The FDA recently approved Ingrezza (valbenazine) for the treatment of adults with tardive dyskinesia.
Payers are no stranger to the challenges of treating patients with complex psychiatric conditions. These patients often represent less than 5% of members, yet can be responsible for more than 10% of spend, as they tend to utilize more expensive settings of care and have a greater likelihood of having multiple comorbid conditions. With the approval of Neurocrine Bioscience’s Ingrezza for the treatment of adults with tardive dyskinesia (TD), payers will likely welcome this new therapeutic option as a cost-effective treatment, with the hopes of increasing adherence to antipsychotic medication therapy and reducing emergency department visits and inpatient stays, 2 major areas of spend.1
From a competitive standpoint, the timing of Ingrezza’s approval is crucial. Teva recently received marketing approval for Austedo in the treatment of chorea associated with Huntington’s Disease.2 Austedo is expected to be approved for treating TD in late August, which means Neurocrine has a 4-month headstart in communicating its value proposition to patients and providers. Ingrezza enjoys some advantages over Austedo, including once-daily dosing and the lack of a black-box warning for depression. Pricing for both drugs is expected to be as high as $60,000, and, unsurprisingly, management will take place through the specialty pharmacy channel.
Even with these potential timing and adherence advantages, how can Neurocrine, an otherwise small fish in a large pond, carve out its niche as treatment provider of choice for neurologic and psychiatric-related disorders? How can Neurocrine avoid being caught up in a pricing-and-contracting war with one of the leading manufacturers of generic drugs? To answer this, Neurocrine should look to the orphan drug playbook, and understand the ways manufacturers of these drugs prove their products’ value to patients, providers, and payers. From this standpoint, there are 3 keys to a successful Ingrezza marketing campaign, including:
Educating and Supporting Physicians
Engaging physicians through the use of high-quality clinical evidence will be key to Neurocrine’s initial launch strategy. Even though the etiology of TD in patients on antipsychotic medications is predictable, TD is often misdiagnosed or underdiagnosed. Neurocrine must communicate clearly and widely the diagnostic tools used to identify TD (the AIMS test), and Ingrezza’s efficacy in reducing the severity of TD in clinical trials. Ingrezza’s 160-person sales force includes 12 medical science liaisons who, for over a year, have been tasked with generating awareness among key thought and opinion leaders. Continuing this campaign and creating a sense of urgency among clinicians will be central to Neurocrine’s marketing strategy.
Patients at greatest risk for TD are also among the neediest in terms of support and access. Neurocrine will benefit their brand by not only supporting uninsured and underinsured patients through financial assistance programs, but also working actively with the patient’s case manager to ensure continuity of care. These activities may include helping provide coverage and reimbursement support, appointment scheduling, working with specialty pharmacies to ensure access and timely dispensing of drugs, and providing updates on the patient’s progress to their physicians. Owning this process is key to maintaining the relationship with a traditionally non-adherent patient population, as well as generating real-world effectiveness data to drive additional sales going forward.
Enabling a Strategic Specialty Pharmacy Relationship
The support described above can only be achieved through a close relationship with the patient’s specialty pharmacy. Neurocrine should realize that specialty pharmacies serve as the patient’s advocate, helping to find financial assistance to enable access and improve speed to therapy. Having the right specialty pharmacy partner ensures the proper collection and reporting of adverse events as well as patient-reported outcomes that may provide insights to inform future marketing and outreach efforts. Ingrezza’s high price tag will put it squarely in payers’ sights for intensive cost management, so ensuring that specialty pharmacy efforts are accomplished correctly and consistently will boost Neurocrine’s negotiating efforts and image as a trusted provider in behavioral health therapy.
The approval and release of Ingrezza is an exciting advancement in the field of psychiatric drug therapy. Reducing the disruptive impact of mental illness on patients, including the side effects of their medications, is a tremendous opportunity. Crafting an appropriate, evidence-based image for Ingrezza, and providing the intensive patient support programs as well as enabling key specialty pharmacy relationships, are all vital to the commercial success of this promising drug.
1. FDA approves first drug to treat tardive dyskinesia [news release]. FDA’s website.
. Accessed April 12, 2017.
2. Teva announces FDA approval of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s Disease [news release]. Teva’s website.
. Accessed Apr. 4, 2017.