Improving Patient Access to Biologics: Q&A with Melissa Paige (Part 1 of 2)

Web Exclusives - Ovarian Cancer

Q: The number of biologics and targeted therapies available for patients has exploded over the past decade. The process by which patients gain access to these drugs can be complicated and challenging to navigate. How has your health system expanded patient support services to meet patients’ needs?

A: We started the program at our health system approximately 10 years ago. I work in the pharmacy department, so in the beginning, we were helping patients access manufacturer-sponsored programs for oral drugs. Over time, however, we saw that access was becoming more difficult across the board. Patients on Medicare were having difficulty paying for their medications, patients on commercial insurance plans were getting denials, and overall, patients needed help navigating the access process for oral and infused drugs. In response, we expanded into infused drugs that were covered under the medical benefit.

When we started, we had only 2 employees. Today, we have an entire team under the Specialty Pharmacy, which allows us to provide support in many other therapeutic areas, including cancer. We really understand the value that manufacturer support services and field reimbursement specialists can provide to our institution while making sure a patient can start and stay on their therapy while affording all their other medical care.

Q: Your team has really grown over the years. What is your specific role in the pharmacy department?

A: We have a full team to navigate the access process. Typically, I am not the first person to review a new drug request received by our department. We have others on the team who adjudicate the claims at the pharmacy. Although some claims do not require additional support, many do. I (along with a few others), deal with anything related to patient access.

It is our responsibility to address any complicated issues. If we have a new specialty drug, or a limited distribution drug, we determine who the key stakeholders are, and figure out the best process for getting that drug to the patient.

One of the first steps is to determine how the manufacturer support program can help us. We start with the program enrollment process and engage the field reimbursement specialist to educate us on the details of the program. From there, we educate our staff on how to use the program to benefit our patients—helping with training, protocols, and processes that mesh with our clinic workflow.

Q: How do you determine which manufacturer-sponsored programs and resources will be most effective in helping your institution to overcome or address barriers to treatment?

A: When we are notified about a new program or resource, the first thing we do is look at it to see how far it will get us in the patient journey. The first consideration is ease of use. Remember, each manufacturer has 1 product, and we must fold it into a clinic that is using maybe 50 different medications with approximately 20 different brands.

If it is an oral medication, we run it through the pharmacy benefit and obtain the preauthorization. We understand how limited distribution works. We often run a soft claim once the preauthorization is approved so that we can assess the requirements for getting the drug to the patient.

The clinical staff members are focused on treating patients, so they do not necessarily understand all these nuances. After we folded the access process under our team and streamlined it with the help of manufacturer program support, it has worked out much better.

When we are introduced to new manufacturer programs, we start using these programs for select patient and payer populations, perhaps requesting help with appeals for difficult payers that have erected barriers to access. In these cases, we engage the company’s reimbursement specialists for support. Once we establish a good comfort level with a program, we typically expand our use of the program for additional services, such as benefits investigation if needed, and follow-up with prior authorization and documentation.

I know that many health systems limit access to industry representatives, but I have advocated for the value that pharma can bring to the table. However, it is critical that the institution retains control of patient care and leverage support services in ways that line up with our processes and operational workflow. That being said, manufacturer programs can provide a great deal of value, and it is a disservice to the health systems if they are not introduced to these resources.

Q: It sounds as though your team manages the entire access process, with the help of manufacturer programs and resources when it makes sense. Do you ever utilize other sources of support?

A: Yes, especially during “blizzard season,” a term we use to describe the end of one calendar year and the beginning of the next. That is when I know that all my patients on Medicare will need assistance. Depending on our workload, we might voluntarily send those prescriptions to a specialty pharmacy. We like working with specialty pharmacies that can help facilitate the foundation support process for patients who are not eligible for other sources of financial assistance.

At the end of the day, we want the patient to receive the medication as quickly as possible, because we recognize that time to treatment can affect clinical outcomes.

Q: Do you encounter any issues with mandatory specialty pharmacy distribution limiting your ability to fill prescriptions for oral specialty drugs?

A: We would like to fill whatever we can through our Specialty Pharmacy, but we always check with the patient to confirm their preferences.

Of course, sometimes payers mandate that prescriptions are filled by their in-network specialty pharmacies, even if it is the first 14-day split fill. In addition, we cannot fill some of the drugs because of other restrictions. In that case, the manufacturer usually has their own narrow distribution network for the drug. Other than that, we try to fill everything else in house.

Q: You mentioned that you have become more involved in helping patients obtain access to healthcare practitioner–administered therapies. How has that changed over the years?

A: Increasingly, we have seen our payers—whether they are self-funded employer plans or health system plans—make the decision to route claims through the pharmacy benefit.

By doing so, they have put policies in place that limit our ability to procure drugs and administer them in our main infusion center. As a result, we have encountered challenges to the buy-and-bill process that has been in place for a long time. We are seeing site-of-service denials, meaning they do not want us to use our own stock, and they want patients to be treated at a standalone infusion site rather than in our outpatient clinic. We have been seeing this with more and more of our healthcare practitioner–administered therapies. We continue treating them in our infusion site, but we fill it through a specialty pharmacy under that patient’s medical benefit.

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Last modified: April 27, 2020