When Marie D'Orsaneo's rheumatoid arthritis worsened three years ago, her doctor prescribed Rituxan, an expensive injectable drug that her employer-sponsored health plan had to sign off on first.

In the four weeks D'Orsaneo waited for that approval, the 41-year-old physician's assistant says her health deteriorated so rapidly she had to leave her job, move in with relatives and was eventually hospitalized.

"I couldn't afford to pay for the drug on my own," says D'Orsaneo, who lives in Philadelphia and estimates Rituxan costs about $7,000 per month plus facility costs. "But waiting came with a huge cost of its own."

Fewer and fewer consumers today can count on their prescription drug benefits to cover all the medications they take with no restrictions. Overall prescription drug costs have fallen, thanks to greater use of generics. The exception is specialty drugs, typically biologics, for which there are currently no substitutes. In addition to rheumatoid arthritis, these medications often treat difficult-to-manage conditions including multiple sclerosis, chronic pain, HIV and cancer.

Approximately 57 million Americans rely on specialty drugs, according to the Independent Specialty Pharmacy Coalition. The cost is high — averaging $1,766 per prescription in 2011, according to prescription benefits manager Express Scripts. Traditional drugs cost $53.97 per prescription on average.

The number of patients who could benefit from these more sophisticated therapies will only continue to grow, in some cases by 15 percent annually. "By 2016, seven of the top-selling drugs are going to be specialty drugs," says Adam J. Fein of Pembroke Consulting, whose clients are pharmaceutical manufacturers.

Employers are struggling to contain costs. Many have adopted tiered prescription benefit plans, with specialty drugs in the fourth tier, which has the highest cost-sharing either through co-payments or co-insurance. Plus, only about half of employees have any annual cap on how much co-insurance they'll pay on fourth-tier prescriptions, according to the 2012 Kaiser/HRET Employer Health Benefits Survey.

Also common is requiring prior approval for a particular drug or "step therapy" where a patient must try a number of cheaper drugs before they will cover certain prescriptions. Other prescription plans mandate where pharmacy members must purchase specialty drugs. A new trend limits the quantity of medication dispensed to cover 30 days in order to prove it is effective first, according to a recent survey by drugmaker EMC Serono Inc.

The issue, patient advocates say, is that any cost-savings must be weighed against severe health consequences like D'Orsaneo's. "For rheumatoid arthritis, for instance, waiting for prior authorization or trying an ineffective drug first can mean the loss of a joint. How do you price losing the use of your thumb?" says Seth Ginsberg of the New York-based non-profit Global Healthy Living Foundation.

Several states, including California, New York and New Jersey, are now considering legislation that would ban so-called "fail first" policies, Ginsberg says. "Insurance plans should not come between the patient and the doctor who is right there with them, deciding what the best course of treatment is."

Some relief is in sight. Starting in 2014, the Affordable Care Act will require insurers to restrict out-of-pocket costs, including for prescription drugs. The cap for an individual will be about $6,000 and $12,000 for families.

There are steps a patient can take now to help ease the path to the medication they need. Here are few tips: 

• Contact the drug manufacturer directly. Fein recommends doing this before ever reaching out to your health plan because most have a group that assists patients in navigating the insurance approval process as quickly as possible.

  You may qualify for the drugmaker's patient assistance program, which can bring down the price dramatically. Seven out of 10 biologic makers, for instance, have programs to offset co-pays, according to a September survey by Zitter Group, a life-sciences research firm.

  Drugmaker Amgen's copay offset program for Enbrel, a rheumatoid arthritis and psoriasis treatment, for example, saved patients, on average, $180.82 per prescription in copays during the first three quarters of 2012, according to the Zitter Group research. Patients paid no co-pay at all for the first six months on treatment, and $10 per refill for the next six months.

• Charm your doctor's office administrator. Health plans often require prior authorizations to be faxed in triplicate. That's why one of the biggest hurdles to treatment can be the paperwork alone, necessitating a great deal of patience from your doctor's staff. Being polite and persistent goes a long way.
• Work with your doctor to document your health history. Maintaining an on-going record of what therapies you've tried in the past can head off some questions in a prior approval process upfront.

  "We've had clients whose insurance companies will make them go back and try medicines they've already failed on years before," says Brittany Allen, a staff attorney for the group Advocacy for Patients with Chronic Illness. "But some allow a look-back period that will grandfather them in."

  Doctors can also help find creative solutions. When Pat Killingsworth was diagnosed in 2007 with multiple myeloma, a bone marrow cancer, his doctors at Mayo Clinic prescribed Revlimid, an oral chemotherapy drug. But his health insurer, Blue Cross/Blue Shield, refused to pay, saying the FDA had not approved Revlimid for newly diagnosed patients and insisting he try an older therapy first.

  With the help of his doctors and nurses, Killingsworth found a loophole -- he'd previously had radiation therapy -- and his insurance appeal was granted. "It wasn't what the insurance company originally wanted, but they accepted it anyway," Killingsworth, now a patient advocate living in Weeki Wachee, Florida.

• Ask your employer for help. Three in five workers are in a self-insured health plan, according to the Kaiser 2012 survey. That means their employer has assumed the financial risk of enrollees' medical claims, even if a third-party firm administers them.

  Going to your employer directly then can sometimes speed up the approval process, Allen says, especially if you have been with the company for several years. Although rare, self-insured employers may also be willing to overrule their health plan in the case of a denial.

• Appeal plan decisions. The worst-case scenario is that a request for a treatment is turned down. Every decision, however, can be appealed, a process that your insurer should provide instructions on in its denial letter. In Allen's experience, about 80 percent of appeals have led to a denial being overturned. Here again, however, maintaining comprehensive medical records is important.
• Pay attention to deadlines. "If you miss one, you don't get another chance," Allen adds.

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