What Pharmacists Should Know About the Pitfalls of Step Therapy


A ‘fail-first’ policy by the Centers for Medicare and Medicaid Services could be a nightmare for patients with cancer, according to the Community Oncology Alliance.

Although the Centers for Medicare and Medicaid Services (CMS) has recently authorized a policy that allows step therapy for Medicare Part B drugs for patients with Medicare Advantage, the practice is detrimental to patients, according to members of the Community Oncology Alliance (COA).1

CMS officials recently released their final rule for Medicare Part D that will maintain the status of cancer as a “protected class” in Medicare Advantage (MA). Although several in the health care community applauded this decision, organizations such as the COA took aim at the CMS decision, which allows MA plans to use “fail first” step therapy for new starts of Part B drugs for cancer and other serious diseases. In a press release, COA noted that it could mean “patients with cancer will face nightmares of delays and denials while trying to access their physician-prescribed treatments.”2

COA Executive Director Ted Okon, MBA, and Lee Schwartzberg, MD, FACP, executive director, West Cancer Center, recently spoke on this issue at the COA 2019 Community Oncology Conference.

Step therapy is the practice of using cheaper or more profitable medicines for the insurer before covering more expensive treatments for patients, according to Okon and Schwartzberg’s presentation.

“Step therapy is something that is forced by the insurer. It is antithetical to personalized medicine and is destructive, cookbook medicine. It is defective and less effective therapy,” Okon said in an interview with Specialty Pharmacy Times.

In the interview, Okon added that patients have been harmed by step therapy, and that is why states are legislating to protect against this practice.

“Nineteen states have passed laws and 10 are preparing to,” he said.

However, patients not living in these states are vulnerable. They must first fail step therapy medicines before getting access to drugs that are preferred by their oncologists.

“Regardless of what the oncologist would prescribe and what patients want, they are forced to take a drug that is less effective and may actually be more expensive for the patient. Step therapy is perhaps the most patient-harmful dictate that we have seen in a long time,” Okon said in the interview.

In the presentation, Okon and Schwartzberg explained that choosing medicines based on price or profit is arbitrary and inferior. In addition, it is hard to evaluate the outcomes of step therapy. Perhaps most importantly, this method is “totally lacking consideration of the patient experience and patient-related costs,” they explained.

They said fail first step therapy puts “burdens on both the patient and the practice.”

“I have seen physicians and oncologists who have themselves been diagnosed with cancer panic because of having to be subjected to step therapy,” Okon explained. “The government believes they are going to save money by giving power to the insurer. In the case of Medicare Advantage they believe they will do better at controlling costs than the physician, pharmacist, or the rest of the medical team.”

Okon and Schwartzberg’s presentation provided several examples of cancer drugs that must be tried as “fail first” options before other medicines can be covered by insurers. For example, Humana, in cases of multiple myeloma or solid tumor with bone metastases, and Blue Cross Blue Shield, in cases of breast cancer to prevent skeletal-related events, require bisphosphonates pamidronate (PAM) and zoledronic acid (ZOL), and solely allow the use of denosaub after PAM or ZOL. The conditions for allowing denosaub are that the disease must have progressed, the patient must have an intolerance, or PAM or ZOL must be contraindicated for some reason. Humana exempts prostate cancer from this requirement, Okon and Schwartzberg noted.

COA officials noted in a recently-issued statement that even though CMS proposes patient safeguards, such as an appeals process, “it is incomprehensible to require patients receiving cancer treatment, or their already overwhelmed and distressed family members and/or caregivers, to first fail on inferior, sometimes inappropriate cancer therapy, let alone navigate a bureaucratic appeals process.

“Moreover, allowing broader use of prior authorization and ‘fail first’ step therapy for protected classes, places an additional administrative burden on providers to sort through utilization management processes in order to ensure access to cancer treatment in a timely manner. It is not uncommon for community oncology practices to spend many valuable hours on overcoming [pharmacy benefit manager] and plan sponsor denials of medication needed by critically ill patients.”

In the statement, officials with COA asked the Trump administration to rescind the final rule and reconsider allowing “fail first” step therapy in Medicare.

In the interim, “what pharmacists must do is make sure that there are no contraindications or anything else that would harm the patient. The pharmacist is on the front line in getting the right drug to the patient,” Okon explained in the interview. “What the medical community can do is tell patients that when they select their insurance plan, they had better reconsider Medicare Advantage and instead choose a Medicare fee-for-service plan to avoid being subjected to step therapy.”

“The decision has been taken out of the hands of medical professionals and given to big corporate middlemen who are now making medical decisions,” he added. “This is all about a profit model and not in the best interest of patients, who do not have the option to override step therapy by paying out of pocket due to the cost of cancer treatment medication,” Okon explained to Specialty Pharmacy Times.


  • Okon T and Schwartzberg L. Step Therapy & Utilization Management: Medicine & Politics Converge. Presented at: Community Oncology Alliance 2019 Community Oncology Conference; April 4-5, 2019; Orlando, FL.
  • CMS allows middlemen to force patients to “fail first” on cancer drugs while paradoxically keeping cancer a protected class [news release]. Washington, DC: Community Oncology Alliance; May 23,2019. https://www.communityoncology.org/cms-allows-middlemen-to-force-patients-to-fail-first-on-cancer-drugs-while-paradoxically-keeping-cancer-a-protected-class/?fbclid=IwAR31w_c9kmgrC-uB0PerFBqlh8yh9fUgyH2ipjRo4QKfjeBl8Ij09BrHDy4. Accessed May 29, 2019.

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