Vol. 12 •Issue 3 • Page 18
Asthma Specialists Criticize Prior Authorization Rules for Rescue Medications
Keeping the cost of prescription drugs down is an estimable, indeed, necessary goal. One prominent actuarial firm, the Segal Co., recently predicted that retail prescription drug costs could escalate by 19.5 percent in 2003. But the cost-saving measure known as prior authorization has rankled some asthma specialists.
As a hedge against the rising cost of inhaled corticosteroids and beta2-agonists, many HMOs have placed some asthma medications on their preferred lists, called formularies. Asthma drugs not appearing on formularies, even rescue meds, require preapproval to get covered.
Now Medicaid officials are doing likewise. Faced with state budgets severely stressed by the lingering recession, Medicaid programs in Illinois, Iowa, Louisiana, Florida, West Virginia, Indiana, Texas, Connecticut and New York either require prior authorization for some asthma medications or are considering it, according to the American College of Allergy, Asthma and Immunology (ACAAI).
But what happens when a Medicaid asthma patient suffers a serious exacerbation and the rescue medication he or she needs isn’t on the state’s list? The physician must spend time navigating bureaucratic channels to obtain the drug — time that, asthma specialists say, could mean the difference between life and death.
“A policy of prior authorization to use acute care or rescue medications is foolhardy and, moreover, potentially deadly,” said ACAAI President Robert Lanier, MD.
An October 2002 poll of the ACAAI’s 4,200 members found a strong majority (74 percent) doesn’t want legislators and HMO administrators to cripple their ability to practice in emergency situations.
“The doctor has to jump through hoops to get these drugs approved,” Matt Wilson, MD, of Tri-State Allergy Inc., told the ACAAI. “While I have staffed my office so I can take care of people on Medicaid, a lot of doctors don’t have the staff to sit on the phone and get prior approval for these medicines.”
It’s not just the time involved or the hassle, Dr. Lanier said. It’s the possibility that prior approval for a drug may not come soon enough, if at all.
“Asthma exacerbation is usually a nocturnal problem,” he said. “What chances do you have of getting someone in the middle of the night to authorize a drug? They’re not very good.”
Asked if he agreed that keeping some asthma medications off formularies would help lower costs, Dr. Lanier answered, “Sure it will. But I’ll tell you what does it better: death. Death is the ultimate economy in medicine.”
Medicaid officials defend the policy of prior authorization as a matter of fiscal survival. In Illinois, for instance, prescription drugs rank as the second most expensive line item in the Medicaid budget, just after in-patient hospital rates, said Steve Bradley, RN, bureau chief for the state’s Bureau of Comprehensive Health Services, which administers Medicaid.
Prescription drug costs “are growing at an unsustainable rate of 15 to 19 percent annually,” Bradley said. “Illinois is getting close to spending $1.5 billion per year in drugs for its 1.6 million Medicaid recipients.”
Bradley stressed that no asthma patient in Illinois must wait for emergency asthma medications. “If someone is in the middle of an asthma attack, they aren’t going to (a drugstore),” he said. “They are heading for the nearest ER.”
ERs are paid an all-inclusive rate for services provided during a patient’s visit, he added. And if a patient should show up at a pharmacy when the state Medicaid office is closed, that pharmacy can dispense 72 hours worth of the med “and we guarantee payment for that amount.”
Illinois “has one of the most aggressive and successful prior-authorization programs in the country” and receives few complaints about its preferred list of inhaled corticosteroids and beta2-agonists, Bradley said. “It has gone extremely well.”
The state’s Drugs and Therapeutics Committee includes a board-certified allergist along with pharmacists and physicians. Committee members meet quarterly and on an as-needed basis after that. Their decisions are “first and foremost, clinically based,” and few conflicts arise between the committee’s recommendations and the department’s policy decisions, he said.
State rules require a turnaround time for prior authorization requests of one business day. “More often, it’s a matter of hours,” Bradley said. “We do about 550,000 prior authorization requests annually. Not all are preferred drug list requests; some are daily dose max overrides and other special exceptions.”
Bradley’s department has never heard of a patient suffering a serious complication that may have been avoided had the patient received a drug not on its preferred list. However, he acknowledged, “That doesn’t mean it hasn’t happened.”
Describing the use of prior authorization among managed care organizations, Susan Pisano, vice president of communications for the American Association of Health Plans, Washington, D.C., said “to a greater or lesser extent” some HMOs use formularies, but others don’t.
“It is among a number of tools used to keep the prescription drug benefit affordable,” she said.
Formulary committees composed of pharmacists and physicians choose quality over cost when recommending to plans which drugs to include, Pisano added. The cost issue comes into play only when there are two drugs that are equivalent in terms of evidence of their effectiveness and one is lower in cost.
“If a physician believes there is a quality of care issue, he or she can raise that with the medical director of a plan,” Pisano said.
Prior-authorization policies built upon evidence-based guidelines are worthwhile, offered John Murray, MD, an asthma researcher at Vanderbilt University Medical Center, Nashville, Tenn.
“However,” he added, “the major sense physicians have is that the process is driven by money.”
HMOs usually focus on the cost of items without considering their long-term benefits, including which are safer for long-term use or which can reduce hospitalizations and ER visits, Dr. Murray said.
“The problem with any managed care group directing formularies is looking only at the pharmacy cost and not the total cost to the patient and also the fact that, on average, a patient stays with any insurance plan for less than two years,” he said. “So there is no reason for the companies to think long-term costs.”
Another problem, he said, is “bundling,” where a pharmaceutical company contracts for their drugs to get on formulary, at an overall favorable price for the insurer. Therefore, the company mandates those drugs be used first-line — even though, individually, some of them may not be the best.
In short, HMOs put up bureaucratic barriers for financial reasons “so that what may be best for a patient is difficult to get,” Dr. Murray said. “If a physician feels strongly and is willing to make the fight, usually the drug can be obtained. But this time is not reimbursed and difficult to do every time it comes up. So there is a great deal of reluctance to do it.”
Dr. Lanier suspects that prior authorization is a cost-shifting maneuver designed to put costs back on patients. “Other specialties will see the same thing in time,” he warned. “Asthma and allergy is being attacked now because they are not seen as that important by the public.”
Newer drugs “will always cost more than older drugs,” he pointed out. “If we rolled all the meds back to 1990, we could really knock the devil out of the federal budget for drugs. But care would suffer.”
To illustrate, he mentioned levalbuterol (Xopenex®, Sepracor) a drug not found on formularies in Illinois and elsewhere. A purified form of albuterol, levalbuterol in many cases causes fewer side effects in children, and studies have shown it reduces hospitalizations, Dr. Lanier said.
Levalbuterol costs about a dollar more a dose than albuterol. That doesn’t sound like much, but a hospital dispensing 100,000 doses a month would feel the pinch. The question is, does the higher cost up front pay for itself in fewer hospital admissions and ER visits? Nobody asks that question, Dr. Lanier charged.
“The people whose turf it is to control pharmacy costs are not the same people whose turf it is to control hospital costs,” he said. “Everybody is protecting their own turf, not getting together.”
Michael Gibbons is senior associate editor of ADVANCE.
ASTHMA DRUGS PLACED ON PREFERRED LIST
In West Virginia, Medicaid paid $250 million for prescription medications during fiscal 2002, said John Law of the state’s Department of Health and Human Resources. “For fiscal 2003, we project the cost will be $310 million — more than what Medicaid pays to keep about 10,000 West Virginians in nursing homes.”
A pharmacy and therapeutics advisory committee took action to curb these costs by placing the following asthma drugs on a preferred list:
• fluticasone propionate (Flovent®, GlaxoSmithKline)
• fluticasone propionate and salmeterol xinafoate (Advair™, GlaxoSmithKline)
• montelukast sodium (Singulair®, Merck & Co.)
• salmeterol xinafoate (Serevent®, GlaxoSmithKline).
Doctors in West Virginia need preapproval to prescribe:
• budesonide (Pulmicort™, Astra Zeneca)
• beclomethasone dipropionate (Vanceril®, Schering-Plough)
• flunisolide (Aerobid®, Forest Laboratories)
• zafirlukast (Accolate®, Astra Zeneca).
“This has taken no drugs away from Medicaid recipients,” Law said. “And if I go to get my medicine and find that it needs preapproval, the pharmacist has to give me a three-day supply.”