Don Tracy, Associate Editor 

Image Credit: Adobe Stock Images/ADD PHOTO

A recent report from the Healthcare Affordability Index revealed that nearly half of the US population can no longer afford proper medical care or prescription refills. According to an article recently published in 

affordability is down to a record low of 55%, falling six points since 2022. While this mainly affects patients over the age of 50 years old, the report also found that patients under the age of 50 are the most likely to struggle when it comes to health care affordability, with 53% unable to cover their bills.

“One of the key issues is that so many individuals—especially people on Medicare are faced with—is high out-of-pocket costs for prescription medications,” said Amy Niles, chief mission office, the PAN Foundation. “That’s just one piece of it. Over the years, what people pay at the counter has been really high. Unfortunately, it’s also the reason why one out of three adults walk away from the pharmacy counter, they can’t afford those out-of-pocket costs.”

The Pan Foundation is a nonprofit that works to provide financial assistance to patients that struggle to afford their medications on their own.2 Niles explained that PAN has implemented a number of initiatives to help alleviate issues such as access and affordability for healthcare patients.

“A key reason why the PAN Foundation exists is to provide an important safety net for people who find themselves to be underinsured or challenged with affording their out-of-pocket costs for their prescription medications, and we do this by offering financial assistance across nearly 80 different disease funds,” said Niles. “Another important piece of our mission is the advocacy work that we do. For example, the Medicare reforms that were passed as part of the Inflation Reduction Act (IRA) two years ago were reforms that we long advocated for, and now we’re turning our attention to education around the two reforms that are going to take place in January. What they do is make prescription medications more affordable for Medicare beneficiaries.”

On August 16, 2022, the IRA was signed into law, with provisions that aim to boost financial relief for patients with Medicare through the expansion of benefits, lowering drug costs, and strengthening Medicare. According to the Department of Health and Human Services (HHS), this includes some of the most expensive and most frequently used drugs in the Medicare program that treat conditions such as heart disease, diabetes, and cancer. HHS stated that in 2023, Medicare would have saved $6 billion if negotiated prices had been in effect earlier.

Alan Balch, CEO of the Patient Advocacy Foundation, offered 

his thoughts on how the IRA has worked so far.

“There are two different levels of what the IRA is trying to do. Is the goal to help individuals save money or is it to save Medicare? Those two things might not be the same,” said Balch. “We’re starting to see that patients may have to pay more in premiums and deductibles to pay for some of the protections that are awarded to them as part of the IRA, while Medicare itself still saves money. Those who are still implementing Medicare still have the ability to charge more in premiums and out-of-pocket costs.” 

Balch suggested that more time is needed to fully understand how effective the IRA has been. He stressed that while there have been some early benefits, more challenges come with it.

“I’d say it’s still too early to tell if the IRA is achieving its goal, but I will say that for the old benefit design with the catastrophic coverage and the exposure that it led to, it really put a certain portion of the Medicare population at high risk,” Balch added. “There’s around 1.5 million people who are paying above the $2,000 cap, and those are mainly patients who are on specialty drugs reaching catastrophic coverage. The IRA does prevent those high out-of-pocket costs, which is a good thing, but the challenge is that the protection has to be paid for somewhere in the system.”

found that 70% of patients have found themselves making financial or personal sacrifices to afford their prescriptions. Its 2020 Medication Access Report indicated that the COVID-19 pandemic has resulted in millions of people in the United States facing issues related to healthcare insecurity. This includes a quarter of the workforce filing for unemployment, 30% of healthcare providers revealing that patients weren’t able to cover prescription payments due to the pandemic, and challenges with understanding technology associated with telehealth. As a result, 29% of patients admitted to forgoing healthcare services altogether.

Balch explained other factors that he believes may have caused patients to neglect their healthcare, specifically during the COVID-19 pandemic. Balch noted that many people were unable to access their healthcare providers or basic services because of widespread lockdowns.

“A lot of people were immunocompromised, so even if they could see the doctor, they would just stay home. Some people recognized that they could do okay with less healthcare,” explained Balch. “We did a survey where a reasonable portion of patients said that they weren’t getting care anymore and were doing okay. Then there was this post-COVID phase where we’ve had rapid inflation. Now, these low-income patients are exposed to the rise in housing costs, the cost of groceries, and everything else going up. There’s always been a segment of the population that has had to make these decisions, but I think post-COVID, we’ve seen an increase in patients that are more willing to forgo their healthcare before basic necessities. Before COVID, it was the complete opposite.”

According to polling data from KFF, around half of US citizens reported difficulty in affording healthcare costs, with one in four stating that either they or a family member have recently faced challenges paying for healthcare in the past year. The same one in four also stated that they have skipped or postponed getting healthcare they needed because of the cost. Sixty-one percent of uninsured patients also reported that they went without needed care because of the cost. Additional statistics found that 60% of Black adults and 65% of Hispanic adults face difficulty in affording health care costs compared to 39% of White adults.

“This is unfortunately all too common,” said Niles. “At the PAN Foundation, we hear about this every single day from the people that we help. Prior to receiving help, they often share their experiences with us…If they are fortunate to receive assistance from us or in another way, they’re able to start and adhere to treatment. But more importantly, the quality of life for them and their families increases.”

In response to the financial issues numerous patients are facing, Balch offered a look at what initiatives the Patient Advocate Foundation were implementing to help alleviate these burdens.

“During the pandemic, we implemented a number of programs on behalf of a number of other organizations. They were just additional forms of financial assistance, whether it be for disease treatment or for COVID specifically,” he said. “We still have some financial assistance that we offer, and I’m sure that there are others that still do as well, but it was much different during COVID. There was an outpouring of financial assistance for people during COVID. A lot of that has now gone away. Currently, we’re helping patients, usually in financial ways, but it’s taking us double the amount of time post-COVID.”

1. US Health Care Now Unaffordable for Nearly Half of Americans. 

July 17, 2024. Accessed September 5, 2024. https://www.newsweek.com/us-healthcare-unaffordable-americans-1925972#:~:text=Overall%2C%20the%20survey%20found%20that,and%2044%20percent%20in%202011.

Accessed September 16, 2024. https://www.panfoundation.org/about-us/

Accessed September 5, 2024. https://www.hhs.gov/inflation-reduction-act/index.html#:~:text=President%20Biden's%20prescription%20drug%20law,strengthening%20Medicare%20for%20the%20future.

4. New Data Reveals Nearly 70% of Patients Make Personal or Financial Sacrifices to Afford Medications. 

June 23, 2020. Accessed September 5, 2024. https://insights.covermymeds.com/press/new-data-reveals-nearly-70-of-patients-make-personal-or-financial-sacrifices

5. Americans’ Challenges with Health Care Costs. 

March 1, 2024. Accessed September 5, 2024. https://www.kff.org/health-costs/issue-brief/americans-challenges-with-health-care-costs/

Articles

Despite support from patient assistance programs and legislation designed to combat growing healthcare costs, challenges remain. 

Healthcare Access and Equity: Can Recent Initiatives Improve Affordable Healthcare for All Americans? 

Image Credit: Adobe Stock Images/New Africa

Results from a pooled analysis of the Phase III SWIFT-1 and SWIFT-2 trials demonstrated that GSK’s depemokimab, a biologic targeting severe asthma with type 2 inflammation, significantly reduces exacerbations of the condition. GSK stated that the treatment is the first ultra-long-acting biologic for asthma to be evaluated in Phase III trials.

“With a dosing schedule of just two injections per year, depemokimab has the potential to be the first approved ultra-long-acting biologic with six-month dosing. This could offer physicians and millions of patients with severe asthma an option that provides reassurance of sustained suppression of a key marker of type 2 inflammation and a reduction in the rate of exacerbations and hospitalization – the fundamental treatment goal in asthma,” said Kaivan Khavandi, SVP, global head, respiratory/immunology R&D, GSK, in a press release.

SWIFT-1 and SWIFT-2 were replicate 52-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trials. These trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants, respectively, who were randomly assigned to receive depemokimab or a placebo. Additionally, participants received standard-of-care treatment with medium- to high-dose inhaled corticosteroids plus at least one additional controller. The primary endpoint was reduction in the annualized rate of clinically significant exacerbations over 52 weeks vs. placebo. The secondary endpoint was clinically significant exacerbations requiring hospitalization or emergency department visits compared to placebo.

Results revealed a 54% reduction in exacerbation rates among patients administered depemokimab compared to placebo over 52 weeks. In SWIFT-1, depemokimab reduced exacerbations requiring hospitalization by 72% and lowered exacerbations requiring hospitalization by 48% in SWIFT-2.

The incidence of adverse events (AEs) was similar in both trials. In SWIFT-1, 73% of both the depemokimab and placebo cohorts reporting AEs. In SWIFT-2, 72% of the depemokimab cohort reported an AE compared to 78% in the placebo cohort. The most frequently reported AEs were related to COVID-19, as the trial was conducted during a time of high COVID-19 prevalence.

According to the Asthma and Allergy Foundation of America, over 27 million people in the United States are currently living with asthma, equaling 22 million adults. It is more common in females, with 10.8% of women experiencing it compared to 6.5% of adult males. Currently, around 4.5 million US children are living with asthma. In 2021, 39.6% of adults aged 18 years and older reported having multiple asthma attacks in one year. However, Centers for Disease Control and Prevention statistics have shown that the rate of asthma attacks fell from 54% to 41% between 2001 and 2020.

“As a physician, it is encouraging to see results of research that could evolve the management of severe asthma. For me, preventing exacerbations and particularly those that lead to hospitalizations is a treatment priority for the people I see with severe asthma. Not only are exacerbations traumatic for patients, and contribute to pressures on healthcare systems/hospitals, but each exacerbation can cause irreversible changes to the tissue of the lungs that over time can lead to permanent loss of lung function and make a patient’s breathing progressively more difficult,” said David Jackson, FRCP, MSc, PhD, lead author, SWIFT-1, SWIFT-2, professor of respiratory medicine, King’s College London, clinical lead, severe asthma, Guy’s and St Thomas’ Hospitals, London, in the press release.

1. Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations. 

September 9, 2024. Accessed September 10, 2024. https://www.gsk.com/en-gb/media/press-releases/depemokimab-late-breaking-data-presented-at-ers-show-a-54-reduction-in-severe-asthma-exacerbations/

Asthma and Allergy Foundation of America. 

Accessed September 10, 2024. https://aafa.org/asthma/asthma-facts/#:~:text=Over%2027%20million%20people%20in,about%201%20in%2012%20people.&text=Over%2022%20million%20U.S.%20adults%20ages%2018%20and%20older%20have%20asthma.&text=Asthma%20rates%20are%20highest%20in,Native%20adults%20in%20the%20U.S.

A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab. 

GSK’s Depemokimab Significantly Reduces Asthma Exacerbations 

Image Credit: Adobe Stock Images/Ирина Батюк

Bayer and NextRNA Therapeutics have agreed to terms to co-develop small molecule therapeutics that target long non-coding RNAs (lncRNAs) in oncology, with a focus on addressing diseases driven by these RNAs. According to the companies, the partnership will focus on disrupting pathological lncRNA interactions with RNA-binding proteins (RBPs) using NextRNA programs. Additionally, the joint venture will involve the advancement of two oncology programs, including one in early preclinical development, with Bayer having the option to select another target for joint development.

“With NextRNA’s exceptional expertise and lncRNA platform, we aim to advance novel small molecule therapeutics against a new class of targets in oncology,” said Juergen Eckhardt, MD, head, business development and licensing, pharmaceuticals division, Bayer, in a press release. “This partnership further adds to our mission to build one of the most transformative and diversified oncology pipelines in the industry.”

Under terms of the deal, NextRNA will receive up to $547 million in payments, research funding, and royalties, including up-front and near-term milestone payments for both programs. Additionally, Bayer will be granted access to NextRNA’s approach to inhibit the function of lncRNAs by disrupting the interaction between lncRNAs and RBPs with small molecules. According to NextRNA, its platform combines the computational engine NextMap with deep lncRNA biology expertise and a diverse set of biochemical, biophysics, and chemistry capabilities.

“We are excited to partner with Bayer, a recognized leader in life sciences and oncology innovation,” said Dominique Verhelle, PhD, MBA, co-founder, CEO, NextRNA, in the press release. “This collaboration recognizes lncRNAs as an exciting target class and confirms NextRNA’s position as both a leader in this space and a partner-of-choice for companies seeking to develop transformative small molecule therapeutics across disease areas. We look forward to working closely with the Bayer team to advance first-in-class cancer therapies while continuing to build our pipeline in oncology and neuroscience.”

1. Bayer and NextRNA Therapeutics Enter Strategic Collaboration to Develop Small Molecules Targeting Long Non-Coding RNAs (lncRNAs) in Oncology. 

August 28, 2024. Accessed August 28, 2024. https://www.businesswire.com/news/home/20240828587249/en

The joint venture aims to disrupt pathological lncRNA interactions with RNA-binding proteins using NextRNA’s platform.

Bayer, NextRNA Therapeutics Agree to Strategic Collaboration to Develop Small Molecule Therapeutics

Image Credit: Adobe Stock Images/Media Srock

Eli Lilly has expanded the availability of Zepbound (tirzepatide) by introducing single-dose vials in 2.5 mg and 5 mg doses. According to the company, these vials are now available via self-pay for patients with an on-label prescription, expanding the supply of the obesity treatment, which has been in high demand. The new single-dose vials are priced over 50% lower than other incretin medications for obesity and can be accessed through a self-pay pharmacy component of 

, providing patients a guarantee that they are receiving genuine Lilly medicine. The move aims to address rising demand while ensuring patient safety through a multi-step prescription verification process.

"We are excited to share that the Zepbound single-dose vials are now here, further delivering on our promise to increase supply of Zepbound in the US," said Patrik Jonsson, EVP, president, Lilly Cardiometabolic Health, Lilly USA, in a press release. "These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option. In a clinical study, the 5 mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off."

In terms of pricing, a four-week supply of the 2.5 mg Zepbound single-dose vial is $399, while the 5 mg dose is $549, considerably lower than half the list price of other incretin medicines for obesity and in line with the Zepbound savings program for non-covered individuals, according to Lilly. The company added that the self-pay channel enables a transparent price by removing third-party supply chain entities and allowing patients to access savings directly outside of insurance.

In clinical studies, Zepbound 5 mg has demonstrated significant weight loss results, helping patients achieve up to 15% weight loss over 72 weeks compared to 3.1% for placebo.

"People living with obesity have long been denied access to the essential treatment and care needed to manage this serious chronic disease," said James Zervos, chief operating officer, Obesity Action Coalition, in the press release. "Expanding coverage and affordability of treatments is vital to people living with obesity. We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality. Now, it's time for policymakers, employers and insurers to work with pharmaceutical companies to ensure no one is left behind in receiving the care they deserve and need."

Lilly warns against the use of Zepbound if a patient or a patient’s family member have ever had medullary thyroid carcinoma, a type of thyroid cancer. Additionally, patients should not use Zepbound if they have multiple endocrine neoplasia syndrome type 2 or have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. Severe adverse events (AEs) associated with Zepbound include stomach problems, kidney failure, gallbladder problems, pancreatitis, severe allergic reactions, hypoglycemia, and depression. Common AEs include nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn.

"Despite obesity being recognized as a serious chronic illness with long-term consequences, it's often misclassified as a lifestyle choice, resulting in many employers and the federal government excluding medications like Zepbound from insurance coverage," said Jonsson, in the press release. "Outdated policies and lack of coverage for obesity medications create an urgent need for more innovative solutions. Bringing Zepbound single-dose vials to patients will help more people living with obesity manage this chronic condition. We will also continue to advocate for a system that better aligns with the science."

1. Lilly releases Zepbound® (tirzepatide) single-dose vials, expanding supply and access for adults living with obesity. 

August 27, 2024. Accessed August 27, 2024. https://investor.lilly.com/news-releases/news-release-details/lilly-releases-zepboundr-tirzepatide-single-dose-vials-expanding

The new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50% lower than other incretin medications for obesity. 