Step Therapy leads to delay in treatment for MS patient
When Daniel Ford was diagnosed with multiple sclerosis in December 2015, it was a shock to both him and his wife, Gayle Taylor-Ford.
But what happened next shocked the Overland Park couple almost as much.
Ford’s neurologist told them there was something that could help halt the disease’s progression. But insurance probably wouldn’t pay for it.
“He said, ‘You need to be on an infusion therapy called Tysabri. However, I know from experience your insurance company is going to deny it. Then we will have to appeal it and we may have to appeal it twice before they’ll approve it and this process on the average takes 90 days,’ ” Taylor-Ford said. “So we had a new diagnosis, horrible symptoms and no treatment for 90 days.”
Ford’s treatment was delayed due to a medical management tool that insurance companies call “step therapy,” but critics often call the “fail first” policy.
Insurers use step therapy to try to steer clients toward less expensive, older treatments to see if that works for them before they “step” up to something newer and usually more expensive.
They say it helps them hold down premiums while also encouraging doctors to stick to proven therapies.
“Health insurance providers exist to ensure better outcomes and affordability for everyone,” Cathryn Donaldson, a spokeswoman for American’s Health Insurance Plans, said in a written statement. “This is exactly what medical management (including tools like step therapy) delivers. Step therapy allows us to design approaches to care that are most effective and offer the most value and benefit for the patient.”
But patient advocacy groups say unregulated step therapy allows insurance companies to impose an unrealistic, one-size-fits-all approach to medicine that prevents doctors from using their best clinical judgment to tailor treatments to individuals.
A coalition of 20 such groups, including the National MS Society, the American Diabetes Association and the American Cancer Society, are lobbying Kansas legislators to create restrictions on how insurance companies use step therapy and when doctors can override it.
“Step therapy has shown to have a negative impact on patients, including delayed access to the most effective treatment, disease progression, and significant burdens on health care providers and their patients, as well as increases in health care costs,” according to the American Academy of Dermatology, which tracks step therapy use and legislation.
The academy says that 60 percent of commercial insurers were using step therapy as of 2010.
At least 14 states have enacted step therapy restrictions, including Missouri in 2016. Bills were introduced in at least a dozen other states last year, including Kansas.
“Unfortunately, (the Kansas bill) is essentially a national effort — being considered in several states — specifically designed to allow pharmaceutical companies to exploit the step therapy process, driving up costs for everyone, and fueling out-of-control drug costs,” Donaldson said. “This is another example of how Big Pharma continues to advocate for less restrictive oversight or review of their therapies so they can continue to push high-cost drugs with no accountability.”
In Kansas, the step therapy bill didn’t get out of committee last year. Kari Rinker, a lobbyist for the National MS Society, said the coalition plans to reintroduce it this year with slight changes to the language.
Kansas Rep. Dan Hawkins, a Republican from Wichita who is chairman of the House Health and Human Services Committee, said he doesn’t plan to schedule a hearing on it.
“Step therapy has been in existence for the commercial (insurance) side for 17 years,” Hawkins said. “To go and change it is just going to drive the cost of insurance up and we don’t need to drive it up any further.”
The bill is also in the Senate Public Health and Welfare Committee, which had a hearing on it last year but didn’t vote on it. Kansas Sen. Vicki Schmidt, a Republican from Topeka who chairs that committee, didn’t respond to a request for comment.
Rinker and other proponents of the bill say they’re trying to give people with private insurance the same type of prescription medication protections that legislators have given to people on Kansas Medicaid, or KanCare.
Their bill doesn’t keep insurance companies from using step therapy entirely, or restrict the use of generic equivalents. But it would require insurance companies to grant an exception to step therapy under several circumstances, including when doctors believe it won’t work based on their clinical judgment.
Taylor-Ford testified for the bill last year and said she plans to do so again this year. She said her husband developed two lesions on his spinal cord while he was waiting to get approved for Tysabri. The process went exactly as his doctor predicted it would, with multiple denials and a 90-day delay.
After he got on the medicine, his condition stabilized.
“Through that 90-day window, my symptoms got a lot worse because we couldn’t halt the progress,” Ford said. “It’s a big nasty loop that you have to go through with the insurance company every time.”