In ‘Huge’ Move, WHO Adds Key Hepatitis C, Cancer, TB Drugs To Essential Medicines List

The World Health Organization today published its updated Model List of Essential Medicines, including high-priced new treatments for hepatitis C, cancers and multi-drug resistant tuberculosis (MDR-TB) that were quickly applauded by the public health advocacy community.

“This is huge,” Ellen ’t Hoen from Medicines Law & Policy told Intellectual Property Watch.

WHO said in a release that the move “opens the way to improve access to innovative medicines that show clear clinical benefits and could have enormous public health impact globally.”

Critical medicines added to the list include trastuzumab (cancer), imatinib (cancer), daclatasvir (hep C), sofosbuvir (hep C), bedaquiline (TB) and delaminid (TB).

“When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them,” WHO Director General Margaret Chan said in the release. “Placing them on the WHO Essential Medicines List is a first step in that direction.”

Hepatitis C affects some 150 million people worldwide and half a million die each year, WHO said. Until recently, the medicines for this had minimal benefits and strong side effects. New breakthrough versions have become available, but “high prices currently make them unaffordable and thus inaccessible to most people who need them,” WHO said.

The list is updated every two years by an expert committee, which WHO said is made up of recognised specialists from academia, research and the medical and pharmaceutical professions. This year, the committee “underscored the urgent need to take action to promote equitable access and use of several new highly effective medicines, some of which are currently too costly even for high-income countries,” the UN health agency said.

The meeting of the 20th Expert Committee on the Selection and Use of Essential Medicines was held from 20-24 April at WHO. According to WHO, the expert committee considered 77 applications for medicines to be added to the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc).

Positive Reaction for Patients

“This is huge” ’t Hoen said. “When the WHO Essential Medicines list (EML) was first conceived as a tool for government and healthcare providers seeking to meet the health needs of their populations, medicines were added to the list when they could be made widely available at low cost.”

“But with the addition of new, important medicines to the WHO Essential Medicines List priced to break the budgets of healthcare systems worldwide, in high-income countries as well as in the developing world, it is clear that the paradigm for the EML has shifted,” she said. “When the WHO deems medicines medically essential, governments, companies and the international community need to take actions to see that they are made available and affordable.”

“Such a response is especially needed as new medicines are increasingly patented around the world and thus only available at monopoly prices that prevent widespread access.” ‘t Hoen added. “Unless we act. Essential Medicines need to be affordable medicines.”

Knowledge Ecology International in a blog post today called the changes to the list “seismic” and a “revolution”.

It said: “Credit for this quiet revolution in the WHO EML which saw the addition of costly cancer drugs (imatinib, trastuzumab and rituximab) must go to the World Health Organization’s Department of Essential Medicines and Health Products (EMP) in shepherding the review of subsection 8.2 on Cytoxic and Adjuvant Medicines (cancer medicines) and the Union for International Cancer Control (UICC) and its partners for conducting a Cancer Medicines Review in 2014.”

The full WHO press release is reprinted below:

WHO moves to improve access to lifesaving medicines for hepatitis C, Drug-resistant TB and cancers

NEW MODEL ESSENTIAL MEDICINES LIST PUBLISHED TODAY

Geneva, 8 May 2015 – The World Health Organization (WHO) today published the new edition of its Model List of  Essential Medicines) which includes ground-breaking new treatments for hepatitis C, a variety of cancers (including breast cancer and leukaemia) and multi-drug resistant  tuberculosis (TB), among others.  The move opens the way to improve access to innovative medicines that show clear clinical benefits and could have enormous public health impact globally.

“When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them,” said WHO Director General, Dr Margaret Chan.  “Placing them on the WHO Essential Medicines List is a first step in that direction.”

Increasingly, governments and institutions around the world are using the WHO list  to guide the development of their own essential medicines lists, because they know that every medicine listed has been vetted for efficacy, safety and quality, and that there has been a comparative cost-effectiveness evaluation with other alternatives in the same class of medicines.

The list is updated every two years by an Expert Committee, made up of recognized specialists from academia, research and the medical and pharmaceutical professions. This year, the Committee underscored the urgent need to take action to promote equitable access and use of several new highly effective medicines, some of which are currently too costly even for high-income countries.

These included new medicines to treat Hepatitis C, which affects about 150 million people globally, killing approximately half a million people each year, when chronic infection develops into liver cirrhosis or liver cancer.  The disease is present in high- and lower-income countries alike, with higher concentrations in several middle- and low-income countries.

Until recently, treatment for the disease presented minimal therapeutic benefits and serious side effects.  Five new medicines – direct acting oral antivirals – have recently come on the market transforming chronic hepatitis C from a barely manageable to a curable condition, the new medicines have few side effects and high tolerance in patients.  All five products, including sofosbuvir and daclatasvir, were included in the List.  But high prices currently make them unaffordable and thus inaccessible to most people who need them.

“Treatments for hepatitis C are evolving rapidly, with several new, highly effective and safe medicines on the market and many in the development pipeline,” said Dr Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation.  “While some efforts have been made to reduce their price for low-income countries, without uniform strategies to make these medicines more affordable globally the potential for public health gains will be reduced considerably.”

Cancers figure among the leading causes of illness and death worldwide, with approximately 14 million new cases and 8.2 million cancer-related deaths in 2012.  The number of new cases is expected to rise by about 70% over the next two decades.  New breakthroughs have been made in cancer treatment in the last years, which prompted WHO to revise the full cancer segment of the Essential Medicines List this year: 52 products were reviewed and 30 treatments confirmed, with 16 new medicines included in the List.

“Some of these medicines produce relevant survival benefits for cancers with high incidence, such as trastuzumab for breast cancer,” explained Dr Kees De Joncheere, WHO Director of Essential Medicines.  “Other treatment regimens for rare cancers such as leukemia and lymphoma, which can cure up to 90% of patients, were added to set a global standard.”

TB remains one of the world’s most deadly infectious diseases.  In 2013, 9 million people fell ill with TB and 1.5 million died from the disease.  Over 95% of TB deaths occur in low- and middle-income countries.  After about 45 years of scarce innovation for TB medicines, 5 new products were included in the EML. Four of these, including bedaquiline and delamanid, target multi-drug-resistant TB.

The Committee also recommended supporting off-label uses in cases where there is clear evidence of major health benefits, though no licensed indication, such as for many medicines for children.

“The Essential Medicines List includes medicines on the basis of safety and efficacy evidence, not on the basis of approved indications within national jurisdictions or availability of licensed alternatives,” added D De Joncheere.  “For example, when it reviewed the application to include ranibizumab, to treat severe eye diseases such as macular degeneration, the Committee looked at  the evidence base and the price difference with bevacizumab – the medicine currently listed. The Committee agreed to maintain bevacizumab as the preferred medicine, rejecting the ranibizumab application. ”

“It is important to understand that the Essential Medicines List is the starting block and not the finishing line,” concluded Dr Kieny.  “Its purpose is to provide guidance for the prioritization of medicines from a clinical and public health perspective.  The hard work begins with efforts to ensure that those medicines are actually available to patients.”

Note to Editors

The meeting of the 20^th Expert Committee on the Selection and Use of Essential Medicines was held from 20 to 24 April 2015 at WHO Headquarters.  The Expert Committee considered 77 applications for medicines to be added to the 18^th WHO Model List of Essential Medicines (EML) and the 4^th WHO Model List of Essential Medicines for Children (EMLc).  WHO technical departments were involved and consulted with regard to applications relating to their disease areas.

Access the medicines list here:

• EML 2015: http://www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf

• EML Children 2015: http://www.who.int/medicines/publications/essentialmedicines/EMLc2015_8-May-15.pdf

• Executive summary:  http://www.who.int/medicines/publications/essentialmedicines/Executive-Summary_EML-2015_7-May-15.pdf

• Hepatitis C WHO fact sheet: http://www.who.int/mediacentre/factsheets/fs164/en/

• Cancer WHO fact sheet: http://www.who.int/mediacentre/factsheets/fs297/en/

• TB WHO fact sheet: http://www.who.int/mediacentre/factsheets/fs104/en/