Even if those goals are achieved, the policy will add “one more layer of administrative burden,” Dr Grubbs asserted. “Our [ASCO] membership polling shows that the number 1 issue right now is the work [physicians] do for preauthorization.”

“There’s no question that we have to reign in the costs of drugs. Nobody’s going to argue against that,” said Ramaswamy Govindan, MD, professor of oncology at the Washington University School of Medicine in St. Louis, Missouri. “But we have to make sure that we provide our patients with the best available treatment options based on efficacy and toxicity.”

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“Efficacy is foremost,” he said. “We don’t want to offer cheaper therapies that are not as effective for cancer patients.”

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In theory, Dr Govindan said, if there are no issues with efficacy and toxicity between two anticancer drugs, we should use a less expensive therapy.

“But in reality, unfortunately, most of the drugs in the same class are priced at the same level,” he added.

Step therapy is “ill-advised” and would delay care by requiring additional steps of approval and restricted access to the newest drugs, noted oncologist Lucio Gordan, MD, of the Florida Cancer Specialists & Research Institute in Gainesville, Florida.

Outcomes and disease control could be “gravely worsened” by step therapy, he said.

It could even lead to avoidable toxicities, Dr Gordan speculated. Ironically, that could increase costs if patients are treated in emergency departments or hospitals to manage those adverse effects.

The new policy would require Medicare Advantage plans to offer a formulary-exception appeals process for patients but that would add a “convoluted review” by middlemen who are less familiar with cancer treatment than the patient’s team, Dr Gordan said.

The utilization management approach is an attempt to cut costs and improve treatment predictability, said Fred Schnell, MD, FACP, medical director of the Community Oncology Alliance in Washington, DC.

“That’s the intent,” Dr Schnell said. “But the thing that really bothers me about step therapy in cancer is that if it’s a critical decision point at the front end of a patient’s care, and not fifth-line therapy for advanced colon cancer, the choices really can be life-or-death choices. A bad choice can lead to bad outcomes that are not reversible. This isn’t hypertension or diabetes — cancer’s not like that. Patients may never recover from a bad choice.”

Oncology has dealt with step therapy for quite some time on the private insurance side, Dr Schnell noted.

“It’s been a roller-coaster,” he said. “Some companies make it quite onerous and others focus on a few disease sites. None of the oncologists like it because the people making decisions on the payer side are, for the most part, not oncologists.”

Because of their costs, tyrosine kinase inhibitors (TKIs) will “definitely be in the mix” as Medicare Advantage plans adopt step-therapy restrictions, Dr Schnell predicted.

“Myeloma will be a big target, too, because of the extreme cost of some therapeutics,” he said. Insurers who have adopted step-therapy restrictions for private health insurance plans have focused on myeloma and common, high-volume cancers like breast, colon, lung and prostate cancer, he added.

Biosimilars and supportive care drugs will also likely be affected, Dr Schnell said. “Supportive antiemesis and growth factors are expensive,” he noted.

“Step therapy also ties up a lot of staff time to launch appeals and overcome objections,” Dr Schnell said. “That causes delays — it creates roadblocks for implementing care. Decisions can take forever, particularly if you appeal. It’s unclear who will field these appeals or what the timelines will be. Days trickle into weeks. That happens. Weeks trickle into months. And the patient is stuck in the middle.”

For the moment, CMS is “offering suggestions rather than rules” about appeals, allowing Medicare Advantage plan insurers to self-regulate, said Caitlin Donovan of the National Patient Advocate Foundation, in Washington, DC. Without government oversight, plan transparency and the speed of appeals could become a problem, she warned.

Because the Medicare Advantage enrollment period is yearly from October 15 through December 7 — every year it could be difficult or impossible for patients to switch plans when the medication they need is subject to step-therapy restrictions, Donovan and others noted.

The CMS policy proposal could add to already “very significant” pressures for community oncology practices, Dr Gordan cautioned, hastening a trend of shuttered practices and shifts to cancer care at more expensive health systems.

The policy represents “cookbook medicine,” according to Ted Okon, of the Community Oncology Alliance. “Step therapy isn’t new — it’s used on the commercial side and it’s caused horror stories. It’s not just branded drug vs generic and use the generic first. It puts the insurer in the position of middleman, telling physicians what they have to try first.”

Several states have passed laws that limit step therapy for privately insured cancer patients.4 But no such protections apply to Medicare Advantage programs, Donovan confirmed.

“This is a new chapter in Medicare Advantage,” said Dr Grubbs. “It’s something we’ll have to watch very carefully.”


  1. Centers for Medicare & Medicaid Services. Re: Memo of August 7th regarding prior authorization and step therapy for Part B drugs in Medicare Advantage. https://searchlf.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2018-9-10-Signed-on-Letter-to-Verma-re-Step-Therapy.pdf. Updated September 7, 2018. Accessed September 11, 2018.
  2. Centers for Medicare & Medicaid Services. CY 2019 Step Therapy Qs & As. https://dpap.lmi.org/DPAPMailbox/Documents/Part%20B%20Step%20Therapy%20Questions%20FAQs_8-29-18.pdf. Updated August 29, 2018. Accessed September 11, 2018.
  3. Centers for Medicare & Medicaid Services. CMS empowers patients with more choices and takes action to lower drug prices. https://www.cms.gov/newsroom/press-releases/cms-empowers-patients-more-choices-and-takes-action-lower-drug-prices. Updated August 7, 2018. Accessed September 11, 2018.
  4. The National Psoriasis Foundation. Step therapy legislation by state. http://www.steptherapy.com/step-therapy-legislation-by-state/. Accessed September 11, 2018.