WHO Expert Committtee adds trastuzumab, imatinib, daclatasvir, sofosbuvir, bedaquiline and delaminid to EML

On Friday, 8 May 2015, the World Health Organization (WHO) unveiled its 19th WHO Model of Essential Medicines (April 2015).

With respect to cancer drugs (Section 8.2, Cytoxic and Adjuvant Medicines), the Executive Summary noted that the Committee added 16 new medicines.

These medicines will be included on the complementary list of the EML for the treatment of specific cancers. The Committee recommended that the Model Lists should specify the cancers for which use of each medicine is recommended. Among the medicines recommended are some high-cost medicines including imatinib, trastuzumab and rituximab. The Committee also recommended, among others, the addition of aromatase inhibitors, bendamustine, capecitabine, cisplatin, oxaliplatin and transretinoic acid.

It should be noted that in January 2013, Knowledge Ecology International (KEI), the University of California (San Francisco), Universities Allied for Essential Medicines (UAEM), Third World Network (TWN) and Young Professionals Chronic Disease Network: YP-CDN submitted a Proposal for the Inclusion of Trastuzumab in the WHO Model List of Essential Medicines for the Treatment of HER2-Positive Breast Cancer to WHO’s Expert Committee on the Selection and Use of Essential Medicines. 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.

With respect to antituberculosis medicines (Section 6.2.4), the Executive Summary noted,

For the treatment of multi-drug resistant tuberculosis (MDR-TB), extensively drug resistant tuberculosis (XDR) and pre-XDR, the Expert Committee recommended the addition of bedaquiline, delamanid and linezolid to the complementary list, and the addition of terizodone(as an alternative to cycloserine) to the core list. Similarly, linezolid and terizidone were recommended for the EMLc. The Committee supports the use of these medicines recommended in WHO guidelines, with careful selection of patients, close monitoring to control adverse events and active pharmacovigilance. The Committee also recommended the addition ofrifapentine to the core list of EML and EMLc for the treatment of latent TB infection.

With respect to antihepatitis medicines (Section 6.4.4), the Executive Summary noted,

The Expert Committee recommended that a new section be inserted to the core EML to include medicines for the treatment of viral hepatitis infections, with sub-sections for hepatitis B, and hepatitis C. The Committee recommended the addition of entecavir and tenofovir for the treatment of hepatitis B, and the addition of six oral direct-acting antiviral medicines including daclatasvir, ledipasvir + sofosbuvir, ombitasvir + paritaprevir + ritonavir with or without dasabuvir, simeprevir, and sofosbuvir, for the treatment of hepatitis C. The recommendations for inclusions were based on the comparative efficacy, increased tolerability and the potential public health impact of these medicines. The very high cost of hepatitis C medicines was considered and the Committee recommended that WHO take actions at global level to make these medicines more accessible and affordable.

In a press release WHO released today, “WHO moves to improve access to lifesaving medicines for hepatitis C, Drug-resistant TB and cancers” the Organization noted,

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.

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 currentlymake 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.

“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.” (Source: WHO Press Release, 8 May 2015, WHO moves to improve access to lifesaving medicines for hepatitis C, Drug-resistant TB and cancers

Here below is a compilation of quotes from various actors in reaction to the publication of the 19th WHO Model List of Essential Medicines.

Ellen ‘t Hoen, Medicines Law & Policy

This is huge. 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. 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. Essential Medicines need to be affordable medicines.

Dr. Jennifer Cohn, Medical Director, MSF Access Campaign

The EML is an essential tool for countries, regulators and procurers—such as Médecins Sans Frontières—alike. The inclusion of medicines just added to the EML sends an important signal that initial high prices should not be a barrier preventing countries from considering use of medicines that can have an important public health impact. Having these medicines on the EML can precisely create the pressure that is needed to overcome pricing and access barriers. The EML can help more proactively signal to manufacturers that they should prioritize registration in high-burden countries, and to countries that they should include the drug on their national EML. EML and the WHO Preqaulitication Programme (PQP) need to work hand in hand to ensure that PQP is strengthened and adequately funded, and can include assessments of more medicine categories supported by the EML.

Dr. Kalyani Menon-Sen, Coordinator, Campaign for Affordable Trastuzumab

The Campaign for Affordaable Trastuzumab welcomes the inclusion of Trastuzumab in the WHO EM list. This is an implicit acknowledgement of our contention that HER2+ breast cancer is a public health emergency in India and in many other countries of the global south. Access to so-called “designer drugs” like Trastuzumab has so far been restricted to those who are able to pay the ridiculous prices demanded by patent-holders. That must change. Now that it is declared an “essential medicine”, it strengthens our hands in demanding that it be provided through the public health system.

KM Gopakumar, Legal Advisor and Senior Researcher, Third World Network

Many new medicines in the new essential medicine list are not available at an affordable price due to patent protection in many WHO Member States. A s result access to these medicines are denied to many needy people. WHO should not only encourage but also provide technical assistance to developing country Member States to take policy measures including use of TRIPS flexibilities such compulsory licenses or government use to break patent monopolies and ensure access at affordable price”.

Dr. Sandeep Kishore, MD/Ph.D
Resident Physician, Yale School of Medicine
President, Young Professionals Chronic Disease Network

This is a watershed moment for the global NCD community, including patients and front-line providers. The move to add key neoplastics, clopidogrel for cardiovascular disease and landmark Hep C drugs helps re-define essentiality based on clinical need — and not cost or cost-effectiveness alone. We now need to ensure that our governments procure and distribute these medicines in the public sector at the cheapest prices possible, if not for free. Matched financing and pre-qualification processes to empower, enable and deliver these core medicines for NCDs will help move the needle – now, not tomorrow for millions of patients with NCDs.

Dr. Kavitha Kolappa
Psychiatry Resident, Massachusetts General Hospital, Harvard University; and board member of YP

This is nothing short of a game-changer, getting as of yet still costly drugs on the WHO EML, it is – simply put, a demonstration of priorities, that we needs these life-saving medications to be cheaper, and we need them now. It is a symbolically powerful step and the WHO is on the right side of history here.