Some Cancer Drugs Excluded from New WHO Essential Medicines List Because of Cost

High cost has prevented some cancer drugs from being included in the World Health Organization’s (WHO) updated Essential Medicines List (EML) and Essential Medicines for List Children (EMLc) released on Wednesday.

These include “patented, highly-priced” treatments for lung and breast cancer.

“With the cancer medicines, we are facing now an issue where we have a very high burden of disease and very expensive, highly-priced medicines,” said Dr Benedikt Huttner, secretary of the expert committee that advises the WHO on the EML.

“For some of the medicines [cost] was one of the factors leading the expert committee not to recommend them currently,” Huttner told a WHO global press conference.

Among the new recommended EML cancer drugs are a treatment for Kaposi sarcoma and a medicine to stimulate the production of white blood cells to reduce the toxic effect of some cancer medicines on bone marrow, as well as the extension of some children’s cancer treatments to cover three additional cancers.  WHO’s essential medicines lists are widely used by countries in medicines procurement choices and decisions about what drugs to include in government subsidized medicines plans. 

Access to medicines a killer for cancer patients

Access to medicines remains a killer for cancer patients, and the 30% survival rate for children with cancer in low-income countries, in comparison to more than 90% for children in high-income countries, reflects this, said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“Every year, an estimated 350,000 children are diagnosed with cancer in low and middle-income countries (LMICs). Many of them cannot access the treatment they need,” noted Dr Tedros.

“Only 25% of low-income countries covered childhood cancer medicines in their health benefit packages. This subjects children and families to significant suffering and financial hardship or puts them at risk of receiving substandard and falsified medicines.”

James R Downing, CEO of St Jude Children’s Research Hospital

EML Pricing group still not formed

Despite several WHO mentions of the high cost of drugs excluded from the list, an EML sub-group on pricing, which was recommended by experts in 2021, still hasn’t been been launched.

At Wednesday’s press conference, Huttner reaffirmed it was going to be set up soon – even though it hasn’t begun its work yet.

“There is actually going to be also an advisory group advising WHO on how to deal with the issue of highly-priced medicines,” he stated.  The new working group is supposed to develop more systematic strategies for monitoring medicines prices and for assessing and making high-priced, but essential drugs more affordable, as part of WHO and EML processes.   

‘Where you live in the world’ is a major determinant for children’s cancer survival

A major determinant of survival for children with cancer is “where you live in the world”, James R Downing, CEO of New York City’s St Jude Children’s Research Hospital, told the press conference.

“In developed countries, we have made incredible progress against paediatric cancer with cure rates approaching 90% for many of the more common paediatric cancers. Yet the rest of the world has been left behind,” he added.

In 2021, St Jude Hospital announced that it would contribute $200 million over six years to improve access to cancer drugs for kids via the Global Platform for Access to Childhood Cancer Medicines, an initiative that it is running with the WHO.

The initiative aims to provide an uninterrupted supply of free, quality-assured cancer medicines to low- and middle-income countries – focusing first on six of the most common cancers that cause over half of childhood cancers. The aim is to raise survival rates to at least 60% in these countries by 2030.

Interruptions in medicines access a key factor undermining children’s survival

This followed earlier work between St Jude and the WHO via the Global Initiative for Childhood Cancer, which identified lack of access to medicine and interruptions in supply as key factors undermining the survival of children with cancer.

“Some 40-60% of children being treated for cancer will have disruptions in their access to chemotherapy, and that decreases their chance of cure,” said Downing. 

“In other countries, the quality of the drugs is not up to standards, and so they’re getting inferior drugs that are leading to inferior treatment.”

The platform is being piloted in six countries initially, with UNICEF as a collaborating partner.

“The idea is that we will set up a secretariat at the WHO that will manage this, and that we will have a procurement agency that will produce those drugs with generic drug producers,” Downing explained.

“We will know the market size because of the analytics that we have developed and then we will be able to ship those drugs into those countries. And we know their capacity to use those drugs effectively to treat children with cancer because they’re part of the St Jude Global Alliance and we have spent energy and time training them and putting forward to them the exact protocols they should be using to treat those children.”

Another challenge is the lack of diagnostic tools to diagnose cancer in LMICs, and St Jude is also working on a platform to develop and distribute cheaper diagnostics.

Children undergoing chemotherapy

Multiple sclerosis drugs included on EML for first time

In other new EML additions, medicines for the treatment of multiple sclerosis (MS) have been included on the essential medicines list for the first time ever, along with new treatments for cardiovascular conditions and infectious diseases.

Three medicines that can slow MS – cladribine, glatiramer acetate and rituximab – have been added. Multiple sclerosis is a chronic, debilitating disease of the nervous system affecting approximately 2.8 million people worldwide. 

Fixed-dose combinations of multiple medicines (commonly called ‘polypills’) for the prevention of diseases of the heart and blood vessels, have also been added to the EML for the first time.

“The list is an important tool for achieving universal health coverage, providing guidance to governments, health facilities and procurers on which medicines are the best value in terms of benefits for individuals and communities. The EML includes medicines only on the basis of solid evidence for safety and efficacy. Approved indications within national jurisdictions or the availability of on-label alternatives is not a decision criterion,” said Huttner. 

Other medicines for infectious diseases that have been listed in the new EML include:

  • ceftolozane + tazobactam, effective against multi-drug resistant bacteria, including difficult-to-treat infections caused by carbapenem-resistant Pseudomonas aeruginosa; the drug is a ‘reserve’ group antibiotic, under WHO’s three-tiered  “AWaRe” system for judicious antibiotic use, meaning it should only be used when other treatments have failed.
  • pretomanid to treat multidrug-resistant or rifampicin-resistant tuberculosis;
  • ravidasvir (to be used in combination with sofosbuvir) for the treatment of chronic hepatitis C virus infection in adults;
  • monoclonal antibodies for Ebola.

Altogether, the recommended changes bring the number of medicines on the WHO essential medicines list, which is updated every two years, to 502 drugs for adults and to 361 for the essential medicines list for children. 

But the WHO warned that “rising prices and supply chain disruptions mean that all countries now face increasing problems in ensuring consistent and equitable access to many quality-assured essential medicines”.

Image Credits: National Cancer Institute, National Cancer Institute, USA.

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