Implementing changes in a health system to promote biosimilar adoption is not easy, but by implementing a program, there could be substantial savings.
With a larger number of biosimilars on the US market, there have been clear cost savings for not only payers, but also for patients. However, implementing changes to encourage the use of biosimilars over the originator products that providers are familiar with has not necessarily been smooth, according to Chelsee Jensen, PharmD, pharmaceutical formulary manager, Mayo Clinic.
Speaking during a session about oncology biosimilars at the Academy of Managed Care Pharmacy annual meeting, Jensen provided a biosimilar strategy from a health system perspective. It has been documented that there are some barriers to uptake due to provider hesitation over prescribing biosimilars, but that’s not the only hurdle biosimilars need to overcome. There are also implementation issues with formulary management and workflows and electronic health records (EHRs), as well as financial and policy issues, such as pricing and rebates and payer demands for specific products, Jensen explained.
A health system’s process for biosimilar adoption needs to include 3 main components:
Mayo Clinic operates across 4 states, and all allow for therapeutic substitution, so it was the path the system chose to promote biosimilar adoption. Therapeutic substation is a process that health systems and managed care organizations have adopted to accommodate the lack of interchangeable biosimilars. So far there are no interchangeable oncology biosimilars approved.
Through the therapeutic substitution process, the pharmacy and therapeutic committee makes decisions on which products are therapeutically equivalent and expected to yield similar effects to the reference product. This decision gives pharmacists permission to substitute the drug based on a predefined protocol.
Jensen explained that the biosimilar adoption strategy was also financially favorable because Medicare reimburses biosimilars at average sales price (ASP) of the reference product plus 6%. ASP for the reference oncology products was decreasing because they were losing market share to the biosimilar products.
However, she acknowledged that there is still an incentive to use the higher cost product when reimbursement is based on a percentage of billed charges.
“We need to do the right thing here, and we need to promote price transparency,” Jensen said. “And we need to think about the patients and the fact that financial toxicity is a real thing.”
From the health system perspective, a biosimilar strategy is not as easy as picking a preferred biosimilar because payers are selecting their own preferred products and they might be different than what the health system picks. In addition, providers don’t always know their patient’s insurance and it will be unrealistic to ask them to track on top of that the preferred biosimilar for each payer.
There are also logistical concerns. In the oncology space, there are 18 oncology biosimilars approved for 6 originator products—bevacizumab, epoetin alfa, filgrastim, pegfilgrastim, rituximab, and trastuzumab. While there is only 1 approved biosimilar for epoetin alfa, there are 6 approved for trastuzumab. Pharmacies are concerned there could be safety issues if multiple biosimilar options for each product are carried as well as space restraints to stock everything. Additionally, if the patient is treated with the wrong product, they could get a surprise bill if they receive a biosimilar that is not the payer’s preferred product.
The Mayo Clinic’s implementation process started with all biosimilars being declared therapeutically equivalent to the originator product and a preferred product selected based on contracting. All biosimilars were added to the formulary to facilitate payer demands.
Then, the preferred product was built into the EHR as the default product and advanced order groupings were used to make it easy to change to the biosimilar product.
Finally, as part of the workflow, prior authorization was communicated to the pharmacy, and the pharmacy would change to the covered product using therapeutic substitution. In addition, the pharmacies were instructed to cover a good amount of stock of the preferred biosimilar, decent stock of the reference, and a smaller stock of the non-preferred biosimilars.
“We really had to be agile and truly track this closely,” Jensen explained. Mayo Clinic tracked the program at 3-month intervais, tracking the spend on the preferred biosimilar, non-preferred biosimilars, and reference product to see the trends. The system wanted to be able to see if it was moving away from the reference products to the preferred biosimilars and if there were any issues with people still ordering reference products.
In the 6 months after setting up the program for the hematology/oncology space, Mayo Clinic found that 82.8% of new starts were on biosimilars and 79.6% were on the formulary-preferred biosimilar. Trastuzumab had the highest compliance of all biosimilar doses at 95.7%, but rituximab had the highest compliance for the formulary-preferred biosimilar at 94.8%. Epoetin alfa, which only has 1 approved biosimilar, had the lowest compliance at 54.4%.
Reviewing the market share from June 1, 2021, to August 30, 2021, compared with baseline (September 1, 2019, to August 31, 2020), Mayo Clinic saw significant market share increases for biosimilars:
The 12-month savings of the program were also significant, Jensen said. Preimplementation, Mayo Clinic spent $93 million vs $72 million postimplementation. The savings of $23.1 million represented 24.3% reduction in pharmaceutical spend.
“So, we're very excited about those results within our health system,” Jense said.
For more on the discussion from this session, please see additional coverage on The Center for Biosimilars® website.