The increasingly expensive costs of prescription drugs is a major concern in our nation today, not only for those patients who may be uninsured or underinsured, but also for their managing physicians.
As we are all very much aware, rising healthcare expenditures have been a leading topic of discussion during recent years. There are many factors that can contribute to the high costs associated with medical treatment.
Why are prescription drug costs increasing?
A recent article in The New York Times cited six reasons for the skyrocketing cost of prescription drugs in the United States as compared to other developed nations:1
- Lack of a central negotiator. Rather than a unique government body capable of negotiating directly with drug makers, the current system in the United States encompasses tens of thousands of individual health plans, resulting in far less bargaining power for the individual subscribers.
- As part of the Inflation Reduction Act of 2022, Medicare now has the ability to directly negotiate the prices of select high-expenditure, single-source drugs without generic or biosimilar competition on behalf of their constituents. However, for the vast majority of individuals with private insurance or other government programs, no such capacity exists.
- Lack of price controls. While other countries (e.g., France) can impose caps on the growth of a drug companies’ sales, there are no similar regulations in the US market. Moreover, US drug companies are not subject to legal restraints on introductory sticker prices for new drugs entering the market.
- The system inherently creates incentives toward the use of higher-priced drugs. Pharmacy benefit managers (PBMs) that negotiate with manufacturers on behalf of employers and health plans stand to make more money in “rebate fees” from manufacturers when the sticker price of a drug is higher. Likewise, doctors and hospitals who “buy and bill” for drug therapies administered in their facilities receive a percentage of the drug cost as reimbursement from 3rd party payers.
- Hence, their compensation for a drug like ranibizumab, which costs $1,800 to $2,000 per dose, is considerably higher than for a comparable agent like bevacizumab, which runs about $50 to $60 per dose.
- The current system is both fragmented and complicated. According to a representative from the Pharmaceutical Research and Manufacturers of America (PhRMA), “The United States is the only country that allows middlemen, such as PBMs, to profiteer on medicines unchecked.” Manufacturers retain only about half of the total spend from healthcare payers on prescription drugs before discounts are applied, according to a 2022 study funded by PhRMA.2
- Patent manipulation allows prices to remain higher longer. Patents grant drug manufacturers a temporary monopoly on their newly approved products, during which lower-priced generics are prohibited from entering the market. Companies in the US have discovered creative methods to prolong that period, including tactics such as accumulating patents that are only tangentially related to the drug in question.
- In ophthalmology, this is often seen as a minor change in the drug’s marketed concentration or an alteration to its delivery system (i.e., vehicle).
- Drug prices ultimately rise to whatever limit the market will bear. Drug companies often maintain that prices are reflective of the value that their products provide to patients and society; moreover, they are representative of the immense costs incurred by large-scale clinical trials, including both successful and unsuccessful drugs. However, the direct relationship between research budgets and associated drug costs has yet to be established.
The impact of drug costs on ophthalmic care
It is an unwritten rule in both optometry and ophthalmology that we invariably prescribe what we consider to be the best and most appropriate therapy for any given condition. This applies whether we are managing an insidious, sight-threatening condition like glaucoma or a primarily symptom-driven disorder such as allergic conjunctivitis or dry eye disease (DED).
At the same time however, we must acknowledge the realities of clinical practice, understanding that a patient's financial status is often the limiting factor in determining what treatments we can logically employ. This is true not only for the uninsured, but for patients with insurance coverage as well.
Despite the substantial benefit offered by health insurance, patients with both commercial and government plans may be subject to a litany of restrictions when it comes to pharmaceutical coverage. It is commonplace for product formularies and mandatory prior authorizations to limit access to many newer (and hence more expensive) forms of therapy; in the latter scenario, it may be necessary to first document failure with another “preferred drug” in a similar class.
While newer drugs may not be expressly prohibited, patients are often forced to bear the full burden of associated costs, with little or no compensation from their respective insurance provider. Even when partial insurance coverage is available, higher copayments for second or third-tier drugs may be prohibitive for individuals on a strict budget.
Without question, higher drug costs often have a direct impact on patient compliance and disease outcome. Logically, if patients cannot afford to purchase the medications they require to maintain health, poor outcomes can be anticipated.
Hence, practitioners often find themselves in the undesirable position of having to prescribe alternative therapies that may be less effective, require more frequent dosing, or have a greater propensity toward adverse events than their treatment of choice.
From the clinician’s perspective, these alternative options may seemingly have no rhyme or reason to them, but often reflect the age of the drug and prior negotiations that the manufacturer has established directly with a PBM. Generic substitution is another common tactic, though it is well known that not all patients respond similarly to generics as they do to branded medications.3
Addressing the challenges of prescribing for DED
Given what we know about the high costs of drugs and 3rd parties’ efforts to limit their use, it can be challenging for eyecare providers to reconcile their prescribing practices. Indeed, many have learned this lesson through trial and error, and now opt to simply prescribe what they know in advance will have the likeliest chance of being filled at the lowest cost.
While this practice may serve patients financially, it is difficult to argue that such action is always in the patient’s best interests, particularly if we have foreknowledge that the patient will experience a lack of efficacy, poor compliance, or an adverse reaction.
Patient assistance programs for DED
In order to bridge the financial gap that exists for many patients today, pharmaceutical manufacturers regularly establish a range of patient assistance programs (PAPs), which are designed to offset costs that may not be covered or reimbursed by 3rd party payers. This is particularly true in cases of newly approved products, which can require prior authorization, carry high copayment requirements, or simply be excluded from the patient’s formulary.
Currently, there are seven prescription agents approved by the United States Food & Drug Administration (FDA) for the management of dry eye disease; these are noted in Table 1. Regarding alternative formulations, only cyclosporine ophthalmic emulsion 0.05% has a generic equivalent at the present time.
While each manufacturer may have a unique name for their assistance program or portions thereof, a few major categories of support are standard.
These can include:
- Free initial samples for eligible patients.
- A copayment offset program, i.e., a “savings card” or “copay card” for eligible patients.
- An affiliated service that evaluates patients’ insurance coverage and/or finances to determine eligibility for specific programs or discounts.
- A support program to help navigate the prior authorization process for patients and physicians’ offices.
- A partnership with one or more centralized, online pharmacies to provide maximum cost reduction as well as direct shipping to patients.
- A program that provides reduced or no-cost medications for those with verifiable financial hardships (commonly capped at 200% of the defined federal government's poverty threshold, based upon family size).
There are numerous reasons why manufacturers are willing to utilize these assistance programs, which ultimately offset millions or even billions of dollars in potential revenue. Of course, there is the altruistic element; companies realize that many potential patients would not be able to afford these critical medications, and therefore create programs to help those who would otherwise go without.
Additionally, PAPs can serve to bolster a company's reputation with both physicians and patients, providing beneficial publicity for the company while simultaneously generating potential tax write-offs in terms of charitable contributions.
Most importantly, PAPs are often implemented in conjunction with new product launches in an effort to promote new treatment modalities and deflect attention from the “sticker shock” of wholesale drug prices, which in the case of Rx products for DED may be upwards of $700/month.
Finally, for new drugs in the marketplace, total prescription numbers during the first year often represent a critical benchmark that may be communicated to PBMs and the broader insurance community as a means of gaining more favorable placement on formularies.
Regardless of motives, it has been demonstrated that manufacturers most commonly use these programs to promote sales of high-cost, later-in-class entrants and to compete against new entrants sharing the same mechanisms of action.4
Limitations of PAPs
Under current guidelines, the vast majority of PAPs are not accessible to those with government-issued insurance such as Medicaid, Tricare, the US Department of Defense (DOD), the US Department of Veterans Affairs (VA), or any other state or federally-funded program.
Medicare, which historically also precluded subscribers from taking advantage of PAPs, has recently loosened some of its restrictions, specifically for Part D enrollees. Policies vary substantially with regard to specific manufacturers and even drugs, so it’s best that Medicare patients contact one of the affiliated services to help determine their individual eligibility for specific programs.
Tools to help your DED patients (and others!)
There are numerous programs available to patients and providers that can help navigate the tumultuous environment of drug coverage. Some are applicable to all sorts of prescription drugs, whether topical medications for glaucoma or oral medications for systemic maladies like hypertension. Others are dedicated solely to products that are specifically indicated for ocular disease management.
Let’s explore a few of the more popular tools used by eyecare offices around the country:
- CoverMyMeds: CoverMyMeds was founded in 2008 and has been a subsidiary of the McKesson Corporation since early 2017. According to the website, it is a healthcare software company that assists patients in obtaining their medications by automating the prior authorization process and connecting the healthcare network.
- CoverMyMeds connects to more than 500 electronic health record systems (EHRs), 50,000 pharmacies, and 900,000 providers. In addition, it offers solutions for medication access, affordability, and adherence, while also providing access to specialty therapies and case managers for high-touch support services.
- NeedyMeds: NeedyMeds is a dedicated nonprofit organization committed to improving access to affordable healthcare for individuals in need. In addition to other services, they offer access to drug safety and prescribing information, a variety of PAPs (both company-based and charitable organizations), and coupons or copay cards across a broad range of pharmaceuticals.
- This website is designed primarily for patient access rather than physician utilization.
- BlinkRx: One of the more well-known and popular PAPs for eyecare patients is BlinkRx, a digital pharmacy service operated by Blink Health Administration, LLC. BlinkRx can connect patients with a wide range of medications—from atorvastatin to warfarin—via manufacturers who partner with the company’s website.
- With regard to dry eye treatment options, both Xiidra (lifitegrast 5% ophthalmic solution) and Miebo (perfluorohexyloctane ophthalmic solution) are accessible at the lowest possible price through this platform.
- Once BlinkRx receives the doctor’s prescription (via E-prescribe or fax), they utilize a text platform to communicate directly with the patient. Their hub network obtains and analyzes the patient’s insurance to determine their copay and deductible, assists in obtaining additional coverage for the prescribed medications whenever available, and even provides free home delivery.
- Team pharmacists can help address any patient questions, and also assist with refills and reminders to help ensure better compliance.
- BlinkRx can even provide support for those who may require a prior authorization.
- PhilRx: Like BlinkRx, PhilRx is a digital hub platform that helps to streamline medication access for both patients and providers. The platform empowers retail and specialty-lite manufacturers with an alternative channel solution that can help to improve patient access and maximize covered dispenses.
- PhilRx operates in much the same manner as previously discussed; physicians can submit prescriptions directly through their EHR system, or they can fax the prescription if needed. Once PhilRx receives the physician’s request, they immediately initiate communication with the patient via text messaging.
- Once a patient opts in and confirms their information (a process that typically takes about 2 minutes), they are enrolled in the program, with no apps to download. PhilRx will then determine if the individual patient is eligible for copay support, an adherence program, or any of a number of different offerings for the medication in question.
- Additionally, they will determine if a prior authorization is required, and if so, they can initiate the process using the CoverMyMeds platform previously discussed.
- In terms of dry eye treatment options, PhilRx currently helps provide access to the following medications: Cequa (cyclosporine 0.09% ophthalmic solution), Tyrvaya (varenicline solution 0.03mg nasal spray), and Vevye (cyclosporine 0.1% ophthalmic solution).
- SimpleFill: SimpleFill is another unique nationwide advocacy service that utilizes available PAPs offered directly through the various pharmaceutical companies. They can also research additional assistance programs and apply for them on behalf of patients, accessing any potentially available funding, including the Social Security Extra Help Program for eligible individuals.
- Patients must apply directly to SimpleFill, who gather both their personal and their physician’s information in order to determine their eligibility (a process that requires 3 to 5 weeks in most cases).
- Once approved, SimpleFill maintains, manages, and services the patients' medications. DED products that can be accessed through this program include: Restasis (cyclosporine 0.05% ophthalmic emulsion), Xiidra (lifitegrast 5% ophthalmic solution), and Miebo (perfluorohexyloctane ophthalmic solution).
Additional offerings from pharmaceutical companies
In addition to the larger digital platforms already discussed, most pharmaceutical manufacturers offer their own branded patient assistance programs, which may provide reduced or no-cost medications for those with verifiable financial issues, and/or a copayment offset program for those with (typically commercial) insurance. Note that copay assistance programs are unique to each individual product, and stipulations vary considerably.
Some of these programs are listed below:
- myAbbVie Assist: myAbbVie Assist is a program that provides needed medications to the uninsured as well as those with Medicare or commercial insurance that is insufficient to cover the associated costs. Restasis is available through this program, as are other Abbvie ophthalmic drugs.
- MyAlcon: This program offers copay assistance for a variety of Alcon pharmaceuticals, including Eysuvis (loteprednol etabonate 0.25% ophthalmic suspension). It also provides direct access to the AlconCares program, which provides medicines at no cost to eligible US patients without prescription insurance coverage or are experiencing financial hardship.
For FDA-approved DED products, the following programs are available for patients who wish to use their own local pharmacy rather than a digital hub program:
- CEQUA Co-Pay Program: Through this program, eligible patients with commercial health insurance may pay as little as $0 for 60 vials (1 box) of Cequa. Patients with any government-issued health insurance (e.g., Medicare, Medicaid, DOD, VA, etc.) are ineligible for this program.
- MySavings / MIEBO Copay Card: With the MIEBO Copay Card, eligible, commercially insured patients may pay as little as $0 for both new prescriptions and refills.
- It is also available for “not covered patients,” i.e., those without health insurance or who have private/commercial insurance, but the drug is not covered on the plan’s formulary, has a National Drug Code (NDC) block, prior authorization, step edit, or other restrictions that have not been met.
- The Copay Card may not be used by anyone with Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, VA or DOD coverage, or any other federal or state healthcare programs.
- RESTASIS Savings Program: This program makes Restasis available to most eligible commercially-insured patients for as little as $0 for a 90-day supply, via a company-issued “savings card.” Other restrictions may apply for those with government-issued health insurance.
- TEAMTyrvaya: In addition to connecting patients with PhilRx, individuals may opt to fill their prescriptions at a local pharmacy instead, and obtain a copay savings card.
- This program provides eligible, commercially insured patients with Tyrvaya for as little as $10, up to a savings maximum of $275 for each 30-day prescription, or a maximum of $825 for each 90-day prescription, through December 31, 2024.
- This offer is not valid under Medicare, Medicaid, or any other federal or state program.
- Vevye Savings Program: This program makes Vevye available to patients with commercial insurance for as little as $0, and for those without commercial insurance or covered by Medicare for as little as $79. Other restrictions may apply for those with government-issued health insurance.
- Xiidra Savings Card: Through this program, eligible, commercially insured patients pay $0 for their first prescription of Xiidra, up to a 90 day supply. After the first fill, eligible patients may pay as little as $0 for additional prescriptions of Xiidra, with limitations (once every 21 days for 30-day fill and 63 days for a 90-day fill).
- This offer is not valid for patients whose prescriptions are reimbursed by any federal or state healthcare program, including Medicaid, Medicare, or TRICARE.
Conclusion: Facilitating awareness of PAPs for DED therapies
Our knowledge regarding these patient assistance programs is only of value if we share that information with our patients. In most offices, it falls to the doctor to initiate the cost conversation, perhaps explaining why they’ve selected a particular drug, and acknowledging that insurance providers often make the process challenging for dry eye disease therapy.
From there, it typically falls to the doctor’s scribes, technicians, and other office staff to carry the torch forward, providing clarification, answering questions, ensuring that all appropriate information has been communicated, and initiating any necessary approval processes on the patient’s behalf. If patients prefer not to utilize these programs, as they sometimes do because of unfamiliarity or skepticism, we can of course direct them to their local, preferred pharmacies.
However, experience has demonstrated that local pharmacies can rarely match the savings or the processing speed of a centralized hub pharmacy, and more and more patients seem to be realizing this as well. At this financially challenging time in our history, it can be difficult for physicians to fully utilize the management tools available to us to help manage our patients’ ocular health.
Many treatments are beyond reach for some individuals, even those who may be fortunate enough to have health coverage. Fortunately, programs exist that can help to mitigate these sometimes overwhelming costs. In the case of DED, we now have a wide range of treatments available for both acute and chronic disease management, and with them, the capacity to improve the quality of life for millions of Americans.
Helping our patients gain greater access to these vital medications is a goal shared by physicians and manufacturers alike. By proactively educating individuals about these programs and utilizing them whenever possible, we can simultaneously help our patients, our practices, and the manufacturers who provide these valuable assets and support our professions.
