Atrial Fibrillation, Eliquis, And The Inflation Reduction Act

Authored by Allison DeMajistre via The Epoch Times (emphasis ours),

Atrial fibrillation, often referred to as “AFib,” is the most commonly treated type of heart arrhythmia. This condition is now considered the new cardiovascular disease epidemic. In the United States, an estimated 3 to 6 million people have AFib, with projections suggesting that this number could reach 16 million by 2050.

(Raihana Asral/Shutterstock)

AFib is an irregular, sometimes rapid heart rhythm that occurs when abnormal electrical impulses override the heart’s natural pacemaker. Having AFib puts people at a three-to-five-times greater risk for ischemic stroke from a blood clot traveling from the heart to the brain. One of the primary ways to prevent a clot is to take an anticoagulant or blood-thinning medication.

“AFib contributes to turbulent flow inside the heart. The irregularity of the blood flow allows for a pause in the blood flowing through the heart, allowing the blood to clot. This then can be sent to the brain[,] causing strokes,” Dr. Ken Perry, an emergency physician in Charleston, South Carolina, told The Epoch Times via email.

The 2023 published clinical guideline for anticoagulant therapy to prevent stroke for AFib patients recommends a direct oral anticoagulant (DOAC), specifically the medication Eliquis (apixaban), because it has a lower risk of gastrointestinal bleeding than other DOACs.

Patients taking Eliquis for AFib must continue taking the medication if they’re experiencing an abnormal rhythm or at risk of going back into it. Missing even one dose could significantly increase the risk of having a stroke.

Unfortunately, for many people in the United States with AFib, Eliquis, the most commonly prescribed anticoagulant to prevent blood clots, can cost a patient up to $594 per month, depending on their insurance, Medicare Part D plan, or other type of coverage.

In 2022, Congress passed the Inflation Reduction Act (IRA), which includes several provisions to help lower prescription drug costs for Medicare beneficiaries. One of those provisions allows the Centers for Medicare & Medicaid Services (CMS) to negotiate the prices of some medications with drug manufacturers. In August 2023, CMS selected 10 Medicare Part D drugs for negotiation, and Eliquis was first on the list.

CMS Negotiations

According to a CMS factsheet, about 3.7 million Medicare Part D enrollees used Eliquis from June 2022 to May 2023. The total Part D gross covered prescription cost to Medicare for the same period was $16.5 billion.

A CMS representative told The Epoch Times via email that “The IRA helps people who take anticoagulant medications through Medicare Negotiation. Any negotiated prices agreed to between Medicare and participating drug companies will be announced by September 1, 2024, and become effective beginning in 2026.”

However, many AFib patients and health professionals believe the IRA will have several unintended consequences, including higher prescription costs and limited access to medications. They argue for oversight of pharmacy benefit managers (PBMs), as these managers have the authority to remove drugs from formularies or switch them to higher-cost tiers while securing larger rebates from more expensive drugs.

Who Are the Pharmacy Benefit Managers?

Pharmacy benefit managers are often overlooked intermediaries between drug and insurance companies. Three major PBMs—CVS Caremark, Optum RX, and Express Scripts—account for approximately 80 percent of medication fulfillment in the United States. They play a central role in pricing drugs for insurers, deciding which drugs will be most accessible to consumers, and determining how much pharmacies are paid for these medications.

Mellanie True Hills, a patient advocate and the founder and CEO of the American Foundation for Women’s Health and StopAfib.org, spoke at the CMS Medicare Drug Price Negotiation Program Patient-Focused Listening Session in October 2023. She and many others voiced concerns about the impact of the IRA and CMS drug negotiations on the pricing and accessibility of Eliquis.

“There is a misperception by the White House and patients that the problem is the drug companies. What they don’t realize is the pharma companies are over the barrel, just like we are,” Ms. Hills told The Epoch Times.

However, J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, stated in an op-ed titled “Elevating the Value of the Employer-PBM Relationship” that “Contrary to the narrative that some pharmaceutical companies want policymakers to believe, employers and health plan sponsors hire PBMs because they provide a wide range of pharmacy benefit options that help payers offer high-quality, cost-effective prescription drug benefits.”

Drug pricing in the United States is complex. It begins with the drug companies developing a drug and making a list price. The drug wholesalers make the drugs and transport them to the pharmacies. The patient pays a copay, and the pharmacy sends a bill the insurance company pays. Although the flow sounds simple, it doesn’t account for the PBMs, which add further complexity to the chain.

PBM Rebates

PBMs work on behalf of insurance companies, large employers, and government agencies. One of their main responsibilities is lowering drug costs for these organizations. They achieve this by negotiating rebates with drug manufacturers. The rebates are paid to the PBMs, who retain a portion of the savings and pass the remainder on to the insurance companies or employers.

In exchange for rebates, PBMs include a drug on their formulary, the list of drugs that pharmacies offer. PBMs utilize a tiered system to manage these drugs. Medications with a higher tier typically have a lower patient copay, motivating drug companies to provide higher rebates in exchange for a favorable tier placement. PBMs can remove a drug from the formulary altogether, potentially limiting patient access to that drug.

Theoretically, rebates and formulary placement should lower drug costs for consumers, yet unfortunately, the opposite often occurs. According to an issue brief published by the Commonwealth Fund, PBMs report that 90 percent of rebates are passed on to health plans and payers. However, small payers and employers often report that they don’t receive these savings, and the drug-specific rebates are kept confidential between manufacturers and PBMs, making it difficult for commercial plans to assess the actual cost savings for their members.

In a 2023 Congressional Oversight Committee hearing addressing the role of PBMs in prescription drug pricing, members and witnesses highlighted how PBMs monopolize the drug market to drive up prices. Despite bipartisan agreement that PBMs increase consumer costs and adversely affect patient care, no decisive action was taken against them. In December 2023, a Senate bill with only a few provisions was introduced.

“Congress cannot risk leaving employers to fend for themselves against pharmaceutical giants or restrict flexibility, options and savings that help businesses design benefits that work best for their unique needs, achieve savings that supports [sic] their ability to sponsor, and invest in high-quality benefits and unlock better health outcomes for their employees,” Mr. Scott stated in his op-ed.

PBMs and Drug Access

When PBMs have to pay more for a drug without receiving a substantial rebate from the drug manufacturer, it negatively affects their margins. According to the Alliance for Patient Access, the PBMs will sometimes remove the drug from their formulary, forcing patients to either pay the total price out-of-pocket or switch to a different drug that may be similar but not the one prescribed by their doctor.

Ms. Hills said a similar situation happened in December 2021, when many patients received word that CVS Caremark was dropping Eliquis from its formulary. This allowed patients to either take another anticoagulant—rivaroxaban or warfarin—or pay the total out-of-pocket cost for Eliquis.

The American College of Cardiology and patient advocacy groups pressured CVS Caremark to reverse its decision. In July 2022, CVS Caremark reinstated Eliquis on its formularies, stating that the drug was re-added after securing a lower net cost from the drug manufacturer.

Despite CVS Caremark’s decision to reinstate Eliquis, concerns persist about the potential loss of affordable access to the medication. These concerns are fueled by the possibility that CMS negotiations might force drug companies to lower prices, resulting in inadequate rebates for PBMs and potentially affecting the drug’s formulary status.

Nonmedical Drug Switching Risks

Nonmedical switching, especially with a medication like Eliquis, can be harmful to patients.

“One of the problems is that patients taking Eliquis twice a day, switching to Xarelto (rivaroxaban), which is only taken once a day, could cause confusion and a potential overdose, putting them at risk for bleeding. When a patient is stable, they should be left on that medication,” Ms. Hills said.

An article published in Research and Practice in Thrombosis and Haemostasis detailed a letter from CVS Caremark to Beth Waldron, a patient advocate for the National Blood Clot Alliance, who also takes Eliquis. The letter informed her that they were removing Eliquis from the formulary.

“The stated approval criteria required that I first take and fail Xarelto or have another clinical indication, which was undefined,” Ms. Waldron wrote. “And if the exemption was approved, it would be at a higher coverage tier, making it subject to coinsurance and deductible. For me, this would mean an additional US$2400 a year.” The failure of Xarelto could also result in developing a potentially deadly blood clot.

According to Ms. Hills, when a medication is removed from the formulary and a patient is forced to switch medications, they can ask their doctor to submit a prior authorization to the insurance company stating the patient’s need for one medication over another. However, some patients don’t have time for the prior authorization process.

The American Society for Preventive Cardiology published a 2022 report on the impact of nonmedical switching on patients taking a blood thinner. According to the report, patients forced into nonmedical switching by health insurers indicated that the switch took a toll on their overall health. Specifically, 28 percent reported side effects, 22 percent reported resurfacing of symptoms, 7 percent had a heart attack, and 4 percent had a stroke.

CMS Initiatives and Updates

The Epoch Times emailed CMS and asked if any stipulations would be in place to ensure that PBMs don’t interfere with Eliquis’ accessibility and pricing for Medicare beneficiaries and people with private insurance.

CMS did not answer the question about PBMs. However, it did offer specific details about the IRA price negotiations and the Extra Help program, available for people with incomes up to 150 percent of the federal poverty level. The IRA has expanded eligibility for the program, which can lower premiums and reduce out-of-pocket costs for prescription drug coverage.

Ms. Hills said she recently received encouraging news from CMS. The agency has asked patients for comments about incorporating patient input into revising the negotiation process for the second round of talks with drug companies to ensure patient access to medications under Part D.

“Within that, there are two things they’re asking about,” said Ms. Hills. “No. 1 is considering concerns around patient access disruption under Part D due to the combination Part D redesign would lead to coverage restrictions.”

CMS also wants patient input about reviewing Part D sponsor formularies annually to evaluate and address instances where selected drugs are unfavorably placed on tiers or subjected to more restrictive utilization management than nonselected drugs in the same class. “CMS is actually recognizing that this is a problem, and they’re asking for input on it,” she said. “Apparently, they heard us.”

The pharmaceutical industry is currently engaged in a legal battle with the federal government, attempting to block the negotiations by alleging that the program violates federal law and is unconstitutional. Despite these efforts, negotiations are ongoing and are expected to continue until August 1. The maximum fair price for the first 10 drugs, including Eliquis, will be announced on Sept. 1 and will take effect at the beginning of 2026.