What happens when the patient goes to the pharmacy to fill a prescription? Many times, you won’t know and you never find out.

What might happen: The pharmacist explains that the prescribed medication is not on the patient’s formulary. Then the patient might end up getting a generic when the brand name is necessary. Or, the patient might needlessly pay out-of-pocket when an equivalent, covered drug would have been substitutable. Or, worse yet, the patient might simply give up and leave the pharmacy with no medication at all.

These scenarios can sometimes be avoided if you take a little bit of time to learn how to deal with problems when the drug plan’s formulary says ‘no’ to your Rx.

Why Have a Formulary?
Formularies restrict the options of drugs covered in a plan. But, why exclude any drug that a patient might need? Why do health plans even have formularies?

“The primary reason formularies exist is to keep costs down,” says optometrist and registered pharmacist Jill Autry, of the Eye Center of Texas. “Prescription drug plans make contracts to get the best deal on drugs. They also limit the number of options to streamline the choices—especially when there are similar drugs in a single drug class. So, it’s not only a pharmaceutical issue, but also a monetary issue.”

Among glaucoma drugs, for example, not all the prostaglandin analogs may be available on the drug plan’s formulary. And, different drug plans include different agents. “The problem is, you usually don’t know what’s on the formulary,” Dr. Autry says. “Aetna is going to have one prostaglandin, but UnitedHealthcare is going to have a different one. Some plans will have two, but they won’t have the third. Most of the time, you won’t know.”

Even if you did know, it still wouldn’t be easy. “We just can’t keep track of which drug is on which formulary. That would be a full-time job trying to do that,” says Cynthia Heard, associate professor of optometry and low vision residency supervisor at the Eye Center at Southern College of Optometry.

Help Patients Avoid the 'Donut Hole' in Medicare Part D
By Robert J. Noecker, M.D., M.B.A., Randall D. Seifert, Pharm.D., and Cholappadi Sundar-Raj, O.D., Ph.D.

One of the concerns practitioners commonly hear about is patients’ cost for out-of-pocket for medications. This can ultimately influence whether a prescription is filled or stretched out by skipping days.

Treating ocular disease is not only about looking through the slit lamp and writing an Rx. In today’s economic environment, eye care practitioners also face daily challenges to ensure that patients can obtain and take their medications. So, we’re also involved with such tasks as learning formulary coverage, obtaining prior authorizations, and handling pharmacy call backs.

In the management of glaucoma, long-term medication therapy is integral to stemming progression. Almost 50% of patients require multiple agents, and a majority of glaucoma patients have their medications covered by Medicare Part D.1 By understanding this program and its implications, we can help to minimize some of the issues patients face, enhance their drug adherence, and improve their long-term outcomes.

Medicare Part D and the Donut Hole
The advent of Medicare Part D for drug coverage has been one of the most significant changes in health care coverage this past decade. In this program, patients pay premiums of $304 a year, on average.2 Once a patient meets his or her $275 deductible, approximately three-quarters of the cost of the drug is covered, provided that a preferred agent is selected.

The patient receives coverage until reaching a threshold of $2,700. Above this amount, the patient falls into the infamous “donut hole”—a coverage gap that requires full payment until the patient meets a total expense of approximately $6,136. Once the patient reachers this higher amount, the government picks up 95% of the expense of drugs.

Low-income seniors under Medicaid are considered “dual eligible” as they can also receive Medicare Part D. These individuals do not have to pay monthly premiums, have no deductibles, have low co-pays, and are not subject to the “donut hole.”

A variety of Part D drug benefits are available and this can create confusion. For instance, plans under the same organization—such as AARP—can offer several plans with different premium levels, deductibles and benefits. So, while one AARP patient may pay $60 a month for one prostaglandin, the next patient may not have the same benefit—and perhaps not even be covered at all.

Stretching Meds
Many practitioners commonly hear about the cost their patients have to pay out-of-pocket for medications. However, almost one-third of patients never let their doctor know that cost is such an issue.3 Instead, they simply do not fill a prescription or they skip days to stretch it out.

Interestingly, the Kaiser Family Foundation found that approximately one-quarter of their Medicare Part D standard enrollees fell into the “donut hole” coverage gap, and stayed there for four months on average.2 Many of these patients even admitted to altering their medication schedule or discontinuing therapy altogether.

Shrank and colleagues looked at this issue in patients taking chronic medications who had a three-tier pharmacy benefit.4 Those on tier-2-preferred agents (lowest co-pays) were 30% more likely to achieve adequate adherence than those patients on non-preferred medications. Patients were more compliant in the subsequent year, meaning they remained on therapy long-term.

In the management of glaucoma, we seek to keep our patients’ pressures as low as possible. To this end, we believe patients will fill their glaucoma medications every month. In reality, many fall short of our expectations. By stretching out a bottle or taking the medication prior to an eye care visit, patients may be actually filling their prescriptions only between six and eight times a year.

What Can We Do?
Practitioners may need to take a closer look at a few strategies to improve patient access and adherence.

• Ask for drug card. We need to understand that a patient’s drug and health care coverage are not always the same. Eye care practices usually copy the Medicare card for services, but fail to obtain the separate drug card. As a result, we are left without critical information regarding what is covered and what may be preferred. We can have the reception desk ask to copy the patient’s drug card and empower a staff member already handling refills or reimbursement to be the office specialist on medication coverage.

• Get familiar with the formulary. Furthermore, we should become familiar with the formulary coverage of different drugs in the major plans in our areas. Most Part D plans have a tiered cost-sharing structure with incentives for enrollees to use less expensive generic and “preferred” brand-name drugs. Plans define tier 2 as preferred and tier 3 as non-preferred agents on their formularies.

With glaucoma medications, we can evaluate which agents might have a broader coverage base. Prescribing preferred or tier 2 agents can lower our patients’ co-pays and prevent them from reaching the “donut hole” sooner. This can help minimize pharmacy call backs or an unfilled prescription. In the UnitedHealth Rx Value Plan, for example, the monthly co-pay for a preferred brand medication is $35 vs. $69.60 for the non-preferred medication, netting a difference of $415/year.5 For dual eligible patients, this difference would be greater.

The top 15 Medicare Part D plans nationally cover more than 85% of enrolled lives. In the prostaglandin analog category, where out-of-pocket cost can be a concern, 97% of the lives in these top 15 plans in 2008 had preferred access for Travatan or Travatan   Z (travoprost, Alcon), 84% for Lumigan (bimatoprost, Allergan), and 42% for Xalatan (latanoprost, Pfizer).6

• Ask about mail-order. Double check on quantity limits (QL) to see if coverage allows larger bottles to save on co-pays. Ensure that dual eligibles are aware of their coverage. Ask your patients to check to see if their plan has a mail-order option, which can allow for a 90-day supply (three bottles) for only two co-pays.

• Consider generics. Determine where generics can be appropriately used, provided that they make sense clinically. These are usually covered on tier 1. In October 2008, the FDA approved a generic version of the fixed combination of timolol/dorzolamide, which may make a reasonable alternative to Cosopt (Merck).

• Watch the step therapy. Keep your eyes open for step therapy coming down the line. For example, step therapy for a tier 3 or a non-covered prostaglandin would require an adequate trial on a covered tier 2 prostaglandin before the carrier covers this agent. By being proactive regarding this, you can eliminate unnecessary call backs.

• Patients max out plans later in the year. Realize that the “donut hole” will occur for many patients during the final quarter of the year. Have a plan in place by working with your patients and company representatives. This is particularly important for those individuals taking multiple medications.

• Stay current. Information is power. Utilize resources such as www.fingertipformulary.com and company representatives to obtain current coverage information.

• See for yourself. Finally, we need to watch our patients’ medication-taking behavior a little more closely. Request that they bring their bottles back. Ask more open-ended questions regarding how they are taking their medications. We should not rely on IOP control alone, but rather make sure we are looking at the big picture by evaluating disease progression through repeated visual fields and imaging.

Making a Difference
In today’s environment, we can make a difference. As practitioners, we need to recognize that access to medications and managed care are very important issues. Payers influence behavior with co-pay differentials, prior authorizations, or step therapy requirements.

So, we need to have a plan. Knowing which agents are preferred and covered on formularies can not only help with the administrative issues we have to manage as a result but, more importantly, impact patient adherence and the longer-term outcomes with the treatments we prescribe for our glaucoma patients.

Dr. Noecker is vice chair and associate professor of ophthalmology and director of the glaucoma service at University of Pittsburgh Medical Center Eye Center. He is a consultant for Allergan and Alcon, and is on the speakers’ bureaus for Merck and ISTA. Dr. Seifert is senior associate dean and professor at the University of Minnesota College of Pharmacy, Duluth. Dr. Sundar-Raj is assistant professor of ophthalmology at the University of Pittsburgh Medical Center Eye Center.

1. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):701-13.
2. Kaiser Family Foundation. The Medicare Part D Coverage Gap: Costs and Consequences in 2007. 2008 August. Available at: www.kff.org/medicar/7811.cfm (accessed October 25, 2008).
3. Piette JD. Cost-related medication underuse: do patients with chronic illnesses tell their doctors? Arch Int Med. 2004;164(16):1723-4.
4. Shrank WH, Hoang T, Ettner SL, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006 Feb 13;166(3):332-7.
5. UnitedHealth Rx Basic Summary of Benefits. Available at: www.uhcmedicarerx.com/online_documents/ovation/pdf/pdp/en/2009/SBPDP3064597_XUBE000.pdf-2008-09-23 (accessed January 24, 2010).
6. Fingertip Formulary. Available at: www.fingertipformulary.com (accessed December 1, 2008).

Perils of Switching Meds
To further complicate things, drug plans seem to change their formularies all too often. “It seems like they switch from time to time. We might have started a patient on a particular prostaglandin six months ago, and all of a sudden now their carrier doesn’t cover that particular one,” says Dr. Heard, who authors the pocket-sized “Optometry Drug Guide” (Anadem Publishing). “We may have to change the patient’s therapy midstream, although typically to another prostaglandin. At least we’re not locked out of that class of drug.” But, switching meds midstream can complicate care and compliance.

“With Medicaid, it seems to change every year,” Dr. Autry says. “We’ll spend a year switching every Medicaid patient over to, say, Xalatan (latanoprost, Pfizer). Then the next year, we have to switch everybody back to something else.”

In the future, electronic medical records and e-prescribing may simplify this, allowing prescribers to take a quick glance at the patient’s electronic chart to see what’s covered on the formulary and what isn’t, Dr. Autry predicts. (But she doesn’t predict this kind of electronic prognostication will be widely used any time soon.)

So for now, patients may just have to go through trial and error when they fill a prescription. For instance, the patient takes the prescription to the pharmacist, only to be told that the medication is not covered. This can confuse the patient, and possibly derail the prescriber’s therapeutic plan.

“Most times, we don’t find out until the patient actually takes the prescription to the pharmacy and is told that that the prescribed drug is not on the formulary list for their covered plan,” Dr. Heard says. Usually, the pharmacist will call and notify the prescriber.

But sometimes, a busy pharmacist doesn’t have the time to explain all this to the patient, Dr. Autry says. “Then, unfortunately, the patient leaves the pharmacy with the impression that the medication is not covered at all, and they don’t get it filled,” she says. “In those cases, we don’t find out until patients come back for follow-up and explain that they didn’t get their medication. Or sometimes, we lose the patient to follow-up altogether.”

Other times, the patient doesn’t learn or doesn’t understand that there are other, similar medications that are covered on the formulary. So, the patient winds up paying out-of-pocket for the expensive prescribed medication instead of simply paying a co-pay for a similar medication of the same drug class.

“What should happen is that pharmacist should call the physician and ask about switching the patient to the different medication that is on the formulary,” says Randall Thomas, O.D., M.P.H., of Concord, N.C., and co-author of Review’s annual “Clinical Guide to Ophthalmic Drugs.”

But, it’s also the doctor’s job to keep costs in mind when choosing a medication for the patient, Dr. Thomas says. Indeed, at least one in 10 Americans cite cost as a barrier to medication compliance.1 Even worse, nearly half of glaucoma patients discontinue their drops within six months.2 So, now more than ever, “physicians have a responsibility to prescribe thoughtfully,” Dr. Thomas says.

To that end, these doctors discuss the formulary issues for the following ocular drug classes.

Glaucoma Drugs
“In my experience, when you’re dealing with formulary issues in ocular disease, most of the time you’re talking about glaucoma,” Dr. Autry says. And most of the time, she says, those issues are with the prostaglandins.

That’s because prostaglandins are among the most expensive medications in eye care, and they’re used indefinitely—for the rest of the patient’s life. So for these reasons, prescription drug plans keep their purse strings tight for this class of medication.

Fortunately, any formulary should include at least one of the prostaglandin analogs if not two, Dr. Autry says. So, if the prostaglandin you wrote for is not covered, a similar one should be.

“Among the prostaglandins, there are some subtle differences in terms of local side effects, but generally—in the larger scheme of things—the efficacy is about the same,” she says. “So, if cost is a concern, and you don’t have a reason that a different prostaglandin is contraindicated in the patient, then why not switch?”

Dr. Thomas agrees. “I’ll just write on the prescription pad, ‘Prostaglandin ophthalmic solution—dispense the least expensive.’”

Occasionally, the drug plan requires that a drug from a less expensive class must be attempted first, and then fail, before a more expensive class of drug is used. For example, a beta-blocker should be tried before a prostaglandin.

If that’s the case, Dr. Heard steers the patient toward a generic version. “In many big pharmacies, generic prescriptions are $4 a bottle. That’s a good option for patients, as opposed to paying a much larger co-pay for a medication that’s vital for them to maintain their vision and their lifestyle.”

But, when nothing but a particular drug class will do, then it’s up to the prescriber to call the drug plan and request that the patient get what he or she needs.

 “Usually when you call, you’re talking to a nurse practitioner or a physician assistant, not an eye doctor,” Dr. Autry says. “So, you have to explain why this patient needs to be on a drug from a different class—whether it’s because of compliance, side effects, or a history of failing a drug in that class. Often they’ll approve it when you make your case.” Have back-up documentation ready to send, if necessary.

For example, “one instance in which I don’t want the patient to be switched is between brand name Alphagan P (brimonidine 0.1%, Allergan) and generic brimonidine 0.15% or 0.2%, which has a significantly higher incidence of ocular allergy that will eliminate the ability to use brimonidine in any strength in the future,” Dr. Autry says.

Of course, not all doctors agree on all therapeutic options. Alphagan P is a good drug, Dr. Thomas says, but generic brimonidine is acceptable. “Generic brimonidine is much less expensive than Alphagan P and performs just as well, although it does have the potential to cause more ocular surface redness,” he says.

Among the carbonic anhydrase inhibitors, Dr. Thomas also recommends using generic dorzolamide or generic dorzolamide/timolol maleate now that the name brands of Merck’s Trusopt and Cosopt are available generically.

Also worth noting: “When Xalatan goes generic in March 2011, that should be a huge financial break for glaucoma patients,” Dr. Thomas predicts.

The generic vs. brand name question also comes up when using steroids. For tough cases, doctors usually insist on the name brand.

“If it’s a mild or moderate case of iritis, then generic prednisolone acetate is perfectly fine,” says Dr. Thomas. “But if it’s severe, you want Allergan’s Pred Forte (prednisolone acetate 1%). If your mother came in to see me with a bad iritis, I would write out Pred Forte and I would say to her, ‘You make sure that you get Allergan’s Pred Forte, because you don’t want a generic version of this drug. You need the real deal.’”

Dr. Heard agrees. “Pred Forte continues to be the better option because of the bioavailability of the drug—the generic just does not work the same way on the eye,” she says. “It just does not penetrate the cornea and get to the site of action where we really need it to go. So, we do have to go to bat for the patient when it comes to Pred Forte.”

As a rule, most pharmacists are required to make generic substitutions when one is available, Dr. Autry says. Pred Forte will likely be on the patient’s formulary, but at a higher cost than the generic prednisolone acetate. So, when you fill out the prescription for Pred Forte, you have to write “brand name medically necessary,” “dispense as written,” or something similar, Dr. Autry says. (The wording differs in many states.)

Even if you check the box “dispense as written” on the Rx, most states require a generic to be dispensed unless you hand write the state-specific wording. “Write it out on the prescription,” Dr. Autry says.

For extended use of a steroid, Dr. Thomas also steers patients away from generic prednisolone acetate and toward brand name Lotemax (loteprednol 0.5%, Bausch & Lomb).

“You don’t want to use a steroid chronically that’s not an ester-based steroid. So, if you’re going to prescribe steroids chronically, as in chronic uveitis or in dry eye, you truly need to demand for it to be loteprednol—and the same will be true when loteprednol goes generic,” he says. “Sometimes I’ll say to the patient, ‘There’s a drug you can get for four dollars—generic prednisolone acetate—but for your condition, we need you to use Lotemax because it’s a different chemistry and it’s just going to be much safer for you to use long term.’” This way, the patient can question the pharmacist if the pharmacist substitutes the generic.

The formulary issues for antibiotics likely involve fourth-generation fluoroquinolones. “We know there’s less resistance to fourth-generation fluoroquinolones vs. the fluoroquinolones that have been around in medicine for 20 or 25 years,” Dr. Heard says. “The plan might have an older, less expensive drug on their formulary that’s technically in the same class, but because of resistance issues, we know it probably won’t work as well as some of the newer fluoroquinolones.”

Adding to the problem: the acute nature of an infection, which needs a quick solution. “Something like a corneal ulcer is a real quandary because we might give a patient a sample to start treatment, and then the patient goes to their pharmacy and finds out that one that we gave them ends up not being on their formulary,” Dr. Heard says.

It’s problematic to switch drugs at that critical time, she says. Instead, “we either work with the patient to figure out how to get the drug at a reasonable price, or we end up giving them an additional sample because we’re seeing them on daily basis,” she says. “Then once we’re out of the woods, we’ll either switch to the other drug that’s on their formulary, or we’ll keep giving them samples of what we have—and hopefully we have it—until we can get them to a place where they’re healing nicely and we’re not concerned any more that the situation could actually get worse vs. better.”

Dr. Heard says she’s familiar with the patient assistance programs to help get patients free or reduced-cost medications. But, “the turnaround time to get approval on those can be three or four weeks,” she says. “And, when someone has a corneal ulcer, you have to act much faster than that. Typically, we use those programs for our glaucoma patients.”

Dry Eye
Usually, when a drug is unique, it will be included on the formulary, Dr. Autry says. Restasis (cyclosporine, Allergan), the only prescription medication indicated for producing more tears, is one such drug. But, that doesn’t mean that prescribing Restasis is smooth sailing. “The problem is that some drug plans require prior authorization before approving it,” Dr. Autry says. Why? Because it’s an expensive drug that the patient will be on for an indefinite period.

“So, it’s not that the formulary says ‘no.’ It’s that they want you to go through a couple of hoops in order to get it approved for the patient,” she says. Usually, that means a phone call to the insurer where you have to state your case. The only complication: The patient has to give you the drug plan’s phone number (provided by the pharmacist), or tell you exactly which plan he or she is on so you know which number to call. Again, the patient may misinterpret the situation and leave the pharmacy thinking Restasis isn’t covered, and may be lost to follow-up.

Now that topical ketotifen is available over the counter, patients have an easy, effective and affordable way to treat ocular allergies. “In fact, I steer people to over-the-counter options as opposed to them purchasing something more expensive through their insurance,” Dr. Heard says.

Then again, “if the patient has a small co-pay, sometimes it’s actually more affordable to go through their insurance as opposed to buying over-the-counter,” she says. For example, a patient’s co-pay might be $7, but a 10mL bottle of Alaway (ketotifen, Bausch & Lomb), or a 5mL bottle of Zaditor (ketotifen, Novartis), costs about $14.

“You don’t want to end up with compliance issues that could be prevented on the front end,” Dr. Heard says. Dealing with formulary issues is just one part of an overall strategy to help your patients to obtain—and properly use—the drugs you want them to use.

1. Kennedy J, Morgan S. A cross-national study of prescription nonadherence due to cost: data from the Joint Canada-United States Survey of Health. Clin Ther. 2006 Aug;28(8):1217-24.
2. Nordstrom BL, Friedman DS, Mozaffari E, et al. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005 Oct;140(4):598-606.