Background/Purpose

A growing number of publications suggest that biological DMARDs, predominantly approved for RA, can be efficacious treatment options for several rare rheumatic diseases.  These potentially efficacious treatments are often “out of reach” because of inability to obtain insurance coverage.  Insurers routinely deny coverage of “off-label use” because of the absence of double-blind placebo controlled studies demonstrating efficacy.  This type of evidence is only infrequently available for these rare rheumatic diseases.  The medical director for the insurer often has no familiarity with the disease, the potential consequences of non-treatment or the inadequacy of more accessible therapies.  The addition of a pharmacist as part of a multidisciplinary team can provide an effective resource in successfully navigating the medication prior authorization process.

Methods

Our approach involves the use of a clinical pharmacist in development of comprehensive, evidence-based appeal letters.  These letters are drafted by a clinical pharmacist (PharmD.) and pharmacy interns who perform extensive literature searches including all relevant case reports and clinical data related to disease state and drug therapy.  The PharmD’s then summarize that data as justification for use of therapy.  Appeal letters are then drafted to include an explanation of the patient’s circumstances, disease manifestations, progression, prognosis, as well as the treatment history, and the comprehensive review of current literature on the rationale for and experience with the proposed therapy.  

 

Results

Since January 2009, our pharmacist has drafted and submitted approximately 141 letters.  We have decreased the rate of initial “denials” for off-label use to near zero.  We estimate that we have saved the physicians and support staff approximately 100 hours while achieving the desired outcome for both patients and physicians. We estimate that the average rheumatologist will have a need for between 5- 15 of these letters per quarter. If we calculate the value of physician time based upon billable dollars, we would estimate a net saving for individual physicians of between $1000 and $4000 hours per quarter. Additionally, we have decreased the time associated with the approval process from an average of 4-6 weeks to less than 4 weeks.

Conclusion

The issuance of an evidence based approach to the off-label appeal process has decreased the time associated with approvals and prevented the need for mention of litigation or liability.  Due to time constraints, the ability to provide this level of patient care would not be possible without the assistance of the clinical pharmacist.  The practice of pharmacy has expanded its scope to include extensive clinical training beyond the preparation and dispensing of medication.  Pharmacists have the capacity to provide a wide range of patient-oriented services.  As part of their education, PharmD’s have extensive training in scientific literature evaluation and drug information. Based on our experience and success, it is clear that PharmD’s are an underutilized resource in the ambulatory care setting and can greatly improve patient-care outcomes.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pharmacist-developed-letters-may-enhance-success-in-obtaining-insurer-approval-for-off-label-use-of-biologics/