NEW CANCER DRUGS ADDED TO WHO ESSENTIAL LIST

The World Health Organization (WHO) has added 16 new cancer drugs to its list of essential medicines for low- and middle-income countries.

However, cautioned Gilberto Lopes Jr, MD, MBA, scientific director of Oncoclinicas do Brasil in São Paulo, this does not mean that these drugs are going to be in every doctor's office next week.

"There are a lot of obstacles in the way," he said during a Global Oncology Symposium Special Session held here at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.

Recommendations for the inclusion of these medicines were based on the expertise of more than 90 oncologists who are members of the Union for International Cancer Control, as well as from organizations such as ASCO and the European Society of European Oncology. They came up with 22 new medications to be added to the list, and 16 have been approved. "They are considered to be important and should be available around the world," said Dr. Lopes.

The addition of these 16 agents has extended the current list of cancer medicines to 46, and the recommendations are based on their impact in saving lives and reducing suffering.

But the challenge begins right now," Dr. Lopes emphasized.

Three of the new drugs — imatinib (Gleevec, Novartis), rituximab (Rituxan, Genentech), and trastuzumab (Herceptin, Genentech) — are very expensive, which can add significant cost to a patient's treatment regimen.

Adding trastuzumab to the current standard regimen increases the cost from about $300 to $40,000, he pointed out. "The same is true for rituximab. Adding rituximab to CHOP significantly increases the cost, from under $200 to $6000."

This increase in price is formidable, particularly for countries with limited resources.

The other cancer drugs added to the list this year are anastrozole, all-trans retinoic acid, bendamustine, bicalutamide, capecitabine, cisplatin, filgrastim, fludarabine, gemcitabine, irinotecan, leuprorelin, oxaliplatin, and vinorelbine.

Significant Gaps Between Rich and Poor

The WHO Model List of Essential Medicines is a set of medicines that "satisfy the priority healthcare needs of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford." The intent is to provide an internationally recognizable set of selected drugs to help nations choose how to treat their priority health needs. The list is updated every 2 years by an expert committee.

Full reviews of cancer medicines were conducted in 1984, 1994, and 1999.

To select drugs for inclusion, Dr. Lopes explained, four main dimensions are considered, each with three levels.

Table. Criteria for Selecting Drugs for Inclusion

Dimension	Level
Efficacy and safety of therapy	cure, near cure, prolongation of survival/palliation of symptoms with adequate safety
Burden of disease	low, mid, and high
Cost effectiveness of the drug/regimen	highly cost-effective, cost-effective, not cost-effective
Resource requirements for drug use	low, middle, high

In developed countries, at least two-thirds of patients live for 5 years or more; several decades ago, less than half did.

"For those of us who treat patients in low- and middle-income countries, most of these advances are an inspiration and represent hope for the future," he said. However, they "are not our current reality."

There are big gaps in survival between high-income and low- or middle-income countries. One reason is that the latter spend far less money in cancer control, Dr. Lopes pointed out. "We have more than half the cancer cases globally in low- and middle-income countries, but we only spend about 6.2% of the global costs. This represents 90.0% of the global expenditure gap, which means that is what we would need to spend to reach the level of high-income countries."

Fortunately, things are starting to change. There has been a historic political commitment for cancer and other noncommunicable diseases by the United Nations.

Pushing Down Cost

The burning question, Dr. Lopes noted, is "how can we improve cost-effectiveness?"

Right now, there are several ways of doing that, such as making drug development cheaper and more effective by using biomarkers. Another way is to increase the use of generics, biosimilars, and access programs.

Another more far-reaching proposal is to create a global fund and alliance to fight cancer in low- and middle-income countries. Through engagement, goal setting, and multiple stakeholder involvement, such a fund would provide recipient countries with incentives to create and develop their health and human capital infrastructures with adequate technical support, Dr. Lopes explained. "These would be the lowest-income countries we have in the world today."

Cancer is a major global healthcare issue today and access is, or will be, a major issue in all countries," he summarized. "The WHO essential medicines list is a first step, but an important first step. And it is a major victory in our global public health fight against cancer."

Low-income countries, in particular, will need help accessing all of the drugs on the list, Dr. Lopes added. "But as it takes a village to raise a child, it will take the whole world to control cancer in low-and middle-income countries. And we will only be able to do that if we create innovative funding and ways of getting all those efforts together."

Dr. Lopes reports relationships with AstraZeneca, Fresenius Kabi, Merck Serono, Merck Sharp & Dohme, Novartis, Roche/Genentech, BMS, Lilly, ImClone, Pfizer, and SanofI