Ontario – Access to Treatments

Province of Ontario

Access to Treatments

Guide to Accessing TKIs for CML Patients in Ontario

This guide is designed to help Chronic Myeloid Leukemia (CML) patients in Ontario understand how to access Tyrosine Kinase Inhibitors (TKIs) through various programs and resources. TKIs are essential medications for managing CML, and ensuring access is critical for effective treatment.

The Ontario Trillium Drug Program (TDP) is designed to assist Ontario residents, including those living with Chronic Myeloid Leukemia (CML), who have high prescription drug costs relative to their household income. Here’s a detailed explanation of how the program works specifically for CML patients who are employed:

1. What is the Trillium Drug Program?

The Trillium Drug Program is part of the Ontario Drug Benefit (ODB) program and provides coverage for high-cost prescription medications, such as tyrosine kinase inhibitors (TKIs) used to treat CML (e.g., Imatinib, Dasatinib, Nilotinib). The program helps individuals and families whose drug costs are significant compared to their income, even if they have private insurance.

2. Eligibility for Trillium

To qualify for the TDP, patients must:

  • Be an Ontario resident with a valid OHIP card.
  • Not qualify for other ODB coverage (e.g., seniors, social assistance recipients).
  • Have private insurance that does not cover 100% of drug costs (partial coverage is acceptable).
  • Spend a significant portion of their net household income on prescription medications.

3. How Does Trillium Work for CML Patients?

For employed individuals with CML, the program works as follows:

Step 1: Application Process

Define Household Income:

  • Household income includes the income of the patient, their spouse, and any dependent children under 25 years of age.
  • Trillium calculates eligibility based on net income (after taxes), as reported to the Canada Revenue Agency.

Submit the Application:

  • Complete the Trillium Drug Program application form.
  • Provide details of your private insurance coverage (if applicable).
  • Submit the form online or by mail to the Ministry of Health.

Step 2: Deductible Calculation

Trillium assigns a deductible based on approximately 4% of household net income, divided into four equal installments for each quarter of the program year (August 1 to July 31).

Example:

If the net household income is $100,000, the annual deductible would be approximately $4,000, or $1,000 per quarter.

Step 3: Coverage for High-Cost Drugs

For CML Patients on TKIs:

  • CML medications like Imatinib, Dasatinib, and Nilotinib are covered under the Exceptional Access Program (EAP) within the ODB formulary. A physician must submit an EAP request justifying the need for the medication.
  • Once approved, the Trillium program covers the cost of the TKI after the deductible is met.

Step 4: Private Insurance Coordination

If the patient has private insurance:

  • The private insurer is billed first.
  • Trillium covers the remaining portion of the medication cost that is not reimbursed by the insurer.
  • Patients must provide proof of the insurance payout (e.g., Explanation of Benefits) when submitting claims.

4. Costs for Patients

Deductible:

  • Paid out-of-pocket before Trillium coverage begins.

Co-payment:

  • After meeting the deductible, patients pay up to $2 per prescription as a co-payment.

5. Key Benefits for CML Patients

  • Ensures access to high-cost TKIs essential for managing CML.
  • Protects against catastrophic drug expenses.
  • Integrates with private insurance to minimize out-of-pocket costs.

6. Important Considerations

Annual Renewal:

  • Patients must renew their Trillium Drug Program enrollment each year and file taxes to maintain eligibility.

EAP Approval:

  • Timely approval from the Exceptional Access Program is critical for uninterrupted medication access.

Documentation:

  • Keep all receipts and insurance statements for proper claim submission.

7. Example Scenario

Patient Profile:

  • A 40-year-old CML patient living in Ontario, earning $80,000 annually with private
    insurance covering 80% of drug costs.

Calculation:
1. Household income = $80,000.
2. Annual deductible = 4% × $80,000 = $3,200 ($800 per quarter).
3. Cost of Dasatinib = $5,000/month = $60,000/year.
4. Private insurance pays 80% = $48,000.
5. Out-of-pocket cost = $60,000 – $48,000 = $12,000.
6. Trillium pays $12,000 – $3,200 deductible = $8,800.
7. Patient pays the $3,200 deductible and $2 co-pay per prescription.
8. Applying for Trillium

Steps:

  • Obtain an application form from the Trillium Drug Program website or call 1-800-575-5386.
    complete the form and submit income details, insurance information, and supporting documentation.

Accessing TKIs Through Pharmaceutical Company Programs

In some case, employer sponsored, or private drug plans may have high co-pays. Co-Pays are the amount you pay after the deduction. In that case, pharmaceutical companies often sponsor patient support programs, administered by third parties such as Innomar, Bayshore, or McKesson, to help patients access TKIs. The steps to access the programs are essentially the same as obtaining coverage from your private plan/ employer drug plan:

1. Consult with your oncologist or hematologist for a prescription and necessary
documentation/referral.

Submit a Special Authorization request to your insurance provider, along with supporting
medical documents.For non-generic TKI’s there are patient support programs:

1. Asciminib (Scemblix): Mfg. Novartis

Patient support program Sentia – PSP contact information:
Phone: 1-855-736-8421
Fax: 1-866-636-8421
Email: psp@sentia-exp.ca

2. Nilotinib (Tasigna): Mfg. Novartis

Patient support program Sentia – PSP contact information:
Phone: 1-855-736-8421
Fax: 1-866-636-8421
Email: psp@sentia-exp.ca

3. Bosutinib (Bosulif): Pfizer Liaison (1-844-616-6888)

4. Ponatinib (Iclusig): Paladin Labs Distribution Program for patients.
Contact 1.877.318.4462 or Email: PalSupport@bayshore.ca for support

Generic TKIs and Cost-Saving Options

With the availability of generic TKIs like dasatinib, patients may find these alternatives more affordable. Consult your healthcare provider about switching to a generic medication if cost is a concern. Key Resources for Support.

Here are some organizations and programs that can assist with accessing TKIs:

1. CML Society of Canada: Provides guidance on medication access.
2. Ontario Trillium Drug Program: Helps cover high prescription costs.

Conclusion

Navigating medication access can be complex, but multiple resources and programs are available to ensure CML patients receive the treatment they need. Speak with your healthcare provider, review your insurance policies, and explore provincial programs like Trillium to find the best solution for your situation.