New step therapy law called step in right direction

Feb 1, 2017

Advocates are applauding Gov. Andrew Cuomo's signing of new step therapy legislation for 2017. However, health insurers are projecting an additional half-billion dollars in drug costs because of the law.

"At the beginning I was very ill, extremely ill. I was given 3-5 years to live."

Suzanne Carrow suffers from chronic myeloid leukemia or CML. It is a rare blood disease that most often affects older adults and can have a number of symptoms, including sleepiness.

To counter her fatigue, Carrow's physicians at Roswell Park Cancer Institute prescribed the sleep disorder drug Provigil, which proved effective for her for years.

"What they wanted to have me do was to try three different drugs and, uh, see if those would work, you know, be cost-effective and what-not," Carrow says. "So, many letters and many interviews and I was fortunate enough not to have to do it."

However, every November her doctors had to re-certify that the drug was still effective.

Now, imagine going through that scenario for each of the 14 drugs Carrow is currently on - and the many others that became necessary over the 18 years she has been dealing with CML. Dr. Eunice Wang, chief of Roswell's Leukemia Service, says Carrow has tried nearly everything on the market for CML.

"We were aware that, having had her go through this, that there're many agents that didn't work for her," Wang said, "and for an insurance company to tell us that we need to re-try or repeat agents that in the past had not worked for her purely for financial reasons, I think is putting her suffering and prioritizing money over the patient's symptoms and her overall cancer care."

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Step therapy requires medical treatments to be pre-authorized by the patient's health insurance before starting. Patients must "fail first" on less expensive treatments that have been proven effective for most people before stepping up to more expensive or risky ones.

It can be as simple as trying a generic before a brand name drug, but is often much more involved for the specialty drugs used at Roswell and similar treatment centers.

"Why should we have to be put through that? If something is working for a cancer patient, to help them with their treatment and, you know, to essentially stay alive, why take that away from them? Why make them go through, you know, drug after drug?" Carrow asks. "And we know drugs maybe take 4-6 weeks to work: going through one that doesn't work, the second one doesn't work, the third one that doesn't work and then you're back to square one - the original drug - and in the meantime, you've wasted three months." 

Physicians can request an exception - like Carrow received for Provigil - but it can take days, weeks or even months to negotiate. Olean Republican State Senator Catharine Young sponsored the bill signed by the Governor.

"When you spend so much time and sometimes weeks and even months trying to get the proper treatment for a patient, this expedites the entire process so that the doctor's request has to be responded to within 72 hours for the patient," Young says. "Now, if it's an emergency situation, then the insurance company has to respond to the doctor's request almost immediately, within 24 hours."

Wang calls the new law a step forward, especially for patients with complicated illnesses, like cancer.

"This is something that people are really, really scared about. They're scared about all aspects of it. I've had a number of them freak out when they can't get some medication of their 10- or 13-drug regimen," Wang says. "I think it is going to place some of the decision making back into the hands into the physicians and having the physicians and the patients be more of the determinants of what medications are working for them than someone at the insurance company."

"I'm thrilled and it's a great victory for the patients of New York State because this legislation ensures that medical treatments are patient centered, that patients will get the proper care and appropriate therapies that they need," says Young. "So this is a long, hard-fought battle. I have more than 80 organizations - such as Roswell Park, Lupus Association, Cancer Society and so on - who supported this bill because they understand how important it is to the people of this state."

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The New York Health Plan Association - representing 29 managed care plans that provide comprehensive health care services to more than 7 million New Yorkers - says there is no evidence step therapy limits access to treatments, as insurers already follow less-broad federal guidelines for the practice. HPA Spokesperson Leslie Moran says the state's new law allows physicians to bypass nearly all review by insurance companies.

"Essentially what this law will do is to create an avenue for providers to sidestep or circumvent step therapy in virtually every instance and, simply, be able to prescribe drugs without any utilization review or without any oversight from the health plan," Moran says.

Moran says independent review is aimed at keeping treatments safe and high quality, as well as cost effective. The HPA projects $222-$530 million in higher drug costs without outside independent review by insurance companies. The calculations are based upon a survey of 13 Association-member plans, including New York State open enrollment, the Essential Plan, Medicaid and Child Health Plus.

"Specialty pharmacy costs went up close to 20 percent in 2016 and they're expected to do the same in 2017," says Moran. "So the pressure to provide affordable health care to New Yorkers is more important today than ever before and one of the biggest drivers of health care costs is pharmacy costs."

She says the timing of the new law also is unfortunate, because insurers already had submitted and approved their plans and rates for 2017 when it took effect on January 1. In addition, the HPA says, "there is no process to add or otherwise modify these policies or adjust premiums to reflect the new costs of the bill" for 2017.

In a related story, BlueCross BlueShield of Western New York on Wednesday announced it has eliminated the need for preauthorization on more than 200 medical services. Preauthorization is the process health plans use to determine if a prescribed drug, treatment or service is medically necessary before insurance will cover it.

Like step therapy, preauthorization can take days, weeks or months to negotiate. BlueCross says its announcement aligns with "a recent call by the American Hospital Association and American Medical Association to reduce prior authorizations in the interest of efficiency and patient care." The insurer says the change also reflects "significant feedback from physicians and patients."