AAO and AGS Statement on Glaucoma Eye Drop Restrictions
Changes in our health care system continue to create unintended consequences for glaucoma patients who rely upon pharmaceutical benefit plans to provide their glaucoma medications. Eye drops are different than pills. Eye drops are difficult to administer by over 2/3 of patients with many having trouble accurately administering a single drop onto their eyes. Many of these patients are faced with the additional difficulties of early refill denials due to quantity restrictions, lack of access to certain medications due to limited formularies, and high out-of-pocket copays.
Chronic medical therapy of glaucoma is a critical and cost-effective first line of treatment. Gaps in the treatment of glaucoma can lead to vision loss and blindness. This statement is submitted on behalf of members of the American Glaucoma Society (AGS), an organization of over 700 ophthalmologists who specialize in glaucoma care and surgery, and the American Academy of Ophthalmology (Academy), the world’s largest association of over 29,000 eye physicians and surgeons. We are committed to providing optimum care for the glaucoma patient.
Pharmacy benefit programs with Medicare Part D, and non-Medicare commercial health insurance plans, typically have strict limitations on the frequency of medication refills prescribed for chronic conditions. Plans restrict patients from refilling medications earlier than the single month or 90-day refill date. The number of drops in various bottles of glaucoma medications is known, assuming a constant bottle angle and pressure on the bottle. Despite the fact that bottles may contain more drops than the labeled quantity, there are numerous reports of patients running out of drops prematurely and patients unable to obtain refills under their plans prior to the allowed refill date. The current monthly volumes of eye drops allowed by health plans are often inadequate due to common and inadvertent wastage of drops when eye drops are applied. Often this leads to patients either stretching out their eye drop prescription (e.g., taking a twice daily medication once a day) or discontinuing their use of eye drops until the next allowable refill under their drug plan; creating a gap in care where the patient’s disease may worsen.
The AGS and Academy are very concerned about inadequate access to necessary medication for chronic glaucoma treatment. In 2009, and again in 2010, our organizations approached the oversight committee for the Medicare Part D drug plans and were able to effect changes that resulted in an easing of the refill restrictions. Medicare Part D drug plans now allow an override of the refill limits when patients seek to refill their eye drop prescription at 70% of the predicted days of use, e.g., at day 21 for a 30-day supply. In addition, physicians can now request authorization for even earlier refills for patients in need.
Eight state ophthalmology societies have been successful in working with their state legislators to enact laws, enabling patients to refill their eye drop medications on demand for commercial drug plans as of 2014. While these activities have helped alleviate some of the barriers to eye drop medication access in some populations, the AGS and Academy hope to eliminate refill access problems for all patients. The AGS and Academy entreat health insurers with pharmacy benefit plans, and their pharmacy benefit managers, to study this issue further and re-evaluate their refill policies for eye drop medications. The AGS and Academy would be delighted to assist with this process.
Restricted and tiered formularies for glaucoma eye drop medications have become standard policy for all pharmaceutical benefit plans in Medicare Part D and commercial insurances. Various strategies are employed to incentivize patients and encourage providers to use the least expensive glaucoma medication. Some drugs are restricted by “quantity limits” and are subject to the concerns we described above. Other drugs are restricted by “step therapy” that requires physicians to prescribe and document the discontinuance of a lower-tier drug before allowing access to a higher-tier medication. Finally, some drugs are placed in a prohibitively high-cost tier. Because each drug plan formulary is different, this information is often lacking to both the physician and patients until the patient presents their prescription to their pharmacist, although some electronic prescribing systems now provide tier-level information for some plans. Pharmacists, however, have direct patient-specific access to tier-level copay amounts, deductibles, drug plan prior authorization fax numbers and addresses, while physicians do not. This limits our members’ ability to counsel patients about drug costs and restrictions. Step-therapy often requires multiple interactions with the drug plan on the part of the physician to provide records, sometimes from many years prior, to prove to the plan that the patient has tried and failed a particular therapy. During this time-consuming process, the patient is denied access to needed medications.
A particularly troubling feature of formulary management is the ability for drug plans to switch tiers for their drugs on a yearly basis. The most common scenario is for brand name drugs within the same class to be moved back and forth from one tier to another, presumably due to the negotiated costs and rebates of the drug. The workflow cost to an insurer making a formulary tier change within class is negligible, while the cost to a physician’s practice is high. Managing phone calls from patients and pharmacists who want to avoid the higher copay or are concerned about a change in medication, rewriting and authorizing prescriptions, and educating patients and fielding their questions about a medication change and potential side effects is time-consuming and costly to a practice, while achieving no real benefit for the patient. In addition, if a change in medication is made, patients must return to the office for an earlier re-evaluation, increasing health care spending (often more than the price differential to the pharmacy plan).
The AGS and Academy ask the pharmacy benefit managers to carefully evaluate their formulary changes with these issues in mind, ensuring that both physicians and patients have timely access and reasonable cost for their glaucoma medications. Plans should consider a system whereby a patient who has had documented success with a particular medication in a prior year is allowed to continue at the same or lower tier-level copay in subsequent years.
In addition, the Academy, along with other medical organizations, has suggested that the Center for Medicare and Medicaid Services (CMS) create a billing code that would reimburse a physician whenever the practice is managing a drug prescription issue that develops solely due to a formulary change from an insurer.
In the United States, there are millions of patients treated with topical eye medications each year. In the treatment of glaucoma, almost 75% are treated with more than one medication simultaneously for long periods of time, often years. It has long been recognized that non-adherence is a significant roadblock to successful treatment of patients even when appropriate medications are easily available. Inadequately treated glaucoma leads to irreversible vision impairment and blindness. Although there are patients who are vigilant in taking their eye drops regularly and on schedule, ophthalmology is relatively unique, however, as even compliant patients may not be able to administer eye drops correctly and may waste a significant volume every day. Unlike pills, eye drops are difficult to use and are a less reliable drug delivery system. We have found that, even in experienced glaucoma patients who self-administer their eye drops, between 53–61% regularly administer more than one drop at a time, many without even realizing it. These numbers are increased in those with poor vision from glaucoma, cataract, or retinal diseases. Eighty percent of these patients with visual comorbidities are unable to adequately instill a single eye drop at a time.
Physical disabilities can also interfere with the administration of eye drops. It is particularly difficult for older patients to master and perform this task proficiently. Eye drop administration requires both the technical ability to easily squeeze out a single drop and the hand-eye coordination to find the eye and squeeze the drop onto the eye. Regrettably, especially in older individuals where glaucoma is more common, diseases such as arthritis, tremor, Parkinson disease, and other neurological and musculoskeletal problems make it difficult to accurately squeeze the bottle to administer just a single drop. It is not uncommon for some patients to require double the allowed volume.
Ophthalmologists are increasingly aware that restrictions on medication availability are a component of poor outcomes in glaucoma treatment. It is well recognized that increased cost is associated with lack of adherence. Expecting the patient to pay full retail prices out-of-pocket for additional medication to cover the refill gap or for non-formulary medications is unrealistic, even if the patient is made aware that such an option exists.
High copays for drugs and increasingly popular high-deductible insurance plans will likely exacerbate patient concerns about drug costs in the future. Physicians and patients should have direct, easy access to all the cost information available for all drug plans in real-time, including links to online authorization portals for all drug plans.
Glaucoma patients who go untreated, even for relatively short periods of time, run the risk of worsening vision loss and increased likelihood of requiring surgical intervention for their disease. Surgical intervention carries far greater risk than chronic medical therapy and increases health care costs. Vision loss from glaucoma has been associated with an increase in the rates of falls, depression, difficulty with facial recognition, inability to drive, reading difficulty, reduced physical activity, and nursing home admissions.
The AGS and Academy entreat health insurers with pharmacy benefit plans and their pharmacy benefit managers to study these issues further and re-evaluate their refill and formulary tiering policies for eye drop medications. Strategies to increase eye drop availability should be immediately instituted to prevent interruption and gaps in treatment for our patients.
American Glaucoma Society, June 2009; revised and approved January 2014
American Academy of Ophthalmology, Quality of Care Secretariat, June 2009; revised and approved January 2014
Copyright© 2009–2014. American Academy of Ophthalmology and American Glaucoma Society®. All rights reserved.
Please Note: The Centers for Medicare & Medicaid Services (CMS) issued a memorandum to insurers advising them to ease restrictions on early refill requests for topical ophthalmic drugs. Patients are directed to contact 1-800-Medicare if a patient receives a denial. Click here for instructions.