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Afinitor® loss of exclusivity: what you need to know

As of October 2021, all dose formulations of Afinitor® lost exclusivity, and generic versions (everolimus) can now be marketed for sale at pharmacies. The TSC Alliance® wants to ensure the TSC community understands what this means and offer some action steps to prevent any delay in medication access.

Losing exclusivity simply means the brand-name drug is no longer protected from generic drug competition. In this scenario, FDA-approved generic equivalents (everolimus) of name brand Afinitor® can legally be prescribed with a prescription. It is important to understand a generic designation does not mean lesser value or efficacy. Generic medications must be biologically similar to the name brand formulations and therefore be interchangeable for treatment management.

Insurance companies will then negotiate drug prices from pharmaceutical manufacturers through third party companies known as pharmacy benefit managers (PBMs). Common PBMs are Express Scripts, CVS Caremark and OptumRx. Once an agreement has been reached, insurance companies will decide what medication (brand, generic or both) to include on the insurance plan pharmacy drug list (PDL) known as the formulary (preferred) medication. This simply means your insurance plan will list the preferred medication available to you on your PDL. Because additional options are available, it is not uncommon for insurance plans to adjust what medication is covered; therefore, if your plan once covered the brand (Afinitor®), it might now only cover generic form (everolimus). Since we are in the new year, it is essential to understand what option is listed as your preferred medication. Most plans have online portals that will allow you to confirm which available option is preferred.

The TSC Alliance understands abrupt medication changes are never ideal; however, we also want to make sure our community feels comfortable knowing that interchanging this medication between name brand versus generic is a safe option. We recommend you discuss which option is best for you or your loved one, but ideally it is reasonable to stick with the medication covered under your plan. Therefore, if your insurance no longer covers brand Afinitor® but covers the generic option, then switching to your medication over should be seamless.

Because these drugs are equivalent, drug tapering or drug vacation prior to switching over to the generic option, does not seem to be necessary. Furthermore, the name brand and generic dosages are equivalent; thus, if you were taking Afinitor® 10 mg you would take everolimus 10 mg. Side effects will be similar between brand and generic, and there is no clinical evidence for “new” side effects during the transition. However, we understand a small population of individuals can be sensitive to even small changes in medication and might experience different side effects. If you or your loved one has had specific issues regarding this in the past, we strongly encourage you to discuss it with your prescribing healthcare provider.

As with any change, some difficulties in co-pay assistance with drug coverage is to be expected. At this time, those enrolled in Afinitrac as of December 31, 2021, will continue to receive co-pay assistance for an undisclosed amount of time. Generic drugs tend to be less expensive, but we understand cheaper does not always make it more affordable to the consumer. Unfortunately, the TSC Alliance is not aware of any assistance programs currently for generic options. GoodRx.com is a coupon app that may help reduce costs. Please contact your local healthcare provider if you need additional assistance with options during these changes.