​Oncology biosimilars: Frequently asked questions

June 16, 2020

These frequently asked questions (FAQs) were developed to answer questions about the upcoming changes to how AmeriHealth HMO, Inc. and AmeriHealth Insurance Company of New Jersey (collectively, AmeriHealth) will manage U.S. Food & Drug Administration (FDA)-approved biosimilars for three specific reference products.

1. What change is AmeriHealth making regarding the prescription of reference products and biosimilars?

AmeriHealth is constantly evaluating its policies and industry trends to identify innovative opportunities to make specialty drugs more affordable without limiting members’ access to life-saving medications. On May 15, 2020, the following FDA-approved biosimilars were designated preferred products over the reference products listed below. Effective July 1, 2020, AmeriHealth will enforce the use of these preferred products for all members who are new to treatment.

Reference products Preferred biosimilar products

Bevacizumab
(marketed as Avastin®)*

  • Mvasi(bevacizumab-awwb)
  • Zirabev® (bevacizumab-bvzr)

Rituximab
(marketed as Rituxan®)

  • Ruxience™ (rituximab-pvvr)
  • Truxima™ (rituximab-abbs)

Trastuzumab
(marketed as Herceptin®)

  • Kanjinti™ (trastuzumab-anns)
  • Trazimera™(trastuzumab-qyyp)

*Bevacizumab will continue to be covered for ophthalmologic indications, without precertification approval, for all branded products (e.g., Avastin, Mvasi, Zirabev).

2. What is the difference between a reference product and a biosimilar?

A biologic drug is sourced from living material. A reference product is the initial biologic drug approved by the FDA with a particular molecular makeup. Avastin, Rituxan, and Herceptin are examples of three unique reference products.

According to the FDA,1 a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indication(s) described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of that product has been established, just as it was for the reference product.

3. Is a biosimilar the same as a generic drug?

No. Although biosimilars and generic drugs are lower-cost versions of existing drugs, biosimilars are not generics. A generic drug is the same as an existing FDA-approved drug in terms of dosage, form, safety, strength, route of administration, quality, and performance. Biosimilars cannot be considered generics because they are made from living material that, by its nature, exhibits variability; generic and brand drugs do not have this variability.

Despite the variability, FDA-approved biosimilars are safe, effective treatment options. The preferred biosimilars have no clinically meaningful differences from Avastin, Rituxan, and Herceptin in terms of safety and effectiveness.

4. Why is AmeriHealth making this change?

We believe everyone should have access to safe, effective drugs when needed. Avastin, Rituxan, and Herceptin are most frequently given in the hospital outpatient facility due to risk of adverse effects during treatment. Due to this, these drugs cannot be managed through our Most Cost-Effective Setting Program, so we pursued alternative cost-containment strategies. Preferring these biosimilars over Avastin, Rituxan, and Herceptin can help improve medical cost effectiveness and member access to specialty drugs, while also spurring competition that lowers costs for everyone.

5. How does this strategy work?

Members currently receiving Avastin, Rituxan, and Herceptin will be approved to finish their regimens to maintain continuity of care.

These drugs have a high rate of new starts. Members who start treatment on or after July 1, 2020, will have no experience with, or brand loyalty to, either the reference products or the biosimilars. For these members, AmeriHealth will prefer the biosimilars over the reference products.

6. Are reference products and biosimilars interchangeable?

No. The FDA defines an interchangeable product1 as a drug that “may be substituted for the reference product without the involvement of the prescriber.” At this time, the FDA does not recognize interchangeability between reference products and biosimilars. Our biosimilar strategy for this class of drugs is based on preferred products, not interchangeability.

FDA-approved biosimilars are safe, effective treatment options. The biosimilars we are preferring with this change have no clinically meaningful differences from Avastin, Rituxan, and Herceptin in terms of safety and effectiveness.

7. If these drugs are being used to treat a condition other than cancer, does this change still apply?

Yes. AmeriHealth will only cover preferred biosimilars for these drugs, in accordance with the coverage criteria in our medical policies. This includes all FDA-approved indications and any off-label requests approved through our precertification process in accordance with our off-label medical policy.

The only exception is that bevacizumab for ophthalmologic indications will be covered, without precertification approval, for all branded products (e.g., Avastin, Mvasi, Zirabev).

8. If a member currently has precertification approval for Avastin, Rituxan, or Herceptin, does he/she need to transition to a preferred biosimilar?

To preserve continuity of care, AmeriHealth will cover treatment for members who currently have precertification approval for Avastin, Rituxan, or Herceptin. These members will not be required to transition to a preferred biosimilar. However, if the provider and member want to switch to a preferred biosimilar, the provider does not need to update the member's existing authorization; it will be matched to pay the claim.  

9. Some reference products have more biosimilars on the market than those designated as preferred. Will AmeriHealth cover requests for these non-preferred biosimilars?

Non-preferred biosimilars to these reference products (e.g., Herzuma®, Ogivri®) will not be eligible for coverage on or after July 1, 2020, unless the member has obtained precertification approval for the drug prior to that date.

10. Do providers need to obtain precertification approval for preferred biosimilars?

Yes. If a reference product requires precertification approval from AmeriHealth, all biosimilars to that reference product also require precertification approval. The only exception is that bevacizumab for ophthalmologic indications will be covered, without precertification approval, for all branded products (e.g., Avastin, Mvasi, Zirabev).

11. If a provider wants to start a member on Avastin, Rituxan, or Herceptin on or after July 1, 2020, will AmeriHealth cover these requests?

Requests for reference products may be eligible for coverage for members who have a documented intolerance or contraindication to the preferred biosimilars.

12. Where can providers find more information about this change?

AmeriHealth will send detailed letters to network providers affected by ​this change in June 2020. In addition, our medical policies have been updated to reflect new coverage criteria for these preferred biosimilars and their respective reference products. The following policies were posted to our Medical Policy Portal as Notifications on February 13, 2020, went into effect May 15, 2020, and will be enforced effective July 1, 2020:

  • #08.00.33o: Trastuzumab (Herceptin®) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta™)
  • #08.00.50u: Rituximab (Rituxan®) Infusion and Related Biosimilars, and Rituximab/Hyaluronidase Human for Subcutaneous Injection (Rituxan Hycela®)
  • #08.00.66n: Bevacizumab (Avastin®) and Related Biosimilars for Oncologic Uses

13. How have providers been notified of the changes to these policies?

On February 13, 2020, these policy changes were announced via:

  • the Medical Policy Portal;
  • Partners in Health UpdateSM, our online newsletter;
  • AmeriHealth NaviNet® web portal (NaviNet Open) Plan Central in a message containing a summary of the changes to the polices and a link to the Medical Policy Portal.

Learn more

Please refer to the Medical Policy Portal to view the most recent version of these policies, as they will supersede the information in this FAQ. If you cannot find the information you are looking for here and have further questions, please email us at oncologybiosimilars@amerihealth.com. Be sure to include your name, contact number, and provider ID number in your email. 

1https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchange able-products

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