REPRODUCTION REQUIRES PERMISSION OFJ.L. GLENNIECONSULTINGINC. 1
U
NDERSTANDING THE
T
RILLIUM
D
RUG
P
ROGRAM
O
BJECTIVES
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
D
ISCLAIMER
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. GLENNIECONSULTINGINC. CONFIDENTIAL
F
IRST
- I
MPORTANT
F
ACTS ABOUT
THE
TDP
Applies
to
Ontario
ONLY!
Not
a
drug
program
it
is
a
financial
assistance
program
based
on
financial
need
high
out
of
drug
costs
(+/
‐
private
plan
or
type
of
plan)
Provides
access
only
to
drugs
already
covered by
ODB
for
their
core
recipients
ALSO
‐
need
to
meet
the
same
clinical
criteria
(i.e.,
use
of
previous
therapies)
Patient
must
demonstrate
out
of
drug
costs
S
O
,
WHERE DOES
TDP
FIT
?
OPDP – T
HE
B
IG
P
ICTURE
Trillium Drug Program
6
The OPDP includes
one major, several smaller drug programs (for special patient populations), and the TDP for financial
assistance.
ON
Drug
Benefit
(ODB)
Program
New Drug Funding Program Special Drugs Program Visudyne Program
Inherited Metabolic Diseases
Program
RSV Program for Infants
+
D
RUG COVERAGE WITH
TDP
ODB
Program
ODB
Formulary
General
Benefit Limited Use
Conditional Listing
EAP
REPRODUCTION REQUIRES PERMISSION OFJ.L. GLENNIECONSULTINGINC.
7
S
COPE OF
F
UNDING
HC
APPROVALS VS
. ODB F
UNDING
22,000+
3,200+
8
NOTE:
Not
all
marketed
drugs
are
covered
by
A
PPLYING FOR
TDP
B
ACKGROUND ON THE
TDP
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
H
OW TO TELL IF A PRODUCT
IS FUNDED BY
ODB
1)
Search
the
ODB
e
‐
formulary
• http://www.health.gov.on.ca/en/pro/programs/drugs/odbf_eformulary.aspx
2)
Check
the
EAP
list/reimbursement
criteria
(i.e.,
prior
authorization
system)
• http://www.health.gov.on.ca/english/providers/program/drugs/eap_criteria_list.ht
ml
3)
Check
the
drug
submission
status
reports
• http://www.health.gov.on.ca/english/providers/program/drugs/status_single_sourc
e_subm.html
4)
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 OFJ.L. GLENNIECONSULTINGINC.
E
LIGIBILITY
R
ULES
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 ORprivate insurance does not cover 100% of prescription drug costs
AND
- householddrug 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
A
M
I E
LIGIBLE FOR
TDP?
“B
ACK 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. GLENNIECONSULTINGINC. CONFIDENTIAL
TDP A
PPLICATION
P
ROCESS
(1)
FIRST:
See
TPD
brochure
and
application
form
(on
‐
line)
Annual,
paper
‐
based
application
process
Approval
based
on
out
‐
of
‐
drug
expenditures
4%
of
household
net
income
(“deductible”)
Expenditures
must
occur
before TDP
application
will
be
considered
Full
disclosure
of
private
insurance
coverage
information
TDP A
PPLICATION
P
ROCESS
(2)
Review
by
TDP
Approval
notification
from
TPD
Informed
of
quarterly
deductible
On
‐
line
adjudication
process
once
approved
Still
have
out
of
costs
until
TDP
deductible
reached
REPRODUCTION REQUIRES PERMISSION OFJ.L. GLENNIECONSULTINGINC.
P
OTENTIAL PHARMACY LEVEL SCENARIO
FOR A PRIVATELY
I
NSURED PATIENT
TDP eligibility approved Patient takes Rx to Pharmacy Pharmacy adjudicates via private insurer Pharmacy adjudicates balance via TDP 16
C
ASES
S
TUDIES
T
YPES 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)
18C
ASE STUDY
#1
FUNDED BIOLOGIC
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 registration
‐ MD to f/u with EAP
Supply TPD with paper receipts for expenditures b/t TDP application and approval timeframes
REPRODUCTION REQUIRES PERMISSION OFJ.L. GLENNIECONSULTINGINC.
19
EAP
CRITERIA FOR REMICADE IN
RA
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.
C
ASE STUDY
#1
FUNDED BIOLOGIC
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 registration
‐MD to f/u with EAP
Supply TPD with paper receipts for expenditures b/t TDP application and approval timeframes
REPRODUCTION REQUIRES PERMISSION OFJ.L. GLENNIECONSULTINGINC.
21
C
ASE STUDY
#2
UNFUNDED PRODUCT
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
22
C
ASE STUDY
#3
NEW DRUG PRODUCT
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 OFJ.L. GLENNIECONSULTINGINC.
23
F
URTHER
I
NFORMATION ABOUT THE
TDP
http://www.health.gov.on.ca/en/public/programs/drugs/programs/odb/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 : [email protected] 24
R
EMEMBER
- I
MPORTANT
F
ACTS ABOUT THE
TDP
Applies
to
Ontario
ONLY!
not
a
drug
program
it
is
a
financial
assistance
program
based
on
financial
need
high
out
of
drug
costs
(independent
of
type
of
private
plan)
Provides
access
only
to
drugs
already
covered by
ODB
for
their
core
recipients
ALSO
‐
need
to
meet
the
same
clinical
criteria
(i.e.,
use
of
previous
therapies)
Patient
must
demonstrate
out
of
drug
costs
before applying
to
TDP
REPRODUCTION REQUIRES PERMISSION OFJ.L. GLENNIECONSULTINGINC.
