MCBS

How Valuable is a Cancer

Therapy ?

Noha El Baghdady

European Thoughts

“With increasing budget

constraints and the need to make trade-off s in health spending, assessing the value of cancer medications has taken center

stage in the discussion of drugs and drug prices”

What about us ?

ESMO and ASCO have taken steps to guide the medical community in assessing the value of oncology therapies by releasing their value

assessment frameworks and to facilitate the discussion on reimbursement and payment

based on value, adapted to different countries and regions.

Early 2015

The European Society for Medical Oncology (ESMO)

The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS)

a relative ranking of the magnitude of clinically

meaningful benefit

Shortly after ESMO-MCBS v1.0 publication

The American Society of Clinical Oncology (ASCO)

ASCO value framework

comparisons of a new treatment regimen with the prevailing standard of care for a specific

clinical cancer indication

ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS)

The ESMO magnitude of clinical benefit scale (ESMO-MCBS v1.0)

• ESMO-MCBS v1.0 has been developed only for solid cancers.

• Given the profound differences between the curative and palliative settings the tool is presented in two parts.


• Based on initial recommendations from 276 members of the ESMO faculty and a team of 51 expert biostatisticians ESMO MCBS V1 developed.

• ESMO intends to apply this scale prospectively to each new anticancer drug/intervention that will be European Medicines Agency (EMA) approved.

Drugs that obtain a high score will be

highlighted in the ESMO clinical

guidelines with the aim of prompting

rapid endorsement by health

authorities across the European Union.


• The ESMO tool is presented in two parts:

1.Treatments with curative intent (A,B,C)

2.Non-curative interventions (5,4,3,2,1)

ESMO-MCBS v1.0 Forms (Form 1)

Evaluate

adjuvant and other

treatments with

“curative intent. “

This scale is graded A, B or

C.

For early data

demonstrating high DFS without mature

survival data.


• ESMO scores were obtained for the cancer drugs from Form 1 were categorized to:

High benefit (A,B)

low benefit (C)


used for studies of new agents or

approaches in the management

of

cancers without curative intent.

scale is graded 5, 4, 3, 2, 1,

where grades 5 and 4

represent a high level of

proven clinical benefit

2a, 2b,2c versions


Forms 2a

used for therapies

evaluated using a primary

outcome of OS.

Forms 2b

is used for therapies

evaluated using a primary endpoint

of PFS or TTP.

Forms 2c

used for therapies evaluated in non-

inferiority (equivalence)

studies and for

studies in which the primary

outcomes are QoL, toxicity or response

rate (RR).


• ESMO scores were obtained from form 2 for the cancer drugs were categorized to:

High benefit (3-5)

low benefit (0-2)

Results of First Study Assessing Clinical Impact of ESMO-MCBS V 1.0,

07 2016

The Medical University of Vienna (MUV)

• Analysed treatments and scored trials on the ESMO-MCBS and the resulting data was in line with clinical experience.

Treatment of advanced lung cancer at the Medical University of

Vienna

Treatment Setting MCBS

Erlotinib vs carboplatin

(OPTIMAL, CTONG 0802)*

Zhou et al27

First-line IIIB or IV, non-squamous, EGFR-mutated

4

Nivolumab vs docetaxel (Checkmate 057) Borghaei et al43

Second-line squamous cell lung

cancer

5

Field testing of the ESMO-MCBS for the treatment of advanced breast cancer at the

Medical University of Vienna


Trastuzumab+CT±pertuzumab (CLEOPATRA)*

Swain et al10 Swain et al11

First-line metastatic, HER2-positive

4

Pegylated liposomal doxorubicin vs conventional doxorubicin Brien et al22

First-line metastatic 4

Field-testing of the ESMO-MCBS for the treatment of advanced colorectal cancer at

the Medical University of Vienna


FOLFIRI±cetuximab

(CRYSTAL)*

Van Cutsem et al45

First-line metastatic

stratified for KRAS

wild type

4

FOLFOX4±panitumum

ab (PRIME)*

Douillard et al46

First-line metastatic

(post hoc KRAS,

NRAS BRAF wild

type)

4

Field testing of the ESMO-MCBS for the treatment of advanced gastric cancer at

the Medical University of Vienna


FOLFIRI vs ECX

Guimbaud et al64

Advanced first-line

gastric or gastro-

oesophageal

adenocarcinoma

2

Salvage

chemotherapy vs best

supportive care

Kang et al70

Second-line or third-

line gastric or gastro-

oesophageal cancer

after cisplatin/5FU

2

The Medical University of Vienna Conclusions

• The MCBS is an excellent tool for daily clinical practice of a tertiary referral center.

• It supports treatment decisions based on the clinical benefit to be expected from a novel approach such as immunotherapy.

Results of First MENA Region practical experience Assessing Clinical Impact

of ESMO-MCBS V 1.0, 2015

ISPOR 18th Annual European Congress, Milan, Italy , 2015

• To evaluate the association between Israel’s reimbursement decisions ESMO-Magnitude of Clinical Benefit Scores

• Israeli reimbursement decisions (2013-2015) demonstrate concordance with ESMO magnitude of clinical benefit scoring.

ISPOR 18th Annual European Congress, Milan, Italy , 2015

• 38 cancer drugs were candidates for the 2013-2015 National List of Health System (NLHS )

• An ESMO score was available for 19/22 approved drugs and 15/16 non-approved drugs

Exceptional cases

Approved:

1.Sorafenib - advanced thyroid carcinoma (ESMO-2)

“unmet need” – no alternative treatment available.

Exceptional cases

Non approved:

1.Docetaxel- advanced gastric cancer (ESMO-4)

–A similar drug “paclitaxel” is already provided by health plans, ESMO grade did not compare to paclitaxel.

Limitations of the ESMO-MCBS v1.0

• The ESMO-MCBS can only be applied to comparative research outcomes; it is therefore not applicable when evidence of benefit derives from single arm studies.

Conclusion

• ESMO MCBS is a clear and unbiased statements

regarding the magnitude of clinical benefit from new therapeutic approaches. • Also, it provides a

standardized approach for quantifying the clinical

benefit and credible comparison of therapeutic

effectiveness of various cancer treatments.

Thank you !

MCBS

Health & Medicine

Transcript of MCBS