Oral Oncology Products: What Makes Them So "Special-ty"?

As new novel therapies emerge and more oral agents are launched, pharmacists need to take notice and stay up to date on these life-extending products.

As the list of available oral products continues to grow, so does the management of these miraculous life-extending products by all of the payers. Oncology was once viewed as a niche disease category where injectable/infusion products were administered by community oncologists or cancer-focused health care systems. Over the past decade, the area of oncology and cancer treatment has been fortunate enough to be the focus of the American population and research dollars. With that support, new novel therapies with greater targeting and disease affinity have led to longer life expectancies and have forced a drastic change in the patient care continuum and product distribution models. With more than 750 oncology products in the pipeline and 35% expected to be oral agents, all pharmacists need to take notice and start developing solutions today to be part of the “future.” ¹

What Makes These Pills So “Special”?

Cost. Some oral oncology products may cost $3000 to $10,000 a month per patient. The cost of preordering and holding the inventory is high and a risk the pharmacy must take. What if the patient does not pick up the prescription or return for the refill, or unexpectedly passes away? These risks can be partially mitigated by setting expectations with patients. Patients need to fully understand the costs and processes before starting therapy. Additional communication with the patient is crucial to proper inventory management. A proactive call to a patient 5 days before the refill date will allow the pharmacy to clinically support the patient, but also to better understand when, and if, to order product. Additionally, some therapies are weightbased or patient-specific, which may force bottles to be opened and be partially dispensed.

Enhanced Insurance Research. It is not best practice to simply do a test claim or adjudicate an oral oncology prescription. Often this sole activity will only provide a narrow window into the information needed to fully understand a patient’s insurance benefit. As pharmacists, we need to dive much deeper: What is the copay? Coinsurance? Benefit tier? Is there a preferred pharmacy? What is the copay/ coinsurance if the patient goes to that preferred pharmacy vs yours? Is there a mail order requirement or benefit? Does the patient have medical and pharmacy benefits? For the specific therapy, is it a better alternative to bill the medical vs the pharmacy benefit?

Fully understanding the benefit options for the patient and allowing them to be part of the decision will build strong loyalty. Sometimes your pharmacy may not be the best option for the patient and a transfer of the prescription will be required. Although you may lose a prescription, most will return for their adjuvant therapies. Typically, patients getting a prescription from a non-preferred pharmacy has severe cost implications for the patient. If the patient learns that they could have paid a $100 copay at a preferred pharmacy and you charged them $850 as a nonpreferred pharmacy— and did not inform them of their options— you will likely lose that patient and other family members permanently.

Prior Authorizations. As a best practice, we should assume that the vast majority of, if not all, oral oncology products require a prior authorization by the payer. This activity should be part of the enhanced insurance research. Payers typically use Prior Authorization edits as a tool to decrease costs, but also ensure preferred distribution channels, treatment guidelines, clinical pathways, and companion diagnostics. The trend is that these activities will continue and increase as more products emerge from the pipeline. Denials typically occur when²:

• The treatment is considered experimental or is not on compendia listing or guideline
• There is inadequate supporting data or evidence
• The treatment is considered experimental or not on FDA label
• For administrative reasons (ie, coding)
• The treatment is considered experimental or is not within required pathway
• The payer review panel feels treatment is not medically necessary

The payers will continue to take a more direct role in managing appropriate utilization. Take the extra time to document all the information gathered. If you incorrectly collect the information it could lead to accounts receivable complications later if a claim is rejected/audited.

Compassionate Care Program Coordination. Another integral part of the oncology patient continuum of care is working with Compassionate Care Programs (eg, Medication Financial Assistance Programs, Patient Assistance Programs, Co-Pay Assistance Programs). As the cost burden shifts to your patients, so does the professional responsibility of researching and understanding Compassionate Care Programs. These programs offered and funded by manufacturers, advocacy organizations, and professional organizations all focus on helping the patients. Programs often include financial support if qualified, educational support, and “empathy.” All are keys to assisting your customers as they navigate their way during a difficult time.

Ongoing Patient Care/Adherence. Once the prescription is dispensed, it is vital to continue to support patients taking oral oncology agents. Some medications have significant side effects, which without counseling can lead to noncompliance and drop-off of therapy. Fully understanding the potential challenges and providing advice (in conjunction with the physician’s efforts) can lead to better patient health outcomes. Follow-up calls to the patient or caregiver typically occur after a few days on therapy, at 3 weeks, at the time of refill, and minimally monthly, based on the stratification of the patient and the severity of the disease progression.

There is large opportunity for those pharmacists who make the effort, do the research, and find solutions for their customers. Managing oral oncology products is much more than traditional pharmacy— and it is a business opportunity.

It is providing extra “special-ty” attention to those patients that require our help the most in their time of need—a time of expensive drugs, complex clinical regimens, many doctors, complex insurance navigation, family worries, and a lot of stress. A single motivated pharmacist can make such a difference in so many lives.

David Suchanek, RPh, is senior vice president of Biotech and Specialty Services at D2 Pharma Consulting, LLC, a consulting firm which focuses exclusively on pharma services in the life sciences industry. Mr. Suchanek is a member of the Specialty Pharmacy Times Editorial Board. For more information, visit www. SpecialtyPharmacyTimes.com.

References

1 Moseley WG, Nystrom JS. Dispensing oral medications: why now and how? Community Oncology. PublishedAugust 2009.

2 The Zitter Group. The Managed Care Oncology Index. www.zitter.com/download/OncologyIndex_Prospectus.pdf. 2011.