Section 8 Forms: Renal Pharmacists Network

This section is designed to allow the sharing of information among those helping patients to procure affordable medications. Lacking a federal formulary, drugs are currently covered differently in different provinces. If you would like to add information pertinent to your own province, please e-mail Brenda Bruinooge (bbruinooge@yorkcentral.on.ca).

Important Announcement for Venofer users in Ontario

Notice to Pharmacies

The Ministry of Health and Long-Term Care has introduced an amendment to subsection 9(3)(a) of the Ontario Regulation 201/96 under the Ontario Drug Benefit Act (ODBA). This is the section of the regulation that lists a number of compounded injectable products that are not eligible for reimbursement unless a valid Section 8 approval is in place.

Iron sucrose (Venofer(r)) has been added to the list of products that require Individual Clinical Review (ICR/Section 8) approval prior to being reimbursed as an extemporaneous mixture. To facilitate the transition, ICR/Section 8 requests for iron sucrose will be processed on an urgent basis for the next 3 months.

Please be reminded that claims reimbursed under the ODBA are subject to post-payment verification. Claims submitted during the 3 month transition will not be subject to audit.

Any questions on the implementation of this amendment can be directed to the HNS Help Desk at 1-800-668-6641.

Ontario Drug Coverage Shared Forms

These forms were developed by Social Workers and Pharmacists at Renal Units across Ontario for the purpose of allowing patients to benefit from optimal drug therapy in an environment where medications used may not be covered under the provincial Drug Benefit Formulary.

In Ontario, the Ontario Drug Benefit Program has a drug formulary divided into 2 areas: Formulary of approved drugs, and Limited Use Drugs (requiring special Prescription pads and 3 digit codes to assure predefined criteria are met). An additional approval mechanism for non-formulary medications is via the Individual Clinical Review (Section 8) process.

The Section 8 Program is designed to allow Individual Clinical Review (ICR) by members of the Drug Quality and Therapeutics Committee (DQTC) on a case by case basis. They fax approvals or rejections to the fax numbers listed on the application form (as defined by you, the user). Approval is for 6 to 12 months only.

Some forms are listed here and you are free to modify and alter as needed. Please also e-mail Brenda Bruinooge (bbruinooge@yorkcentral.on.ca) if you have other forms which not included here or if you have additional information that could be added to these ones.

There is also a separate discussion forum on Drug Coverage which includes Section 8 concerns.

Download Forms

Renagel® / Sevelamer®

Renagel® now has section 8 (ICR) status with the Ontario Drug Benefit Formulary in Ontario. Please note that the new 400mg and 800mg strengths have also been approved for section 8 status. Please see the following for details: Announcement (.pdf).

The 400mg and 800mg tablets have arrived on the Canadian market. The following chart can help in converting the dose: Dose Conversion (.pdf).

Attention Health Care Professionals

Are you having problems getting coverage for your patients on Renagel®? There is now a toll-free number to help with your funding questions.

Introduction New Renagel® Reimbursement Helpline: 1-866-401-8323
A new reimbursement HELPLINE has been set up to help you get coverage for Renagel® under your insurance plan.
Most private and public insurance companies cover Renagel®. In fact, most private plans provide unrestricted open coverage where you need only fill your prescription at you local pharmacy.
You should note however that not all insurers and plans reimburse the same way. For most public plans, you or your doctor may need to file additional documentation to obtain a prior authorization for reimbursement for Renagel® costs.
If you have questions about your coverage, you can call the new Renagel® Reimbursement HELPLINE. Reimbursement specialists will be able to help you verify your benefits and answer any other questions you may have about Renagel® reimbursement.
The Renagel® Reimbursement HELPLINE is open from 8:00 am until 8:00 pm EST Monday through Friday. Simply call 1-866-401-8323 and a specialist will be pleased to help you.

Note: If you are having trouble getting Section 8 approval in Ontario, you may want to view this sample letter to the Ministry of Health.

Visit Genzyme's web site for more information. Keep in mind that this is a U.S. based site, and therefore the Canadian Prescribing Information is not available.


	The Renal Pharmacists Network Réseau de pharmaciens en néphrologie