Thursday, July 30, 2020

NASTAD Releases 2020 Monitoring Project Annual Report

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor

In early June 2020, the National Alliance of State and Territorial AIDS Directors (NASTAD) released its “2020 National RWHAP Part B and ADAP Monitoring Project Annual Report”, and within, unveiled some interesting statistics.


In Calendar Year (CY) 2018, the Ryan White HIV/AIDS Program (RWHAP) provided service to 283,480 clients. This represents 26% of the estimated 1.1 million people estimated to be living with HIV in the U.S. (NASTAD, 2020). This represented a 16% increase from the 245,245 clients served in CY2017.  By comparison, in 2018, Medicaid was the largest source of coverage for adults living with HIV in the U.S., covering 40% of People Living with HIV (PLWH) (Dawson & Kates, 2020).

A more interesting revelation is how those clients are access healthcare via the RWHAP’s AIDS Drug Assistance Program (ADAP). Of the 242,727 clients who received services via ADAP in CY2018, 54% of them did so using insurance (either public, or private insurance for which the ADAP program paid premium(s), deductibles, and/or cost-sharing/co-payments), whereas 46% benefited from the full-pay prescription program, only (NASTAD, 2020).

Addition interesting info are as follows:

RYHAP Part B:
  • Among RWHAP Part B clients served during calendar year 2018, 49% had incomes less than 100% of the federal poverty level (FPL) whereas 12% of the general population were living at or below the FPL. By comparison, 53% of RWHAP Part B clients were reported as having incomes below 100% FPL in calendar year 2017.
  • RWHAP Part B clients were also more likely to be people of color (57% vs. 23%), with the majority 82% of clients of color reported as Black/African American.
  • By ethnicity, 21% of RWHAP Part B clients were reported as Hispanic/Latinx (vs. 18% in the general population).
  • The majority of clients served identified as male (72%) whereas 26% were identified as female. Comparatively, 49% and 51% of the U.S. population in 2018 were reported as male and female, respectively. This difference is reflective of the disproportionate prevalence of HIV among men nationally; 76% of all adult PLWH in 2017 were male.
  • One percent of RWHAP Part B clients were reported as transgender in CY2018, 86% of whom identified as trans women, 3% as trans men, and 10% as transgender - other.
ADAP:
  • Forty percent of ADAP clients served in CY2018 had incomes below 100% FPL, 13% less than those served by RWHAP Part B (53%).
  • In 2017, 40% of all RWHAP clients were enrolled in Medicaid.
  • 44% of ADAP clients were reported as people of color – slightly less than the 57% of RWHAP Part B clients.
  • A greater proportion of ADAP clients (89%) were Black/African American, compared to 82% of RWHAP Part B clients.
  • 27% were of Hispanic/Latinx ethnicity (vs. 21% among RWHAP Part B clients).
  • By gender, ADAP clients were more likely to be male than those PLWH served by RWHAP Part B; 77% of ADAP clients were reported as male, 21% as female, and 1% as transgender.
  • Among transgender ADAP clients, 84% were reported as trans women, 3% as trans men, and 13% as transgender – other.
It is clear, from NASTAD's reporting, that the Ryan White HIV/AIDS Program continues to serve a vital role in ensuring that PLWH in the U.S. continue to have access to the essential healthcare and medication coverage and services necessary to reach viral suppression and the elimination of HIV in the United States. The report can be downloaded online at https://www.nastad.org/PartBADAPreport.

References:
  • Dawson, L. & Kates, J. (2020, July 09). Insurance Coverage and Viral Suppression Among People with HIV in the United States, 2015-2018. 4. Washington, DC: Kaiser Family Foundation: Charts & Slides. https://www.kff.org/slideshow/insurance-coverage-and-viral-suppression-among-people-with-hiv-in-the-united-states-2015-2018/
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Thursday, July 23, 2020

Is Long-Lasting, Injectable Medication the Future of HIV Therapy?

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Long-lasting medication to treat patients living with HIV/AIDS has been a goal of the medical field since the early days of the epidemic. Currently, most HIV therapies include daily medication involving multiple pills, which has proven to be expensive for the average patient, as well as potentially challenging for medication adherence. That could be changing, because an investigational, long-acting, injectable, 2-drug regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV is showing promise.

At the 2020 Conference on Retroviruses and Opportunistic Infections, ViiV Healthcare announced results from its 96-week global phase III FLAIR study. The results demonstrated the injectable therapy "continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC)." Also, compared to their previous, oral treatment, patients who participated in the study expressed a high level of treatment satisfaction at week 48, as well as week 96 (ViiV Healthcare).

Cabotegravir
Photo Source: Christian Today

"Our focus on creating innovative treatment options for people living with HIV is further supported by these long-term findings of a long-acting injectable HIV treatment regimen. The efficacy and safety data of cabotegravir and rilpivirine at 96 weeks, as well as a high level of treatment satisfaction for the long-acting regimen, further encourage us as we work to bring this treatment option to people living with HIV," said Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare.

"Seeing the longer-term data is really exciting. It confirms that the long-acting, two-drug regimen of cabotegravir and rilpivirine has maintained its efficacy and has the potential to be a generally well-tolerated alternative to the standard-of-care, daily, oral pill. For some people living with HIV, reducing their dosing schedules from 365 days per year to 12 may be a realistic option in the future," said Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London (ViiV Healthcare).

The use of cabotegravir has implications broader than HIV therapy, too. Injectable cabotegravir is also being evaluated for pre-exposure prophylaxis (PrEP). Whereas the aforementioned news of cabotegravir’s (in combination with and rilpivirine) initial effectiveness in treating patients is new to celebrate, questions still remain as it relates to its use in HIV prevention - one being its effectiveness in women living with HIV.

As it relates to PrEP, Molly Walker wrote in MedPage Today on May 19 that she worries this drug will be approved for only one HIV positive population.

"While results for the long-acting HIV prevention medication cabotegravir are promising in men who have sex with men (MSM), there is still no data on this drug in women, begging the question of whether this will be another HIV prevention option that ends up being approved for only one population," said Walker (MedPage Today).

Mitchell Warren is executive director of AVAC: Global Advocacy for HIV Prevention. He described the experience with another drug, F/TAF as 'completely dropping the ball early on in the process'. According to Walker, the experience with cabotegravir is not similar to F/TAF.

Thousands of women are getting cabotegravir injections and the same data safety monitoring board oversees both studies," he noted, adding HPTN 083 data has not been fully analyzed and yet to be peer reviewed. "It's still a long way from submission to the FDA and other regulators," said Warren.

Unlike F/TAF trials, the test trials for cabotegravir is almost 'fully enrolled' among women, which is promising. Warren also noted that if cabotegravir is effective in HIV positive women or at-risk women, it could be good news to those who still carry the social stigma of taking multiple pills a day.

"While PrEP has been "normalized" in the gay community, he added, the idea of carrying "a large pill bottle" still imparts a great deal of stigma for at-risk women," Warren said.

Warren emphasized that having more options with HIV medications is helpful to those around the world, citing that many women are comfortable getting injections every 3 months for contraception.

Cabotegravir is still in the testing stages, but the initial results of effectiveness in trail patients has been positive. The hope is that this new drug will be effective for both men and women, while also lessening the social stigma of taking large dosages of pills to treat and prevent HIV.

References:
  • ViiV Healthcare (2020, March 9). ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting injectable treatment regimen in adults living with HIV-1. Retrieved from https://viivhealthcare.com/en-gb/media/press-releases/2020/march/viiv-healthcare-presents-positive-long-term-data-from-phase-iii-/#:~:text=Cabotegravir%20is%20being%20developed%20by,prior%20to%20long%2Dacting%20injection
  • Walker, Molly (2020, May 19). HIV Injectable Tx May Work in Men -- But What About Women? MedPage Today. Retrieved from https://www.medpagetoday.com/hivaids/hivaids/86580.
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Thursday, July 16, 2020

CMS Co-Pay Accumulator Rule Aims to Increase Consumer Costs

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor

Co-Pay Accumulators are management tools used by health insurance companies, Pharmacy Benefit Managers (PBMs) and other health plans that excludes co-pay assistance coupon and program payments from counting toward patients’ deductibles (Schweitz, 2019). The Centers for Medicare & Medicaid Services (“CMS”) recently promulgated new rules potentially excluding drug manufacturer co-pay assistance programs towards patient out-of-pocket cost sharing and deductibles.

Co-Pay Accumulators

I wrote about this issue, last September, for the ADAP Advocacy Association (read blog, here), and have been asked to take another look at this issue after CMS decided, after some deep soulless searching and poor timing, to put this program fully into place in the middle of a pandemic outbreak.

Here is the rule in question:
1. See, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020, Final Rule, 84 Fed. Reg. 17454 (April 25, 2019) (the “Final Rule”).2. 45 C.F.R. § 156.130(h) reads in its entirety as follows:“(h) Use of drug manufacturer coupons. For plan years beginning on or after January 1, 2020:(1) Notwithstanding any other provision of this section, and to the extent consistent with state law, amounts paid toward cost sharing using any form of direct support offered by drug manufacturers to enrollees to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have an available and medically appropriate generic equivalent are not required to be counted toward the annual limitation on cost sharing (as defined in paragraph (a) of this section).”3. In general, “accumulator programs” are a relatively recent component of pharmacy benefit designs offered by many health insurers and PBMs for commercially insured enrollees. Accumulator programs track utilization of drug manufacturer-sponsored copay or other assistance to ensure that the drug manufacturer contribution no longer counts toward an enrollee deductible. Accumulator programs tend to reduce the health insurers’ or plan sponsors’ overall contribution to the total spend on high-cost branded prescription medications as opposed to shifting more cost toward them when accumulator programs are not in effect. There are many variations of these programs depending on plan design and other factors.4. See, Final Rule at 17544 - 17545.5. See, The Center for Consumer Information & Insurance Oversight, Affordable Care Act Implementation FAQs - Set 12, Q1 and Q2 (February 2, 2013), and Affordable Care Act Implementation FAQs - Set 18.
Looking for a bit more insight, I turned to JD Supra, a great source of press releases and legal analysis for those looking at government rules and regulations. Here was their finding in May 2020:

The Final Rule states that consistent with specific state law, coupons, and copay cards offered directly by drug manufacturers may be, but are not required to be, counted towards a patient’s annual cost-sharing limit under the plan. This is a notable change from CMS’ prior proposal that would prohibit copay accumulator programs for branded drugs without therapeutic alternatives. (Fox, Atkins, & Trunk, 2020)

Essentially, what a co-pay accumulator attempts to do is increase the amount of money consumers pay in order to decrease the amount of money insurers have to pay, once their annual deductible and/or Out-of-Pocket Maximum (OPM) is met. When consumers are allowed to count co-pay assistance cards against their deductible/OPM, they reach those limits sooner, meaning that insurers are then on the hook for every pharmaceutical fill after that date.

But the rule change at CMS is trickier than that, according to another JD Supra author:
"In conclusion, the Final Rule prohibits individual market, small group, large group and self-insured group health plans from using accumulator adjustment programs only when there is no generic for a branded pharmaceutical.  However, under federal law, all such health plans may continue pharmacy benefit designs which do not count manufacturer coupons toward an enrollee’s maximum out-of-pocket cost sharing (a) when there exists a generic equivalent for a branded drug, and (b) under any circumstances, for more expensive biologics. 
Still, as a final cautionary note, please keep in mind that the Final Rule, by its own terms, does not pre-empt state laws. Some states are considering or have passed legislation that may prohibit the use of accumulator programs regardless of the availability of generic substitutes. However, such state laws, if passed, may be limited to health insurers and may not be able to reach self-funded group health plans which are governed by ERISA. Thus, those subject to the Final Rule must remain cognizant of similar laws in the states in which they offer health benefit plans. (Hanna, 2019)."
The problem with this issue is that the CMS rule is aimed directly at insurers providing plans for the Medicare program. For those unfamiliar with that whole mess, Medicare insurance programs are offered to eligible beneficiaries not by state, but by zip code, meaning that there are well over 1,000 plans and options being offered across America. As a result of this, trends in the general health insurance market tend to follow the standards set by Medicare insurers, because they essentially glut the market (and, frankly, it’s just easier).

National Association of Insurance Commissioners

And this is the crux of this piece: can State Insurance Commissioners (and thus, state laws) use their influence and sway to essentially force insurance companies to count co-pay assistance cards toward deductibles/OPMs? The answer is a big, “…maybe?”

In most cases, federal law supersedes state law. In this case, that law is the Affordable Care Act (ACA, aka Obamacare). In order for states to engage in the health insurance marketplace (where consumers can buy individual plans), they have to live under ACA rules. As part of that, this new CMS rule would apply to the ACA, as well. That, however, is also unclear.

However, some states, such as Arizona, Illinois, Virginia, and West Virginia, have passed laws that prohibit insurers from using Co-Pay Accumulators in part, or in total. While Arizona and Virginia’s laws have a bit of wiggle room in their language, allowing for insurers to argue that they can use them in certain instances, both Illinois and West Virginia bar their utilization, outright, by not distinguishing between prescription drugs that do or do not have generic equivalents (Aimed Alliance, n.d.).

So, there’s not a lot of real light, here, to guide our way.

Advocates could attempt to get states to push through laws banning the practice (which, I think they should do, regardless of any advocacy), but let’s be honest – most state legislatures are out of session, for the remainder of 2020, and they’re almost all in the middle of an election year. There’s not going to be much movement on this issue until after November 4th.

The real question is whether or not federal rules supersede State Insurance Commission rules. If so, who the hell knows what’s going to happen, next?

References:
  • Aimed Alliance. (n.d.) COPAY ACCUMULATORS – ENACTED LAWS. Washington, DC: Aimed Alliance. Retrieved from: https://aimedalliance.org/copay-accumulators-enacted-laws/
  • Fox, A., Atkins, E., Trunk, S. (2020, May 29). HHS Clarifies Position on Copay Accumulators? Or Does It?. Sausalito, CA: JD Supra, LLC: Legal News. Retrieved from: https://www.jdsupra.com/legalnews/hhs-clarifies-position-on-copay-19750/
  • Hanna, D. (2019, June 18). HHS Issues Final Regulation Of Drug Co-Pay Accumulator Programs:. Sausalito, CA: JD Supra, LLC: Legal News. Retrieved from: https://www.jdsupra.com/legalnews/hhs-issues-final-regulation-of-drug-co-93372/
  • Schweitz, M.C. (2019, January). The Cost-Shift Conundrum of Copay Accumulator Programs. Thorofare, NJ: SLACK Incorporated: Healio: Healio Rheumatology: Practice Management. Retrieved from: https://www.healio.com/rheumatology/practice-management/news/print/healio-rheumatology/%7B04769e45-fca4-4ce6-90be-8f441d6afc7d%7D/the-cost-shift-conundrum-of-copay-accumulator-programs
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Thursday, July 9, 2020

Reflections from an HIV Advocate's Journey: Ken Pinkela

By: Ken Pinkela

I guess you can say I am an HIV advocate by necessity…

I left home 7 days after high school graduation in 1985 and reported to Basic Camp at Fort Knox, Kentucky. I had an amazing life and career. I have lived and been stationed around the world. From Europe to Hawaii to Asia and across the United States. I was diagnosed with HIV while deploying to Iraq in July 2006 – it was a total surprise. Everything changed at that moment.

I could no longer be assigned to a combat unit.I could no longer volunteer to deploy in support of any overseas operation. I could no longer be stationed in Korea, and I no longer had control over my HIV status. It was hard enough as it was to be told by a stranger, and be pulled away from your friends and at that time was going to get a detachment command, but it was the shear overwhelming nature of being treated “different…”

Ken Pinkela

I headed back to Washington, DC and to what would be a very long tour at the Pentagon. But like so many other gay and HIV-positive service members…I had to try harder…work harder and deflect every question about why I was not able to deploy. I was even “coached” to lie and not let anyone know I was HIV-positive because of the fear and stigma in the chain of command.

I even went as far as to demand to be treated at the Navy Infectious Diseases Clinic in Bethesda, and not the Army Clinic at Walter Reed. I knew that I needed to be as far away from the Army, and I am a firm believer in mental health support that at the time only the Navy offered as a part of HIV care.

So if you’ve ever been in an HIV support group, there are the introductions and I’ve been HIV-positive for xx years...imagine these young service members because for them it was “days” since diagnosis, and the fear of disclosure to anyone of any rank. My parental advocacy kicked in. I would go to “group” in uniform. The clinic staff asked me not to do it (out of their own internal rank stigma/fear) but very soon realized why I was doing it. These young enlisted soldiers and sailors sitting amongst strangers, scared about life and their own military career. I’d be there, and in turn identify as Ken and HIV-positive...and at that moment I was just one of them. We were connected, and I found myself an accidental advocate and it felt right.

Sadly, my story turns very dark in 2009, when I was informed that I was under investigation for “HIV exposure” by a then “anonymous” complaint. It wasn’t until 2012 that I was court-martialed, and imprisoned at Fort Leavenworth without any evidence, denied the phylogenetic testing I volunteered for and even my family were called lairs by a US Army military judge. We later learned that a former U.S. Army First Lieutenant fabricated and lied that I had miraculously “exposed” him (not infected him) without any sexual contact. The Army never conducted an investigation and even denied my volunteering for phylogenetic analysis ,which would prove my HIV is not his HIV.

Ken Pinkela

I was released from prison in 2013, and have been on a war footing ever since. I will not stop telling my story and advocating to abolish HIV criminalization. My fight continues even today! Yes, for myself and my family – as I lost everything…I lost my home, my career and a 29-year retirement. I can’t get a job due to the conviction, and only recently successfully won back my Veterans Affairs medical benefits from early Gulf War combat injuries that had me hospitalized for a year at Walter Reed.

It’s not an easy fight. I’ll admit that I cry every single day…its cathartic and helps clear my mind.

The struggle is real for all advocates and it’s also personal for many of us…it really is for me!

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Thursday, July 2, 2020

Reflections from an HIV Advocate's Journey: Lynea Hogan

By: Lynea Hogan

My HIV advocacy journey has been a trail of learning and growing experiences that shaped me to become who I am today; a vibrant fulfilled and alive woman living with HIV. I could not imagine that I would ever be able to say that when I was diagnosed in 1998. Pregnant with my son and unsure of both of our futures I felt alone, swallowed up in darkness and incredible despair. I was one of the lucky ones diagnosed after antiretrovirals hit the market, but my emotional and mental health was what was failing me.

Lynea Hogan

It took 15 years of battling with my diagnosis alone before I took the advice of mental health professionals and attended my first HIV Support Group. I left those meetings invigorated and inspired to dig deep and give of myself completely. My life was forever changed because of it, I gained an entire community of fierce warriors including mentors that guided me into advocacy and community outreach. I also joined the Consumer Advisory Committee in my area of Eastern Virginia and many other community boards dedicated to education, prevention, and the well-being of People living with HIV and AIDS. I am a member of the Positive Women’s Network. I became a Greater Hampton Roads Planning Council member and dived into the Quality management side of HIV care by representing the consumer voice on the Clinical Quality Management Committee of the Virginia Department of Health. I completed certified Peer educator training and volunteered in a rural clinic. Every year I speak with Nursing students and Doctors about the patient perspective, living with HIV. I was honored at the SisterLove Inc. 2020 leading women’s society and received awards of recognition of service within my state.

I have been invited to attend many National conferences on HIV including the Ryan White Conference on HIV, HealthHIV SYNChronicity, ADAP Advocacy Association's 2018 Conference, as well as their 2019 ADAP Fireside chat in Richmond, which was an intimate gathering of stakeholders focused on issues affecting PLWHA in the state of Virginia (i.e., access to care and Ryan White services). I’ve gained so much knowledge from these experiences, they’ve laid the groundwork for a retreat I’ve organized with colleagues to support, inform, and provided fellowship for people living with HIV in the State of Virginia, scheduled for later this year.

The goal in advocacy is to meet people along your journey, learn from them, build networks, and bring others along to complete the mission. I am thankful to the mentors that saw something in me that I did not see in myself and I am grateful they convinced me that it was worth investing in that tiny light that shill shone inside of me. I hope that as I grow and expand upon this work that I have that kind of impact on someone else. Too often we get caught up in our own lives that we do not stop to see that others are carrying the same load but if we work together, we can get so much further.

Lynea Hogan, outside

There is still so much left to do. I find myself thinking about future generations and how important It is that those that come after us are left with a roadmap to where we want to go, not follow our journey but get to the destination. That place is one of love, kindness, justice, and no HIV. I believe it can happen because so many of us are doing the work right now. I want this for my beautiful son who is now a young man HIV negative because of the medications that came in time to save his life. I do this for him.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.