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Denial of methotrexate prescriptions post- Roe yields ‘condemnation’


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Healio interviews


Disclosures:
Feldman, Newmark, Saag and Young report no relevant financial disclosures.

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The June 24 Supreme Court decision to overturn Roe vs. Wade continues to reverberate across all of health care, including rheumatology, dermatology and cancer treatment — and in this instance all three at once.

Just 2 weeks after the Dobbs vs. Jackson decision, anecdotal reports began to emerge of patients being denied methotrexate prescriptions because the drug has been used to end ectopic pregnancies.

graphic with quote from Newmark

Anecdotal reports of patients being denied methotrexate prescriptions because the drug has been used to end ectopic pregnancies have been reported across social media, as well as to several medical professional organizations, since the U.S. Supreme Court overturned federal abortion protections in June.

Steven Newmark, JD, MPA, chief legal officer and director of policy at the Global Healthy Living Foundation, explained these reports.

“So far, we have heard of two scenarios regarding the methotrexate access issue,” he said.

In one scenario, people who are able to give birth are being informed at the pharmacy that their prescription will not be dispensed because the pharmacist is aware that methotrexate can be prescribed to end an ectopic pregnancy, which always results in terminating the fetus to save the life of the mother.

“Patients are being asked to provide extra verification that, as a woman of childbearing age or not, that they need the medication for their illness and not to end a pregnancy,” Newmark said. “Women are being asked for extra information even if they have been on the medicine and simply need a refill.”

The second issue, according to Newmark, is that women are reporting that their rheumatologists are reluctant to prescribe methotrexate without better understanding how trigger laws may impact their ability to legally prescribe the medication.

“Reluctance to dispense or prescribe methotrexate is frustrating,” Newmark said. “FDA-approved medications undergo extensive review and, once approved, can be prescribed by doctors and used by patients, as indicated or off-label at the doctor’s discretion. There is no legal impediment for any person prescribed methotrexate to be fearful of losing access to this vital medication used by millions of people living with arthritis, psoriasis and other conditions.”

For Kenneth G. Saag, MD, president of the American College of Rheumatology and a professor of medicine at the University of Alabama at Birmingham, these reports are, to say the least, problematic.

“It goes without saying that methotrexate is one of our pivotal drugs in rheumatology,” he told Healio Rheumatology.

Regarding pregnancy outcomes, Saag noted that the drug may cause birth defects in approximately 10% of cases and has been associated with miscarriage in an estimated 40% of pregnancies.

“These two issues have led to some general consternation by some health care providers and some pharmacists of what the implications are of using this drug post-Roe in places where state legislation may impose penalties in instances leading to fetal loss,” he said.

Although Saag also noted that the early reports have been anecdotal, he stressed that the rheumatology community should be on high alert.

“The consensus is that this could be a bigger problem,” he said. “We want to ensure that patients and providers can make their own decisions about their disease management.”

Understanding the scope of where this issue stands at present could be critical in minimizing further fallout moving forward.

‘Ethically and legally problematic’

“Anecdotally, both CreakyJoints and the Global Healthy Living Foundation were contacted by women, only, facing new hurdles to refilling or securing a new prescription to methotrexate,” Newmark said. “It is both ethically and legally problematic that women are required to provide more rationale/clinical evidence regarding why they require their prescription compared to others. It is also an invasion of privacy and disruptive of the patient-physician relationship.”

In addition, the editors of the Lancet Rheumatology penned an editorial outlining where many members of the medical community stand.

“Many medical organizations, including the American Medical Association and the American College of Obstetrics and Gynecology (among many others), have released official statements condemning the Supreme Court ruling as a medically baseless, immoral infringement on the patient–doctor relationship and a violation of human rights,” the authors wrote. “The Lancet Rheumatology joins these voices of condemnation.”

Such a statement from health care professionals is one thing. An executive order from the White House is another altogether.

Executive action

On July 13, HHS issued a statement directly addressing potential denial of methotrexate prescriptions, announcing that federal law prohibits pharmacies from refusing to fill prescriptions that may end a pregnancy to patients who are able to become pregnant.

In the guidance, pharmacies, as recipients of federal financial assistance — including Medicaid and Medicare — were “reminded” of their obligation under civil rights laws to refrain from discrimination based on race, color, national origin, sex, age, and disability.

“Today, following President Biden’s Executive Order on ensuring access to reproductive health care, the U.S. Department of Health and Human Services (HHS) is issuing guidance to roughly 60,000 U.S. retail pharmacies, reminding them of their obligations under federal civil rights laws,” the statement read. “The guidance makes clear that as recipients of federal financial assistance, including Medicare and Medicaid payments, pharmacies are prohibited under law from discriminating based on race, color, national origin, sex, age and disability in their programs and activities.

“This includes supplying prescribed medications; making determinations regarding the suitability of prescribed medications for a patient; and advising a patient about prescribed medications and how to take them,” it continued. “The action is the latest step in the HHS’ response to protect reproductive health care.”

Newmark underscored the point in the executive order that pharmacists are at risk of violating federal civil rights laws if they deny filling prescriptions to medications that could be used for abortions. He believes this order is essential, given that state legislatures around the country are moving forward with restrictive abortion laws.

“State legislatures — particularly those in trigger states and red states — are leaping into action to further restrict access to legal abortions, including medicated abortion,” he said. “Specifically, in Texas, SB.4 is a law that specifically names methotrexate as one that needs to be carefully monitored because it is known to as an abortion-inducing drug, prescribed for ectopic pregnancies.”

The Global Healthy Living Foundation is pushing back in Texas, according to Newmark.

“We sent a letter to the governor describing the issue and are looking to work with patients in that state to advocate in favor of protections for chronic illness patients,” he said. “We are monitoring other states, as well. Again, we cannot stress enough that methotrexate has been used for decades — 60 years — for a variety of conditions, including autoimmune illnesses. Individual states cannot regulate the use individual medications that are FDA approved.”

Meanwhile, the ACR is focusing on education, according to Saag.

“At ACR, we have created a task force to develop tools and educational materials for physicians and other providers,” he said.

In addition, the ACR on July 25 issued recommendations on the allocation of methotrexate. These recommendations, which argue that methotrexate doses should be filled “without delay,” should apply “particularly in states where restrictive abortion laws are creating confusion and barriers to care.”

The ACR recommendations are:

  • Oral and subcutaneous methotrexate prescriptions in doses “typical for rheumatology” should be filled without delay and with the assumption that they are not being used for abortion.
  • Rheumatology professionals should counsel patients who are able to become pregnant that they should use “highly effective contraception” while using methotrexate. In addition, “contraception must remain accessible to these patients.”
  • State and federal law must protect health professionals and patients who are prescribing and using methotrexate for rheumatic diseases.

The Lancet editorial also aims to educate the clinical community of the parameters of what is happening with methotrexate.

“In a post-Roe USA, rheumatologists and patients will likely be faced with the difficult choice between the most effective, guideline-aligned therapies (eg, MMF or cyclophosphamide for lupus nephritis) plus long-acting contraception or — for women with contraindications or intolerance to contraceptives — suboptimal disease control with pregnancy-safe options (eg, azathioprine for lupus nephritis),” the authors wrote.

The authors of the Lancet paper additionally stressed that disadvantaged and marginalized groups, particularly Black women, are likely to bear the brunt of reduced access to methotrexate prescriptions, should these anecdotes become the norm.

To that point, Saag mentioned that rheumatologists should not be the only targets for instruction and education.

“We at ACR are also working on patient-facing messages,” he said.

For these and other reasons, it is important for every practicing rheumatologist to take steps to safeguard methotrexate prescriptions for every patient in their practice.

‘Call your rheumatologist’

For Kristen Young, DO, a rheumatologist at the University of Arizona College of Medicine, it is important to highlight one starting point for clinicians.

Kristen Young

“Rheumatologists should not be withholding medications based on age or possible childbearing status,” she said.

The next step is to rely on the treatment paradigm that has fueled rheumatology practice for decades.

“Patients want appropriate treatment, but they also want information, so having a patient-centered conversation and being open and honest about the benefits and risks from methotrexate is important,” she said.

However, the conversation should also cover the misinformation being spread about the drug, according to Young.

“It is important to let patients know they can keep taking methotrexate for their rheumatic disease,” she said. “We have had some patients misunderstand news stories and stop their methotrexate thinking that they will be in trouble. Don’t do that. If you have questions, call your rheumatologist.”

Madelaine A. Feldman

Madelaine A. Feldman, MD, FACR, president of the Coalition of State Rheumatology Organizations, and founder and past president of the Rheumatology Alliance of Louisiana, meanwhile suggested a clear-eyed examination of the supply chain may be useful.

“First, we need to discover where the hold-up points are,” she said. “Is it the pharmacies or some other link in the chain?”

Young agreed.

“It is reasonable to engage with local pharmacists to ensure you understand why methotrexate or other medications are being withheld or not distributed,” she said.

Working directly with pharmacies or the Board of Pharmacy in one’s state to ensure prescriptions are handled as smoothly as possible is another option Feldman suggested.

“If there is an ongoing delay from a particular pharmacy, we should obtain in writing any necessary and unnecessary steps that have been added to obtaining a methotrexate prescription,” she said. “At that point we can take the exact roadblock to the Board of Pharmacy or the insurance commissioner, depending on the agency at fault, and determine how to make sure that this is taken care of from the top.”

The good news is that, if the indication is clear in the electronic health record, then most patients should face minimal barriers to accessing this medication, according to Newmark. However, he also believes that ongoing vigilance is warranted.

“We also encourage rheumatologists and pharmacists to research how the Dobbs decision impacts reproductive health in their state so that they have clarity about the concerns their patients may have about family planning and their personal health care,” he said. “We hope that rheumatologists and pharmacists will advocate for health policies and laws that put the patient first, no matter what medicine they need or health services they require.”

Putting the patient first is critical for Young, as well.

“Methotrexate is used for a wide variety of rheumatic diseases and going without it can mean flares that range from debilitating pain to critical illness,” she said. “Although there are many other medications for rheumatic diseases, methotrexate remains the cornerstone of many treatments. Having it abruptly removed from a patient’s medical regimen can lead to flares of their disease, which in some situations can mean critical illness. But more than anything, methotrexate is used most commonly, and is our first line medication, in rheumatoid arthritis. It gives people the ability to function without debilitating joint pain.”

References:

HHS press release:
https://www.hhs.gov/about/news/2022/07/13/hhs-issues-guidance-nations-retail-pharmacies-clarifying-their-obligations-ensure-access-comprehensive-reproductive-health-care-services.html

Lancet Rheumatol. 2022;doi:10.1016/S2665-9913(22)00189-8.

The American College of Rheumatology, Guiding Principles for Policymakers on Methotrexate Access Following the Dobbs Decision; https://www.rheumatology.org/announcements



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