Off label use is defined as prescribing a medication for a reason that is not officially indicated by Health Canada. It is common and legal. Common examples may be the use of amitriptyline for migraine prophylaxis, or the use of gabapentin for neuropathic pain. While they may not have the approved indications by Health Canada, their uses nowadays are almost synonymous with routine clinical practice. But as we move into a national pharmacare, it is important to be more cognizant of which medications (especially expensive ones) are used for off label indications as they may have reimbursement implications.
To manage or contain drug costs, many drug insurance companies may impose various strategies. Common examples include the use of generic medication or dispensing a larger quantity of supply at a time. Almost universally, these strategies help to save on drug costs but do not involve restricting prescribing practices. Prescribers are still liberal in their ability to decide on what options to select for treating specific conditions. However, when insurance companies start imposing any clinical criteria for specific drugs, that is when the freedom to prescribe is affected.
In Ontario where the provincial drug plan is administered via Ontario Drug Benefits program, there are limited use criteria for various medications; special authorizations may be allowed via the Exceptional Access Programme. They may be aimed to ensure specific drugs are only prescribed in specific conditions. For example, the use of oral vancomycin is prescribed only when cheaper alternatives (e.g. metronidazole) have been tried, failed or not tolerated. These cost-containing mechanisms are effective in some ways but may discriminate against specific individuals where a relatively new treatment is being used for a rare condition – so rare that there may be emerging clinical evidence but insufficient to provide a blanket statement for routine recommendation. For these individuals, they may not have access to these emerging treatments due to lack of routine reimbursement coverage.
Currently many private insurance drug companies may impose some special authorizations for expensive medications. But their clinical criteria are often not as strict as provincial criteria. As we move forward with National Pharmacare plan, we should not forget this subset population who may require expensive medications for off label use that are currently supported by private insurance coverage. Mechanism should be in place to balance to need to contain costs as well as access to innovative therapies that may not have sufficient time to establish clinical evidence or recommendations.
Do you have any experience with off label use of medication that may be affected by drug coverage challenges? I would love to hear about your experience.
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