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The World Health Organization’s new list of essential medicines, those which should be available to everyone, anywhere, was issued today. To answer the rising concern about antimicrobial resistance, the antibiotics on the list have been divided in three groups, the last of which are to be used as a last resort. The list includes the first combination therapy to treat all six types of hepatitis C. However, no second line treatment for breast cancer has been added this year.

The Model List of Essential Medicines [pdf] issued today is the 40th edition, which “is an international blueprint for the most important medicines at our disposal to address global priority diseases,” Marie-Paule Kieny, assistant director general, Health Systems and Innovation, told a press briefing today.

The WHO also issued a model List of Essential Medicines for children [pdf].

According to a WHO press release, the updated list adds 30 medicines for adults and 25 for children, and “specifies new uses for 9 already-listed products, bringing the total to 433 drugs deemed essential for addressing the most important public health needs.”

These medicines are chosen according to evidence of safety, efficacy, and public health relevance, she said, adding, “Essential medicines should be available in health systems everywhere at all times.”

The 2017 list took into account a review of all 39 essential antibiotics on the list against 21 common syndromes, she said.

Kieny explained that those antibiotics have been classified into three groups: access, watch, and reserve. This classification seeks to contain antimicrobial resistance, optimise antibiotic treatment, and preserve last resort antibiotics.

The antibiotics in the “access” category have a low resistance potential and should be available at all times, those in the “watch” category have a higher resistance potential and should be limited to a number of indications, and antibiotics in the “reserve” category should be kept as a last resort for life-threatening infections, due in particular to multi drug-resistant bacteria, Kieny elaborated.

Reserve antibiotics include: 4th and 5th generations of cephalosporins. Key access antibiotics include amoxicillin.

“We hope that this new categorisation of antibiotics emerging at a time when political awareness of the issue is high, will increase countries’ commitment to tackle the problem in targeted ways,” she said.

In practice, tackling the antimicrobial issue through a different use of antibiotics requires new energy and new funding, including further research to come up with better implementation practices, she said.

“The political will is there,” she added, but it should be translated into strong policies, including better monitoring of antibiotics use.

Hepatitis C, Leukaemia, TB

Suzanne Hill, director, WHO Essential Medicines and Health Products, remarked on the new addition on the list of the first combination therapy to treat all six types of hepatitis C (sofosbuvir + velpatasvir). This approach as two major benefits, she said. First it allows countries without sophisticated diagnostic equipment to have an option to use one treatment covering all kinds of hepatitis C, and the second is that the treatment is once a day, easy and convenient to take, improving the treatment outcome.

Also on the list a new medicine to treat tuberculosis in children and adolescents who have the form of the illness that is multidrug resistant, she said.

Two additional oral cancer medicines to treat leukaemia that has become resistant to standard treatment have been added to the list, Hill said.

Very High Prices, Scope to Bring Them Down

Currently, many of these medicines are sold at very high prices and may be unaffordable for health systems, irrespective of the wealth of the country, Hill said.

The fact that those expensive medicines are now included in the List of Essential Medicines “sends a strong message to all public health actors,” she said, adding that “those medicines provide true public health benefits and really should be made available when needed.”

Prices must be affordable for health systems, said Hill, mentioning the recently convened Fair Pricing Forum (IPW, WHO, 12 May 2017). For some products, she said, “there is clearly scope to bring prices down considerably for life-saving or priority medicines through a series of strategies such as better cooperation between payers, better transparency about prices, and insuring that the pricing model adopted insures a sufficient return on investment for companies, but does not bankrupt health systems.”

“The essential medicine list is one of the first steps in the direction of fair pricing because when we designate a medicine as essential, buyers have some leverage in negotiating for the final purchase price.”

Marcus Sprenger, director, Antimicrobial Resistance at the WHO, said today is an important day from an antimicrobial perspective. Optimising the use of antibiotics is the 4th objective of the Global action plan on antimicrobial resistance, welcoming the new way of grouping antibiotics in the new list, he said.

Answering a question about the number of medicines still protected by patents, Kieny said some 15 percent of the medicines on the list are still protected.

No New Breast Cancer Medicine, Nor Long-Acting Analogue Insulin

During the annual World Health Assembly held last week, some cancer patients and civil society groups called for new second-line treatments for breast cancer to be added to the list, underlining the fact that those treatments are inaccessible for many women, both in developing and developed countries (IPW, WHO, 30 May 2017). Kieny confirmed that no molecule for second line treatment of breast cancer was added to the list this year.

Health Action International (HAI) today commended a decision by the WHO to reject a proposal to include long-acting analogue insulin to the list.

According to a HAI press release [pdf], the inclusion of long-acting analogue insulins on the list would have “increased pressure on national governments to purchase” those products, which are seven to nine times more expensive than human insulin, “while providing limited added value to users.”

The release explains that insulin, which is used to treat diabetes, is largely off-patent, but has only three manufacturers that dominate 90 percent of the market. There are two main types of insulin: human insulin and analogue insulin, according to the release.