CVS Caremark has reordered its list of preferred therapeutics, adjusting the emphasis on biosimilars, and demonstrating that preferential status can change at any time.
Whether payers put biosimilars on formulary, vs originator products, depends in large part on the respective deals they strike with manufacturers over payment. In some cases, biosimilars may be the better deal; in others, originator products.
A look at CVS Caremark’s formulary changes for July 2021 helps to illustrate the shifting sands of payer preferences.
A few changes reflect better value obtainable from biosimilars. For treatment of certain cancers, the bevacizumab originator Avastin is now non grata and has been replaced on the CVS formulary by the biosimilar Zirabev.
Similarly, the originator trastuzumab Herceptin has been replaced by the biosimilars Kanjinti and Trazimera.
The formulary also reflects that sometimes one biosimilar will outdo another as far as pricing.
The revised CVS list of options allows the rituximab biosimilar Ruxience in place of Riabni and Truxima, both of which were formerly biosimilar rituximab options and have been removed. The originator rituximab is Rituxan.
Lantus Gets Dropped
The originator insulin glargine Lantus was previously the CVS preferred drug in its class for long-acting diabetes medication; however, this has been replaced by Basaglar and Levemir (insulin detemir).
Basaglar is not officially a biosimilar, as it was not approved under the Public Health Service Act, which encompasses the formal biosimilar pathway legislation. But Basaglar is a “follow-on,” which is a class of copy biologics that may meet the requirements for biosimilarity but have not been approved as such.
Interestingly, Semglee, which the FDA approved this summer as a biosimilar to and interchangeable to Lantus, is not on the CVS formulary list, either as a replacement or former preferred product.
Semglee was originally approved under the nonbiosimilar 505(b)(2) regulatory pathway, in June 2020. Its makers applied for interchangeable status, which they received in July 2021, as this offered the product improved positioning for market acceptance.
Further, Lantus has been dropped from the CVS formulary before and has found its way back on, demonstrating that there’s always room for renegotiation between payers, pharmacy benefit managers (PBMs), and manufacturers.
Multiple Pegfilgrastims Are Dropped
In its updated formulary, CVS has replaced a number of granulocyte-colony stimulating factors, for the control of neutropenia in patients undergoing chemotherapy, with a single biosimilar: Ziextenzo (pegfilgrastim).
The products that got removed from formulary? They were a mixture of originator products and biosimilars. They included Amgen’s originators Neulasta and the Neulasta wearable injection device, Onpro, along with the biosimilars Fulphila and Udenyca.
Udenyca is the flagship biosimilar product for Coherus BioSciences and held a 19% share of the pegfilgrastim market during the second quarter of 2021, down 1 percentage point from the previous quarter. However, revenues for Udenyca were up 6% to $88 million, which goes to show that market share, sales volume, and pricing do not always move in tandem.
The formulary revisions demonstrate that CVS doesn’t dismiss originator products “with prejudice,” meaning permanently, nor does it follow any consistent pattern with biosimilars, although a look at the inner workings of the contracting process and the bottom line attached to each product might be revealing. Unfortunately, that’s proprietary information.
“CVS Health’s PBM relies on a range of strategies to drive towards the lowest net prescription drug cost for our clients and members, including generating more competition through biosimilars,” said Phillip J. Blando, spokesman for CVS, in response to an inquiry from The Center for Biosimilars®. “These strategies helped us keep the rate of growth in prescription drug costs for our clients to less than 3% in 2020.”
In the United States, there are now 30 approved biosimilars, of which 21 are on the market, and this increasing number allows companies such as CVS to play biosimilars off originator products in the effort to squeeze concessions from manufacturers and achieve the lowest-cost deal. Further, there are cost differences between biosimilars that may influence the PBM’s choice of one biosimilar vs another.
The Center for Biosimilars® publishes a regularly updated list of biosimilar approvals in the United States and European Union.