NCL offers support for Star Rating for Biosimilars Act, H.R. 2855

October 13, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (724) 799-5392

Washington, DC—The National Consumers League (NCL) is pleased to support the Star Rating for Biosimilars Act, as introduced by Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH). NCL believes that implementing a rating system for biosimilars would incentivize insurers to provide lower cost drug alternatives and alleviate the financial burdens on patients.

The Centers for Medicare and Medicaid Services (CMS) currently has a star ratings system for insurance plans under Medicare Advantage and Part D. The quality measures capture items such as clinical quality, beneficiary satisfaction, patient outcomes, and regulatory compliance. This rating system helps the CMS evaluate which plans to keep and discontinue. To date, we do not have a comparable rating system where biosimilars are concerned. “Biosimilars are on average 30 percent cheaper than their biologic counterparts, yet many existing barriers in our current healthcare plans prevent patients from accessing these cost-saving medicines,” said NCL Director of Health Policy Jeanette Contreras.

The Star Ratings for Biosimilars Act would require the CMS to put in place a five-star performance rating system for biosimilar products under Medicare Advantage Plans. For each plan, the ratings will be based on quality measures meant to evaluate the level of access that each insurance plan provides to biosimilars, such as whether a biosimilar is on the formulary, and the percentage of enrollees prescribed a biosimilar when its biologic counterpart is available. Aside from Advantage Plans, the bill would also require the CMS to incorporate these measures into a similar rating system for plans under the Medicare Part D prescription drug benefit.

The NCL believes in transparency as a core function of informed decision-making. Knowing whether cost saving biosimilars would be available to enrollees under various Medicare (including the Medicare Advantage plans) and Part D plans would bring in more transparency to help consumers be more informed when selecting a plan. “Allowing consumers to see which plans are offering access to lower cost biosimilars would also incentivize Medicare plans to increase patient access to biosimilars,” said Contreras. We encourage Congress to pass the Star Rating for Biosimilars Act in order to broaden access to and encourage increased provision of cost-saving biosimilars.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

National Consumers League applauds decision to ban vaccine misinformation from YouTube

September 29, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—The National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, today applauded YouTube and its parent company Alphabet for their decision to ban anti-vaccine misinformation from the platform. NCL has been a leading voice in promoting vaccine confidence and pushing online platforms to do more to counter misinformation and disinformation about COVID-19 and vaccines, which has contributed to far too many preventable deaths.

The accounts being removed are known anti-vaccine organizations. Robert F. Kennedy’s Children’s Health Defense Fund, one of the most high-profile anti-vaccine organizations in America, was responsible for more than half of the paid advertisements on Facebook in years past. Joseph Mercola, founder of Mercola.com Health Resources, authored an article falsely stating that COVID-19 vaccines released via emergency authorization may cause massive side effects. Tenpenny Integrative Medical Center, spearheaded by physician, Sherri Tenpenny, promotes alternative health in lieu of vaccines and authored the book, “Say No to Vaccines: A Resource Guide for All Ages.”

The following statement is attributable to NCL Director of Health Policy: Jeanette Contreras:

“Vaccine hesitancy driven by rampant misinformation online is costing lives every day and prolonging a pandemic that has devastated consumers financially as well as physically. YouTube’s decision to ban anti-vaccine misinformation, while overdue, is nonetheless an important step forward in the fight against the COVID-19 pandemic.”

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL lends support to Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act, H.R. 2815

September 24, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—The National Consumers League (NCL) is pleased to support the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act (H.R. 2815), introduced by Representatives Adam Kizinger (R-IL) and Kurt Schrader (D-OR). NCL believes that expanding the use of biosimilars is a safe and effective option for making prescription drugs more affordable for all.

In the midst of a pandemic, consumers across the country are unable to receive necessary care for many reasons — the most prominent being high costs. Biologics are among the fastest-growing segments of the prescription product market, and costly to the patients who rely on them. What is unique about biologic treatments is that they are directly able to combat the underlying cause of a disease. NCL is committed to educating consumers about the value of biosimilars as alternatives to biologics.

Consumers are largely unaware that similar to generic prescription drugs, biosimilars are the generic equivalent to their biologic counterpart. As with generic prescription drugs, FDA-approved biosimilars have no clinically meaningful differences from their reference biologics. Biosimilars function in the same way as biologics and are subject to the same rigorous testing by the FDA to ensure their safety. The FDA has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more. Biosimilars can enter the market once the patent protections for brand-name biologics expire, and when multiple options exist on the market, competition drives prices down.

NCL believes that biosimilar treatment options are a great way to ensure that cost is not a factor that inhibits access to care. Currently, Medicare beneficiaries pay 20 percent coinsurance on Part B drugs, which includes both biologics and biosimilars. On average, biosimilars cut the price of biologics by about 30 percent, which provides beneficiaries with significantly lower prices than the biologic alternative. While biologics make up a small percentage of the total number of drugs on the market, and just 2 percent of prescriptions filled, they represent 40 percent of all drug spending.

Currently, Medicare reimburses participating physicians based on the average sales price (ASP) of a drug with an additional 6 percent of the reference price. However, because biosimilars are cheaper than biologics, physicians more often prescribe the higher-priced treatment. NCL supports increasing the reimbursement percentage for biosimilars as a way to incentivize physicians to prescribe biosimilars. The BIOSIM Act would maintain the 6 percent reimbursement for prescribing a biologic and increase the return for prescribing biosimilars to 8 percent for a five-year period.

The BIOSIM Act provides the needed incentives to boost utilization by providers to prescribe biosimilars and makes it cheaper for beneficiaries to receive the care they require. “If enacted, this policy would not only provide significant savings to consumers, it would also drive down Medicare spending overall,” said NCL Director of Health Policy Jeanette Contreras. “Congress should act on passing the BIOSIM Act in order to increase access to safe and effective biosimilars that provide consumers an affordable alternative to high-cost biologics.”

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

AAPI Heritage Month: The ‘Model Minority Myth’ and its negative impact on health disparities

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

The month of May marks Asian American Pacific Islander (AAPI) Heritage Month, a time where we celebrate, honor, and reflect upon the vast contributions members of the AAPI community have made to our collective society. The AAPI community comprises more than 23 million individuals with origins from 20+ countries, who speak more than 200 languages or dialects, and it is the fastest growing subset of the population.

The AAPI community is one that harbors complex cultural and historical narratives, and varied generational traumas, such as colonialism, war, and the trials of immigration. The AAPI community’s resilience against these factors, while commendable, has contributed to the myth of the “Model Minority,” and has led to a host of social and health inequities. The model minority myth is one rooted in “positive” stereotypes. It is the assumption that deems AAPI individuals as docile, over-achieving, high-earning, and well-educated—denoting AAPI individuals as exemplars to other communities of color. While at face value these qualities are considered desirable, they tend to relegate an astoundingly diverse community to a monolith, resulting in a detrimental impact on their overall wellbeing.

Due to these unrealistic cultural standards, AAPI consumers face a host of internal and external barriers when interacting with the healthcare system, and are often deterred from seeking necessary care. According to a 2019 Substance Abuse and Mental Health Services Administration (SAMHSA) study, AAPIs have the lowest help-seeking rate for mental health services than any racial or ethnic group. Cultural identity, faith, stigma, and fear contribute to lower utilization of mental health services. Other systemic barriers such as disparities in access to culturally competent care also influence underutilization.

AAPIs are also the only racial or ethnic group for whom cancer is the leading cause of death. Despite facing a confluence of cancer risks, due to unique exposures and environmental factors, AAPIs are screened significantly less for cancers compared to other Americans. Because the model minority myth implies that AAPIs are “better off,” screening, public health, and cultural needs are often masked.

This is best demonstrated by the case of Susan Shinagawa, a leading Asian American breast cancer activist and cancer survivor, whose multiple attempts to obtain screening for a suspected lump in her breast was denied, due to the belief that “Asian women don’t get breast cancer.”

The pandemic has illuminated disparities experienced by AAPIs, such as being overrepresented among frontline healthcare workers, increasing risk of exposure to COVID-19. As a result, case fatality among AAPI healthcare workers is three times greater than their white counterparts. AAPIs also tend to live in multigenerational households, more than other minorities, where 29 percent of AAPI households consist of two or more generational families, further increasing risk of household transmission. Approximately 30 percent of AAPIs have limited English proficiency, augmenting overall barriers to care and government relief resources. This disparity has been especially cumbersome for AAPI consumers seeking telehealth, an integral part of our lives throughout the pandemic, where 50 percent of AAPIs with limited English proficiency were less likely to utilize telehealth than individuals with English proficiency.

One way to dispel the model minority myth and encourage greater health equity for AAPI consumers, is to disaggregate racial and ethnicity data in research studies. Disaggregation of data simply means breaking data into smaller, more precise segments. For example, recent United States census data reveal that AAPIs were less likely overall to live in poverty. However, when that data is disaggregated, it shows that Hmong, Bhutanese, and Burmese Americans experience higher incidence of poverty, in contrast to the greater AAPI community. Disaggregating data not only paints a more accurate picture regarding the different social and demographic characteristics that impact varied health statuses within the community, it influences proper allocation of community resources.

Disaggregation of data can only also happen when there is a prioritization of AAPI participants in research. The most illuminating example of this is highlighted by a 2019 study, which revealed that in the past 26 years, only 0.17 percent of the National Institute of Health’s (NIH) budget was allocated to research focused on the AAPI community. These gaps in funding have led to a paucity in data necessary for public health officials and policy makers to meaningfully address AAPI-specific health disparities. A lack of representation in research impacts how AAPI consumers seek, access, and utilize healthcare. It also impacts the greater community public health goals, impacting health equity for everyone.

Greater investments in culturally competent care, AAPI-focused research, and preventive services, such as screening and early intervention, can help improve overall health outcomes for AAPI consumers. The National Consumers League commends the Biden-Harris Administration’s efforts, such as the COVID-19 Hate Crimes Act and the establishment of a subcommittee on Structural Drivers of Health Inequity and Xenophobia, which aim to ensure the federal government’s response to COVID-19 mitigates anti-Asian xenophobia and bias. These measures are critical in addressing structural inequities experienced by the AAPI community, enhancing community health outcomes as a whole.

The decline in COVID-19 testing nationwide could derail pandemic response wins

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

COVID-19 testing has been a critical component of the nation’s pandemic response, as health officials monitored the virus’s progression and set policies that supported back-to-school and return-to-work initiatives. Increased testing capacity has enabled our most essential industry sectors to resume activities that continue to carry us through the pandemic. However, as vaccines become more accessible and we surpass initial goals for population-wide immunizations, testing has declined by 35 percent daily since mid-January.

Testing provides a reliable snapshot into the virus’s trajectory that allows for proper allocation of vital resources (e.g., supplies, personal protective equipment (PPE), and medical equipment) and essential personnel. Data from testing rates are also critical for vaccine manufacturers, as they evaluate how the virus is mutating and further efficacy of the vaccine. The uptick in vaccinations, while incredibly promising, may have induced an inflated sense of security and diminished caution towards the virus. However, in the midst of rising variants, the decline in testing may very well be the Trojan horse that derails national efforts to combat the virus.

Testing has also declined in part due to a shift in focus to getting vaccinated. While vaccines are equally important, we need adequate COVID-19 testing for public health surveillance purposes. There needs to be sufficient capacity and public health messaging in place to encourage individuals who have potentially been exposed to SARS-CoV-2, or coronavirus, to get tested immediately.

Dr. Nasia Safdar, Medical Director for Infection Prevention at UW Health, states “we are seeing a decline in testing,” she said. “If we see the numbers continue to decline sharply, at some point then it may not be worthwhile to do widespread testing, but we’re certainly not there yet.” Without these measures, our healthcare system will be rendered unequipped to deal with dormant and emerging threats, like potential outbreaks and continuous mutations of the virus.

There are a couple of strategies that could help us get a hold on precipitous testing rates. It is estimated that a national program for universal mass testing for unvaccinated people would cost a few billion dollars a week—an amount that still presents a cost-benefit when considering potential shutdowns. The American Rescue Plan has appropriated $50 billion for expanded testing, which could help the situation significantly.

Another aspect of the problem is a lack of testing sites. With so many resources currently devoted to expanding vaccination sites at pharmacies and hospitals, people need places to get tested. Greater corporate involvement in the response could be a potential avenue for increasing capacity.

Finally, the Food and Drug Administration (FDA) is working to advance development and approval for over-the-counter (OTC) and point-of-care (POC) tests. Obtaining a greater number of FDA-approved OTC and POC COVID-19 tests could help address issues with logistics and access, and would give schools, workplaces, and communities more options for reliable and accurate screening.

The pandemic is far from over and experts predict that COVID-19 will likely be endemic, meaning it will be detected regularly, even if within small pockets of the population. We need all possible public health interventions at our disposal to ensure that we can effectively limit the spread of the virus and preserve ongoing plans to reopen the economy so that we can start the process to sustainably reintegrate back into society.

Dr. Safdar further emphasized, “the vaccines are great as they are, they’re not 100 percent. There will be a certain number of people that will…contract the illness despite having been vaccinated. It might be a milder condition which is very welcome news, but nonetheless, to make a diagnosis and figure out what treatment is required, you have to get a test.” Testing continues to be a simple, yet powerfully effective measure to prevent the massive spread of COVID-19 and we must persist in our efforts towards early detection.

NCL supports permanently lifting restrictions on access to mifepristone

April 26, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—The National Consumers League (NCL) applauds the U.S. Food and Drug Administration (FDA) for moving to increase access to the abortion pill, mifepristone. As of April 12, the FDA will temporarily allow mifepristone to be dispensed by mail for the duration of the COVID-19 public health emergency. Patients are now able to obtain a safe and effective abortion pill through a telemedicine consult, without risking exposure to COVID-19 with an in-person visit.

Though mifepristone has been used in the United States for more than 20 years to safely and effectively end early pregnancies and treat early miscarriage, the FDA has placed particular restrictions on mifepristone when it’s used for pregnancy termination. Unlike other medications, patients can only obtain the abortion pill directly from a certified medical provider who has a prescriber agreement with the drug manufacturer.

In the early months of the pandemic, the American College of Obstetricians and Gynecologists (ACOG) and other provider groups filed a lawsuit that challenged these restrictions and subsequently won the suit to temporarily lift the restrictions to abortion care during the pandemic.

“This was a win for women’s health, but more importantly for women who live in rural and medically underserved communities who rely on telemedicine for their health care,” said NCL Executive Director Sally Greenberg.

The win, however, was short-lived. In January 2021, the Supreme Court ruled in favor of an appeal by the Trump Administration that put an end to the temporary lift, effectively restricting patient access to medication abortion care.

On April 11, Acting FDA Commissioner Janet Woodcock, sent a letter to ACOG and the Society for Maternal-Fetal Medicine (SMFM), stating that the FDA reviewed recent evidence and found that using telemedicine to provide abortion pills would not increase risks and would help patients avoid potential exposure to COVID-19.

“While we welcome this temporary change, we urge the FDA to continue to review the evidence and scientific data and permanently lift unnecessary restrictions beyond the public health emergency. If it’s safe enough to prescribe through telemedicine during COVID, then it is clearly safe enough to use beyond COVID,” said Greenberg. “We hope the FDA will consider the vast health and socioeconomic benefits that increased access to medically safe abortion via telemedicine would pose for women who rely on this essential reproductive service.”

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Antimicrobial Resistance is a major looming threat to global health systems

By Sally Greenberg, NCL Executive Director

If the pandemic has taught us anything, it’s that threats to our health care system can change lives, both in our communities and around the world. We have learned the value of preparedness and that the ability to respond to massive, impactful events is not easy or without compromise. Thankfully, as summer nears, we see that gradually, countries around the world are in a much better place, thanks to access to vaccines and greater knowledge of how to diagnose and care for patients.

Certainly, we can hope that lessons learned from our recent experience with the COVID-19 pandemic will put us in a better position to identify and address a health issue before it develops to pandemic proportions. But I would urge us to remain vigilant. There are other threats to our health care system that exist and deserve attention…now. One major threat to world health delivery systems is about to have its moment: Antimicrobial Resistance (AMR).

Antimicrobials, which include antibiotics, are critical to maintaining our health. Chances are, in the course of the year, someone in your family will take an antibiotic for an ear infection, an abscessed tooth, a hip replacement, organ transplant, or cancer treatment. In recent years, we have learned that taking too many antibiotics can lead to resistance and therefore a loss of effectiveness. This is true, but it’s important to note that the antimicrobials used to treat resistant infections are much more intense and used in more extreme circumstances than the antibiotics most of us are familiar with.

Antimicrobials fight bacteria and other causes of serious infection and are often the last line of defense against fatal infection. Antimicrobial resistance needs to be taken seriously. The Centers for Disease Control and Prevention (CDC) estimates that approximately three million Americans suffer from AMR infections each year with close to 50,000 deaths annually. Other estimates have placed annual deaths from AMR at 162,000, which makes AMR the third leading cause of death in the U.S. today. Surprised?

Here’s what surprised me: there has only been one new class of antibiotics approved in OVER 30 YEARS. Think about that. We have seen game-changing progress in medicine and treatments for countless diseases and conditions, but not AMR. And then think about how many causes of infection have become resistant to the tools we have to fight them.

AMR is a complex problem that’s not going to be easily solved. It takes years and years and billions of dollars to develop a molecule to fight AMR. Today we are faced with a slim menu of therapeutic options now and we find ourselves years away from expanding those options. I fear that AMR may be our next worldwide health emergency and I am not alone: The World Health Organization (WHO) lists AMR as one of the top ten health threats today. Sadly, it’s not a matter of “if”…but rather “when”.

Medicines don’t work forever. With the limited number of effective antimicrobials, we are looking straight down the barrel of the next health emergency. It’s difficult to even contemplate pivoting from all that we have been through with COVID to a new focus on something else equally frightening, but history tells us that being unprepared comes at a heavy cost. And being prepared is exactly what we need to do.

Jeanette Contreras portrait

Expanded Medicaid coverage for postpartum care

By NCL Director of Health Policy Jeanette Contreras

The COVID-19 pandemic has enlightened us to how the social determinants of health adversely impact maternal outcomes in low-income, medically underserved communities. Year after year, the United States continues to have the highest maternal mortality ratio among wealthy countries. In efforts to address this disparity, the American Rescue Plan Act includes a provision that allows states to expand Medicaid coverage to women for up to one year after childbirth.

The dismal maternal and infant mortality rates are directly correlated with the health disparities that disproportionately afflict black, indigenous, and women of color. A 2019 report from the Centers for Disease Control and Prevention (CDC) found that Black women were 3.3 times more likely than white women to die from pregnancy-related complications and Native American and Alaska Native women were 2.5 times more likely than white women to die within a year after childbirth.

Medicaid has traditionally been seen as a safety net for low-income pregnant women and children, providing health coverage that funds more than four in ten births in the U.S. each year. Under federal law, Medicaid must cover pregnant women with incomes up to 138 percent of the Federal Poverty Level (FPL) through 60 days postpartum. Each year, over 1.6 million women across the U.S. are effectively placed at risk for becoming uninsured when that 60-day coverage period ends.

Women who live in states that expanded Medicaid under the Affordable Care Act (ACA) are eligible to continue their health coverage through Medicaid. Additionally, the Families First Coronavirus Response Act, which passed last year, provides states with a 6.2 percent increase to the Federal Medical Assistance Percentage (FMAP) rate to cover new enrollees eligible under the ACA Medicaid expansion as long as the Public Health Emergency is in place or at least throughout 2021. However, the women living in the 14 states that have yet to expand Medicaid would find themselves uninsured.

Under the American Rescue Plan, for the next five years, states have the option to extend Medicaid and the Children’s Health Insurance Program (CHIP) eligibility to pregnant individuals for 12 months postpartum. Though each state’s Medicaid program is different, the inclusion of this provision incentivizes states to extend health care to mothers during the most vulnerable time in their lives. This increased access to health care will pave the way towards improving health disparities for our most at-risk women and infants beyond the pandemic.

Consumers face an unfair disadvantage at the pharmacy counter

By Sally Greenberg, NCL Executive Director

Everywhere we turn these days, we find ourselves wondering if we are getting a fair deal. Americans continue to suffer the economic consequences of a year-long global health pandemic, and many of us are trying to stick to the essentials and stretch our dollars where we can. As COVID-19 has reminded us, there aren’t many issues families face that are more significant than access to health care.

Families can’t go without essential prescriptions and often wonder why the price seems to go up each time they go for a refill. In fact, we are likely paying more than necessary at the pharmacy counter, but we don’t often know — or even think to ask — why.

A variety of factors drive drug costs, some of which are obvious: the cost of research and development, distributing the product, the pharmacies’ profits – but there is one far less known cause of price increases: PBMs, short for pharmacy benefit managers.

Most people have never heard of PBMs, and PBMs like it that way. They are billion-dollar companies that control more than 80 percent of the prescription drug formularies, (formularies are the lists of drugs that a health plan allows its members to access) — in the United States.

Because of their outsized role, too often PBMs determine how much consumers, businesses, government agencies, and others pay for medicines. As originally conceived, PBMs were meant to help ensure that patients get a fair deal by:

  • working with manufacturers to ensure rebates (or savings) for medications
  • working with insurance companies to determine which medications are covered
  • working with pharmacies to set the price points and help reimburse pharmacies for dispensing prescriptions.

In theory, PBMs should be lowering costs for everyone. However, as they have evolved and grown, they’ve become greedy and self-serving entities, scooping up discounts for themselves and throwing consumers under the bus. All the while, their profits continue to soar as they are all among the top Fortune 500 companies.

Sadly, PBMs have also found ways to manipulate the system and put their own profits first.

Insulin is a prime example. Diabetes patients who need their medication to survive are increasingly left with fewer options for treatment. When PBMs get involved, consumer costs increase.

One recent analysis found that the total value of rebates and discounts for insulin on an annual basis amounts to more than $5,000 per patient. Another report explained that the net price on one insulin product — what the company earns as revenue — declined by 53 percent since 2012, while the list price increased 141 percent. As the WSJ story explains, this is in part due to PBM middlemen meddling. In order to ensure formulary positions (which PBMs control), companies are paying more and more each year.

Consumers don’t know where high drug prices come from and they shouldn’t have to — the system needs to deliver affordable, accessible, safe and effective medications without any entities taking an unfair or hidden profit. The stakes are too high as we look ahead to the health challenges that millions face with the Covid pandemic.

NCL joins with many other groups, including America’s Agenda, United Food and Commercial Workers International Union, HMC Healthworks, Union of Bricklayers and Allied Craftworkers, National Community Pharmacists Association, National Alliance of State Pharmacy Associations, Diabetes Leadership Council, and Diabetes Patient Advocacy Coalition in helping to expose hidden, and frankly, indefensible profits being directed to the coffers of PBMs — money that should be redirected to bring drug prices down for patients and consumers.

Let’s all ask hard questions about PBMs’ role in our healthcare system and whether we can’t be using the profits they are taking to lower drug costs. Share this story with others. Talk with your friends and family. Ask your local pharmacist questions.

Consumers – not PBMs — should come first at the pharmacy counter. Stay tuned for more from us on this, and let’s continue the conversation.

Ensuring completion of series for the COVID-19 vaccine

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

After 10 dark months and over 350,000 lives lost, there is finally light at the end of the tunnel in the fight against COVID-19. Developing a vaccine for COVID-19 in such a short timeframe was made possible by dedicated efforts on the part of scientists, public health experts, and private and public partnerships. It is truly a triumphant medical achievement.

Now health care providers face another summit to scale—ensuring compliance for the vaccine to encourage efficacy and herd immunity. The leading vaccines for COVID-19, Pfizer BioNTech, and Moderna, will require two doses to ensure efficacy. Evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose. Clearly, aside from the distribution and administration, ensuring completion of series for the vaccine will be a critical logistical challenge.

It is estimated that 75 to 85 percent of the population will need to be vaccinated in order to reach herd immunity. That’s a lot of people. And if we account for the odds of those who will receive the vaccine and do not complete their series, we’ve got a long road ahead before the pandemic is behind us.

While both the Pfizer BioNTech and Moderna vaccines were found to be 95 percent effective, require two doses, and use similar mRNA vaccine technology, they differ in timelines. The Pfizer BioNTech vaccine requires two doses that are spaced three weeks apart, and Moderna’s vaccine requires two doses that are spaced four weeks apart. Coordinating efforts to ensure that patients get the correct vaccine in a timely manner, will be a massive undertaking.

There are multiple barriers to address in order to enhance vaccine compliance to end the pandemic. The vaccine is expected to induce flu-like symptoms and may deter some patients from getting their second dose if they aren’t warned about what to expect. Common side effects of the vaccine include headache, fever, chills, soreness at the site of delivery, and fatigue, but patients will need transparency about all potential side effects.

All patients who receive the COVID-19 vaccine will be given vaccine cards (see below). These cards will help track the type of vaccine administered, the dosage, date, and other information pertinent to providers and patients to ensure the completion of a series. Similar to contact tracing, massive follow up will be required via text messages, along with other interventions to remind patients of their upcoming second dose.

Source: CNN

The Food and Drug Administration (FDA) has issued a statement on the importance of properly adhering to FDA-issued vaccine guidelines. The vaccines have been issued with specified dosages and are scheduled at timed intervals. Individuals are instructed against reducing the number of doses (only taking one shot), extending the length of time between their booster vaccines, or changing guidance that is not rooted in evidence-based science, as it will directly impact the efficacy of the vaccine. Until new data is released by scientists and manufacturers of the COVID-19 vaccine regarding changes in dosage or schedules, FDA encourages continued adherence to its current issued guidance.

Vaccine hesitancy will surely further complicate matters. A study conducted by the Kaiser Family Foundation revealed that African Americans are increasingly skeptical of a COVID-19 vaccine. The findings allude to generational distrust of government and medical institutions by people of color, specifically, African Americans, where vaccine hesitancy has been influenced by lived experiences with discrimination and systemic racism. A successful vaccination plan will not only consider the herculean task of distribution and administration but should provide credible outreach within communities of color to foster confidence in the COVID-19 vaccine.

The National Consumers League continues to educate consumers on the importance of vaccine safety and compliance through our advocacy and engagement with the FDA. Our best line of defense against the pandemic is vaccine confidence and adherence. We encourage all who are able to get vaccinated for their own health and the health of their loved ones and community.