Working with Specialty Pharmacies for Oral Drugs for CLL / SLL

This article focuses on an important player in the current treatment of CLL, the pharmacies that manage the care of patients on oral drugs for CLL. These are called specialty pharmacies and they differ greatly from the mom-and-pop drug stores of my youth and the large pharmacies most of us now use regularly.  I have included some personal anecdotes, in italics. 

What is a Specialty Pharmacy

The National Association of Specialty Pharmacy defines specialty pharmacy as “a state-licensed pharmacy that solely or largely provides medications for people with serious health conditions requiring complex therapies.” Along with being state-licensed and regulated, specialty pharmacies are often overseen by an independent third-party nationally recognized accreditation organization. Accreditation demonstrates commitment to quality, safety, accountability and adoption of nationally recognized standards of practice. Specialty pharmacies serve patients with diseases such as CLL who require medications that may be expensive and more complex than most prescription medications. The complexity of these medications may be due to the drug itself, the way it is administered, the management of its side effect profile, the disease or condition it is used to treat, special access conditions required by the drug manufacturer, payer authorization or benefit requirements, patient financial hardship or any combination of these. Typically, specialty pharmacies are centralized and interact with patients remotely (by phone, text, or computer face-to-face interactions) and use courier delivery services to deliver medications directly to the patient’s home (e.g. FedEx, UPS).

Specialty pharmacies maintain their own medical record for each patient which includes a detailed medication profile, both prescription drugs, over the counter drugs (OTCs), and individualized drug and disease(s) care management plans. The pharmacist may obtain some information from the oncologist, but the pharmacists take a health history and obtain updates from the patient, other health care providers, care partners and the health insurer case management team. The intake interview will include asking about other diseases and medications. Before refilling medications, the pharmacist will inquire about any changes in health or new symptoms. Patient education about how to take and store the medication, how much fluid should be taken each day, and foods that interact with the medication are routine. The specialty pharmacy’s patient-centric model is individualized to meet the specific healthcare needs of each patient and the expert services that specialty pharmacies provide drive adherence and persistency, proper management of medication dosing and side effects, and ensure appropriate medication use. Because of this personalized attention, automated medication refills do not occur. The pharmacy team contacts the patient, typically by phone, to schedule delivery of medications.

One of the key reasons specialty pharmacies were created was for insurance companies to optimally control the costs of drugs (which can be over $100/pill or over $400/day for the drugs listed above).  Therefore, specialty pharmacies closely track how many pills you should have left and ask you exactly how many there are in the bottle before dispensing to avoid sending more pills than necessary. The pharmacy doesn’t want you to miss doses but also doesn’t want to send another full 30-day supply if you did miss taking the pills (whether accidentally or because of your doctor’s order). Refills for more than a 30-day supply of an oncology medication are unlikely due to frequent dosage adjustments and medication changes based on patient response.

Specialty pharmacists and technicians assume some of the roles that would otherwise have to be played by the oncologist’s office. This includes helping to verify coverage and benefits, satisfy prior authorization requirements, identify and enroll patients in any available financial assistance programs and monitoring, and documenting and reporting of patients’ response to treatments (including the presence of any side effects) and adherence between office appointments.

According to the Pharmacy Care Management Association, specialties pharmacies offer:

• 24-hour access to specially trained pharmacists and technicians.
• Communication with patients’ physicians (e.g. oncologist) consultations to address patient side effects.
• Monitoring for adverse reactions and non-adherence and providing interventions when warranted.
• Patient care management services to ensure patient safety.
• Data analytics that drive better patient outcomes.

The Specialty Pharmacy Business

Specialty pharmacies are accredited by independent third-party organizations. These include Accreditation Commission for Health Care (ACHC) and Utilization Review Accreditation Commission (URAC). Accreditation assures the training of staff, adherence to best pharmacy practices, quality of facilities and adequacy of customer service. 

About one-fourth of such specialty pharmacies are within a health care or hospital system, one-fourth are part of a retail pharmacy company, and one-fourth are split between other types of health care providers (e.g. oncology practices) or health plans / benefits managers. The remaining one-fourth are independent businesses.

The six largest specialty pharmacies that serve people with CLL (and their parent company) are: CVS, Accredo (Cigna), Optum (United Health), Walgreens, Centerwell (Humana), Onco360 / CareMed (Brightspring). The total revenue from specialty pharmacies in 2023 was almost $250 billion, with the first three on the list generating most of that. Specialty medications account for over half of U.S. medication spending while accounting for less than 3% of the total prescriptions dispensed in the US annually.

How to Select a Specialty Pharmacy

Usually, decisions about starting treatment for CLL occur over a number of oncology clinic appointments and are rarely urgent. This allows the patient with CLL to consider the options. For initial treatment in 2024, the National Cancer Care Network suggests long-term (e.g. life-long) use of a BTKi (e.g. acalabrutinib) or time-limited treatment with a BCL-2 (e.g. venetoclax)-based protocol. A variety of other options for treatment are offered in research studies. Research clinics typically dispense study medications directly, rather than through a specialty pharmacy. Read my article on making treatment decisions in CLL for more commentary on deciding about therapy options.

In addition to choosing a therapy protocol, you may have to select a specialty pharmacy. Most health insurers, including Medicare Part D plans, have a limited network of specialty pharmacies. Some only offer one choice. For example, in 2022 the Federal Employee Blue Cross Plan offered options of Avella, Biologics, Diplomat and Onco360, but in 2024 this health plan offers only CVS / Caremark Specialty Pharmacy. Therefore, an important step is to call your health plan (or look on-line) to determine your choices for the CLL drugs being considered. This should be done as soon as you are considering treatment! It is optimal to call one or more pharmacies covered by your insurer to introduce yourself and ask questions listed below before the oncologist sends in a prescription, to feel confident that your needs will be met in a timely and professional manner.

Your oncologist may have a preferred specialty pharmacy. That could include one operated by the oncology practice or the hospital where they work. Even if not on your insurance plan list, you may be able to get the initial month’s supply of medication from that pharmacy, but then your insurer may require you to switch to another pharmacy for subsequent refills. It will save you time to have only one intake process and avoid treatment interruption, so start with your preferred pharmacy on your insurer’s list and remain with them for the entire course of therapy (or until your health plan’s options change) to minimize gaps in care. Your oncology clinic cannot require you to use the pharmacy they prefer or own. 

The process of enrollment with a pharmacy can take a week or more, so don’t put off making a choice. I let my oncologist send my initial prescription to the Mayo Clinic specialty pharmacy. They did a great job, but two weeks later I spent several frustrating hours, during an obinutuzimab IV infusion session, trying to figure out why my venetoclax couldn’t be refilled by Mayo and what I needed to do to start over with a new specialty pharmacy. 

If you have a choice of pharmacies, here are some things to consider:

• Is it accredited as a specialty pharmacy by an independent third-party oversight organization (see above)?
• Are the pharmacists on staff members of the National Association of Specialty Pharmacy and / or do they hold advanced credentials (i.e. Certified Specialty Pharmacist (CSP) or Board Certified Oncology Pharmacist (BCOP) (which would demonstrate a commitment to learning and professional development)?
• Will the pharmacy team help you sign up for any co-pay assistance program for which you may be eligible? See the CLL Society Financial Resources webpage for those programs.
• If you are on a co-pay assistance program, will the pharmacy collect from them on your behalf? I was helped by the Genentech sponsored program that covered all but $5/month of my co-pay. The specialty pharmacy billed that to my credit card, but collected about $7000/month from my insurer. I never checked how much the co-pay assistance program also paid, but it would have only been up to my annual out-of-pocket maximum for all health care which was $9100.
• Where are its distribution centers? If there is only one or all are at the other end of the country, weather problems could delay deliveries significantly.
• What is their typical turnaround time?
• Will the pharmacy contact you to arrange prescription refills, or will you have to remember and call them?
• Is there a pharmacist on-call 365 days a year for 24 hours a day?
• Does the pharmacy offer online communications (patient portal, secure email, HIPAA compliant two-way texting)?
• To the extent this matters to you, is the specialty pharmacy a for-profit or non-profit?
• How much experience does it have with the drug you will be taking?
• Do they answer the phone promptly and transfer you quickly to someone when you call to make these inquiries?
• Do they offer ongoing pharmacist support?

Some of this information may be found on the specialty pharmacies’ websites, but you should call and interview someone before deciding and informing your oncologist where to send the prescription.

The Veterans Administration Oncology Pharmacy Program

If you get your CLL care in the Veteran Administration (VA) Health Care system, the pharmacy process is fully integrated with other care. One medical record is shared by your primary care team, your oncologist, the oncology clinic pharmacist and the dispensing team. The oncology clinic pharmacist serves as the specialty pharmacist to perform education (in-person, through video visits, and by phone) and to monitor medication issues between clinic visits. The VA is accredited, including the pharmacy programs, by the Joint Commission. Delivery of CLL medications, as with other oral drugs, is handled through the US Postal Service. A difference between the VA and specialty pharmacists is that the VA has a general call center that can triage issues 24 hours a day, but a pharmacist with expertise in cancer drugs is not available 24/7. The out-of-pocket costs for CLL drugs may be substantially lower when obtained through the VA than through other insurance programs. Some co-pay assistance programs exclude people with VA pharmacy benefits. CLL Society has a number of educational and support services specifically for Veterans, which can be found on the Veterans with CLL webpage.

What Does a Specialty Pharmacist Do

Specialty pharmacists share responsibility with your oncologist in the success of your treatment. They should be highly knowledgeable about the drug you are taking and have easy access to detailed information about that drug. To achieve success, their roles (and that of pharmacy staff) include:

• Collecting information about you before the first doses are dispensed.
• Teaching you how to store and take your medications, both by phone and with printed materials (usually prepared by the manufacturer). This may include a fancy starter box.
• Informing you of dietary and water intake requirements. For my oral medication, I had to drink 6 to 8 glasses water per day for the first few weeks and avoid grapefruit juice and certain other fruits. The specialty pharmacy sent me a starter kit created by the drug company that included a water bottle that had to be filled twice a day.
• Mailing your medications with all appropriate labels on the bottle to remind you of precautions. If any are unclear to you, talk to your pharmacist. My bottle had a label warning about taking if pregnant, a reminder not to drink grapefruit juice, instructions to take with food and water, and a statement to discard pills after 42 days. This short expiration is based upon information from the manufacturer.
• Contacting you to plan for delivery of refills with plenty of time in the event of delays due to the need for new prescription information from the doctor or inclement weather. My late refill was due in part because of a dose reduction that required a new prescription from the doctor.
• Re-assessment at each refill focused on changes to your health status and medications, side effects, challenges you may have with taking your medications as directed, and an overarching focus on helping you achieve your treatment goals.
• Communication with your oncologist about changes in your condition.
• Reporting to the Federal Drug Administration of any significant side effects for the monitoring program. I did have some non-life-threatening new problems during treatment, such as diarrhea due to Norovirus and new onset cough, which later responded to asthma treatment. After I had completed therapy, someone called me on behalf of the FDA to get detailed information on those adverse drug reactions.

How to Use a Specialty Pharmacy

You, as a patient, are ultimately responsible for taking your prescribed medications as directed by your oncologist and the specialty pharmacist. This is not a passive process. Here are some strategies and tips for success in this process.

• Start planning early. As described above, making a decision about the choice of therapy and selection of a pharmacy well before you need the first pill that will be taken. If your treatment protocol requires a month of infusions before starting oral medications, it is best to work with your specialty pharmacy even before you start your infusions. Ideally you have both the infused and oral therapies approved through your insurance before your first infusion dose.
• Make time to complete the intake interview with the pharmacist. Have your health history and medication list, including over-the-counter medications, ready for that.
• If you need non-childproof medication containers, ask.
• Have your calendar available to schedule deliveries.
• If you prefer a certain time of day for deliveries (e.g. AM vs. PM), ask.
• Be home for deliveries, if possible, as signatures are often required, and leaving the box on the doorstep may or may not be permissible, due to risk of theft or weather damage to the box or pills. There may be options to have the package left at a nearby commercial business for you to pick up.
• Put a reminder on your calendar about the need for refills 10-14 days before the day you will need the refill (or about 2 weeks after you start a new 30-day bottle). That allows you to schedule delivery on a convenient day at least 1 week before you will run out, allowing for any delays. You should also confirm with your pharmacy when to anticipate their refill reminder outreach.
• Call your pharmacist before starting any new prescription or non-prescription medications to verify there are no interactions. Medications for CLL can be less effective or become toxic when taken with many types of other medications or dietary supplements.
• Call your pharmacist with any new symptoms. The pharmacists can document your condition, may be able to consult with your doctor on your behalf efficiently, and can help you decide whether to take the next dose while waiting for instructions from your oncologist. Even if you have received care for the issue already, such as in an emergency room or from your oncology practice, let your pharmacist know.
• Count remaining pills before you speak with the pharmacy about refills.
• Be honest if you are having difficulty taking the pills, due to problems remembering, swallowing, or side effects, or if there are problems affording your medications. The pharmacist can typically help you find solutions.
• Discuss significant changes in diet with the pharmacist, especially if you decide to eat or drink a significant amount of any one thing.

Summary

Specialty pharmacies manage oral medications used for CLL treatment. They enable patients to successfully complete or stay on therapy through close monitoring, regular outreach, and thorough patient assessment. Choosing and working well with a specialty pharmacy requires some time and effort from patients with CLL, but this effort is invaluable to drive optimal outcomes.