Two new glaucoma drugs approved in late 2017 are not on the 2018 Medicare Part D formulary, creating quandaries for physicians who would like to prescribe them and for patients who may have to pay out of pocket.
While latanoprostene bunod (Vyzulta, Bausch + Lomb) and netarsudil ophthalmic solution 0.02% (Rhopressa, Aerie Pharmaceuticals) are the two latest examples, it is not uncommon for the timing and length of the approval process to lead to delays in coverage, but there are ways to address the situation.
Drug companies often try to mitigate the situation with payment assistance plans or vouchers, but drug discount programs usually do not work with Medicare Part D, said Savak "Sev" Teymoorian, MD, MBA, Harvard Eye Associates, Laguna Hills, CA.
However, if patients make the personal choice to buy medications outside of their Medicare Part D prescription drug plan, the price could be lowered with a co-pay card, voucher, or bridge program, said Miranda Gill, MSN, RN, NEA-BC, director of clinical innovation, CoverMyMeds, Columbus, OH.
"To help patients get on and stay on the medications they need, medication adherence programs, patient assistance programs, and disease specific foundations are some forms of assistance that I would attempt to explore with my patients," Gill said.
These organizations can be discovered through the Patient Access Network Foundation (https://panapply.org).
While it is drug- and disease-dependent, if assistance is identified, the amount of aid a patient receives can be significant, Gill said.
Physicians can also write a request to Medicare to ask for a coverage determination or an exception. There are three ways to go about this: call the patient's plan, write a letter, or send a completed "Model Coverage Determination Request" form to ask for a coverage determination or exception.
Once a plan has received the standard request, it has 72 hours to notify the sender of its decision. Forms and instructions can be found at https://www.cms.gov/
When the lack of Medicare coverage for the two glaucoma drugs becomes a concern, the key to finding a solution is discussion between physician and patient.
"Our goal isn't to dictate care, it's to educate the patient," Dr. Teymoorian said. "We can advise and recommend what we would do, and most patients take our recommendation if possible."
"It is really important for providers and prescribers to involve the patient and be as transparent as possible with the information that they have available to them, discussing the unique clinical indicators that are prompting them to prescribe this particular medication and how it plays into their individual care plan," Gill said.In this process of shared decision making, clinicians need to explain not only clinical indictors but also efficacy and side effects, as well as cost and accessibility, she added.
"However, most providers don't have access to patient pay information, and the patient is often unaware of the out-of-pocket costs until they arrive at the pharmacy," she said.
"Luckily, there are tools available that enable prescribers to view patient cost-share information while the patient is in the office," Gill said. "RxBenefit Clarity, for example, is a tool that delivers the most accurate patient pay and real-time benefit information in the prescribing workflow, which can help prescribers have more informed conversations with their patients that can help drive adherence."
It is also helpful to outline the process of drug approval and addition to Medicare formularies so that patients understand that decisions about coverage are made not by their doctors but by the government agency. And while it is difficult to predict when (or if) a drug will be added to the formulary, patients who are likely to use a medication long-term may be reassured by the prospect that high out-of-pocket costs could be a temporary obstacle if a drug is added to the Medicare formulary within a matter of months.
The discussion also should explore include alternative medications to achieving treatment goals if no options exist to lower the cost of a drug and the patient is unable or unwilling to pay the full amount.
"Our goal is to take care of the patient's vision regardless of the price," Dr. Teymoorian said. "The price is very important, because it comes into play, but we shouldn't eliminate an option that we think is right for the patient strictly based on price. We need to at least present alternatives to the patient and let them decide what's the best option."An alternative to latanoprostene bunod would be to prescribe one of the already approved prostaglandin analogs, which should achieve similar intraocular pressure reductions. But there is no drug similar to netarsudil ophthalmic solution, a rho kinase inhibitor that has a novel mechanism of action and has been placed in a new class of drugs.
This distinction is important, since patients may more readily pay out of pocket for a drug that has no alternatives, especially if it seems to have an advantage, such as the use of netarsudil ophthalmic solution as a once-daily adjunct to a prostaglandin, Dr. Teymoorian said.
Even if patients are willing to pay for a drug that is not covered by Medicare Part D, it may take some negotiating with local pharmacies to ensure that they can fill the prescription.
Not all pharmacies are willing to stock these drugs because of lower demand, Dr. Teymoorian said, and physicians may need to identify those that carry or will order them and encourage patients to visit these locations.
"Aerie Pharmaceuticals is committed to working with the physician and payer communities to ensure that our products are available to the patients who need them," said Tom Mitro, president and chief operating officer, Aerie Pharmaceuticals, in a prepared statement: "We have been proactive in meeting with Medicare Part D plans about [netarsudil ophthalmic solution 0.02%] and expect to achieve favorable formulary coverage by January 2019.
"In the interim, physicians are able to gain access to [netarsudil ophthalmic solution 0.02%] for their patients in Medicare Part D by submitting a prior authorization to the particular payers insuring the patients," he said. "Aerie has partnered with one of the leading reimbursement support services to facilitate this prior authorization process for patients, physicians, and Part D plans."For Bausch + Lomb, the company's goal is to make latanoprostene bunod affordable and accessible to the millions of open-angle glaucoma and ocular hypertension patients who may benefit from this treatment option, said the company in a prepared statement.
"As such, we are actively working with commercial and Medicare health insurers and pharmacy benefit managers to expand access for all insured patients, which includes almost 103 million lives today. We also continue to work to secure Part D coverage for 2019," the company said.
Today, most commercially insured patients can utilize the company's co-pay assistance program, available through the product's website (www.vyzulta.com). For qualified patients who do not have adequate commercial insurance coverage or who are without any insurance coverage, the patient assistance programs are designed to help those qualified patients who are unable to otherwise afford treatment, according to the company.
In March, Bausch + Lomb said it also announced an agreement with Express Scripts, which covers the product under an access position on both the commercial Express Scripts National Preferred and Basic formularies, giving access to an additional 23 million patients in the United States.
Finally, for commercial or Part D patients, Bausch + Lomb noted that eye-care professionals can submit either an electronic prior authorization (ePA) or request coverage for a non-formulary product through CoverMyMeds to help their patients obtain access to latanoprostene bunod.
The product is also included in CoverMyMeds' HubExpress platform, which monitors and helps both pharmacies and HCP's manage through requests for product coverage made to health insurers and PBMs. If a request is approved, HubExpress will follow-up with the pharmacy to ensure the script is dispensed, and if denied, HubExpress will contact the office to start an appeal or identify another course of action.
Savak "Sev" Teymoorian, MD, MBA
Dr. Teymoorian is a speaker and consultant for Aerie Pharmaceuticals and Bausch + Lomb and conducts research for both companies.
Miranda Gill, MSN, RN, NEA-BC
Gill did not report any disclosures.