In Spotlight on Market Access, Precision senior research economist James Baumgardner provides his perspective on HHS’ proposed changes to Medicare Part D loosening government restrictions on 4 protected drug classes, including those to treat HIV. Baumgardner cautions the rule changes “directly imperils those with HIV who have Medicare as their source of health coverage,” and urges greater adoption of HIV prevention efforts, including the use of new PrEP treatments that can greatly reduce the risk of acquiring HIV.

The complete article can be viewed below:

Administration Calls for Eradication of HIV, But Could HHS Proposal Undermine Effort?
AIS Heath

HHS recently unveiled a multipronged initiative that it is undertaking in order to achieve the goal of nearly eliminating the U.S. HIV epidemic within 10 years, which experts say is attainable. But that push may be hamstrung by other administration moves, including the recent HHS proposal to loosen restrictions governing the protected drug classes in Medicare Part D.

The agency offered details on the initiative through a report titled Ending the HIV Epidemic: A Plan for America. The goal is a 75% reduction in new infections in five years and at least a 90% decrease in 10 years. To achieve this, it has four strategies:

1. Diagnosing people as quickly as possible after they are infected;
2. Treating the infection quickly and effectively in order to achieve sustained viral suppression;
3. Protecting at-risk individuals from acquiring the virus, including through the use of pre-exposure prophylaxis (PrEP); and
4. Detecting and responding quickly to any growing HIV clusters.

The initiative will focus on providing resources to “geographic hotspots” consisting of 48 counties; Washington, D.C.; San Juan, Puerto Rico; and seven states “that have a substantial rural HIV burden”: Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma and South Carolina.
According to the Centers for Disease Control and Prevention, at the end of 2015 around 1.1 million Americans at least 13 years old had HIV. An estimated 15% of them had not been diagnosed yet. In 2017, there were almost 40,000 new infections in the U.S. and six “dependent areas.”
In his State of the Union speech, President Donald Trump noted that “in recent years we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once distant dream within reach.…We have made incredible strides, incredible. Together we will defeat AIDS in America and beyond.”

Researchers have indeed made great progress in developing an array of treatment options with various mechanisms of action. The HIV pipeline is full as well, including vaccines. And while industry experts have praised the initiative and said it is indeed possible to achieve its goals, they caution that it will take some effort. Complicating matters, they say, is that the administration may be thwarting its own efforts.
“It’s a laudable goal,” contends James Baumgardner, Ph.D., senior research economist at Precision Health Economics. “With improved screening, treatment, prevention treatment and understanding of behaviors and motivations, we have the tools to achieve the administration’s goal to reduce the number of new HIV infections by at least 90% in 10 years.

“However, we will need to do better across the full spectrum of care — screening, prevention and treatment — to achieve the goal,” he continues. “Getting infected people into care and keeping them on medications that achieve viral suppression is key, and there are many facets of our health care system that can play a role in achieving that. Viral suppression reduces infectivity, and other well-known strategies also exist to reduce the number of new infections.” In addition, he says, increasing PrEP uptake “in at-risk populations…will be important.”

Bruce Packett, executive director of the American Academy of HIV Medicine (AAHIVM), tells AIS Health that the “plan to eliminate new HIV infections by 2030 is theoretically plausible; we have the mathematical modeling to back it up, which entails getting every person living with HIV in the country on a treatment regimen that is appropriate for them, and getting all those at high risk for seroconversion on PrEP.”
The most promising aspects of the HHS effort, Packett says, include “the cross-agency cooperation in the federal government,” involving several agencies and the Indian Health Service, as well as the focus on the areas of the country “most affected by the epidemic in terms of new infections. This targeted focusing of resources should bridge some of the care, treatment and prevention access gaps currently existing in those so-called ‘hotspot’ parts of the country, particularly in the poorer and more rural southeast.”

However, he adds, “You could argue that the focus on these at-risk communities is simply pulling a significant socioeconomic ‘scab,’ where there are much bigger structural issues at play: economic disinvestment, structural issues of race, paucity of access to public services, substance abuse and other widespread mental health issues as a result of the lack of opportunities and wealth, cultural issues around gay and trans stigma, and so on. These are all related to the demographic and geographic ‘pockets’ of the country where the HIV epidemic has been allowed to thrive, and some ‘big-picture’ thinking along these lines may be needed to well and truly eliminate the epidemic entirely.

According to Packett, “many of those people who are living with HIV, or otherwise at high risk, have many co-conditions and co-morbidities related to both their physical and mental health that need to be addressed in order to maintain viral suppression and thus reduce what’s called the ‘community viral load,’ which is directly related to the broader risk of contracting HIV in certain communities. We know that ‘undetectable equals untransmittable,’ so our focus must be on treatment as prevention in these at-risk populations and communities.”

In addition, “outreach to the patient population is important, both to encourage screening — many infected people may not know it — and then to encourage and make it easier for infected people to get treatment and remain adherent to treatment,” says Baumgardner. He points to greater efficacy and lower adverse events among treatment options, which now include single-tablet regimens. But that’s not to say that this condition is an easy one to treat.

“Because the patient can take a single tablet, adherence is better with such regimens, and this plays back into reducing viral loads more effectively,” Baumgardner notes. “Drug resistance is less likely to develop if a patient adheres to the prescribed treatment regimen. It’s also the case that some patients suffer adverse events on some medications and would better tolerate other therapies. Some patients have sensitivities to certain components of some HIV therapies, and therefore they need to be on something else. Sometimes the virus mutates while a person is taking one HIV medication, causing drug resistance, and the patient needs to be switched to a different medication to bring the viral load back down in order to slow disease progression and reduce their potential infectivity.”

People who have not acquired HIV but are at high risk of doing so can reduce their chances of this with PrEP. The FDA approved Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) for PrEP in at-risk adults in 2012 and in adolescents in 2018. When taken as directed, the drug can reduce the risk of sexually acquiring HIV by more than 90% and of acquiring it through drug injection by more than 70%.
In June 2017, the FDA approved the first generic version of Truvada, from Teva Pharmaceuticals USA. The company said at the time that it had reached a settlement on when it could come to market, but it did not say when that would be. And just last month the FDA issued guidance on developing systemic drug products for PrEP, including long-acting drugs and delivery systems, with an eye on supporting the development of such products.
Late last year, the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation statement on PrEP, endorsing clinicians’ offering PrEP in conjunction with antiretroviral therapy to people at high risk of acquiring HIV. The agency said it had “found convincing evidence that PrEP is of substantial benefit in decreasing the risk of HIV infection in persons at high risk of HIV infection, either via sexual acquisition or through injection drug use. The USPSTF also found convincing evidence that adherence to PrEP is highly correlated with its efficacy in preventing the acquisition of HIV infection.”

But poll results released in late March by the Kaiser Family Foundation revealed that only 42% of the public overall knows about PrEP. That percentage, however, is an improvement over the 14% aware of it in 2014.

And an analysis by the Centers for Disease Control and Prevention released in March 2018 found that only a small percentage of people who could benefit from PrEP actually received it. Specifically, although there were approximately 1.1 million Americans at high risk of contracting HIV in 2015, only 90,000 prescriptions for PrEP were filled in community pharmacies that year.

But challenges exist even among those with a Truvada prescription. A recent article in the Journal of the International AIDS Society said a study of PrEP users revealed “substantial non-persistence on PrEP medication in both year 1 and year 2” and only two out of five users persisting over the two-year period. So what is needed to enhance PrEP persistence?

“Greater access to and broader education around PrEP is the only thing that will improve PrEP persistence and adherence,” replies Packett. “This starts with the health clinics and the providers understanding what the PrEP guidelines are, what questions to ask around risk and to know how to provide appropriate prevention counseling.”

“Right now we are still early in the introduction and evolution of the use of PrEP,” observes Baumgardner.
In addition, Packett says, “access to regular care and treatment is the other big factor. If patients are moving in and out of coverage, this interrupts the relationships that they build with their care provider and could quite easily negatively impact prevention/PrEP persistence, regular counseling and testing.”

But addressing all these complex challenges may prove difficult.

“The problem is that there are other moves by the administration that are chafing against this effort: its stigmatizing of LGBT people; its attacks on Title X funding, where the clinics that serve poorer women, including high numbers of women of color who are at higher risk for contracting HIV, are imperiled. We saw this in Indiana, where there was an outbreak of HIV and HCV [i.e., hepatitis C] in 2014, not long after a Planned Parenthood clinic near the outbreak area was closed,” says Packett. He also points to the administration’s efforts to dismantle the Affordable Care Act, “which affects coverage and access for many Americans who may be uninsured or underinsured without the benefits of the ACA.”

Also potentially threating the initiative’s goals, he says, is the HHS proposed rule (CMS-4180-P) to allow Medicare Part D plans to limit coverage of drugs in the six protected classes (SMA 1/7/19, p. 1). Except in limited circumstances, Part D plan sponsors must include all available drugs within six protected classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals and antineoplastics.

CMS is proposing for these drugs (1) the broader use of prior authorization and step therapy; (2) the ability to exclude a new formulation of a drug that doesn’t have a unique route of administration, regardless of whether the existing drug is still available; and (3) the ability to exclude a drug if its price increases, relative to the price in a baseline month and year, beyond the rate of inflation.

According to the Kaiser Family Foundation, about one-quarter of people with HIV are Medicare beneficiaries.

In late November, when the proposal was unveiled, The AIDS Institute maintained that “this proposal runs contrary to current US government HIV treatment guidelines, which state that prior authorizations for HIV drugs ‘result in fewer prescriptions filled and increased nonadherence…and have substantially reduced timely access to medications.’ Step therapy is unheard of in the treatment of HIV due to the danger of developing resistance to an entire class of drugs and potential side effects.…Not all HIV medications are the same, and not every person living with HIV is the same. Providers are best able to prescribe the HIV drug that works best for the patient.”

If step therapy and prior authorization are applied to antiretrovirals, “that means that patients may have to start on a therapy that may not be optimal for them — potentially increasing the likelihood of certain adverse events — or be switched to a different therapy when they become eligible for Medicare or switch Medicare drug plans,” points out Baumgardner. “When this type of policy is followed in a large HIV population, the numbers start to add up in terms of poorer outcomes and corresponding costs.”

“It’s also important to recognize that the proposed rule includes circumstances under which an antiretroviral drug could be excluded from coverage by a Part D drug plan,” he continues — “if it’s considered to be a new formulation of an existing drug or if its price rises faster than a general measure of inflation. Just think about that. Inflation is the average increase in the price of goods. That means many goods’ prices rise faster than inflation since inflation by definition is an average of the price increases across all goods (weighted by volume of sales) — that’s just a mathematical fact. Many drugs could be excluded from coverage by this kind of rule. Efficacious drugs against HIV might be excluded from coverage by Part D plans.

“Also, to turn to the ‘new formulations’ part of the proposed rule, new formulations can be more efficacious than those they are replacing, and sometimes that’s because patients adhere better with the new formulation,” he continues. “The proposed rule would allow drug plans to not cover such medications even though they may be more effective in real-world practice at reducing viral loads, minimizing side effects, and reducing infectivity.

If implemented, the proposal “directly imperils those with HIV who have Medicare as their source of health coverage,” contends Packett. “We know that these patients on Medicare are older and/or disabled, which means that they likely have other conditions and diseases that also need to be treated along with their HIV.” Issues with adherence to regimens may threaten their ability to maintain viral suppression, “so in those cases maybe a one-pill-per-day option is strongly preferred, or perhaps even a protease inhibitor-based option should be considered. Some have the virus with a certain resistance profile that may need to be taken into consideration when trying to choose an effective regimen. In none of these cases should a plan or PBM be deciding what options are available to providers who treat HIV.”

He points out also that using prior authorization and step therapy “may not save Medicare any money at all” when it comes to HIV drugs. That’s because “some of the cheaper regimens that plans prefer may in fact be clinically inferior, leading to poorer health outcomes and bigger long-term health costs down the road — anything from bone density issues to kidney malfunction. Side-effect profiles of certain treatments may lead to poorer adherence and thus greater transmissibility of the virus. If the virus has certain drug resistances, or develops them over time due to poor adherence or delayed access to the prescriptions, that too may lead to higher viral loads and more risk in terms of spread.”

Last month, Precision Health Economics released a memo assessing the potential impact of the implementation of the proposed rule that analyzed exactly these potential outcomes. Among the findings are the following:

• If step therapy and prior authorization were used compared with no access restrictions, from 2020 through 2029, there would be 7,200 additional all-cause deaths and 84,000 more renal and bone adverse events.
• These adverse events would result in $1.08 billion in additional costs due to the medical care needed to treat them.
• These utilization management tactics could result in more than 6,750 new HIV infections due to higher viral loads among Medicare beneficiaries with HIV. The memo notes that while those infections would be from the Medicare population, “the new cases would be distributed across the general population meaning that those new patients who received treatment and were insured would have various sources of coverage including private payers, Medicaid, and Medicare.”
• If the drug formulation and pricing provisions were implemented, this could lead to an additional 8,000 all-cause deaths and 87,600 additional renal and bone adverse events between 2020 and 2030.
• Costs due to these adverse events would total more than $1.1 billion from 2020 through 2029.
• Restricting therapy options could result in more than 7,600 new infections from increased viral loads “from use of suboptimal therapies among patients with HIV.”

The memo estimates that the potential impact of all three changes would be closer to the predictions tied to the drug formulation and pricing provisions, as opposed to adding the estimates together. “As is evident, most of the negative consequences of the combined proposal come from the potential elimination of treatments with high efficacy and low adverse event rates from the first line of treatment, which can happen under both step therapy designs and under provisions that could eliminate a drug from the formulary. Thus, the vast majority of the costs of the full proposal would arise from greater use of step therapy alone.”

Baumgardner tells AIS Health that although the memo did not analyze the proposal’s potential impact on PrEP, “in general, one would be concerned that some or all potential options for patients to use PrEP might be eliminated or that some therapies may be held back until a patient suffered an adverse event, which then allowed them to go to the next medication in a step-therapy design. Also, because the Medicare population is older, HIV infection could be more problematic, as the likelihood of comorbidities is greater.”

According to Packett, “Providers need access to the full armamentarium of HIV drugs without delays in order to prevent certain drug-drug interactions or to deal with drug-resistant virus in some of these older patients. It’s another clear and critical case where providers need to be calling the shots in terms of prescribing the appropriate drug regimens, not the plans. Anything else could affect not just the individual long-term health of people living with HIV in Medicare but also their partners and communities.”

Beyond worsened health outcomes, Baumgardner says other potential unintended consequences exist. “First, you have the chilling effect on spending aimed at new innovations. Any rules that might substantially reduce access to a new innovation affect the environment in which innovator firms make decisions about development.

“Second, you add another consideration to pricing decisions that could be counterproductive,” he adds. “And finally, there’s a real concern that drug plans and [Medicare Advantage] drug plans would use step therapy, prior authorization and the formulary exclusion provisions as selection tools to discourage HIV patients from choosing their plans. These types of adverse selection strategies were a concern from the advent of Medicare Part D.…The protected class rule was intended to combat the selection issue.…Those concerns are just as relevant today as they were when Part D was first designed.”

View the HHS report at https://bit.ly/2WPQrWX and the Precision Health Economics memo at https://bit.ly/2FEXpb3. Contact Baumgardner through Tess Rollano at trollano@coynepr.com and Packett at Bruce@aahivm.org.