OPDP BULLETINS DECEMBER 21-28, 2016

OPDP Notice No. 16164 posted December 21, 2016 Notice from the Executive Officer: Funding of Grastofil (filgrastim) under the Ontario Drug Benefit program

 

Ontario Public Drug Programs, Ministry of Health and Long-Term Care

Notice from the Executive Officer: Funding of Grastofil (filgrastim) under the Ontario Drug Benefit program

December 21, 2016

Effective December 22, 2016, Grastofil (filgrastim) will be funded under the Ontario Drug Benefit (ODB) Program for eligible ODB recipients to prevent and treat neutropenia associated with chemotherapy. The following strengths and Drug Identification Numbers (DINs) will be added to the Formulary:

·         Grastofil (filgrastim) 300 mcg/0.5mL pre-filled syringe (DIN: 02454548)

·         Grastofil (filgrastim) 480 mcg/0.5mL pre-filled syringe (DIN: 02441489)

Grastofil (filgrastim) is a subsequent entry biologic (SEB) to Neupogen (filgrastim) and was approved by Health Canada in December 2015. Grastofil (filgrastim) will be listed on the ODB Formulary/Comparative Drug Index (Formulary) as a General Benefit (GB).

Subsequent entry biologics (SEBs) are biologics that are similar to, and would enter the market after the patent for an innovator biologic has expired. They are similar to generic drugs and are considered safe and effective, undergoing the same regulatory review as innovator biologics through Health Canada. SEBs present an important opportunity to achieve better value for money for biologic drugs and will help to support long-term sustainability and accessibility of Ontario’s public drug programs.

Prescribers are encouraged to consider Grastofil (filgrastim) for new starts of a filgrastim regimen and a decision to begin treatment with Grastofil (filgrastim) should continue to be aligned with recognized clinical guidance, including but not limited to that released by Cancer Care Ontario at: https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=352101

Neupogen (filgrastim) will continue to be funded, at this time, for those patients that meet the LU criteria.

To further inform healthcare providers and patients, we have also included a Frequently Asked Questions (FAQs) document for reference purposes.

If you require further clarification or have questions regarding this matter, please send your question(s) to PublicDrugPrgrms.moh@ontario.ca or call:

Pharmacists - call the ODB Pharmacy Help Desk at: 1-800-668-6641

Other health care providers - call ServiceOntario, Infoline at 1-866-532-3161 TTY 1-800-387-5559. In Toronto, TTY at 416-327-4282.

Grastofil Frequently Asked Questions

1.   What is the funding status of Grastofil (filgrastim)? Is it safe and effective?

Effective December 22, 2016, Grastofil (filgrastim) will be funded under the Ontario Drug Benefit (ODB) Program for eligible ODB recipients to prevent and treat neutropenia associated with chemotherapy.

Prescribers are encouraged to consider Grastofil (filgrastim) for new starts of a filgrastim regimen and a decision to begin treatment with Grastofil (filgrastim) should continue to be aligned with recognized clinical guidance, including but not limited to that released by Cancer Care Ontario at:

https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=352101

Health Canada has reviewed the safety and efficacy of Grastofil (filgrastim) and approved the drug for use in the following indications:

·         To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

·         For the reduction in the duration of neutropenia, fever, antibiotic use and hospitalization, following induction and consolidation treatment for acute myeloid leukemia;

·         To reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g. febrile neutropenia, in patients undergoing myeloablative therapy followed by bone marrow transplantation.

·         For the mobilization of autologous peripheral blood progenitor cells in order to accelerate haematopoietic recovery by infusion of such cells, supported by filgrastim after myelosuppressive or myeloablative chemotherapy.

·         For chronic administration to increase neutrophil counts and to reduce the incidence and duration of infection in patients with a diagnosis of congenital, cyclic or idiopathic neutropenia.

·         In patients with HIV infection for the prevention and treatment of neutropenia, to maintain a normal absolute neutrophil count.

Please refer to Health Canada’s website for further details on the market approval of Grastofil (filgrastim) at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd-smd-2016-grastofil-156897-eng.php#sbd

2.   Will there be any changes to the funding status of Neupogen (filgrastim) effective with the December 2016 ODB Formulary update?

Neupogen (filgrastim) is currently funded for under specific circumstances as a Limited Use (LU) benefit on the ODB Formulary, and through the ministry’s Exceptional Access Program (EAP) according to clinical criteria.

There will be no changes to the funding status or criteria for Neupogen (filgrastim) effective with the December 2016 ODB Formulary update.

Claims for Neupogen (filgrastim) will continue to be reimbursed under the ODB program when prescribed in accordance with the LU criteria and accompanied by a valid, fully completed prescription with the appropriate LU documentation (Reason For Use, RFU code).

Additionally, patients who have an existing Exceptional Access Program (EAP) approval for Neupogen (filgrastim) can continue to receive Neupogen (filgrastim) for the duration of the EAP approval period.  The ministry will also consider EAP renewal requests for Neupgen (filgrastim) for patients with existing EAP approvals.

3.   What is difference between Grastofil (filgrastim) and Neupogen (filgrastim)?

Grastofil and Neupogen are both filgrastim products. Filgrastim is a hematopoietic agent medicine that helps to prevent or treat neutropenia (low white blood cell count) during cancer treatment.  Grastofil (filgrastim) is approved by Health Canada as a subsequent entry biologic (SEB) to Neupogen.  Grastofil (filgrastim) and Neupogen (filgrastim) are manufactured and marketed by different companies.

Grastofil (filgrastim) is currently available as pre-filled syringes.

4.   What is the rationale behind funding Grastofil (filgrastim) as a General Benefit on the ODB Formulary?

Health Canada is responsible for assessing the safety and efficacy of drug products, including SEBs such as Grastofil (filgrastim) before they can be approved for sale in Canada. SEBs are subject to the same regulatory requirements as biologics.

Additionally, the clinical, economic and patient group evidence was reviewed through the national Common Drug Review (CDR), as with other drug products, including biologics, and a positive funding recommendation was rendered in support of funding for Grastofil’s (filgrastim) approved indications.

SEBs present an important opportunity to achieve better value for money for biologic drugs and will help to support long-term sustainability and accessibility of Ontario’s public drug programs. Listing Grastofil (filgrastim) as a General Benefit (GB) will support timely access to this product.

5.   Are there other jurisdictions currently funding Grastofil (filgrastim)?

Yes. Grastofil (filgrastim) and other SEB filgrastim products have been prescribed and dispensed through European public drug plans for many years. Additionally, the Saskatchewan Cancer Agency has been funding Grastofil (filgrastim) for approved indications since May 2016.

6.   How will this change impact patients?

Patients will see little to no impact to their care as a result of these changes. Patients currently receiving Neupogen (filgrastim) for a course of therapy to treat or prevent neutropenia will continue to be covered for this product. Prescribers are encouraged to consider Grastofil (filgrastim) for new starts of a filgrastim regimen. For those patients prescribed Grastofil (filgrastim), they may wish to be trained, or have a caregiver trained, to self-administer this product as it is available in a pre-filled syringe for ease of use. However, there may be instances such as use in pediatric patients where a vial format is preferable for dosing purposes.

7.   How will this change impact prescribers writing prescriptions for filgrastim?

Prescribers should ensure all prescriptions for filgrastim going forward indicate the brand name of the product requested, either Grastofil (filgrastim) or Neupogen (filgrastim). Preprinted orders, where applicable, should also be updated to reflect this distinction.

8.   How should pharmacies submit claims for Grastofil (filgrastim)?

When a prescription for filgrastim is received, pharmacists should verify whether the prescription is for Grastofil (filgrastim) or Neupogen (filgrastim). Pharmacies should submit claims using the drug identification number (DIN) for Grastofil (filgrastim) 300 mcg/0.5mL or 480 mcg/0.5mL when indicated on the prescription, and should continue to submit claims for Neupogen (filgrastim), where applicable, with the appropriate RFU code and/or EAP confirmation.

9.   What are Subsequent Entry Biologics?

Subsequent entry biologics (SEBs), also referred to as biosimilars or follow-on biologics, are biologics that are similar to, and would enter the market after the patent for an innovator biologic has expired. They are similar to generic drugs. However, unlike generic drugs, biosimilars are not deemed bioequivalent to, nor interchangeable with, their reference drugs. SEBs are subject to the same regulatory requirements as biologics.

OPDP Notice No. 16164A posted December 21, 2016 RE: Notice from the Executive Officer: Funding of Grastofil (filgrastim) under the Ontario Drug Benefit program

 

Ontario Public Drug Programs, Ministry of Health and Long-Term Care

Notice from the Executive Officer: Funding of Grastofil (filgrastim) under the Ontario Drug Benefit program

December 21, 2016

Effective December 22, 2016, Grastofil (filgrastim) will be funded under the Ontario Drug Benefit (ODB) Program for eligible ODB recipients to prevent and treat neutropenia associated with chemotherapy. The following strengths and Drug Identification Numbers (DINs) will be added to the Formulary:

·         Grastofil (filgrastim) 300 mcg/0.5mL pre-filled syringe (DIN: 02454548)

·         Grastofil (filgrastim) 480 mcg/0.8mL pre-filled syringe (DIN: 02441489)

Grastofil (filgrastim) is a subsequent entry biologic (SEB) to Neupogen (filgrastim) and was approved by Health Canada in December 2015. Grastofil (filgrastim) will be listed on the ODB Formulary/Comparative Drug Index (Formulary) as a General Benefit (GB).

Subsequent entry biologics (SEBs) are biologics that are similar to, and would enter the market after the patent for an innovator biologic has expired. They are similar to generic drugs and are considered safe and effective, undergoing the same regulatory review as innovator biologics through Health Canada. SEBs present an important opportunity to achieve better value for money for biologic drugs and will help to support long-term sustainability and accessibility of Ontario’s public drug programs.

Prescribers are encouraged to consider Grastofil (filgrastim) for new starts of a filgrastim regimen and a decision to begin treatment with Grastofil (filgrastim) should continue to be aligned with recognized clinical guidance, including but not limited to that released by Cancer Care Ontario at: https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=352101

Neupogen (filgrastim) will continue to be funded, at this time, for those patients that meet the LU criteria.

To further inform healthcare providers and patients, we have also included a Frequently Asked Questions (FAQs) document for reference purposes.

If you require further clarification or have questions regarding this matter, please send your question(s) to PublicDrugPrgrms.moh@ontario.ca or call:

Pharmacists - call the ODB Pharmacy Help Desk at: 1-800-668-6641

Other health care providers - call ServiceOntario, Infoline at 1-866-532-3161 TTY 1-800-387-5559. In Toronto, TTY at 416-327-4282.

Grastofil Frequently Asked Questions

1.   What is the funding status of Grastofil (filgrastim)? Is it safe and effective?

Effective December 22, 2016, Grastofil (filgrastim) will be funded under the Ontario Drug Benefit (ODB) Program for eligible ODB recipients to prevent and treat neutropenia associated with chemotherapy.

Prescribers are encouraged to consider Grastofil (filgrastim) for new starts of a filgrastim regimen and a decision to begin treatment with Grastofil (filgrastim) should continue to be aligned with recognized clinical guidance, including but not limited to that released by Cancer Care Ontario at:

https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=352101

Health Canada has reviewed the safety and efficacy of Grastofil (filgrastim) and approved the drug for use in the following indications:

·         To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

·         For the reduction in the duration of neutropenia, fever, antibiotic use and hospitalization, following induction and consolidation treatment for acute myeloid leukemia;

·         To reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g. febrile neutropenia, in patients undergoing myeloablative therapy followed by bone marrow transplantation.

·         For the mobilization of autologous peripheral blood progenitor cells in order to accelerate haematopoietic recovery by infusion of such cells, supported by filgrastim after myelosuppressive or myeloablative chemotherapy.

·         For chronic administration to increase neutrophil counts and to reduce the incidence and duration of infection in patients with a diagnosis of congenital, cyclic or idiopathic neutropenia.

·         In patients with HIV infection for the prevention and treatment of neutropenia, to maintain a normal absolute neutrophil count.

Please refer to Health Canada’s website for further details on the market approval of Grastofil (filgrastim) at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd-smd-2016-grastofil-156897-eng.php#sbd

2.   Will there be any changes to the funding status of Neupogen (filgrastim) effective with the December 2016 ODB Formulary update?

Neupogen (filgrastim) is currently funded for under specific circumstances as a Limited Use (LU) benefit on the ODB Formulary, and through the ministry’s Exceptional Access Program (EAP) according to clinical criteria.

There will be no changes to the funding status or criteria for Neupogen (filgrastim) effective with the December 2016 ODB Formulary update.

Claims for Neupogen (filgrastim) will continue to be reimbursed under the ODB program when prescribed in accordance with the LU criteria and accompanied by a valid, fully completed prescription with the appropriate LU documentation (Reason For Use, RFU code).

Additionally, patients who have an existing Exceptional Access Program (EAP) approval for Neupogen (filgrastim) can continue to receive Neupogen (filgrastim) for the duration of the EAP approval period.  The ministry will also consider EAP renewal requests for Neupgen (filgrastim) for patients with existing EAP approvals.

3.   What is difference between Grastofil (filgrastim) and Neupogen (filgrastim)?

Grastofil and Neupogen are both filgrastim products. Filgrastim is a hematopoietic agent medicine that helps to prevent or treat neutropenia (low white blood cell count) during cancer treatment.  Grastofil (filgrastim) is approved by Health Canada as a subsequent entry biologic (SEB) to Neupogen.  Grastofil (filgrastim) and Neupogen (filgrastim) are manufactured and marketed by different companies.

Grastofil (filgrastim) is currently available as pre-filled syringes.

4.   What is the rationale behind funding Grastofil (filgrastim) as a General Benefit on the ODB Formulary?

Health Canada is responsible for assessing the safety and efficacy of drug products, including SEBs such as Grastofil (filgrastim) before they can be approved for sale in Canada. SEBs are subject to the same regulatory requirements as biologics.

Additionally, the clinical, economic and patient group evidence was reviewed through the national Common Drug Review (CDR), as with other drug products, including biologics, and a positive funding recommendation was rendered in support of funding for Grastofil’s (filgrastim) approved indications.

SEBs present an important opportunity to achieve better value for money for biologic drugs and will help to support long-term sustainability and accessibility of Ontario’s public drug programs. Listing Grastofil (filgrastim) as a General Benefit (GB) will support timely access to this product.

5.   Are there other jurisdictions currently funding Grastofil (filgrastim)?

Yes. Grastofil (filgrastim) and other SEB filgrastim products have been prescribed and dispensed through European public drug plans for many years. Additionally, the Saskatchewan Cancer Agency has been funding Grastofil (filgrastim) for approved indications since May 2016.

6.   How will this change impact patients?

Patients will see little to no impact to their care as a result of these changes. Patients currently receiving Neupogen (filgrastim) for a course of therapy to treat or prevent neutropenia will continue to be covered for this product. Prescribers are encouraged to consider Grastofil (filgrastim) for new starts of a filgrastim regimen. For those patients prescribed Grastofil (filgrastim), they may wish to be trained, or have a caregiver trained, to self-administer this product as it is available in a pre-filled syringe for ease of use. However, there may be instances such as use in pediatric patients where a vial format is preferable for dosing purposes.

7.   How will this change impact prescribers writing prescriptions for filgrastim?

Prescribers should ensure all prescriptions for filgrastim going forward indicate the brand name of the product requested, either Grastofil (filgrastim) or Neupogen (filgrastim). Preprinted orders, where applicable, should also be updated to reflect this distinction.

8.   How should pharmacies submit claims for Grastofil (filgrastim)?

When a prescription for filgrastim is received, pharmacists should verify whether the prescription is for Grastofil (filgrastim) or Neupogen (filgrastim). Pharmacies should submit claims using the drug identification number (DIN) for Grastofil (filgrastim) 300 mcg/0.5mL or 480 mcg/0.8mL when indicated on the prescription, and should continue to submit claims for Neupogen (filgrastim), where applicable, with the appropriate RFU code and/or EAP confirmation.

9.   What are Subsequent Entry Biologics?

Subsequent entry biologics (SEBs), also referred to as biosimilars or follow-on biologics, are biologics that are similar to, and would enter the market after the patent for an innovator biologic has expired. They are similar to generic drugs. However, unlike generic drugs, biosimilars are not deemed bioequivalent to, nor interchangeable with, their reference drugs. SEBs are subject to the same regulatory requirements as biologics.

OPDP Notice No. 16165 posted December 28, 2016 UPDATE regarding Changes in the Way Social Assistance Clients Access Drug Coverage

 

Ontario Public Drug Programs Division, Ministry of Health and Long-Term Care

UPDATE regarding Changes in the Way Social Assistance Clients Access Drug Coverage

December 28, 2016

As previously communicated in the Notice from the Executive Officer released on September 2, 2016, the Ministry of Community and Social Services (MCSS) has changed the way social assistance clients access drug coverage under the Ontario Drug Benefit (ODB) program.

Starting December 1, 2016, most clients will no longer receive a monthly paper drug eligibility card.  Instead, they will use their Ontario health card to access drug coverage under the ODB program.

This change applies to all recipients of the

·         Ontario Disability Support Program (ODSP), including First Nation ODSP clients and Assistance for Children with Severe Disabilities (ACSD) and

·         Ontario Works, including M’Chigeeng First Nation Ontario Works and Temporary Care Assistance (TCA)

Clients who are not eligible for an Ontario health card will continue to receive a monthly paper drug eligibility card until they obtain a health card.

How does this change affect pharmacists?

If a client’s social assistance eligibility or plan code cannot be validated through the Health Network System (HNS), pharmacists should contact the Social Assistance Verification (SAV) Helpline toll-free at 1-888-284-3928. The helpline has been operational since September 1, 2016. As of December 1st, the hours of operation were extended from 7:00 a.m. to 7:00 p.m. Monday to Friday (excluding statutory holidays).

Pharmacists must process drug claims through the HNS prior to calling the SAV Helpline.  To reduce wait times, pharmacists should limit requests for confirmation of eligibility by the SAV Helpline to a maximum of five cases per call.  Note that requesting confirmation of eligibility for more than five people during one call will significantly impact response times for all pharmacists.

For more information on the changes in the way social assistance clients access drug coverage, please visit:  http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx

Using Paper Drug Card issued in November 2016 for December 2016

To further support pharmacists and social assistance clients as they transition to the new process, pharmacists can accept paper drug eligibility cards issued in November 2016 as proof of social assistance eligibility during the month of December 2016.

Who can I contact with questions? 

Please contact MCSS at: SASM-Q&A@ontario.ca for questions related to the Paperless Drug Card initiative

For all ODB related questions, please call the ODB Pharmacy Help Desk at: 1-800-668-6641

Categories: OPDP Bulletins

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