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Clozapine and Clozaril®

PDF (98 KB)

This brochure describes substituting generic clozapine for brand Clozaril® for Wisconsin Medicaid and BadgerCare Recipients and SeniorCare Participants

What is changing?

Effective September 1, 2004, the Wisconsin Medicaid program will require Prior Authorization (PA) for all brand drugs for which federal Food and Drug Administration (FDA) approved generic drugs are available. This includes Clozaril®. The Medicaid pharmacy budget is one of the fastest growing parts of the State budget. The substitution of generic clozapine for Clozaril® has been shown to be a clinically appropriate way to lower drug costs.

Many other states, private health plans, hospitals, and health maintenance organizations (HMOs) began requiring generic substitution for Clozaril® some time ago. In Wisconsin, approximately 70% of Medicaid recipients taking clozapine are already using a generic. It is anticipated that the majority of the remaining 30% can be switched without difficulty.

This change applies to you if you are taking Clozaril®. If you are already taking generic clozapine, no change is necessary.

If your prescriber can show that you should not use generic clozapine, he/she will work with your pharmacist to obtain PA for you.

What is generic substitution?

When a drug company develops a new medication, it obtains a patent for the new product. The patent prevents others from making the new medication without the original company’s permission for approximately 15 years. Since only the original company is allowed to make the medication, it can name any price it wants. This medication is called the brand name medication. Novartis held the patent for clozapine, which is sold under the brand name Clozaril®.

After the patent runs out, it is legal for other companies to also make the same medication. When made by other companies, the medication, which has the identical active ingredient as the brand name, is called the generic medication. Generic medications are sold for about one-third the cost of brand medications. Several companies currently make generic clozapine.

How is a generic medication different from a brand name medication?

For both a brand name medication and a generic medication:

  • the active ingredient is the same; and

  • the amount of active ingredient in each pill is the same.

The rest of the materials in pills consist of:

  • binders that keep the pills stuck together

  • coatings that make the pill easy to swallow and determine how fast the pill dissolves

  • dyes that make the pills different colors.

The binders, coatings and dyes are different for each generic and brand name pill.

Active ingredients for Clozaril

Clozaril®

Active ingredients for clozapine

clozapine

The active ingredient is identical.

Getting ready to switch to a generic medication

Your prescriber will need to write a new prescription for you for generic clozapine. Your pharmacist will need this new prescription to dispense generic clozapine for you on or after September 1, 2004.

If you or your prescriber (or your family or case manager, if desired) are concerned about the change to generic clozapine, you should review the pattern of your symptoms while taking Clozaril®. Some people have very few symptoms or side effects while taking medications. Other people experience changes in their symptoms even when taking the same dose of the same drug over time. It is important that you and your prescriber have a clear idea of what your symptom pattern is before you make the switch.

Your prescriber might also wish to see if your body absorbs generic clozapine at a different rate than it absorbed Clozaril®. To do this, he/she would test your blood while on Clozaril® and then test it again after the switch to generic clozapine was made. The results of these two tests would help your prescriber decide if a different amount of clozapine was getting to your nerve cells and help him/her decide if the dose needs to be adjusted.

"What if I just don’t feel the same?"

Only a small portion of persons switched to generic clozapine have needed to be switched back to brand Clozaril®. Similar changes in Medicaid and private insurance have already happened in many other states. In those states, almost all patients were able to do just as well on generic clozapine as on Clozaril® and most didn’t need any dose change.

Wisconsin Medicaid has provided a way to change back to Clozaril® in certain situations. They are:

  • You have an allergic reaction to a something in the binding agent, coating or dye in a generic formulation.

  • You experience adverse reactions not experienced on Clozaril®.

  • You experience therapeutic failure on a generic formulation.

If any of these three situations apply to you, your prescriber will work with your pharmacist to obtain PA for you.

If you have questions, you can contact Medicaid Recipient Services (Voice/TTD) at 800-362-3002.


Department of Health and Family Services
Division of Health Care Financing
Division of Disability and Elder Services
PDE 3192 (07/04)