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IDENTIFYING AND ADDRESSING MARKET ACCESS CHALLENGES WITH ANTI-VEGF THERAPIES FOR PATIENTS WITH RETINAL DISEASE

By: David Eichenbaum, MD, Moderator; Larry Halperin, MD; Pamela Pautler JD, MBA; Jonathan L. Prenner, MD; Winston Wong, PharmD

This course has expired. You can still review the content but course credit is no longer available.

Supplement Credits: 1.0

The use of anti-VEGF therapies for retinal diseases raises numerous issues in today’s health care environment when the cost of treatment is often as much a consideration as the efficacy and safety. Thus, payers have become more involved in managing the use of these agents, potentially interfering with clinical decision making. The following roundtable brings together thought leaders in the retina field to discuss the challenges they face in obtaining access to anti-VEGF medications for their patients and how they overcome those challenges.

Expiration Date: Friday, May 31, 2019
Release Date: May 31, 2019

Learning Objectives

Upon completion of this activity, the participant should be able to:

Identify and implement algorithms, decision-making tools, and patient communication approaches that can be used to determine the most appropriate treatment for the patient.

Identify opportunities to advocate against prior authorizations and step policies and appeal them.

Discuss the potential impact of the Drug Quality and Security Act and opportunities to advocate for continued access to compounded ophthalmologic drugs.

Describe the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) on ophthalmology and its potential impact on the prescribing of anti-VEGF agents.

Accreditation and Designation Statement

ACCREDITATION STATEMENT

Evolve Medical Education LLC (Evolve) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide CME for physicians.

CREDIT DESIGNATION STATEMENT

Evolve designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Faculty and Disclosures

DAVID EICHENBAUM, MD, MODERATOR

Clinical Assistant Professor, Department of Ophthalmology

University of South Florida College of Medicine

Retina Vitreous Associates of Florida

Tampa, Florida

LARRY HALPERIN, MD

Clinical Professor of Surgery, Ophthalmology,

Florida Atlantic University College of Medicine

Retina Group of Florida

Fort Lauderdale, Florida

PAMELA PAUTLER JD, MBA

Practice Administrator

Retina Vitreous Associates of Florida

St. Petersburg, Clearwater, and Tampa, Florida

JONATHAN L. PRENNER, MD

Associate Clinical Professor, Chairman,

Department of Ophthalmology

Robert Wood Johnson Medical School

Rutgers University

NJRetina

New Brunswick, New Jersey

WINSTON WONG, PharmD

President, W-Squared Group

Longboat Key, Florida

 

DISCLOSURE POLICY

It is the policy of Evolve that faculty and other individuals who are in the position to control the content of this activity disclose any real or apparent conflict of interests relating to the topics of this educational activity. Evolve has full policies in place that will identify and resolve all conflicts of interest prior to this educational activity.

The following faculty/staff members have the following financial relationships with commercial interests:

David Eichenbaum, MD, has had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Alimera Sciences; Allergan plc; Genentech; Notal Vision; and Regeneron Pharmaceuticals, Inc. Grant/Research Support: Alcon; Allergan plc.; Clearside Biomedical; Genentech; Novartis; and Opthotech. Speaker’s Bureau: Allergan plc; Genentech; and Notal Vision. Stock/Shareholder: BIRC, Clearside Biomedical; Humera; and US Retina.

Jonathan L. Prenner, MD, has had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Alcon; Genentech; and Regeneron Pharmaceuticals, Inc.

Larry Halperin, MD, has had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Regeneron Pharmaceuticals, Inc.

Pamela Pautler JD, MBA; and Winston Wong, PharmD, have no financial relationships with commercial interests.

EDITORIAL SUPPORT DISCLOSURES

Erin K. Fletcher, MIT, director of compliance and education, Susan Gallagher-Pecha, director of client services and project management, Evolve; and Debra Gordon, writer, have no financial relationships with commercial interests. Jaya Kumar, MD, peer reviewer, has no financial relationships with commercial interests.

Disclaimer

The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of Evolve, Retina Today, or Regeneron Pharmaceuticals, Inc.

OFF-LABEL STATEMENT

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The opinions expressed in the educational activity are those of the faculty. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

INTRODUCTION

The introduction of anti-VEGF agents for the treatment of age-related macular degeneration (AMD), diabetic retinopathy (DR), and retinal vein occlusion (RVO), transformed the management of these conditions. While the clinical benefits of these compounds are well documented, their use brings up other issues for ophthalmologists, namely, cost.1-5 Thus, payers have become more involved in managing the use of these agents, potentially interfering with clinical decision making.6 The following roundtable brings together thought leaders in the retina field to discuss the challenges they face in obtaining access to anti-VEGF medications for their patients and how they overcome those challenges.

— David Eichenbaum, MD, moderator

INITIAL TREATMENT

DAVID EICHENBAUM, MD: We use antiangiogenic injections in common retinal diseases such as neovascular macular degeneration, diabetic macular edema (DME), and RVO. When we’re considering using these injections, we have three commercially available products to choose from: bevacizumab, ranibizumab, and aflibercept. There is also an expanding array of investigative products. When treating a patient with a common retinal disease, what do you consider when deciding on an initial treatment for that patient, including efficacy and the medical and financial burden of treatment?

LARRY HALPERIN, MD: There are a variety of factors, including, but not limited to, the disease entity and the patient’s insurance, including whether or not the patient can be placed on a copay assistance program (which most can). A discussion with the patient then takes place concerning branded and off-label drugs, which I try to help direct because most patients will follow whatever we recommend. It results in a conversation around shared decision making (Figure 1).

Figure

Figure 1. A Shared Decision Making chart, courtesy of the Agency for Healthcare Research and Quality.

JONATHAN L. PRENNER, MD: I echo Dr. Halperin’s sentiment. We always attempt to provide patients with as much information as they can handle, but it depends on who the patient is and often what the practice setting is like. For some patients, I’ll present a brief narrative about disease pathology and how you can intervene with any of the three biologics, as there is absent product differentiation, in terms of efficacy. That leads me into a discussion about potential safety issues for branded and nonbranded drugs.

My practice in Princeton, New Jersey, includes a highly educated patient population. For more sophisticated patients, I find myself discussing pharmacodynamics and pharmacokinetics in great detail. I attempt to match the detail of the discussion to what the patient wants to receive and then proceed from there.

DR. EICHENBAUM: Some patients start on FDA-approved antiVEGF agents, and we have the discussion about cost and coverage at the outset of therapy, while some patients start on bevacizumab. When a decision is made to convert a patient from bevacizumab to an FDA-approved agent, or from one FDA-approved agent to another, the protocols of most published studies offer lack of efficacy of the initial agent as the indication for converting to a new drug. The decision to convert is often prompted by disease activity, lack of efficacy, or lack of durability,7-11 which is when we convert in clinical practice as well. At that point, we often discuss the financial burden of the FDA-approved agents.

In your practice, Dr. Halperin, what is the next step a patient takes when the decision is made to start with or convert to a higher cost FDA-approved therapy to achieve a better outcome?

DR. HALPERIN: The next step is to have a direct conversation with the patient, which is when I l like to show the patient their OCT to demonstrate where we started and where we are currently. I use the OCT to explain our goal, whether there is subretinal fluid or intraretinal fluid, or if there is still a hemorrhage in the eye and the vision hasn’t moved.

The next step is to discuss other options. Some insurance payers demand the use of a specialty pharmacy, in which case we might have the opportunity to use a sample of a branded drug to initiate treatment and then work through the specialty pharmacy for future treatments. If we don’t have that constraint, we typically will have the patient sign the forms to start engagement with a copay assistance program then initiate the change at that visit. We create a schedule to assess the benefit of the change and the time frame for reevaluation.

DR. EICHENBAUM: Who initiates copay assistance or benefits verification, or looks for financial support through a foundation or other organization that provides assistance?

DR. HALPERIN: The technicians involved in seeing the patient, along with myself, will have a brief conversation. Then our front desk and back office staff confirm the insurance and connect patients with entities that provide assistance. We ask most patients to register with those entities as a precaution. It may appear that the patient is covered with Medicare and that they have a good secondary, but there are still issues with copays, whether it’s through deductibles or other costs. Those assistance programs and funds can be very helpful to patients.

DR. EICHENBAUM: What do you do in your practice, Dr. Prenner?

DR. PRENNER: We start many of our patients on branded drugs. Thus, our decision-making process is a bit different as we are commonly going to have to face the issue of cost and financial exposure for our patients up front. When we do convert from one drug to another, I’m less worried about anatomic response than visual response. If patients are seeing well, the presence of a bit of fluid doesn’t concern me enough to convert to another drug.

When we have a new patient come in with exudative AMD, DME, or RVO, and the patient elects to be treated with a branded drug, we immediately perform a benefits investigation. That process is carried out by our front desk and back office staff who assist the patient to determine what their exposure may be. If they are underinsured or uninsured, one of the assistance programs/foundation support programs available may help.

We don’t use samples in our practice; we typically ask patients to return for their initial injection unless there is real pressure to perform the injection the first day, at which point we’ll use bevacizumab.

DR. EICHENBAUM: That’s an important point. Like your practice, Dr. Prenner, I start most patients on a branded drug after a conversation regarding efficacy and safety. We often use samples to initiate treatment, either at that visit or at a visit shortly following the initial diagnosis before the benefits investigation is completed.

Dr. Prenner, why does your practice choose not to use samples?

DR. PRENNER: I think it’s uncommon to find a case where there is substantial pressure to treat someone within 48 hours of diagnosis. First, I don’t desire to convert patients back and forth between agents. If I deliver a sample and then discover that they’re not going to be covered by insurance, I have to then switch them to bevacizumab. The reverse is also true if the patient’s preference is to use the branded drug, but we started with bevacizumab.

Second, I want to identify why we are attempting to treat patients on the first day of diagnosis. Important considerations are patient convenience, particularly if you practice in a rural environment. I live in the most populated part of the country, and most of our patients live within 10 miles of our offices. In our location, returning to the office is not a major problem.

Third, when we consider our clinical registration trials of aflibercept and ranibizumab, patients were not treated immediately, and results were excellent.3,4,12,13 Many days passed prior to initiation of treatment, as patients required screening, imaging, and validation/grading of the imaging prior to randomization and treatment.

This should give you confidence that we shouldn’t lose our therapeutic window if we don’t start treatment immediately. In cases where there is a submacular hemorrhage or a monocular patient, particularly if there was a bad outcome in the fellow eye, I start them on bevacizumab. Most patients will do well with their first injection, and I will typically not change their agent at that point.

DR. EICHENBAUM: I agree. There was an abstract from 2017 that looked post hoc at the patients in HARBOR who had treatment initiated in window but at different times following screening, and there was no difference in visual outcomes between patients treated at the earliest quartile and the latest quartile (Figure 2). This analysis suggests that patients do not need to be injected the same day as diagnosis to get good results.14

Figure

Figure 2. BCVA over time according to the HARBOR Trial.

The primary reason we treat the same day in our practice is patient convenience. It comes down to the patient having a general burden of coming back. I think our patients in Florida may be more elderly and more infirm than your patients, Dr. Prenner.

Ms. Pautler, what systems are in place for when we decide to do branded FDA-approved higher cost treatment on a patient, whether as additional therapy or as a conversion? What roles do we have in the offices to ensure that the patient’s exposure is limited and that the practice’s exposure is limited? How can we be as sure as possible that there is coverage for the selection of agents?

PAMELA PAUTLER JD, MBA: At every visit, whether new or established, we verify the insurance information is up to date by checking the insurance benefits. We identify patient copayments, insurance deductibles, and coinsurance amounts. If we know the patient is going to be treated with a specific drug, one of our technicians performs a benefits investigation, and we enroll the patient into a copay assistance program. Once this benefits process is completed we know the patient’s treatment will be fully covered.

The process is disrupted when the physician examines the patient and decides to change the medication from one drug previously authorized by the insurance carrier to another. Insurance authorizations are issued for a specific drug CPT code. In this case, we have to pause and use a sample medication; this requires us to redo the whole process to ensure we have an authorization on file for the new drug. Our technicians are intimately involved in the process with the patient, so they are well-versed on the insurance benefits, the copay assistance, and the patient’s treatment plan.

DR. EICHENBAUM: Dr. Wong, as a member of the insurance industry, how does this look from the other side of the payer equation? Say a patient comes in and an FDA-approved drug is selected for an on-label indication. Either a sample is used, or the patient is requested to return after the benefits investigation, possibly using one of the support programs from the pharmaceutical company. How does it look from the payer side when that benefits investigation comes through?

WINSTON WONG, PharmD: Generally, if you look at the carrier, everyone is required to have a set of medical policies in place. Each carrier has medical policies for the use of the anti-VEGF agent for specific indications, and when the call comes in for an authorization the first thing that is looked at is whether an authorization is required (Figure 3).

The “unmanaged” plans don’t require an authorization; they still have to follow medical policy, but authorization is not required.

Figure

Figure 3. The prior authorization process. Photo courtesy of Dr. Wong.

And if you’re in a managed plan where an authorization is required, information, including whether the drug is being used for the indication that is in the medical policy out of medical necessity, is required. If the information provided matches the medical necessity criteria, then the authorization is issued. As Ms. Pautler stated, that authorization is usually issued for a specific drug or J code. If there is a need for a change of the drug, then we have to go through the process again.

ADDRESSING THE ROADBLOCKS

DR. EICHENBAUM: Let us consider what to do when this process doesn’t go smoothly, as issues related to access to drugs are a frequent occurrence. For example, consider a patient with DME who comes in for a visit that involves the selection of an antiangiogenic treatment, and there is a delay in reimbursement. What do you do when the antiangiogenic claim has aged to 60 or 90 days, and there is a delay in reimbursement for an appropriately authorized stock drug?

DR. HALPERIN: Unfortunately, this is a common scenario. I frequently turn to FDA-approved treatment as my initial treatment; on occasion, we later discover we aren’t being compensated. We investigate the issue and often it is something minor, such as the correct diagnosis wasn’t assigned to the drug. This can be fixed quickly and reimbursement is obtained. Other times, it isn’t so simple.

DR. EICHENBAUM: How many staff members do you have in your practice to manage this occurrence?

DR. HALPERIN: We have 11 physicians and utilize three full-time employees to monitor reimbursement and obtain preauthorization from insurance. They also assist to supervise the billing company and manage the postings of payments. We use an outsourced billing company, but our insurance is confirmed in-house. Any struggles with reimbursement are handled partially in-house but also with the billing company.

DR. EICHENBAUM: Are you satisfied with how your in-house reimbursement supervisors work hand-in-hand with the outsourced billing company?

DR. HALPERIN: Given the system that we all live in, yes. Ideally, every patient would have an insurance card when they walk in and you would be confident you would be compensated, but that is not our reality. We really do need these people, and they work efficiently.

DR. EICHENBAUM: Many retina specialists, comprehensive ophthalmologists, and other medical doctors use outsourced billing companies. The companies are often paid based on a percentage of the gross reimbursement. In my experience with outside billing companies, this would essentially eliminate any margin for buy-and-bill drugs and could even create a loss with every drug, unless those drugs are carved out from the billing company as a separate pool of revenue not subject to the same percentage as clinical services. Is that how your billing company works?

DR. PRENNER: You identified a couple of key points. One is that the profitability of using branded drugs is very small. This panel has identified some of the features leading to the somewhat surprising economics involved. One consideration is the human capital required to manage the process of using these agents and limiting loss rate. The second is that many of us use a billing services to manage our overall billing. Those work quite well for the majority of our work. However, there are going to be claims that don’t rise to the threshold set for automated systems to trigger, which require additional full-time employees to work on those claims. The profitability of using branded drugs appears significant on first inspection, but as you look deep into data surrounding branded drug use, the margins are quite small.

In my practice, we have 18 retina specialists in 15 offices, and we use a publicly traded, independent billing company. It’s very efficient and effective for us. Using these services works well at scale; the expertise helps interface with the systems and manage the liabilities of a nonhuman billing process.

DR. EICHENBAUM: Dr. Prenner, how does your practice handle a reimbursement aging 60 to 90 days or an inadequate or incomplete reimbursement for an FDA-approved drug? Does that meet the threshold that you set for these automated claims with regards to financial significance for your practice?

DR. PRENNER: We have three full-time employees who are in charge of billing who manage this process. They determine what the breakdown in the process is and work to solve the problem.

DR. EICHENBAUM: Our practice faces the same issues, but we have five retina specialists and five offices. We frequently have delayed reimbursement or inadequate reimbursement. We have an in-house billing system and use three full-time employees who are devoted completely to billing who also work with these types of claims and delayed reimbursement.

Ms. Pautler, please elaborate on how our practice handles delayed reimbursement or inadequate or underreimbursement.

MS. PAUTLER: We have a robust practice management system, including an electronic health record system. We transmit clean claims within a day and a half of the date of service. In Florida, we have a prompt pay-or-deny statute requiring the carriers to pay or deny a claim within 18 days. If a payment delay occurs because a referral or an authorization wasn’t linked correctly to the claim, this can be quickly corrected and resubmitted to the carrier. We’re seeing insurance carriers deny claims until additional medical information is submitted. We respond quickly and submit those medical records for review. Despite our attempts, the carriers can extend out the number of days they have to process the claim. We typically maintain an average day of accounts receivable to 20 days.

It becomes a challenge with some insurance carriers making excessive requests for medical records or proof of medical necessity. These requests extend the window of time they have to pay the claim even though the claim is clean and well supported. We have a process to follow up 15 to 20 days and document every call made to the carrier. We don’t have many claims denied or delayed, which is proof that our process is working.

DR. PRENNER: If you are efficient on the front end, you shouldn’t see a volume of denials on the back end, but it still occurs. When it does occur, you are best served by an infrastructure in place to deal with it. When you’re completing the volume of treatments that a typical retina practice does, while the incidence rate will be low, the prevalence rate is still going to be fairly high.

DR. HALPERIN: We work hard to manage trends in our billing errors, because the key is to get it right the first time. If we know there’s a payer that is always asking for medical information, we provide that medical information along with the bill, so we can avoid the initial denial. If we don’t get it right on the first try, we look at why and try to determine trends so we can prevent them in the future.

DR. WONG: In Florida, are most of your issues with commercial plans or with Medicare?

MS. PAUTLER: With the age of our patients and the age-related diseases treated in our practice, the issues are with the Medicare replacement plans. We are also seeing patients with state plans that require special handling. For instance, some plans require that we obtain the drugs through a specialty pharmacy, which adds an additional step in the process.

DR. WONG: Everyone has a prompt-pay requirement for clean claims in which all required information is provided and no additional information is needed to process the claim. If there’s something missing, it falls out of that prompt-pay time frame. Ensuring that the prior authorization has been obtained in advance helps ensure a ‘clean’ claim.

Looking back to the mid-2000s when these therapies first came around, I can see plans being a little more cautious. It’s a costly therapy, especially at that time, and I can see them wanting to have the information to be sure the drugs are being used appropriately. Today, with the open authorizations and medical policies available, if an authorization is required, that information’s already been collected. Payment should be made if the claim was submitted clean. If there’s information missing, then you should provide the information and get paid promptly.

Yes, there may be plans that are more stringent or try to push things through their specialty pharmacy, which should also be conveyed with the authorization—that you’ll be paid for the drug—but you have to get the drug from a specific pharmacy. This usually occurs to manage the distribution channel to obtain the most cost effective product versus going on the free market.

DR. EICHENBAUM: To summarize, to reduce the rate of delayed reimbursement or inadequate or underreimbursement by submitting clean claims, use appropriate on-label diagnoses, investigate benefits prior to using a stock medication, check the authorization if required, and comply with specialty pharmacy requirements from certain payers so the stock drug is not tied up in this type of situation.

THE STEP THERAPY DILEMMA

DR. EICHENBAUM: Let us consider the DME patient, for whom FDA-approved therapy is recommended. How do you handle a call from the insurance company’s medical director benchmarking off-label treatments or step therapy? Dr. Prenner, do you have any step therapy plans in your practice?

DR. PRENNER: We don’t currently. I think there’s a bit of debate about the validity of those step policies. At the ASRS level there has been an aggressive attempt to reduce these policies by highlighting the importance of physician choice. The ASRS has been very clear that our ability to have physician choice is critical.15

DR. EICHENBAUM: In the absence of step therapy, how often do you get a phone call from a medical director discussing off-label treatment or asking you to consider off-label treatment?

DR. PRENNER: I have never received one.

DR. HALPERIN: We have this sort of activity in Florida; it comes in a variety of forms, from seemingly inquisitive to more confrontational meetings and conversations where you’re asked to explain why bevacizumab is not the first-line drug for all types of macular problems. We ascribe to the ASRS stance that step therapy is a form of forced medical decision making from payers and that the choice of drug should be made between the physician and the patient. Some payers can be quite aggressive.

DR. EICHENBAUM: I agree. In Florida, we have had payers come to our practice with various aggressive tactics to influence the choice of drug. I think that the ASRS does provide appropriate guidance. The ASRS has a series of points that any retina specialist confronted with these discussions can use.16 Additionally, the FDA approves only two commercially-available therapies for common retinal diseases. Between the FDA label and the ASRS guidance, it’s important for retina specialists to know that there is ammunition they can easily access when confronting this type of problem.

Dr. Halperin, how do you handle reauthorization requests or other onerous requests or appeals that are very time intensive for your fulltime employees? Do you provide some information up front, or have you looked for trends in your payer environment? Do you outsource that type of work to the billing company? Or do you do that in house with your billing supervisors?

DR. HALPERIN: I agree that it’s time intensive. Copying paper charts was actually faster. Now that we have electronic records, you have to make sure that all the different parts of the record are included. And it’s not always straightforward.

Certain payers will want documentation to ensure on a very consistent basis that we’re following their guidelines and medical decisions, both as a quality measure for medical care and for any other type of billing issue.

When it becomes egregious, it’s a frustrating problem, and we have conversations directly with payers. We have an outsourced consultant we use who will communicate with the payer about these medical information requests. We try and get the medical directors on the phone and take us off their so-called audit list to get the requests down to a reasonable level.

DR. PRENNER: Unfortunately, I think these are becoming more common, and you have to accept that aggressive communication may be required. You are respecting the patient’s wishes for a treatment course, and I am confident that by doing so you are in good standing. While there is some paperwork, usually you’ll wind up being approved. I haven’t lost one of those battles yet.

DR. HALPERIN: I agree 100%. We generally don’t lose because we’re always right with what we’re doing on behalf of the patient. But that doesn’t stop the insurer from asking over and over again; it reaches the point of harassment. You may need to engage an attorney to communicate with the payer that their requests are approaching breach of contract and that they’re not entitled to ask for extensive medical information on every patient you see. We are happy to provide an appropriate and reasonable amount of medical documentation.

SWITCHING AGENTS

DR. EICHENBAUM: Let us consider a patient with wet AMD who has had a series of treatments with any of the three commercially-available agents. The patient returns after a second attempt at extension to 6 weeks from 4 or 5 weeks. This patient presents with fluid and has now failed two attempts at extension to 6 weeks on agent A. The decision is made to use an FDA-approved agent, whether switching from one FDA-approved agent to the other or switching from bevacizumab to an approved agent. Do any of your situations differ significantly from the following step-by-step fashion?

In our practice, if a patient with a failed extension with drug A is going to be switched to FDA-approved drug B, the patient usually receives an injection with a sample of that drug that day for his or her convenience. Then, the patient discusses options for copay assistance or foundation support with a technician and signs a benefits investigation form. We enroll the patient in the manufacturer’s patient support program and have a fairly quick turnaround regarding the patient’s insurance benefits.

The patient returns at the next prescribed visit. In this particular scenario, it would probably be 6 weeks or sooner. The patient then often receives stock medication with patient support as provided by the pharmaceutical company. If the patient is on a commercial managed care plan or a Medicare Advantage plan that requires a specialty pharmacy, we’ve obtained the drug, and it’s administered at this visit. The patient is charged for the out-of-pocket coinsurance or copay. We usually settle that charge at the time of service at the front desk, so we can go on with treatment with this FDA-approved agent, hopefully with further extension and better anatomic and visual outcome for the course of the disease.

DR. PRENNER: Because we prefer not to use samples, our process is to consider changing the therapy the day before implementing the change. If patient responds suboptimally on drug A, at the next visit we would consider additional treatment with drug A or perhaps switching to drug B based on the exam findings. Then, as the patient checks out, we make sure they go through the benefits investigation process for the new drug. That way, we’ll be able to change drugs at the next visit if the findings demand that. And the rest of the process is very similar to what you described.

DR. HALPERIN: Our process is similar for the vast majority of patients treated with a stock drug on the first day. We even make the diagnosis or make a decision to change that day because they have Medicare and a secondary insurance, and we’re very familiar with the secondary and know that everything is going to be fine. We are not using hundreds of samples because many patients can be treated on the day of diagnosis without a problem.

DR. PRENNER: Dr. Halperin, do you treat patients who have not had a benefits investigation if they have Medicare and a supplemental insurance?

DR. HALPERIN: Yes. I’ve always treated the patient on the day of diagnosis, which is the first time I see them. I find patients are appreciative because they don’t have to return to the office, and they like knowing we have initiated treatment for their condition. That’s why samples are helpful when we’re skeptical of payment, but, most of the time, we’re not skeptical of payment so we don’t have to use samples frequently.

DR. EICHENBAUM: We do the same. We treat them with stock medication on the day of diagnosis if the patient is a Medicare patient and carries a known secondary. We do verify that secondary is active when the patient checks in.

DR. HALPERIN: I have found that I am less likely to switch between drugs and more likely to work with the interval. I definitely change drugs, but frequently I don’t see that it makes a huge difference.

DR. EICHENBAUM: I agree. When looking at the FDA-approved agents, especially in wet AMD, there is more of an interval consideration than a product consideration in the vast majority of patients.14 But I do think that the FDA-approved agents probably have somewhat more potency, better safety and predictability, and certainly more data than the off-label agent, which is primarily why we use a lot of FDA-approved drugs in our practice.1,17-19

From the provider’s perspective, what do you have at stake in this individual clinical scenario for a wet AMD patient for whom you’re recommending FDA-approved therapy?

DR. PRENNER: I think the goals are to allow for fair assessment of the pathology, review the relevant data for efficacy and safety, and then allow the patient to make an educated decision in partnership with the doctor. As Dr. Halperin pointed out earlier, many patients will follow what the doctor recommends. Having the flexibility to not be influenced by forces other than data and patient and doctor preference is key. We try to design a process that makes sure there is as little friction as possible so we can spend our time doctoring and as little time as possible on nonpatient care.

DR. EICHENBAUM: From the perspective of the insurance plan, Dr. Wong, what stake do you have when an FDA-approved drug is being recommended for wet AMD? What do you want to see happen in this scenario with the patient?

DR. WONG: Our goal, as stakeholders, in health care is to see the patient treated optimally and receiving the best outcomes they can. As a payer, we also want to see that the optimal clinical outcome is reached in the most cost-effective way. In discussions that I’ve had with colleagues over the past few years, I don’t see this class being managed as tightly as it once was. As I look at the national payers and their policies, they are all covering the branded products. They’re not really showing any preferences one way or another.

However, I’m looking at national commercial products that are paid by employers and individual benefits. That may not necessarily be the same scenario when you get to a more pricesensitive or cost-sensitive line of business, such as Medicare and Medicaid. It may be in those instances that payers are trying to manage more aggressively.

Listening to the discussion for the reauthorization, I would agree that if you have to photocopy the entire chart, as well as possibly have a discussion with a medical director, that is a little onerous. But, using an analogy with oncology, not every health plan has an oncologist on their staff. We don’t have an oncologist as a medical director, so I doubt that the plans are going to have a retinal specialist as a medical director, either. What you may be viewing as an onerous request is really part of a more generic reauthorization process requesting information to determine if the initial regimen has been effective. As a result, the reauthorization request may seem onerous in this disease state, but in other disease states, it may not actually be.

Not to defend the payers, but I don’t believe that any payer is going to intentionally try to overburden you with the reauthorization process. It’s really designed to be more of a checkpoint in that you received the initial authorization for reimbursement for services. Payers will check in again to confirm it’s a valid indication or it’s medically necessary to continue your patient on that treatment. A payer’s main objective is to see that patients have the best outcomes and to leave the decision making to the retinal specialists.

DR. EICHENBAUM: Ms. Pautler, from the practice administrator view, what should the practice do to achieve the best clinical outcome in this scenario?

MS. PAUTLER: We’re going to do whatever is necessary to support the physician and their decision to treat the patient regardless of the carrier and specific drug. But at the end of the day, there must be a full accounting of all the stock drug inventory and fully supported clean claims submitted in a timely manner to the carrier for reimbursement. We also keep the patient informed and try to limit their potential financial exposure by checking benefits and enrolling eligible patients into copay assistance programs.

DR. EICHENBAUM: To take the perspective of the patient, the patient wants to be better. This sentiment has been shown in the published literature; patient perceptions of their general health and quality of life are profoundly affected by wet AMD.20 If improving vision takes a few more visits or costs somewhat more, our best data imply that patients believe that effort is worthwhile as long as they are getting the best outcome they can for their vision. As a patient, I want to get better, and I want to have trust in my doctor. I want my doctor to be my advocate.

As practice owners or practice administrators, we do have to think of the logistics of delivering care, but when we make decisions as physicians we have to remember that the patients want to trust us, and they want to get better.

From the perspective of the manufacturer, what does the pharmaceutical company want to do in this scenario?

DR. PRENNER: Pharmaceutical companies believe in their branded products and the efficacy, safety, and track record associated. They want to make sure patients have access to their drugs in a timely fashion, so they are motivated to do what they can within the confines of the regulatory processes in place to assist patients and physicians in retaining the freedom to choose therapeutic direction.

It’s interesting that, as providers, we’re suspicious of the motivations of nonproviders in this process. It’s good to hear Dr. Wong’s commentary suggesting we’re probably more aligned than we think. Some of it may just be certain processes or logistics that we could probably all improve on.

DR. HALPERIN: We may see the payers as this sort of monolithic entity, but they are very large, if not enormous, bureaucracies. While there are parts of these entities that fall in line with some of the notions Dr. Wong said this evening, I would question whether all aspects and all people in the entity fall in line. I would argue that they don’t.

Some medical directors and people involved in helping expedite patient care are really caring and concerned for patient outcomes and patient experience. However, we struggle to convince others in the bureaucracy of these extremely large payers that what we’re doing is right only to find out that another group of people at a level above them don’t respect the opinion of their coworkers. This requires us to go through the whole process again.

DR. WONG: I agree with you from the standpoint that whenever you have more than one person in the room, you are going to have a difference of opinion, and you will have a difference in philosophy. And the bigger the organization, the more diversity of opinion and philosophy. You will always find someone in the organization in which everything is a black-and-white situation, and they’re not taking anything in from the clinical aspect or even the opinion of the physician.

From the payer’s side, I could almost say the same thing of physicians we’ve talked to. You will find physicians who are genuinely interested in their patients, and they will talk to us and give us their rationale for the treatment regimen, and it’s a very civil, educational discussion. And you have other physicians who say, ‘I want to give this regimen because I want to give this regimen,’ without any justification. It’s a give and take on both sides.

As Ms. Pautler stated, you know which payers have the most requirements. Proactive preparation is your best way to work with payers. If you’re proactive and you can provide that clean claim up front, then you’ll reduce the amount of denials and delays down the line. It’s all in that preparation.

DR. EICHENBAUM: What can we do to optimize the outcome when we select an agent we think the patient will do best with? One with extensive evidence and experience in that retinal disease state? There are a couple of points we discussed that focus on collaboration and efficiency and driving home the best clinical outcome for this patient that we can obtain with commercially available drugs in 2018.

Dr. Wong, you noted the importance of getting things right on the front end when submitting claims. I would submit that prior to that first claim, the initial step when utilizing buy-and-bill drugs is performing the benefits investigation. As discussed, the pharmaceutical companies have services that help with this. They’re easily accessible. Use them; it can take some of the burden off the practice. Always keep the patient’s best interest at heart. We have the ability to manage retinal diseases better today than when I finished my fellowship 10 years ago. And between the agents that we have available and the processes we can put in place to make sure they are accessible, we can get predictable, good outcomes.

CONCLUSION

DR. EICHENBAUM: What are the main takeaways from today’s discussion?

MS. PAUTLER: Once a physician determines the treatment plan, the next step is to identify the insurance carrier and the plan benefits. The practice needs a well-defined process with everyone involved from the front desk to the physician. Every visit requires insurance verification and possibly a new preauthorization, referral, or a specialty pharmacy medication. Communication and coordination are key to clinical efficiency and prompt claim payment.

DR. PRENNER: There is a great deal of synergy between all stakeholders. Working through some of those processes together can be really effective going forward. At the end of the day, everybody wants to do what’s best for each patient, and I think that requires patient and physician choice.

DR. HALPERIN: The patient always comes first. We are obsessed with patient care, outcome, and experience as well as protecting vision. The reality of the situation is that these medications are not free, and they’re not cheap. But you could argue that the value in a dose of the medication is incredible because we all know what happened to patients before these drugs were available—they lost their vision. We’re fortunate to live in a time of incredible medical advancements, but the advancements cost money. We have to work with the insurance carriers, with our patients, and with our colleagues to determine how to provide the best care.

DR. WONG: The goals that we all have are very similar. I can’t emphasize enough that it’s crucial to be proactive and have the necessary information readily available, so a clean claim can be submitted. If there is a payer out there who is being difficult, don’t stop voicing your concern. The squeaky wheel will eventually result in someone taking a closer look at your situation and finding a solution. Have an open discussion in terms of what you’re experiencing, and what you see. Payers are not unreasonable. They just have a lot of people they’ve got to talk to.

DR. EICHENBAUM: Thank you for the discussion.

 

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