The late-phase Parkinson’s disease (PD) pipeline has swelled, but new drugs face a challenging U.S. access and reimbursement environment. While treatment paradigms in PD have been stable for some time, an influx of recently launched and emerging PD drugs in the United States may be poised to alter the course of PD treatment. But these drugs come at a tense time in the U.S. pharma market; the rising cost of healthcare and the high cost of prescription medications have dominated U.S. pharma news, and payers are fighting back harder than ever, excluding expensive drugs from formularies and imposing stricter restrictions and cost-sharing measures on the drugs they do cover. These strategies impact physician prescribing practices by restricting choice, and also prompting physicians to prescribe cheaper or generic medications to reduce their patients’ out-of-pocket costs, even when a more expensive therapy would be preferable. Market access hurdles for new brands may be especially arduous in highly generic markets with elderly cost-sensitive patient populations such as PD, in which approximately two-thirds of patients are covered by Medicare. In October 2016, we surveyed U.S. Medicare payers and neurologists who treat PD to assess the current and future access and reimbursement landscape for PD, and the results were telling.

A case study: the new antipsychotic Nuplazid. Nuplazid, one of the most highly anticipated PD drugs of the past few years, launched in the United States in May 2016 (check out our post from that time, previewing the drug’s market potential). Nuplazid is the first antipsychotic approved in the United States for the symptoms of PD psychosis (PDP), which DRG epidemiologists estimate afflicts approximately 40% of diagnosed PD patients and, according to our research, is currently undertreated. Before Nuplazid’s launch, physicians treated PDP by adjusting patients’ dopaminergic regimen (which is needed to treat motor dysfunction but can increase the risk of psychosis) or prescribing off-label generic antipsychotics, which are supported by limited evidence in the PD population and can worsen motor symptoms. In contrast, Nuplazid won FDA approval for treating the symptoms of PDP and has a selective mechanism of action that does not worsen motor dysfunction. Based on these key differentiators, Acadia priced the drug at $65/day (wholesale acquisition cost), making it the most expensive antipsychotic on the market and one of the most expensive PD brands.

Payers may need convincing about Nuplazid’s value proposition. DRG research shows that although most Medicare plans cover Nuplazid (Medicare Part D plans must cover all or substantially all antipsychotics), nearly all cover them on high formulary tiers, leading to higher copays/cost-sharing, and most employ reimbursement restrictions to limit drug use: on Medicare plans, most payers impose prior authorization restrictions for PDP (anecdotally, one interviewed KOL also mentioned payers requiring a normal MMSE score) or, less commonly but still notably, step therapy (requiring patients to try and fail one or more off-label antipsychotics first). To optimize coverage for Nuplazid, Acadia could benefit from demonstrating clinical superiority (and, ideally, the potential for medical cost savings) compared to off-label antipsychotics, but for now at least, our surveyed payers appear to be unconvinced: when asked, few believe that Nuplazid is a breakthrough treatment or that its clinical value is “commensurate with the price,” and most don’t agree that Nuplazid has value over other antipsychotics just because it has FDA approval and clinical evidence supporting its efficacy in the PD population. Some surveyed payers even report imposing 24% coinsurance (on average) on Nuplazid, which could add up to several hundred dollars per month in out-of-pocket cost to the patient.

Physicians want to use Nuplazid earlier and more often, but are hitting reimbursement roadblocks. As we expected back in May, providers see the clinical value of Nuplazid. In contrast to payer opinion, many of our surveyed neurologists believe that Nuplazid holds value over other antipsychotics thanks to its FDA approval and clinical evidence supporting efficacy in the PD population (though most agree with payers that the drug’s price is not commensurate with its clinical value). Two-thirds of surveyed neurologists report that they prescribe Nuplazid (a surprisingly high number considering the drug’s short time on the market), but they prescribe it to less than a quarter of their patients with PDP (compared to approximately 60% taking off-label antipsychotics). Nearly all of these neurologists experience moderate to extreme difficulty getting Nuplazid reimbursed by payers, and most say that reimbursement restrictions and patients’ out-of-pocket cost restrict their prescribing. Similarly, those neurologists who have access to the drug but don’t prescribe it at all primarily blame high out-of-pocket cost and reimbursement restrictions. The result? Physicians want to use Nuplazid more often—even first-line (see figure)—but they can’t. Indeed, in data not shown, although 70% of surveyed neurologists would prefer to use Nuplazid as one of their first three treatment strategies for PDP (if cost and reimbursement issues didn’t hold them back), less than half actually do.

Is Nuplazid an exception or the rule? What is/will be the market access fate of other recently launched drugs (such Impax’s Rytary and AbbVie’s Duopa) and the many emerging therapies we expect to launch in the United States in the next five years? The answer may be nuanced and will depend heavily on drug price, innovation, and clear clinical differentiation or proof of clinical superiority (and, for payers, cost effectiveness) relative to key competitors for each, but Nuplazid’s example as an admittedly costly but also novel and important product that targets a key area of unmet need in PD suggests that forthcoming PD brands may struggle—especially within the key domain of treating motor symptoms, where numerous safe, effective, well-tolerated, generic drugs are available and can serve many PD patients sufficiently in early and intermediate stages of the disease.

In-depth analysis of access and reimbursement issues for Nuplazid and other current and emerging PD drugs can be found in DRG’s 2016 Parkinson’s Disease Access & Reimbursement (US) module, publishing this month.

 

How Glympse Bio oversubscribed their Series B funding amidst the pandemic

View Now