[Ip-health] WHO publishes Meeting Report of the Informal Advisory Group on the Availability and Affordability of Cancer Medicines

Thiru Balasubramaniam thiru at keionline.org
Mon Jul 2 23:59:09 PDT 2018


WHO publishes Meeting Report of the Informal Advisory Group on the
Availability and Affordability of Cancer Medicines
Posted on July 2, 2018 <https://www.keionline.org/28272> by Thiru

In May 2017, the 70th World Health Assembly passed a cancer resolution
(WHA70.12, Cancer prevention and control in the context of an integrated
approach <http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_R12-en.pdf>).

At the time KEI provided the following commentary on the cancer resolution

On Tuesday, May 30, 2017, delegates meeting at the 70th World Health
Assembly in Geneva passed a resolution that gives the World Health
Organization (WHO) a new mandate for its work on cancer prevention and
treatment. The resolution is an important milestone in focusing the
attention of the UN body on the disparities of access to treatment. The
most controversial issue in the resolution was the text dealing with
pharmaceuticals, and in particular, pricing and access, transparency of R&D
costs, and to conduct a feasibility study of delinking R&D costs, including
incentives, from drug prices. (James Love)

The World Health Organization has a fresh mandate that we think can be used
to address the most transformative reforms to make cancer drugs available
at affordable prices, but it will take a lot of work to move this forward.
We look for Dr. Tedros to take the bull by the horns to lead WHO’s work on
transparency, affordability, and delinkage. (Thiru Balasubramaniam)

The cancer resolution instructed the Director-General:

to prepare a comprehensive technical report to the Executive Board at its
144th session that examines pricing approaches, including transparency, and
their impact on availability and affordability of medicines for the
prevention and treatment of cancer, including any evidence of the benefits
or unintended negative consequences, as well as incentives for investment
in research and development on cancer and innovation of these measures, as
well as the relationship between inputs throughout the value chain and
price setting, financing gaps for research and development on cancer, and
options that might enhance the affordability and accessibility of these
medicines. (Source: WHA70.12).

The technical report will be submitted to the Executive Board by October
2018 for its consideration in January 2019; WHO will convene a member state
and stakeholder discussion on the technical report during the third quarter
of 2018.

As part of the WHO’s implementation of the cancer resolution, the
Secretariat convened a meeting of an informal advisory group from 4 April
2018 to 6 April 2018 to “provide expert advice on the benefits and
consequences of various pricing approaches and on options for improving the
availability and affordability of cancer medicines” (Source: Improving
affordability and effectiveness of cancer medicines
WHO, 29 June 2018). On Friday, 29 June 2018, the World Health Organization
(WHO) published the 13-page Meeting Report
 of the Informal Advisory Group on the Availability and Affordability of
Cancer Medicines

WHO convened the informal advisory group to provide expert advice on:

   - the scope of the report, analytical feasibility and case studies;
   - the benefits and consequences of various pricing approaches for cancer
   - options for improving availability and affordability of cancer

In relation to transparency and the price of cancer medicines, the advisory
group provided the following analysis:

Transparency: Sustainable pricing, access and health care systems must be
based on transparency, although it was noted that definitions of the term
are varied and inconsistent. Areas needing clarification include the
specific information to be made transparent, the relevant stakeholders who
need access to that information, and the objectives and outcomes of such a
transparent system. For example, the net transaction prices of cancer
medicines should be disclosed to relevant stakeholders,but perhaps not to
the public. On the other hand, pricing and reimbursement decisions, their
impact and rationale should be communicated to the public when appropriate,
to foster a common understanding and promote accountability.The technical
report should analyze the potential consequences of making (actual) prices
publicly available.

In relation to transparency and the R&D costs of cancer medicines, the
advisory group said,

Research and development costs: Transparency is also needed regarding
public spending on, and public sources of funding for,research and
development. A single medicine may be used to treat multiple stages of
disease or for different indications, making it difficult to appropriately
allocate research and development costs. The technical report should
discuss the influences of these costs, comparators, competitors and
consumers on pricing of medicines.

In terms of pricing of cancer therapies, the advisory group noted that it
is “difficult to establish how industry sets prices since there are
variable markets and information asymmetry”.

Pricing policies in countries: Countries are urged to create and enforce
policies for equitable access, sustainable supply and procurement. It is
difficult to establish how industry sets prices, since there are variable
markets and information asymmetry. The price setting for patented products
is different from generic products. Some prices of patented medicines are
confidential and therefore non-transparent, though there is some indication
that policymakers are becoming increasingly aware of the impact and
consequences of policies that rely on external reference pricing (ERP, see

With respect to health technology assessment and external reference pricing
(ERP), the advisory group said,

Controlling costs: Launch prices can be high, although mechanisms such as
health technology assessment(HTA), ERP, and additional negotiation may
result insubstantial discounts. The experts recommended that the report
should discuss the role of negotiation in obtaining affordable prices for
cancer medicines and describe the relative success across countries.
Proactive engagement by governments in determining initial pricing for a
product and improving negotiation skills could be initial steps in
controlling spending.There is a lack of knowledge about the clinical
benefits and risks of many newer cancer medicines, particularly at launch
when initial pricing and coverage is determined. It is important to be able
to identify patients who will benefit from certain medicines to keep the
costs under control. Newer generation medicines that extend longevity are
associated with increased costs because of longer treatment courses and
higher unit costs.

The advisory group further contended that external reference pricing would
not lead to equitable access.

In relation to managed entry agreements, the advisory group provided the
following analysis,

Experts pointed to a lack of concurrence on the scope and structured
processes of managed entry agreements implemented to date. While these
should not become the norm, managed entry agreements could be useful in
exceptional cases for expenditure control, for example in the case of
medicines with anticipated high expenditure and uncertain longer-term
clinical benefits. The utility of managed entry agreements must be weighed
against the administrative burden and appropriate contract terms. Questions
to explore include the impact of such policies on evidence generation, and
their feasibility in low-income countries.

In terms of patient access initiatives, the advisory group highlighted the

challenges created when products are provided to patients prior to national
assessment or outside of the regular reimbursement system. These create
pressure on the country to continue access and they support a lack of

The advisory group provided the following analysis in relation to the role
of biosimilar cancer medicines in promoting competition,

Competition: Leveraging competition on price and supply among cancer
medicines, including patented medicines that produce similar outcomes, was
suggested.For products that have gone off-patent, any misperception of
inferior quality of generic or biosimilar medicines should be corrected.
National regulatory requirements for biosimilars could be streamlined to
promote competition and to avoid the duplication of clinical trials in
different national settings.

In relation to voluntary licensing, the expert advisory group recommended
to expand the mandate of the Medicines Patent Pool (MPP). In addition, the
advisory group recommended “taking advantage of the flexibilities offered
in the Trade-Related Aspects of Intellectual Property Rights

Some of the key policy options proposed by the advisory group included:
- Mechanisms should be explored for designing differential pricing that is
sensitive to the health system’s ability to pay and that takes into
consideration the costs of goods. The design of such a system should be
driven by country and regional needs, rather than reactive to market forces.
- Price increases without explicit justification should be prohibited. It
could be useful to leverage competition on price and supply among cancer
medicines with suitable substitutes, including patented medicines that
produce similar outcomes.
- Various options were suggested for promoting cross-sector and
cross-border collaboration for information sharing, regulatory measures,
and procurement. Possibilities include a) sharing information on medicine
prices and technical assessments (for example horizon scanning and HTA) and
b) encouraging regulatory requirements for biosimilar medicines to ensure
safety and quality,to stimulate competition and to avoid duplication of
clinical trials in different national settings. Pooling efforts for
negotiation and procurement, particularly for patented medicines, should be
put in place where appropriate and practicable.
- The use of voluntary licensing and the mandate of the Medicines Patent
Pool should be expanded, and the flexibilities of the TRIPS agreement be
implemented to facilitate access to affordable treatment when necessary.
- Transparency of pricing approaches and prices of cancer medicines needs
to be improved. Relevant stakeholders should disclose the net prices of
cancer medicines, although full public transparency may or may not be
- Prices along the value chain have to be controlled including mark-ups.
Costs of research, development and production, including any public sources
of funding, should be reported to the public when appropriate. This will
help foster a common understanding and promote accountability.
- Incentives for research and development on cancer treatment should be
realigned and updated. Incentives are particularly needed for research on
cancers affecting smaller populations (rare cancers, paediatric cancers and
formulations for pediatric oncology),and for health service research to
improve system efficiencies (rational use and packages of care).

The experts of the advisory group will “provide ongoing additional data and
information to support technical analyses and case studies” to feed into
the comprehensive technical report on cancer. In addition, it is understood
that the Member State and stakeholder discussion on the technical report
(to be held in the third quarter of 2018) will provide an opportunity to
share perspectives including any lacunae. For example, the zero draft of the
 WHO Roadmap on Access to Medicines and Vaccines 2019-2023
 includes language directing that coordinated actions on health research
and development be predicated upon the principle of delinkage – something
that is currently missing in the report of the advisory group. Perhaps this
could be addressed in the technical report’s discussion of incentives on
R&D on cancer therapies, including “options that might enhance the
affordability and accessibility of these medicines.”

The list of participants for the April 2018 consultations is reproduced

Annex: List of participants

Expert advisers

Moses Chisale Central Medical Stores Trust, Malawi
Avram Denburg University of Toronto, Canada
Gihan Hamdy El-Sisi Ministry of Health and Population, Egypt
Saed Jaddoua King Hussein Cancer Center, Jordan
Jin Soo Lee Korea National Cancer Center (Emeritus)
Miriam Naarendorp Ministry of Health, Suriname
Kamaruzaman bin Saleh Ministry of Health, Malaysia
Sakthivel Selvaraj Public Health Foundation of India
Netnapis Suchonwanich National Health Security Office (Emeritus), Thailand
Fatima Suleman (Chair) University of KwaZulu-Natal, South Africa
Richard Sullivan Kings Institute of Cancer Policy, United Kingdom
Fola Tayo Caleb University, Nigeria
Sabine Vogler Austrian Public Health Institute

All experts completed the Declaration of Interest form.

The Secretariat considers that none of the declarations constitute a
conflict with the objectives of the group.


Suzanne Hill Director, EMP Department
Sarah Garner Coordinator, EMP/IAU
Hanne Bak Pedersen Regional Advisor, WHO Regional Office for Europe
Andrew Rintoul EMP/IAU
Nicola Magrini EMP/IAU
Lorenzo Moja EMP/IAU
Allison Colbert EMP/IAU
Swathi Iyengar EMP/IAU
Anne Hendriks EMP/IAU
André Ilbawi NVI/MND
Dario Trapani NVI/MND

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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