Economic, managed care realities force glaucoma patients to reassess priorities

Cost concerns are an ever-present reality for glaucoma patients, but the effects of the down economy and managed care deficiencies are currently redefining treatment protocols.

Glaucoma patients with limited financial resources may be making decisions about their care with detrimental implications. For some, the confounding influence of managed care is leading to skipped appointments, rescheduled tests, delayed prescribed doses or “drug holidays” — the practice of intentionally stopping medication for an extended period of time.

According to some experts, these practices are a dangerous and troubling development, especially given that medication compliance is crucial to avoid IOP fluctuations. But for some patients who are forced to prioritize their spending, medical care falls by the wayside.

“I think it comes down to how people are spending their disposable, or not so disposable, income,” Robert J. Noecker, MD, MBA, said. “Most people have to pay some portion of their medical care, and like it or not, medical care, except at the extreme level, is something that can be put off. Rightfully or wrongfully, people can put it off.”

Robert J. Noecker, MD, MBA, has noticed the impact of the down economy on patient compliance issues. Image: Massimino C

In addition, patients may not be comfortable discussing financial problems with their care providers, further affecting how the current economy is changing the way glaucoma care is delivered.

Switching agents

Dr. Noecker said he recently had a glaucoma patient who was being managed medically on a prostaglandin agent. The patient’s glaucoma was well-controlled, but the agent was a non-preferred tier 3 agent under the patient’s prescription drug plan.

Although the medication was having the desired effect, the patient thought the $75 a month price tag was becoming burdensome. After looking at options in the patient’s plan, however, Dr. Noecker was able to switch the prescription to a preferred tier 2 agent, saving the patient nearly $50 a month.

“She was really appreciative of my sensitivity to that. Sometimes that’s easy to do, sometimes it’s not. But I think it kept her engaged in her treatment decision rather than allowing her to fall off on her own,” Dr. Noecker said.

Making that switch seems to be in line with published studies showing that patient adherence to medical therapy

improves when prescription drug costs are lower. According to Dr. Noecker, because compliance is an essential element of glaucoma therapy, acknowledging a patient’s economic hardship may be valuable.

Although changing medications may be a simple solution, shifting a patient’s particular management plan is not as easy, especially when managed care is involved.

Managed care is now nearly ubiquitous, but it remains a confusing system for patients and practitioners alike. In addition, Medicare Part D, which subsidizes prescription drug coverage, has made the issue more complex.

Under the Part D system, a portion of drug costs is covered after a patient pays a premium. There is a ceiling on the total yearly amount, after which patients are expected to pay full price for drugs until a second cap is reached.

For instance, under the 2009 plan, with premiums of $304 a year, patients pay a $295 deductible, and 75% of drug costs are covered until the total for the year reaches $2,700. After reaching the first benchmark, the patient pays 100% of drug costs until expenditures total $6,136, after which Medicare pays for 95% of drug costs.

That intermediate coverage gap, referred to as the “doughnut hole,” may spur some patients to take actions that are detrimental to their care. For instance, patients may skip doses, alter their dosing schedule or stop taking medication altogether.

“It is something that does happen,” Dr. Noecker said. “I wouldn’t say it’s commonplace, but it does happen. I’ve had patients who tell me they do these kinds of things.”

Noncompliance with glaucoma therapy and the accompanying risk of increased IOP fluctuation mean that some patients are unnecessarily putting themselves at risk of disease progression. By being aware of the potential issue, though, clinicians may be able to avert these kinds of troubling developments.

Opting for a plan-preferred agent is one strategy, but glaucoma specialists may also think about switching to generics, even if it means switching between classes of drugs. However, physicians need to be aware that some Part D plans require a “step edit,” which requires a patient to fail one medication before being covered for an alternative medicine, Dr. Noecker said. In addition, safety and efficacy must be considered when switching medications.

“Generic timolol is better than nothing, but I think in terms of safety and efficacy, prostaglandin analogues are still the best thing to use,” Dr. Noecker said.

Medicare doughnut hole

One of the difficulties associated with Medicare is that coverage differs from patient to patient. Additional factors can also affect how care is delivered. These include the economy, fluctuations in gas prices for patients who travel long distances to appointments, institutional policies limiting pharmaceutical companies from distributing samples and a lack of funding for patient-assistance programs.

“It has been kind of the perfect storm because a lot of it is coming at the same time. At our institution, the change in industry relationships means we can’t receive samples, which is probably coming at an inopportune time, but it is institutional policy and is in line with other institutions across the country,” Dr. Noecker said.

Growing economic problems mean that patients are paying for more drugs out of pocket. For glaucoma patients, many of whom are elderly, retired, on fixed incomes or taking multiple medications, that means the doughnut hole is being reached sooner.

One potential effect of the doughnut hole is noncompliance. According to Dr. Noecker, a Kaiser Permanente study found that about one-quarter of patients fall into the doughnut hole and remain there for up to 4 months; the study also found that many patients altered dosing regimens or skipped prescriptions in an effort to manage costs.

In his own practice, Dr. Noecker said he is seeing patients hit the coverage gap earlier in the year, which only ups the risk of noncompliance. Citing another study, Dr. Noecker said that patients are statistically more likely to adhere with a medical plan when drug costs are lower and equally likely to remain compliant after the first year if they remain on long-term therapy.

If achieving compliance is crucial, then physicians need to help patients avoid the doughnut hole. Dr. Noecker said a plan-preferred agent can make a significant difference. For instance, under the 2009 United Health Care Rx Value Plan in Texas, the co-pay for the preferred agent is $35 a month, which is significantly lower than the $69.90 for non-preferred agents – representing a cost savings of about $415 a year.

Prostaglandin analogues, often the preferred agent in glaucoma management, are one area in which glaucoma specialists may be able to help realize cost savings for patients. According to Dr. Noecker, for patients enrolled in the top 15 Medicare Part D plans nationally – a data set representing about 85% of total domestic enrollees – about 97% have preferred access to Travatan Z (travoprost ophthalmic solution 0.004%, Alcon), 84% to Lumigan (bimatoprost ophthalmic solution 0.03%, Allergan) and 42% to Xalatan (latanoprost ophthalmic solution 0.005%, Pfizer).

Requests for alternatives

Problems with medication costs are not exclusive to Medicare or other managed care plans. As expected, patients with limited or no insurance coverage are also being affected.

According to Tony Realini, MD, who has a number of uninsured or underinsured patients in his practice in West Virginia, cost considerations must focus on the high price of delivering care. He said that some of his patients who pay out of pocket are asking him to delay or skip tests or are seeking generic alternatives to medications.

Tony Realini

“The economy’s downturn has impacted the way I’ve been taking care of glaucoma patients, and not because I want to change the way I’m doing things, but because [patients] are asking me to,” Dr. Realini said.

One of the changes in Dr. Realini’s practice has been a drop in prostaglandin prescriptions and an increase in beta-blocker usage. Prostaglandin therapy is considered gold-standard therapy in some circles, but a move to beta-blockers may not be the concession that some think.

“Beta-blockers were the glaucoma community’s favorite drug in 1978 when they first came out, and we loved them right up until the day the first prostaglandin came out. I think the benefit of the move away from beta-blockers has been greatly exaggerated in the prostaglandin era,” Dr. Realini said.

That view is supported, he said, by some of the phase 3 trials of prostaglandins that found equal IOP-lowering efficacy compared with timolol. The biggest difference between the two classes may be safety concerns.

“For those patients who have contraindications, the switch [to beta-blockers] simply isn’t feasible,” Dr. Realini said. “But they are once-a-day drugs, they are cheaper than prostaglandins, they lower intraocular pressure about as well as a prostaglandin, and in patients in whom they are not contraindicated, they are probably just as safe as a prostaglandin.”

Moving a patient to a generic may not always be feasible or even desirable. Dr. Realini still uses prostaglandins as front-line therapy because they are “the safest, most effective, most conveniently dosed class of drugs we have.”

In addition, he said that being uninsured does not always mean being unable to pay, so it is important to engage patients in a conversation that relates the pros and cons of both classes. Some studies have shown patients are willing to pay more for drugs they perceive to be more effective.

Fewer tests, fewer glasses, more surgery

Glaucoma specialists may also be able to compromise with cost-concerned patients in the area of testing. Visual field testing is a valuable tool for assessing progression of or conversion to glaucoma. Imaging the optic nerve regularly is necessary to track potential sight-threatening sequelae. These tests have roles in glaucoma therapy, but they also carry a price tag and may be cost-prohibitive to an uninsured patient.

According to Dr. Realini, patients in his practice have approached him about delaying or skipping routine testing. For patients who are stable on therapy or who are glaucoma suspects, delaying a test is not a huge concern. Other patients, however, may require additional education and counseling.

“For a patient whose visual field last month showed a change and who is back this month to confirm the change so we can decide whether or not to alter therapy, I’ll usually explain to them that it’s not an option to put it off, that there is a consequence to putting it off,” Dr. Realini said.

Another form of testing that concerns patients is refractive exams. If the cost of the test itself is not prohibitive or is covered by insurance, the ancillary fee for purchasing spectacles may be an issue. As a result, patients may want to put off buying them.

“That’s probably the most telling because with a refraction, dollar-for-dollar, the patient actually gets some positive and noticeable benefit for their money,” Dr. Realini said.

The economic climate, though, may be an opportunity to think creatively. For instance, insured patients without prescription drug coverage may be eligible for surgical intervention to relieve their drug burden, resulting in a long-term cost benefit. In Dr. Realini’s practice, a number of patients have asked about this option.

“At first, I was shocked to hear that,” he said, “because no one ever asks for surgery.”

Dr. Realini realized that there may be a role for selective laser trabeculoplasty. Although he typically reserves the procedure for patients who are not well-controlled on two medicines, Dr. Realini said SLT may be an option if a patient can be controlled on one medication.

Dr. Noecker also noted a role for surgical intervention, especially when a patient is scheduled for cataract removal.

“It’s a tougher decision when it’s a purely economic reason,” Dr. Noecker said. “I will do it if a patient asks for it, but it’s a much easier decision when the control is borderline. We do a fair amount of SLT in the office for that reason.”

A sensitive subject

Like many glaucoma specialists, Gail F. Schwartz, MD, is seeing patients who are concerned about drug costs and insurance coverage. But some patients are unwilling or embarrassed to talk about the economic burden, she said. Instead, they may reschedule appointments, or skip them altogether, until they are able to pay for prescriptions.

Gail F. Schwartz

“It was most noticeable at the end of last year when patients were already in their doughnut hole for their Part D plan. A lot of patients were rescheduling for after the first of the year when their prescription plan resumed,” Dr. Schwartz said.

Many patients, she added, were not aware of alternatives that may be available. For instance, giving product samples provided by pharmaceutical companies may be a very short bridge solution, and many manufacturers offer free or low-cost medications to patients who qualify for economic hardships.

Another option may be educating patients on the coverage benefits they might already be eligible for, including getting a 3-month supply of medication for the price of two co-pays. Mail-order prescriptions may be another cost-saving alternative.

Dr. Schwartz said she discusses surgical options for patients who are marginally controlled, but is apprehensive about rescheduling routine tests and exams.

“I would sooner have them fill out a financial waiver for their portion of it if they would meet criteria than to withhold care,” she said.

Cost may be a mitigating factor in glaucoma care, but ensuring quality care should be a top priority, according to Dr. Schwartz. She begins discussions with patients regarding front-line therapy with questions about the limits of their drug coverage, and while she typically chooses a prostaglandin analogue as first-line therapy, Dr. Schwartz is willing to start certain patients on beta-blockers as primary therapy.

Dr. Schwartz also noted that “not all generics are created equal, and there should be some caution in opting for generics in certain patients.”

Patients switching medications, whether in class or to a generic, may require additional monitoring to ensure that management has not been compromised.

“These patients will require a follow-up visit to see whether the switch will be as efficacious and as well-tolerated,” Dr. Schwartz said. – by Bryan Bechtel

Would you consider any changes to address coverage gaps that occur as a result of Medicare Part D? If so, what types of changes?

• Robert J. Noecker, MD, MBA, can be reached at the University of Pittsburgh Medical Center, Eye and Ear Institute, 203 Lothrop St., 8th Floor, Pittsburgh, PA 15213; 412-647-2200; fax: 412-647-5119; e-mail: noeckerrj@upmc.edu.
• Tony Realini, MD, can be reached at West Virginia University Eye Institute, 1 Stadium Drive, P.O. Box 9193, Morgantown, WV 26505; 304-598-6884; fax: 304-598-6928; e-mail: realinia@wvuh.com.
• Gail F. Schwartz, MD, can be reached at Glaucoma Consultants, 6565 N. Charles St., Suite 302, Baltimore, MD 21204; 410-825-9225; fax: 410-825-9229; e-mail: schwartzgf@aol.com.

Are pharmacy benefit managers useful for patients?

The role of pharmacy benefit management companies has been disputed in the managed care system.

Often, these services — acting as intermediaries between drug manufacturers, pharmacies, insurance companies and patients — are able to lower drug costs for end users through volume purchasing and generic substitutions. Through negotiations with preferred vendors, pharmacy benefit managers (PBMs) are able to secure brand medications at lower costs, either offered through the primary insurance plan or as a resale option.

However, what seems like a beneficial program may not be acting in the best interest of patients. According to Alan L. Robin, MD, they may even be forcing lesser care on unsuspecting patients.

“The PBMs have really put the screws to many people. They tell patients that a bottle of medication should last a month, whereas in reality it may last for only a week or two. They change which tier a specific medication is on, they change the payment schedule to the tiers, and so many individuals may be stuck on generics,” Dr. Robin said.

And in glaucoma, a move to generics may not be a desirable outcome because “the percentage of people who will respond to IOP lowering is less with a beta-blocker than it is with a prostaglandin,” Dr. Robin said. Whereas patients may think that a generic alternative is equally efficacious, they may not understand the full ramifications of selecting a front-line agent from a class of drugs many glaucoma specialists consider to potentially be inferior, both in terms of side effects, adherence and efficacy.

“Most patients don’t know the difference between a beta-blocker and a prostaglandin or an alpha-agonist. So they really don’t know what is more suitable for them from a physical and ophthalmic perspective,” Dr. Robin said. “What I think is happening in many people is that the economy is dictating a sort of second class care that is not as effective because patients cannot afford their medication.”

One of the tools PBMs commonly use, according to Dr. Robin, is supplying multiple months of medication for a reduced co-pay. These bulk purchases appear to a useful and cost-saving benefit, but for a patient set that already struggles to instill eye drops, making a bulk purchase last could be problematic.

Dr. Robin said he recently completed a study that found that up to 50% of glaucoma patients are unable to deliver one eye drop at a time and that the difficulty in executing instillation may be an underappreciated element of glaucoma care.

• Alan L. Robin, MD, can be reached at 6115 Falls Road, Suite 333, Baltimore, MD 21209; 410-377-2422; fax: 410-377-7960; e-mail: arobin@glaucomaexpert.com.