On July 1, 2021, a new Anthem policy on drug dose reduction for dozens of oncology treatments became effective in 14 states (CA, CO, CT, GA, IN, KY, ME, MO, NV, NH, NY, OH, VA, and WI). Physicians and patients across the country are questioning whether this has become a prime example of a private payer coverage policy that is driven more by fiscal concerns than evidence-based medicine, interfering with patient access to standard-of-care treatments.
Anthem introduced a new dose reduction policy to physicians in those 14 states via an April 2021 Physician Medicare communications document, as part of their commitment to “identifying ways to achieve better health outcomes, lower costs, and deliver access to better healthcare experiences for consumers.” The communication states the following1:
Effective for dates of service on or after July 1, 2021, providers for our Medicare Advantage plan members covered by Anthem will be asked in selective circumstances to voluntarily reduce the requested dose to the nearest whole vial for over 40 oncology medications [which were listed]….Providers will be asked whether or not they will accept the dose reduction at the initial review point in the prior authorization process.…If the patient is considered unable to have his or her dose reduced, then a second question will appear asking for the provider’s clinical reasoning….The dose reduction questions will appear only if the originally requested dose is within 10% of the nearest whole vial. This threshold is [according to Anthem] based on current medical literature and recommendations from the Hematology and Oncology Pharmacists Association (HOPA) that it is appropriate to consider dose rounding within 10%.
As justification for this policy, Anthem is referencing a position statement from HOPA published in March 2018.2 This paper was an exploration of a general belief that dose changes ≤10% were not expected to reduce the safety or efficacy of therapy. The authors discussed rounding treatments both up and down by up to 10%, and suggested that each institution use collaborative stakeholder consensus to create institutional guidelines for dose rounding.
This paper did not create a formal policy change across the industry. It did not lead to changes in the “approved dosage indicated” in official FDA package inserts for these 40-plus drugs, nor did it result in modifications to dosage and medication usage listed in the National Comprehensive Cancer Network Clinical Guidelines. Yet, Anthem has based a new policy on this position statement—only for doses being reduced, not rounded up.
Are Payers Encroaching on Physician Decision-Making?
The authors of the HOPA paper suggested the following:
“Institutional guidelines for dose rounding on anticancer agents, including criteria for automatic dose rounding, the allowable percentage, and institutional processes for operationalizing and documenting dose rounding, should be determined by collaborative stakeholder consensus. Exceptions to dose rounding should be determined a priori. Additional studies that evaluate the impact of dose rounding on patient outcomes are warranted.”2
They were not endorsing a universal dose reduction across the board for 40 specific drugs by a single payer for a single type of insured patient.
Why would Anthem implement a “voluntary” policy based on a single paper published 3 years ago? Is a policy voluntary if the physicians who decline to implement the suggested dose reductions are then required to explain their reasoning before a prior authorization can be completed? Why does this policy target over 40 drugs where a reduction is not driven by clinical or medical indications, and only for 1 insurance class of patients? The push to dose reduce is driven by the payer to get the dosed medication down to what can be obtained from complete, not partial, vials, purely for cost-savings. If the approved treatment at the standard dose would involve a combination of vials, this policy seeks to force savings by basically eliminating the part of a standard dose that would come from a partial vial. This policy makes no mention of patient health status, consent, or notification to patients that their insurer has decided on its own that the dose their physician has determined to be standard of care be reduced by up to 10%. Nor does it suggest informing patients that this is a policy put into place for them as Medicare Advantage patients, and that if they had other insurance, they might be receiving standard-of-care dosing.
Doses are clearly identified in FDA-approved labels. Clinical trials that led to dose intensity indications with ultimate approval were based on tight clinical parameters. Physicians modify doses during treatment on an ad hoc basis on patient health status, weight, and toxicity concerns. The authors of the HOPA paper specifically suggested additional institutional studies and consensus consideration before making further decisions that affect patient care and access to published standards of care regarding dosing.
Liability and Access Issues
How can a payer justify pushing physicians to treat certain insured patients with less medicine than clinical standards indicate is appropriate? What would be the legal and even malpractice implications for both the payer and the physician for a dose reduction based on the vial usage rather than on clinical indications linked to the individual patient needs? What liability issues might arise if a patient who was subjected to a non-evidence–based dose reduction ends up with an adverse outcome or if a patient with one type of insurance (eg, Medicare Advantage) receives less medication than a patient with the same condition who has a different type of insurance? Where is the evidence that dose reductions based solely on vial usage are even medically appropriate? The oncology community, through investigation and consensus, defines guidelines for treatment. This is not an appropriate role for those who pay for care.
Often, payers will float a trial policy in select states. If there is not much discussion or pushback, they may then transition the policy from a voluntary to a mandatory status, or expand it for additional states or insurance categories. It is important to work together and identify trends and issues that could adversely affect patient access to quality care. The Anthem issue is already rising from local state levels to national attention, in groups such as the National Oncology State Network (NOSN). This organization works with its volunteer state members and other national organizations and partners to develop talking points and responses to policy concerns so that no one state is left to deal with these issues alone.
If You See Something, Say Something
What can the oncology community do? If you see something, say something. Watch for unusual new approaches to the management of oncology care. If a policy does not make sense, has little supporting evidence, or would adversely affect patients’ health, access, or quality of care, raise the alarm. Speak to your state oncology societies, to your colleagues, and to the Oncology Practice Management community, as well as to organizations such as NOSN. I am always willing to investigate looming trends that are being floated as trial balloons.
If you are in one of the states affected by this Anthem (or any other insurer) policy, please feel free to reach out to me at
I am a strong advocate for collaboration between payers, providers, employers, and patients. When done carefully and with appropriate analytics and evidence, together we will soon transform healthcare delivery from reactive care to more cost-effective, proactive care, and in turn, reduce the burden of cancer on our communities. Unfortunately, this trial policy makes no sense and will create liability and access issues for the vulnerable Medicare Advantage patients insured by Anthem in select states. We can do better, and this is the time to speak up—before policies such as this are expanded.
References
- Anthem Kentucky Provider Communications. Oncology dose reduction program beginning July 1, 2021. April 1, 2021. https://providernews.anthem.com/kentucky/article/oncology-dose-reduction-program-beginning-july-1-2021-2. Accessed July 12, 2021.
- Fahrenbruch R, Kintzel P, Bott AM, et al. Dose rounding of biologic and cytotoxic anticancer agents: a position statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018;14:e130-e136.