Experimental Drugs: In Your Health Plan and Stop Loss Policy

Experimental drugs are a proposed treatment for an illness such as cancer that has been tested in a laboratory and has received approval from the FDA to begin treatment on people.[i]   They have many uses that are vital, and often times the circumstances are life and death.  Even so, they are not always covered under all insurance plans across the United States, due in part to the unknown efficacy and cost of the drugs.  If experimental drugs are covered under your plans it is essential to take note in what instances they are covered, specifically clinical trials or off label drug use.  Therefore, if you are choosing an underlying plan (HMO, PPO) or a stop loss policy (for self insured plans) for your employees it is important to know what is covered under each.

There are a couple uses of experimental drugs to make note of, and make sure which, if not both your plans cover.  These are clinical trials and off label drug use.

Clinical Trials: What are they?[ii]

  • Clinical trials test new drugs or new forms of treatment for a disease
  • New screening or diagnostic treatments
  • Options for improving the quality of life for people that are suffering
  • Makes sure the drug works as expected and is safe
  • Works in treating the specific disease or illness that is being tested

Off Label Drug use:  What are they?[iii]

  • These are FDA approved drugs, but not approved for treatments that they weren’t intended for
  • Off label drug use is common in treating cancer as treatment is always evolving and changing

Off Label Drug Insurance issues:

  • Reimbursement with insurance companies can be tricky as they will often times deny drugs that are not being used for their intended purpose
  • If well respected studies show positive results of the particular drug helping your disease the insurance company may agree to pay

Currently, about 1 in 20 Cancer patients get involved in clinical trials of experimental drugs.[iv]  Yet, in a 2008 study 8 in 10 Doctors were found to have used drugs off label.[v]  That said, since clinical trials of drugs are common enough and off label drug use even more common it is important to check your Groups health plan thoroughly.  Moreover, the groups underlying plan may cover clinical trials and off label drug use, but your Stop Loss Policy may not!

Solution: Protecting yourself and your employees from gaps in coverage

  • FIRST  check the definitions and exclusions section of both policies – see specifically what they cover and what they do not
  • If your stop loss policy does not cover experimental drugs and/or off label drug make sure it is changed to mirror the underlying plan document
  • Or, have the stop loss carrier add an endorsement to the policy stating exactly what is covered under experimental drugs, off label drug use and clinical trials.  Don’t be afraid to tell them what you want to be covered!

Insurance policies that ensure the maximum amount of coverage, specifically in self insured health plans will guarantee that the Group will not be held responsible for non covered services.  Understanding the complexity of experimental drugs in both clinical trials and off label drug use can be daunting.  Therefore, ask your broker or consultant what your current plans cover, as well as any new laws and regulations.



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