by Dennis M. Sponer, CEO, ScripNet
Previously, this column has addressed the rising utilization and cost of opioids in workers’ compensation. An issue that that has gotten much press recently, particularly related to Actiq and Fentora, is the practice of prescribing off-label drugs. Off-label can be defined as the prescription and use of medications in a manner different than that approved by the Federal Drug Administration (FDA). The FDA does not prohibit off-label prescriptions, even if that use is outside of the context that the FDA has approved them to be marketed, because off-label is not necessarily improper. The Centers for Medicare & Medicaid Services (CMS) and other organizations have compendia-listed uses for drugs like Neurontin, which is well documented as being effective for neuropathic pain, but is classed as off-label because it has neither been submitted nor received FDA approval for that purpose. Workers compensation payers and their PBMs need to work together to determine which and when off-label drugs are appropriate and set up processes to control authorization and dispensing when it presents a risk to injured workers or an opportunity for abuse.
A 2006 study published in the Archives of Internal Medicine reported that up to one-fifth of all drugs are prescribed off-label. Powerful pain relievers such as Buccal Fentanyl, also called Actiq as a lozenge or Fentora as an effervescent, have been approved by the FDA for managing breakthrough cancer pain, but are being prescribed for work-related injuries. Actiq accounts for over $60 million in drug spend for workers’ compensation and as much as 80% of Actiq usage is off-label. A California Workers’ Compensation Institute (CWCI) study on ‘Prescribing Patterns of Schedule II Opioids’ focused on the use of Buccal Fentanyl in the California workers’ comp system. CWCI reported more than 14 percent of claims with minor back injury had at least one prescription for Actiq or Fentora, with no evidence of cancer-related illness or injury among any of the injured workers in the study sample.
So whose responsibility is it to determine when an off-label drug is appropriate? The pharmaceutical manufacturer who makes it? The physician who prescribes it? The pharmacist who dispenses it? The patient who consumes it? Or, the payer/claims adjuster who approves it?
Manufacturers, in all cases, will have obtained FDA approval for producing the drug http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm and the law does not limit or interfere with a physician’s ability to prescribe or administer any legally marketed product to a patient for any condition or disease within a legitimate health care practitioner-patient relationship, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Manufacturers, however, are prohibited from marketing drugs for off-label purposes. In a number of cases manufacturers have been fined, including: Cephalol (Actiq), who paid $425 Million, and Warner Lambert (Neurontin) who paid $430 Million, for promoting off-label drugs to physicians.
By law, physicians are given wide latitude to prescribe and administer legally marketed drugs to their patients. While, with exception, the vast majority act in the best interests of their patients, they can be heavily influenced by the pharmaceutical manufacturers through education and monetary incentives, despite the possible negative outcomes it can have for patients, including dependence, addiction, and death.
Patients who are in pain will rely on the advice of their physicians. Some act in their own self interest and will not abuse themselves. For others there is a risk of abuse, dependence, addiction and diversion.
It comes down to workers’ compensation claims adjusters that approve the off-label use and the Pharmacy Benefit Managers (PBM) that administer their pharmacy programs. ScripNet has established programs with clients to identify and monitor specific drugs for off-label use and puts the protocol in place at the point of sale to pre-approve or adjudicate usage, including adjuster and physician outreach for letters of medical necessity to determine if the injuries are compensable.
The role of a PBM is to work with payers’ claims adjusters to establish guidelines up-front through the use of Formularies (Prospective Drug Utilization Reviews), to manage the approvals/prior authorization and adjudication process at the point-of-sale (Concurrent DUR), and/or to identify possible abuse or diversion after the fact (Retrospective DUR). While off-label prescribing and use is not always inappropriate, all parties involved must be aware of the risks to the patient and the potential for abuse and waste, and act accordingly.