Member365 ADAP Community Opens for HIV Advocates

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association earlier this week launched its new Member365 ADAP Community, which is an online portal designed to raise awareness, offer patient educational programs, and foster greater community collaboration. Ultimately, value-driven community engagement will increase support for the AIDS Drug Assistance Program (ADAP) by further connecting people living with HIV/AIDS, advocates, community organizations, healthcare groups, government agencies, pharmacies, pharmaceutical companies and other stakeholders.

Ryan White HIV/AIDS Program and ADAP stakeholders can create their new member profile at https://tinyurl.com/p63s2mde.

The Covid-19 pandemic has changed the public health paradigm, and the ADAP Advocacy Association is staying ahead of the curve to ensure advocacy efforts remain relevant. The new Member365 ADAP Community allows members to manage their profile, engage directly with other Ryan White HIV/AIDS Program stakeholders, register for advocacy and educational events, contribute to threaded discussion boards, post job vacancies, and participate in flash surveys, among other things. The Member365 technology presently is being used by some other leading health organizations, including the U.S. Centers for Disease Control & Prevention (CDC), New York State Pain Society, and Canadian Society of Physician Leaders. 

Photo Source: Member365

The Member365 ADAP Community builds on the success of the patient-centric ADAP Directory, The which is a convenient online resource to locate AIDS Drugs Assistance Program information for all U.S. states and territories. The ADAP Directory is available online at https://adap.directory. 

Murray Penner, U.S. Executive Director for the Prevention Access Campaign (U=U) summarized, "In my 25 years working with ADAPs in a variety of capacities, I've always felt as though the program is one of the most impactful HIV programs in our nation's response. And it always feels like it's cobbled together with tape and paper clips and on the verge of collapse at various places. This new space will build critical awareness and connections for advocacy and we look forward to being a part of it."

Jen Laws, independent policy consultant and ADAP Advocacy Association board member, agrees. "We are witnessing unprecedented challenges facing our public health infrastructure, due to Covid-19. Simply look at what is happening in Arizona, Georgia or Texas. Stakeholders need to communicate more effectively with one another to better address health disparities and social determinants of health. The Member365 ADAP Community will allow us to do so in the HIV space, including a critically important opportunity for partners in advocacy to recruit talent from affected community via job postings."

The Member365 ADAP Community includes the following organizational partners: 

• Advocacy Organizations - Community Access National Network (CANN), HealthHIV, North Carolina AIDS Action Committee (NCAAN), Prevention Access Campaign, RAD Remedy, Southern Black Policy & Advocacy Network (SBPAN), Triangle Empowerment Center
• AIDS Service Organizations - AIDS Alabama, Community Education Group
• Healthcare Organizations - Legacy Health Endowment
• Patient Assistance Programs - MedData Services, NeedyMeds, Patient Access Network (PAN) Foundation, Patient Advocate Foundation (PAF)
• Pharmaceutical Industry Partners - AbbVie, Gilead Sciences, Janssen Pharmaceutical Companies | Johnson & Johnson, Merck, Theratechnologies, ViiV Healthcare
• Pharmacy Benefit Mangers - Magellan Health, Ramsell Corporation, ScriptGuideRx
• Pharmacies - Avita Pharmacy, Maxor National Pharmacy Services Company, Walgreens
• Professional Associations - Professional Association of Social Workers in HIV/AIDS (PASWHA), 
• State Departments of Health - ADAP Coordinators & Linkage to Care Coordinators
• Trade Associations - Partnership for Safe Medicines, Pharmaceutical Research and Manufacturers of America (PhRMA)

The new Member365 ADAP Community can be accessed online at https://adap.member365.org. Stakeholders can join the community online at https://tinyurl.com/p63s2mde.

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.

Bridging the Gap: Why Patient Assistance Programs Matter to PLWHAs

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The Covid-19 pandemic has exposed numerous cracks in the U.S. public health system, but it has also demonstrated why patient assistance programs are invaluable tools bridging the gap for people living with HIV/AIDS (PLWHAs) who might have otherwise fallen through the cracks. Generally speaking, patient assistance programs assist people who have health insurance, but whose plans include high deductibles and/or high copayments; patient assistance program help people who are in-between jobs or maybe recently expired COBRA [Consolidated Omnibus Budget Reconciliation Act] insurance; and patient assistance programs often serve as a lifeline for people who have no health insurance and don't qualify for public assistance programs, such as the AIDS Drug Assistance Program (ADAP) or Medicaid.

The ADAP Advocacy Association has witnessed an increase in the number of PLWHAs inquiring about what help exists for them during Covid-19's uncertainty. Therefore, it seems relevant and timely to once again share information about some of the amazing patient assistance programs that exist for patients.

Photo Source: therigy.com

• NeedyMeds https://www.needymeds.org 

NeedyMeds is a 501(c)(3) national non-profit that connects people to programs that will help them afford their medications and other healthcare costs. NeedyMeds is not a program, so you can't sign up. They are an information source. They list programs that may provide you with assistance. You apply directly to those programs. NeedyMeds doesn't process any applications, determine eligibility, or supply medications. NeedyMeds does offer a useful Drug Discount Card. The free NeedyMeds Drug Discount Card App is available for iPhone and Android. In addition to the drug discount card and pharmacy finder to help you locate the 65,000-plus pharmacies nationwide that accept the NeedyMeds Drug Discount Card, the updated version has a drug pricing tool so you will know the estimated price of the drug when you pick it up at the pharmacy. 

• Partnership for Prescription Assistance https://medicineassistancetool.org

Pharmaceutical Research and Manufacturers of America (PhRMA) created the Medicine Assistance Tool (MAT) to provide a dedicated search engine that allows users to search for financial assistance resources available to them, their loved ones or patients in their lives through the various biopharmaceutical industry programs available for patients who are eligible. MAT is a free-to-use search engine that focuses its searches on patient assistance resources available to eligible patients. 

• Patient Access Network (PAN) Foundation https://www.panfoundation.org

PAN Foundation is an independent, national 501 (c)(3) organization dedicated to helping federally and commercially insured people living with life-threatening, chronic and rare diseases with the out-of-pocket costs for their prescribed medications. Partnering with generous donors, healthcare providers and pharmacies, they provide the underinsured population access to the healthcare treatments they need to best manage their conditions and focus on improving their quality of life. PAN Foundation's HIV Treatment and Prevention Fund (currently closed) offers financial assistance for HIV treatment and prevention medications. The annual assistance amount is $3,400, but patients may apply for additional assistance at the end of their eligibility period (subject to the availability of funding).

• Patient Advocate Foundation (PAF) https://www.patientadvocate.org

PAF is a national non-profit organization, which provides case management services and financial aid to patients with chronic, life-threatening, and debilitating illness. In 2020, PAF provided direct relief to more than 192,000 patients from all 50 states and each US territory representing 629 distinct diagnoses through 44 unique patient service programs. Their mission is reflected in the practical problems addressed and the specific populations served, including its HIV, AIDS and Prevention Co-Pay Relief Program. The annual maximum award level is $7,500. It also now offers Medical Insurance Premium Assistance!

• RxAssist https://www.rxassist.org/patients

RxAssist is a nationally recognized, web-based medication assistance resource center. Established in 1999 with funding from The Robert Wood Johnson Foundation, RxAssist gives providers, advocates, consumer and caregivers comprehensive, up-to-date information in an easy to use format. It also offers a prescription discount card, Inside Rx, with saving on medications made simple. 

The ADAP Advocacy Association does not endorse one of these programs over another one, but rather encourages PLWHAs facing medical financial toxicity to consider all of the available options. Patient assistance programs reinforce the importance of the partnerships that exist between industry and non-industry partners, and any time is a good time to remind our community about them!

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.

Canadian Drug Importation – What’s the State of the Issue

By: Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines

A number of people have inquired with PSM recently about what’s going on with Canadian drug importation.

To recap:  last year the Trump Administration finalized a federal rule that would permit state and tribal Canadian drug importation programs. PSM, the trade association PhRMA, and the Council for Affordable Healthcare, filed in federal court challenging the rule.  At the end of last week, the [Federal] Government filed a motion to dismiss the lawsuit claiming that “possible future injuries to Plaintiffs’ members are overly speculative and not imminent.” Since we’re a party to the lawsuit, I’m not going to speak about that motion.

At the same time the Gov’t opposed the suit, Gov. Ron DeSantis (FL), one of the two states that has a pending application with HHS to start importing Canadian medication, held a press conference at a large empty warehouse that DeSantis says is ready to receive shipments of Canadian medication as soon as the federal government approves Florida’s importation plan.

Based on the schedule of deliverables of the contract Florida has with it’s vendor, they have probably already completed deliverables worth $8.9 million and likely paid that vendor.

The dangers of Florida’s program remain:

There is no Track and Trace in Canada like there is in the U.S.

As of today, medicine that comes off a factory floor for American patients has a serial number on it that allows traceability. Congress required this after Florida so poorly regulated their wholesale market that counterfeit medicines without enough active ingredients spread throughout the U.S. from Florida harming patients nationwide.  Any medicine purchased from a Canadian wholesaler will be suspect because we can’t trace it back to the factory floor. Canada has no Track and Trace system.

Florida has proposed slapping a barcode on medicine they buy from Canada and calling it Track and Trace, but it is not. This medicine is inherently less safe than the medicine made for the U.S. market because there’s no way to know if it really came from the factory.

Counterfeiters have grown even bolder through the pandemic

We’ve seen counterfeiters selling fake masks, fake surgical gloves, and fake COVID tests all over the U.S. Outside the U.S. we’ve seen fake vaccines in Poland, China, and Mexico, and fake therapeutics like the fake Remdesivir recently found in India shown here.

In Canada, two different criminal gangs were caught faking pharmacy-sized packaging for their counterfeit medicines. It has not been detected in the legitimate Canadian supply chain yet.

This seems like a terrible time to go “on the honor system” with wholesalers in Canada that may not even be able to be forced into U.S. courts if their failures hurt American patients.

Few people know that a wholesaler in Canada was caught distributing counterfeit cancer medications to U.S. patients in the last few years. How we can assume it’s suddenly safe to do this again seems ludicrous.

Photo Source: Partnership for Safe Medicines

Florida does not seem to take federally mandated testing for fakes seriously

When Florida was passing their Canadian importation program through the legislature they swore they would do lots of testing:

“So if Canada imports a drug from another country and then they come to Florida, we will inspect every batch … And of course members, that’s part of U.S. Law. We’re not going to violate any part of U.S. law or Canada law to implement this program.” Statement by Senator Bean at March 25, 2019 hearing at ~01:20:30

“So we’re having labs open it, test it, take it apart, look at it, do analytics to test its potency, its reliability, to make sure it hasn’t been tampered with at all.” Statement by Senator Bean at April 18, 2019 hearing at ~02:20:50

Then, when they filed their application with HHS, they changed their mind. In its submission to HHS the state of Florida asserts that it will “not be necessary to perform statutory testing” on imported drugs.

It seems Florida’s commitment to safety is quite transient, which is of great concern given the fact that…

There is no liability protection for pharmacists or patients who dispense or receive counterfeit medicines

Florida legislators specifically rejected proposals to create a victim’s compensation fund for patients hurt by counterfeits brought in through this program. Additionally, they have never addressed the concerns pharmacies have about their own liability if they end up inadvertently dispensing counterfeit medications that hurt patients under this program.

Florida appears ready to do imminent harm to patients by buying medicine from unsafe sources whose provenance they cannot verify and they seem unwilling to test thoroughly. They will subsequently throw up their hands when some of it turns out to be fake and patients are hurt and pharmacies are dragged into liability litigation.

There are ideas on the table that can reduce the price of medicine without sacrificing safety, Canadian drug importation is not one of them.

This opinion piece was also published in the June 4th edition of the PSM Update.

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.

Why Managed Care's Fail First Requirements are a "Step" in the Wrong Direction

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Rationing healthcare is never a good thing for patients, especially for patients living with chronic health conditions such as HIV/AIDS. It is especially true for prescription medications. Unfortunately, an increasingly common technique involves private and public healthcare payers requiring step therapy...or step protocol...or fail first requirements, whereby inexpensive drugs (and therapies) must be prescribed rather than more expensive drugs (or therapies). Sadly, such requirements not only undermine the provider-patient relationship, they also have proven to be less cost-effective in the long run.

A recent study among patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) demonstrated that plan-level access restrictions on novel disease-modifying antirheumatic drugs (DMARDs) negatively impacted medication adherence and treatment effectiveness. Step therapy resulted in poorer outcomes evidenced by 19% lower odds of treatment effectiveness and 19% lower odds of medication adherence for RA patients, compared to their counterparts without similar access restrictions.[1]

In a recent opinion piece published in The Hill, David R. Karp and Ann M. Palmer best summarized why step therapy is bad medicine: "Step therapy delays timely access to clinically appropriate treatment and endangers the health and well-being of patients whose conditions can deteriorate beyond repair if they are not able to receive prompt care. It's incredibly frustrating and frightening for Americans whose lives and bodies depend on very specific treatments. And it's no less infuriating for health care providers who find their care and clinical decision-making undermined by insurance companies with no first-hand knowledge of their patients' individual circumstances."[2]

Photo Source: Patients Rising

Though a bit dated, Patients Rising published an excellent analysis on the dangers of step therapy. From their perspective, step therapy hurts patients by restricting access to the right treatment.[3]

Coupled with other dangerous, anti-patient insurance policies — such as co-pay accumulators — step therapy becomes even more problematic. Co-pay accumulators amount to nothing more than the greedy health insurance industry (and other payers) making prescription drug coverage less affordable for patients, especially for those living with chronic health conditions such as HIV/AIDS.

W. David Hardy, M.D., chair of the HIV Medicine Association and an adjunct professor of medicine in the division of infectious diseases at Johns Hopkins University School of Medicine, summarized why HIV care is threatened by fail first requirements: "Step therapy is never an appropriate practice or approach for treating HIV because the use of an ineffective or toxic drug can lead to viral resistance or nonadherence. It can also render other drugs in a patient’s treatment regimen ineffective."[4]

Photo Source: STAT

In Congress, some legislators are trying to put treatment decisions back in the hands of patients and doctors. Senator Murkowski (R-AK), Senator Hassan (D-NH), Senator Cassidy (R-LA), Senator Rosen (D-NV), Representative Ruiz (D-CA-36), Representative Wenstrup (R-OH-2), Representative McBath (D-GA-6), and Representative Miller-Meeks (R-IA-2) have introduced the Safe Step Act of 2021 (S. 464/H.R. 2163). The legislation would improve step therapy protocols and ensure patients are able to safely and efficiently access the best treatment for them.[5]

Innovative treatments can help slow disease progressions for those living with HIV/AIDS, and millions of patients living with numerous other chronic diseases. That is why it is so important to have access to incredible scientific innovations so that patients can live full, productive and active lives. But the step therapy insurance practice is a barrier to that access. Patients and their doctors shouldn't have to jump through hoops to get the medicine they know will work best.

[1] Boytsov, N., Zhang, X., Evans, K.A. et al. Impact of Plan-Level Access Restrictions on Effectiveness of Biologics Among Patients with Rheumatoid or Psoriatic Arthritis. PharmacoEconomics Open 4, 105–117 (2020). Retrieved online at https://doi.org/10.1007/s41669-019-0152-1.

[2] Karp, D., Palmer M. Step therapy hurts America's sickest patients — reasonable parameters are needed now. The Hill (2021, May 25). Retrieved online at https://www.msn.com/en-ca/news/newspolitics/step-therapy-hurts-americas-sickest-patients-—-reasonable-parameters-are-needed-now/ar-AAKnuFg.

[3] Wilcox, J. STEP THERAPY: EVERYTHING YOU NEED TO KNOW ABOUT “FAIL FIRST” INSURANCE POLICY. Patients Rising (2016, August 23). Retrieved online at https://www.patientsrising.org/step-therapy-explained/#:~:text=Patients%20Rising%20Perspective%3A%20Step%20therapy%20tramples%20patients%20From,medications%2C%20especially%20treatments%20for%20cancer%2C%20aren’t%20easily%20interchangeable..

[4] Hardy, W. D. HIV care is threatened by proposed changes to Medicare Part D. STAT (2019, January 24). Retrieved online at https://www.statnews.com/2019/01/24/medicare-changes-threaten-optimal-hiv-care/#:~:text=Step%20therapy%20is%20never%20an%20appropriate%20practice%20or,other%20drugs%20in%20a%20patient’s%20treatment%20regimen%20ineffective.

[5] S.464 - Safe Step Act. 117th Congress (2021-2022). Retrieved online at https://www.congress.gov/bill/117th-congress/senate-bill/464/text.

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.