Barriers to Biologics

Biologics have dramatically improved our ability to treat psoriasis. Coal tar ointments and baths were once common; today, many patients achieve clearance or near clearance of their chronic skin conditions with biologic treatment administered just once a week to once every few months.¹ Many dermatologists and their patients refer to biologics as “miracle drugs.” However, getting the miracle drug into the hands of the patient is not always easy. Our academic dermatology clinic faces challenges on a daily basis when initiating patients on biologic therapy. 

Navigating the Process

Perhaps the main barrier to easily getting a patient on a biologic remains the high cost of these drugs.² In a study comparing cost-effectiveness of commonly used biologics for the treatment of moderate to severe psoriasis in the United States, the biologic costs per-patient-year were $62,177 for adalimumab (Humira), $47,250 for brodalumab (Siliq), $81,215 for ixekizumab (Taltz), $70,796 for secukinumab (Cosentyx), and $69,155 for ustekinumab (Stelera) for psoriasis.³ Without insurance coverage, such costs are out of reach for most patients.

Getting approval from insurance companies is another big hurdle. The prior authorization (PA) process is a means to avoid improper medication use and control health care costs.⁴ While this may be beneficial in theory, the PA process for biologics can be a nightmare. 

Part of the PA process for biologic drugs may be step therapy. Often, patients are expected to have failed one or more other systemic medications for their skin conditions before coverage will be considered for the medication that the physician thinks is best. Even when the patient has failed those medications in the step therapy ladder, the payer may deny coverage if patient was not on medication for a certain number of months or if the treatment is not well-documented. Submitting the PA forms to the insurance, awaiting their decision, submitting additional information if requested, and appealing the decision in the case of denial are among the many steps which physicians and their staff often need to complete. 

For a provider, this cumbersome authorization process can require far more time than the clinic visit itself. Patients, meanwhile, may experience treatment delays, potential disease progression, and ongoing suffering while they wait. Making the process more complicated, PA requirements may change over time. The PA process may also vary from state to state, or from one insurance company to another, and vary again for Medicare/Medicaid patients. 

Alternative Means

The final outcome of this lengthy process does not necessarily lead to a happy ending for the patient. The biologic therapy may be denied, or even if approved, may require a hefty copay that the patient simply may be unable to afford. In such scenarios, patients may benefit from assistance programs through which they can obtain biologic therapy for free or for a small price. Almost every drugmaker has such financial assistance programs available for their medications. It is important to be familiar with this option as this may be the only way to get their patient on the “miracle drug.” These programs may be difficult to navigate and may be limited in duration, but for now they have provided many patients good support, making the biologic drugs much more accessible.

Obtaining the medication through one of these assistance programs also requires the physician and patient to complete many forms. In our clinic, we have observed that this process is most efficient when there is a dedicated team member familiar with different biologic drugs and patient assistance programs who can complete required documentation during the clinic visit when the medication is prescribed. Many patients may not be tech savvy enough to complete required forms online or may not have the means to scan/email or fax the paperwork; a missing form or incomplete section of a form can halt the patient from getting on medication for weeks or months. 

Lastly, our patients have benefited from availability of free biologic samples in our clinic. The drug samples can be crucial for starting patients on biologic therapy in a timely manner and preventing patient suffering and worsening of their disease while they jump through the hurdles of getting medication approval. Unfortunately, there are no guarantees about the availability of such samples. In the long run, access to biologic therapies needs to improve to minimize these challenges and provide patients with timely, effective treatments. 

Mr Haidari is a research fellow in the center for dermatology research at Wake Forest School of Medicine in Winston-Salem, NC.

Dr Feldman is with the center for dermatology research and the departments of dermatology, pathology, and social sciences & health policy at Wake Forest School of Medicine. 

Disclosures: Mr Haidari has no relevant financial relationships. 

Dr Feldman has received research, speaking and/or consulting support from a variety of companies including Galderma, GSK/Stiefel, Almirall, Leo Pharma, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Valeant, Abbvie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate and National Psoriasis Foundation.  He is founder and majority owner of www.DrScore.com and founder and part owner of Causa Research, a company dedicated to enhancing patients’ adherence to treatment.

References

1. Sawyer LM, Cornic L, Levin LA, Gibbons C, Moller AH, Jemec GB. Long-term efficacy of novel therapies in moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis of PASI response. J Eur Acad Dermatol Venereol. 2019;33(2):355-366. doi: doi:10.1111/jdv.15277

2. Gu T, Shah N, Deshpande G, Tang DH, Eisenberg DF. Comparing biologic cost per treated patient across indications among adult US managed care patients: A retrospective cohort study. Drugs Real World Outcomes. 2016;3(4):369-381. doi:10.1007/s40801-016-0093-23. 

3. Wu JJ, Feldman SR, Rastogi S, Menges B, Lingohr-Smith M, Lin J. Comparison of the cost-effectiveness of biologic drugs used for moderate-to-severe psoriasis treatment in the United States. J Dermatolog Treat. 2018;29(8):769-774. doi: doi:10.1080/09546634.2018.1466022

4. Bhat S, Zahorian T, Robert R, Farraye FA. Advocating for patients with inflammatory bowel dsease: How to navigate the prior authorization process [published online February 8, 2019]. doi:10.1093/ibd/izz013