Why Managed Care's Fail First Requirements are a "Step" in the Wrong Direction

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Rationing healthcare is never a good thing for patients, especially for patients living with chronic health conditions such as HIV/AIDS. It is especially true for prescription medications. Unfortunately, an increasingly common technique involves private and public healthcare payers requiring step therapy...or step protocol...or fail first requirements, whereby inexpensive drugs (and therapies) must be prescribed rather than more expensive drugs (or therapies). Sadly, such requirements not only undermine the provider-patient relationship, they also have proven to be less cost-effective in the long run.

A recent study among patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) demonstrated that plan-level access restrictions on novel disease-modifying antirheumatic drugs (DMARDs) negatively impacted medication adherence and treatment effectiveness. Step therapy resulted in poorer outcomes evidenced by 19% lower odds of treatment effectiveness and 19% lower odds of medication adherence for RA patients, compared to their counterparts without similar access restrictions.[1]

In a recent opinion piece published in The Hill, David R. Karp and Ann M. Palmer best summarized why step therapy is bad medicine: "Step therapy delays timely access to clinically appropriate treatment and endangers the health and well-being of patients whose conditions can deteriorate beyond repair if they are not able to receive prompt care. It's incredibly frustrating and frightening for Americans whose lives and bodies depend on very specific treatments. And it's no less infuriating for health care providers who find their care and clinical decision-making undermined by insurance companies with no first-hand knowledge of their patients' individual circumstances."[2]

Photo Source: Patients Rising

Though a bit dated, Patients Rising published an excellent analysis on the dangers of step therapy. From their perspective, step therapy hurts patients by restricting access to the right treatment.[3]

Coupled with other dangerous, anti-patient insurance policies — such as co-pay accumulators — step therapy becomes even more problematic. Co-pay accumulators amount to nothing more than the greedy health insurance industry (and other payers) making prescription drug coverage less affordable for patients, especially for those living with chronic health conditions such as HIV/AIDS.

W. David Hardy, M.D., chair of the HIV Medicine Association and an adjunct professor of medicine in the division of infectious diseases at Johns Hopkins University School of Medicine, summarized why HIV care is threatened by fail first requirements: "Step therapy is never an appropriate practice or approach for treating HIV because the use of an ineffective or toxic drug can lead to viral resistance or nonadherence. It can also render other drugs in a patient’s treatment regimen ineffective."[4]

Photo Source: STAT

In Congress, some legislators are trying to put treatment decisions back in the hands of patients and doctors. Senator Murkowski (R-AK), Senator Hassan (D-NH), Senator Cassidy (R-LA), Senator Rosen (D-NV), Representative Ruiz (D-CA-36), Representative Wenstrup (R-OH-2), Representative McBath (D-GA-6), and Representative Miller-Meeks (R-IA-2) have introduced the Safe Step Act of 2021 (S. 464/H.R. 2163). The legislation would improve step therapy protocols and ensure patients are able to safely and efficiently access the best treatment for them.[5]

Innovative treatments can help slow disease progressions for those living with HIV/AIDS, and millions of patients living with numerous other chronic diseases. That is why it is so important to have access to incredible scientific innovations so that patients can live full, productive and active lives. But the step therapy insurance practice is a barrier to that access. Patients and their doctors shouldn't have to jump through hoops to get the medicine they know will work best.

[1] Boytsov, N., Zhang, X., Evans, K.A. et al. Impact of Plan-Level Access Restrictions on Effectiveness of Biologics Among Patients with Rheumatoid or Psoriatic Arthritis. PharmacoEconomics Open 4, 105–117 (2020). Retrieved online at https://doi.org/10.1007/s41669-019-0152-1.

[2] Karp, D., Palmer M. Step therapy hurts America's sickest patients — reasonable parameters are needed now. The Hill (2021, May 25). Retrieved online at https://www.msn.com/en-ca/news/newspolitics/step-therapy-hurts-americas-sickest-patients-—-reasonable-parameters-are-needed-now/ar-AAKnuFg.

[3] Wilcox, J. STEP THERAPY: EVERYTHING YOU NEED TO KNOW ABOUT “FAIL FIRST” INSURANCE POLICY. Patients Rising (2016, August 23). Retrieved online at https://www.patientsrising.org/step-therapy-explained/#:~:text=Patients%20Rising%20Perspective%3A%20Step%20therapy%20tramples%20patients%20From,medications%2C%20especially%20treatments%20for%20cancer%2C%20aren’t%20easily%20interchangeable..

[4] Hardy, W. D. HIV care is threatened by proposed changes to Medicare Part D. STAT (2019, January 24). Retrieved online at https://www.statnews.com/2019/01/24/medicare-changes-threaten-optimal-hiv-care/#:~:text=Step%20therapy%20is%20never%20an%20appropriate%20practice%20or,other%20drugs%20in%20a%20patient’s%20treatment%20regimen%20ineffective.

[5] S.464 - Safe Step Act. 117th Congress (2021-2022). Retrieved online at https://www.congress.gov/bill/117th-congress/senate-bill/464/text.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.