HIV/AIDS Community Unites Against Harmful Part D Proposal

Leading stakeholders within the HIV/AIDS community recently penned op-eds outlining the detrimental effects that the Trump administration's proposed drug pricing rule would have on patients. The authors astutely note that a "one-size-fits-all" approach is the wrong solution given the complexity of the disease as well as the individual needs of HIV patients. Stakeholders also emphasized that reliance on step therapy and prior authorization would create additional barriers to access for lifesaving treatments.   

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• Crain's New York Business: New Yorkers Have a Lot to Lose From Trump's HIV Plan – "Trump’s proposed changes would limit the protected classes, allowing insurance companies to dictate care for those living with HIV by requiring the cheapest and often less effective medications. This would result in more deaths and increased numbers of new infections. If ending the AIDS epidemic is the goal, Trump should be pursuing policies that mean more, not fewer, people will be able to get the care they need. We’ve made so much progress since we first started the fight to end HIV, but we still have work to do. New York state has the highest rate of people over 55 living with HIV in the country, with more than 45,000—and concentrated in the five boroughs. We need to ensure that these folks get the healthcare and treatment they need to continue living long and healthy lives, with the added benefit that they would be unable to transmit HIV to others." – Mr. Kelsey Louie, CEO of the Gay Men's Health Crisis (GMHC).

• The Pride: HIV Status in America – "These protections have allowed patients to access the innovative medications that have made a difference in the lives of people diagnosed with serious medical conditions. Curtailing these protections and restricting treatment options is a recipe for worsening health outcomes and higher long-term health care costs. Patients living with HIV/AIDS understand, more than anyone, the need for multiple avenues for care. Medications effect people differently, with varying levels of success. Ensuring a wide array of options for potentially life-threatening illnesses is not only the right choice medically, but the right choice morally. These poorly conceived policies are particularly salient for marginalized populations like the Latino and LGBT communities. Members of these groups typically face multifaceted, at times intersectional, obstacles to adequate care due to systemic barriers and general stigma. It has been a long climb toward eradicating this bigotry, but our communities have persevered." – Mr. Richard Zaldivar, Founder and Executive Director of The Wall Las Memorias Project. 

• Manhattan Times: Trump's Threat – "These six classes of drugs serve patients living with complex conditions such as HIV/AIDS, mental illness, epilepsy and cancer, which require individualized treatment regimens to maximize success. Medicare insurance plans must cover all drugs in these classes to ensure the best possible health outcomes for patients. Unfortunately, under the Trump administration’s proposed changes to these protections could be curtailed, allowing plans to cover fewer of these critical medications. Patients in need of tailored care, particularly those who belong to marginalized communities who already face barriers to health care access, could suffer as a result of these new policies. HIV disproportionately affects the African American and Latino communities." – Mr. Guillermo Chacón,  President of the Latino Commission on AIDS and Founder of the Hispanic Health Network. 

• USA Today: I Am An HIV-Positive Memphian And I'm Warning Against A Plan That Would Harm Other People Like Me –  "By changing Medicare Part D’s protected classes designation, insurance companies would be able to deny certain forms of care through cost-cutting measures, interrupting care for hundreds of thousands of patients. When used correctly, effective antiretroviral medications suppress the virus and keep it at undetectable levels, preventing new HIV transmission. When this treatment is interrupted, or a doctor’s prescription is overruled for different, cheaper treatment by insurance companies, a patient not only runs the risk of rejecting the treatment, but it may lead to viral resistance or nonadherence. This fail-first model of care not only harms the patient in the short term, but runs the risk of severely limiting a patient’s health and well-being in the long run. That in turn runs the risk of spreading HIV further, undermining public health and fanning the flames of fear and stigma among marginalized communities." – Mr. Marvell L. Terry II, Founder of Red Door Foundation. 

• Roll Call: Trump’s HIV Plan is Bold. But Can He Back It Up?​ – "The proposed changes would allow for the exclusion of new formulations of drugs which could limit access to promising long-acting HIV treatments that are under development, but not yet approved for use. If implemented, plans could newly require prior authorization and increase the hassle factor that causes interruptions in HIV treatment. Some plans may want to gain a reputation as a difficult plan for people with HIV, to avoid them as enrollees. Moreover, prior authorization and step therapy (wherein a person has to first try one medication before getting approval to use another) are generally not clinically appropriate for managing HIV. If people with HIV are required to use a regimen that may have side effects or contribute to other health problems, their health could suffer. If individuals are forced to take medications that make it harder to adhere to daily treatment, they could develop resistance, which could limit their ability to use not only one drug, but whole classes of drugs or drug regimens. In addition to this serious personal cost, fostering resistance through short-sighted pharmacy denials has larger public health implications. These seemingly small changes could be extremely harmful." – Mr. Jeffrey S. Crowley, Program Director of infectious disease initiatives O’Neill Institute for National and Global Health Law at Georgetown Law.

• The Hill: Older Americans Will Suffer if White House Cuts HIV Funding –​ "President Trump’s latest proposal would allow health insurance plans to limit the HIV/AIDs medications they cover through Medicare Part D. Patients relying on Medicare Part D, would be one of six 'protected classes' now denied access to their needed medicines. The proposal is shortsighted, as it surely will not save the costs projected in the proposed budget. This is because of the rise in health costs, hospitalization and far more expensive acute treatment and strains on health systems, including in the mental health arena.This can be cited in the AJMC 2018 study, which found roughly $2.28 in additional costs, which was a result of HIV more restrictive formularies not unlike those being proposed now." – Dr. Michael W. Hodin, PhD, CEO of the Global Coalition on Aging. ​

• Los Angeles Sentinel: Californians are at Risk with Donald Trump's Rollbacks to Smart HIV Policies –​ "Lifesaving HIV medications are considered a protected class under Medicare Part D, and the protected classes ensure access to those medications. Trump wants to change the protected class status and give unprecedented power to insurance companies by putting them in between doctors and patients. By changing the protected classes, millions of people, including hundreds of thousands of people living with HIV could suffer. Trump’s proposed changes opens the door to allowing “step therapy,” which can force people to take less effective medications first before proving they don’t work and getting access the treatment their doctor thinks is best for them. This opens the door to drug resistant viruses and threatening the lives of people with HIV and undermining prevention efforts." – Mr. Phill Wilson, founder and former President and CEO of the Black AIDS Institute.

• Dallas Voice: First, Do No Harm –​ "Trump’s new rule would allow Medicare Part D to use the same practice that private health plans and pharmacy benefit managers use, including step therapy and prior authorization, which creates frustrating delays that too often harm patients. By allowing for prior authorization — requiring providers to seek and gain approval by an insurance provider before covering specific medications — and step therapy — forcing patients to try certain medications first before allowing coverage for other medications — this rule would harm patients. These practices are already incredibly serious problems for people living with HIV with private insurance, especially when the 'try first' medications are not as well-studied or have been shown to be clearly inferior to the nationally-recognized treatments. And, unlike high blood pressure treatment where trying one medication first will not lower efficacy of future medications, failing one HIV treatment results in resistance that impacts the future ability to treat HIV. This increases the risk for poor health outcomes and increases the risk of transmission of the virus to others. As a doctor, I’ve seen these practices play out with dangerous results."  –  Dr. John Carlo, CEO of Prism Health North Texas. 

• The Advocate: Trump's Hazy Plan to End HIV Comes Into Focus –​ “With recent advances, we certainly stand on doorstep of ending HIV transmission as soon as 2025. Democrats will prioritize protecting preexisting condition protections, expanding Medicaid to ensure health care access, and prescriptions drug costs. We will support proven methods of prevention, including sterile syringe access and PrEP. We will recognize that to defeat this epidemic we must target our efforts where new infections are disproportionately occurring - especially in the South and among young, gay men of color - while protecting legacy communities. We will oppose the harmful proposed Medicare Part D rule that would push lifesaving drugs out of reach for people living with HIV. And we will continue our efforts to ensure key investments in Ryan White, CDC prevention, and lifesaving research.”  –  Mr. Neal Broverman. 

• The Body: The Trump Administration's Drug Pricing Proposals for People With HIV, Explained –​ "Part of that law set up certain 'protected classes' of medicine that severely limited how much plans could hold back certain drugs -- and HIV care is one of those classes. This means that, when it comes to HIV and other protected classes of health care, Medicare Part D plans have to basically cover all available drug options, leaving all the judgment to doctors and patients, even when those options are the most expensive and, some might argue, comparable to cheaper options. In the case of HIV, for example, this means that Medicare Part D plans must cover single-tablet regimens like Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), making life (and adherence) as easy as possible for patients, even though certain multiple-tablet regimens may be cheaper. But now the administration is talking about maybe putting some restrictions on those protected classes in Part D, such as making a doctor and patient at least start with a cheaper option and permit them to move on to another only if they can show that the cheaper one failed in some regard. (That's called 'step therapy.') Or they might put prior-authorization requirements on protected-class drugs."  –  Mr. Tim Murphy. 

• Miami Herald: Trump Wants to End HIV Transmissions by 2030. That Means, He Should Withdraw Proposal That Undercuts Treatment ​ –​ "Trump’s proposal would allow for policies like 'step therapy,' where patients are forced to try lower-priced drugs and prove that they are ineffective before they can receive the medication that is right for them. It could also allow insurers to require prior authorization, forcing providers to get approval from insurance companies before prescribing medications. Delayed treatment and inaccurate medications can have potentially devastating health consequences on people living with HIV. For example, Eric, who lives on Florida’s Treasure Coast, has fought to get the medication he needs to keep him healthy for a decade. At times, he even paid for his life-saving HIV medication out-of-pocket because his insurance company denied him coverage for the most effective regimen for him. Now that he is covered under Medicare Part D, Eric has had access to that most effective treatment, which keeps him healthy and the virus suppressed. If he is forced to change his medication because of the administration’s proposed rule change, Eric fears it could be life threatening. He’s not alone." – Ms. Nadine Smith, co-founder and CEO of Equality Florida; and Ms. Alejandro Acosta, HIV Advocacy Project Coordinator of Equality Florida. 

• Morning Consult: We’ve Seen the Height of the HIV Epidemic. We Can’t Let Trump Take Us Back​ –​ "Central to ending the HIV epidemic is preventing new transmissions, and data shows the best way to do that is allowing people to quickly access the right medicine that keeps their virus in check, making it impossible to spread to others. Trump’s proposed rule puts that in jeopardy by removing restrictions against 'step therapy,' meaning insurers would be able to require Medicare enrollees living with HIV to prove less-effective medications don’t work before agreeing to cover more-effective, but more expensive treatments. Trump argues that this is an effort to control costs, which we agree is a worthy issue, but reforming cost on the back of people living with HIV is the wrong way to solve the problem. More than 700,000 people with AIDS have died since the beginning of the epidemic. We’ve seen the height of the HIV epidemic. We can’t go back." – Mr. Nic Carlisle, Executive Director of the Southern AIDS Coalition. 

• STATNews: HIV care is threatened by proposed changes to Medicare Part D –​ "CMS has long demonstrated its understanding of the importance of unimpeded access to effective treatment for conditions that include HIV by requiring Part D drug insurance plans to cover all or nearly all drugs in six protected drug classes, including antiretroviral treatments for HIV. In recognition of the importance of an individualized approach to HIV treatment, HIV medications have had the added protection of being covered without restrictions. The proposed rule would change that. While still requiring that Part D plans cover the drugs, it would allow them to impose obstacles to some drugs based on cost. Those obstacles would include requiring prior authorization, a time-intensive process that forces doctors to justify the prescriptions they write to insurance company staff who often have no expertise in treating HIV. Prior authorization is not a good idea for treating HIV, due to the potential consequences of delaying the start of treatment and possibly causing dangerous lapses in treatment." – Dr. W. David Hardy, chair of the HIV Medicine Association. ​

• Tallahassee Democrat: Altering Medicare Part D could harm Floridians living with HIV –​ "Currently, HIV drugs classified as anti-retrovirals are considered one of the six 'protected classes' of medicine. This means that Part D plans are required to cover 'all or substantially all' medications within these classes without exception. The proposed changes, however, would undermine these protections and allow Part D plans to restrict the number of drugs offered under each class. Additionally, the proposal would allow plans to impose requirements for prior authorization and step-therapy for HIV medications. Step-therapy is a harmful practice that forces patients to prove that a cheaper medication failed to meet their needs before they are permitted to use a drug originally prescribed by their physician. This change strips doctors of their autonomy and undermines their ability to offer the medications that best fit patients’ specific needs. Step-therapy is not a practice endorsed by current HIV treatment guidelines." – Dr. Jonathan Appelbaum, Vice-chair of the American Academy HIV Medicine.

• Charlotte Observer: Trump Administration Proposal Threatens HIV Patients​ –​ "HIV medicine is not a one-size fits all approach. Under this new plan, Medicare would be able to ignore the treatment plan I have designed to meet a patient’s specific needs and provide him or her, instead, drugs that are cheaper and may not work as well. Patients may also not take the cheaper drugs as consistently, which can also lead to poorer health outcomes for my patients. Not only is this a personal health problem, but it has serious public health ramifications. When people living with HIV take their medications regularly, they are much less likely to transmit to others. Therefore, when government-induced alterations seek to undermine access in the name of cost-saving, we are all at risk. Today, HIV is no longer a death sentence, thanks to the advancement of antiretrovirals. To pull those protections would be taking an archaic step back. For health care providers like me, who have spent decades treating and caring for these individuals, this is simply unacceptable." – Dr. J. Wesley Thompson, Medical Director of HIV Care at Amity Medical Group 

• The Hill: Trump's Medicare Rule Change Threatens to Reignite AIDS Epidemic –​ "HIV medicine is not a one-size fits all approach. Under this new plan, Medicare would be able to ignore the treatment plan I have designed to meet a patient’s specific needs and provide him or her, instead, drugs that are cheaper and may not work as well. Patients may also not take the cheaper drugs as consistently, which can also lead to poorer health outcomes for my patients. Not only is this a personal health problem, but it has serious public health ramifications. When people living with HIV take their medications regularly, they are much less likely to transmit to others. Therefore, when government-induced alterations seek to undermine access in the name of cost-saving, we are all at risk. Today, HIV is no longer a death sentence, thanks to the advancement of antiretrovirals. To pull those protections would be taking an archaic step back. For health care providers like me, who have spent decades treating and caring for these individuals, this is simply unacceptable." – Jesse Milan Jr. CEO of AIDS United