Insurance payers now have detailed guidance on the appropriate use and coverage of biologic agents in the management of rheumatoid arthritis, thanks to a document prepared by the American College of Rheumatology.
“Insurance companies would like to put the various biologics on the market in rank order,” according to Dr. Karen S. Kolba, chair of the ACR's Committee on Rheumatologic Care.
Although the Food and Drug Administration and the agents' labels do indeed spell out which patients are candidates for which agents, insurers would like to make that determination more formal and binding, such that a patient must fail to respond to drug A and drug B before receiving drug C.
In the case of rituximab (Rituxan), the FDA recommends that a patient with RA must have failed to respond to a tumor necrosis factor–blocking agent before being considered as a candidate for this B cell–depleting therapy, a position that most rheumatologists would find reasonable.
Problems arise when an insurer decrees that patients may receive rituximab only when they have failed to respond to all other biologic therapies.
“Some [agents] are given subcutaneously and some are self-administered. The self-administered agents may be less expensive, depending on the dose needed. But rituximab is a reasonable choice for some patients, even though it is infused,” said Dr. Kolba, who is in private practice in Santa Maria, Calif.
The ACR's Model Biologics Policy 2010, which is available to members through the ACR Web site, lists the HCPCS (Healthcare Common Procedure Coding System) code sets for each biologic.
Also listed are the CPT codes for the drugs' routes of administration and the ICD-9 diagnosis codes for every clinical conditions for which a biologic agent is an appropriate, indicated treatment.
The policy also details the medically necessary, FDA-approved indications for each biologic.
For example, adalimumab (Humira) has the following indications: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and plaque psoriasis.
The ACR's policy notes that special considerations with the use of adalimumab include the need to test for active or latent tuberculosis, to monitor hepatitis B virus carriers during treatment for reactivation, and to monitor those patients who are taking concomitant anti-TNF-alpha therapy such as anakinra (Kineret) or abatacept (Orencia), which would increase the risk of infection.
The policy lists the possible off-label uses for the agents as well as information on the route of administration and dosing.
Regarding etanercept, the policy notes that the agent may be used in combination with methotrexate or as monotherapy in RA. Golimumab (Simponi) must be used in combination with methotrexate.
The use of anakinra is appropriate in patients with severely active RA who have failed to respond to at least one disease-modifying antirheumatic drug.
Dr. Kolba added that insurance companies are already in the habit of seeking the ACR's guidance on issues relating to the appropriate use of biologics, so there is a precedent of their following these recommendations.
With this guidance document, the ACR continues to show insurers that the college remains a fair and reasonable source of information on the medications “that are best for our patients,” Dr. Kolba told Rheumatology News. “Expensive drugs may prove to be the most cost effective because they control disease activity and prevent joint destruction.”
The policy is available online at www.rheumatology.org/practice/office/insurance/Model_Biologics_Policy.pdf