Box 2. Box 2 How payers are implementing OBA

In a practical sense, OBA has been unfolding as a difficult-to-track patchwork of clinical guidelines, stopgap measures and caseworker decisions, forming a de facto, rather than strict standardized, policy. Without formal pronouncement of changes initiated by payers, many stakeholders—patients, physicians, manufacturers and investors—have been blindsided. Furthermore, with policies advancing in unchecked fashion, the healthcare community must decide which aspects are inevitable evolutions that appropriately address previous excesses and which are deserving of active resistance.

Payers have created a wide variety of policies and programs to help control drug use and mitigate costs, serving as the backdrop to enforce an OBA position. Many of these have been ported over to the management of biologics. Though these programs can clearly help target biologics to the most appropriate patient population, aid with compliance and avoid waste, they also can be taken to an extreme in which one can reasonably question whether patient access is being unduly restricted. Various programs tracked by The Bruckner Group are listed below, although this is not an exhaustive list.

Formulary and patient out-of-pocket. The formulary is a routinely revised list of those drugs available to a plan holder, organized by tier according to which products the insurer prefers for a particular therapeutic need. The higher the tier—most plans have 3 or 4—the more a patient will have to pay out of pocket to obtain the drug. The intent is that a nominal payment varying from $5–50 will provide patients with a financial incentive to choose the preferred drug. With many plans requiring a 20% out-of-pocket payment for biologicals, patients unable to pay the thousands required are de facto being denied access.

Authorizations and utilization reviews. For many drugs and virtually all biologics, physicians must obtain prior authorization from an insurance company before a drug can be provided to a patient. The complexity of a prior authorization can vary widely. Some simply restrict drugs to those for whom they are medically necessary, denying access for cosmetic reasons, for example. Others require a broad array of clinical tests, previous treatment failures and particular health status. Even with a complete and qualified prior authorization, physicians report inexplicable denials, which they must then take time to fight. Utilization reviews and frequent reauthorizations can lead to confusion, frustration, treatment gaps and treatment discontinuation.

Step therapy. Before some drugs are made available to patients, physicians must first try, and patients fail, specified alternative therapies. Assuming that a good number of patients will respond to a lower 'step', these policies can be an effective way of preventing knee-jerk use of expensive alternatives. At the same time, many patients and physicians feel that these programs just delay or prevent patients from being put on the best possible alternative as soon as possible, perhaps allowing progression and serious events that otherwise would have been avoided.

Guidelines as rules. Evidence-based clinical guidelines are intended to provide direction and assistance as physicians individualize a patient's care. Instead, guidelines are increasingly being misused as categorical rules that must be followed to the letter. For example, if clinical studies show that the majority of patients will respond to a particular dose within three months, payers will not make higher doses or longer durations available to physicians. These restrictions are enacted even in the face of additional evidence demonstrating that some patients would, in fact, respond with a more tailored therapeutic course. Similarly, drug labels are being strictly interpreted not only to restrict off-label use, but to minimize the population to whom a drug might be made available within the disease area for which it was approved.

Disease management. In its most elaborate form, disease management provides chronic disease patients with integrated care across all aspects of their lives, including clinical services, drug choice and compliance, nutrition, psychological support and education. Unfortunately, often for those on a biologic, what is called disease management is actually more like mandatory case management provided directly through the specialty pharmacy. In these programs, an insurance representative oversees and even 'approves' a physician's treatment plan, continually reviewing patient use to ensure proper compliance and avoid waste (that is, conforming to payer guidelines).

Physician profiling. Physicians contracted by payers are increasingly targeted as a conduit for payer pharmacy policy. Physician profiling for economic efficiency and prescribing patterns has become routine for specialties that commonly treat with expensive biologics. Dedicated payer personnel monitor physician use and address those whose use of expensive drugs is beyond some benchmark. With the increased application of pay-for-performance programs in which physician payment is linked to performance measures, including adherence to guidelines, it is only a matter of time before these programs make their way to biologicals management.