THE CHALLENGE AND OPPORTUNITY

image6

Advances in childhood cancer care have made cure a reality for more than 80% of children in high-income countries (HICs). Sadly, these advances have not translated into similar success in low- and middle-income countries (LMICs). In these countries, where approximately 80% of the world’s children live, less than 20% of children will be cured.


A major impediment to the effective care of children with cancer in LMICs is lack of access to essential medicines. This lack of a consistent supply of affordable and high quality chemotherapies can be predicated by unpredictable demand, difficulties in procurement, ill-defined or unreliable distribution mechanisms, limited national formularies, erratic drug prices and stocks, unsuitable product formulations and uncertain quality, and the need for families to pay for these medicines. 


Access to essential medicines is one of the key determinants of childhood cancer survival globally. The World Health Organization’s (WHO) Essential Medicines List (EML) sets the basic bar that all national governments should meet in the provision of medicines. The recently revised EML includes an expanded list of core medicines required for multiple cancer treatments, including the most prevalent childhood cancers. Ensuring access to such medicines is an explicit component of the broader right to health enshrined in international human rights conventions. Additionally, access to essential radiotherapy is also recognized to be an essential component for decreasing mortality of children diagnosed with cancer around the world. 


Growing recognition of the mounting role that pediatric cancer will play in global childhood mortality has created a window of opportunity for innovative collective action on this issue. lacc

image7

As a response to this global disparity and need to increase access to childhood cancer essential medicines for 80% of the world’s cancer children living in LMICs, the ACCESS (Access to Childhood Cancer Essentials) Initiative was launched in January of 2018, in Sharjah UAE. 


Under the patronage of Her RoyalHighness, Sheikha Jawaher Bint Mohammed Al Qasimij, andsponsorship by the American Childhood Cancer Organization (ACCO) and Friends of Cancer Patients (FOCP), co-chairs Dr. Avram Denburg, pediatric oncologist from Sick Kids Hospital, Toronto and chair of the SIOP Essential Medicines Group, and Ruth Hoffman, CEO of ACCO and President of Childhood Cancer International brought together high-level stakeholders who were committed to addressing this global disparity. Representatives from the global childhood cancer community, international health governance institutions, international development institutions, civil society, corporate partners, academia and the pharmaceutical industry worked collectively to identify tractable, scalable and sustainable solutions to current barriers to drug access for children with cancer in LMICs.

image8


Among the priority actions articulated by ACCESS stakeholders was the need for improvements in drug procurement through accurate forecasting and innovative financing. The establishment of a Global Childhood Cancer Drug Bank, modeled on existing initiatives for vaccines and antimicrobials, was endorsed as a key component of efforts to ensure efficient, cost-effective, consistent and quality supply of essential cancer medicines for children.

image9

Availability

image10

Availability relates to how medicines are produced and distributed. Barriers to availability include but are not limited to: inadequate drug production, secondary to weak market incentives or poor forecasting of childhood cancer treatment needs; national failures to comply with EML recommendations; and rigid regulatory frameworks governing drug licensing and importation.


Availability Goals:


1.  Development of a database listing reliable suppliers of essential pediatric cancer drugs.


2.  Research to assess and understand barriers to national formulary compliance with EML recommendations across LMICs.


3.  WHO-led attempts to harmonize national regulatory regimes through regional collaboration, to facilitate pooled procurement.


4.  Efforts to develop a not-for-profit capacity for the development of off-patent cytotoxics for children, with the potential for global scale-up.

Accessibility

image11

Accessibility refers to a given medicine’s location in relation to the person in need. Cancer medicines are often inaccessible in LMICs because of weak systems of supply management, including poor inventory controls, fractured supply channels, and inadequate infrastructure for proper transport and storage.


Accessibility Goals:

 

1.  Human resource investments in pediatric pharmacists, whose scientific and on-the-ground knowledge is critical to sound policies on supply chain management for childhood cancer drugs.


2.  Development of specific guidelines on infrastructural and oversight requirements for injectable chemotherapeutics for children.


3.  Formalized voice for childhood cancer experts in national policymaking on drug procurement and supply.

Acceptability

image12

Medicines for children with cancer are distinct since many require formulation as sterile injectables; consequently, they are complicated to produce, require cold storage, and have short shelf lives. Moreover, they are dosed by weight or body surface area, making it difficult to manufacture vials that minimize waste, or for pills, doses appropriate to varying stages of child development. These characteristics often limit drug acceptability. 


Acceptability Goals:


1.  Development of intra- and inter-institutional policies to minimize vial wastage. 


2.  Regional partnerships with trusted producers to ensure reliable production processes, with a view to minimizing the introduction of potential harmful excipients.


3.  Research into patient and provider experiences of cancer medicines use in LMIC settings.

Affordability

image13

Affordability refers to the relationships between cost, price, and ability to pay and addresses issues related to drug price determination, how medicines are purchased, and the effects of these factors on patient access. Barriers to affordability include national resource constraints and competing health system priorities; small, fragmented markets for pediatric cancer drugs; thin industry profit margins due to patent expiry; and absence of public or employer-based health insurance.


Affordability Goals:


 1.  Expanded public insurance coverage for essential childhood cancer medicines.


2.  Regionally pooled purchasing.


3.  Reduction or removal of importation tariffs on childhood cancer medicines.


4.  Exploration of innovative financing approaches to the provision of off-patent cytotoxics.

Quality

image14

Quality incorporates drug safety and efficacy and addresses problems related to drug counterfeiting, improper production, and inadequate quality surveillance or absent pharmacovigilance. 


Quality Goals:


1.  Development of a certified list of reputable drug suppliers and formulations to guide national procurement.


2.  Improved modalities of inter-institutional and health care user knowledge sharing on drug quality, including through creative uses of mobile technology, to facilitate improved post-marketing quality surveillance.


3.  Enhanced training programs for LMIC pharmacists and bedside providers in the safe and accurate preparation and administration of chemotherapeutics in children.


4.  Expanded research into novel, cost-effective point-of-care quality diagnostics.