evaluation. The

less of their income since May 2017. The company

company does have existing agreements of thisprovides evidence of how patient reach has been

Performs above average in terms of ensuring

nature in place that were established before theincreased through these approaches.

continuous supply of medicines in LMICs. Eisai

current period of analysis and meet all inclusion

is involved in technology transfers with thirdTwo manufacturing capacity building initiatives

party manufacturers in LMICs, and has a system

included for analysis. Neither manufacturing

in place to work with relevant stakeholders to

No use of licensing agreements. Eisai does not

capacity building initiative included for analysis

communicate issues that may affect the supply

engage in voluntary licensing for products inmeets all Good Practice Standards (GPS). Eisai's

chain, works with several active pharmaceuti-

scope of the Index. It publicly states it would con-performance is below average in this area. The

cal ingredient (API) suppliers/produces in-housesider granting non-exclusive voluntary licences in

number of initiatives meeting all inclusion criteria

APIs, manages a buffer stock of relevant products

certain circumstances.

is lower than average and fewer initiatives meetand is involved in supply chain capacity building

all GPS than what is average for this indicator. In

initiatives.

criteria for evaluation.

No evidence of filing for registration its newone of the included initiatives, since 2013 Eisai

product in any country in scope. Eisai did nothas built and improved pharmaceutical manufac-

Has a policy for reporting substandard and fal-

disclose evidence of filing for registration its new

turing capacity of an Indian local manufacturer,

sified (SF) medicines in countries in scopeproduct in any of the top ten high burden coun-

Saurav, to supply diethylcarbamazine for lym-of the Index in less than ten days. Eisai has atries. Among old products, its most widely filed

phatic filariasis elimination.

policy for reporting SF medicines to national

product, eribulin (Halaven®), indicated for breast

health authorities and the WHO within 24 hours

cancer, has been filed for registration in 31 coun-

The one supply chain capacity building initiative

to seven days. It provides evidence of short-tries within scope of the Index, including threeincluded for analysis meets all Good Practiceened reporting time frames for cases which only

high burden disease countries, such as Morocco

Standards. Eisai's performance is average in thisrequire visual inspection to be confirmed based

and Pakistan. Eisai filed two of its seven products

area. The number of initiatives meeting all inclu-

on the Risk Evaluation Committee.

assessed in one LIC.

sion criteria is lower than average and fewer
initiatives meet all GPS than what is average for

Donates in response to expressed need andEisai is not eligible for assessment of suprana-

this indicator. NTD Supply Chain Forum is a mul-monitors delivery. Eisai has public policies andtionally procured products.

ti-partner initiative that aims to deliver the drugs

supply processes in place to ensure ad hoc dona-of neglected tropical diseases for donations fromtions are carried out rapidly in response to

Has access strategies for the healthcare prac-

the first to last mile and tracks progress and logis-

expressed need, and it monitors the delivery oftitioner-administered product in scope of thistics improvement of operations in countries indonations.

analysis. Eisai performs above average in thisscope of the Index.
Publicly commits to the achievement of elim-area. The company provides examples of access32

Has engaged in piloting one inclusive busi-

strategies which consider affordability in both aThree health systems strengthening initia-

ination, eradication or control goals in one

UMIC and an LMIC for the only product assessed,

tives included for evaluation. None of the threestructured donation programme for neglected

including efforts to reach additional patients using

health systems strengthening initiatives included

tropical diseases or malaria. Since 2013, Eisai

pricing strategies that consider relevant payers’

for analysis meet all GPS. Eisai's performance ispublicly commits itself to eliminating lymphatic

ability to pay. For example, Eisai obtained national

below average in this area. The number of initi-

filariasis by donating diethylcarbamazine tablets

reimbursement in China for eribulin (Halaven®),atives meeting all inclusion criteria is lower thanin 25 countries in scope of the Index for an unlim-a breast cancer medicine as well as implemented

average and fewer initiatives meet all GPS thanited period of time.