expanding access to essential cancer products

Expanding access to essential cancer products

Recent Progress and Workplan

André Ilbawi, MD

Medical Officer, Cancer Control

World Health Organization

Elena Fidarova, MD



Roberta Ortiz, MD



Sandra Luna-Fineman, MD

Consultant, Cancer Control


Dario Trapani, MD

Former consultant, WHO

IEO, Istituto Europeo di Oncologia

Felipe Roitberg, MD



Ben Anderson, MD

Consultant, Breast Cancer Control


Saki Narita, PhD



SEVENTIETH WORLD HEALTH ASSEMBLY WHA70.12

Agenda item 15.6 31 May 2017

Cancer prevention and control in the context of

an integrated approach

The Seventieth World Health Assembly,

Having considered the report on cancer prevention and control in the context of an integrated

approach;1

Acknowledging that, in 2012, cancer was the second leading cause of death in the world with

8.2 million cancer-related deaths, the majority of which occurred in low- and middle-income

countries;

Recognizing that cancer is a leading cause of morbidity globally and a growing public health

concern, with the annual number of new cancer cases projected to increase from 14.1 million in 2012

to 21.6 million by 2030;

Aware that certain population groups experience inequalities in risk factor exposure and in

access to screening, early diagnosis and timely and appropriate treatment, and that they also

experience poorer outcomes for cancer; and recognizing that different cancer control strategies are

required for specific groups of cancer patients, such as children and adolescents;

Noting that risk reduction has the potential to prevent around half of all cancers;

Aware that early diagnosis and prompt and appropriate treatment, including pain relief and

palliative care, can reduce mortality and improve the outcomes and quality of life of cancer patients;

Recognizing with appreciation the introduction of new pharmaceutical products based on

investment in innovation for cancer treatment in recent years, and noting with great concern the

increasing cost to health systems and patients;

Emphasizing the importance of addressing barriers in access to safe, quality, effective and

affordable medicines, medical products and appropriate technology for cancer prevention, detection,

screening diagnosis and treatment, including surgery, by strengthening national health systems and

international cooperation, including human resources, with the ultimate aim of enhancing access for

patients, including through increasing the capacity of the health systems to provide such access;

Recalling resolution WHA58.22 (2005) on cancer prevention and control;

1 Document A70/32.

WHA70.12

2

Recalling also United Nations General Assembly resolution 66/2 (2011) on the Political

Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of

Non-communicable Diseases, which includes a road map of national commitments from Heads of

State and Government to address cancer and other noncommunicable diseases;

Recalling further resolution WHA66.10 (2013) endorsing the global action plan for the

prevention and control of noncommunicable diseases 2013–2020, which provides guidance on how

Member States can realize the commitments they made in the Political Declaration of the High-level

Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases,

including those related to addressing cancer;

Recalling in addition United Nations General Assembly resolution 68/300 (2014) on the

Outcome document of the high-level meeting of the General Assembly on the comprehensive review

and assessment of the progress achieved in the prevention and control of non-communicable diseases,

which sets out the continued and increased commitments that are essential in order to realize the road

map of commitments to address cancer and other noncommunicable diseases included in the Political

Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of

Non-communicable Diseases, including four time-bound national commitments for 2015 and 2016;

Mindful of the existing monitoring tool that WHO is using to track the extent to which its

194 Member States are implementing these four time-bound commitments to address cancer and other

noncommunicable diseases, in accordance with the technical note1 published by WHO on 1 May 2015

pursuant to decision EB136(13) (2015);

Mindful also of the WHO Framework Convention on Tobacco Control;

Also mindful of the Sustainable Development Goals of the 2030 Agenda for Sustainable

Development, specifically Goal 3 (Ensure healthy lives and promote well-being for all at all ages) with

its target 3.4 to reduce, by 2030, premature mortality from noncommunicable diseases by one third,

and target 3.8 on achieving universal health coverage;

Appreciating the efforts made by Member States2 and international partners in recent years to

prevent and control cancer, but mindful of the need for further action;

Reaffirming the global strategy and plan of action on public health, innovation and intellectual

property;

Reaffirming also the rights of Member States to the full use of the flexibilities in the

WTO Agreement on Trade-related Aspects of the Intellectual Property Rights (TRIPS) to increase

access to affordable, safe, effective and quality medicines, noting that, inter alia, intellectual property

rights are an important incentive in the development of new health products,

1 Available at http://www.who.int/nmh/events/2015/technical-note-en.pdf?ua=1 (accessed 19 May 2017).

2 And, where applicable, regional economic integration organizations.

• Develop resource-stratified tool kits to establish and implement comprehensive programmes…leveraging work of other organizations

OP1

• Collect, synthesize and disseminate evidence on the most cost-effective interventions for all age groups…and to make an investment case for cancer prevention and control

OP2

• Strengthen the collaboration with nongovernmental organizations…development of effective and affordable new cancer medicines;

OP5

• Prepare a comprehensive technical report … that examines pricing approaches…and options that might enhance the affordability and accessibility of these medicines;

OP9

WHO Mandate

WHO Response

Cancer early detection

Cancer workforce

Access to cancer products

Cancer plans & investments

WHO Cancer Initiatives

4

WHO Global Initiative for

Childhood Cancer

Target 60% survival

To save 1 million lives by 2030

Launch

201818

2021

23

2023

>50

2025

Global strategy to accelerate

the elimination of cervical

cancer as a public health

problem

Target elimination of cervical

cancer by 2100

WHO global

breast cancer

initiative

Launch Q1

2021

WHO Initiative

5

425,000 children (0-19 yrs) Five-year survival

<20% LMIC

Incidence Mortality

HIC >80%85% in LMIC;

not preventable~100,000 amenable deaths

per year

Treatment services not accessible

55%

Low quality care

30%

No capacity to diagnose

5-15%

Delays

(weak PHC)

5-15%

What explains survival difference?

Justification and Context

R & D

Manufacture

Market registration Select,

pricing, reimburse

Procure, supply

Prescribe

Dispense Use

Small market with poorrevenue incentives

Unpredictable market: low and unreliable volumes

High market entry costs, cumbersome registration

Inefficient selection, poor pricing, limited cancer budget

Fragmented supply chain, facility-based purchasing,

inaccurate forecasting

Absent, outdated or inappropriate guidelines

Frequent stock-out, abandonment of treatment

Need for end-to-end support

Value Chain Approach to Cancer Products

Benefit package composition

Patent filing

Registration records

National EML

National guidelines

Accessible at point of careAffordable, diagnostics & workforce

Pricing approaches

WHO database & survey

MPP (MedsPal)

Government websites and industry

WHO database, partners (Toronto), web

WHO database and partner repositories

ESMO surveysWHO Country missions

WHO database (countries, MedMon), partners (e.g. IQVIA, St Jude)

Data sources

Post-market surveillance

Access to Medicines: Data


Patent filing


National EML

National guidelines


Pricing approaches

Current situation: Current drug prices in country

New scenario: Global reference drug prices

Potential annual saving

= $500,000

ItemGlobal ref

cost per unitPrice paid by country

% difference

5-FU, 500mg vial (50mg/ml) 2.40 5.71 138%

Cisplatin 50mg (1mg/ml) 6.05 22.14 266%

Cyclophosphamide, 1g 9.25 5.43 -41%

Docetaxel 20mg/ml, 80mg 17.51 21.43 22%

Doxorubicin, 50mg vial 5.41 20.71 283%

Etoposide 100mg (20mg/ml) 2.03 10.00 393%

Filgastrim, 30 MU 4.50 54.29 1106%

Irinotecan, 300mg 4.66 220.53 4637%

Letrozole 0.42 0.95 128%

Leucovorin, 50mg 2.34 4.54 94%

Oxaliplatin, 100mg 74.77 18.33 -75%

Paclitaxel 100mg (6mg/ml) 11.08 107.14 867%

Tamoxifen, 20mg tablet 0.11 0.08 -33%

Zoledronic acid 4mg 25.45 164.29 546%



Patent filing


National EML

National guidelines


Pricing approaches

1. Who is purchasing? Government or facility2. Who is supplier? Any oversight?3. What volumes are needed? Forecasting and

tender limitations

Bias against childhood cancer ?

10% Arsenic vs

80% cisplatin

Bias toward expensive therapies ?

60% rituximab vs

40% 6-MP

Substandard and Falsified Products


Patent filing


National EML

National guidelines


Pricing approaches

Post-market surveillance

• Cancer products for inclusion in PQ programme– Mandate and partner network available

• WHA 70.12 (2017)• WHO Global initiatives (childhood, cervical and

breast) and development bank interest

– Technical products in place• Management guidance available/emerging

– Evidence of need – market analysis complete• SF products document → patient harm• Market failures common

– Successful case studies – monitoring country impact• WHO/UN procurement for all cancer products• Biosimilars trastuzumab and rituximab, HPV test

Conclusion

• WHO cancer team ready for detailed dialogue– Draft list of products,

list of countries

– Broad multi-sectoral network engaged with resources available

THANK YOU

André M. Ilbawi

[email protected]



Patent filing


National EML

National guidelines


Pricing approaches

Country Inclusion ExclusionTotal number of

intervention (pages)

Cost informa

-tion

A Cancer diagnostics and treatmentSelect advanced

therapies>10,000 (1383) Yes

B

Cervical and breast cancer treatment.

Diagnosis and complications from other cancers, e.g. anaemia or

obstruction

Cancer treatment other

than cervical and breast

cancer.

~100 (3) No

CChemotherapy (details), surgery

(details) and radiotherapy (details)Not specified

~1000-2000 (26)

Yes

D 8 cancersRanked priority (high, medium,

low)400 No

E Cervical cancer screening Not specified 100-200 (5) Yes

Only 9% of countries cost cancer plans

Of 5 countries,

only 2 cover > 10

medicines in WHO EML



Patent filing


National EML

National guidelines


Pricing approaches

Medicine on EML# of countries

(139)

Prednisolone 131

Methotrexate 127

Tamoxifen 117

Cyclophosphamide 115

5-Fluorouracil 110

Vincristine 107

Cisplatin 92

Mercaptopurine 88

Asparaginase 67

Filgrastim 55

Tretinoin (ATRA) 47

Imatinib 44

Trastuzumab 34

Pegaspargase 4

Medicine on nEML(not on WHO EML) # of countries

Bevacizumab 34

Sample findings:• # of countries with trastuzumab =

# of countries with bevacizumab (25% of nEML)



Patent filing


National EML

National guidelines


Pricing approaches

Adjuvant trastuzumab indicationsSystematic review of breast cancer clinical GLs (2008-2018; n=49)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

HIC UMIC LMIC LIC

All T>1cm T>0.5cm

pT1a

pT1b

Budget impact (KYG): trastuzumab for all HER2+: > $USD 10mil (3-5x estimated current budget)

Discordant with nEML for 90% LMIC



Patent filing


National EML

National guidelines

Pricing approaches

ESMO International Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines



Access to Medicines: WHO SupportBenefit package composition and selection

Registration

National guidelines

Pricing approaches

WHO pricing database

Assessment toolPlanning / costing Workforce strategy



Patent filing


National EML

National guidelines


Pricing approaches

ItemGlobal ref

cost per unitPrice paid by country

% difference

5-FU, 500mg vial (50mg/ml) 2.40 5.71 138%

Cisplatin 50mg (1mg/ml) 6.05 22.14 266%

Cyclophosphamide, 1g 9.25 5.43 -41%

Docetaxel 20mg/ml, 80mg 17.51 21.43 22%

Doxorubicin, 50mg vial 5.41 20.71 283%

Etoposide 100mg (20mg/ml) 2.03 10.00 393%

Filgastrim, 30 MU 4.50 54.29 1106%

Irinotecan, 300mg 4.66 220.53 4637%

Letrozole 0.42 0.95 128%

Leucovorin, 50mg 2.34 4.54 94%

Oxaliplatin, 100mg 74.77 18.33 -75%

Paclitaxel 100mg (6mg/ml) 11.08 107.14 867%

Tamoxifen, 20mg tablet 0.11 0.08 -33%

Zoledronic acid 4mg 25.45 164.29 546%https://globalpricing.com/news/pfizers-newest-range-of-biosimilars-are-set-to-significantly-undercut-roches-best-selling-avastin-herceptin-and-rituxan-on-pricing-what-will-be-the-impact-on-roc/

https://globalpricing.com/news/pfizers-newest-range-of-biosimilars-are-set-to-significantly-undercut-roches-best-selling-avastin-herceptin-and-rituxan-on-pricing-what-will-be-the-impact-on-roc/

Coherency Across Value Chain


Patent filing


National EML

National guidelines

Pricing approaches


Country A Country B

Yes No

Yes

Yes, subcutaneous

No

None

No

NoOOP with some coverage

N/A

None

Yes

Yes

Successful

Access to Medicines: Data and Support

National policies & priorities

Essential medicine list

Clinical guidelines &

protocols


Patent filing


National EML

National guidelines


Pricing approaches

Need for end-to-end support?

Access to Medicines: Integrated UN Support

What? UN agencies generate LTA or pool request, initiate tender, negotiate price, facilitate supply • Medicines selected among EMLc• No/limited role in warehousing

Why? • Improve quality = only accept SRA-approved

manufacturers• More favorable process = volume • Faster availability = bypass regulatory pathways

How?• Governments commit / finance • Work with UNICEF, UNDP & others

expanding access to essential cancer products

Documents