Download OReilly Susan O Reilly

NATIONAL CANCER CONTROL PROGRAMME’S
APPROACH TO CANCER DRUGS IN IRELAND
Dr Susan O’Reilly MB, FRCPC, FRCPI
National Director
National Cancer Control Programme
IPHA Annual Meeting
29th Nov 2012
Caption: Dublin Bay 2011. Photo courtesy of David
Branigan, Oceansport
National Cancer Drug Management
The Challenges:
•
•
•
•
•
•
•
Oral drugs: PCRS ≥ 50% of expenditure.
Parenteral drugs: Individual hospitals.
Overall “spend” ≥ €150m - €200m per annum.
Growth rate: 18% per annum in hospitals.
New drugs > €45,000/QALY.
Patients increase by 5% per annum.
National financial situation.
National Cancer Drug Management
• Gradual implementation of central funding for
high cost drugs 2013 onwards.
• Protocols/Order Sets/Patient information.
• Registration by diagnosis.
• Financial/reimbursement process in planning.
• NCCP Technology Review Committee, March
2011.
Membership of NCCP Technology
Review Committee
• A minimum of three members recommended by relevant
professional society, faculty or college, who have content
experience in the specific discipline and are approved by the NCCP
Director. (e.g. Medical Oncology, Haematology, Radiation Oncology
and Surgical Oncology)
• A minimum of one Pharmacist.
• A minimum of one member with Health Economics,
Pharmacoeconomics or statistics and epidemiology expertise.
• A minimum of one invited participant from a related clinical discipline
(e.g. Pathology or Radiology).
• One representative appointed by HIQA
• Up to three additional members may be appointed.
Drug Expenditure
Oncology Drug Expenditure 2011
National Totals
RITUXIMAB (Mabthera)
10,601,696
BORTEZOMIB (Velcade)
5,793,562
PEMETREXED(Alimta)
3,239,492
PANITUMUMAB(Vectibix)
1,781,965
BEVACIZUMAB (Avastin)
6,402,944
CETUXIMAB (Erbitux)
4,555,272
AZACITIDINE (Vidaza)
2,549,465
TRASTUZUMAB (HERCEPTIN)
16,447,077
TOTAL
€
51,371,474
To end May 2012
5,496,648
2,723,860
1,486,738
1,118,853
3,091,009
2,237,859
1,420,288
8,478,547
€
26,053,801
Projected (for these 8 drugs)
€
62,529,122
Ipilimumab YTD (Oct.)
€
3,000,000
Summary of Process for New Medicines (or new treatment indications)
with budget impacts: 2012
New Medicine Marketed:
Company applies for pricing &/or
reimbursement
Clinical Guidelines
Company
Submission
Price Negotiations (CPU)
NCCP Technology
Review Committee
Clinical Strategy &
Programmes
NCPE
Pharmacoeconomic
Report (RR or HTA)
Inputs to decision making
•Clinical effectiveness
•Cost effectiveness
•Severity of disease
•Unmet needs
•Policy considerations
•Funding available
•Other funding priorities
•PRICE NEGOTIATION etc, etc
Input from
Clinicians
(on request from
HSE)
Company
Submission
NCPE
Pharmacoeconomic
Report
HSE Drugs Group
Prioritisation
Process
Funding
Decision
Administrative process
Input into decision /
recommendation making
Output is a
Recommendation
Ultimate
Decision
HSE Medications Management
2013 onwards
• Hospital and PCRS drugs.
• Medicines Management Programme.
• Health Technology Assessment
– new drugs
• Existing Drugs Assessment.
• Prescribing Guidance
– tools & education
• Quality/Risk oversight.
• Industry Liason.
• Analysis and Audit.
HSE Drugs
• Legislation in progess
- low cost alternatives
- Delisting
• 2012 IPHA Agreement.
Drugs which have been considered
by NCCP Technology Review
Committee:
• Oncotype DX – Approved
• Ipilimumab – Approved
• Abiraterone – Approved. Available 01/12/12.
• Cabazitaxel – Reviewed. Discussions ongoing.
Drugs which are due to be
considered by the Committee:
Drugs HTA required
Company
Tumour
Bendamustine (Levact)
SymBio Pharmaceuticals /
Cephalon
Chronic lymphocytic leukemias & lymphomas.
Eribulin (Halaven)
Eisai Inc
Metastatic breast cancer
Everolimus (Votubia)
Novartis Oncology
SEGA - Sub Ependymal Giant Cell Astrocytoma
Mifamurtide (Mepact)
Takeda
Osteosarcoma
Catumaxomab (Removab)
Trion Pharma
Malignant ascites
Femtelle test
American Diagnostica GmbH
Breast cancer
Vemurafinib (Zelboraf)
Roche
Metastatic Melanoma
Teysuno (S1)
Taiho Pharmaceutical Co
Gastric Cancer
Brentuximab
Takeda
Hodgkin lymphoma & ALCL (systemic anaplastic large cell
lymphoma).
Ruxolitinib (Jakavi)
Novartis
Splenomegaly or disease-related symptoms in myelofibrosis
Axitinib (Inlyta)
Pfizer
Renal Cell carcinoma
Essential Components of a
Successful Approval Process
Strive to achieve and maintain:
• Ethical (principle of reasonable fairness across patient
groups).
• Evidence-based.
• Clinically favorable balance of benefit versus toxicity.
• Consensus development re threshold of costeffectiveness.
Essential Components of a
Successful Approval Process
• Health Economics.
• Affordable (total budget impact).
• Accessible (by expert tumours site groups and
industry).
• Timely.
• Transparent multidisciplinary process.
• Stakeholder involvement.
Implementation Principles
• Education/information for doctors/patients.
• Universal access for eligible patients.
• Compliance with standards.
• Drug utilisation monitoring.
• Periodic evaluation and population-based outcomes.
Treatment Support
• Chemotherapy Protocols.
• Pre-printed doctors’ orders.
• Patient education handouts.
• Cancer Management Guidelines.
• Systemic Therapy Policies (standards and safety for
patients and staff).
Education & Research
•
•
•
Foster the culture of clinical research
participation and innovation across
professional disciplines and services.
Collaborate with professional Colleges and
Universities to support continuous professional
education.
Develop primary care skills in prevention,
diagnosis, care and follow up to facilitate safe,
high quality care in the community.
IPHA Agreement 2012
• The agreement provides for agreed principles and policies for the
reimbursement of new medicines in Ireland. In the case where a
product requires a pharmacoeconomic assessment the QALY
threshold to be used in the HTA process will be €45,000. Those
products which satisfy the HTA criteria (including meeting the
€45,000 QALY criterion) as agreed with the HTA Authority prior to
submission of application will be added to the relevant
reimbursement scheme.
• However, the agreement provides that exceptional products, which
fail to satisfy the €45,000 QALY threshold for a variety of reasons,
may be processed for inclusion in the reimbursement list subject to
meaningful discussions between the HSE, DOH, relevant clinicians
and the Drug Company.
National Plan for Medical Oncology
In development 2011 onwards:
•
Multidisciplinary human resource planning.
•
Evidence-based national guidelines, treatment protocols.
•
Baseline assessment of drug safety processes 2012/13.
•
Quality and safety policies for safe drug delivery.
•
NCCP Technology Review Committee for oncology drugs
and related molecular tests implemented March 2011.
•
National oncology drug budget planned for 2013.
•
NCCP Chief Pharmacist appointment, Jan 2013.
National Tumour Groups
Initiated May 2011:
Gastrointestinal
Breast
Genitourinary
Lung
Gynaecology
Role:
Development and promulgation of site-specific, evidence-based
multidisciplinary clinical practice guidelines.
– Adopt
– Adapt
– Innovate
Initial leadership representatives from:
Surgery
Related experts e.g.
Medical Oncology
- Respirology
Radiation Oncology
- Gastroenterology
Pathology
Diagnostic Imaging
BC Provincial Oncology Drug Budget
$200,000
$180,000
In ’ 000s (C dn $)
$160,000
$140,000
$120,000
$100,000
$80,000
$60,000
$40,000
$20,000
$0
"000s (Cdn $)
% growth
02/03
03/04
04/05
05/06
06/07
07/08
08/09
09/10
10/11
11/12
57,263
62,061
74,218
90,560
100,032
114,032
130,032
151,032
173,932
198,932
16%
8%
20%
22%
10%
14%
14%
15%
15%
14%
BC Patients Receiving Drug
Treatment
35,000
30,000
25,000
20,000
15,000
10,000
5,000
0
00/01
01/02
02/03
03/04
04/05
05/06
06/07
07/08
08/09
09/10
10/11
# of patient
20,499
23,460
24,332
25,237
26,411
28,013
29,442
30,209
31,591
32,765
33,512
% grow th
5%
14%
4%
4%
5%
6%
5%
3%
5%
4%
2%
2010/11 Top 10 Oncology Drug Costs
Bevacizumab (Avastin®)
Imatinib (Gleevec®)
5.8%
Oxaliplatin (Eloxatin®)
7.7%
LHRH agonists
5.3%
Bortezomib (Velcade®)
8.8%
4.4%
Docetaxel (Taxotere®)
3.9%
Lenalidomide (Revlimid®)
9.5%
Aromatase Inhibitors
3.8%
Trastuzumab (Herceptin®)
10.6%
Rituximab (Rituxan®)
11.4%
Other
28.8%
Costs of Drugs by Tumour Group
$50,000,000
$45,000,000
Costof drugs by Tumour Group
$40,000,000
$35,000,000
$30,000,000
$25,000,000
$20,000,000
$15,000,000
$10,000,000
$5,000,000
$0
Head &
Neck
Leukemia
& BMT
2003-04 11,804,704 1,305,178 9,095,434 14,366,067 2,752,122
239,774
2004-05 14,416,488 2,386,711 10,825,41015,715,706 2,495,067
281,578
2005-06 24,575,727 2,725,711 15,377,38516,037,222 2,154,815
334,868
2006-07 33,414,710 2,938,326 21,391,58716,603,008 1,570,074
Breast
CNS
GI
GU
Gyne
Lung
Lymphom
Pediatrics
a
Sarcoma
Skin
5,074,598 1,473,829 11,512,044 737,179
1,023,086
303,897
7,800,070 2,672,137 15,998,300 748,351
1,192,464
423,873
9,016,095 3,697,258 16,797,906 883,065
1,414,396
600,149
421,243 10,111,421 4,476,915 18,415,893 454,220
1,621,633
660,563
2007-08 31,722,802 3,627,433 18,021,01817,656,974 1,908,933
534,535 12,398,696 4,981,153 19,949,404 1,623,441 2,761,948
346,294
2008-09 32,804,881 3,780,017 24,150,92119,421,849 2,142,629
947,096 14,691,005 5,913,745 22,218,509 2,246,688 3,582,753
423,081
2009-10 33,828,115 3,131,763 28,965,66420,747,111 2,132,351 1,452,565 13,923,736 7,176,725 37,801,260 1,815,376 3,997,065
504,802
2010-11 34,428,395 3,714,541 32,155,72522,158,074 1,925,894 1,594,156 18,719,094 7,268,966 44,603,078 1,807,354 4,127,241
704,187
No of Patients receiving Drug Treatment by
Tumour Group
16,000
14,000
# of Patients Receiving Drug Treatment by Tumour
Group
12,000
10,000
8,000
6,000
4,000
2,000
0
Leuke
Head &
mia &
Neck
BMT
Lung
Lymph Pediatri Sarco
oma
cs
ma
Skin
911
987
2,815
276
133
110
303
1,345
1,422
4,018
221
165
163
1,010
368
1,308
1,601
3,186
252
222
306
6,990
1,021
387
1,306
1,516
3,249
182
222
296
2,867
7,283
973
456
2,019
1,341
2,758
321
296
158
460
3,201
7,718
1,048
514
2,350
1,501
2,825
356
243
127
2009-10 13,875
495
3,537
7,635
1,253
769
2,006
1,673
3,589
306
286
143
2010-11 13,960
509
3,545
7,973
1,234
800
2,279
1,612
3,395
301
298
150
Breast
CNS
GI
GU
Gyne
9,661
298
2,160
5,854
799
189
2004-05 11,150
410
2,503
6,603
929
2005-06 11,913
468
2,860
6,704
2006-07 12,675
477
2,975
2007-08 12,906
466
2008-09 13,924
2003-04
Average Cost per Patient per year
by Tumour Group
$16,000
Cost per patient by tumour group (in $)
$14,000
$12,000
$10,000
$8,000
$6,000
$4,000
$2,000
$Breast
CNS
GI
GU
Gyne
Head &
Neck
Leukemia
& BMT
Lung
Lymphom
Pediatrics Sarcoma
a
2003-04
$1,222
$4,380
$4,211
$2,454
$3,444
$1,269
$5,570
$1,493
$4,090
$2,671
$7,692
$2,763
2004-05
$1,293
$5,821
$4,325
$2,380
$2,686
$929
$5,799
$1,879
$3,982
$3,386
$7,227
$2,600
2005-06
$2,063
$5,824
$5,377
$2,392
$2,133
$910
$6,893
$2,309
$5,272
$3,504
$6,371
$1,961
2006-07
$2,636
$6,160
$7,190
$2,375
$1,538
$1,088
$7,742
$2,953
$5,668
$2,496
$7,305
$2,232
2007-08
$2,458
$7,784
$6,286
$2,424
$1,962
$1,172
$6,141
$3,715
$7,233
$5,057
$9,331
$2,192
2008-09
$2,356
$8,217
$7,545
$2,516
$2,044
$1,843
$6,251
$3,940
$7,865
$6,311
$14,744
$3,331
2009-10
$2,438
$6,327
$8,189
$2,717
$1,702
$1,889
$6,941
$4,290
$10,533
$5,933
$13,976
$3,530
2010-11
$2,466
$7,298
$9,071
$2,779
$1,561
$1,993
$8,214
$4,509
$13,138
$6,004
$13,850
$4,695
Skin
Number of new invasive cases (1995 to 2008) [solid
line] with projected numbers to 2035
Age standardised survival at 5 years for cancers diagnosed in
2000 - 2002 (all), 2002 - 2006 (Ireland)
and 2005 – 2007 (others)
Source: Irish data NCRI 2008 & international data Lancet 2010
Irish cancer survival can
improve by up to 10% if we
successfully implement
well-organised cancer
control systems.
Critical Success Factors
•
•
•
•
•
Population-based screening.
Early diagnosis/Stage Shift.
Multidisciplinary Teams.
High Volume/Expert Centred.
National Standards/Guidelines/Protocols/policies/
Processes.
And……..
• Doctors and Specialist Nurses.
• Allied Health Professionals.
• Tools of the trade:
–
–
–
–
–
Diagnostics
Theatres
Ambulatory/Inpatient resources
LINACS
Drugs
Conclusion :
Canadian Rockies, March 2009
It takes a team to get to the top!