Step Therapy

What’s the History? What’s Happening Today?

Step therapy was initiated in the 1980s in response to rising prescription medication costs (American College of Rheumatology, 2019). The plan was formulated by companies managing health care plans, and is still used today by health insurance companies, as well as some government run programs such as Medicare (Hemophilia Federation of America, 2016). Under step therapy protocols, patients may have to try and fail medications, treatments or therapies that cost less than the original treatment prescribed by the practitioner. Step therapy can be helpful in reducing unnecessary expenditures, as long as the cost-savings initiative does not supersede evidence-based practices (Fischer & Avorn, 2017). Unfortunately, for some patients, step therapy has led to a delay in care. Step therapy has also negatively affected patients with certain chronic diseases that require more expensive treatments (HFA, 206). It has also been problematic for patients that have to switch insurance plans. A patient may have already failed multiple treatments with the previous insurance company; however, the new insurance company may require the patient to fail the same treatments they have already failed in the past (HFA, 2016). Below is a great video that explains how step therapy protocols work and impact patients.

Currently, policies are being introduced to modify step therapy protocols. These policies are being introduced at the federal and the state level. On April 10th, 2019, H.R. 2279 was introduced at the federal level. On February 3rd, 2020, H. B. 2420 was introduced at the state level in Arizona. Both bills have similar proposals to modify the current step therapy protocol. For example, both bills propose that exceptions may be made in unique cases. Both bills also propose that once a medication appeal has been made, the insurance company is required to respond to the appeal within a reasonable amount of time, typically within 24 to 72 hours depending on the severity of the disease or condition. If an appeal is made, the prescriber must thoroughly document why the treatment of choice is not suitable for the patient. While these bills offer some flexibility for the patient and the prescriber, Fischer and Avorn warn the public that an increase in insurance costs will result from policies aiming to restrict Step therapy (2017). Yet, this is not a reason for people to become discouraged from advocating for change. So far, the proposals being made will not eliminate step therapy, but allow the prescriber to appeal an insurance company’s refusal to cover a medication. 

Alliance for Patient Access. (2015, July 15). Understanding step therapy [Video]. YouTube. https://www.youtube.com/watch?v=zg6mjEnUMv0

American College of Rheumatology. (2019). American college of rheumatology position statement: Step therapy. Retrieved from https://www.rheumatology.org/Portals/0/Files/Step%20Therapy.pdf

Fischer M. A. & Avorn J. (2017). Step therapy—Clinical algorithms, legislation, and optimal prescribing. The Journal of the American Medical Association. 317(8):801–802. doi:10.1001/jama.2016.20619

Hemophilia Federation of American. (2016). Issue brief: Non-medical switching and step therapy. Retrieved from https://www.hemophiliafed.org/uploads/PGR_IssueBrief_NonMedicalSwitching_2016-10-25.pdf

Safe Step Act of 2019 – 2020, H. R. 2279, 116th Cong. (2019). Retrieved from https://www.congress.gov/bill/116th-congress/house-bill/2279/text

Step Therapy of 2020, H. B 2420, 54th Legislature Second Regulatory Session . Retrieved from https://www.cqstatetrack.com/texis/redir?id=5e2166244149

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32 thoughts on “Step Therapy”

  2. Karen-

    Step therapy has long frustrated me as a patient, and now as a provider. As clinicians, we are ethically bound to suggest what we think will be most efficacious for our patients. Insurance companies are driven to keep costs low and produce higher profits. Our current profit-driven insurance system means that patients are secondary to the bottom line. As long as insurance companies are motivated by the cost of therapy, rather than the efficacy we will continue to have these issues. When patients have undesirable side effects, is this considered a step therapy failure? Nayak and Pearson (2014) recommend that insurers take such cases into consideration. Patient quality of life can be diminished while advancing through multiple steps.

    Along with the insurance companies, drug companies are increasing prices on existing medications. New medications are priced astronomically high. For many, they are being priced out of continuing their pharmaceutical therapies. Congress is loathe to act in the face of lobbying cash, even as their constituents are suffering from price gouging. Drug importation has to be considered as a possible remedy.

    Reference
    Nayak, R. K. & Pearson, S. D. (2014) The ethics of ‘fail first’: guidelines and practical scenarios for step therapy coverage policies. Health Affairs, 33(10). https:/doi.org/10.1377/hlthaff.2014.0516

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  3. Hi Karen,

    I found your blog particularly enlightening for me because this cost-cutting approach with its unintended consequences is new to me, probably because I haven’t recently had any personal experience with it. However as an advocate, the first thing I thought of were survivor experiences with cancer treatment, which often involve taking drugs to attenuate the side effects of treatment such as anti-nausea drugs; protection against potential side effects such as neutropenia; and novel combinations of new drugs based on oncologists’ experiences. Reading your blog, I envisioned how “step therapy” could impact all of these situations.

    In general, I find that ACCC website (Association of Community Cancer Centers) is instructive when it comes to sophisticated treatment issues that affect patients. One of the great benefits of the ACCC approach is that the site makes information targeted at clinicians available to the public. Indeed, as recently as November 2019, ACCC’s blog focused on the impacts of step therapy and announced a just-completed 4-part series produced by ACCC to help clinicians (and proactive survivors) better understand the impact of step therapy on oncology.

    First the blog explained the history of step therapy under Medicare. I learned that in August 2018, rules were promulgated that made Medicare Advantage (MA) plans subject to step therapy as a cost-cutting procedure effective January 2019. It has already been a year since the policy began, and the impact on Medicare patients is huge. According to ACCC, more than 20 million Medicare beneficiaries, about 34%, are enrolled in MA plans, including my husband.

    The website describes additional, new changes including a May 2019 rule that expanded step therapy to Medicare Part B drugs, although there are some exceptions for patients under treatment. Still if my husband were to become a newly diagnosed patient, he would be affected; the step therapy rules apply to new patients.

    The 4-part lecture series has a local connection. One of the four oncologists who comprise the panel is Rafael Fonseca, MD, Getz Family Professor of Cancer & Professor of Medicine at the Mayo Clinic here in town. The first two lectures focus on unintended consequences of the policy, and they aren’t good. Forcing patients to fail first can include side-effects that require immediate hospitalization, turning the cost-cutting theory into a costly and dangerous act. The second lecture focuses on barriers to prescribing drugs designed to prevent unwanted side-effects.

    The link to this sobering information about the impact of step therapy on cancer survivors is https://www.accc-cancer.org/projects/step-therapy-lecture-series/lectures.

    Thank you Karen for bringing this practice to my attention. While I never give advice about treatment, I can point survivors to the website if they wish to better understand how these policies and their implementation might affect them or a loved one.

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  4. The ethics of step therapy sound reasonable in practice, but the idea that finances of big insurance companies get in the way of providing care is so ridiculous to me that I want to tell patients that have been harmed due to this kind of policy to seek legal action. I feel this would be more just and a possibly better way to force change in the industry compared to the “Physician Review Committees “, and other insurance company self-developed research.
    This makes me think that the deciding factors for first-line choices need to be taken away from the insurance companies and given to saying the American Academy of Family Practice or other specialist organizations. There is little ethical justice without checks and balances in these organizations. Insurance companies have a bottom line and I feel this can get in the way of patient care when these same companies get to decide which medication is the first-line choice.
    In regards to HB2420 it is a good first step with the limiting of a 24hr response the strongest step so far. Sadly, I feel all these means is that insurance companies are simply going to continue to do what they have always done. deny requests first until you as the provider push the issue further. Hopefully, this won’t be the case, but from my experience, I have little hope.

    State of Arizona House of Representatives. (2020). Step therapy. Retrieved from https://www.cqstatetrack.com/texis/redir?id=5e2166244149

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  5. Thank you for your informative post on step therapy. I have encountered this in my workplace. Often, a provider will make a recommendation for a prescription to manage overactive bladder symptoms. Patients will notify our office that they were unable to pick up the prescription because their insurance requires them to try an alternative class of the drug before they consider covering the prescribed medication. However, the alternative medications which insurance requires patients to try have been linked to increased incidences of dementia and Alzheimer’s disease, which were factors considered by the provider during the prescribing process. As a result, this had led to a personal inquiry as to how medications under step therapy are chosen. According to the United Healthcare step therapy program, medications approved under the program have been vetted through extensive peer-reviewed medical literature, clinical trials, drug comparison studies, clinical practice guidelines, efficacy, and side effects (United Healthcare, 2020). This is interesting to read as my clinical example contradicts the process of how medications are chosen under the step-therapy program.

    While efforts in step-therapy aim to promote cost-savings, it unfortunately has costly effects on patients’ health. In addition to delayed care, social determinants of health are also affected by step-therapy. Step-therapy prevents availability and accessibility, social determinants of health. Consider patients of low socioeconomic status. Patients are already at a disadvantage in accessing adequate health care and may be subjected to a patchwork of health services (Longest, 2016). Additionally, they may be even more affected by limitations in step-therapy if high financial costs are associated with the first-trial medications in step-therapy. This process renders low income patients unable to seek care in an efficient and cost appropriate manner.

    References:

    Longest, B.B. Jr. (2016). Health policymaking in the United States. (6th ed.). Chicago, IL: Health Administration Press.

    United Healthcare. (2020). Clinical program drug step therapy – commercial. Retrieved from https://www.uhcprovider.com/en/resource-library/drug-lists-pharmacy/clinical-drug-step-therapy.html

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  6. As I read more about your topic, I was reminded of genetics and clinical decision support. In Clinical decision support: The road to broad adoption, Dr. Greenes discusses how the increasing knowledge in genetics has given rise to the pursuit of “personalized” or “precision” medicine (Greenes, 2014). The field of pharmacogenomics plays a large factor in the pursuit of this “personalized” medicine goal. I wonder if the pursuit of “personalized” medicine will eventually reduce the likelihood of step therapy. Or perhaps there will just be specific protocols and “steps” for certain genotypes. Pharmacogenomics is still early in its development, but eventually, it could bypass “step-therapy,” because we would naturally eliminate medications/ treatments that would not be beneficial or less effective than others, ultimately reducing cost.
    Additionally, I would be curious to know if the insurance companies have done a work-flow analysis and deeply investigated the real cost of this policy. How many hours do agents spend analyzing/reviewing/processing clinician requests for exceptions? How much time is lost on the provider side to these requests? Some studies suggest that there is limited quality evidence demonstrating reduced cost from step therapy and that there may be increases in the use of other services such as inpatient and emergency room visits (Nayak & Pearson, 2014).

    Greenes, R. A. (2014). Clinical decision support: The road to broad adoption (2nd ed.) [Kindle Version]. Retrieved from amazon.com
    Nayak, R. K., & Pearson, S. D. (2014, October). The ethics of ’fail first’: Guidelines and practical scenarios for step therapy coverage policies. Health Affairs, 33, 1779-1785. https://doi.org/10.1377/hlthaff.2014.0516

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  7. Your blog has been very informative and I really enjoyed the video you posted this week. Step Therapy policies are so frustrating for providers and patients. I have seen issues with “Fail First” policies in my work and in my clinical experiences. I am in the mental health NP track and it is so exciting to read studies about promising new medications. However, with the insane costs and insurance companies not willing to pay, it seems like getting patients these medications is far from reach. What shocked me in the video you posted was that 1/5 patients may not end up receiving treatment at all! These policies place such a burden on providers and healthcare agencies and sadly, some prior authorizations are not completed. I have seen patients who return for their follow up appointment and have not even started the medication that was prescribed at the last appointment. Gaps in care like this make patients suffer more. The bills you mentioned would make some difference, but place the cost back on tax payers and consumers. The article you cited had some very interesting points. Fischer and Avorn (2017) report that there are “clinical and economic nuances” that may not be addressed with simplistic policies and policies that only address step therapy may just add to the complexity of the healthcare system. They argue that insurers should have evidence-based policies for avoiding unnecessary expenses, while also having transparent policies about the criteria for covering medications (Fischer & Avorn, 2017). It should also be easier for prescribers to obtain permission for overriding step therapy.
    Reference
    Fischer, M., & Avorn, J. (2017). Step therapy—Clinical algorithms, legislation, and optimal prescribing. JAMA, 317(8), 801-802. doi: 10.1001/jama.2016.20619

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  9. Hi Karen,

    This such a concerning subject, I personally have had many friends affected by these protocols. It was very frustrating for them and potentially could have led to an adverse effect on their health. One such friend had stop taking an diabetic medication that was effectively controlling her diabetes. Her insurance company had changed and the new company would not cover her current diabetes medication and she was forced to change to a medication that was not as effective at controlling her diabetes. This resulted in her having uncontrolled diabetes for months before the insurance company would agree to pay for the medication she had originally been on.

    As future nurse practitioner I am sure I will encounter this and will need to jump through hoops to get medications covered for my patients. This concept is difficult for many providers and for their patients, providers want to do what is best for their patients. Shryock (2018) the editor at Medical Economics suggests that physicians and patients work together to encourage legislative change regarding fail first. In addition he suggests physicians work with professional societies and leverage their advocacy resources.

    That is good to hear there are current bills at both federal and state levels addressing some aspects of this problem.

    References

    Shryock, Todd. (2018). DRIVING CHANGE IN MEDICINE. Medical Economics, 95(12), 10-35.

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  10. Thank you for your interesting blog this week, Karen. It was great to catch up on reading your blog! It is interesting that companies have to increase their prices to compensate for those meds that are no longer patented. The private sector plays a huge role in step therapy because they set the prices for the medications. I was not familiar with pharmacy benefit managers (PBM) so I looked into that a bit more. PBMs provide medication coverage for over 200 million people in the US and create formularies for insurance companies that drive down medication costs (Shrank, Porter, Jain, & Choudry, 2009). They increase value in the healthcare system and improve quality of care by offering services like medication delivery services (Shrank et al., 2009). Medication adherence in those with chronic illnesses is a huge problem. PBMs can track whether or not patients are filling their prescriptions and provide education and patient outreach to those who are non-adherent (Shrank et al., 2009). PBMs are used to make sure that patients are receiving cost-effective medications. However, this could be an issue because it may not necessarily be the best medications that the prescriber is recommending. But, in other cases it can help manage patient costs when they identify formulary medications that may be as effective as or more than what the provider prescribed.
    Reference
    Shrank, W. H., Porter, M. E., Jain, S. H., & Choudhry, N. K. (2009). A blueprint for pharmacy benefit managers to increase value. The American journal of managed care, 15(2), 87-93. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2737824/

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  11. Karen, I agree that electronic health records and e-prescribing are helpful for those affected by step therapy. Individuals are able to receive the right medication quickly, and make changes promptly if needed. One area I think there could still be improvement with the use of technology is medications that require prior authorization. There are times when patients meet the requirements to receive a branded or high cost drug by insurance standards, but it still can take days or weeks to receive authorization. A system that can verify the patient meets requirements via simple data entry would be beneficial, so there are not delays. I have seen this while in a neurology clinic. Patients are often given samples in hopes to fill the gap between being prescribed the medication, and when they will be approved to pick it up. There have also been times where patients wait until authorization to start on critical medications, or are prescribed a less appropriate medication in the interim. It will be interesting to see how technology evolves to allow for easier prescribing in the future.

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  12. Hello Karen,

    I agree with you in that technology has a significant role in the healthcare system. It took us a century to go from scribbled notes to the ability to access medical information on hand-held devices and cell phones. Taking this into consideration almost 75% of all communication among healthcare organizations still happen via fax machines (Nguyen et al., 2015). It was interesting to read how the advancements in technology impact your step therapy. Advances in technology and communication and innovation helps patient safety significantly. The Institute of Medicine’s report, Preventing Medication Errors 2007, states that poor communication and exchange of medical information at transition points for patients from one provider to another are responsible for many medical errors and adverse drug events (Eysenbach et al., 2019). Great blog Karen!

    References
    Eysenbach, G., Huang, Y., Bestek, M. Wen, H., Chang, W., Hsu, M., . . . Chu, C. (2019). An
    Assessment of the Interoperability of Electronic Health Record Exchanges Among
    Hospitals and Clinics in Taiwan. JMIR Medical Informatics, 7(1), E12630.
    Nguyen, C., Mcelroy, L., Abecassis, M., Holl, J., & Ladner, D. (2015). The use of technology for
    urgent clinician to clinician communications: A systematic review of the
    literature. International Journal of Medical Informatics, 84(2), 101-110.

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