Download additional patient related benefits are the key to price

ADDITIONAL PATIENT RELATED BENEFITS ARE THE KEY TO
PRICE NEGOTIATION IN GERMANY – PRACTICAL EXPERIENCE
WITH BENEFIT DOSSIERS AND THE ASSESSMENT PROCESS
Dr. Olaf Pirk
Dec 15 2012
© 2012, Olaf Pirk Consult • 1
Agenda of today’s workshop
Along the process last years experience is presented by “process
ow ners”
Note: Pharmaceuticals that are already on the
market may also become subject of a benefit
assessment.
Ins titute for Quality
and Efficiency in
H ealth Care
Benefit assessment
Report
Commis s ion pos s ible
G-BA
Dr. Meriem Bouslouk
Market
launch
Additional
benefit
H earing
D os s ier
M anufacturer
Federal Joint
Committee (G BA)
Federal Joint
Committee (G BA)
Benefit
assessment
Benefit
assessment
GKV-SV
Sorry – n.a.
Dr. Olaf Pirk
(D ecis ion)
(internet Publication)
No additional
benefit
Manufacturer´ s
price
Reference price not pos s ible
FRP Reference
price
M anufacturer
AB
Prof. Dr.
Cost/benefit
Frank-Ulrich
Fricke
Decision
assessment
No
agreement
H ead as s ociation
of the
SH I s cheme
(G KV)
Rebate negotiations
Not
accepted
Arbitration Panel
Ins titute for Quality
and Efficiency in
H ealth Care
(e.g. bas ed
on international prices)
Agreement
Discounted
‘net’ price
D ecis ion
Retroactive
Discounted
‘net’ Price
Valid until the end of the
process
(s et freely)
Market launch
3 months
6 months
12 months
15 months
FRP = fixed reference price
© 2012, Olaf Pirk Consult • 2
1
Agenda of today’s workshop
After the presentations and your questions we plan to simulate a
hearing at the G-BA
Physicians
©
© 2012,
2012,Olaf
OlafPirk
PirkConsult•
Consult 3
•
Manufacturer (and others)
Your part
SHI
3
AMNOG – Benefit Assessment by
the G-BA
Dr Meriem Bouslouk
Desk Officer Pharmaceuticals Department
Federal Joint Committee (G-BA)
2
The Federal Joint Committee = The G-BA
Since 1 July 2012:
Mr Josef Hecken
Dr Regina Klakow-Franck
Dr Harald Deisler
5
The G-BA and its subcommittees
6
3
The early benefit assessment - Course
Publication
of the
dossier and
the
assessment
Submission
of the
dossier
Resolution
on the
benefit
6 months
3 months
3 months
Benefit assessment (proposal by
the IQWiG)
Hearing procedure and resolution
7
Zoomed in: Hearing procedure and resolution
Publication
of the
assessment
= Start of
the hearing
procedure
Resolution
on the
benefit
Oral
hearing
3 months
3 weeks
Written
statements
2-3 weeks
Overview of
the
statements
Analysis of the w ritten and oral
statements / decision making
8
4
Resolution in the plenary session
Plenum = decision-making body of the Federal Joint Committee
9
Resolution on the additional benefit
The extent of the additional benefit over the appropriate comparator
and the therapeutic importance of the additional benefit taking into
account the severity of the disease:
1) Major additional benefit--------------2) Considerable additional benefit
6) Non-quantifiable
3) Minor additional benefit--------------4) No additional benefit
5) Less benefit than the appropriate comparator
10
5
G-BA resolution
• Resolution is part of the Pharmaceutical Directive and includes:
• Additional benefit over appropriate comparator
• Number of patients
• Requirements for quality-assured administration
• Costs of treatment, also in comparison with the appropriate
comparator
…for each therapeutic indication
• Resolution is published on the website of the G-BA and in the
Federal Gazette.
• Resolution can be time-limited.
11
Appropriate comparator
•
Determined by the G-BA
•
Defined criteria (Chapter 5, section 6, Rules of procedure of the
G-BA)
•
Can be requested within a consultation with the G-BA
•
Advice by the G-BA upon request also on endpoints, patient
groups, AMNOG procedure, etc.
12
6
Consultations with the G-BA: course
Pharm aceutical
com pany
G-BA
Office
PEI
BfArM
(before phase 3)
Pharmaceuticals
Subcommittee
Consultation
Draft
minutes of
the meeting
Comments,
addendums
Final
minutes of
the
meeting
8 weeks
13
Example : Rilpivirine
Resolution: 5 July 2012
Indication: HIV 1 infection (combination therapy, treatment naïve patients)
Dossier: Major additional benefit
• (+) Neurological AE
• (+) Skin AE
IQWiG: Considerable additional benefit
• (+) Virological response (men)
• (+) Neurological AE
Hearing procedure: Importance of AE, virological response
(effect over time, gender?)
G-BA : Minor additional benefit
• (+) Neurological AE
14
7
Example: Vemurafenib
Resolution: 6 September 2012
Indication: unresectable or metastatic melanoma (BRAF V600 mutation-positive)
Dossier: Major additional benefit
• (+) Overall survival
IQWiG: Considerable additional benefit
• (+) Overall survival
• (−) Harm because of AE
Hearing procedure: AE manageable?
G-BA : Considerable additional benefit
• (+) Overall survival
• (+) AE significant, but manageable
15
Consequences of the G-BA resolution
•
Major, considerable, minor or non-quantifiable additional benefit
 Negotiations between SHI and pharmaceutical company
•
No additional benefit
 Negotiations, price then not higher than appropriate comparator
 Possible allocation to a reference price group?
 Cost-benefit analysis upon request of the company (€ and time!)
•
Benefit is less than benefit of the appropriate comparator
 Possible requirement of studies
 Possible exclusion from/restriction on reimbursement
16
8
www.g-ba.de
 [email protected]
The Negotiation Process with the National Association of
Statutory Health Insurance Funds (GKV-SV)
Dr. Olaf Pirk
Dec 15 2012
© 2012, Olaf Pirk Consult • 18
9
All new drugs will be freely priced at launch for max. 6 months;
drugs with additional benefit will have up to 12 months free
pricing
Ins titute for Quality
and Efficiency in
H ealth Care
GBA
Early assessment
period
Benefit assessment
Report
Commis s ion pos s ible
(Assessment for orphan
drugs with revenue
H earing
D os s ier
< 50 mill Euro (in 12 months) submit a
Federal Joint
M anufacturer
dossier
but do not need toCommittee
prove(Gadditional
BA)
benefit )
Market
launch
(Publication)
(D ecis ion)
No additional
benefit
No agreement Price fixed
by arbitration retroactive
to 1yr post launch
(s et freely)
3 months
M anufacturer
No
agreement
H ead as s ociation
of the
SH I s cheme
(G KV)
Not
accepted
Arbitration Panel
Ins titute for Quality
and Efficiency in
H ealth Care
Cost/benefit
assessment
Decision
Rebate negotiations
(e.g. bas ed
1. Max. reimbursed price determined
by prices)
fixed reference
on international
Reference price not
pos s ible group (no direct restrictions on MNF list price)
price
Agreement
D ecis ion
FB Reference
price
Market launch
+6 months
free pricing
Additional
benefit
Benefit
assessment
Manufacturer´ s
price
Agreement
Reimbursed at negotiated
discounted net price
Federal Joint
Committee (G BA)
Benefit
assessment
+6 months free
pricing
GKV-SV
Rebate
negotiation
2. If no FRP possible: price must not exceed annual
treatment costDiscounted
of comparator
Discounted
GKV-SV Rebate
Valid until the end of the
Retroactive
price
Price
process
negotiation (direct restriction)
6 months
12 months
* No assessment for drugs with GKV-revenue < 1 mill Euro in 12 months
15 months
GKV = SHI = Statutory Health Insurance; FRP= fixed
reference price; MNF = manufacturer
© 2012, Olaf Pirk Consult • 19
The Negotiation Process with the National Association of SHI
(GKV-SV) has started in January 2012
• GKV-SV will schedule the dates for the negotiation
• Negotiation language is German; interpreters allowed
• GKV-SV will host the meetings
• Length of one meeting is 4 hours
2
Month: 1
First meeting
within 4 weeks
after G-BA
decision
3
4
5
There are two further meetings planned,
between the first and the last meeting. Upon
agreement of parties another meeting is
possible: Meaning 4 are planned, 5 are possible
Negotiation
Each party is allowed
to send 5 participants
into negotiation; 2 in
addition are allowed
Upon agreement.
6
Last meeting
max. 3 weeks
prior to price
publication
Publication in
official price
list: Lauer Taxe
Negotiation
Guest of the national
association of private health
insurances; upon proposal he
is allowed to ask questions and
to talk if all parties agree.
Private health insurance has to
“agree” within 5 working days
after last negotiation date to
Rebate / reimbursement price.
© 2012, Olaf Pirk Consult • 20
10
The Negotiation process is fixed in the framework agreement
between Pharmacos and GKV-SV
• D os s ier modules 1 to 4 , the I Q WiG assessment
and the G - BA decision as published in the
internet are regular parts of the negotiation
proc es s
• Furthermore the P harmaco has to provide
− real drug prices for other European countries
− planned annual s ales according to patient
group
− c osts of c omparable drugs
• T he information has to be provided 5 working
days prior to the firs t negotiation date
• T he form of provis ion mus t be according to the
dos s ier as defined by G - BA
P arts of module 5 c an be us ed during
negotiation if parties agree on
− earliest in first meeting the information
needed from module 5 s hould be
dis cussed
C riteria for setting the reimbursement price
1 . D ec ision of G - BA regarding additional benefit
2 . Benefit as s essment inc luding the dos sier of
the pharmac o
3 . Real P rices of the drug in E uropean c ountries
4 . A nnual treatment costs of c omparable drugs
© 2012, Olaf Pirk Consult • 21
All Criteria to Set the Reimbursement Price are Known
Criteria on which the price
negotiation is based
(§ 130b SGB V)
Additional criteria which
might influence the price
negotiation if parties agree to
use in negotiation
• Outcome from the early benefit
assessment acc. § 35a SGB V
•
Extent of additional benefit: none,
minor, considerable, major, nonquantifiable.
•
Affected GKV-target population
•
Annual GKV-cost of product and
appropriate comparator in affected
target population
• Cost-benefit-analysis / cost-offset data
/ budget impact from GKV perspective
National
rebate
negotiation
• Data on compliance, persistence or
other patient-relevant outcomes
• …Others not yet considered?
• Real prices of the product in other
European countries
• Annual treatment costs of
comparable drugs
• Any data available on treatment
reality or product benefit which were
not selected for further analysis in
module 4
First negotiation has
started Jan 23 2012
Attention: Supportive data
should be already described in
the dossier and listed at least
in module 5
GKV = Statutory Health Insurance; SGB V = 5 th Book of Social Code
© 2012, Olaf Pirk Consult • 22
11
The basket of European reference price countries for price
negotiation is valid since March 2012
1 . A us tria
2 . Belgium
3 . C zec h Republic
4 . D enmark
5 . Finland
6 . Franc e
7 . G reec e
8 . I reland
9 . I taly
10 . N etherlands
11 . P ortugal
12 . Sweden
13 . Slovakia
14 . Spain
15 . U K
© 2012, Olaf Pirk Consult • 23
© Grafik: OPG, Presseagentur für Gesundheit
In the Rebate Negotiation the Price Will Be Set as Surplus on
the Price of the Appropriate Comparator
Additional benefit
Rebate negotiation
• Negotiation starts earliest 6 months after launch
• Price vs. comparator depends on different
criteria
• Discounted ‘net’ price will be published directly
in the price list (so called Lauer-Taxe); two prices
will be presented: list price and reimbursed price
Launch price
2
The surplus in € is then recalculated to a
rebate (percentage) on the original launch
price
1
The price range is set by
European reference prices as upper and
appropriate comparators price as lower
level
Negotiation in that range is based on the
extent of additional benefit, the comparable
prices and further data of module 5.
Publication in
official price
list: Lauer Taxe
%
€
European
reference
price
Appropriate
comparator
price
© 2012, Olaf Pirk Consult • 24
12
19.4% Rebate for Ticagrelor Will Replace 16% Manufacturers
Rebate
Ex factory Prices for DDD
€3.00
Ti ca grelor
€2.50
 0,15€
-19,4%
-16%  0,40€
Euro
€2.00
Cl opi dogrel
 0,08€
•
-3,4%
Basis of the negotiation result is
–
–
ex manufacturers price
100 tablet package á 90 mg at
124,00 ex manufacturer price
–
DDD
€1.50
Reduction
of
mandatory
rebate end
of
2013 to 6%
€1.00
€0.50
€-
old DDD
Clopidogrel ex manu. Price
Brilique ex manu. Price
old DDD old DDD 16%
6%
new DDD
DDD
manuf.
manuf. (generic)
- 19,4%
rebate
Rebate
€0.22
€2.48
€2.08
€2.00
DDD
(Iscover)
DDD
(Plavix)
€2.00
€2.01
•
•
DDD is 2 tablets: 2.48 €/day
Price reduction is from 2.48 to
2.00  new rebate 19.4%
•
Mandatory rebate was 16% on
the old price: 0,40€/DDD
€2.33
GKV-SV and AZ negotiated on basis of DDD and manufacturers price ist a price reduction of 0,48€
The contract is valid until end of 2014. Meaning, the real rebate is for 2012 – 2013: 3.4% (0,08€
based on daily costs). For 2014 the real rebate is: 13.4% (0,33€ based on daily costs).
First Price Negotiation for an Orphan Drug Resulted in a
“Stepwise” Rebate: -27%
Before negotiation: 98.90 €
Daily treatment costs (€)
-16%
Rebate in total: -27%
Before negotiation: 83.08 €
After negotiation: 72.20 €
C ompany did not negotiate on
replac ing the manufac turer‘s rebate
of 1 6 % : 1 1% are initially granted
on top!
When by law the manufac turer‘s
rebate is reduc ed c ompany will
additionally grant this 16%!
Source: GKV SV; APU=ex-manufacturer price
© 2012, Olaf Pirk Consult • 26
13
Status of negotiations so far: 13 rebated prices
• 11 prices by direct negotiation
• 1 by agreement prior to arbitration decision
• 1 by arbitration decision
A dditional Benef it
M C M (N Q )
M C M (N Q )
Rebat e
• 4 „opt outs“
© 2012, Olaf Pirk Consult • 27
Zentrum für Gesundheitsökonomie Neumarkt
Prof. Dr. Frank-Ulrich Fricke
If the negotiation with the GKV-SV fails it will start
THE ARBITRATION PROCESS
Seite 28
14
Zentrum für Gesundheitsökonomie Neumarkt
Prof. Dr. Frank-Ulrich Fricke
§ 130b (5) SGB V
Der Spitzenverband Bund der Krankenkassen und die für die Wahrnehmung der wirtschaftlichen Interessen gebildeten maßgeblichen
Spitzenorganisationen der pharmazeutischen Unternehmer auf Bundes ebene bilden eine gemeinsame Schiedsstelle. Sie besteht aus einem
unparteiischen Vorsitzenden und zwei weiteren unparteiischen Mitgliedern
sowie aus jeweils zwei Vertretern der Vertragsparteien nach Absatz 1. Die
Patientenorganisationen nach § 140f können beratend an den Sitzungen
der Schiedsstelle teilnehmen. Über den Vorsitzenden und die zwei weiteren
unparteiischen Mitglieder sowie deren Stellvertreter sollen sich die
Verbände nach Satz 1 einigen. Kommt eine Einigung nicht zustande, gilt §
89 Absatz 3 Satz 4 und 5 entsprechend.
Seite 29
Center for Health Economics
Prof. Dr. Frank-Ulrich Fricke
The Independent Members of the Arbitration Board
Independent
Chairman
Independent Member
Industry Associations
Independent Member
SHI
Dr. Manfred Zipperer
Dr. Jörg Ludwig Pfletschinger
Dr. Herbert Reichelt
Deputies
Deputies
Deputies
Gerhard Schulte
Erika Behnsen
Dr. Ottfried Zierenberg
Prof. Dr. Frank-Ulrich Fricke
Dr. Leonhard Hansen
Prof. Dr. Eckart Fiedler
Seite 30
15
Center for Health Economics
Prof. Dr. Frank-Ulrich Fricke
Members of the Arbitration Board for Compound-specific
Arbitrations
2 Vertreter
2 representatives
of the
Herstellermanufacturer
unternehmen
2 Vertreter
representatives
GKV-SpV
of the SHI
Arbitration
Schiedsstelle
panel
(7 Mitglieder)
(7 members)
3 impartial
3 unparteiische
members
MItglieder
Seite 31
Center for Health Economics
Prof. Dr. Frank-Ulrich Fricke
Objectives of the Arbitration Process
n Definition of an appropriate reimbursement price valid as of month 13
after market introduction
n Arbitration between the parties (manufacturer/ head association of the
SHI) and their conflicting positions
Seite 32
16
Center for Health Economics
Prof. Dr. Frank-Ulrich Fricke
Initiation of the Arbitration Process
n Application by the parties
n Based on the dossier and the evidence submitted with the application
n Additional evidence can be requested by the arbitration board
Seite 33
Center for Health Economics
Prof. Dr. Frank-Ulrich Fricke
Criteria for the Arbitration Board
Without Additional Benefit
n Reimbursement price is subject
to § 130b (3) SGB V (annual
treatment cost of the
appropriate comparator)
n (no reset of the appropriate
comparator)
n (no re-assessment of the
additional benefit)
With Additional Benefit
Additional benefit as defined by
the G-BA
annual treatment cost of the
appropriate comparator
Prices of comparable drugs
European reference prices
Seite 34
17
Center for Health Economics
Prof. Dr. Frank-Ulrich Fricke
Character of the Procedure
Arbitration is based on applications and collateral evidence
If the parties agree during the arbitration process the arbiration ceases
Otherwise the board tries to understand the conflicting positions and
comes up with an arbitration based on the criteria mentioned above
The arbitration is not another negotiation
Seite 35
Summary
AMNOG in a nutshell
• Since the beginning of 2011, each NCE must be supported by a
benefit dossier defining the additional benefit of the drug in relation
to the appropriate comparator.
• If a benefit is shown, the new reimbursed price after one year on the
market w ill be a surplus on the reimbursed comparator price,
according to the additional benefit. If no additional benefit is shown,
the reimbursed price after one year may not be higher than that of
the appropriate comparator.
© 2012, Olaf Pirk Consult • 36
18
Summary
AMNOG in a nutshell
• The decision is based on a dossier submitted by the manufacturer,
which draws on all the available clinical trials.
• An incomplete dossier means no additional benefit is shown, in
w hich case the reimbursement price will be set and/or negotiated by
the head association of the sick funds.
• If the negotiation fails, an arbitration body will determine the
reimbursed price on the basis of international reference prices. No
health economic data are requested during the entire process. The
negotiation is based on the drug price accruing for the sick funds
plus extra costs, based on additional resources used as mentioned in
the physician’s information leaflet.
© 2012, Olaf Pirk Consult • 37
Interactive: The Hearing
Physicians
Manufacturer (and others)
Your part
SHI
©
© 2012,
2012,Olaf
OlafPirk
PirkConsult•
Consult 38
• 38
19
Interactive: Hearing at the G-BA Subcommittee Drugs
You are the main actors in this hearing
• You act as the follow ing stakeholder with following aim
− GKV-SV (SHI representative)
no new budget impact
− SHI accredited physician
no money to waste for drugs, but
more money for physicians‘ services
− Hospital physician
no money to waste for drugs, but
more money for hospitals‘ services
− Patients‘ representative
safe and highly efficient drugs at
low prices
− Manufacturer of new drug
show the high additional benefit
− Other Manufacturer
support or fight the comparator
© 2012, Olaf Pirk Consult • 39
Interactive: Hearing at the G-BA Subcommittee on Drugs
The case: Dolorex®, a new drug against headache
• Pivotal study against placebo showed
− 50% pain relief within 30 minutes lasting for 24 hours
− Qol increase by 50%
− Adverse events are minor with exemption of an enormous foot
perspiration lasting 24 hours
• Appropriate comparator was named as aspirin
− Indirect comparison showed a 10% pain relief
• IQWiG proposed a clue for minor benefit regarding pain that is
outweighed by the additional harm by the adverse events:
no additional benefit
© 2012, Olaf Pirk Consult • 40
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