A Qualitative Study of Provider Thoughts on Implementing Pre-Exposure Prophylaxis (PrEP) in Clinical Settings to Prevent HIV Infection

via PLoS ONE, by Emily A. Arnold, Patrick Hazelton, Tim Lane, Katerina A. Christopoulos, Gabriel R. Galindo, Wayne T. Steward, Stephen F. Morin

ABSTRAST

Background

A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States.

Methods

Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time.

Results

Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations.

Conclusions

While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.

Read the full text here.


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State doctors: their real, everyday world

via Daily Maverick, by Karen Milford

I am a doctor working in the state sector, and this is my response to the article entitled ‘Baragwanath’s Shame: A good man dies’.

Firstly, I want to give you an idea of what a typical weekend morning is like in the trauma unit of a South African tertiary hospital. It’s 8am on a Sunday, and the morning handover round is just starting in the unit. The weekend’s carnage is plain for all to see. The resuscitation unit is over-full, serving as temporary home to seven ventilated patients. These are people so critically ill that they need what lay-people call ‘life support machines’ to keep them breathing: ventilators that push breaths in and out of their bodies because they can’t take those breaths themselves. In the passage is an eighth patient on a stretcher, being manually ventilated by a paramedic. They have been there for three hours, waiting patiently for a space to open up in the resus area for them.

Down the passage are more patients, wedged as closely together as possible. They’ve all suffered some sort of trauma: they’ve been stabbed or shot, hit by cars or thumped by thugs, throttled by their boyfriends or beaten by community members. Some of them are elderly people who fell and broke their hips whilst on the way to the bathroom, others are teenaged boys who broke their legs playing soccer. They’ve filled up all the stretchers in the unit, and have flowed over to the chairs, wheelchairs and benches. One has made a nest of blankets on the floor. They’re asking for water and bedpans and receivers to vomit into. They’re asking for help and pain medication.

Mandy de Waal’s article made me angry, not because I don’t want the horrors of state hospitals reported on, but because of her failure to put the opportunity she was given to good use. She scratched the surface and told us one thing: that doctors sometimes act without compassion and don’t properly communicate to patients and families what is happening. But she could have dug deeper and pulled out the evil root at the base of this ugly tree to show us. The public healthcare system is appalling. It is not equipped to deal with the burden of disease in this country. Whether this is due to a lack of funds or simply mismanagement and wasting of available funds is a question worth asking. Whether or not it can be fixed by changing the people running the system is another.

Read the rest.

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Views of policymakers, healthcare workers and NGOs on HIV pre-exposure prophylaxis (PrEP): a multinational qualitative study

[This is of great interest to the Mapping Pathways team as our work is quite similar. Very interesting!]


via British Medical Journal, by Ana Wheelock, Andreas B Eisingerich, Gabriela B Gomez, Emily Gray, Mark R Dybul, Peter Piot

Abstract

Objectives To examine policymakers and providers' views on pre-exposure prophylaxis (PrEP) and their willingness to support its introduction, to inform policy and practice in this emerging field.

Design Semistructured qualitative interview study.

Setting Peru, Ukraine, India, Kenya, Uganda, Botswana and South Africa.

Participants 35 policymakers, 35 healthcare workers and 21 non-governmental organisation representatives involved in HIV prevention.

Results Six themes emerged from the data: (1) perceived HIV prevention landscape: prevention initiatives needed to be improved and expanded; (2) PrEP awareness: 50 of 91 participants had heard of PrEP; (3) benefits of PrEP: one component of the combination prevention arsenal that could help prioritise HIV prevention, empower key populations and result in economic gains; (4) challenges of PrEP: regimen complexity, cost and cost-effectiveness, risk compensation, efficacy and effectiveness, stigmatisation and criminalisation, information and training and healthcare system capacity; (5) programmatic considerations: user eligibility, communication strategy, cost, distribution, medication and HIV testing compliance and (6) early versus late implementation: participants were divided as to whether they would support an early introduction of PrEP in their country or would prefer to wait until it has been successfully implemented in other countries, with around half of those we spoke to supporting each option. Very few said they would not support PrEP at all.

Conclusions Despite the multiple challenges identified, there was general willingness to support the introduction of PrEP. Yet, strengthening existing HIV prevention efforts was also deemed necessary. Our results suggest that an effective PrEP programme would be delivered in healthcare facilities and involve non-governmental organisations and the community and consider the needs of mobile populations. Comprehensive information packages and training for users and providers would be critical. The cost of PrEP would be affordable and possibly segmented. Extensive counselling and innovative monitoring measures ought to be considered.

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CENTER FOR HEALTH LAW AND POLICY INNOVATION OF HARVARD LAW SCHOOL SHARES FINDINGS DEMONSTRATING THE IMPORTANCE OF NATIONAL HEALTH REFORM

via law.harvard.edu

PRESS RELEASE

Fact sheet offers findings that show the benefits of health reform as U.S. Supreme Court Rules on Patient Protection and Affordable Care Act (ACA)

JAMAICA PLAIN, MASS. – The Center for Health Law and Policy Innovation of Harvard Law School (the Center), applauds today’s U.S. Supreme Court ruling on the Patient Protection and Affordable Care Act (ACA), which upheld the constitutionality of the individual mandate and of the Medicaid expansion, but with limits that have the potential to significantly undermine the Medicaid expansion. The Center has recently found that similar health reforms in Massachusetts have led to significant individual and public health benefits.

“Here in Massachusetts, we have demonstrated that health reforms result in increased access to needed care and treatment for our most vulnerable residents, including individuals with HIV and other chronic illnesses,” said Robert Greenwald, director of the Center.

The Center has released a fact sheet that highlights some of the findings of an upcoming report on health reform in Massachusetts.  The findings demonstrate that health reforms similar to those included in the ACA lead to significant health benefits.

An individual mandate that requires most adults to carry health insurance, a voluntary Medicaid expansion, and subsidized private health insurance for low-to-moderate income uninsured residents are key reforms included in the ACA that have been in place in Massachusetts since 2006. These initiatives contribute greatly to the following outcomes:

• Between 2006 and 2009, new HIV diagnoses fell by 25 percent in Massachusetts compared to a 2 percent national increase.

• Between 2002 and 2008, Massachusetts’ AIDS mortality rates decreased by 44 percent compared to 33 percent nationally. 

Along with these important health outcomes, the Massachusetts Medicaid program has seen decreased inpatient costs for this population, and the Massachusetts Department of Public Health estimates that it has saved over $1.5 billion in HIV health care costs since the reforms, in part due to decreased HIV transmission.

A working draft of the Massachusetts HIV/AIDS Resource Allocation Project is available here.

“Today’s ruling will expand access to care for millions of Americans. However, we are concerned that the Court’s decision that the federal government may not withhold all Medicaid funding for states who choose not to participate in Medicaid expansion will perpetuate unequal access to care and health disparities. It is critical that low-income Americans, including those living with HIV, be able to reap the benefits of health reform,” said Greenwald. He added, “In terms of putting the ACA into action, the devil is in the details. We must continue to advocate to make sure that our federal and state governments implement the ACA in ways that turn the law’s potential for increased access to care into reality.” 

Martha Minow, Dean of Harvard Law School, noted, “We have cleared a major milestone today, but the real work is just beginning. As we know from Massachusetts, the gains did not happen overnight. Now is the time to work to ensure that the Affordable Care Act truly translates into access to care for millions of Americans, including our most vulnerable, and that the many promises of health reform are fulfilled.”

The Center for Health Law and Policy Innovation of Harvard Law School works to increase access to healthcare for vulnerable populations, particularly low-income people with chronic illness, as well as to support legal, regulatory, and policy structures that enable people to make healthy lifestyle choices.

Read it all here.


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SUPREME COURT RULING ON AFFORDABLE CARE ACT HUGE VICTORY FOR PEOPLE LIVING WITH HIV/AIDS

Press Release via San Francisco AIDS Foundation:

San Francisco, June 28, 2012 — Today the United States Supreme Court delivered a huge victory to nationwide efforts to establish a health care system that works for everyone, including the 1.2 million people living with HIV/AIDS in the United States. By upholding the Affordable Care Act (ACA), today’s decision delivers on the promise of health care for more than 30 million uninsured Americans. The historic ruling also upheld long-overdue protections for people with HIV and other chronic diseases, including safeguards against denial of coverage or exorbitant premiums for the especially sick, and annual and lifetime coverage limits for people with costly medical conditions.

“For the first time in the history of the epidemic, the ACA will dramatically expand health care access to people previously considered ‘uninsurable,’ including millions of Americans with HIV/AIDS and other serious illness,” said Neil Giuliano, CEO of San Francisco AIDS Foundation. “Today, we move one step closer to having a health care system that supports access to care and treatment that prevent illness and disease progression, rather than a ’sick care system‘ that promotes disability and illness by limiting coverage options.”

The Affordable Care Act will address the failings of the current health care system by expanding Medicaid to all low-income people, creating open, competitive, fair marketplaces for uninsured and under insured individuals and families to purchase private insurance, and providing subsidies to lower-income individuals to make insurance affordable. An estimated 1.2 million people are living with HIV in the United States and need access to high-quality, uninterrupted medical care to stay healthy, reduce new HIV infections, and cut long-term health care costs.

“While today’s ruling is a huge victory, there’s no time for rest. We must continue our efforts to educate people affected by HIV about the key components of the ACA and how it will affect access to quality HIV prevention, care, and treatment,“ said Courtney Mulhern-Pearson, director of state and local affairs at San Francisco AIDS Foundation. “It is critically important that all Americans have accurate information about the law, how it will benefit them, and what it means for their health and the health of their communities.”

With today’s historic decision, San Francisco AIDS Foundation will redouble its efforts to ensure that health care reform implementation proceeds full steam ahead. The foundation urges Congress to acknowledge that the Affordable Care Act is the law of the land by fully funding health care reform and ending efforts to repeal it. Progress must not be held hostage by politics.

“Today’s decision underscores the importance of continued funding of the Ryan White CARE Act during this time of transition to health care reform,” said Ernest Hopkins, director of legislative affairs at San Francisco AIDS Foundation. “In order to effectively transition clients and fully realize the promise of health care reform, we must continue our work with elected officials, policy makers, and peer organizations to secure the future of the Ryan White CARE Act.”



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Tenofovir Shortage Exposes Problems in Health Management in South Africa

via allafrica.com, by Khopotso Bodibe

The recent shortage of a crucial antiretroviral drug, Tenofovir, is but just a symptom of an underlying general problem of health management in South Africa. Part of this is the lack of oversight on drug supplies and availability by the national Health Department.

At the heart of the seven months' long shortage of Tenofovir, which started running out in October last year is nothing else, but poor planning. For the whole of last year, the Health Department had a donated stock of the drug from the United States' government and retained two pharmaceutical companies, Aspen Pharmacare and Sonke Pharmaceuticals to produce a tiny fraction of the supply.

It was only when small quantities of the donated stock of Tenofovir were left that the Health Department urgently requested the two drug manufacturers in November to increase their production and supply 100 % of the stock, with Aspen Pharmacare responsible for producing 70% and Sonke Pharmaceuticals 30% of the required Tenofovir packs for an estimated 1.2 million patients. But the two failed to meet the demand at short notice, leaving patients in dire straits. Director of Section 27 and executive member of the Treatment Action Campaign, Mark Heywood, says this demonstrates a general lack of planning by the Health Department to address drug shortages in the country.

"Planning is absolutely crucial. If I was the Minister of Health, then I would instruct that the relevant official in the Department of Health has a monthly meeting with the pharmaceutical companies, with key people in some of the provinces just to assess on an on-going basis, not necessarily because there's a crisis, but just to make sure that they are looking at what are the drugs are the drugs in the system, are the drugs in the pipeline, are we getting to people, where is the weak point in the chain? If you put that type of system in place, then we wouldn't be facing what we are facing now", according to Heywood.

The recent shortages of Tenofovir, for example, occurred as a result of the Health Department not informing the contracted drug manufacturers in good time that a shortage was looming. Thus, they were not able to produce the required amounts. In addition, Aspen Pharmacare and Sonke Pharmaceuticals neglected to inform the Health Department that producing 1.2 million packs of Tenofovir within the required time would not be possible.

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Hoover Institution: Reshaping Global Health, Time for a Structural and Philosophical Shift

via Hoover Institution Stanford University, by Mark Dybul, Peter Piot, and Julio Frenk

Excerpt:

However, the focus on specific diseases has imposed and exposed fault lines in delivering services in places where many suffer from multiple health issues at the same time or at varying points in their lives. Although studies have shown that hiv interventions have reduced overall mortality and that malaria and immunization programs have reduced childhood mortality in the near term, it seems highly likely that more lives will be durably saved if a person afflicted by different health problems has access to services for all of them. Although there are limited supportive data, we believe it is likely that an integrated approach focused on the health of a person and community is more cost-effective than a silo approach focused on a specific disease or health threat. Yet, existing global health institutions were designed for specific diseases and have not effectively shifted to embrace a broader vision. It is time for a Bretton Woods-style agreement to guide a new international health strategy and rationalize its structure.

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The Affordable Care Act's Impact on People Living With HIV

via Associated Press, by David Crary

For many HIV-positive Americans, and those who advocate on their behalf, these are days of anxious waiting as the Supreme Court ponders President Barack Obama's health care overhaul.

This loose-knit community — made up of activists, health professionals and an estimated 1.2 million people living with HIV — has invested high hopes in the Affordable Care Act, anticipating that it could dramatically improve access to lifesaving care and treatment. The act is now in limbo as the high court deliberates on its constitutionality, notably its requirement that most Americans obtain health insurance. A ruling could come in June.

"The HIV treatment community sees the act as a critical step in our fight against the AIDS epidemic," said Scott Schoettes of Lambda Legal, a national gay-rights advocacy group. "People have been counting on it, making plans based on its implementation, so for it to be pulled out from under their feet at this point would be a tremendous loss."

Among its many provisions, the health care law has two major benefits for HIV-positive people: It expands Medicaid so that those with low incomes can get earlier access to treatment, and it eliminates limits on pre-existing conditions that have prevented many people with HIV from obtaining private insurance.

Under current policies, low-income HIV-positive people often do not qualify for Medicaid if they are not yet sick enough to be classified as disabled.

In the view of advocacy groups, this creates a cruel Catch 22 — at a stage when they are still active and productive, these people can't afford the antiretroviral treatments that could help them stay that way. Only when their condition worsens are they able to qualify for Medicaid and get treatment that might have prevented the deterioration.


Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

The Impact 'The Affordable Care Act' Will Have on HIV Treatment and Care

via HuffPost Chicago, by Gregory Trotter

For the 1.2 million Americans living with HIV, the Affordable Care Act will be utterly life-changing. For some, it will be life-saving.

Just ask Will Wilson, 58, who was diagnosed with "full-blown AIDS" in 2002.
"It will basically mean freedom," said Wilson, a Chicago resident and an advocate for the Illinois Alliance for Sound AIDS Policy.

For the first time, Wilson will be able to purchase private insurance without fear of being rejected for his preexisting condition. The former graphic designer will be able to aggressively re-enter the job market without risking his continuous access to lifesaving HIV drugs that cost him $3,000 a month.

He'll have options he's never had.

This week, the Supreme Court has heard oral arguments on the constitutionality of the Affordable Care Act, specifically the legality of the individual mandate provision and the expansion of Medicaid. It is slated to rule in June on what is widely considered to be the most important Supreme Court case in decades. Many people living with HIV/AIDS and other preexisting conditions will be hoping and praying that the court rules in favor of health care reform.

In January, the AIDS Foundation of Chicago (AFC) signed on to a legal brief -- along with 130 other HIV/AIDS organizations throughout the country -- asserting that the Affordable Care Act is, in fact, constitutional. It's also necessary to stopping the AIDS epidemic in the United States.

"The list of supporters for our brief urging the court to uphold the ACA continues to grow because of the law's enormous potential to impact the domestic AIDS epidemic," said Scott Schoettes, HIV Project Director for Lambda Legal, the legal firm that submitted the brief.

About 24 percent of people living with HIV are uninsured, according to data from the U.S. Department of Health and Human Services. The majority of people living with HIV depend on Medicaid and Medicare for medical treatment.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Measuring quality of life concerns for people living with HIV

via Aidsmap, by Michael Carter

Fears about transmitting HIV to others, worries about the future, self-esteem problems, difficulty sleeping and treatment issues are now important quality of life concerns for people living with HIV that are not measured by existing resources, according to a report on a new quality of life measurement tool published in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The tool – called PROQOL-HIV (Patient Report Outcomes Quality of Life – HIV) - was developed with the participation of 152 HIV-positive patients in nine countries on five continents.

“PROQOL-HIV is a novel multidimensional HIV-specific HRQL [health-related quality of life] instrument that strives to be sensitive to socio-cultural context, disease stage and treatment in the HAART [highly active antiretroviral therapy] era,” write the authors. “Important new HRQL issues were uncovered from the culturally diverse experiences of PLWHA [people living with HIV/AIDS] in previously under-represented populations.”

Effective antiretroviral therapy has transformed the prognosis of many HIV-positive patients. However, people living with HIV still experience considerable changes in their health-related quality of life. Tools to measure such outcomes were developed in the era before potent HIV treatment became available. Moreover, they did not take account of the geographic, ethnic and cultural diversity of the epidemic.

Therefore an international team of investigators set out to develop a new instrument that was sensitive to the impact of HIV therapy, different diseases stages and applicable across settings. It derived from in-depth interviews conducted with patients living with HIV in 2007 and 2008. The patients were recruited in high-, middle- and low-income countries.
The interviews identified eleven broad areas of concern.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Obama Pushes More Competition on Biologic Drugs

via The New York Times, by Andrew Pollack

President Obama is not giving up when it comes to trying to introduce competition to expensive drugs made by biotechnology.

Tucked into the president’s deficit reduction plan released on Monday was a proposal to reduce the market exclusivity offered to brand-name biologic drugs to seven years, down from the 12 incorporated in the 2010 federal health care legislation.

That would allow so-called generic versions of such drugs to reach the market sooner, saving an estimated $3.5 billion in federal health spending over 10 years, or a little over one-tenth of 1 percent of the $3 trillion the president’s deficit reduction plan is supposed to save in a decade.

Biologic drugs are proteins made in living cells, like Avastin and Herceptin for cancer and Enbrel and Humira for rheumatoid arthritis. Such drugs can cost tens of thousands of dollars a year and are not subject to the same rapid onset of generic competition as drugs made in chemical factories, like Lipitor and Prozac.
The issue was a thorny one during the debate in Congress over the health care legislation.

The biotechnology industry argued it needed 12 years of freedom from lower priced competition to recoup research and development costs. Any less, it argued, would retard innovation. The generic industry, as well as many insurers and employers who pay health care bills, said a much shorter period would suffice.

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Models: Tools to Improve Decision Making about HIV

Via AIDS.gov, by Ronald Valdiserri, M.D., M.P.H.

For those of us who work in the HIV/AIDS field, the month of July was dominated by exciting HIV prevention news coming out of the International AIDS Society meeting in Rome. Results from the HPTN 052 study showed that early, compared to delayed, antiretroviral treatment resulted in a 96% reduction in HIV transmission to uninfected partners. The TDF2 study conducted by CDC in partnership with the Botswana Ministry of Health, found that a once-daily pill containing two anti-HIV drugs reduced the risk of acquiring HIV infection by about 63% in a study population of healthy, heterosexual men and women. These and other study findings continue to add weight to the notion that HIV treatment is prevention. All of us are encouraged when we think about how these findings could be translated into real world settings in a way that would bring us closer to achieving the goals of the National HIV/AIDS Strategy.

Without minimizing the tremendous enthusiasm that rightly attends the prevention breakthroughs that were presented in Rome, I would like to talk about another scientific discussion that took place in July. As it turns out, this meeting was also held in a world capital, although to a much smaller audience. And while the results of this two-day meeting didn’t garner media attention the same way as the Rome meeting did, the topics under discussion were no less consequential.  In mid-July, I was very fortunate to attend a two-day workshop on “Modeling and Evidence-Based Decision Making” sponsored by amfAR, the Foundation for AIDS Research and cosponsored by the Kaiser Family Foundation, the National Alliance of State and Territorial AIDS Directors, and the Urban Coalition for HIV/AIDS Prevention Services. Meeting participants included colleagues from state and local departments of health, academia, federal government, and professional and community-based organizations.

Colleagues from Los Angeles, San Francisco, Maryland, and New York City shared with us their experiences with using various models to assist in making decisions about “optimizing” HIV prevention investments. Using different approaches, each of these health departments was trying to answer the same question, “What combination of prevention services and activities will result in the greatest reduction of the number of new HIV infections?”

At the onset of the meeting, we were reminded that modeling is used in other areas of health and public policy decision-making, especially when leaders are trying to combine diverse information from a variety of sources in order to make sound decisions at a population level.  However, even the biggest fans of modeling reminded us that a model is not a “crystal ball” nor is it infallible.  Instead, what models do is provide a tool to help us make better decisions about complex realities. Good models should always be clear about the inputs and assumptions that were used to generate the results. And perhaps most importantly, they should be used to guide rather than to conclude any discussions about how best to allocate resources.

Read the rest here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

PrEP Financing: Recommendations from Project Inform

Project Inform recently released a report titled Financing and Delivery Mechanisms to Increase Pre-Exposure Prophylaxis (PrEP) Access in Populations at High-Risk of HIV Infection. Available here, the report discusses issues related to financing for PrEP to ensure that it becomes a viable, accessible prevention method for MSM. Here as an excerpt from the executive summary of the report:

One promising new HIV prevention strategy is the use of ARVs as pre-exposure prophylaxis (PrEP) among high-risk men who have sex with men (MSM). Several clinical and cost-effectiveness studies demonstrate that PrEP has the potential to reduce HIV infection rates for high-risk MSM in a cost-effective way. However, policymakers continue to face questions regarding how to improve drug adherence, offer services to the most high-risk individuals including African-American and Latino MSM and transgender women, and ensure that adequate financing mechanisms are in place to pay for the many biomedical and behavioral components of PrEP.

Policymakers seeking to increase PrEP access must further contend with the current political reality of constrained financial resources for public health assistance, including for state Medicaid programs and for HIV prevention programs that serve individuals at high-risk of HIV infection. Strategic opportunities for financing and delivery still exist, but numerous public and private sources will need to be mobilized for PrEP to reduce HIV infections in significant numbers.

Key financing and delivery opportunities include Gilead’s application for FDA approval of a prevention label for Truvada; National Institutes of Health (NIH) and Centers for Disease Control (CDC) funding for demonstration projects in San Francisco, Boston, and other U.S. cities; private and public health insurance coverage for PrEP; a Gilead-funded Patient Financing and Delivery Mechanisms to Increase PrEP Access 5 Assistance Program to help low-income patients pay for PrEP; and opening the PrEP drug market to non-Truvada PrEP formulations. Given that new clinical and cost evidence for PrEP is expected to arrive from a variety of studies and projects in the coming years, policymakers will need to adapt their implementation of PrEP accordingly.
Policy Recommendations:

The recommendations in this report are designed to help HIV policymakers and advocates like Project Inform improve PrEP access in a manner that is clinically effective, cost-appropriate, and politically feasible in line with existing research and evidence.

Consequently, this report recommends the following:

        1.) Support Gilead’s request for FDA approval of a prevention label for Truvada

        2.) Encourage the NIH and CDC to finance demonstration projects

        3.) Ensure public insurance coverage for PrEP through state Medicaid programs

        4.) Ensure private insurance coverage for PrEP

        5.) Advocate that Gilead develop a Patient Assistance Program (PAP) for PrEP

        6.) Encourage non-Truvada PrEP formulations and promote price breaks for Truvada

        7.) Promote PrEP in tandem with other combination approaches to HIV prevention

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]