Achieving the promise of rare and orphan disease therapies is a challenge for both patients and pharmaceutical companies alike. The patients served by these medications have often waited years for a diagnosis, only to be confronted with yet another arduous process to qualify for insurance coverage and obtain reimbursement for these high-cost treatments. HCPs and their staff are overburdened, creating even more delays for patients who have already waited too long – these delays can be devastating to the patient. A different go-to-market strategy for both rare and orphan disease patients and their HCPs is required.
Enter Field Reimbursement Managers (FRMs). FRMs are in the unique position to leverage their payer industry expertise to provide education around how to navigate the administrative burden of prior approvals, reimbursement and HUB services for these patient groups. The end result is enhanced speed to therapy for these patients, thereby increasing the potential for improved outcomes and meeting strategic expectations.
The rise of orphan drugs has changed the treatment dynamic
With the lost dominance of blockbuster drugs, many in the industry have turned their attention to the development of medicines to treat the estimated 7,000 rare diseases impacting millions throughout the world over the past few decades.¹ The United States has provided regulatory encouragement with the Orphan Drug Act (ODA) of 1983 providing developers of rare disease drugs with longer market exclusivity and tax credits for clinical trial expenses and other supportive policies offering free waivers and research grants for orphan drug development. However, of the 389 orphan drugs on the market in 2019 treating 1.8 million patients, the average cost of an orphan treatment to each patient was $32,000, with treatments ranging from $6,000 to $500,000 per year. ²Cell and gene therapies cost hundreds of thousands of dollars or more.³
Once your market access team has obtained coverage of your orphan drug or cell and gene therapy with the requisite payers, you now need to address the overburdened HCP office and the anxious, and often exhausted, patient who should benefit from your therapy. Because payers are using prior authorizations as one way to manage the high cost of these therapies, HCP offices are spending 35+ minutes per prior authorization, averaging 40-45 cases a week⁴ when this time could be better spent administering to the needs of patients. Once all coverages are in place, patients are often waiting over 30 days for their first dose. This is an untenable process for patients whose health and well-being should be the primary focus of the commercialization process. Helping the patient and HCP office by educating them on how to navigate these challenges with payers and HUB services needs to be a key element in your commercialization strategy.
FRMs streamline access to treatment
The FRM plays a critical role in getting patients timely access to their therapy. They function as an educational resource to HCPs and their staff in overcoming the many challenges patients face in starting treatment. While field sales teams are promoting the features and benefits of the medication to the HCP, they are applying their expertise in the payer landscape to educate the HCP and office staff on the needed patient qualifications for treatment, prior approvals, reimbursement and support programs.
To best facilitate timely patient access to medications, they should be armed with up-to date local, regional and national payer requirements along with medical and prescriptions claims data and knowledge on ICD-10, HCP5 and NDC codes. With this information and data at their disposal, they are in the best position to address coverage options and educate HCP offices on how to complete prior approval forms with robust data and alignment with the required details. Once the patient is approved, FRMs will work with HUB services and specialty pharmacies as necessary to see where there are roadblocks in the process to treatment initiation.
Another important aspect of the FRM’s communication with the HCP office is to provide information on the patient support programs available to the patient and provide education on how to enroll patients. These support programs have proven to be invaluable assisting patients with understanding their disease, its treatment, the process to obtain their medication and the importance of their adherence to their therapy protocol.
Optimizing FRM Engagement
“The importance of the FRM to your go-to-market strategy for rare and orphan disease therapies cannot be overstated. Their role in speeding patient access to treatment and improving patient outcomes is critical to the patient and your commercialization success.”
Vice President of Field Access and Reimbursement
Where FRMs fit within your organization will depend on your unique culture. In their role, they can be part of your patient services team, your commercial team or your market access team. Ideally, they interact and draw information on the national, regional, and local access and reimbursement landscape from all three disciplines to best fulfill their role as an FRM. No matter where they sit within your organization, it is always important to leverage their strategic access to payers, HUBs and HCPs.
Your payer policy landscape will serve to drive your FRM resource allocation, and the size of your team and their time in the field will depend on the life cycle of the treatment. For many, pursuing a 1:4 FRM/Sales ratio will be optimal during the first 24 months of the product cycle. Once coverage is normalized, a virtual FRM engagement may be the best use of resources to keep HCP practices up-to-date on payer policies and any other changes impacting coverage and reimbursement.
A key consideration in how you build your team will be if you are looking for proactive or reactive FRMs in overall account engagement. There are numerous roles they can play in addition to ensuring optimal access to prescribed products and affiliated services by educating on pre-approvals, coverage and reimbursements. FRMs can also play a vital role with HCOs, IDNs, and group practices to regularly review revenue cycle management procedures, making sure that reimbursements on medications are current. They can maintain specific access and reimbursement account plans for assigned accounts. They can also proactively consult as a policy expert for national, regional, and local plans, including PBMs and employer carve-outs.
No matter what their assigned role within your organization, FRMs are navigating a complex healthcare and payer landscape. Each must be experienced in the overall healthcare regulatory environment and the policies of the various national, regional and local payers respective to treatment.
Supporting rare and disease patient access to timely treatment with quality FRMs
While policy makers and payers strive to change pricing and improve patient access, we can help support timely and compliant patient access to your cell and gene therapy or orphan drug with a customized FRM program. We can provide a complete FRM team built from the ground up, FRMs to supplement an existing team or strategic FRM consulting
As your partner, you can be assured of our support every step of the way with our quality and industry expertise. To learn more contact us by clicking here.
1. Office of the Commissioner, US FDA. Orphan drug act excerpts (2022) https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-act-relevant-excerpts#:∼: text=(2)%20The%20term%20%22rare,developing%20and%20making%20available%20in
2. Institute for Clinical and Economic Review (ICER). The next generation of rare disease drug policy: Ensuring both innovation and affordability. Published April 7, 2022. Accessed March 2, 2023.
3. Reuters. Spark’s price for Luxturna blindness gene therapy too high: ICER (2022) https://www.reuters.com/article/us-spark-icer/sparks-price-for-luxturna-blindness-gene-therapy-too-high-iceridUSKBN1F1298
4. American Medical Association. (2023, March 13). Toll of Prior Authorization Exceeds Alleged Benefits, Say Physicians. Retrieved from https://www.ama-assn.org/press-center/press-releases/toll-prior-authorization-exceeds-alleged-benefits-say-physicians