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
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.
(marketed as Avastin®)*
- Mvasi™ (bevacizumab-awwb)
- Zirabev® (bevacizumab-bvzr)
(marketed as Rituxan®)
- Ruxience™ (rituximab-pvvr)
- Truxima™ (rituximab-abbs)
(marketed as Herceptin®)
- Kanjinti™ (trastuzumab-anns)
*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
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
3. Is a biosimilar the same as a generic
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
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
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
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
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
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
Requests for reference products may be eligible for coverage for members who
have a documented intolerance or contraindication to the preferred
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
- #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
- 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.
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 email@example.com. Be sure to include
your name, contact number, and provider ID number in your email.
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