Mansoor A Khan BS MS BCOP Senior Clinical Pharmacist OncologyHematologyBMT King Abdulaziz Medical City Jeddah Ministry of National Guard Health Affairs SOPA Meeting on September 14 2019 in Crown Plaza Hotel Riyadh KSA ID: 918009
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Slide1
Cost Impact Of Biosimiliars in Oncology
Mansoor A Khan, BS, MS, BCOP
Senior Clinical Pharmacist Oncology/Hematology/BMTKing Abdulaziz Medical City, JeddahMinistry of National Guard Health Affairs
SOPA Meeting on September 14, 2019in Crown Plaza Hotel Riyadh, KSA
Slide2Objectives
Describe the Pharmacoeconomic impact of substituting the most expensive oncology biologics with their approved biosimiliars in KSA and MN-GHA formulary with examples of trastuzumab, bevacizumab and rituximab
Describe pharmacoeconomic impact of biosimiliar filgrastim at MN-GHA-JeddahShare the results of comparative study of Biosimilar Filgrastim with Originator Fligrastim for Peripheral Blood Stem Cells Mobilization and Collection of CD34+ Stem Cells and Engraftment in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation at KAMC-WRDiscuss the challenges faced by biosimiliars on the eve of second generation biologics by innovators2
Slide3Why integrating Biosimiliars into Oncology Practice is necessary: A cost saving impact?
Biologics are significant drivers of globally escalating healthcare costs. It is estimated that global market for biologics will reach $ 66.4 billions in 2019Biosimiliars have potential to offer cost savings with comparable efficacy and safety to innovator products and increase the access of treatment to more patients.
3Pere Gascon. The evolving role of Biosimiliar in haematology–oncology: a practical perspective. 2015, Vol. 6(6) 267– 281Campen CJ. Integrating Biosimiliars Into Oncology Practice: Implications for the advanced practitioner. J Adv Pract Oncol. Volume 8 No 7. Nov/Dec 2017
Slide4Pharmacoeconomic evaluation of Biosimiliarsin Oncology Hematology
Analytic tools to determine Pharmacoeconomic value of Biosimiliar are opportunity cost, cost effectiveness and cost minimization analyses.Cost minimizations analyses should be used when comparing one Biosimiliar to originator considering they have same efficacy and safety.
4Henry D and Taylor C. Seminars in Oncology, Vol 41,No2,Suppl3,April2014
Slide5Cancer Incidence report Saudi Arabia 2015
5
Slide6GDP/GNI Per Capita Income
country
GNI PPP US$ in 2016GDP PPP US$ in 2016UAE72,850111,066USA
58,00052,194UK
42,100
41,602
Canada
42,346
35,256
France
42,380
30,049
Kingdom of Saudi Arabia
55,760
21,395
NHS threshold ICER for drugs
approval
------
£20,000 to £30,000 per QALY gained.
26,157 USD to 39, 236 US
$
per QALY gained
What’s Threshold ICER for KSA
------
Unknown:
Perhaps
? < 21000 US
$
/
Qaly
gained (78,750 SR/
Qaly
gained)
6
Slide7Cost-effectiveness analysis
Compare two or more independent therapies
Incremental cost-effectiveness ratio (ICER)aDecision rule:Choose the new technology if
7
Slide8Pertuzumab + Trastuzumab use in Adjuvant breast cancer setting in KSA
Categories
Compared Chemotherapy + trastuzumab + pertuzumab q3 weeks Vs Chemotherapy + trastuzumab (APHINITY Trial)
EfficacyAfter a median follow-up of 45.4 months, the proportion of IDFS events in the intent-to-treat population was 7.1% (n=171) in the pertuzumab arm and 8.7% (n=210) for those receiving placebo (HR 0.82; 95% CI: 0.67, 1.00; p=0.047).
ICER/QALY
427,
104
SR per patient for a marginal risk reduction in
recurrence
costing
107 million
SR per 250 patients for
clinically no meaningful outcome
Cost effectiveness
Its not cost effective and rejected by MN-GHA as its
GDP X 5.5
KSA
ICER is approximately
427,000 SR/QALY gained.
Threshold for approval is roughly 78,000/QALY
gained. Need to negotiate with company to reduce the cost to be cost effective in KSA.
8
N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5
Slide9Trastuzumab without Pertuzumab use in Adjuvant breast cancer setting in KSA
Categories
Compared Chemotherapy + trastuzumab + pertuzumab q3 weeks Vs Chemotherapy + trastuzumab (APHINITY Trial)
EfficacyAfter a median follow-up of 45.4 months, the proportion of IDFS events in the intent-to-treat population was 7.1% (n=171) in the pertuzumab arm and 8.7% (n=210) for those receiving placebo (HR 0.82; 95% CI: 0.67, 1.00; p=0.047).
ICER/QALY
146,952
SR per patient for comparable
risk reduction in
recurrence
costing
36.7 million SR
per 250 patients for
clinically meaningful outcome compared to
107 million SR
when Trastuzumab is used without pertuzumab.
Cost effectiveness
Trastuzumab monotherapy
is cost effective compared to combination of Trastuzumab and Pertuzumab in the adjuvant setting but its still
GDP X2
KSA
ICER is approximately
146,952 SR/QALY gained.
Threshold for approval is roughly 78,000/QALY
gained. Need to negotiate with company to reduce the cost to be cost effective in KSA.
Substitution of Trastuzumab with biosimiliar trastuzumab will result in ICER of 73,000 SR/QALY which is
GDP X1
9
N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5
Slide10Cost Impact of approval of Trastuzumab biosimiliar in the Kingdom
Total number of breast cancer patients in KSA = 2000
25% breast cancer patients are Her2neu positive and need TrastuzumabCost of 1 patient receiving trastuzumab per year =
125,062 SR in adjuvant setting when used alone
Yearly cost is 62.5 million SAR for 500 patients
Expected saving by approving biosimiliar Trastuzumab in the Kingdom will be nearly
30
million SAR with a GDP X 0.8
10
Slide11Annual Oncology Expenditures: Formulary Drugs Only at MNGHA, KSA11
Slide12Annual Expenditures of the Top 10 Expensive Formulary drugs in 2016 at MNGHA, KSA
12
Slide13Expected expenditures of 3 biologics (Trastuzumab, Rituximab and Bevacizumab) in 2019
Biologics
Expenditures in 2016Expenditures in 2019 (30% increase)Trastuzumab20.78 million SAR27 million SARRituximab18.07 million SAR
23.5 million SARBevacizumab11.24 million SAR14.6 million SAR
Total
65 million SAR
13
Slide14Cost Impact of adding biosimiliars of 3 biologics (Trastuzumab, Rituximab and Bevacizumab) in MNGHA formulary
Expenditures of 3 biologics in 2019
65 million SARExpected discount from Innovators after the addition of Biosimiliars30%Expected discount from Biosimiliars after discounted price of Innovators20%Expected new expenditures after the addition of Biosimiliars32.5 million SAR (50% decrease)
Cost saving impact of addition of Biosimiliars into MNGHA formulary32.5 million SAR
14
Slide1515
Practical example of Filgrastim Biosimilar use in MNGHA and its cost impact
Slide16Colony-Stimulating factors (CSFs) productsGranulocyte colony stimulating factor (G-CSF)
Filgrastim (Neupogen) 300 mcg/mlFilgrastim (Zarzio
) 300 mcg/0.5 ml (Biosimiliar)Peg-filgrastim (Neulasta)Dose: 6 mg Subcut once/chemotherapy cycle (long acting) 16
Slide172006 ASCO recommendationsPrimary Prophylaxis:
Clinical trial data support the use of CSF when the risk of FN is in the range of 20% or higherIn patients who have a high risk of FN regardless the incidence of FNFor “dose dense” regimens CSFs are required and recommended
17
Slide18Biosimiliar Filgrastim (Zarzio) was added in February 2014.Price of Neupogen brand was 450 SAR/ vial before addition of Zarzio which was reduced to 225 SAR after biosimiliar was added into MNGHA formulary
18
Name of GCSFUnit Price (SAR)Consumption/year in MNGHA, KSACost/year (SAR)Filgrastim 300 mcg/ml (Neupogen)
2257,898 Injections (23%)1,777,050
Filgrastim
300 mcg/ml (Zarzio) BS
96
26,908 Injections (77%)
2,583,168
Total= 34,806 Injections
4,360,218
Cost Impact of addition of Biosimilar
GCSF in the formulary
Slide19Cost Impact of addition of BiosimilarGCSF in the formularyAnnual consumption of filgrastim 300 mcg injection is
34,806 Injections at all the regions of MNGHA, KSA 19
Cost of Brand Neupogen (SAR)/yearCost saving by using biosimiliar GCSFCost of Brand Neupogen using current price of 225 SAR/injection34,806 X 225 = 7.83 millions7.83 million- 4.36 million =
3.47 million/year Cost of Brand Neupogen
using previous price of 450 SAR/injection
34,806 X 450 =
15.66
millions
15.66 million- 4.36 million =
11.30
million/year
Cost saving
since February 2014 after addition of Zarzio
60 million (Approx.)
Slide20Role of GCSF in Febrile NeutropeniaHigh risk cancer patients were treated with IV antibiotics with or without GCSF in a randomized trial. GCSF recipient had below mentioned.
Grade 4 neutropenia (median 2 Vs 3 days, P = 0.0004) Antibiotic therapy (median 5 Vs 6 days, P = 0.013)
Hospital stay (median 5 Vs 7 days, P= 0.015)No survival benefit20Garcia-Carbonero R , et al: A multicenter randomized trial. J Natl Cancer
Inst 93:31-38, 2001.
Slide21Pharmacoeconomic impact of Biosimiliar filgrastim in the management of Febrile Neutropenia (FN)21
Duration
of treatmentCost1 day of hospitalization in non ICU setting1500 SAR/day1 day of IV antibiotics2000 SAR/day6 days of IV antibiotics12,000
SAR7 days cost of hospitalization10,500 SAR
Total cost of febrile neutropenia
episode without GCSF
22,500 SAR
Cost of 5 days
therapy with Biosimiliar GCSF
480 SAR
Note: Use
of GCSF in the management of FN will reduce antibiotics duration and LOHS by 1 day and 2 days respectively
Cost of managing
FN episode when GCSF is used
15,980 SAR
Cost saving impact of using GCSF/FN
episode
6,520 SAR/FN episode
Cost saving impact of using GCSF/1800 FN episode
11.73 million SAR
Impact of
using GCSF/150 FN episode/month
Saves 150-300 admission days
Slide2222
Maha Islami, Mansoor A Khan, Nuha Fairaq, Abdulmajeed Alnatsheh, Sameer Alamoudi and Muhammad Aseeri
Slide23Study Results: Autologous SCT
Biosimiliar Filgrastim (Zarzio)
Original Filgrastim (Neupogen)P-valueMobilization RegimenChemotherapy+Zarzio (n=35)Chemotherapy+Neupogen (n=39)
Median CD34+ cells collection
5x10
6
/kg
5.5x10
6
/kg
0.64
Engraftment
Median neutrophil engraftment 10 days
Median neutrophil engraftment 11 days
0.83
Median platelet engraftment= 12 days
Median platelet engraftment= 13 days
0.23
Mobilization regimen
Zarzio monotherapy (n=14)
Neupogen (n=9)
Median CD34+ cells collection
3.76x10
6
/kg
4.44x10
6
/kg
0.21
Engraftment
Median time to neutrophil and platelet
engraftment was same
Median time to neutrophil and platelet
engraftment was same
NS
23
Maha Islami, Mansoor A Khan, Nuha Fairaq, Abdulmajeed Alnatsheh, Sameer Alamoudi and Muhammad Aseeri
Slide24Study Results: Allogenic SCT (healthy donors)
Biosimiliar Filgrastim (Zarzio)
Original Filgrastim (Neupogen)P-valueMobilization regimenZarzio monotherapy (n=8)Neupogen monotherapy (n=9)
Median CD34+ cells collection6.4x106 /kg 6x106 /kg
0.21
Engraftment
Median neutrophil engraftment=13.5 days
Median neutrophil engraftment = 14 days
0.62
Median platelet
engraftment=13.5
days
Median platelet engraftment = 14 days
0.62
24
Maha Islami, Mansoor A Khan, Nuha Fairaq, Abdulmajeed Alnatsheh, Sameer Alamoudi and Muhammad Aseeri
Slide25Study Results: Cost Impact
Biosimiliar Filgrastim (Zarzio)
Original Filgrastim (Neupogen)Mobilization regimen (autologous SCT)Zarzio monotherapy (n=14)Cost= SR 23,520Neupogen monotherapy (n=9)Cost= SR 32,076
Mobilization regimen (autologous SCT)Chemotherapy+Zarzio (n=35)
Cost= SR 60,480
(mobilization and engraftment)
Chemotherapy+Neupogen
(n=39)
Cost= SR 175,500
(mobilization and engraftment)
Mobilization regimen (Allogenic SCT)
Zarzio
(n=8)
Cost= SR 6,144
Neupogen
(n=9)
Cost= SR 38,250
Total cost
SR 90,144 (n=57)
SR 245,826 (n=47)
Cost Difference
SR 155,682
in
the favor of Zarzio although 10 extra patients were treated in the Zarzio arm. We would have spent nearly 600,000 SR if only neupogen was used in all 114 patients Vs 180,000 SR with Zarzio
25
Conclusion:
Biosimilar GCSF is comparable to original GCSF in terms of efficacy when used as mobilization agent in combination with chemotherapy or as monotherapy in both autologous and allogenic BMT patients and is a cost effective treatment option.
Maha Islami, Mansoor A Khan, Nuha Fairaq, Abdulmajeed Alnatsheh, Sameer Alamoudi and Muhammad Aseeri
Slide26Challenges of second generationbiologics and biosimiliarsSecond generation biologics: SC formulations of Rituximab, Trastuzumab and Bevacizumab
They may have improved, efficacy tolerability and convenient administration patternUse cost effective analysis NOT cost minimization analysis26
Biologics1st generation patency expiry year
Second generation approval statusCommentsRituximab
MabThera®/Rituxan® IV Injection expires
in
2018
FDA approved Subcut Rituximab in 2017.
EMA approved Subcut Rituximab in 2014
Fixed dose of 1400 mg is administered as SQ as apposed
to IV over > 6h
Trastuzumab
Herceptin
® IV Injection
expires
in
2019
EU approved Subcut Trastuzumab in 2013,
FDA has accepted BLA of Subcut Trastuzumab
(Already approved by SFDA)
Fixed dose of 600 mg is administered as SQ as apposed to IV over 0.5-1.5h
Bevacizumab
Avastin
®
IV Injection expires
in
2020
Subcut Bevacizumab is in Phase
II
Clinical Trials
SQ
administration Vs 1-1.5h
Henry D and Taylor C. Seminars in Oncology, Vol 41,No2,Suppl3,April2014
Slide27SummarySubstitution of reference biologics with their approved biosimiliars results in expanded access of biologicals to cancer patients
Addition of Biosimiliars to the formulary has significant cost saving budget impactBiosimilar GCSF is comparable to original GCSF in terms of efficacy when used as mobilization agent in combination with chemotherapy or as monotherapy in both autologous and allogenic BMT patients and is a cost effective treatment optionSecond generation biologics have posed challenge to biosimiliars of first generation biologics. But addition of first generation biosimiliars should be encouraged to have healthy competition between innovator and biosimiliar
27
Slide28Set the ambition first, then take a first concrete step
“The best time to plant a tree was 20 years ago. The second best time is now”.
Chinese proverb28
Slide2929
Thank you
Questions?