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By Thomas Goldsmith

Patients, doctors and family members affected by the prescription practice called “step therapy” brought personal stories to the General Assembly Thursday in support of a bill that would prohibit it in some cases and limit it in others.

Photo credit: Rose Hoban

The bill, House Bill 1048, defines step therapy as an approach “under which patients are required to try one or more prescription drugs before coverage is provided for a drug selected by the patient’s health care provider.” The practice has been widely adopted by insurance companies, in part in response to demand for specific new drugs targeted to consumers by advertising.

Thursday’s event, put on by the National Patient Advocate Foundation, was part of an advocacy day designed to bring legislators’ attention to the bill, which is being called “Reduce Barriers to Improve NC Health and Safety.’ The bill has passed the House, but not the Senate.

Proponents of step therapy describe the practice as a necessary cost-saving measure. At an earlier legislative hearing this year, Tom Friedman, North Carolina State Health Plan policy liaison, said step therapy saves the plan for state employees about $10 million in its $700 million annual prescription-drug budget.

Panelists — including two physicians, a patient advocate who has rheumatoid arthritis and a state lobbyist for the American Cancer Society Cancer Action Network — resisted assertions that efforts to limit step-therapy represent a “mandate” that would harm providers.

“I suggest that they disregard the label of ‘mandate,’ when it is a word that is thrown around haphazardly when we are talking about lives at stake,” said rheumatologist Dr. Gwenesta Melton.

Protracted conflict with insurance companies and third-party vendors over step-therapy prescriptions has taken a toll on Melton’s practice, she said: “They are upset because they think that we are going to run amok and put all these people on these expensive drugs.”

Before some patients are approved for the most efficacious drug for their conditions, they can spend months or years taking the less expensive drugs that make up the first steps of the process, Melton said.

On the other hand, many patients may come into their doctors asking for a new, expensive, medication they saw in an advertisement, when an older, generic drug can suffice.

The legislation, sponsored by Rep. David Lewis (R-Dunn), would require insurers to allow exemptions from step therapy in cases where doctors find that the drug required by the insurer is not in the patient’s best interest.

A section of the bill specifically endorsed by Duke physician Dr. Steven Prakken prohibits step therapy when a doctor has prescribed abuse-deterrent opioids. These relatively new painkillers are designed to lose their potency if altered for potential abuse by crushing or cooking them.

“That’s a deterrent to abuse,” Prakken said. “Since they are more expensive, you can’t use them first” under step-therapy protocols, he said.

The federal Food and Drug Administration recently urged pharmaceutical companies to develop generic equivalents of abuse-deterrent drugs, while noting that some questions persist about how effectively the medications actually keep people from misusing them.

“Abuse-deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding,” a March FDA statement said.

“It does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death – notably, the FDA has not approved an opioid product with properties that are expected to deter abuse if the product is swallowed whole.”

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Thomas Goldsmith

Thomas Goldsmith worked in daily newspapers for 33 years before joining North Carolina Health News. Goldsmith is a native Tar Heel who attended the UNC-Chapel Hill, and worked at newspapers in Tennessee...

2 replies on “Patient Advocates Push for Limits on Step-Therapy Prescription Practices”

  1. Under this legislation, would a person who has been using a biologic be
    required or expected to move to a cheaper drug regimen and prove it’s less
    effective before insurance will cover the more expensive biologic?

    1. This is Thomas Goldsmith, the reporter. I wouldn’t think so, as the purpose of that part of the bill is protect people from unnecessarily having to go through less effective meds first. But much would depend on the specific biologic, the insurance company and your doctor. Under the bill, the doctor could get an exemption from step therapy if it were in the best interest of the patient.

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