May 2019 Edition Vol.11, Issue 5

The Politics of Step Therapy

By John McCleery

In first fail step therapy, a patient must literally fail first on an inexpensive drug before getting access to the first choice drug prescribed by their doctor. While first fail step therapy may not be a new concept— it’s commonly used by commercial insurance health plans—it is new to Medicare Advantage (MA) plans, which makes it rather controversial.

Many states have laws on the books to curb step therapy, but the politics of step therapy is that HHS is allowing MA plans to implement fail first step therapy in their utilization management to reduce their drug expense. The target of implementing step therapy in MA plans is Medicare Part B drugs that are administered under a physician’s supervision (i.e., chemotherapy injectables and biologics). The concern is that this could lead to access problems for patients with cancer from getting the right drug at the right time.

In a session at the 2019 Community Oncology Conference titled, “Step Therapy and Utilization Management: Medicine and Politics Converge,” Ted Okon, executive director, Community Oncology Alliance (COA) led a lively discussion with Lee Schwartzberg, executive director, West Cancer Clinic, Germantown, TN, on the practice of fail first step therapy and how it affects oncology decision making.

Dr. Schwartzberg specializes in the treatment of breast cancer, with a specific focus on new therapeutic approaches, targeted therapy, and supportive care.

He explained that certain classes of drugs, “all expensive, of course,” are chosen to have a step therapy option. In some cases, they’re supportive care drugs, but in others they’re actual therapeutics. If the drugs that are chosen were equally effective, Dr. Schwartzberg might see step therapy as a reasonable approach, “but they’re often inferior,” he said. “And who among us wants to give an inferior drug to a patient and let them fail, especially to a cancer patient who may have limited time?”

Even if fail first step therapy makes sense in more chronic diseases, such as hypertension, in cancer, Dr. Schwartzberg said, “it makes no sense.” Giving the best drug upfront the first time gets the best results. “We’ve learned this with forty years of clinical trial evidence,” he said.

Many times, a prescriber often doesn’t know when a patient is going to be subject to a step therapy program. In the case of oral drugs, it happens at the pharmacy and the patient is in a panic about what to do.

Using the supportive care, monoclonal antibody drug, denosumab, Dr. Schwartzberg illustrated how arbitrary fail first step therapy is among five payers (Table 1).

In oncology, denosumab is used to prevent skeletal related events (SRE), such as fractures in patients who have bone metastases or hypercalcemia due to malignancy. Denosumab is also used as an adjunct to treat either osteopenia in the setting of aromatase inhibitors for early stage breast cancer or in osteoporosis for any cause.

“This strategy has been around for a long time with generations of drugs used,” Dr. Schwartzberg explained, adding, “we have head-to-head clinical trial evidence of denosumab being delivered at a certain dose of 120 mg monthly that shows superior efficacy compared with the other drugs.”

Table 1. Step Therapy Protocols for Denosumab by Payer

Payer Indication Step TX Treatment Condition for Denosumab Comment
  • MM or solid tumor w/ bone metastases (BM)
  • Pamidronate or Zoledronic acid
  • Disease progression
  • Intolerance
  • Contraindicated
Prostate cancer exempt
  • Breast cancer prevent SRE
  • Solid tumor prevent SRE
  • Pam or Zol
  • IV bis
  • Ineffective
  • Not tolerated
  • Contraindicated
  • Solid tumor BM prevent SRE
  • Zol
  • History of response to denosumab OR failure/
    no response
  • Contraindicated
  • Intolerant or not a candidate
  • MM or solid tumor w/ BM
  • Hypercalcemia of malignancy
  • None
  • Medically necessary
  • MM or solid tumor w/ BM
  • IV bis
  • Refractory w/in 30 days
  • Contraindicated or intolerant
1 year max

For the treatment of bone metastases in myeloma or any solid tumor, Humana approves pamidronate or zoledronic acid—which are first and second generation drugs—to be used first, but it doesn’t approve the third generation, denosumab to be used first. To access denosumab, the patient must progress on one of the other drugs first, be intolerant, or its contraindicated. For Humana only, they exempt prostate cancer from step therapy. According to Dr. Schwartzberg, this is because denosumab is the only bone-targeted agent in the NCCN guidelines that has Level 1 evidence as a preferred drug.

Blue Cross/Blue Shield also requires step therapy in patients with breast cancer. Pamidronate or zoledronic acid must be prescribed first to prevent any SRE before the patient may access denosumab.

“The patient literally must fail in a way that could lead to serious complications,” Dr. Schwartzberg said. “It’s ineffective to have a bone related event and now have to be admitted to the hospital with a broken hip that could’ve been prevented because the patient didn’t get the therapy that was best.”

For Cigna and the case of solid tumor bone metastases, the payer prefers zoledronic acid to be used first, but if the patient had previously responded to denosumab, they’ll allow for it to be used first line.

Aetna does not have fail first step therapy for denosumab. The drug has a broad indication for use in multiple myeloma or in solid tumor bone metastases. “This insurer considers denosumab as medically necessary in this condition,” Dr. Schwartzberg said.

At United Healthcare, IV bisphosphonate is required first in bone metastases if the patient is refractory. Dr. Schwartzberg doesn’t understand the term refractory in this condition, because either something happens or it doesn’t. “It’s not clearly refractory in the same way we would measure a tumor response,” he said. The payer also has an additional restriction on denosumab of a one year max “which is not necessarily based on the evidence,” he pointed out.

“These inconsistencies among insurers is totally arbitrary,” Dr. Schwartzberg said. Apparently, it’s the luck of the draw according to a patient’s insurer if they will be able to access first line denosumab for bone metastases.

When it comes to therapeutics, Dr. Schwartzberg said that Humana refers to the step therapy approach as “patient centered care coordination.”

“This is a good example of 1984 newspeak,” he said.

Humana has in mind to give their patients patient-centered care but does not allow them to get Lutathera first—a drug that has been shown to increase efficacy—over their fail first step therapy drug, somatuline depot or sandostatin LAR.

For breast cancer, “I’m not convinced the data on doxil is as good as the data on doxorubicin. I would love to give a patient doxil who has severe neutropenia to doxorubicin previously, but that decision making is taken away from me. Same goes for nab-paclitaxel. Right now, my hands are tied for a triple negative patient, the worst prognosis subgroup of breast cancer patients. If that patient has Humana, I cannot give her what I consider the best first-line therapy.”

Mr. Okon said that Humana is the largest MA insurer and that’s a concern that MA plans may use step therapy for cost-effective reasons but may limit access to the right drug for the right patient at the right time.

In closing, Dr. Schwartzberg, said that when it comes to step therapy it’s antithetical to personalized medicine. “There really are so many problems with it that it’s remarkable we stand for it,” he said. “Not only can I not get the drug I want, based on that patient’s history, but why would I want to give a patient who has borderline creatinine, a drug that increases creatinine? Or if a patient has neuropathy to give a drug that I perceive to be inferior because of other toxicities?” he said.

Because step therapy is a PBM insurer-based product, it takes a very narrow view of what the cost is and doesn’t consider the patient experience. “What happens to the patient who has an outcome that’s inferior because of the step therapy drug that was prescribed?” He explained that scenarios like that only lead to more cost to the system. “I can’t think of another strategy that is so misaligned,” he said.

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