Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E162.46

14 (2021)*

Astellas Pharma Inc
Stock exchange: TSE • Ticker: 4503 • HQ: Tokyo, Japan • Employees: 14,522

PERFORMANCE IN THE 2022 INDEX
16th place. Astellas performs below average, with a weak
performance in Product Delivery, where it has a comparatively
poor performance for its equitable access strategies.
However, it has strengthened its R&D access planning

How score was achieved
4.29

Governance of AccessResearch & Development

2.05

Product Delivery

2.18

processes.

01

Governance of Access: 8th place. Astellas performs well in

23Average

Leader45

this area. It has an access-to-medicine strategy that is integrated within the overall corporate strategy and a robust setof compliance controls to mitigate the risk of non-compliancein countries in scope of the Index, but the responsibility of its

Product Delivery: 16th place. Astellas performs below average

access-to-medicine strategy lies indirectly with the board.

in this area. It applies access strategies for two of its products
in some countries in scope of the Index. The company newly

Research & Development: 13th place. Astellas has a below

engages in a high-quality supply chain capacity building initia-

average performance in this area. It has a structured accesstive but lacks engagement in other areas such as manufactur-

planning process in place and applies this to all late-stage

ing capacity building and inclusive business models.

pipeline candidates. However, it has a small-sized priority
R&D pipeline compared to peers and does not engage in R&D
capacity building.

OPPORTUNITIES FOR ASTELLASCHANGES SINCE THE 2021 INDEX

Establish direct board-level responsibility for access to medicine. Astellas has• Launched Corporate Strategic Plan in 2021 with Accessan access-to-medicine strategy. The Sustainability Advisory Panel, responsible forto Health, including the implementation of its access-to-

this strategy, reports to the CEO. Instead, the CEO can become a member of theSustainability Advisory Panel, putting the responsibility for the access-to-medicine
strategy at the board level.

medicine strategy, as part of its sustainability strategic goal.
• The Astellas Global Health Foundation awarded a threeyear grant to the Academic Model Providing Access toHealthcare (AMPATH) for a programme that will provide

Expand the geographic coverage of access plans to include more lower-middle and400,000 people in Kenya with access to mental health

low-income countries. Astellas has access plans in place for all late-stage candidates.

programmes.

For example, it has access plans in place for zolbetuximab (IMAB362), indicated foroesophageal cancer, in six countries in scope of the Index. These are all upper-middle
income countries. Astellas can increase the number of countries in scope of the Index
included in R&D access plans and specifically focus on low- and lower-middle income
countries with the highest burden of disease, such as Mongolia, Malawi and Zimbabwe.
Expand access to innovative medicines for non-communicable diseases. The company
can increase affordability and supply through equitable access strategies and/or nonexclusive voluntary licensing to products such as gilteritinib (Xospata®) for leukaemia
and ipragliflozin (Suglat®) for diabetes. These products can further be filed forregistration in countries within the scope of the Index, especially where the burden of
disease is the highest, such as Ethiopia and Bolivia for gilteritinib and Guyana, Sri Lankaand Suriname for ipragliflozin.

5All 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 wherethe 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.
*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard

competitive ranking is used. Therefore, adirect comparison with Astellas' previous
rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical

Astellas' products are sold in 49 out of 108

Therapeutic areas: Immunology, oncology

countries in scope of the Index. Astellas

Revenue by segment (2021) – in JPYand urology.

has sales offices in 14 countries, and sells via

Pharmaceutical

Product categories: Innovative medicines

suppliers and/or pooled procurement in an		M&A news: Astellas acquired its own shares andadditional 35 countries.

Total

1,323.00 bn
1,323.00 bn

cancelled its treasury stock in March 2022 for
JPY 29.4 billion.

Sales by geographic region
Revenue (Bn JPY)

Sales in countries in scope

1,400
1,200
1,000
800
600
400
2000

In scope, has sales offices
In scope, any sales

20172018

2019

International/Others

In scope, no sales

Europe/Canada/Australia

Not in scope

2020

2021

China/Taiwan/Hong KongJapanUSASAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Astellas has a total of 23 R&D projects in scope, with six projects target-Astellas has six medicines in scope, four of which are on patent. 50% ofing a priority disease. The other 17 R&D projects target other diseases inthese medicines (3) are on the WHO EML. The off-patent medicines targetscope. Projects targeting priority diseases include schistosomiasis, Chagas

cancer (1) and HIV/AIDS (1). The on-patent medicines target cancer (3) anddisease and leishmaniasis. Of projects targeting other diseases in scope,diabetes mellitus (1).

the focus is oncology (14 projects).
Four R&D projects are in late-stage development that target either a priority disease (1) or address a public health need in LMICs (3).* Evidence ofaccess planning was in place for 100% of these projects.

23 projects in the pipeline

6 products as selected for analysis by the Index†

Communicable**3

Communicable** 0

Neglected tropical3

Neglected tropical 0Maternal and neonatal 0Maternal and neonatal 017020304050
projects in the pipeline

1020304050
products on the market

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***Total

Vaccines

4100

1006

Contraceptives

Targets established R&D priorities

13off patent

20200000

Addresses needs of LMICs*

111104

Other projects in scope

9211013

Other

the clinical phase of development wereincluded for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separatelythroughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-4

Medicines on patent

Diagnostics*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 inTotalDiscovery

WHO EML

Breakdown of products

Other10

Breakdown of projects

61

Multiple categories

WHO EDL05

Non-communicableMultiple categories 0

Non-EMLNon-communicable‡0000

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

Astellas Pharma IncGOVERNANCE OF ACCESSRANK 8SCORE 4.29

Has an access-to-medicine strategy with meas-ing premature deaths from non-communicablefraud-specific risk assessment, country risk-based

urable objectives, integrated with the overall

diseases by 2030. It facilitates accountabil-assessment, a continuous system to monitor

corporate strategy. Astellas performs strongly.

ity and transparency by consistently sharing theactivities, audits (both internal and external, cov-

It has an access strategy integrated across theoutcomes of its access-to-medicine activities,

ering third parties and in all countries where itcompany business as one of its strategic goals inincluding its response to COVID-19, in a cen-operates) and has formal processes to ensure

its Corporate Strategic Plan. The strategy cov-tralised manner within its Access Accelerated

compliance with company standards by thirders all therapeutic areas in which the company isinitiative Year 4 Report.

parties. No breaches in countries in scope ofinvolved. The highest responsibility for access lies

the Index were publicly found in the period of

indirectly with the board, with the Sustainability

Performs above average in responsible promo-

Advisory Panel overseeing social activities, includ-tional practices. Astellas’ sales agents are noting access.

solely incentivised on sales volume targets. The

Publicly supports the Doha Declaration oncompany, however, sets sales incentives at theTRIPS and Public Health. Astellas publicly shares

Provides evidence of financial access-related

individual level for agents. Astellas does not pub-support of the Doha Declaration on TRIPS andincentives at the executive level. Astellas per-licly disclose information related to transfers of

Public Health with regard to the Least Developed

forms well. It incentivises some senior executives

values to healthcare professionals in countries inCountries. However, it expresses reservations onto perform on certain access-related factors withscope of the Index (e.g., payments for attendingthe use of compulsory licensing and states that

financial rewards. The CEO also has access-re-events or promotional activities) unless required

it does not believe IP protection is a primary fac-

lated incentives linked to its remuneration plan.

by local regulations, but it has a policy and guid-

tor in limiting access to health. There is evidence

ance limiting such transfers at the global level,of industry association lobbying on IP and theincluding in countries in scope of the Index.

usage of TRIPS flexibilities, namely compulsory

Publicly discloses outcomes of its
access-to-medicine activities. Astellas performsanalysis.

licensing, by national governments in some coun-strongly in transparency of access activities. ItHas a robust set of compliance controls totries in scope of the Index. As a member of the

publicly discloses commitments on improving

ensure that governance efforts are not under-industry association, Astellas, like all other mem-social sustainability, measurable goals, objectives,

mined by non-compliant or corrupt activities.

ber companies in scope of the Index, is by default

and targets for improving access to medicine in

Astellas performs strongly, demonstrating evi-

connected to this activity.

countries in scope of the Index, towards reduc-dence of all components looked for by the Index:

RESEARCH & DEVELOPMENTRANK 13SCORE 2.05

Access planning processes encompass all pro-tel in partnership with the Pediatric Praziquantel

These plans focus mainly on registration prepara-

jects in the pipeline. Astellas has a structuredConsortium.

tion in countries in scope.

R&D. The process is intended to be applied to allSome projects address a public health need inDoes not publicly disclose R&D investment

R&D projects (both in-house and collaborative)

LMICs,* with 100% (3/3) of late-stage candi-data disaggregated by disease category, prod-

for diseases in scope of the Index.

dates covered by access plans. In this analysis,

uct type or phase of development. Astellas does

Astellas has three late-stage R&D projects thatnot disclose disaggregated R&D investment data

A small-sized priority R&D pipeline comparedtarget a disease and/or product gap not yet

to global health organisations.

to its peers. Astellas has six projects, including

established as a priority by global health stake-one late-stage candidate in its pipeline that tar-holders. These projects are all deemed by theNo R&D capacity building initiatives included

gets a priority product gap. The company focuses

Index to offer a clear public health benefit forfor evaluation. There is no evidence — in theon various priority areas, including schistosomi-people living in LMICs.* Primarily, these pro-public domain or disclosed to the Index — ofasis, Chagas disease and leishmaniasis. Astellas

jects have clinical trials in countries in scope ofR&D capacity building initiatives active during thehas an access plan in place for its late-stage can-the Index and/or are first-in-class molecules.

period of analysis that met inclusion criteria fordidate targeting a priority product gap. This plan

Most target cancer. Astellas provides evidence ofevaluation. Astellas' performance is below aver-is for the development of paediatric praziquan-access plans for all three late-stage candidates.

age in this area.

process in place to develop access plans during

PRODUCT DELIVERYRANK 16

SCORE 2.18

Publicly commits not to enforce patents inthe patent statuses for small molecules in scope

third-party researchers. Astellas engaged incountries in scope. Astellas publicly pledges

via the Pat-INFORMED database. Astellas dis-

one new IP-sharing agreement with third-party

to neither file for nor enforce patents in Least

closes patent information such as filing date,research institutions or drug discovery initiatives

Developed Countries and LICs.

grant number, grant date and jurisdiction.

established during the current analysis period

Publicly discloses information on patent status.

Is an average-performing company in terms ofcompany does have existing agreements of thisLike most of its peers, Astellas publicly discloses

sharing intellectual property (IP) assets withnature in place that were established before thethat meets all inclusion criteria for evaluation. The

7*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

current Index cycle and meet all inclusion criteria

the UMIC example provided. Evidence of patientpopulations) in LMICs. Astellas performs below

for evaluation.

reach is available for two products in UMICs.

average in this area.

No use of licensing agreements. Astellas does

No manufacturing capacity building initiatives

Performs above average in terms of ensur-

not engage in voluntary licensing for products inincluded for analysis. There is no evidence — ining continuous supply of medicines in LMICs.

scope of the Index. It publicly states it would con-the public domain or disclosed to the Index — ofAlthough there is no evidence of technology

sider granting non-exclusive voluntary licences inmanufacturing capacity building initiatives active

transfer initiatives that meet inclusion criteria forcertain circumstances.

during the period of analysis that met inclusion

evaluation, Astellas does have a system in place tocriteria for evaluation. Astellas' performance iswork with relevant stakeholders to communicate

below average in this area.

issues that may affect the supply chain, has a dual

Filed to register new products in two countries
in scope on average. Astellas did not disclose

active pharmaceutical ingredient sourcing strat-

evidence of filing for registration any of its new

The one supply chain capacity building ini-egy for some products and is involved in supply

products in any of the top ten high burden coun-tiative included for analysis meets all Goodchain capacity building initiatives. The company

tries. Among old products, its most widely filed isPractice Standards. Astellas' performance ismanages a buffer stock of relevant products inenzalutamide (Xtandi™), for prostate cancer, filed

average in this area. The number of initiatives

countries with Astellas warehouses and oth-in 40 countries in scope of the Index. The productmeeting all inclusion criteria is lower than aver-erwise works to ensure that third parties havereaching most LICs is micafungin (Mycamine®),age and fewer initiatives meet all Good Practicerelevant stocks.

used in HIV/AIDS complications, filed in six of theStandards (GPS) than what is average for this27 LICs within scope of the Index.

indicator. The Astellas Global Health Foundation

Has a policy for reporting substandard and fal-partners with Academic Model Providing Accesssified medicines in countries in scope of theAstellas is not eligible for assessment of supra-

to Healthcare (AMPATH) to build ancillary support

Index in less than ten days. Astellas has a policy

nationally procured products.

services including pharmaceutical supply chains,for reporting falsified medicines within ten days

electronic health records and medical supplies toto national health authorities and the WHO, but

Has access strategies for some of the health-deliver mental health services in Kenya. This initi-

applies a separate process to substandard med-care-practitioner-administered products inative meets all GPS.

icines. It provides evidence of shortened time

scope of this analysis. Astellas performs below

frames for reporting for cases which only require

average in this area. For one of the two prod-

One of the four health systems strengthen-visual inspection by experts to be confirmed anducts assessed, the company provides evidence

ing initiatives included meets all Good Practice

are not contingent upon laboratory analysis.

of pricing strategies considering some affordabil-Standards. Astellas' performance is below aver-ity factors for all assessed income levels (UMIC,age in this area. The number of initiatives meeting

Donates in response to expressed need andLMIC, LIC). For example, Astellas applies a pric-

all inclusion criteria is average but fewer initia-

monitors delivery. Astellas has public policies

ing strategy that considers relevant payers’ ability

tives meet all GPS than what is average for thisand supply processes in place to ensure ad hoc

to pay for micafungin (Mycamine®) in a UMIC.

indicator. The Astellas Global Health Foundation

donations are carried out rapidly in response toPatient reach is available for one product only inawarded a grant to the END Fund which works

expressed need, and it monitors the delivery ofa UMIC.

to deliver neglected tropical disease (NTD)

donations.

treatments through mass drug administration
Has access strategies for some of its self-ad-mechanisms designed to control and eliminate

Has no long-term donation programmes forministered products for some countries inNTDs in the Democratic Republic of Congo. This

neglected tropical diseases (NTDs) or malaria

scope for this analysis. Astellas performs below

initiative meets all GPS.

that are eligible for analysis under this indicator. Astellas is not engaged in any structured

average in this area. For one of the three prod-8

ucts assessed, the company provides examples

Has no inclusive business models that meet

donation programmes for NTDs or malaria whereof access strategies which consider affordability

all inclusion criteria. There is no evidence thatelimination, eradication or control goals are pos-factors in countries of all assessed income levels

Astellas has engaged in the piloting or scale-up ofsible and that are eligible for analysis under this(UMIC, LMIC, LIC). For example, Astellas applies

any inclusive business models that aim to meetindicator.

a pricing strategy that considers relevant pay-

the access needs of populations at the base ofers’ ability to pay for enzalutamide (Xtandi™) in

the income pyramid (including other underserved