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Weighing Cost Effectiveness for Biomarker Utilization in Immunotherapy
Lisa Davis, PharmD, FCCP, BCPS, BCOP, professor of Pharmacy Practice and Science at the University of Arizona College of Pharmacy, and Matthew Farber, MA, senior director of Patient Care and Advocacy: Oncology, Fertility, & Multiple Sclerosis at Walgreens Company recently spoke during a session at the Asembia 2019 Specialty Pharmacy Summit. Together they discussed potential biomarkers that are being examined to predict response to immunotherapy, analyzed the costs of utilizing these biomarkers, and described data that should be considered when completing the formulary review process.
Dr Davis highlighted the biomarkers for immunotherapy at the top of the sessions. According to Dr Davis the following are biomarkers for immunotherapy:
- Tumor immunogenicity
- TMB
- dMMR
- Microsatellite instability (MSI)
- Inflamed tumor microenvironment
- PD-L1
In addition, Dr Davis highlighted the biomarkers for FDA-approved indications. She said included malignancy type, biomarker, and approved drug. She highlighted the following:
- Cervical cancer
- PD-L1 CPS >1
- Pembrolizumab
- CRC
- MSI-H or dMMR tumors
- Nivolumab
- Nivolumab + ipilimumab
- Pembrolizumab
- Gastric cancer
- PD-L1 CPS >1
- Pembrolizumab
- NSCLC
- High PD-L1 expression (TPS) >50% (First Line)
- PD-L1 expression (TPS) >1%
- Pembrolizumab
- Triple-negative breast cancer
- PD-L1 expression >1%
- Atezolizumab + paclitaxel protein bound
- Urothelial carcinoma
- PD-L1 expression >5%
- PD-L1 CPS >10
- Atezolizumab
- Pembrolizumab
- MSI-H cancer
- MSI-H or dMMR tumors
- Pembrolizumab
Mr Farber then joined the biomarker conversation. He analyzed and discussed the costs associated with these therapy options. He highlighted treatment decisions based on mutation results, costs associated with mutation tests and treatment, the prior authorization process, and patient assistance.
According to Mr Farber, oftentimes payers support biomarker testing in oncology. He explained that these tests “can lead to the right treatment for the right patient at the right time.” Meaning, payers will be paying for the drugs a patient is likely to respond to rather than paying for a treatment that may have little therapeutic effect.
Mr Farber highlighted the findings of a 2011 survey of commercial and government managed care helath plans. According to the survey findings, many respondents were reluctant to reimburse biomarker tests without evidence of clinical utility. He said that respondents of the survey felt that the results of the tests may prove ineffective in improving patient outcomes and would be financially wasteful. Finally, he said that 62% or payers felt that in order for oncology diagnostic tests to gain acceptance, they must be accompanied by a demonstration of cost-effectiveness.
Following his discussion of the 2011 survey, Mr Farber discussed the 14 Day Rule that was developed by CMS in 2018. Before the rule, Mr Farber explained that CMS did not “allow reference and independent laboratories to bill Medicare directly for molecular pathology tests If they were ordered less than 14 days from an outpatient’s hospital discharge.”
Following the implementation of the 14 Day Rule, Mr Farber said that the rule, “modified date-of-service policy for hospital outpatients who undergo molecular biomarker tier 1 and tier 2 tests and advanced diagnostic laboratory tests.”
Mr Farber said that it is important to understand that biomarker testing may not be one and done. Patients may require multiple tests, but he noted that payers don’t always cover additional tests. He said that it is important for patients to understand the prior authorization process because payers are still requiring documentation for approvals.
Finally, Mr Farber highlighted 3 patient assistance platforms:
- Patient Advocate Foundation;
- Foundation Medicine; and,
- Myriad.
He said that many test makers are offering financial assistance, including traditional financial assistance organizations.
—Julie Gould
