Transcript South African Oncology Consortium (SAOC)

Creating access through
collaboration: Oncology
Treatment Protocols
Dr Waldemar Szpak
South African Oncology Consortium
3/31/2016
1
ONCOLOGY
WHAT IS THAT ?
What are We Discussing Today?
 What is the SAOC?
 The Outdated PMB definition of treatable cancer
 Principles of SAOC peer review of cancer treatment
Guidelines.
 Benefits of new treatment modalities.
 Pitfals of DSP agreements.
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What are We actually Discussing Today?





Our patients
Our families
Our friends
Our nation
Our future
WHATEVER IS DECIDED TODAY WILL AFFECT US
PERSONALLY TOMORROW !!!!
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What is the SAOC?
The SAOC is a consortium of 156 distinctively trained
medical professionals in the field of cancer
management, representing all the professional
associations in the discipline of oncology, including
medical oncologists, radiation oncologists and clinical
haematologists
The SAOC also represents the best interest of our
patients
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What is the SAOC?
SAOC – a consortium of medical, clinical oncologists and
clinical haematologists established to:
1.To assist Funders with cancer treatment guidelines
based on evidence and cost effectiveness.
2.To assist Funders with independent peer review of
cancer treatment protocols.
What is the SAOC?

SAOC – the consortium of medical, clinical oncologists
and clinical haematologists established to:
3. To standardise conditions required for professional
chemotherapy facility.
4. Independent accreditation of chemotherapy facilities.
All private oncology practices in South Africa are
accredited by SAOC.
Disclaimer
SAOC is NOT associated with any business enterprise
or business networks neither is it contracted to any
preferred pharmaceutical or other suppliers. The choice
of medication and brand names are left to the treating
doctors and/or networks.
Peer Review is anonymous and conducted by qualified
and registered specialists in the field of oncology and
haematology. All patient and doctor details are removed
during the review process.
Disclaimer
There are no financial or other incentives available to
the review panels (or the treating doctors) for making a
specific clinical/treatment recommendation.
All accredited practices accredited by SAOC are
financially or organisationally independent from the
SAOC
Disclaimer
The SAOC does not regualate, coordinate or negotiate any business related
tarrifs for providers or their networks.
It’s only role is:
– the development of cancer treatment guidelines
– peer review of treatment protocols and treatment plans
– an independent from providers or their business network accreditation
of oncology facilities.
It is a low budget , not for profit company.
Board of Directors is not remunerated
What are We Discussing Today?
 What is the SAOC?
 The Outdated PMB definition of treatable cancer
 Principles of SAOC peer review of cancer treatment
protocols
 Benefits of new treatment modalities.
 Pitfals of DSP agreements.
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What is the Problem?
 Oncology treatment is very complex and generally not
fully understood by other medical professionals
 The current PMB description in oncology reflects this
problem in its inconsistency and faults
 The current PMB regulations in oncology are defective
and vulnerable for legal challenges
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Shortcomings of the Current PMB
Definition of Treatable Cancer
 Unfair to patients
– Restriction of cancer treatment tools (chemotherapy and
radiotherapy)
– Very restrictive and unproven scientifically definition of “treatable
cancer” practically excluding from benefits great majority of affected
by cancer patients
 Lack of scientific reference
 Too descriptive and dreadfully outdated
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Shortcomings of the Current PMB
Definition of Treatable Cancer
 Developed without consultations with professionals in cancer
management
 The current PMB regulations in oncology are therefore defective
and vulnerable for the legal challenges as being undemocratic
and unconstitutional
Why ?
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Exclusion of Chemotherapy and
Radiotherapy from the PMB
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
Where the treatment component of a category in Annexure
A is stated in general terms (i.e. "medical management”
or “surgical management”), it should be interpreted as
referring to prevailing hospital-based medical or surgical
diagnostic and treatment practice for the specified
condition”
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Exclusion of Chemotherapy and
Radiotherapy from PMB
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
“Where significant differences exist between Public and Private
sector practices, the interpretation of the Prescribed Minimum
Benefits should follow the predominant Public Hospital practice,
as outlined in the relevant provincial or national public hospital
clinical protocols, where these exist”
“Where clinical protocols do not exist, disputes should be settled by
consultation with provincial health authorities to ascertain prevailing
practice”
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Exclusion of Chemotherapy and
Radiotherapy from PMB
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
PARADOX:
Drugs that are substantially more cost-effective than
available alternatives in the context of PMB therapy are
not available in the majority of academic hospitals.
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Exclusion of Chemotherapy and Radiotherapy
from PMB
– Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
Why were oncologists not consulted ?
The following interventions shall however be
excluded from the generic medical/surgical
management categories unless otherwise
specified:
– i. Tumour chemotherapy
– ii. Tumour radiotherapy
– iii. Bone marrow transplantation/rescue
– iv. Treatments, drugs or devices not yet
registered by the relevant authority in the
Republic of South Africa
…WHY???
THESE
INTERVENTIONS
DO PREVAIL IN
PUBLIC
HOSPITALS !
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Exclusion of Chemotherapy and
Radiotherapy from PMB
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
It is considered inappropriate to exclude systemic treatment
of cancer with chemotherapy, biotherapy or hormonal
therapy (anticancer agents) from the generic
medical/surgical management categories
- SAOC
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
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Exclusion of Chemotherapy and
Radiotherapy from PMB
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
 Certain malignancies can exclusively be cured by
chemotherapy and/or radiotherapy
 In many other cancers adjuvant systemic therapy
significantly reduces rates of tumour recurrence
 In palliative treatment therapy symptoms of malignant
growth are significantly alleviated
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Exclusion of Chemotherapy and
Radiotherapy from PMB
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
 Radiotherapy is often used in an adjuvant setting (to
prevent cancer recurrence) and significantly increases
cure rate
 Radiotherapy can also be used for radical
eradication of the malignancy resulting in cure or
long-term remission
 Radiotherapy is also used in palliation to prevent
pathological fractures or to ease cancer symptoms
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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Exclusion of Chemotherapy and
Radiotherapy from PMB
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
Chemotherapy and radiotherapy are fundamental tools for
the successful and curative (in many instances)
management of cancer
hence
The exclusion of systemic therapy and radiotherapy
from the PMB for cancer is considered to be unethical
and scientifically unsubstantiated
- SAOC
3/31/2016
South
African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
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PMB Definition of TREATABLE CANCER
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
“Treatable” cancers - In general, solid organ malignant tumours
(excluding lymphomas) will be regarded as treatable where:
i.
they involve only the organ of origin, and have not spread to adjacent
organs
ii.
there is no evidence of distant metastatic spread
iii.
they have not, by means of compression, infarction, or other means,
brought about irreversible and irreparable damage to the organ within
which they originated (for example brain stem compression caused by
a cerebral tumour) or another vital organ
iv.
or, if points (i) to (iii) do not apply, there is a well demonstrated fiveyear survival rate of greater than 10% for the given therapy for the
condition concerned
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PMB Definition of TREATABLE CANCER
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
The PMB definition of “Treatable Cancer” has little
practical relevance in the context of points i, ii, iii and
iv
On many occasions the management of early cancer
include the removal of the organ of cancer origin, partial
resection or radiotherapy induced “damage” to the tumour
in the organ of origin
- SAOC
3/31/2016
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
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PMB Definition of TREATABLE CANCER
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
(IV) or, if points (i) to (iii) do not apply, there is a well demonstrated five-year
survival rate of greater than 10% for the given therapy for the condition
concerned.
There are very few disease entities as such in oncology where modern
multi-modality therapy has not resulted in greater than 10%
improvements in 5-year survival for the entity as a whole
Even these patients benefit from palliative treatments which often result
in improvement of their productivity and quality of life
3/31/2016
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
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PMB Definition of TREATABLE CANCER
- Extract from Annexure A of MEDICAL SCHEMES ACT 131 OF 1998
 The term “Treatable Cancer” is misleading and uniquely used for
cancer diseases
 There is no other disease or condition described in the third PMB
draft in a similar restrictive way as “treatable condition or disease”
 According to the South African Constitution every patient has a right
to treatment of his/her disease or condition with no exceptions
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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The SAOC Proposal for PMB Cancer Definitions
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
 The term “Treatable Cancer” should be replaced with the
following:
–
–
–
–
“cancer in curable stage”
“cancer in chronic stage”
“cancer in palliative stage”
“oncological emergencies”
 All stages of cancer should be treated on the basis of
evidence based medicine, taking into account
consideration of cost-effectiveness and affordability
 Due to the course of treatment a patient may change his
status from palliative to chronic or from chronic to
palliative.
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“Cancer in curable Stage”
– Aimed to cure
– Preservation of SA population
– Preservation of workforce
– The most cost effective
Because
Resources recovered by taxes, financial and social contrbutions to
society etc.
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“Cancer in chronic Stage”
– Prolonged symptom free survival
– Preservation of SA population
– Preservation of workforce
– Cost effective
Often survival is extended by significant number of years during which
most of affected patient actively continue their professional or social
roles in families and society.
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“Cancer in palliative Stage”
–
–
–
–
Improve survival with reduced symptoms
Some of patients are still professionally active
Terminal care
Cost effectiveness depends on the type of cancer, comorbidity, general prognosis, time of diagnosis and
line of treatment.
Often survival is extended by significant number of months during which
most of affected patient actively continue their professional/social roles
in families and society.
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“Oncological Emergencies”
Patients present with acute emergency , often newly
diagnosed cancers
– Patient in unstable condition with life threatening
condition requiring immediate intervention
– Majority of these patients may be in fact in curative or
chronic stage of their cancers after stabilization of
their conditions.
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All stages of cancer should be treated on
the basis of evidence based medicine,
taking into account consideration of
cost-effectiveness and affordability
South African Oncology Consortium (SAOC) Submission on (PMB) Consultation Document - Published 25 March 2009
3/31/2016
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What are We Discussing Today?
 What is the SAOC?
 The Outdated PMB definition of treatable cancer
 Principles of SAOC peer review of cancer treatment
protocols
 Benefits of new treatment modalities.
 Pitfals of DSP agreements.
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The SAOC Designed a Unique PMB Protocol
(TIER 1)
SAOC compiled such protocols /guidelines in
coordination with the academic heads of
oncology departments in South Africa
These protocols are being scientifically reviewed
and updated regularly.
 Tier 1 - Equivalent of Prescribed Minimum
Benefits (PMB)
 Tier 2 - Standard of Care
 Tier 3 - Referral Tier (peer review)
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ERBITUX + RT in locally advanced
Head/Neck sq.c.c
Overall survival
Probability of overall survival
1.0
ERBITUX + RT (n=211)
RT (n=213)
0.9
0.8
46%
0.7
(5-year survival
rate)
0.6
0.5
0.4
0.3
0.2
36%
0.1
(5-year survival
rate)
29.3
months
0
0
10
20
49.0
months
30
40
50
60
70
Time (months)
Hazard ratio=0.73 (95% CI: 0.56–0.95); p=0.018
Bonner et al. N Eng J Med 2006; 354:567-578; Bonner et al. Lancet Oncol 2010; 11:21-28
URC PEER REVIEW
TEXT BOOK PATIENT DOES NOT EXIST !!!
Anonymous
Five doctors
Consensus
Appeal
Escalation to other Panel
1st line treatment goals
Patient
group
Group 1:
Group 2:
Group 3:
Patients with
limited but
initially
unresectable
metastases
Patients with
never resectable
metastases, high
tumor burden or
tumor-related
symptoms
Patients with
never resectable
metastases
asymptomatic
and with less
aggressive
disease
Cure
Treatment
goal
Symptom relief
More lifetime
Van Cutsem E, et al. Ann Oncol 2010;21(Suppl. 5):v93–v97;
figure based on Schmoll H-J, Sargent D. Lancet 2007;370:105–107.
What are We Discussing Today?
 What is the SAOC?
 The Outdated PMB definition of treatable cancer
 Principles of SAOC peer review of cancer treatment
protocols
 Benefits of new treatment modalities.
 Pitfals of DSP agreements.
3/31/2016
46
TREATMENT PHILOSOPHY
Even first stage cancer should have been
seen in the context of systemic disease.
• Complete surgical resection – definitive therapy.
• Neo-adjuvant radio/chemotherapy – to allow for complete
surgical resection and remove micro-metastases.
• adjuvant radio/chemotherapy – to complement surgical
resection (radiotherapy) and remove micro-metastases
(chemotherapy.)
Upcoming TREATMENT PHILOSOPHY
 Tools that help to choose most effective treatment.
PHARMACOGENETICS
BREAST
•Oncotype DX
•ER/PR c-erb/her2-neu receptors
COLON
•PreDict DX – colon
 ERCC1 – resistance to platinum agents
• Complete
surgical resection – definitive therapy.
 TS
 RAS
 BRAF
• Neo-adjuvant
radio/chemotherapy – to allow for complete
•MSI for stage II and III
surgical
resection
and remove micro-metastases.
•Irinotecan
Toxicity
(UGT1A1)
•5-Fu Toxicity (DPYD)
LUNG
• adjuvant radio/chemotherapy – to complement surgical
resection
and remove micro-metastases
•EGFR
mutations(radiotherapy)
– lung
•ALK
mutation
(chemotherapy.)
Coordination between treatment
modalities
 Surgery – to remove origin of tumour
– R0 resection
– Least aggressive technique
 Radiotherapy – to destroy tumour or sterilise tumour bed
– IMRT (Intensity Modulated Radiotherapy)
– IGRT (Image Guided Radiotherapy )
– Targeted radiotherapy/brachytherapy
To protect normal
organs
 Systemic therapy – to eradicate metastases and sensitise
cancer cells for radiation.
– Chemotherapy (ideally given in systemic treatment doses if given with
concurrent radiotherapy).
– Targeted therapy
– Within tumour cell
– To interfere with tumour environment and prevent tumour propagation
 Supportive therapy - to alleviate symptoms of cancer and its treatment.
Biological / Targeted therapy
 is a relatively new addition to the family of cancer
treatments that also includes surgery chemotherapy and
radiation therapy.
 Biological therapies use the body's immune system,
either directly or indirectly, to fight cancer or to lessen
the side effects that may be caused by some cancer
treatments.
 Biological response modifiers (BRMs) occur naturally in
the body and can be produced in the laboratory.
Biological / targeted therapy may be
used for the following reasons:
 Stop, control, or suppress processes that permit cancer
growth
 Make cancer cells more recognizable and, therefore,
more susceptible to destruction by the immune system
 Boost the killing power of immune system
Biological therapy may be used for the
following reasons:
 Alter the growth patterns of cancer cells to promote
behavior like that of healthy cells
 Block or reverse the process that changes a normal cell
or a precancerous cell into a cancerous cell
Biological therapy may be used for the
following reasons:
 Enhance the body's ability to repair or replace normal
cells damaged or destroyed by other forms of cancer
treatment, such as chemotherapy or radiation.
 Prevent cancer cells from spreading to other parts of the
body.
What are ‘targeted’ therapies?
Treatments that attack specific targets in cancer cells
without harming normal cells*
Selective delivery of
drug to cancer tissue.
Small molecule
*National Cancer Institute Dictionary of Cancer Terms
Monoclonal
antibody
Biologicals in Tier1 (PMB)
 Imatinib (Gleevec) (GIST, CML, DFSP, masticytosis)
 Rituximab (Mabthera) – DLBCL
 Erythropoietin – limited to certain group of patients
Blood
 Polygam – specific hematological indications
RITUXIMAB in DLBCL
No second line treatment required in 21% of
patients
!
Gleevec in CML
• About 90% of patients diagnosed with this rare disease and
treated with Gleevec will survive more than eight years.
•
Without Gleevec almost all patients with this leukaemia will
die within year or two after diagnosis.
• CML Patients On Imatinib Have Similar to General
Population Survival Rates.
Tier 2 (Standard) –SAOC
 Transtuzumab- (Herceptin) – breast , gastric
 Bevacizumab (Avastin)- colon, breast , lung,GBM
 Cetuximab (Erbitux) – colon , head/neck
Targeted therapeutics





Sorafenib (Nexavar) - liver , kidney
Sunitnib (Sutent) - kidney, GIST, pNET
Everolimus (Afinitor) – kidney , pNET
Temsirolimus (Torisel) - kidney
Tarceva (Erlotinib) – lung
Very powerful class
of medicines for
cancers where
chemotherapy
completely failed
First-line Tarceva nearly triples median
PFS versus chemotherapy
1.0
Tarceva (n=82)
Gem/carbo (n=72)
PFS probability
0.8
HR=0.16 (0.10–0.26)
Log-rank p<0.0001
0.6
0.4
0.2
4.6
13.1
0
0
5
10
Time (months)
15
20
82
70
51
20
2
Gem/carbo 72
26
4
0
0
Patients at risk
Tarceva
Data cut-off: 16 Aug 2010
Zhou, et al. ESMO 2010
SUMMARY OF OS ITT ANALYSES FOR 1 YEAR
TRASTUZUMAB VS. OBSERVATION
ACROSS ANALYSIS TIME POINTS
Median follow-up
(% follow-up time
after selective crossover)
2005
(0%)
2006
(4.1%)
OS benefit
No. of deaths
1 year trastuzumab
vs observation
0.76
29 vs 37
P=0.26
1 yr MFU
0.66
59 vs 90
P=0.0115
2 yrs MFU
In view of the above ? THE QUESTION
?
0.85
2008
4 yrs MFU
(30.9%)
182 vs 213
P=0.1087
Do we waste resources when treating nine weeks only ???????
0.76
2012
8 yrs MFU
(45.5%)
0
278 vs 350
P=0.0005
Favours 1 year trastuzumab
1
HR (95% CI)
Extended from Gianni et al. Lancet Oncol. 2011.
Favours observation
2
Neoadjuvant chemotherapy converts some patients
with initially unresectable liver metastases
Remain non-resectable
Resected after response
Primarily resected
1,200
Patients (n)
1,000
138
13%
966
87%
138
10%
800
600
33%
400
335
200
23%
0
Chemotherapy
Resected
Adam, et al. Ann Surg 2004
Successful resection of liver metastases may double
survival compared to non-resected patients*
1.0
Successful resection
0.6
0.4
25
%
Landmark
OS estimate
0.8
0.2
No liver resection
0
0
12
24
36
Time (months)
48
60
72
Significantly improved 5-year survival rate with
hepatic resection (55%) versus unresected disease (20%)
*Diagnosed 1998–2006, and alive 12 months after diagnosis
Kopetz, et al. JCO 2009
Demonstrated OS improvement in
phase III trials in 1st-line mCRC
FOLFIRI +
ERBITUX
23.5 vs 20.0
FOLFOXIRI
22.6 vs 16.7
OS (months)
KRAS wt
IFL + beva
FOLFIRI
20.3 vs 15.6
20–21
IFL
15
FOLFOX
20–21
FLOX
16
5-FU
11–13
BSC
Fluoropyrimidine
BSC, best supportive care
Irinotecan
Oxaliplatin
Non-resected patients are surviving
longer in recent years
1990–1991
1992–1994
1995–1997
1998–2000
2001–2003
2004–2006
Overall survival (%)
100
80
60
40
20
0
0
12
24
36
48
60
Time (months)
Non-resected patients are now experiencing
longer OS – currently about 2 years
Kopetz S et al. J Clin Oncol 2009;27:3677–3683
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What are We Discussing Today?
 What is the SAOC?
 The Outdated PMB definition of treatable cancer
 Principles of SAOC peer review of cancer treatment
protocols
 Benefits of new treatment modalities.
 Pitfals of DSP agreements.
3/31/2016
66
Communication from the CMS
“With a DSP agreement the provider agrees to a specific
rate of reimbursement with the scheme.
The incentive for the provider is business and
 the incentive for the scheme is reduced costs.
If members are allowed to go to any provider without
a penalty co-payment there would be no incentive for
the provider to agree to reduced rates and the DSP
agreement would be unnecessary.”
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Ethical questions about the DSP
agreements?
 The incentive for the scheme is reduced costs
– Where is true costs reduction?
 In services?
OR
 in exclusions of more expensive but often more effective treatment
options?
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Ethical questions about the DSP
agreements?
The incentive for the provider is business
–
Why must a provider participate in the provider networks to enter into the
DSP agreement?
– Where is true costs reduction?
– In services?
Or
– in exclusions of more expensive but often more effective treatment
options?
– Why can a non-network provider compete with a network by means of
reduction of his service costs, even the same treatment protocols are being
used?
– Why do investigations or medicines ordered by non-DSP provider attract copayment over and above the co-payment for services?
– How do these questions relate to the competition rules or constitutional
rights for freedom of choice?
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Ethical questions about the DSP
agreements?
“If members are allowed to go to any provider without a
penalty co-payment there would be no incentive for the
provider to agree to reduced rates and the DSP
agreement would be unnecessary.”
– Such policy is usually imposed on members, often forcing
them to attend DSP practices situated further away.
– Does this policy reduce patients’ consumer rights ?
– What about constitutional rights ?
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THANK YOU !
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