A piece of legislation on the governor’s desk attempts to bridge two often-contradictory goals: reining in the ever-rising cost of prescription drugs versus giving patients prompt access to medications that doctors believe would be most effective.
Assembly Bill 374 would streamline the process of requesting approval from insurance companies for an alternate medication when physicians think a standard front-line treatment would not succeed.
Currently, some patients with chronic conditions such as lupus, epilepsy and rheumatoid arthritis must follow “step therapy” — a requirement by their insurers that they first try less expensive, typically older drugs before receiving permission to take newer, costlier alternatives.
At least 6.7 million Californians are in health plans that mandate step therapy for at least one drug, according to an analysis conducted by the California Health Benefits Review Program, an independent think tank created to provide impartial advice to the Legislature.
Step therapy, also known as the “fail-first” approach, has generated debate for decades.
Supporters of the practice said it is designed to make sure that patients are not prescribed more-expensive drugs if cheaper ones work just as well. They said the measure not only saves money, but also can curb the sometimes undue influence of pharmaceutical sales representatives peddling new medications that cost much more yet offer only incremental improvement.
Critics said step therapy forces too many patients to endure severe symptoms while they try to prove that cheaper or older medications are ineffective. They said AB 374 is a balanced compromise.
Gov. Jerry Brown’s signature would not come soon enough for Shakita Jones, 39, of San Diego. She has been struggling to gain access to her doctor’s preferred medications since she was diagnosed with lupus, an inflammatory disease, three years ago.
For example, Jones said she was prescribed a steroidal cream called Triamcinolone when blotches began appearing all over her skin — even though her physician said a different medication, Plaquenil, would likely be more effective. Today, her body is covered with the skin splotches, something she believes would have been controlled with Plaquenil.
“Walking around like this, I try not to let it get to me, but I do stand out because I have all of these marks all over my body. As a patient, it makes you feel like you’re not important. It makes you feel like your life doesn’t matter,” Jones said.
Dr. Arthur “Ray” Mabaquiao, a rheumatologist in East County, said he has treated many patients who have been denied access to Benlysta. The relatively new drug costs about $35,000 per year, according to the National Institutes of Health.
Mabaquiao said Benlysta, the first new lupus drug to hit the market in the past half-century, is better at treating severe cases of lupus than older medications that often were approved to combat different conditions.
Sometimes, his patients ended up in the hospital because their front-line medicines did not work.
“It might take more than a year ... by the time they fail the other things they have to try first,” Mabaquiao said.
While there are millions of patients affected by step therapy, the number who seek exemptions appears to be much lower.
The think tank’s analysis found that among the 24 million health-plan members it examined, there were 8.7 requests to override step therapy per every 1,000 enrollees. It projected that the rate would rise to 9 requests per 1,000 beneficiaries if Brown signs AB 374 into law.
That measure was initially opposed by the California Association of Health Plans, but the powerful industry group changed its stance to neutral after the bill’s language was revised to remove specific categories of step-therapy exemptions.
In its current version, the bill requires carriers to consider all requests to override step therapy using the same form that doctors now submit to request prior drug authorization. Physicians could include whatever information they believe best makes the case that their patient should move straight to second-line treatments.
While the bill would provide a quicker waiver-request process for doctors, the ultimate decision about whether to suspend step therapy for specific patients would still be made by insurance carriers.
Krystin Herr, vice president of government affairs and advocacy for the western region of the national Arthritis Foundation, which has supported the bill vigorously, said the legislation would be a true benefit.
“We really believe that when there are patients who don’t fit that one-size-fits-all process, this will allow for them to quickly get what they need,” Herr said.
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