WHO publishes Meeting Report of the Informal Advisory Group on the Availability and Affordability of Cancer Medicines

Posted on 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).

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 medicines;
  • options for improving availability and affordability of cancer medicines

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 below.)

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 transparency.

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 (TRIPS)Agreement”.

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 appropriate.
  • 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 here:

    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.

    Secretariat

    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
    Kiu Tay EMP/IAU
    Allison Colbert EMP/IAU
    Swathi Iyengar EMP/IAU
    Anne Hendriks EMP/IAU
    André Ilbawi NVI/MND
    Dario Trapani NVI/MND