There is no doubt that the cost of health insurance and patient deductibles are rising rapidly and to a degree that far surpasses the rate of inflation. One potential explanation for the increase in health insurance costs in the United States is the increased cost of prescription drugs. Biologic agents made up more than 50% of all prescription spending in the United States in 2020 and are the largest driver of healthcare expenditures for patients with inflammatory bowel disease. An increased use of biosimilars presents an opportunity to significantly reduce healthcare costs and improve patient access to biologic therapies because they are significantly less expensive than the originator. Despite this known potential cost savings, biosimilars are being underutilized in practice today.
We recommend a proactive approach to utilizing biosimilars in your practice for all anti-TNF treatment naive patients because of the cost savings. We recommend all healthcare providers should proactively prepare all patients on an originator biologic of potentially needing to switch to a biosimilar due to a change in one’s insurance formulary.
There is a need to increase biosimilar market share to create competition and decreasing overall treatment costs, while maintaining a high level of patient care. This can be accomplished nationally and at individual centers by:
Biosimilar Education
It is imperative that healthcare providers are educated and up-to-date on the evidence related to biosimilars. Due to the cost savings associated with biosimilar use, many insurance companies are adding biosimilars as a preferred agent on formulary. Insurance companies are requesting that patients switch to the biosimilar. Thus, it is important that all healthcare providers educate their patients on biosimilars to reduce the nocebo effect [Internal Link]. As healthcare providers, we have a duty to limit costs to our patients and the system without negatively impacting health outcomes. Proper education, including use of the resources below, will limit the nocebo effect.
Information Sheets on biosimilars for patients and healthcare providers
- Patient Biosimilar Education Sheet [Internal Link]
- Provider Biosimilar Education Sheet [Internal Link]
Additional Resources
- FDA Biosimilar video series [External Link]
- Pfizer website: Let’s Take a Closer Look at the Characteristics of Biosimilars [External Link]
- Crohn’s and Colitis Foundation: Biosimilars: What You Should Know [External Link]
Setup a Standardized Prior Authorization Process for all Biologics
It will be helpful to have a standardized prior authorization process for biologics at your hospital or practice. This process may vary depending on if the patient is being treated inpatient or outpatient. Regardless of treatment location, it will be helpful to remain up-to-date with the preferred biologics on local insurance formularies. We recommend partnering with your practice’s insurance specialist or drug manufacturer representatives to remain informed in real-time of formulary changes that are occurring.
Be Proactive in all New Outpatient Starts
The decision tree below shows the process of starting the prior authorization (PA) process for all outpatient starts.
Inpatient New Starts
When a patient is admitted into the hospital and a provider is starting them on a biologic medication, typically a PA is not needed prior to initiation of that therapy. However, once the patient is discharged, then a PA will be needed. In an effort to prevent unnecessary switching and delays in the outpatient PA process, it is very important to start a patient on the insurance preferred biologic (originator vs biosimilar) during their hospitalization. This will prevent patients from needing to switch early on.
The diagram below shows one potential process for biologic initiation in the inpatient setting. If you start a patient on Infliximab or Adalimumab inpatient, determine the preferred medication (originator vs biosimilar) prior to administering. Once discharged, obtain the PA.
Approach for All Switches
Often times the first occurrence of patients hearing about biosimilars is when they are notified from their insurance company. This often comes in the form of a letter informing them that they will no longer be able to continue on their current therapy and instead must switch to a biosimilar. Unfortunately, these communication methods often lack adequate information to properly inform patients about the safety and efficacy of biosimilars. Failure to have thorough information communicated may increase a patient’s risk of the nocebo effect.
To better support patients, we recommend a proactive approach to switching to a biosimilar.
- Proactively educate all patients on biologics about biosimilars in an effort to prepare them for any potential future switches. This can be done during clinic visits or a mass electronic communication to your patients on biologic medications. This will help to negate any negative associations with biosimilar use. One great resource to use is the Patient Biosimilars Education Sheet [Internal Link].
- If patients receive an insurance mandate to switch, review the safety and efficacy of switching to the biosimilar.
- Identify other patients that may need to switch. Proactively reach out and review the safety and efficacy of switching to the biosimilar.
If your patient is asked to switch to a biosimilar from the insurance company, it is recommended to follow these five steps:
- Notify the patient of the switch and provide proper education using the patient biosimilar education sheet
- Submit for prior authorization for the requested therapy
- Enroll your patient in copay assistance (if applicable) to ensure there is no change in their out of pocket costs
- Educate your patient on any difference in the delivery device (if applicable)
- Follow up with your patient after the switch to reassure them that you are continuing to monitor their response to the new therapy