Drug Formularies – Will the Future Start in California?
By Robert L. Goldberg, MD, FACOEM, Chief Medical Officer
California is the place I call home, so it’s not unusual that it would be on my mind. But since the state’s legislature passed a bill in late 2015 requiring implementation of a workers’ comp drug formulary, it has been a prevailing topic on a lot of minds in the industry. Although the date of July 1, 2017 has been set as a deadline for implementation, the question remains how exactly the formulary will manifest.
I find it only fitting that, as a state that historically has been a trendsetter, California has the unique opportunity to usher in a new breed of formulary. Although it is certainly not the first state to implement a workers’ comp drug formulary, it could be the first state to take steps to adopt and implement an injury-specific formulary. I’m talking of course about the newly developed drug formulary based on the American College of Occupational and Environmental Medicine (ACOEM) Practice Guidelines.
I say “of course” because I was directly involved with the development of the new formulary. Am I biased? Well, yes. I’m biased in the way that anyone involved in healthcare should be biased toward wanting the best possible outcomes for the patient. And a formulary that puts the patient at the center of the decision-making process is a reasonable approach.
PUTTING THE PATIENT AT THE CENTER
Determining the clinical appropriateness of therapy is not merely a matter of sorting the good apples from the bad. Whether or not a drug is appropriate depends as much on the patient and the specifics of their injury as it does the risk-benefit profile of the drug itself. Even ibuprofen, a drug that is in many instances a safe option for pain management, can have serious or even fatal adverse effects if prescribed at excessive doses or for the wrong patient. To return briefly to my apple metaphor, there is absolutely nothing wrong with a Red Delicious apple – but if you try baking it in a pie, it will fall apart. My point: decisions regarding prescription drug therapy must be made in the right context, or the outcome may be less than optimal.
A formulary is best developed in the context of a robust clinical evidence base. For the ACOEM-based formulary, recommendations were developed first based on each chapter of the practice guidelines as they relate to injury, and then with increasing specificity in terms of condition, and acute vs. chronic phase of treatment. These criteria are then applied to medication class, and finally individual medication.
When recommendations are tied specifically to a clinical diagnosis, they can better define what is appropriate for a particular condition or phase of treatment. The benefits of this are reciprocal. We ensure that patients are getting the most effective treatment for their specific injury. At the same time, we deter prescribing of otherwise “approvable” medications in inappropriate conditions. This avoids incurring expense for medications that don’t provide any significant benefit in a given condition. The injury-based formulary is a complex methodology that goes much deeper and broader than a basic drug list. Which raises the question: how does one actually implement and leverage this type of formulary?
IMPACT ON CLAIMS MANAGEMENT
Touting the potential cost and care benefits of an injury-specific formulary is very easy from an aspirational point of view, but let’s consider the reality of this model from a claims management perspective.
While the methodology itself is more complex, such a model should create dramatic efficiencies downstream. The formulary creates a set of rules around which all stakeholders involved with the care of an injured worker can align themselves. Recommendations for the large majority of treatment decisions as they relate to drug therapy – probably 90% of these decisions – come built into the formulary. From a prescriber standpoint, this means having clear guidance up front on which medications will be approved for their patients. From a claims management standpoint, this means that decisions will be made based upon a strong clinical evidence base. More than ever, we will be able to get the right treatments to the right patients efficiently, freeing up more time to focus on managing more complex issues.
When implementing any formulary model, there are factors to consider that will help determine its success. First and foremost, a formulary must be broadly understood, and a benefit to the ACOEM practice guidelines is that they are widely used. But part of this understanding also relies on ongoing education to increase awareness among prescribers. If physicians are using the formulary to guide prescribing from the start, then the battle is already won.
Finally, the exceptions process that is implemented along with the formulary cannot be overly cumbersome. Just as no drug should be given an unequivocal green light, patients cannot be denied medically necessary treatment. As much as we look upon opioids as the enemy, there are instances where these medications are necessary. For example, patients with severe or catastrophic injury who may require opioids to manage their pain to facilitate recovery and maintain quality of life. In the final analysis, patients and their condition must be at the heart of drug therapy decisions.
Formulary success factors
- Strong base of clinical evidence
- Broadly understood
- Ongoing education/awareness
- Efficient exceptions process
THE FUTURE OF FORMULARIES
There is a quote regarding the Golden State that goes, “Whatever starts in California unfortunately has an inclination to spread.” I tend to take a much more optimistic view of this sentiment. A more clinically based, patient-centric model is the future of state-implemented drug formularies. And my hope is that the future does in fact begin with California.
This perspective was originally published on March 1, 2016 in the Leaders Speak section of WorkCompWire.