Biosimilars

Drug - Biosimilars

May 2020

Preferred	Nonpreferred
Neupogen	Zarxio, Nivestym
Inflectra*, Renflexis*	Remicade*
Fulphila, Udenyca, Ziextenzo	Neulasta
Avastin	Mvasi, Zirabev
Herceptin	Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti
Rituxan	Truxima, Ruxience

* ADDITIONAL CRITERIA APPLIES. Refer to PA criteria sheet for Immunomodulators

Authorization for a non-preferred biologic product or biosimilar will be granted if the recipient has had any one of the listed issues with the preferred agent. Chart notes documenting the issue must be provided at time of request:

• Allergic reaction to a specific inactive ingredient in the preferred biologic product or biosimilar OR
• Adverse reaction to a specific inactive ingredient in the preferred biologic product or biosimilar OR
• Therapeutic success while taking a non-preferred biologic product or biosimilar and therapeutic failure while taking the preferred biologic product or biosimilar documented by patient diary or medical charted notes OR
• The patient has a diagnosis not included in the FDA-approved indications of the preferred product, but is included in the FDA-approved indications of the non-preferred product
• If multiple non-preferred agents exist for a given referenced biologic product, tiers may be applied to the non-preferred agents
• Factors such as patient or prescriber preference or healthcare facility’s or pharmacy’s inability or unwillingness to order or stock the preferred product(s) will not be considered
• Continuation of therapy overrides are not available to bypass required trial(s) of preferred biosimilar or biologic reference product

Prescribers must:

• List the specific drug being requested, including:
  • dosage form
  • strength
  • use directions
• Document when the preferred biologic product or biosimilar was tried and the length of the trial period
• Provide specific clinical documentation of therapeutic failure on the preferred biologic product or biosimilar whenever possible
• Describe the medical problem caused by the preferred referenced biologic. Vague and non-descriptive symptoms are not adequate rationale (e.g., stomach ache)

Billing

• Biologic or biosimilar products administered by qualified health care providers in an outpatient setting must be billed as medical claims
• Biologic or biosimilar products administered in an inpatient setting are not eligible for outpatient reimbursement

Background

Biosimilars were created under the Biologicals Price Competition and Innovation Act (BCPI) of 2009 and signed into law through The Patient Protection and Affordable Care Act (Affordable Care Act) on March 23, 2010. The BCPI Act created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed (approved) biological product.

Under this law, a biological product may be demonstrated to be biosimilar if data show that, among other things, the product is highly similar to an already-approved biological product, also called the reference product, and has no clinically meaningful differences in terms of safety, purity, and potency from the reference product. Therefore, the biosimilar approval relies on the FDA’s previous findings that the FDA-approved reference product is safe and effective.

The MN Drug Formulary Committee (DFC) discussed biosimilars at its public meeting on 8/23/2017 and recommended to the MN Department of Human Services (DHS) by a unanimous vote to adopt the prior authorization (PA) policy above for biosimilars. The DFC also recommended to DHS by a unanimous vote to prefer a biosimilar or biologic product that is the least expensive appropriate alternative and represents an effective and appropriate use of program funds.

Reference: wwww.fda.gov, Information for Consumers (Biosimilars), accessed August 10, 2017

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411