This FAQ was revised on December 29, 2021.

These frequently asked questions (FAQs) were developed to answer questions about the upcoming changes to the preferred product status of several oncology and oncology adjunct therapies.

1. What change is Independence making regarding the prescription of preferred products for oncology and oncology adjunct therapies?

In 2020 and 2021, Independence established preferred products for several oncology and oncology adjunct therapies. We are constantly evaluating industry trends to better manage specialty drug spend. Avastin, Herceptin, Neulasta, and Rituxan are highly used biologic reference products that each have multiple biosimilars, with varying costs.

Effective April 1, 2022, Independence will only approve the use of the preferred products listed below, for members who are starting treatment. The changes to the preferred products are indicated as “NEW". 

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

**Rituximab preferred products apply to all oncology and non-oncology indications.

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

A biologic drug is any drug sourced from living material.

A reference product is the initial biologic drug approved by the FDA with a particular molecular makeup.

A biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product.¹ All biosimilars must meet the FDA's rigorous standards for approval for the indication(s) described in the product labeling.

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 therapies. They have no clinically meaningful differences from the reference products.

4. Doesn't Independence already have preferred products established for these drugs?

Independence designated preferred products for these drugs in July 2020 and April 2021. The preferred products for bevacizumab (Mvasi, Zirabev) and trastuzumab (Kanjinti, Trazimera) will remain the same. However, some of the preferred products for pegfilgrastim and rituximab will change.

Pegfilgrastim and rituximab are highly used drugs that have several FDA-approved biosimilars. Independence is taking advantage of the growing availability of biosimilars, as well as the competitive costs between some biosimilars and reference products. This competition lowers costs and expands member access to more affordable therapies.

Our preferred oncology products are biosimilars, but our preferred oncology adjuncts are a combination of biosimilars and a reference product. All preferred products provide high value to our customers.

5. How does this strategy work?

Members currently receiving a nonpreferred product for these four drugs 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 April 1, 2022 will have no experience with, or brand loyalty to, either the reference products or the biosimilars. New coverage requests for bevacizumab, pegfilgrastim, rituximab, and trastuzumab will only be approved for the preferred products, in accordance with our medical policies.

6. Are these reference products and biosimilars interchangeable?

The FDA defines a biosimilar as interchangeable if it may be substituted for the reference product without the involvement of the prescriber¹.

Although biosimilars and reference products have no clinically meaningful differences in terms of safety and effectiveness, the FDA does not recognize these four reference products and their associated biosimilars as interchangeable.

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

Yes. Independence will cover these preferred products 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 has precertification approval for a nonpreferred product, does he/she need to transition to a preferred product?

To preserve continuity of care, Independence will continue to cover members who currently have precertification approval for a nonpreferred product. These members will not be required to transition to a preferred product. However, if the provider and member want to switch to a preferred product, they may do so.   

9. Some reference products have more biosimilars on the market than those designated as preferred. Are those biosimilars eligible for coverage?

Nonpreferred biosimilars will only be eligible for coverage on or after April 1, 2022 for the following:

• Members who have precertification approval for the drug prior to that date
• Members who have a documented intolerance or contraindication to the preferred products

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

Yes. Requests for all preferred and nonpreferred products must receive precertification approval from Independence. 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. Where can providers find more information about this change?

Independence medical policies for pegfilgrastim and rituximab were updated to reflect new coverage criteria for preferred products. Those policies will be posted as Notifications on December 31, 2021 and will go into effect April 1, 2022.

This is a complete list of medical policies for preferred oncology and oncology adjunct therapies:

Commercial

• #08.00.33p: Trastuzumab (Herceptin^®) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta^™)
• #08.00.50z: Rituximab (Rituxan^®) Infusion and Related Biosimilars, and Rituximab/Hyaluronidase Human for Subcutaneous Injection (Rituxan Hycela^®)
• #08.00.66p: Bevacizumab (Avastin^®) and Related Biosimilars for Oncologic Use
• #08.01.32h: Pegfilgrastim (Neulasta^®) and Related Biosimilars

Medicare Advantage

• #MA08.018f: Trastuzumab (Herceptin^®) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk
  (Herceptin Hylecta^™)
• #MA08.022n: Rituximab (Rituxan^®) Infusion and Related Biosimilars, and Rituximab/Hyaluronidase Human for Subcutaneous Injection (Rituxan Hycela^®)
• #MA08.072h: Bevacizumab (Avastin^®) and Related Biosimilars for Oncologic Use
• ​#MA08.082h: Pegfilgrastim (Neulasta^®) and Related Biosimilars
  
  

12. How have providers been notified of these changes?

On January 1, 2022, these changes were announced via:

• the Medical and Claim Payment Policy Portal;
• the Provider News Center, our online news center;
• a PEAR portal notification announcing the changes and a link to the Medical and Claim Payment Policy Portal.

Learn more

Please refer to the Medical and Claim Payment Policy Portal to view the most recent version of these policies, as they will supersede the information in this FAQ.

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