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No Good Deed Goes Unpunished: How PBM Mandates Increase Practice Variability

In August 2019, OneOncology became one of the first to make available to practices biosimilars to replace therapies for brand-named therapies, Avastin and Herceptin, with Rituxan soon to follow. The decision to recommend using biosimilars instead of the originator products was made with ample efficacy and safety evidence as a commitment to cost conscious cancer care for patients, employers and payers.

The Biosimilar Promise

Combatting the financial toxicity that impacts our patients by contributing to a real-world solution that cuts into the high-cost of healthcare through biosimilar utilization is what drove us to achieve a first-mover status these agents. And today, oncologists remain on the leading edge of biosimilar market that is poised to deliver $133 billion in aggregate savings by 2025, according to a recent report.  

How the PBM Playbook Increases Patient Safety Risk

As biosimilars entered the market in 2015, PBMs were slow to reimburse, but after experiencing more than 20 percent savings from oncologists’ early adoption of biosimilar agents in their first two years of use, PBMs soon employed tactics in the biosimilar market seen in originators to make money at the expense of physicians and patients.

Practices manage and navigate the outsized influence of PBMs have in oncology care on a daily basis. From prior authorization requirements to step therapy requirements to formulary restrictions, PBMs delay care, confuse patients and impose costly mandates on practices in the pursuit of extracting fees for profit.

With biosimilars, the PBM playbook introduces unnecessary variability into practice processes -- and when variability is increased, the potential for errors increases forcing oncologists, pharmacists and administrators to invest in additional quality-management processes to mitigate risk. It’s costly and needlessly threatens patient safety.

How Mandates Introduce Practice Variability

There are 24 commercially available biosimilars in the U.S. and 19 of those are for treatment or supportive care in oncology, meaning that oncology practices must stock, store and administer 80 percent of FDA- approved biosimilars. This places extra mandates on the practice for identifying and segregating each drug. With similar therapies and supportive drugs in stock, the risk for look-alike and sound-alike mistakes increases, meaning the pharmacist requires additional quality-management processes to stock, store and pull the right drug out of the refrigerator to administer it to the patient.

An examination of how PBMs manage the five trastuzumab biosimilars and the originator, Herceptin, sheds light onto how payer practices increase costs and variability for practices and patients. Trastuzumabs are a HER2 inhibitor targeted therapy that blocks the ability of the cancer cells to receive chemical signals that tell the cells to grow.

With six agents, there are multiple manufacturers and payers angling to get their preferred agent of essentially the same type of product into cancer clinics.  Six payers could negotiate rebates with six manufacturers and mandate six different trastuzumbas as their preferred agent.  

The oncology practice also has “no contracting power” to reduce the number of trastuzumabs and stock and administer a preferred agent to avoid look-alike and sound-alike scenarios that are confusing to the provider and increase risks for care teams and patients.

Instead of a vastly improving efficiencies and keeping cost controls top of mind by stocking one of six identical agents, practices are forced into jujitsu maneuvers required to manage multiple versions of an identical agent. Why? In a word – profit.

Manufacturers pay PBMs and direct rebates for making their drug, in this case a biosimilar, the formulary preferred agent. The payers then mandate that physician use this specific biosimilar.  The practice is left responsible for investments to ensure, in this example, that all six agents are stored, handled and administered properly.  

Supportive oncological drugs are another example of how PBM mandates for their preferred agent hinder practices.

Pegfilgraastim is an agent that reduces the chance of infection in some people receiving chemotherapy medications. There are four biosimilar agents for the originator drug, Neulasta. Instead of training and compliance programs to manage one supportive biosimilar for Neulasta, practices must have quality management systems in place for four drugs. Not because any of the agents are better or preferred by a patient, but solely because of an opaque rebate between the manufacturers and the PBM that puts money in the PBMs pocket and ignores what the care team recommends. 

After examining the PBM playbook on biosimilars, I’m left with two questions:

  • Is there a reasonable reason a two-physician practice should have to stock 80 percent of available biosimilars solely to comply with payer mandates?
  • With multiple biosimilars available for a single originator, what is the PBMs motivation for dictating to the practice to use one biosimilar over another?

The answers to these questions prove PBMs have only one motivation – increasing profits off the backs of patients, employers and oncologists.

Solution: Enhance Physician Decision Making

Physicians along with their patients, and not PBMs, need to be at the helm of healthcare decision making. From deciding which therapy is best to being able to receive drugs from oncologists’ in-house pharmacists, when physicians are driving decision making, care is more coordinated, patient-centric, better utilized and ultimately less expensive. Even with hurdles, biosimilars will create enormous value and savings in healthcare. Shining a light on how PBMs practices control biosimilars and introduce variance is yet another example of how the PBM playbook seeks to punish providers – even those who clued them into the biosimilar savings potential in the first place.