Could the Specialty Pharmacy Model Help to Curb the Opioid Epidemic?

Everywhere you turn, the opioid epidemic continues to be a topic of concern. In 2016, there were 42,249 deaths from an opioid-related overdose, with 40% of those fatalities attributed to prescription opioid use. Every day, more than 1000 people are treated in emergency departments for misusing prescription opioids, with billions of dollars spent each year on medical costs, rehabilitation services, social services, and law enforcement related to the opioid epidemic.

With these staggering figures, it’s no wonder the opioid epidemic continues to be of high concern, affecting a large portion of the population and causing a financial strain on the health care system.

Industry leaders have begun to act against the epidemic. These actions include imposing quantity limitations on initial and ongoing opioid prescriptions, making drug disposal units and opioid reversal products more readily available, and expanding the reach of educational services that address the addictive potential of opioids to students, parents, and the general public.

The US Department of Health and Human Services (HHS) published a 5-prong approach to curb the utilization of opioid medications:

1. better addiction prevention, treatment, and recovery services

2. better data

3. better pain management

4. better targeting of overdose reversing drugs

5. better research

There have also been movement to raise awareness regarding the addictive potential of these medications among prescribers and patients via risk evaluation and mitigation strategies deployed by various manufacturers in conjunction with the FDA; however, we are far from reversing the opioid epidemic any time soon.

A Possible Solution?

If we focus on 3 of the 5 pillars from the HHS plan—better prevention and recovery services, better data, and better condition management—and take them out of the context of the opioid epidemic, the specialty model may come to mind. Now you may say, the specialty model typically focuses on rare conditions, and you are absolutely correct.

But keep in mind, key operational components of the model include health care expertise in a particular therapeutic area, financial assistance, benefits verification, and educational and clinical services that ensure both access to necessary treatment options as well as positive health outcomes.

You might also suggest that this would be impossible due to the sheer volume of scripts written on a regular basis or the immediate need for many pain medications. I cannot argue the fact that the sheer volume of opioids prescribed on a daily basis certainly exceeds the patient populations typically seen in a specialty pharmacy for most, if not all, specialty conditions. But aren’t a majority of specialty medications needed in a quick and timely fashion as well? Think about oncology or fertility, for example.

Patients filling these prescriptions require their medication in a timely fashion, which is able to be accommodated by the specialty model. Finally, you might say, opioids cannot be subjected to a specialty network because they aren’t costly enough.

Well, that’s not truly a part of the definition of a specialty drug, according to the National Association of Specialty Pharmacy. Although it is a common characteristic of many specialty medications, there are medication classes, such as HIV and transplant drugs, that are not as expensive as some recently launched agents, yet are in the specialty channel because of the clinical monitoring needed to ensure the best outcomes.

Putting aside some of these questions and arguments, could leveraging the specialty model be a reasonable solution to help curb the epidemic? Sounds like a crazy idea but hear me out.

The Specialty Process

When we consider specialty medications and the fulfillment process, benefits investigation is the first step. This is where insurance information is verified and it is determined whether a medication should be billed under the pharmacy benefit or medical benefit.

Additionally, any plan restrictions, such as formulary preference, prior authorization, or quantity limits, are addressed during this step as well. It is also where co-pays or coinsurances are discussed with patients and where financial assistance is sought after, if necessary. Finally, benefits representatives collect pertinent health information, such as name, address, contact information, and any additional medications used by the patient for both safety and tracking purposes.

Benefits verification focuses on initial data collection and ensuring any potential barriers to medication and care are addressed.

If we were to apply this operational piece of the puzzle to an opioid prescription, benefits research could be completed to address any utilization management and plan parameters that may be in place, something that will likely continue to increase as more emphasis is placed on the epidemic. Benefits representatives could also serve as a resource to collect pertinent health information such as the patient’s full medication history and potential risk for addiction based on medical history.

Benefits representatives could also assist with obtaining financial assistance or seeking out different options for patients to ensure care is accessible, something that may not always be available outside of a centralized network.

The next step in the specialty process is focused on clinical services and education to patients. Clinical services for specialty patients vary based on disease state, but one thing is common. Health care professionals assisting these patients are typically qualified in specific disease states and tend to have more expertise to offer because the professionals working in niche markets see these diseases, medications, and comorbid conditions each day.

They able to assist patients with adherence and refill management, as well as provide customized support based on a patient’s disease severity and comorbidities that may exist. Clinical interventions may also include communication with the prescribing physician to determine a care plan and discuss adverse effects or possible dosage adjustments.

Applying many of these clinical concepts to opioid management seems reasonable and would address some of the concerns brought to light by HHS, specifically regarding better prevention and condition management. Health care professionals who are experts in the area of pain management could ensure appropriate dosing, titration, and transition to non-opioid medications via a proactive, documented patient care plan.

They could also facilitate conversations with prescribers to ensure both patients and prescribers are following clinical guidelines and recommended prescribing practices. Clinical calls to patients could also help physicians monitor patients and red-flag any concerns about misuse or diversion.

They could also ensure management of the underlying condition as well as common comorbid conditions, such as depression or anxiety. Initial and ongoing education regarding the potential risks of these medications, the cost of overdose to patients and families, and information on the safe storage and disposal of prescription opioids could also be incorporated into the fulfillment process.

By providing up-front education and ongoing condition management throughout therapy, this comprehensive support model could help prevent adverse outcomes associated with opioids, including addiction, unintentional overdose, death and, more importantly, prevent individuals from continuing on long-term opioid management when it is not clinically appropriate.

Another operational component of the specialty fulfillment process to consider is the application of Risk Evaluation Mitigation Strategies (REMS) enforced by the FDA to ensure the benefits of a medication outweigh the risks. The REMS requirement for extended-release, long-acting, and immediate release opioid medications is primarily focused on prescriber training and patient education.

Prescriber training focuses on the principles of acute and chronic pain management and both non-pharmacological and pharmacological treatments for pain. Patients are to receive a guide upon receipt of their medication, as well as a patient counseling document in an effort to mitigate the risk of abuse and overdose and deaths from prescription opioids.

Because of the ongoing dilemma with the opioid epidemic, REMS requirements may continue to evolve in the future. Therefore, health care professionals within specialty pharmacies could not only assist with existing REMS programs as they do for other specialty pharmaceuticals, but also assist with any expansion efforts that may come over time.

We recently saw this in 2017 when the REMS requirement expanded to include immediate release products as well as the need to provide additional education to prescribers. Data collection is another operational component that many specialty pharmacies have become very effective at completing.

This may be a result of REMS requirements, manufacturer or payer requirements, or a result of post-marketing data requirements, since many specialty medications are tested in very small patient populations during clinical trials. Whatever the primary driver, specialty pharmacies are in a unique position to collect important information about each patient’s adherence, refill rates, adverse effects, response to treatment, and comorbid conditions.

By encouraging these data to be collected by fewer pharmacies, there is an opportunity to standardize endpoints collected and compile and share information more broadly to better understand the treatment of pain management. There are also opportunities for better inventory management and tracking of opioids across a smaller network of pharmacies versus a broad network.

Whether or not the specialty model would be able to handle the volume of opioid prescriptions across the country is questionable, but in researching some of the statistics provided by the CDC and others, as well as personally being impacted by the epidemic, it is apparent that additional resources and ideas are needed to help curb the use of opioid medications.

Certainly, some of the crucial components of specialty pharmacy, including patient assistance, clinical monitoring and education, and better data collection, seem to be a good start. Specialty pharmacy presents a controlled environment that not only allows access to medications, but also high touch outreach by health care professionals who ultimately become an extension of the physician and the patient’s care team.

Specialty pharmacies are able to implement processes with very tangible controls to ensure access to medications and positive health outcomes, which is a model that certainly seems to make sense when considering the opioid epidemic at a high level.

About the Author

Lauren Meyer earned her Doctor of Pharmacy degree from the Duquesne University School of Pharmacy and is currently enrolled in the Master of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. She has spent the past several years working as a clinical advisor assisting employers with their pharmacy benefit management strategy. Prior to this experience, she completed a PGY-1 managed care residency.