J. L. Glennie Consulting Inc.
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J. L. Glennie Consulting Inc. U NDERSTANDING THE T RILLIUM D RUG P ROGRAM REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. 1 O BJECTIVES 2 Provide an overall understanding of the Trillium Drug Program (TDP) in the context of the broader Ontario Public Drug Programs Develop an understanding of relevant eligibility policies as applied by the TDP Review selected case studies to better understand TDP processes REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. D ISCLAIMER 3 My comments are my own and do not represent the position of any organization to which I have belonged in the past. NOTE: Detailed questions are best addressed via TDP resources and/or directly with TDP staff. J.L. GLENNIE CONSULTING INC. CONFIDENTIAL F IRST - I MPORTANT FACTS 4 ABOUT THE TDP Applies to Ontario ONLY! Not a drug program it is a financial assistance program Provides access only to drugs already covered by ODB for their core recipients based on financial need high out of pocket drug costs (+/‐ private plan or type of plan) ALSO ‐ need to meet the same clinical criteria (i.e., use of previous therapies) Patient must demonstrate out of pocket drug costs before applying to TDP REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. S O , WHERE DOES TDP FIT ? J.L. GLENNIE CONSULTING INC. CONFIDENTIAL 5 6 OPDP – T HE B IG P ICTURE Trillium Drug Program The OPDP includes one major, several smaller drug programs (for special patient populations), and the TDP for financial assistance. ON Drug Benefit (ODB) Program OPDP + New Drug Funding Program Special Drugs Program Visudyne Program Inherited Metabolic Diseases Program RSV Program for Infants REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. D RUG 7 COVERAGE WITH TDP ODB Program ODB Formulary TDP General Benefit Limited Use REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. Conditional Listing EAP 8 S COPE OF F UNDING HC NOTE: Not all marketed drugs are covered by ODB APPROVALS VS . 22,000+ 3,200+ REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. ODB F UNDING A PPLYING FOR TDP J.L. GLENNIE CONSULTING INC. CONFIDENTIAL 9 B ACKGROUND ON THE TDP 10 Purpose: to help people who have high prescription drug costs relative to their household income A financial assistance program (not a program that funds a different list of drugs) Eligibility process – 2 parts: #1: apply for financial assistance qualification #2: pursue drug access Simple (GB): via MD prescription Moderate (LU): via MD prescription + appropriate LU code Complex (EAP): submit for approval per the pre‐set clinical criteria for drugs already funded REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. H OW 11 TO TELL IF A PRODUCT IS FUNDED BY 1) Search the ODB e‐formulary • 2) http://www.health.gov.on.ca/english/providers/program/drugs/eap_criteria_list.ht ml Check the drug submission status reports • 4) http://www.health.gov.on.ca/en/pro/programs/drugs/odbf_eformulary.aspx Check the EAP list/reimbursement criteria (i.e., prior authorization system) • 3) ODB http://www.health.gov.on.ca/english/providers/program/drugs/status_single_sourc e_subm.html Check the “not funded drugs” list (last updated Dec 2011) • http://www.health.gov.on.ca/english/providers/program/drugs/pdf/guidelines_no_f unding.pdf REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. E LIGIBILITY R ULES 12 Parameter ODB TDP Eligibility Live in ON + have a valid ON Health Card Live in ON + have a valid ON Health Card Application process Varies Annual Proof of existing drug expenditures required? -no YES!!! Age/other qualifying factors - senior (>65yo) - Ontario Works, ODSP - Long-Term Care/Home for Special Care resident - Home Care Services - don’t fall into any ODB age/other qualifying groups - No private health insurance OR private insurance does not cover 100% of prescription drug costs AND - household drug costs are 4% of household’s total net/after tax income Deductible and/or co-pay - Variable, depending on recipient category - Deductible (divided quarterly) - $2 co-pay/Rx after deductible paid REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. A M I E LIGIBLE 13 “B ACK FOR TDP? OF THE ENVELOPE ” Calculation of the deductible (see pg. 5 of Guide) Family of 4 (3 adults, 1 child) Total household income $75K + $50K + $10K = $135K Subtract $20K; multiply result by 0.045; add $500 to result; subtract $200 from result (family of 4) Deductible = $5475/y i.e., need to have total household drug costs > $5475/y to make it worthwhile to apply for TDP J.L. GLENNIE CONSULTING INC. CONFIDENTIAL TDP A PPLICATION P ROCESS (1) 14 FIRST: See TPD brochure and application form (on‐line) Annual, paper‐based application process Approval based on out‐of‐pocket drug expenditures 4% of household net income (“deductible”) Expenditures must occur before TDP application will be considered Full disclosure of private insurance coverage information REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. TDP A PPLICATION P ROCESS (2) 15 Review by TDP Approval notification from TPD Informed of quarterly deductible On‐line adjudication process once approved Still have out of pocket costs until TDP deductible reached REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. 16 TDP eligibility approved P OTENTIAL PHARMACY LEVEL SCENARIO FOR A PRIVATELY I NSURED PATIENT Patient takes Rx to Pharmacy Pharmacy adjudicates via private insurer Pharmacy adjudicates balance via TDP REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. C ASES S TUDIES J.L. GLENNIE CONSULTING INC. CONFIDENTIAL 17 T YPES 18 OF DRUGS COVERED UNDER EAP Clinical and cost‐effectiveness in a specific subpopulation of patients Management of potential off‐label use Wide range of outpatient/community‐based therapies Some biologics (RA, PsO, PsA, AS, UC, etc.) Some MS medications (inj) Some oral oncology medications (Note: IVs under New Drug Funding Program) REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. C ASE 19 STUDY #1 FUNDED BIOLOGIC Scenario: Remicade for rheumatoid arthritis; high out of pocket drug costs Step Action 1) Drug coverage Verify if product covered by OPDP Need to meet EAP criteria to undertake step 3) below; publicly available 2) TDP application Submit application form, documentation Include private coverage information, receipts to date 3) EAP application MD submits to EAP ‐ At same time as TDP application ‐ MD should indicate TDP application in process 4) TDP approval ‐ Inform pharmacy and MD of TPD registration ‐ MD to f/u with EAP Supply TPD with paper receipts for expenditures b/t TDP application and approval timeframes REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. Comments EAP CRITERIA FOR REMICADE IN RA 20 For the treatment of rheumatoid arthritis in patients who have: Severe active disease (5 swollen joints and rheumatoid factor positive and/or radiographic evidence of rheumatoid arthritis) despite the optimal use of various formulary disease‐modifying anti‐rheumatic drugs (DMARDs)*. *Optimal use of DMARDs include: Methotrexate (20 mg/week) for at least 3 months and leflunomide (20 mg/day) for at least 3 months in addition to an adequate trial (3 months) of at least one combination of DMARDs; or, Methotrexate (20 mg/week) for at least 3 months and leflunomide in combination with methotrexate for at least 3 months. If the patient could not receive adequate trial(s) of methotrexate and/or leflunomide due to contraindication(s) or intolerance(s), the nature of contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale why other DMARDs cannot be considered. REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. C ASE 21 STUDY #1 FUNDED BIOLOGIC Scenario: Remicade for rheumatoid arthritis; high out of pocket drug costs Step Action Comments 1) Drug coverage Verify if product covered by OPDP Need to meet EAP criteria to undertake step 3) below; publicly available 2) TDP application Submit application form, documentation Include private coverage information, receipts to date 3) EAP application MD submits to EAP ‐ At same time as TDP application ‐ MD should indicate TDP application in process 4) TDP approval ‐ Inform pharmacy and MD of TPD Supply TPD with paper receipts for registration expenditures b/t TDP application and ‐ MD to f/u with EAP approval timeframes REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. C ASE 22 STUDY #2 UNFUNDED PRODUCT Scenario: Neulasta for chemotherapy‐induced neutropenia; high out of pocket drug costs Step Action Comments 1) Drug coverage Verify if product covered by ODB ODB “Unfunded drugs” list 2) Remaining options Continue with level of current coverage REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. C ASE 23 STUDY #3 NEW DRUG PRODUCT Scenario: Fycompa (perampanel) for partial onset seizures; high out of pocket drug costs Step Action Comments 1) Drug coverage Verify if product covered by ODB “Status of Single Source submissions“ list ‐ No funding decision as of Nov 25/13 2) TDP application Submit application form, documentation ‐ “On spec”; no guarantees ‐ must meet financial criteria for TDP ‐ submit out of pocket receipts for Fycompa so far (+ any other ODB‐covered drugs used in household) 3) EAP application MD submits to EAP ‐ At same time as TDP application ‐ “On spec”; no guarantees; will be held until funding decision is made ‐ will need to meet whatever clinical criteria are developed under EAP, if TDP approved REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. 24 F URTHER I NFORMATION ABOUT THE TDP http://www.health.gov.on.ca/en/public/programs/drugs/programs/od b/opdp_trillium.aspx TDP forms http://www.health.gov.on.ca/en/public/programs/drugs/opdp_forms.aspx Inquiries regarding the Trillium Drug Program should be directed to: P.O. Box 337, Station D Etobicoke, Ontario M9A 4X3 Tel : 416‐642‐3038 Fax : 416‐642‐3034 Toll‐Free : 1‐800‐575‐5386 E‐mail : trillium@ontariodrugbenefit.ca REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. 25 R EMEMBER - I MPORTANT FACTS ABOUT THE Applies to Ontario ONLY! not a drug program it is a financial assistance program based on financial need high out of pocket drug costs (independent of type of private plan) Provides access only to drugs already covered by ODB for their core recipients TDP ALSO ‐ need to meet the same clinical criteria (i.e., use of previous therapies) Patient must demonstrate out of pocket drug costs before applying to TDP REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. T HANKS ! J.L. GLENNIE CONSULTING INC. CONFIDENTIAL 26
