The Issue
Under a practice known as nonmedical switching, pharmacy benefit managers (PBMs) can force patients to change from a medication they rely on to a less costly and possibly less effective drug for financial reasons, not medical ones. PBMs accomplish this by dropping the medication from the formulary or increasing the drug’s cost-sharing requirements – typically after the plan year has begun – and then notifying patients they may need to switch to a less expensive treatment in order to avoid a large increase in out-of-pocket costs.
Besides health plans and PBMs, no one benefits from unnecessary medical switches. Rather, the practice exposes patients to less effective therapies, potentially causing adverse side effects, severe allergic reactions, a worsening of symptoms and disease progression. And if that is not bad enough, studies show nonmedical switching actually increases health costs for the nation through more administrative time for doctors and the avoidable lab tests, physician care, emergency room visits and hospitalizations resulting from poorer disease outcomes.
Why Policy Change Is Necessary
More and more, health plans – and not health professionals – are making critical decisions about the medications patients take and insurance practices like nonmedical switching are a major reason why.
Targeting those with complex, chronic and rare medical conditions, nonmedical switching is most harmful to patients who are stable on a specific therapy and lose the ability to keep their disease under control with a less costly alternative. According to studies, patients with Crohn’s disease, diabetes, epilepsy, high cholesterol, hypertension, mental health conditions, pain, psoriasis and rheumatoid arthritis (RA) are especially vulnerable.
Research also documents the negative health consequences associated with nonmedical switching and the impact in poorer health outcomes. Specifically:
- Individuals who have been stable on a medication who are forced to change drugs often experience negative side effects on the new therapy. For example, a survey by the Global Healthy Living Foundation found over three-quarters (77 percent) of chronic disease patients who experienced a formulary change mid-treatment reported side effects from switching to a different treatment.
- Patients subject to nonmedical switching often face relapsing symptoms and disease progression. One study of rheumatoid arthritis (RA) patients found those forcibly switched to a different medication experienced 42 percent more ER visits and 12 percent more outpatient visits within the first 6 months.[1] Another study involving people with epilepsy showed switching caused breakthrough seizures[2] requiring more inpatient and emergency room care.[3]
- Nonmedical switching can limit future treatment options. This is because the practice causes some patients to become less responsive to treatment, even if they are returned to the original medication. [4]
- Nonmedical switching actually increases health care costs. As a case in point, a study showed patients with RA, psoriasis, psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease who were forced to switch treatments for a formulary change incurred 37 percent higher medical costs (including ER visits, hospitalizations, and physician care) and 26 percent higher overall costs than patients continuing on a successful medication.[5]
Not surprisingly, a 2016 survey by the Alliance for the Adoption of Innovations in Medicine (Aimed Alliance) shows 92 percent of patients are strongly opposed to insurance companies employing nonmedical switching policies.[6] The same is true of health professional societies, disease organizations and patient advocacy organizations who have documented the consequences in symptom recurrence, new side effects, and even relapse. Accordingly, there is widespread consensus that new policies are needed to ensure patients stable on their drug regimen can remain on their prescribed treatment and that health plans should not be allowed to stop covering medications that patients are taking after the plan year is underway. Also of importance is mandating a standardized appeals process to protect patients from undue harm.
Our Position
Patients Rising NOW supports enacting legislation to protect patients who are stable on a drug regimen from forced switching for financial reasons and advocates for policy changes based on
these core principles:
- Insurers must be fully transparent about what medications are covered so patients can effectively compare plans and choose the right one for them.
- Health plans should be prevented from making restrictive changes to their formularies
after the plan year has begun or has been renewed. - Nonmedical switching harms patients and should only be allowed when there is the full knowledge and agreement of the clinician and patient
- Patients who are medically stable on a course of treatment should remain on the regimen prescribed by their physician unless there is a medical reason to change their treatment.
Translating these principles into public policy, Patients Rising Now is moving forward as follows:
At the state level, we are working in coalitions with other advocacy organizations to enact laws that will protect patients from nonmedical switching abuses. To date, nine states have introduced legislation in their 2017-2018 legislative sessions to address nonmedical switching: Connecticut, Iowa, Illinois, Maine, New York, Pennsylvania, Tennessee, Utah, and Washington.[7] Additionally, advocacy coalitions are working to introduce bills in a number of states, including Florida and New Jersey.[8]
We also support passage in remaining states of legislation based on the Preserving Patient Stability Act, a model bill from the Alliance for the Adoption of Innovations in Medicine (Aimed Alliance).[9] Among its provisions, the model law prohibits insurers from excluding coverage of a drug when the prescribing provider deems the patient medically stable on the treatment. The model law also requires “a clear, readily accessible, and convenient process” so patients and physicians can request a Coverage Exemption Determination and mandates a response from the insurer within 72 hours.
[1] Signorovitch J, Bao Y, Samuelson T, et al. Switching from adalimumab to other disease-modifying antirheumatic drugs in rheumatoid arthritis without apparent medical reasons: Impact on health care service use. Ann Rheum Dis. 2012:17
( Suppl 3):717
[2] Epilepsy Foundation. 2009. In Their Own Words: Epilepsy Patients’ Experiences Changing the Formulation of the Drugs They Use to Prevent Seizures. Accessible at: https://www.epilepsy.com/sites/core/files/atoms/files/In-Their-Own-Words.pdf
[3] Zachary III WM, Doan QD, Clewell JD, et al. Case-control analysis of ambulance, emergency room or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia 2009 Mar;50(3):493-500
[4] Global Alliance for Patient Access. Non-Medical Switching: Fast Facts. January 2017. Accessible at: http://gafpa.org/wp-content/uploads/GAfPA_Fast-Facts_Non-Medical-Switching_January-2017-1.pdf
[5] Chao J, Lin J, Liu Y, et al. Impact of nonmedical switching on healthcare costs: a claims database analysis. Value in Health 2015;18 (Issue 3); pp A252
[6] Aimed Alliance Poll; Principles for U.S. Health Care. December 15, 2016. Accessible at: http://www.aimedalliance.org/wp-content/uploads/2016/12/Aimed-Alliance-Principles-for-U.S.-Health-Care-Poll.pdf
[7] Aimed Alliance state map. Accessible at: http://www.aimedalliance.org/nonmedical-switching
[8] US Pain Foundation. Non-Medical Switching Bills Announce in Three More States. February 27, 2017. Accessible at: https://uspainfoundation.org/news/non-medical-switching-bills-announced-three-states
[9] Aimed Alliance Non-Medical Switching Legislation. January 2017. Accessible at: http://www.keepmyrx.org/wp-content/uploads/2017/01/Aimed-Alliance-Model-Nonmedical-Switching-Legislation-170103-FINAL.pdf