EML Cancer Medicines Working Group - Elisabeth de Vries on behalf of the EML Cancer Medicine Working Group - WHO | World Health ...
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EML Cancer Medicines Working Group Elisabeth de Vries on behalf of the EML Cancer Medicine Working Group
Cancer: Estimated number of new cases from 2020 to 2040 (0-85+)
~10M deaths
Estimated age-standardized incidence rates (world) in 2020, all cancers
Estimated age-standardized mortality rate (world) in 2020, all cancers
Essential Medicines List of the World Health
Organization for solid tumors
Hormonal Immune checkpoint
Chemotherapeutic medicines Targeted agents Supportive medicines
medicines inhibitor
Bleomycin Gemcitabine Erlotinib Abiraterone Nivolumab Allopurinol
Calcium folinate Ifosfamide Gefitinib Anastrozole Pembrolizumab Mesna
Capecitabine Irinotecan Afatinib Bicalutamide Zoledronic acid
Carboplatin Methotrexate Trastuzumab Leuprorelin Filgrastim
Cisplatin Oxaliplatin Imatinib Prednisolone
Cyclophosphamide Paclitaxel Tamoxifen
Vinblastine
Dactinomycin
Vincristine
Docetaxel
Vinorelbine
Doxorubicin
Etoposide
Fluorouracil
21st WHO Model List of Essential Medicines (March 2019, Amended March 2020)ESMO International Consortium study
Cyclo Cyclo Etoposide MTX MTX
Country: Anastrozol Bleomycin Capecitabine Carboplatin Cisplatin (IV) (tab) DTIC Docetaxel Doxorubicin Epirubicin (IV) 5-FU Ifosfamide Irinotecan (IV) (tab) Oxaliplatin Paclitaxel Tamoxifen VBL VCR Trastuzumab Imatinib
Argentina
Australia
Canada
Chile
High Income
Cyprus
Israel
Japan
Korea, South
Kuwait
New Zealand
Oman
Qatar
Saudi Arabia
Singapore
United Arab Emirates
USA
Uruguay
Venezuela
Algeria
Upper middle Income
Brazil
China
Colombia
Cuba
Dominican Republic Always
Ecuador
Iran
Iraq
Usually
Kazakhstan
Lebanon
Half the time
Malaysia
Mexico
Occasionally
Peru
South Africa Never
Suriname
Thailand Not available
Tunisia
Turkey Missing data
Bangladesh
Egypt
El Salvador
Lower middle
Ghana
India
Income
Indonesia
Kenya
Mauritania
Morocco
Myanmar
Pakistan
Palestine
Philippines
Sudan
Vietnam
Zambia Cherny et al,
Afghanistan
Burkina Faso
Ann Oncol 2016
Income
Cambodia
Low
Haiti
Malawi
Nepal
Tanzania
Uganda
ZimbabweWHO EML 2017, Cancer Medicines Working Group
• The Expert Committee recommended establishment of an EML Cancer Medicines
Working Group
• to coordinate comprehensive evaluation of available treatment options,
across treatment lines and including recently approved medicines
• to support WHO in establishing guiding principles, clarifying what constitutes
a clinically relevant therapeutic effect, for granting the status of essential
medicine to a cancer medicineEML for cancer until now
• Cancer medicines listed since 1st list in 1977
• The last 3 updates doubling of listed cancer medicines, including:
• Addition of biologicals
• 2nd-line therapies
• Immune checkpoint inhibitors
• 57 medicines, 12% of all listed EML medicines.
• Medicine selection
• Curative treatments got highest priority based on delivered benefit (cure or extended survival)
• Threshold for benefit adopted in 2019 by the Expert Committee:
4-6 months survival benefit & ESMO-MCBS score A and B or score 4-5
• Many remain unaffordable at country level
• Comparisons of WHO EML and national EMLs for cancer highlights differences across
countries. Cancer, the clinical discipline, where most countries fall short and often
diverge by listing medicines not recommended by WHO.
➢ Therefore, there a potential role for guidance on medicines for countriesCountries of the members Cancer Medicine Working Group 2020-2021
Proposals for EML procedure
• Available in the WHO website
➢Unsolicited proposals:
1. Pharmaceutic companies
2. Other clinical groups
➢Solicited proposals:
Cancer Medicine working group decided to ask which cancer medicines were considered
relevant:
1) ESMO (ESMO Guideline committee)
2) Indian National Cancer Grid
3) Contacts Latin American countries
→Cancer Medicine working group indicated which medicines relevant
1. Proposals requested from ESMO
2. Secretariat EML commissioned other proposals
•The general principles for the consideration of essential cancer
medicines by the working group
• Efficacy / benefit
• A threshold for benefit: ≥ 4-6 months survival gain
• ESMO-MCBS score of A or B (curative setting), or 4 or 5 (non-curative setting)
• Type of trials
• Availability of data from >1 trial
• Data from high-quality RCTs most important; data must be mature to assess impact on overall
survival; data should show consistent results across trials
• Information about deployment of cancer regimens in countries with varying resources and clinical
capacity useful
• Trials defining need for and length of maintenance therapy are of interest (< treatment durations
that compromise efficacy marginally or not at all, might reduce outlays and allow more patients
treatment access)
• Superiority trials preferred to non-inferiority trials, but non-inferiority trials can be informative
• Disease stage and line(s) of therapy
• Medicines effective in 1st-line are more clinically meaningful and therefore highly desirable
• Indication to be listed
• Inclusion of a medicine on the Lists for an indication does not imply it should be considered
essential for other indicationsSubmissions received for cancer medicines for 2021 EML
• 23 submissions, ~ 30% of all applications to be reviewed:
• 16 applications for new cancer medicines
▪ 7 applications for hematological indications
▪ 9 applications for solid tumor indications
▪ (5 x mAb, 7 x targeted therapies, 2 x hormones, 1 x cytotoxic, 1 x supportive)
• 6 applications for new indications for existing listed cancer medicines
• 1 submission reviewing the available evidence for CAR-T cell therapy (not
proposed for EML inclusion at this time).
→Including 6 applications specifically for children’s cancer – new medicines (2) and new
indications for existing medicines (4)Results application evaluation by the working group
• 16 applications for new medicines – 4 supported by the working group
o Haem adult – x1 ibrutinib CLL
o Solid adult – x1 immune checkpoint inhibitors in NSCLC
o Solid children – x1 everolimus SEGA
o Supportive children – x1 rasburicase
• 6 applications for new indications for existing listed medicines – all
supported by the working group
o Children – 10 new indications (7 solid, 3 haem) for 15 currently listed medicines
(mostly cytotoxics and corticosteroids, only imatinib targeted)
o Adults – 2 new indications for 2 currently listed medicines (1 x solid (carboplatin
head/neck), 1 x haem (imatinib ALL))The enormous issue of high medicine prices
Monoclonal antibodies per disease area
Mullard, Nat Rev Drug Discov 2021WHO initiatives regarding cancer medicines
• WHO Technical Report Pricing of cancer medicines and its impacts
(https://apps.who.int/iris/handle/10665/277190)
• Updated WHO Guideline on country pharmaceutical pricing policies
(https://www.who.int/publications/i/item/9789240011878)
• Pilot procedure for Prequalification of Biotherapeutic Products and Similar Biotherapeutic
Products (trastuzumab and rituximab). To date, 9 PQ’d trastuzumab and 6 PQ’d rituximab)
• WHO cancer prioritization and costing tool: In WHO report on cancer:
https://www.who.int/publications/i/item/who-report-on-cancer-setting-priorities-investing-
wisely-and-providing-care-for-all
• WHO Global cancer initiatives:
1. Global Initiative for Childhood Cancer (https://www.who.int/publications/m/item/global-
initiative-for-childhood-cancer)
2. Global strategy to accelerate the elimination of cervical cancer
(https://www.who.int/publications/i/item/9789240014107)
3. Global breast cancer initiative
(https://www.who.int/news/item/08-03-2021-new-global-breast-cancer-initiative-highlights-
renewed-commitment-to-improve
survival#:~:text=A%20major%20new%20collaborative%20effort,an%20estimated%202.5%
20million%20deaths.)Conclusion: EML and Cancer • Increasing number of patients with cancer • Many good cancer medicines • More good cancer medicines to come • Unequal access to cancer medicines • High prices of cancer medicines make them often unaffordable
Acknowledgment • Cancer Medicine Working Group members • EML staff at WHO
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