Accessing Neuropathic Pain Medications

Through the Ontario Drug Benefit (ODB) program, Ontario's Ministry of Health and Long-Term Care covers most of the cost of over 3,000 prescription drug products listed in the Ontario Drug Benefit Formulary /Comparative Drug Index (Formulary).

In some circumstances, drug products listed in the Formulary may not be effective for some patients. In these exceptional events, if an alternative is available, a request for funding consideration may be made through the Exceptional Access Program (EAP).

For example, for neuropathic pain therapies, pregabalin has been approved by Health Canada and reviewed by the CED, but are not listed on the provincial formulary. For this reason, people who need assistance with the cost of this medication must apply to the EAP and be approved before they are eligible to receive assistance through Ontario's Drug Benefit program.

Through this process, individuals with uncommon clinical circumstances could be provided exceptional access to certain drugs.

To apply for funding consideration through the EAP, a patient's physician needs to submit request. As it stands, each request is reviewed individually by the Ministry. The Exceptional Access request form can also be accessed here.

It is important to note that you must already be eligible for drug coverage under the ODB program before a request for special coverage can be considered through the EAP. Those eligible include:

• People 65 years of age and older
• People on social assistance (Ontario Disability Support Program and/or Ontario Works)
• People residing in homes for special care and long-term care homes
• People receiving professional home care services
• Registrants in the Trillium Drug Program

It is also important to note that if your EAP request is approved, you may be asked to pay some portion of the drug product.

Selected drug-specific criteria used in the consideration of EAP requests are available on the ministry website at: www.health.gov.on.ca/english/providers/program/drugs/eap_criteria.html.

Please visit the following link for more information about the Ontario Ministry of Health and Long-term Care's Ontario Public Drug Programs. www.health.gov.on.ca/english/providers/program/drugs/eap_mn.html.

Inquiries regarding the Exceptional Access Program should be directed to:
E-mail : EAPFeedback.MOH@ontario.ca
Phone : 1-866-811-9893
Fax : 1-866-811-9908

Address: Exceptional Access Program, 3rd Floor, 5700 Yonge St., North York, ON M2M 4K5

Reimbursement Status of Neuropathic Medicine

1. Lyrica® (pregabalin):
   • Under EAP, requests for Lyrica® are considered for patients with neuropathic pain with an ineffective response or intolerable side effects / contraindications* to adequate trials of a tricyclic antidepressant and gabapentin.
     * Side effects and contraindications must be described in detail.
2. Cymbalta (duloxetine)
   • Approved by Health Canada for use as an analgesic in Chronic Low Back Pain, Diabetic Peripheral Neuropathic Pain, and pain associated with Fibromyalgia
   • Full benefit on ODB
3. Sativex (Cannabidioland delta-9tetrahydrocannabinol)
   • For the treatment of neuropathic pain related to multiple sclerosis in patients who have:
     • Ineffective response or intolerable side effects / contraindications to adequate trials* of a tricyclic antidepressant and gabapentin and pregabalin; and
     • Ineffective response or intolerable side effects / contraindications to adequate trials* of Cesamet (nabilone) and Marinol (delta-9-tetrahydrocannabinol); and
     • No contraindications to Sativex therapy.
       * Adequate trial is defined as 2 months unless intolerable side effect(s) occur.

     Note: Side effects and contraindications must be described in detail. Side effects should be deemed serious by the physician such that no further therapy with the agent would be warranted.

     Renewal will be considered for patients responding to Sativex therapy as demonstrated by decreased pain and other pain-related symptoms; no initiation of new analgesics; and no increase in doses of any analgesics.

4. * Neurontin® (Gabapentin):
   • Under EAP, requests for Neurontin® are considered for patients with neuropathic pain after failure of a tricyclic antidepressant (TCA), or carbamazepine, or phenytoin.
   • Evidence of a neuropathic cause is required.
     Note: that gabapentin is only approved by Health Canada as an adjunctive therapy for seizure disorders
5. *Tricyclic antidepressants (ex. amitriptyline, nortriptyline)
   • Full benefit
6. *Carbamazepine
   • Full benefit

* Please note that these medications have not been approved by Health Canada for use in neuropathic pain, however, some physicians found them helpful.