What is Step Therapy?

In August 2018 the Centers for Medicare and Medicaid Services (CMS) introduced “step therapy” to Medicare Advantage plans.  CMS is the federal government agency that administers the Medicare program.  Step therapy is concept in which doctors are required to use inexpensive medications before they use more expensive medications without regard to how well the medications work and what side effects might be caused by the medications.  Medicare Advantage is a type of medical insurance provided by Medicare with the primary goal of reducing the costs of medical care.  Private insurance companies have followed the Medicare Advantage lead in implementing step therapy in 2019.

What eye medications are affected by step therapy?

The most common effect step therapy has had on eye care is in the use of antiVEGF medications. AntiVEGF medications are a group of drugs that have in common the ability to stop abnormal blood vessels from growing and leaking in the eye.  They help control abnormal blood vessels that can lead to blindness from a number of diseases including macular degeneration (caused by age, near-sightedness, and other conditions) macular edema, retinal vein occlusion, and diabetic eye disease.  

Why are antiVEGF medications targeted?

There is a large price difference among antiVEGF drugs.  The most commonly used antiVEGF drugs include Avastin, Lucentis, Eylea, Beovu, and Vabysmo. While a dose of Avastin costs about $50, the price of Lucentis, Eylea, and Beovu is about $2,000 per dose.  Due to an unexpected fluke, Avastin was found to be very effective in the treatment of eye disease AFTER it had been approved by the FDA and priced by the drug company for the treatment of colon cancer.  Because only a fraction of a vial of Avastin is used in the eye, the cost to treat eye disease is fairly low.  Lucentis and Eylea underwent lengthy study to gain approval by the FDA for the treatment of eye disease.  As a result, the drug companies were allowed under current law to set a higher price. 

Are the antiVEGF drugs equal in safety and effectiveness?

Although there are no major differences in safety and effectiveness in most patients, there are some differences among the antiVEGF drugs that might be important in individual patients.  Silicone oil droplets from the syringe may cause bothersome, persistent floaters.  This appears to be more common with Avastin.  Also, Avastin may place an eye at increased risk of infection and blindness because it must be packaged twice.  The potency of the drugs appears to be less with Avastin than Lucentis, which appears to be less potent than Eylea.  This difference in effectiveness may be important in certain patients.  The ophthalmologist (fellowship-trained retinal specialist) is in the best position to make recommendations for the patient. 

What can a patient do?

If step therapy is deemed not desirable by a patient, he or she may consider avoiding medical insurance coverage that mandates step therapy, such as Medicare Advantage.  If step therapy is required by an existing insurer, the doctor may be forced to use Avastin for initial treatment.  Often, the choice of medication may be changed after three or more injections if the treatment effect can be shown to be ineffective to the satisfaction of the insurance company.  

How might the government have handled this issue better?

A better solution to the problem of controlling the costs of medications is competition.  Competition fosters efficiency.  Current federal laws inhibit competition by not allowing Medicare to negotiate prices of medications.  Other laws require excessively expensive and inefficient processes to develop new drugs.  The unintended consequence of these laws was that drug companies lost incentive to develop better drugs.  To compensate drug companies for the laws that cause the high costs required to bring new drugs to market, the government passed more laws that barred competition and allowed drug companies to charge high prices for their drugs.  This was supposed to help drug companies recoup the costs of drug development.  However, the price of lack of competition and high drug costs is born by the patient.    

The government can lower drug costs by increasing competition.  Although Europe is not efficient by any stretch of the imagination, even they have more efficient systems in place for drug development compared with the United States.  The FDA attempts to manage new drug development, but its regulations and processes need to be streamlined.  Patent laws that prevent competition need to be reviewed.  The government can provide a platform to open price negotiation with drug companies.  Doctors should be allowed back into the scene as advocates for their patients instead being gagged by insurance companies due to government regulations.  Patients should be given a transparent view of the process of drug efficacy and pricing. 

By Scott E. Pautler, MD  

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.