Source

Key Facts About the Uninsured Population

Key Points

• More than 3,300 cases, including more than 2,200 deaths, have been reported to date in the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC), making it second only to the 2014-2015 West Africa outbreak that saw nearly 29,000 cases and claimed more than 11,300 lives. The outbreak has lasted a year and a half already, having been first declared by the DRC Ministry of Health on August 1, 2018. There are ongoing concerns about cross-border spread outside the DRC.
• Since July 2019, the outbreak has been considered a “public health emergency of international concern” (PHEIC) by WHO.
• Although the DRC has a history of successfully containing Ebola outbreaks and responders have access to new prevention tools such as an Ebola vaccine, multiple factors have impeded the response in the affected areas this time including violence and insecurity, community mistrust of government and external responders, funding constraints, and a complex political and socioeconomic operating environment.
• U.S. engagement has been limited compared to the 2014-2015 West Africa outbreak where the U.S. played a leading role and mobilized an unprecedented amount of funding, and personnel. In contrast, the U.S. has chosen to play a more limited role in this outbreak due partly to concerns about security, which have led the U.S. to restrict its personnel from working in the outbreak zone. Even so, the U.S. is the largest single international donor to the Ebola response effort in the DRC.
• The U.S. Agency for International Development (USAID) and the U.S. Centers for Disease Control and Prevention (CDC), along with several other U.S. agencies, have provided technical and financial support to international response efforts in the DRC. A USAID Disaster Assistance Response Team (DART), which includes USAID and CDC staff, has been deployed to the DRC since September 2018.
• Policy questions for the U.S. government going forward include whether it will change its approach in order to allow government personnel to engage directly in frontline response activities and how it will support the transition from emergency response to longer-term support for improving health care in the affected areas.

Current Situation

When did the outbreak begin, and what countries are affected?

The current Ebola outbreak was first declared by the DRC Ministry of Health on August 1, 2018 (see timeline of key events below). Almost all cases of Ebola in this outbreak so far have occurred in the two northeastern DRC provinces of Ituri and North Kivu, though a few cases have recently been identified in South Kivu province. This outbreak is the tenth – and by far the largest – in the DRC’s history and the second largest Ebola outbreak ever recorded after the West Africa Ebola outbreak in 2014-2015 that saw 28,616 cases, including 11,310 deaths, in the three most affected countries (Guinea, Liberia, and Sierra Leone).

Cross-border spread remains a concern. Uganda has reported several imported Ebola cases in areas bordering the DRC, with the most recent reported on August 26, 2019. WHO says there is a risk of further spread within the DRC and potentially across borders to Burundi, Rwanda, South Sudan, and Uganda, in particular. Several cases over the summer of 2019 in the large city of Goma, a regional and international transport hub that directly borders Rwanda, highlighted such concerns. Given the risks, neighboring countries have been preparing for possible cases for some time.

How many cases and deaths have there been in the DRC?

As of December 16, 2019, the DRC Ministry of Health reports the country has had 3,348 cases (see figure below), of which there were 2,210 deaths. The number of new cases reported each week has declined noticeably since the end of July 2019, indicating progress has been made in interrupting transmission. Still, cases continue to occur, and recent violence in some Ebola-affected areas has interrupted the response, sparking concerns about this potentially leading to an increase in Ebola cases. Regardless, response activities could be needed for another several months at least, and another increase in transmission remains a concern. The crude case fatality ratio for this outbreak is high, at 66%, as of December 16, 2019.

Health care workers (HCWs), such as nurses and doctors, caring for Ebola patients have been at particularly high risk of infection. At least 169 cases (about 5% of total cases) over the course of this outbreak have occurred among HCWs. This Ebola outbreak has also disproportionately affected children, with about 15 percent of all cases occurring among children under 5 and a higher proportion of the child cases dying from the disease compared with older age groups.

What are the key factors driving the outbreak in the DRC?

Multiple issues make responding to this Ebola outbreak more challenging than any prior outbreaks in the DRC. These include:

• ongoing violence from armed groups that is impeding the response efforts, including violence against Ebola responders, amid long-standing conflict;
• mistrust of the DRC government and outsiders, including Ebola responders, in affected communities;
• disbelief in Ebola (studies find that many in the affected areas believe the Ebola outbreak is not real but rather a hoax perpetrated by the government or other outside parties);
• a shortfall in funding for the Ebola response efforts in the DRC, despite increasing calls from the World Health Organization for donors to fill the gap; and
• transitions in the leadership of the DRC government, including transitions in oversight of the Ebola response.

This combination of factors has made responding to this outbreak a much more difficult challenge compared with previous outbreaks in the DRC (see KFF brief).

Role of the U.S.

U.S. engagement in the current outbreak has been limited compared to its role in the 2014-2015 West Africa Ebola outbreak response, where the U.S. played a major leadership role, mobilizing an unprecedented amount of funding, other resources, and personnel to support the Ebola response. Since then, there have been improvements in the global capacity to respond to Ebola, particularly on the part of WHO, and the DRC has had significant experience in addressing prior Ebola outbreaks; both WHO and the DRC took the lead early on in the current outbreak (see KFF brief). In addition, insecurity in the affected areas of the DRC has prevented U.S. agencies from being more involved, as U.S. personnel have been mostly restricted from working directly in the hardest hit areas due to safety concerns. However, the U.S. has provided significant funding and technical assistance in the DRC and in neighboring countries, working in conjunction with national governments, United Nations (U.N.) agencies, and other organizations leading the response. In fact, the U.S. is the largest donor to the Ebola response effort in the country, having provided over $250 million since August 2018.

While the number of Ebola cases in the DRC continues to decline from a peak over the summer, major challenges remain for the U.S. and other responders, such as: completing the task of interrupting transmission even amid ongoing violence, preventing expansion of the outbreak into other geographic areas, and effectively transitioning from an emergency response to a longer-term development effort to help stabilize and build up health systems in the affected areas.

What U.S. agencies are involved in the response?

The U.S. Agency for International Development (USAID) and U.S. Centers for Disease Control and Prevention (CDC) are the two main agencies contributing to the U.S. government response. USAID’s Office of Foreign Disaster Assistance (OFDA) coordinates U.S. emergency response efforts in the DRC, and in September 2018, the agency deployed a Disaster Assistance Response Team (DART) to the DRC in response to the outbreak. USAID’s Bureau for Global Health provides operational and personnel support. Several CDC offices, including the Center for Global Health’s Division of Global Health Protection and the National Center for Emerging and Zoonotic Infectious Diseases’ Division of High-Consequence Pathogens and Pathology (NCEZID/DHCPP), provide technical and personnel support. CDC efforts in the DRC are coordinated through its Emergency Operations Center (EOC) in Atlanta, which was activated in June 2019 at its lowest level (level 3).

Other U.S. agencies engaged in Ebola efforts include the National Institutes of Health (NIH) (conducting research on drug and vaccine development, including Ebola treatment trials in the DRC); the U.S. Food and Drug Administration (FDA) (regulating drug and vaccine development); and the Department of State (coordinating the U.S. and international diplomatic response).

Are U.S. government personnel working in the outbreak areas in the DRC?

U.S. personnel have been assisting in the DRC since the outbreak was announced in August 2018, but since late August/early September 2018, no U.S. personnel have been allowed to directly engage in response activities in active transmission areas in northeastern DRC. Citing safety concerns due to ongoing violence there, U.S. officials have decided to keep CDC and other U.S. staff away from the front lines of the response. Outside experts have made calls for the U.S. to return CDC staff to affected areas to assist more directly. So far though, there is little indication that the U.S. government will deviate from its current policy, though CDC reports working with the U.S. Department of State to “pre-position CDC staff in Goma to rapidly respond to hotspots where the security situation is permissible.”

Outside of the outbreak zone, U.S. personnel continue to assist. The DART – a “team of disaster and health experts” from USAID and CDC – continues its work in the DRC in response to the outbreak. CDC reports 34 staff working the DRC. Other CDC workers have deployed to WHO headquarters and to neighboring countries, such as Uganda, to assist in keeping the virus from crossing borders and to support countries in preparedness and response activities.

How much funding has the U.S. provided?

USAID reports providing about $266 million toward the Ebola response in the DRC and surrounding countries since the outbreak began in August 2018. Of this amount, $252 million is for activities in the DRC, while $14 million is for preparedness and response activities in Burundi, Rwanda, South Sudan, and Uganda. No estimate is available for the amount that CDC has spent on its Ebola response activities, though WHO reports the CDC has provided $500 thousand in funding to its efforts. The funding for both USAID and CDC, as well as for other U.S. agencies, in the response is not new funding; rather, it has been drawn from unspent FY 2015 emergency Ebola supplemental appropriations provided by Congress at the time of the West Africa Ebola outbreak. For USAID, leftover funding in the International Disaster Assistance (IDA) account that was designated for “assistance for countries affected by, or at risk of being affected by,” Ebola is being utilized for this purpose, and for CDC, leftover funding that was designated for Ebola international preparedness and response is being utilized. CDC’s leftover funding expired at the end of FY 2019 on Sept. 30, 2019 and, per communication with CDC, was expected to have been entirely spent by that time. In recent months, Congress has stated that CDC may use existing funds in the Infectious Diseases Rapid Response Reserve Fund, which was established in FY 2019, for CDC Ebola response.

Global Response Activities

Who leads the response to the outbreak?

The DRC government, including the Ministry of Health, and agencies of the U.N. lead the outbreak response. WHO is the lead U.N. agency for the public health response; other key U.N. actors include the U.N. Office for Coordination of Humanitarian Affairs (OCHA), the U.N. Children’s Fund (UNICEF), the World Food Programme (WFP), and MONUSCO, a multinational peacekeeping force that has been assisting with security. U.N. actors are led by a U.N. Emergency Ebola Response Coordinator.

Other key actors in and supporters of the response include governments of various countries, including the U.S.; multilateral organizations, such as the World Bank and Gavi; international and national non-governmental organizations (NGOs), such as Medicins Sans Frontieres (MSF), International Medical Corps, the Alliance for International Medical Action (ALIMA), and the International Red Cross/Red Crescent; and other partners.

What is the plan for ending the outbreak in the DRC?

Current public health response efforts in the DRC are focused on interrupting chains of Ebola transmission through identifying, isolating, and caring for cases before they transmit the disease further. The goal of the response is to bring the number of cases down “to zero”. Ebola outbreaks are usually declared to be over after 42 days have passed since the last known case (equal to two incubation periods of Ebola virus disease). A national Strategic Response Plan outlines the overall strategy, objectives, and priority activities for responding to the outbreak. There have been four iterations of the plan to date, each covering a specific period of time. The current plan that focuses on the core public health “pillar” of the response covers planned activities from July through the end of December 2019. It addresses strengthening response capacities in priority areas such as: coordination, surveillance and laboratory capabilities, infection prevention and control measures, vaccination, human resources, security, and risk communication among others. Complementary humanitarian response activities are another “pillar” of the response and outlined in a broader integrated Ebola response strategy, which includes efforts addressing food assistance, employment, and economic development in Ebola-affected regions.

Has the outbreak been declared a global emergency?

On July 17, 2019, the WHO Director-General accepted the recommendation of the Emergency Committee and declared the DRC Ebola outbreak to be a “public health emergency of international concern” (PHEIC). A PHEIC is “an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response.” In its declaration, WHO released a set of recommend actions for affected countries, neighboring countries, and all states. This was the fourth time the Emergency Committee had met to discuss a potential PHEIC declaration for Ebola in the DRC; each of the prior three times the Committee recommended not to do so.

At its most recent meeting, on October 17, 2019, the WHO Emergency Committee again recommended that the PHEIC declaration remain in place.

What has been the role of vaccination in the current outbreak?

Vaccination has been an important component of the response since it began. This outbreak marks the first time that an effective vaccine is available and being used as a core component of an Ebola response. Authorities have mostly used a “ring vaccination” approach, targeting vaccination of those who have been in contact with a case of Ebola and the contacts of those contacts, as well as other groups at potential risk of exposure such as health care workers. As of December 8, 2019, over 256,000 people have been vaccinated in the DRC since the start of the outbreak, which has likely prevented hundreds, if not thousands, of Ebola cases already. Authorities have been primarily using a vaccine manufactured by Merck, which the company has provided free of charge to WHO and the DRC for the purposes of the response. The Merck vaccine, which was being deployed on an emergency use basis under a “compassionate use” protocol, received approval from European regulators and prequalification from WHO in November 2019, making it the first officially licensed Ebola vaccine. It is not yet approved and licensed by the FDA (though it is under review and an FDA regulatory decision is expected in early 2020). Costs for vaccine distribution and management of vaccinations in the response are shared among Gavi, WHO, other donors, and the DRC government.

In addition to the vaccination efforts in the DRC, neighboring countries are also vaccinating certain people, such as health workers, in areas at risk of seeing or that have seen Ebola cases due to cross-border spread (like Uganda, with at least 5,000 people vaccinated thus far).

A second Ebola vaccine, manufactured by Johnson & Johnson, is also available. Following recommendations from WHO and other expert groups, the DRC government decided to introduce the second vaccine into some at-risk areas of the country that do not have active Ebola transmission. For example, DRC authorities began vaccinating 50,000 people in Goma with the second vaccine in November 2019, and in December 2019, the DRC and neighboring Rwanda initiated a new vaccination campaign using that vaccine to protect people in at-risk areas on their mutual border.

Is there an adequate supply of vaccine?

It appears there are enough doses of the Merck vaccine to meet the demands of the current WHO/DRC government’s ring vaccination approach. Currently there are enough vaccine doses to vaccinate 300,000 people, which is greater than the total number of people vaccinated in the outbreak over the first 17 months of the response. In addition, WHO reports that Merck will produce enough vaccine over the next 6 to 18 months to vaccinate an additional 1.3 million people. Gavi announced in December 2019 that it will support a new global stockpile of 500,000 doses of Ebola vaccine, to be made available for emergency use as needed.

There is reportedly an adequate supply of the second (Johnson & Johnson) Ebola vaccine, with enough to vaccinate approximately 2 million people.

Are treatments available for those infected with Ebola?

There are no FDA- or other approved treatments for Ebola, though several promising treatments are under development. Four experimental treatments have been studied in a clinical trial among Ebola patients in the DRC, and in August, the U.S. NIH announced that initial results of the trial indicated two of those treatments (the monoclonal antibody mAb114 and the multi-antibody “cocktail” REGN-EB3) showed the most promise. Ebola patients in the DRC enrolled in the trials are offered these two treatments as investigators further evaluate them. The treatments are still under investigation and being offered on a “compassionate use” basis only in the DRC.

What has the response cost, and how much funding has been provided?

From August 2018 through early December 2019 the amount of funding directed to response activities in the DRC included under four iterations of a national Strategic Response Plan has reached $361 million. This amount does not include additional DRC outbreak activities not captured under the plans, nor response costs in Uganda and preparedness costs in neighboring countries.

Funding amounts provided under each of the plans so far:

• August – October 2018: DRC government data show that the first plan was fully funded, with $44.2 million made available to meet the $43.8 million requested for the August to October 2018 period the plan covered.
• November 2018 – January 2019: U.N. data shows that the second plan was fully funded, with donors (largely the World Bank) providing $61.4 million (including some funds leftover from the first phase of the response) of the $61.3 million requested to cover the period through January 2019.
• February – July 2019: U.N. data shows the third plan has received $109.3 million from February through July 2019, of the $147.9 million requested to cover the period through July 2019. This includes $40 million from the World Bank, with more promised, and $31.2 million from USAID.
• July – December 2019: WHO data shows the current plan has received at least $148.3 million from August through early December 2019, of the $287.6 million requested for the public health pillar of the response through December (U.N. data tracking donor funding toward the current plan is not yet available, but WHO is reporting the funding it has received under the plan). The plan has substantially higher funding needs than prior iterations. The broader response strategy, which includes the funding requirements of the public health pillar within its funding assessment, is requesting more than $500 million for the broader DRC response through December; some donors, including the World Bank, United Kingdom, and the European Union, have already announced they will be providing additional funding for the response.

As mentioned earlier, USAID reports providing about $252 million toward the Ebola response in the DRC and about $14 million for activities in neighboring countries since the outbreak began in August 2018 (this includes funding channeled through the DRC national plans as well as funding not captured under the plans). No estimate is available for the amount that CDC has spent on its Ebola response activities, though WHO reports the CDC has provided $500 thousand in funding to its efforts. All U.S. funding for the current outbreak is drawn from existing funding sources (i.e., no new funding has been appropriated to agencies by Congress for this Ebola response, thus far).

See the KFF data note on donor funding for the response for further information.

Key Issues Going Forward

Now well into its second year, the Ebola outbreak in the DRC remains challenging for responders, despite having important tools (such as vaccines and new treatment options) on hand. This is because the underlying factors driving transmission of Ebola in the DRC remain. The security situation shows no sign of abating, and there is a fear that it can always worsen. Mistrust of public health authorities also remains a barrier to response efforts. While it is not possible to predict the trajectory of the outbreak, it could take at least a few more months to fully contain even under good circumstances, so given the complex set of challenges being faced, the outbreak could take even longer than that to be brought under control.

Addressing these longstanding challenges more effectively is the aim of the broader integrated response strategy being implemented in the DRC. This strategy, which includes the public health pillar’s current national plan and is designed to guide the response through the end of December 2019, calls for greater community engagement, support for health and development interventions beyond addressing Ebola alone, a new approach to security, and more coordination among all responders.

Finally, the major questions for the U.S. government going forward include: whether or not it will change its approach and engagement in the DRC to allow U.S. government personnel to directly engage in public health activities on the frontlines of the response, how the U.S. will contribute to finally breaking all chains of transmission, and how the U.S. will support efforts to transition from an emergency response to a longer-term strategy for supporting the health care system in the affected areas to help prevent and contain any future recurrences of Ebola or other outbreaks.

Additional Resources

• DRC Ministry of Health – WHO AFRO Ebola in DRC dashboard
• DRC Multisectoral Committee on Ebola Response (CMRE) daily situation reports (from Aug. 3, 2019)
• DRC Ministry of Health daily situation reports (prior to Aug. 3, 2019)
• WHO DRC Ebola situation reports (earlier reports)
• WHO Ebola disease outbreak news
• USAID DRC Crisis webpage
• CDC Ebola Outbreak in the DRC webpage
• KFF infographic Ebola: 5 Key Questions
• KFF Ebola materials

Key Points

• The ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC) has required increasing amounts of external support from donors (for more information on the outbreak, see KFF’s explainer). Yet there has been limited information about donor funding to date and a lack of a centralized reporting mechanism for tracking funding.
• This analysis provides an updated overview of donor funding for the DRC Ebola response by source. Highlights include:
  • We estimate that from August 2018, when the outbreak began, through early December 2019, approximately $734 million was provided by donors to address Ebola in the DRC.
  • More than half (57.8%) was provided by donor governments bilaterally, including the U.S., with a large share (40.1%) provided by multilateral and international organizations and a small proportion (2.2%) provided by non-profits, such as private foundations.
  • The U.S. provided the largest amount of support ($252 million), followed by the World Bank ($170 million), the United Kingdom ($78 million), the World Health Organization (WHO) Contingency Fund for Emergencies ($73 million), and the European Union ($52 million).
  • About half of funding (49%), including about a fifth of U.S. funding, was provided in direct support of the official DRC response plans, which guide national response strategy and enumerate resource needs. This could have implications for the coordination of donor efforts and whether funding is being directed to the most critical or pressing activities.
  • There is also considerable uncertainty about the future of U.S. support since it is unclear how much funding remains available for use in the response, whether the current administration will request additional funds, and whether Congress will provide such funding.

Donor Funding for the DRC Response

Based on analysis of publicly available information, we estimate that donors provided approximately $734 million in overall financial support for the DRC Ebola response from August 2018, when the outbreak began, through early December 2019 (see Table 1). We attributed funding to donor governments for Ebola when designated for this purpose, whether provided bilaterally to the DRC or earmarked for Ebola but provided to a multilateral organization or instrument. We attributed funding to a multilateral organization where that multilateral organization specifically designated general funds for this purpose. Data sources are provided in Table 1.

More than half (57.8%) of this funding was provided by donor governments bilaterally, including the U.S., with large share (40.1%) provided by multilateral and international organizations, such as the World Bank, and a small proportion (2.2%) provided by non-profits, such as private foundations.

The U.S. government was the largest donor, having provided $252.4 million for activities within the DRC (see Figure 1 and Box 1), followed by the World Bank ($170 million), the United Kingdom ($78.4 million), the WHO Contingency Fund for Emergencies ($73.1 million), and the European Union ($52.4 million).

Funding for National Response Plans

The DRC government, U.N. agencies such as WHO, and other partners prepared four DRC national Strategic Response Plans (“the plans”) to guide and enumerate resource needs for the Ebola response (see Table 2). We found that about half (49%, $361 million) of donor funding for the response – including about a fifth (19%, $47.9 million) of U.S. funding – was identified as directly supporting the national plans.

Donors met the funding requests in the first two plans and mostly met that of the third plan. As of early December, they have provided at least $148.3 million (via WHO) toward the fourth plan, which requests $287.6 million for public health response activities from July through December 2019.

Authorities in the DRC have also requested an additional $225.6 million for July through December 2019 under a broader strategy that includes other activities, such as economic development, to address social conditions that drive the outbreak. In support of this broader strategy, some donors have pledged more funding. The World Bank, for example, pledged up to an additional $300 million ($70 million of which has already been provided), and the United Kingdom pledged up to an additional $62.6 million, or £50 million ($9.7 million, or £8 million, of this funding has already been provided for preparedness efforts in neighboring countries, and $23.8 million of this funding has already been provided to WHO). More recently, the European Union has pledged an additional $54.7 million (€50 million) in support of the broader response.

Key Issues for the U.S. and Other Stakeholders

Maintaining a robust response to Ebola in the DRC over the next several months, and maybe even longer, will require additional donor funding. As such, there are several issues for the U.S. and other donors to consider:

• Overall, information on donor financing is limited and fragmented. No systematic resource or tool for tracking contributions exists, a situation made more complex because the Ebola response is taking place in the context of a broad set of humanitarian crises with multiple multilateral and bilateral funding mechanisms contributing resources across a spectrum of activities (see KFF explainer). For the U.S. specifically, while some data are available, the full range of funding information has not been provided.
• Coordination of donor funding outside official national response plans is unclear. With about half of donor funding for the response – including about a fifth of U.S. financial support – identifiable as directly supporting the official national response plans, it is not clear whether donor efforts are being coordinated effectively and funding provided for the most critical or pressing activities, including those identified under the official national response plans. With regard to the U.S. specifically, there is limited information about how U.S. funding and efforts are coordinated with U.N. and DRC-led efforts.
• The status of U.S. funding going forward is uncertain. It is unclear how much funding remains available for use in the U.S. response, whether the current administration will request additional funds, and whether Congress will provide such funding. At USAID, it is unclear what funds remain in the leftover FY 2015 emergency Ebola funding being used for response activities. At CDC, all leftover FY 2015 emergency Ebola funding was to be spent out entirely by the end of FY 2019, but the agency may use funds from the emergency reserve fund for its Ebola activities in FY 2020 (see Box 1).

The FY 2020 appropriations conference agreement, released by Congress on December 16, 2019 and passed by both the House (12/17) and the Senate (12/19), includes funding for U.S. global health programs at the State Department, the U.S. Agency for International Development (USAID), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH). The agreement still needs to be signed by the President. Key highlights are as follows (see table for additional detail):

State Department & USAID:

• Funding for global health programs, through the Global Health Programs (GHP) account, which represents the bulk of global health assistance, totaled $9.1 billion, an increase of $255 million above the FY 2019 enacted level, and $2.7 billion above the President’s FY 2020 request.
• Bilateral HIV funding through the President’s Emergency Plan for AIDS Relief (PEPFAR) is $4,700 million, flat compared to the FY19 enacted level, but $1,350 million above the FY20 Request ($3,350 million).
• The bill includes $1,560 million as the U.S. contribution to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), an increase of $210 million above the FY19 enacted level ($1,350 million) and $602 million above the FY20 Request ($958 million). The bill states that this amount is for the first installment of the sixth replenishment. In addition, the explanatory statement accompanying the bill reaffirms the U.S. share of 33% of contributions.
• Funding for tuberculosis (TB) totals $310 million, $8 million above the FY19 enacted level, and $49 million above the FY20 Request ($261 million).
• Funding for malaria totals $770 million, $15 million above the FY19 enacted level ($755 million), and $96 million above the FY20 Request ($674 million).
• The bill includes $851 million for maternal and child health (MCH), an increase of $16 million above the FY19 enacted level ($835 million), and $231 million above the FY20 Request ($629 million). Specific areas under MCH include:
  • Gavi, the Vaccine Alliance funding totals $290 million, matching the FY19 enacted level, and $40 million above the FY20 Request ($250 million).
  • Polio funding through all accounts totals $61 million, $2 million above the FY19 enacted level ($59 million), and $38 million above the President’s FY 2020 Request.
  • The bill includes $139.0 million for the U.S. contribution to the United Nations Children’s Fund (UNICEF) provided through the International Organizations and Programs (IO&P) account, $1.5 million above the FY19 enacted level ($137.5 million). While the FY20 Request did not specify a funding amount for UNICEF and proposed to eliminate the IO&P account, it is possible that organizations such as UNICEF could receive funding through other accounts.
• Funding for nutrition totals $150 million, $5 million above the FY19 enacted level ($145 million), and $71 million above the FY20 Request ($79 million).
• Bilateral family planning and reproductive health (FP/RH) funding totals $575 million ($524 million through the GHP account and $51 million through the ESF account), matching the FY19 enacted level, and $316 million above the FY20 Request ($259 million).
• Funding for the United Nations Population Fund (UNFPA) totals $32.5 million, matching the FY19 enacted level; the FY20 Request proposed eliminating funding for UNFPA.
• Funding for the vulnerable children program totals $25 million, $1 million above the FY19 enacted level ($24 million); the FY20 Request proposed eliminating funding for this program.
• Funding for neglected tropical diseases (NTDs) totals $102.5 million, matching the FY19 enacted level, and $27.5 million above the FY20 Request ($75 million).
• Funding for global health security (GHS) totals $100 million in the bill. While this is a decrease compared to the FY19 enacted level ($138 million), $38 million of the FY19 amount was provided through a one-time transfer of unspent emergency Ebola funding. The FY20 conference agreement amount is a $10 million increase compared to the FY20 Request ($90 million).

Centers for Disease Control and Prevention (CDC): Funding for global health provided to the CDC totals $571 million, an increase of $75 million compared to the FY19 enacted level ($496 million) and $114 million above the FY20 Request ($457 million). The entire increase in CDC funding is to support global health security activities.

Fogarty International Center (FIC): Funding for the Fogarty International Center (FIC) at the National Institutes of Health (NIH) totaled $81 million, $3 million above the FY 2019 enacted level ($78 million) and $14 million above the FY20 Request.

Additional Global Health Legislation: The appropriations bill also included the “End Neglected Tropical Diseases Act” as well as the “Preventing Child Marriage in Displaced Populations Act.” Learn more about these two bills on the KFF U.S. Global Health Legislation Tracker here.

Additional Resources:

• “Further Consolidated Appropriations Act, 2020” – Bill Text
• FY2020 State and Foreign Operations Appropriations – Explanatory Statement
• FY2020 Labor, HHS – Explanatory Statement

The table below compares global health funding in the FY 2020 conference agreement to the FY 2019 enacted funding amounts as outlined in the “Consolidated Appropriations Act, 2019” (P.L. 116-6; KFF summary here), the President’s FY 2020 request (KFF summary here).

Key Facts

Drug price concerns in the U.S., including for antiretrovirals, the mainstay of HIV treatment and, increasingly prevention, have prompted the introduction of several policy proposals. One proposal would require manufacturers to provide a rebate to Medicare if prices increase faster than inflation. As a drug class, ARVs lack competition in the U.S. market and few generic options are available, leading to particular concerns over their pricing. We assessed list price changes between 2016 and 2017 for ARVs under Medicare Part D, which is required to cover all or substantially all ARVs. During this period, 48 ARVs were covered by Part D, 38 of which were brand medications and 30 were single source.

According to our analysis:

• Almost three quarters (73% or 35 medications) had list price increases that exceeded the inflation rate between July 2016 and July 2017 (1.7%). This compares to 60% of Part D medications overall. Most of these were brand-name medications (32), and the vast majority were single source (27).
• Of the 8 ARVs that had price decreases over the period, all were available as generics.
• ARVs with the highest total Medicare spending and enrollee utilization had price increases exceeding inflation by at least 5 percentage points. All of these were brand name, single source drugs.

These findings suggest that current proposals that seek to control Part D prices relative to inflation could yield savings.

Background

Ongoing concerns about prescription drug pricing and affordability in the United States have prompted the introduction of policy proposals from the White House, members of Congress, and presidential candidates. Some of these proposals would require drug manufacturers to pay a rebate to the federal government if their prices for drugs covered under Medicare Part B and Part D increase by more than the rate of inflation. Indeed, a recent KFF analysis found that list price increases for more than half of Medicare Part D drugs exceeded inflation in 2017, in some cases by a substantial margin, suggesting opportunities for significant savings under these plans.

We used the same methodology to assess price changes for antiretroviral medications (ARVs) under Part D, which is required to cover all or substantially all ARVs as one of six protected drug classes. ARVs are the mainstay of HIV treatment and, increasingly prevention. National treatment guidelines recommend initiating ARV treatment upon an HIV diagnosis; for those at high risk, pre-exposure prophylaxis, or PrEP, with ARVs is recommended to prevent HIV acquisition.

While only a small share of people in the U.S. have HIV or are on PrEP, spending on ARVs has an outsized impact on prescription drug spending across payers. In addition, concerns have been raised about ARV drug pricing and affordability specifically, where list prices for a typical recommended HIV treatment regimen could range from $22,000 to $38,000 per year. High prices are, in part, driven by the lack of manufacturer competition and minimal availability of generic substitutes within the U.S. ARV market, the very types of drugs targeted by several of the prescription drug policy proposals.

To assess changes in the list prices of ARVs covered by Medicare Part D relative to inflation, we used data from the CMS Medicare Part D Spending Dashboard to identify ARVs used in the two most recent years available (2016 and 2017). List price changes were measured by one-year (2016-2017) changes in average spending per dosage unit amounts reported. Our analysis is based on unit prices that do not reflect manufacturer rebates and discounts to plans, which are considered proprietary and therefore not publicly available (the major proposals being considered are not based on post-rebate prices). Inflation was measured over the same period using the Consumer Price Index for all urban consumers (CPI-U), which was 1.7% between 2016 and 2017. A full methodology can be found here.

Findings

The 2019 Medicare Part D Spending Dashboard includes 48 antiretrovirals that were utilized in 2016 and 2017, including both brand and generic drugs (see Table 1). Most ARVs (38 or 79%) were brand medications and almost two-thirds (30 or 63%) were single source, meaning they had no generic alternative (see Figure 1).

Of the 48 ARVs reported in the 2017 Part D dashboard, almost three-quarters (35 drugs or 73%) had list price increases that exceeded inflation between July 2016 and July 2017 (1.7%). This compares to 60% of Part D medications overall. Most of these price increases were more than 3 times the rate of inflation. Almost all drugs with price increases exceeding inflation were brand-name medications (32), and the vast majority were single source (27). Of the remaining ARVs, 10% (or 5 drugs) had list price increases below inflation between 2016 and 2017, and 17% (8 drugs) had price decreases over this period. All 8 of the ARVs with price decreases were available as generics (see Figure 2).

We examined price increases for ARVs with the highest spending and utilization among Part D enrollees. Among the 10 ARVs with the highest Part D spending in 2017, all were brand-name, single source medications, and all had list price increases exceeding inflation by at least 5 percentage points (see Figure 3). For instance, Genvoya, the ARV with the highest Part D spending, had a price increase of 7.4%. Triumeq, the ARV with the second highest spending, had a price increase of 9.6%, nearly six times the rate of inflation. Truvada, used for HIV treatment as well as PrEP, had the fourth highest Part D spending, and a list price increase of 7.5%. Until 2019, Truvada was the only ARV approved for PrEP.

Among the top 10 most commonly used ARVs, 9 had list price increases exceeding inflation by at least 5 percentage points and, as with spending, all were brand-name, single source drugs (see Figure 4). The top two most commonly used ARVs – Tivicay and Truvada, each with over 36,000 users in 2017 – had list prices that increased by 9.6% and 7.5%, respectively.

Conclusion

As with Medicare Part D drugs overall, the majority of ARVs had price increases that exceeded the rate of inflation by several percentage points. Moreover, reflecting the lack of competition within the U.S. ARV market, most of these were brand-name, single source medications, including those with the highest spending and greatest utilization, the very types of medications targeted by current policy proposals. These findings suggest that such proposals could yield savings for public and private payers and for patients. However, proposals that place limits on year-to-year drug price increases may incentivize manufactures to introduce newer medications at higher prices. This could present particular challenges in the case of HIV, where several newer treatment and prevention regimens are on the near-term horizon.