Fortunately, a lot of discussion is going around about Step Therapy, first brought to our attention by the American Autoimmune Related Diseases Association (AARDA). The discussion has become so prevalent that many, including the U.S. Pain Foundation, are declaring February as “Fail First February.”
What is step therapy and how does it impact the life of a patient?
Those living with a chronic autoimmune disease or living with chronic pain may have personal experience with Step Therapy. Step Therapy is based on a “failed first” policy where, despite which medication your doctor prescribes, insurance companies require that you try cheaper, and sometimes less effective, options first. Paul Gileno, Founder and President of the U.S. Pain Foundation said in a news interview, “[Step Therapy] is the doctor telling you that you need narcotics to treat pain but you must try baby aspirin first.” While that may sound extreme, it is happening to millions of patients across the United States.
For those diagnosed with a form of Myositis (polymyositis, dermatomyositis, inclusion body myositis, and juvenile myositis), a rare autoimmune muscle disease, physicians may recommend drugs such as Imuran, methotrexate, or CellCept as one of the first steroid-sparing, or disease modifying, agents. However, even though your doctor believes one of these drugs is the best drug for you, if the insurance company determines there is a cheaper drug, they will require you to try it first. This is an example of Step Therapy and your doctor is not a part of this decision-making process despite his or her years of experience treating the disease. Step Therapy also does not take into account your medical history. Instead, it is completely reliant upon an insurance company’s drug formulary or certain protocols they have in place. And, while there is an appeals process in most states, it is often not easy to find, navigate, or even file, and in cases where an appeal has been filed, delays are inevitable.
“Insurance companies using Step Therapy force their beneficiaries to first try less expensive, relatively lower quality care before progressing to more expensive, relatively higher quality drugs that may be more effective for the individual patient.” – View source
What is the next step if you fail the drug the insurance company required you to try? Your doctor can attempt to prescribe the original “first option” medication again, but the insurance company can step in once again and require you to try the next cheapest drug. This cycle could continue until you have exhausted all of the cheapest options. At this point, the insurance company may finally approve the drug your doctor originally thought best, after wasting months of your time while your disease may have progressed.
The Step Therapy cycle is even more troubling given that many of the steroid-sparing agents used to treat Myositis can take up to 3 or more months for full efficacy. Therefore, if the insurance company forces you to try 2 drugs that were not recommended by your doctor, a 6-month delay in effective treatment may result. Many autoimmune diseases are best managed when the right medication is prescribed at, or within weeks of, a diagnosis.
The treatment process should not be so difficult. You meet with your doctor, they decide on the best course of treatment, they provide you a prescription, you visit the pharmacy to fill it, and you then start the medication your doctor, the one who knows you best, has ordered. Unfortunately, this process is not happening in a lot of cases. Rather, the insurance companies are stepping in and forcing your doctor to place you on a different, less expensive medication first; sometimes medications you have already tried and failed at an earlier point, or even a medication that is not indicated for your disease or a good option based on your medical history. This is the “failed first” concept. You must try and fail certain medications before the insurance company will approve what your doctor thinks is the best for you.
The insurance company Step Therapy process can cause months of delays, disease progression, and in extreme cases even death due to not receiving timely and appropriate treatments your doctor has prescribed.
Where do we go from here?
In our support groups we learn many things that cannot be taught, but instead are only learned through shared experiences. We have found that each patient is different and will respond differently to the exact same medication. This is an important realization when you think about Step Therapy and its utilization of a “one-size-fits-all” approach.
A study published in the American Journal of Managed Care has some interesting findings. Tami L. Mark, PhD, MBA, director of analytic strategies at Thomson Reuters Health Care and lead author, says that “step therapy is becoming very common and there’s a need to evaluate what its impact is, and not assume what its impact might be.”
Tami Mark goes on to say, “We did find that patients discontinued their medication more so after step therapy was implemented. There was a decrease in prescription drug costs in the step therapy group relative to the control group, although that effect diminished over time. Conversely, we found that emergency room visits and hospitalizations increased and that total medical care costs increased.”
Other studies show that Step Therapy may be dangerous, timely, and may damage the ability for physicians to provide a high level of care to their patients.
- A study published in the American Journal of Medicine found that rheumatoid arthritis patients who delayed disease-modifying treatment for approximately four months experienced significantly more radiologic joint damage after two years compared to patients who began treatment within two weeks of diagnosis.
http://www.amjmed.com/article/S0002-9343(01)00872-5/abstract
- Another study published in The Lancet found that patients with delays of three months or more in treatment had a 12% lower five-year survival rate than those with shorter delays.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(99)02143-1/fulltext
- A study published by the Academy of Managed Care Pharmacy found that 28% of patients reported spending three or more hours trying to obtain second-line drugs from their physicians’ office. http://www.amcp.org/data/jmcp/Research-291-298.pdf
- Another study, published in Dermatology Times, cited that Step Therapy causes physicians and their staff to spend time contacting insurance companies to determine if a drug will be covered, in addition to appealing denied treatments (approximately two hours per patient), which ultimately distracts providers from patient care. http://dermatologytimes.modernmedicine.com/dermatology-times/news/step-therapy-stalls-appropriate-patient-treatment
As these studies demonstrate, Step Therapy is a dangerous obstacle to the successful treatment of patients and has the potential to damage the doctor-patient relationship. Rather than providing the excellent care your doctor wants to they often must use a portion of that time for administrative tasks in getting medications approved. Therefore, we hope you will support AARDA, the U.S. Pain Foundation, and other organizations in their mission to shed light on and bring change to the practice of Step Therapy.
Share your experience with step therapy
It all beings with us, the patients, speaking and reaching out. Share your experience about Step Therapy with us on our website. How did it affect your life? Did it have an impact on your relationship with or care provided by your doctor? How long were your delays in getting appropriate and effective treatments that your doctor first recommended? We want to hear your voice!
When posting about Step Therapy, be sure to use the hashtag, #StepTherapy, to join the conversation.
Sources:
- http://www.managedcaremag.com/archives/0905/0905.formfiles.html
- https://www.prescriptionprocess.com/sites/default/files/Step%20Therapy%20The%20Patient%20Impact.pdf
