Prior authorization and non-formulary drugs

Non-formulary drugs

We will consider request for coverage for medications that are not found in the drug benefit program formulary search on a case-by-case basis. For narcotic (opioid) medications, please read about our approach to opioid treatment.

Prior authorization drugs

All drugs with prior authorization status require pre-approval. For prior authorization drugs, the message Authorization required will display at the point of sale

Prescribers should review the prior-authorization criteria below. If the desired drug is not included in the table, we follow the criteria and administration guidelines suggested by the Ontario Drug Benefit programs, Cancer Care Ontario and Canadian Agency for Drugs and Technologies in Health (CADTH).

The prior-authorization criteria for originator biologic drug and biosimilar biologic drug are equivalent for the same indications; however, biosimilar will be preferentially funded, based on advice from our Drug Advisory Committee, as is the case with the Ontario Drug Benefit programs and the Cancer Care Ontario. We can consider requests for exceptions from the prescriber in rare situations.

Prescribers applying for coverage of a non-formulary or prior-authorization medication must submit a report with the following information:

Rationale for requesting drug
Dose and duration of treatment
Diagnoses and comorbidities. Please include as much detail as possible about type, stage of illness and severity of presentation
Reasons why formulary-listed alternatives may not be appropriate
Current/previous medications tried, or outcome of previous failed medication trials with exact timelines, including detailed regimens, attempted dose escalations and subsequent outcome evaluation
Pertinent laboratory results, imaging and medical status information (e.g., Eastern Cooperative Oncology Group (ECOG) score, CT results, etc.)
Supporting applicable literature evaluating use of the requested medication and/or regimen (non-formulary drugs)
Other applicable information

You can submit your document right to the claim file using our website.

Prior authorization criteria
Drug name	Brands reimbursed	Dosage form/strength	Reimbursement criteria
Botulinum Toxin A (BTX-A)	Botox® Xeomin® Dysport TherapeuticTM	Botox®: 50 U/Vial 100 U/Vial 200 U/Vial Xeomin®: 50 U/Vial 100 U/Vial Dysport TherapeuticTM: 300 U/Vial 500 U/Vial	BTX-A may be approved for the following conditions: Cervical dystonia Blepharospasm/hemifacial spasm Focal spasticity (including upper and lower limb spasticity) Neurogenic detrusor overactivity Prophylaxis of chronic migraine Additionally, the injured person must meet the following criteria: Product being prescribed has an official indication for use in the above condition(s) Doses for each product should reflect product monograph recommendations For neurogenic detrusor overactivity, the following additional criteria must also be met: Patient has a subcervical spinal cord injury; AND Patient has not responded to behavioral modifications or anticholinergic medications, and/or is intolerant of anticholinergic medications; AND Subsequent injections are no less than 36 weeks apart and initial injection must have demonstrated a positive clinical response. For chronic migraine, the following additional criteria must also be met: Patient is experiencing chronic migraine (≥15 days/month, with continuous headache lasting ≥4 hours and ≥4 distinct headache episodes each lasting ≥4 hours); AND Patient has failed ≥3 oral prophylactic medications, defined as <30% reduction in frequency of headache days to adequate doses (as per guidelines/monograph) and adequate durations (i.e. ≥8 weeks). Note:* The inability to complete an adequate medication trial (e.g. intolerable adverse effect, absolute contraindication) will only be considered as one of the three failed drug trials; AND Botox® is being requested by a physician with training in management of headache, and will be administered by a physician with appropriate qualifications & experience. *Beta-blockers, TCAs, verapamil/flunarizine, sodium valproate/divalproex sodium, topiramate, gabapentin Notes regarding continued therapy with Botox® for chronic migraine prophylaxis: Patients with an inadequate response (<50% reduction in headache days per month) after 2 treatment cycles should be discontinued from further therapy. Patients with an adequate response who transition from chronic to episodic migraine should also be discontinued off Botox® within 3 months of that transition. Criteria for resumption of Botox® for chronic migraine prophylaxis (Renewal Criteria): Objective evidence (i.e. headache diary) that the patient has obtained an adequate treatment response; AND Confirmation that the patient has reverted back to chronic migraine upon trial discontinuation. Duration of authorization is determined on a case-by-case basis.
Buprenorphine subdermal implant	Probuphine®	80 mg subdermal implant	Buprenorphine Subdermal Implant may be approved for: Management of opioid dependence Patients clinically stabilized on a dose of no more than 8 mg per day of SL buprenorphine in the preceding 90 days
Buprenorphine ER injection	Sublocade®	100 mg/0.5 mL & 300 mg/1.5 mL extended-release solution	Buprenorphine ER injection may be approved for: Management of moderate to severe opioid use disorder Patients induced and stabilized on an equivalent of 8 mg to 24 mg per day of transmucosal buprenorphine for a minimum of seven days.
Buprenorphine / Naloxone	*Suboxone® + generics	2 mg/0.5 mg 8 mg/2 mg	Buprenorphine / Naloxone may be approved for: Treatment of opioid use disorder Opioid tapering in individuals currently taking high-dose opioids for their work-related injury or illness (MED ≥90/day) Duration of authorization is determined on case-by-case basis.
Diclofenac sodium solution	*Pennsaid® + generics	1.5% w/w in solution	Diclofenac sodium solution may be approved if all of the following conditions are met: Use will be strictly limited to a local / superficial joint [e.g., knee, wrist, elbow, etc.] Use will be limited to 12 weeks An NSAID / COX-2 inhibitor will not be used concurrently High risk of GI adverse events OR failed trial of an oral NSAID
Diclofenac diethylamine gel	Voltaren® Emulgel Voltaren® Emulgel Joint Pain Voltaren® Emulgel Extra Strength	1.16% w/w 2.32% w/w	Diclofenac diethylamine may be approved for treatment if all of the following conditions are met: use is strictly limited to relief of pain associated with recent (acute), localized muscle or joint injuries such as sprains, strains or sports-like injuries (e.g. sprained ankle, strained shoulder or back muscles) use will be limited to 7 days an NSAID / COX-2 inhibitor will not be used concurrently
Tramadol	Short-acting: Tramacet® and generics Ultram® and generics Long-acting: Ralivia® Tridural® Zytram XL® Durela® and generics	Tramadol 37.5mg/Acetaminophen 325mg tablets Tramadol 50mg tablets Tramadol 100mg, 200mg, 300mg ER tablets Tramadol 75mg, 100mg, 150mg, 200mg, 300mg, 400mg XL tablets	Tramadol may be approved in the following situations: Short-acting tramadol: after failure of non-pharmacological treatment of pain and when non-opioids (e.g., acetaminophen, non-steroidal anti-inflammatory drugs-NSAIDs and short-acting opioids (e.g., codeine, Tylenol 3®) have been trialed and are not effective or are contraindicated. Long-acting tramadol: for treatment of chronic musculoskeletal or neuropathic pain when first and second-line agents have been trialed and are not effective or are contraindicated. Prescriber must also provide rationale for use of tramadol over other opioid analgesics. Duration of authorization is determined on a case-by-case basis. Renewal will be granted if objective evidence supports improvement in pain and function.

*If an interchangeable generic product is available, the brand product will only be funded if medically necessary.