While there is not an official accepted definition of an integrated delivery network (IDN), it is clear that these collaborative, multistakeholder groups that may include providers, payers and related entities in a variety of ownership and alliance structures are proliferating within the current health care environment. As these organizations grow in not only number but also size, many of them have moved from their traditional practice of working with group purchasing organizations (GPOs) in their dealings with pharma manufacturers to directly engaging with drug companies. Within this new landscape, it’s important for pharma to understand what IDNs are looking for and how best to work with them.
Elizabeth Oyekan, senior advisor at Precision for Value, says that the prevalence of IDNs makes them increasingly important for pharma manufacturers: “More than 1,500 IDNs employ or partner with more than 3,300 medical provider groups, more than 400,000 physicians and over 66% of hospitals in the U.S.,” she says. “They now represent the majority of the health care spend in the United States, and their percent of spend will continue to grow.
“Many IDNs now dominate and control key markets, especially in densely populated areas,” she continues. “They are accomplishing their goal of creating a more holistic and coordinated care delivery infrastructure to achieve better care, improved patient experience and reduction in total cost of care across the continuum of care by reducing variation in practices, maintaining tight controls on prescribing and practice habits and keeping an unparalleled focus on quality, to name a few approaches. Due to these foci, IDNs are able to exert a lot of leverage with their physician groups as well as payers and can even blur the lines between provider and payer as they grow and leverage their influence.”
According to Matthew Malachowski, Pharm.D., supervisor of specialty pharmacy services at UAB Medicine, part of the UAB Health System, an IDN that has created its own specialty pharmacy, the concept of an IDN providing patient care is certainly not a novel one. But “the ability of IDNs to positively impact patient wellness and the health care landscape, especially in support of pharmacy services, has grown tremendously in the last decade. Some could argue that the health care landscape has actually had a larger impact on IDNs. Recent advances in information technology and communication enable better documentation of patient health and collaboration with practitioners across distant sites of care. The increase in total medical knowledge has led to greater practitioner specialization, requiring better documentation and communication between practitioners, service lines and referral agencies. Changes to institutional reimbursement have led IDN administrators to expand ambulatory services and pharmacy leaderships to incorporate support for patient access and prior authorizations for prescribers.”
In March 2018, Zitter Insights released a white paper titled Why in the World Would IDNs Want to Contract Directly with Pharma? The IDN Perspective that was based on responses from 35 contracting directors at 29 IDNs, comments from more than 30 IDN executives and online survey data on more than 1,500 pharma meetings with 75 IDNs. The white paper revealed that more IDNs are moving away from working with GPOs and instead negotiating directly with manufacturers. When the 35 contracting directors were asked about the reasons behind this shift, the No. 1 response was that the IDNs could get better pricing than their GPOs could (see chart below).
Many reported being confident in their ability to drive the share needed for direct contracts (see chart, p. 7). Indeed, 34 of the 35 respondents said they expect the number of direct contracts they negotiate from 2017 to 2020 will rise; one respondent said it is expected to remain at 100 direct contracts annually. They said the focus will be on high-cost, high-volume agents, with many citing Remicade (infliximab) from Janssen Biotech, Inc., a Johnson & Johnson company.
“IDNs are looking for manufacturers to partner with them on both drug access and price to provide effective specialty services for providers and patients in the system,” says Erin Lopata, senior director, access experience team at Precision for Value. “Collaboration with pharma manufacturers is a key ingredient to success for these pharmacies.”
However, working directly with IDNs may be easier said than done for pharma companies. For one, IDNs don’t fit neatly into the “traditional commercial model based on account representatives making frequent individual provider visits,” says Oyekan.
While providers are still part of the equation, IDN administrators who are not writing prescriptions are likely to be involved. “Beyond clinical considerations, business considerations may carry significant weight in IDN purchasing decisions, which is a major change from the typical purchasing decision making by individual physicians,” she tells AIS Health.
Finding Contacts Can Be Challenging
Another potential problem is determining exactly who these points of contact actually are. “The size of these institutions, both in terms of square footage and number of employees, can make any interpersonal tasks daunting, without factoring in the number of departments and variety of scopes of practice which must be navigated to find the right person to collaborate with on a specific initiative,” Malachowski says.
One further complication, he says he’s been told, is that sometimes it’s difficult to engage with some of these contacts. He says an account manager once described initially entering an IDN as “searching for a person in New York City armed only with their name, and, upon finding that person, learning that they don’t wish to speak with you anyway.” He points out that many IDNs “were historically driven by acute care services, which do not routinely create a welcoming environment for manufacturing liaisons. And to be honest, pharma historically was not doing itself any favors either. But we’ve all grown up since those past interactions, [and] new laws are in place.…Parts of IDNs may be difficult to engage with, especially if you haven’t contacted anyone in the last five years. Try again.”
Once IDN contacts are identified, pharma account executives must determine what their roles and goals are. “Different leaders within the institution will have different needs and responsibilities and generally different attitudes towards manufacturer colleagues,” he says. “While all members of a pharmacy leadership team will be interested in a medication’s effectiveness, place in therapy and safety profile, an inpatient manager will also need to consider institutional formulary control measures, an outpatient manager will need to consider patient access and out-of-pocket costs, and a benefits manager will need to consider utilization, impact to employer contracts and possible downstream cost savings.” Without an understanding of this information, maintains Oyekan, account executives “are unable to effectively educate, advocate, support and effect win-win solutions to help the organization meet its priorities while meeting their own goals.”
Understanding the priorities of the IDN itself is important, she points out, adding that these may be different from the fee-for-service practices with which pharma has traditionally dealt. “IDNs are increasingly assuming risk of their populations in terms of bundled payments and population health management,” Oyekan says. “The more risk they take on, the more focused they are on driving good outcomes at the lowest cost.”
“With value-based care winding its way into changing how health care is reimbursed, IDNs are looking to factor the cost of the medicines in the delivery of care. Pharma companies are not entirely inclined to move into a value-based payment model, so this is potentially a sticking point,” says Ashraf Shehata, principal at KPMG and a member of the firm’s Global Healthcare Center of Excellence.
According to Joe Coppola, managing director and commercial and market access leader at Deloitte, “the main challenge is that the business model is changing in various directions, and pharma needs to tailor their approach to successfully engage with this customer group. Tailoring their approach requires developing an intimate understanding of their value drivers and barriers that impact behaviors and decision making.” He notes that “not all IDNs are the same. They have different patient populations, and some are farther along than others with regards to building out their analytics capabilities and ability to manage patients across the continuum of care. The key for pharma is to understand that this customer group is not homogeneous and to tailor their value propositions accordingly.”
Once a manufacturer has this information, “team members will need to have the business acumen to demonstrate how their products, resources and tools will impact the customer’s bottom line, close identified gaps and optimize the value required by the account,” says Oyekan. “Without these skills and insights, account teams will be challenged in engaging key decision makers in the IDN landscape.”
Malachowski maintains that engaging and negotiating with IDNs is really no different from interactions with other stakeholders. The same entities — provider groups, pharmacy and therapeutics committees and insurer networks, for example — will still need to be addressed, but with an IDN, they all work under the same umbrella. “The issue for pharma will be that this engagement will have to be performed over and over again at multiple institutions, and each interaction will have to be performed with the same care and engagement as the one before.”
‘Let Us Take Care of Our Patients’
As far as what IDNs are looking for in pharma partnerships, Malachowski maintains that one ask is simple: “Let us take care of our patients.” IDNs are unable to do that when, for instance, a limited-distribution contract for a drug means a prescription must be sent to an outside pharmacy even if a patient wants to fill it at the IDN pharmacy.
In addition, he says, “help us take care of our patients. This would include field reimbursement, patient education material, patient-assistance programs and smart phone applications. Lastly, help in changing how we care for our patients. This would include phase 1 and phase 2 research through our investigational drug services departments, collaborative post-market research opportunities with institutional medical teams and data and analytics evaluation through our associated research departments. By working together to better understand the products and the disease states we are treating and developing new agents or new uses for old agents, we can change the fundamental care these patients receive.”
Challenges that pharma can help handle include “optimizing EHR/EMR technology, achieving internal and external quality measures, affordability of services and drugs, variation in practices and processes, optimizing the patient experience and maintaining their bottom line,” says Oyekan.
And while partnership needs will vary depending on the IDN, Coppola tells AIS Health that popular areas are around “real-world evidence, population health and disease education.”
By working directly with IDNs, pharma companies benefit in a number of ways as well.
“IDNs also can act as an outlet to deliver ‘beyond the pill’ services to help the drugmakers better engage patients and improve compliance,” says Shehata. According to the Zitter white paper, one of the reasons why pharma should contract directly with IDNs is that IDNs can help improve patient outcomes (see chart, p. 8). The organizations also can provide drugmakers with outcomes and adherence data.
“IDNs with high degrees of control and centralized decision making can allow pharma companies to be successful in their engagement through identifying champions and utilizing a top-down, cascading approach to implement programs within the institution’s affiliated sites,” asserts Coppola. “Also, risk-bearing IDNs with integrated EMR platforms provide opportunities for innovative strategic partnerships, contracting and evidence generation.”
IDNs can help in situations where small and/or new pharma firms have “a single agent and limited funds,” says Malachowski. “For IDNs, this isn’t our first product launch, and many institutions with retail pharmacies will already have resources, processes and relationships in place, which are ready to help facilitate access to your product and ensure it is used safely and effectively. This is especially important for high-touch products with a narrow therapeutic window, aggressive side effect profile and complicated starting schedule, as the medical team will need substantial help, which they are already routinely receiving for other medications in that disease state and therapeutic class.”
The growing focus on value-based care and risk-based arrangements is aligning pharma and IDN interests, as both strive to improve quality of care, reduce costs and improve patients’ experience, contends Oyekan.
“The challenge, however, remains to gain insights into the inner working of each other’s organizations in the quest to achieving these outcomes,” she says. “Also, both organizations will have to work through the distrust of the past and focus on interdependent thinking to build aligned opportunities and partnerships. As IDNs and pharma companies partner on incremental projects that will support aspects of the agreed-upon goal, they will build the trust and alignment needed to make the Triple Aim a reality for all.”
Contact Coppola through Ellen Conti at firstname.lastname@example.org, Lopata and Oyekan via Tess Rollano at email@example.com, Malachowski at firstname.lastname@example.org and Shehata through Bill Borden at email@example.com.
by Angela Maas
Some Practices Now Are Taking Two-Sided Risk in CMS’s Oncology Care Model Pilot
As CMS’s Oncology Care Model (OCM) starts its third year this month, participants who spoke with AIS Health say it has been an overall positive experience. Developed by the CMS Center for Medicare & Medicaid Innovation (CMMI), the five-year voluntary pilot is aimed at providing better quality and more coordinated cancer care for Medicare fee-for-service beneficiaries, as well as other payers, while at a lower cost. So far, all participants have been in a one-sided risk arrangement, but now, for the first time, some practices are participating in a two-sided risk model. A recent Avalere Health analysis of the OCM’s first year, though, shows that many providers would owe recoupments to CMS under either of the two available two-sided risk models.
The program started in July 2016 with 17 payers and 196 practices; 10 payers and 176 practices currently are participating. The program reimburses providers for episodes of care in the form of a per-beneficiary per-month payment, as well as a possible performance-based payment if Medicare expenditures are below a target price for an episode. The amount of the payment is tied to a provider’s achievement on various quality measures.
According to Russell Hoverman, M.D., Ph.D., vice president of quality programs for Texas Oncology, “enrolling in the OCM has been transformational. We think the incentives are appropriate, and care for patients has been enhanced.”
“In general, participation in the OCM has been a positive experience,” says Amit Sarma, M.D., an oncologist with Virginia Cancer Specialists. “On the upside, the goals of increasing patient satisfaction and decreasing waste in health care are worthy goals. Working towards this has been gratifying. The program allows for practices to be creative in tailoring solutions to their particular patients.”
He also notes how OCM funding has allowed his practice to hire staff specifically to provide patient navigation services, helping out in an area that may be particularly challenging for Medicare patients.
“We’ve definitely seen an improved patient experience driven by the funding and the requirements of the OCM,” says Marcus Neubauer, M.D., chief medical officer for The US Oncology Network, which is part of McKesson Corp. “Data sharing is superior to any other VBC [i.e., value-based care] program we have participated in. Patient rates are decreased for most Network participating practices.”
Hoverman, who also is medical director of managed care for The US Oncology Network, explains that having complete claims data allows practices to locate and focus on areas that need improvement, such as identifying patients at high risk of hospitalization and keeping them healthy and out of the hospital.
Participating in the pilot, says Timothy Murphy, M.D., an oncologist with Rocky Mountain Cancer Centers, has given all members of its care team the “opportunity to ‘think outside the box’ to create a better system of care for our patients. It has fostered creative thinking, team building and better morale, as it is no longer only the physician creating the changes deemed important.”
He also says that participating in the pilot has gotten his practice to focus on reducing costly care for services that could be avoided, such as hospitalizations and emergency room visits. “We are also bringing in advance care planning and palliative care services much sooner in a patient’s cancer journey than previously done. Patients are becoming much more engaged with decisions regarding their care, particularly when it comes to metastatic and incurable cancers.”
Murphy says that within his practice’s market, private payers are taking a cue from the OCM, adopting value-based contracts and moving away from fee-for-service. “As Medicare remains our single biggest payer, private payers are keenly aware of the OCM project and the savings that can be realized while improving the overall quality of care delivered.” CMS has not released overall savings from the OCM so far.
But while participants are realizing a range of benefits to participating, they also say there are aspects of the OCM that could be improved.
“A quicker turnaround on our quality metrics and cost of care for each episode would help us be nimbler with our changes. As it now stands, changes we made over one-and-a-half years ago are only now being made available to us,” says Murphy. This, in turn, makes it “difficult to know whether the changes we enact are beneficial to the overall goal of the program,” he says.
“However, we are pleased that CMMI has been very engaged in the program and has modified some of the original assumptions once they began to evaluate the data,” he adds.
In addition, he says, “it does appear that practices which have historically maintained fiscal restraint as a matter of their daily business may be disadvantaged in this model because they may see a smaller reduction in their cost of care as they were quite fiscally prudent to start with. The model relies too heavily on HCC [i.e., hierarchical condition category] coding, which is an administrative task that really provides no benefit to the patients and caregivers.”
“There has to be continued improvement in the designation of episode costs by better definition of the groups and risks,” maintains Hoverman. “CMMI has been very receptive to these concerns and have made a number of adjustments to date. Drug costs change rapidly, and the model does not keep up with rapid changes in appropriate therapy costs” (see box, p. 4).
Sarma points to “some significant administrative burdens. Specifically, the eligibility/enrollment process is a big challenge, as is the data-reporting requirement.” He also cites the lack of timely data, as well as the fact that “the data analytics support needed to make informed changes is not readily available. These are massive data files that require a high level of expertise to crunch through. I’d love to see CMMI provide analytics support as part of the program (or for a modest fee).”
Neubauer says that CMMI’s OCM team “has been very engaged and willing to work with participating practices to improve the model, but oncology care, especially the drugs, is hard to build into a model, and it is of some concern that the model can’t keep up with new drugs and escalating prices. Also, we would like more insights from CMMI on what specific factors lead to success in the model and which ones are hurting practices.”
In addition to all the changes that have occurred within the OCM so far, there may be an even larger overhaul. “CMS and others are discussing a 2.0 version of OCM, so there’s a lot of talk that while there will continue to be a future OCM, that future OCM may be quite different, and there may be more substantial changes to the payment model to come,” said Richard Kane, an associate principal, policy analytics at Avalere, during a May 21 oncology webinar hosted by the company. One example was seen when the Community Oncology Alliance unveiled its proposed OCM 2.0 in June.
Some Must Switch to Two-Sided Risk
But closer on the horizon is a pretty big change slated for early next year: CMS will require practices that have not achieved a performance-based payment in any of the first four six-month performance periods to switch to one of two two-sided risk models starting in January or leave the program.
The original two-sided risk model was viewed as very financially risky, prompting providers to remain in one-sided risk. But this year CMS unveiled an alternative two-sided risk model that is much more palatable, and some providers are opting now to participate in the OCM through that model. CMS has not disclosed exactly how many providers are doing this.
Sarma and Hoverman both tell AIS Health that their practices are moving into the alternative two-sided model this month. Neubauer says “a few practices in The US Oncology Network” are shifting to the model this month, while others are waiting to see their results from the fourth performance period and will make a decision later this year. So far, no practices within the Network have dropped out of the pilot, “but it is possible this will be the case if they are forced into a two-sided risk option in January.”
Murphy says his practice “will likely be pursuing the alternative two-sided risk model.”
He says that over the first three performance periods, his practice “brought down the total cost of care of our patients. In addition, we have had excellent results in the quality of care metrics reported. We strongly feel value-based care reimbursement models will supplant the fee-for-service model that currently exists.”
But even with the alternative model, a recently released Avalere study shows some concerning information for practices. Based on the first two OCM performance periods, about 70% of participants would owe CMS payments in the original two-sided risk model, while around half of practices would owe CMS payments in the alternative two-sided risk model.
Study: Expensive Novel Drugs Launched After OCM Baseline Period Are Hamstringing MDs
One criticism of CMS’s Oncology Care Model is that providers’ costs are compared with targeted costs that are based partly on their spending from 2012 to 2015, the OCM baseline period. When the actual costs come in below the targeted costs, that earns providers a performance-based payment. But with so many costly oncology therapies launching after the baseline period, this is making it hard for providers to gain a performance-based payment.
That was the focus of a poster presentation by Tennessee Oncology at last month’s American Society of Clinical Oncology meeting. Researchers maintained that “when avoidable inpatient, post-acute, and emergency department (ED) costs are minimized, a practice’s actual costs should be lower than target costs, allowing practices the opportunity for shared and performance-based savings. However, we hypothesized that the ability for an oncology practice to successfully meet target costs may be hampered by the skyrocketing prices of novel therapy drugs implemented into clinical practice after baseline period cost calculations.”
They examined Tennessee Oncology patients with non-small cell lung cancer (NSCLC) and bladder cancer treated during the second performance period (January through June 2017). Those cancers were selected because Opdivo (nivolumab) and Keytruda (pembrolizumab) gained approval for second-line treatment of NSCLC in October 2015, near the end of the baseline period, while Tecentriq (atezolizumab) gained FDA approval for the treatment of chemotherapy-ineligible or second-line bladder cancer in May 2016, after the baseline period.
Among researchers’ findings:
✦ Of the 240 NSCLC cases, 118, or 49%, had costs above the adjusted target cost. Of the 31 bladder cancer cases, 13, or 32%, were above the target cost.
✦ Of those 118 NSCLC cases, 62, or 53%, did not have ED visits, hospitalizations or post-acute care. Of those 13 bladder cancer cases, five, or 38%, avoided those outcomes.
✦ Of those 62 NSCLC cases, 43, or 69%, included treatment with an immunotherapy. All five of the bladder cancer cases included an immunotherapy.
✦ Of those 43 NSCLC cases, 33, or 77%, were in line with National Comprehensive Cancer Network (NCCN) guidelines. Four of the five bladder cancer cases, or 80%, were in line with the guidelines.
Based on those findings, researchers concluded that the use of expensive novel therapies in concordance with NCCN guidelines in indications approved after the OCM baseline period “poses significant challenges to practices. Future value-based care initiatives in oncology need more accurate ways to account for rising drug costs and expanding treatment indications to prevent penalties for following guideline appropriate care.”
For more information on the study, visit https://bit.ly/2Lwvux8.
The Community Oncology Alliance recently urged CMS to give providers one additional performance period before they must decide to transition to two-sided risk or drop out of the program entirely.
Looking at the first two performance periods, “we don’t see dramatic differences in treatment patterns between those practices that are participating in the program versus those in Medicare fee-for-service that are not. So, for instance, we see similar spending on drugs as a share of episode,” which were around 60% of episode costs, said Kane. “The average episode is four drugs. In addition, we see similar spending by oncology practices participating and those not participating in terms of how much they’re spending on novel therapies. So there’s a lot of attention as to whether the OCM payment model would discourage the use of novel therapies. These are newer drugs coming out, and newer drugs often tend to be more expensive.”
“Interestingly, when you look at the first two performance periods, episode costs are decreasing on average both inside and outside the program, and that decrease in costs is driven by less spending on inpatient hospital costs,” he added. Looking ahead, he said, changes to OCM include CMS “using clinical information for some tumor types.…There is a lot of cost variation among tumor types, and practices participating want to be held accountable in meaningful ways given that costs differ greatly depending on the condition of the patient.”
“The things to think about when we’re talking about downside risk and CMS requiring downside risk in the future, this is an issue that has come up with” accountable care organizations, pointed out Kane. “There’s a common conception that downside risk improves incentives, but then there’s also a lot of concern about how fast you make that transition. You don’t want a large exodus from the program out of fear of downside risk. So we know, for instance, that during the first three performance periods, less than a third of participating practices achieved a performance-based payment.
“And then we know conversely that based on the originally available downside risk track, that means about two-thirds would owe a payment if they were in downside risk,” he said. “So this new payment track differs from the original existing one in the sense that it’s created this neutral zone. If you lose only a certain amount, then you will not have to owe a recoupment to CMS,” which he termed “a little bit of a safety net.”
“Many practices simply aren’t qualified or willing to take” on the financial risk in the two-sided models, says Neubauer. “One concern is that the model is so complicated that it is difficult to reasonably predict future performance. On the other hand, the Avalere analysis only included the first two performance periods, and there were significant, favorable, appropriate program adjustments in PP3, so it is likely the results are overstated regarding payback as we get into performance periods beyond No. 3.”
The assessment, Murphy says, “may be a signal to CMMI to continue to adapt the program to allow for more practices to continue.”
Contact Hoverman, Murphy, Neubauer and Sarma via Claire Hatty Crye at firstname.lastname@example.org.
by Angela Maas
This story was reprinted from AIS Health’s monthly publication RADAR on Specialty Pharmacy. For more information, visit https://aishealth.com/product/specialty-pharmacy.
Reality Check: Glaucoma
Our Point of View
Prostaglandin analogs — many of which are available as generics — remain the first-line treatment for glaucoma, as newer branded drugs struggle to gain a foothold in the class, experts say. Second-line therapy involves either switching to a beta blocker or adding a beta blocker to the prostaglandin analog medication, says Mesfin Tegenu, R.Ph., president of PerformRx. Multiple generic beta blockers also are available. “Use of generics is common in this class,” he tells AIS Health. “Given that many beneficiaries who take these products are on Medicare, there is a member cost share that can be significant between brands and generics.” Contracting is a critical component for branded agents, which may struggle to find a market. Formulary coverage is extensive, with generics available at the lowest copay tier and preferred agents in the formulary brand tier.
Under the pharmacy benefit, more than 58% of the lives in commercial formularies are covered without utilization management restrictions. Across all drugs, almost 56% of the lives under Medicare pharmacy benefit formularies are not covered for at least one of the drugs.
For 81% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 33% require multiple steps. More than 25% of payercontrolled pharmacy benefit covered lives require prior authorization, with 43% consisting of policies that are restrictive as compared with a product’s FDA-approved label.
AIS Health’s View
Adherence is a significant problem in glaucoma treatment. Studies have found that around one-quarter to one-third of patients have poor adherence to treatments and that adherence declines over time. Some research has found that adherence in the third year of treatment may be as low as 15%. According to one study, top reasons for nonadherence include forgetfulness, poor self-efficacy (self-confidence), poor knowledge, erroneous beliefs about glaucoma not leading to vision loss and medications preventing vision loss, difficulty with the medication schedule and life stress. Unsurprisingly, those who had multiple barriers to adherence were less likely to adhere to their medication regimen. Payers utilize various tools to improve compliance in glaucoma treatment, including reminder phone calls, text notifications and case management, Tegenu says.
Branded Drugs Struggle to Gain Traction in Glaucoma Treatment
Prostaglandin analogs — many of which are available as generics — remain the first line treatment for glaucoma, as newer branded drugs struggle to gain a foothold in the class, experts say. In addition, compliance with glaucoma therapy remains a significant problem, with plans deploying various reminder techniques to get patients to take their medication. Advances in drug delivery technology may help to solve this problem, albeit at a potentially higher price point.
Prime’s 2019 Formulary Excludes Rhopressa
Prime Therapeutics LLC’s 2019 National NetResults Formulary excludes Rhopressa (netarsudil solution), a new mechanism of action for glaucoma. David Lassen, Pharm.D., chief clinical officer of the PBM, says that “prostaglandin analogs (e.g., latanoprost) are considered the most effective initial treatment. Rhopressa is less effective, has more side effects, and is more expensive than currently available drugs (latanoprost).”
Allergan Announces Positive Trial Results
Allergan plc announced in January positive three-month topline results from the second Phase 3 clinical trial of bimatoprost SR, a first-in-class sustained-release, biodegradable implant for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company says it expects to submit a New Drug Application to the FDA in the second half of 2019
Via Cision PR Newswire
Market Events Drive Changes
In March 2019, the FDA approved Aerie Pharmaceuticals, Inc.’s Rocklatan, the first and only once-daily combination of a prostaglandin analog and a Rho kinase inhibitor. In September 2018, the agency approved Xelpros from Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC). It is a topical ophthalmic and is the first and only benzalkonium chloride-free (BAK-free) form of latanoprost. In late 2017, the FDA approved Bausch Health Companies’ Vyzulta, as well as Aerie Pharmaceuticals Inc.’s Rhopressa, which offers a different mechanism of action.
Pharmacy Benefit Implications
Most policies require trial and failure of a generic or preferred formulary brand, and brands process exclusively under the pharmacy benefit. Medicaid plans most often require prior authorization for coverage of non/formulary agents. Commercial plans require a step through generic or preferred brand prior to use of non-preferred agents.
AIS Health’s View
New drug delivery mechanisms may help with compliance, although not necessarily with cost, Tegenu says. For example, Ocular Therapeutix’s OTX-TP (travoprost insert) is a drug product candidate that is intended to be inserted into the eye’s canaliculus to deliver travoprost to the ocular surface for up to 90 days without preservatives. The goal is to deliver a steady release of travoprost throughout the treatment period without the need for the patient to self-administer eye drops. “This would potentially eliminate the need for patients to utilize daily drops for management of their glaucoma,” Tegenu says. The manufacturer is enrolling patients in a phase III trial. Other companies are working on gel-based and microsphere-based drug delivery mechanisms.