Insurance for Lupus Biologic Therapies

Currently, the FDA has approved two biologic therapies for systemic lupus and two for lupus nephritis. In addition, there are other off-label options. Many biologic therapies are also under development or in the clinical trials pipeline. This makes it an exciting time for lupus patients as there are now more treatment options than ever. 

Biologic therapies are highly effective treatments for conditions like autoimmune diseases and cancers, but they are costly, which leads to scrutiny from insurance companies. 

Private insurance companies will generally cover biologic therapies with prior authorization and step therapy. Prior authorization is the process in which your physician submits clinical notes, lab results, and patient history to the insurance company to demonstrate that the treatment is medically necessary. Step therapy is when an insurer requires the patient to try and fail less expensive medications before they will authorize a biologic medication. Generally speaking, they will want the patient to try at least two medications. 

Insurance companies also use something called formulary tiers. Formulary tiers place medications in specialty tiers. The higher the tier, the more likely the insurance company will require you to pay a percentage of the drug’s cost rather than a flat co-pay. Biologic therapies, due to their cost, tend to fall in the higher formulary tiers. 

Once you and your doctor have determined that you will begin a biologic therapy, and your doctor has submitted the prior authorization, your insurance company will either approve or deny coverage. As stated previously, they will suggest alternative medications for you to try first. If you have tried the medications and failed those, you may go through the appeals process. With the help of your doctor, you can file an appeal. The appeal is a letter of medical necessity that details why prior medications failed and why the requested biologic therapy is the only option. 

Alternatively, the insurance company may arrange a peer-to-peer review, allowing your doctor to meet with their medical expert to provide further details. This is not something the patient traditionally attends. 

Once approved, insurance is billed. How your insurance plan is set up will determine what is covered. Most insurance companies will require you, the patient, to pay a percentage of the drug cost. Again, this is due to the higher formulary tier. If you are unable to pay the suggested amount, many pharmaceutical companies have copay cards or discount programs which reduce your out-of-pocket costs.  In addition, if you are uninsured or unable to afford the medication, most pharmaceutical companies have Patient Assistance Programs that provide qualifying patients with free or lower-cost medications. 

For patients on Medicaid, biologic therapies fall under non-preferred drugs. Non-preferred medications are prescription drugs that a state Medicaid program covers, but typically only after all preferred alternatives have failed. Much like step-therapy, Medicaid will require you to try and fail preferred medications before they will consider non-preferred drugs like biologic therapies. Prior authorization is also required, and an appeal process is available if it’s denied. The formulary of your specific managed care plan determines the final cost. More information can be found on the Ohio Medicaid Drug Coverage Information portal https://medicaid.ohio.gov/stakeholders-and-partners/phm/drug-coverage. 

Medicare covers FDA-approved biologics, but it depends on how the drug is administered. Infused biologics are covered under Medicare Part B. Autoinjectors or self-administered biologics are covered under Medicare Part D. Out-of-pocket costs are capped at $2000.00 per year. Medicare Advantage plans have specific network requirements and utilize prior authorization protocols. 

The entire process for getting biologic therapy approved can be intensive. It requires meticulous physician notes and appropriate documentation. If you need assistance understanding the approval process for biologic medication, contact the LFA, GOC office at 1 (888) NO-LUPUS and ask to speak with our Lead Patient Navigator, Rita Piccin, RN.