CVS Caremark Formulary Exclusion of Eliquis is a Patient Safety Risk

Editor’s note: The recent CVS Caremark decision to exclude Eliquis® (apixaban) from its Preferred Drug List raises critical patient safety issues about whether CVS is illegally practicing medicine and whether CVS actually cares about the patients it professes to serve. In this opinion piece, Michael Wong, JD  (Founder & Executive Director, Physician-Patient Alliance for Health & Safety) discusses these critical patient safety issues and asks patients and clinicians to let CVS know how they feel through two online petitions.

By Michael Wong, JD (Founder & Executive Director, Physician-Patient Alliance for Health & Safety)

Is CVS Caremark Illegally Practicing Medicine?

Beginning in 2022, CVS Caremark (part of CVS Health) has excluded Eliquis® (apixaban) from the CVS Caremark Preferred Drug List. Eliquis is “indicated to reduce the risk of stroke and systemic embolism in patients with NVAF. Eliquis is indicated for the treatment of DVT [deep vein thrombosis] and PE [pulmonary embolism], and to reduce the risk of recurrent DVT and PE following initial therapy.” Eliquis is a Factor Xa inhibitor and is a Direct Oral Anticoagulant (DOAC). 

Practicing Medicine - CVS Caremark Formulary Exclusion of Eliquis is a Patient Safety Risk
Image source: https://pxhere.com/en/photo/1571983

DOACs are considered a next-generation blood thinner as they have demonstrated “superiority or noninferiority to prior standards of care, anticoagulation with vitamin K antagonists (VKA; ie, warfarin), or low‐molecular‐weight heparins (LMWHs), in reducing the risk of thromboembolic complications with similar or reduced bleeding risk. Advantages of DOACs compared with VKAs include fewer monitoring requirements, less frequent follow‐up, more immediate drug onset and offset effects (important for periprocedural and acute bleeding management), and fewer drug and food interactions.”

CVS Caremark’s decision to exclude Eliquis means that patients who are filling their prescriptions through CVS Caremark will need to transition to Xarelto® or be willing to pay 100% of the cost of Eliquis. This means that CVS Caremark has decided that Xarelto must be used by all such patients requiring a DOAC, even though none of these patients has a physician-patient relationship with CVS Caremark. 

In her analysis of Eliquis and Xarelto, Karen Berger, Pharm.D. noted the similarities between the two medications:

Eliquis (apixaban) and Xarelto (rivaroxaban) are NOACs (novel oral anticoagulants), which are a group of newer blood thinners. They are also known as DOAC (direct oral anticoagulants). Unlike Coumadin (warfarin), a popular and older anticoagulant, patients taking Eliquis or Xarelto do not need regular blood tests to monitor levels. Both Eliquis and Xarelto are known as factor Xa inhibitors, but they have some differences.

Eliquis and Xarelto are both approved by the FDA for prescription use and are available in brand name only. No generic is available yet for either drug; however, a generic Eliquis should be available soon. Eliquis is made by Bristol-Myers Squibb. Xarelto is made by Janssen Pharmaceuticals. Both drugs are used by adults, and the dosage varies by indication.

However, although both Eliquis and Xarelto are DOACs and from a lay perspective are essentially the same, Ms. Berger noted the differences, saying:

Eliquis and Xarelto have several indications that are the same—to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation (AFib, or irregular heartbeat), prevent deep vein thrombosis (DVT) in patients who have had hip or knee replacement, treat DVT, treat PE, and to reduce the risk of recurrent DVT or PE following initial therapy.

Additionally, Xarelto has two more indications. Xarelto can prevent venous thromboembolism (VTE) and VTE-related death. Xarelto may be prescribed during hospitalization and after discharge in adult patients who are at risk for complications due to restricted mobility and other risk factors. However, Xarelto should not be prescribed to patients who are at high risk of bleeding. Xarelto is also used with aspirin to lower the risk of major cardiovascular events such as death, heart attack, and stroke in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

Anticoagulants
Please click on the image to read the article, “Ten top tips: Reviewing patients on established DOAC treatment”

The key question and critical issue are should CVS be making medication decisions for patients or should that decision be left to each patients’ physician? Healthcare insurers never went to medical school or are licensed to practice medicine, so why are they practicing medicine? As Ms. Berger has noted:

  • If the patient has restricted mobility and is being discharged, Xarelto may be the more appropriate medication. 
  • If the patient has a high risk of bleeding, Eliquis may be the more appropriate medication.

The title of this article by William E. Bennett Jr. (Associate Professor of Pediatrics, Indiana University School of Medicine) says it all, “Insurance companies aren’t doctors. So why do we keep letting them practice medicine?”

Illegal Practice of Medicine
Please click on the image to read Dr.Bennett’s article

PPAHS does not endorse any specific medication, pharmacy, or pharmacologic product. The choice of which medication to prescribe must be with the physician in consultation with each patient, and not be dictated by a person or company that has no physician-patient relationship.

CVS is Practicing Non-Medication Switching

Non-Medication Switching, which occurs when, without the consent of the patient and the prescribing physician, the prescription is filled by a drug other than the one prescribed. In such cases, the health insurer requires a stable patient to switch from his or her current, effective medication to a less costly, alternative (but not generic) drug by removing the medication from the formulary list, moving a drug to a higher cost tier, or increasing the out-of-pocket costs owed. The Alliance for Patient Access has found that medication switching has resulted in higher patient costs. The American Heart Association and the American College of Cardiology oppose therapeutic substitution, believing that “only the prescribing doctor is equipped to determine the best drug or combination of drugs” and that therapeutic substitution “may result in the patient receiving a drug that doesn’t work well enough, produces life-threatening toxicity, or interacts dangerously with other drugs the patient is taking.”

According to the Alliance for Safe Biologic Medicines (ASBM ​​is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion), “Non-Medical Switching (NMS) is the switching of a patient’s medicine, often at the behest of a third party, for reasons other than the patient’s health and safety. Non-medical reasons for switching a patient’s medicine could include:

  • To increase the profits of a private insurer.
  • To reduce costs for a government agency, or employer.
  • An agreement between the payer and a particular manufacturer to favor that manufacturer’s product.

None of the above reasons have anything to do with the needs or wishes of patients, and just the bottom line of a business.

Does CVS “Care” for Patients?

CVS Caremark’s motto is “Your health is our priority. At CVS Caremark, each and every one of us is dedicated to helping you on your path to better health.” If CVS Caremark really did “care” for patients, they would stop practicing medicine and let patients’ own doctors decide what treatments are in the best interests of their patients.

Alan Lotvin (President, CVS Caremark) says:

Every day, we empower our members to manage their health and well-being through tools and solutions that connect them to the most effective care and medicines. By delivering pharmacy benefits that are more personalized, accessible and affordable, our more than 100 million members can reach better health outcomes and ultimately lead healthier lives.

So, here’s the question, does CVS Caremark care for patients?

Non-Medical Switching is a Patient Safety Issue

As the National Board of Prior Authorization Specialists says:

Non-medical switching is the practice of switching a patient’s medication to a more cost-saving option without increased evidence for efficacy or safety. The insurance company or prescription benefit managers (PBMs) can reduce or completely eliminate coverage for the original prescription. 

These changes in coverage are cost-driven by the insurance company or PBMs. They aim to drive down costs without any data supporting better patient outcomes. 

This non-medical switch could also occur based on reducing coverage or blocking manufacturer copay coupon assistance programs. Because these are necessary for affordability, the prescription would become unaffordable. The patient would then have to switch therapy. This poses risk for side effects, decreased quality of life, more doctor visits, and worse outcomes.

By deprioritizing patient outcomes, non-medical switching has negative consequences for the patient experience.

According to the U.S. Pain Foundation, “Switching should only take place with the full knowledge and consent of the prescribing physician in consultation with the affected patient. “Insurers should not be playing doctor.”

Actions You Can Take

The Physician-Patient Alliance for Health & Safety supports the position taken by the Partnership to Advance Cardiovascular Health.

So, if you are patient (as we all are), please sign this petition on Change.org.

CVS Caremark Non-Medication Switching
Click on the image to watch a video on the impact of non-medication switching.

If you are a doctor, nurse, or another healthcare professional, please sign this petition in support of the letter written by the Alliance for Patient Access has written a letter to urge CVS Caremark to reverse this decision.

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