A very long time ago in my nursing school days, I learned that each kidney has approximately 1 million nephrons comprised of convoluted tubules. Their job is to filter waste products.
Although it sometimes may feel like it, we really do not have to traverse 1 million authorization letters to get a medication approved that aligns with patient care needs. Yet just like the kidney, whose job it is to balance sodium and assist with the ultimate excretion of urea, the authorization process is designed to ensure that there is a match between the requested use of the medication and the information included within the drug package insert. It is an act that balances needs with demand.
Alas, unlike the kidney—which can often compensate for things such as low cardiac output, untreated hypertension, chronic anemia and diabetes—there is no similar compensatory timeline for some of our patients. Time is critical. Time wasted often means more aggressive and erosive disease.
We all have so many patients for whom this scenario plays out daily, where the balance of need vs. damage seems to us to be so tilted in the wrong direction. One of them is a patient of mine, MO, who came to my office 6 months ago with a diagnosis of psoriatic arthritis (PsA). At presentation, she had been stable on a regimen of infliximab 500 mg (or 5 mg/kg) given every 6 weeks for the better part of a decade.
As I do in all new patients who are stable on a specific drug regimen, my stated goal to MO was to keep her disease stable for the next 10 years. As per our practice’s protocol, we ordered a new set of labs and X-rays since neither was included in MO’s record transfer. It took about a month to get these tests authorized by MO’s insurance provider.
MO had several notable symptoms, including a tender joint count of 16 and a swollen joint count of 14. Her acute phase reactants were significantly elevated, with a C-reactive protein of 29 mg/L (normal is between 2-5 mg/L) and erythrocyte sedimentation rate of 79 mm/hr (normal is 10-20 mm/hr). There were no pencil cup deformities evident on X-rays and only a small number of psoriatic lesions. The only other notable findings were a positive anti-citric citrullinated protein level of >250 μ/mL (normal is <20 μ/mL) and a 14.3.3 ETA of >10 ng/mL (normal is <2 ng/mL)
“Just as the kidney will, to a point, compensate for issues surrounding it, as healthcare providers we need to be flexible and assess our patients’ need as their disease evolves.”
Based on this battery of results, as well as MO’s history of response to infliximab, our request to continue using that drug seemed like a no-brainer. Then came our first bump in the road (or solute if you want to keep following the kidney analogy)—MO’s insurance company agreed to cover an infliximab biosimilar (Inflectra) but not infliximab itself. This was despite the fact that the biosimilar is indicated for use every 8 weeks in patients with PsA vs. the every 6 week indication for infliximab. Seeing as our hands were tied, we went along with the insurance company mandate.
It took nearly 3 months from our initial request for infliximab and the first infusion of the biosimilar. Not surprisingly, MO’s disease began to flare during this interregnum.
Soon after MO’s initial infusion, based upon the latest battery of test results, we changed her diagnosis from PsA to rheumatoid arthritis (RA).
While MO had eczema on her elbows, she had no other lesions, and all labs and X-rays were consistent with RA and not PsA.
One of the benefits to MO of this change in diagnosis in that it was easier to get approval for more frequent dosing of the infliximab biosimilar—the package insert indicates that some patients may benefit from treatment as often as every 4 weeks.1 Our current plan is to revert back to MO’s previous dosing of every 6 weeks.
Just as the kidney will, to a point, compensate for issues surrounding it, as healthcare providers we need to be flexible and assess our patients’ need as their disease evolves. In MO’s case, her treatment needs had changed over the years, and to accommodate her new disease definition, she needed us to champion her new treatment needs to her insurer.
Had we continued treating MO for PsA based on her previous history and not ordered new labs and X-rays, we would have been doing her a disservice. Arming ourselves with accurate, objective findings allowed us to better tailor our authorization requests to the package insert and get MO the medication she needs at the frequency she needs it.
Jacqueline Fritz, RN, MSN, CNS, RN-BC, is Owner and Coordinator of Education at the Medical Advancement Center in Cypress, CA. Her primary responsibility is working as an advanced practice nurse for a large rheumatology practice where she is involved in patient visits, research programs, and infusion center coordination. In addition, she enjoys speaking, teaching, and learning about immunology.
1. Inflectra (infliximab-dyyb) prescribing information. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf. Accessed September 6, 2018.