Subject: Provenge/Medicare issue
From: "Kevin Johnson" <[email-masked]>
To: "jschwartz" <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>
Cc: "Skip Lockwood" <[email-masked]>
Date: Mon, 8 Nov 2010 11:44:01 -0500

In case you were not aware, the Centers for Medicare and Medicaid
Services (CMS) has called a meeting next Wednesday (Nov. 17) to consider
the currently available evidence regarding the impact of labeled and
unlabeled use of autologous cellular immunotherapy treatment (PROVENGE)
on health outcomes of patients with metastatic prostate cancer.

Below is an article from today's front page of the Washington Post
(below the fold) - and in which Skip is quoted.  At the bottom, I have
also included the draft voting questions for the meeting.

http://www.washingtonpost.com/wp-dyn/content/article/2010/11/07/AR201011
0704932.html

Kevin S. Johnson

Sr. Vice President, Government Relations and Advocacy

ZERO - The Project to End Prostate Cancer

 

MEDCAC -November 17, 2010
DRAFT QUESTIONS
Autologous Cellular Immunotherapy Treatment of Metastatic Prostate
Cancer 

FDA Label -
PROVENGE is an autologous cellular immunotherapy indicated for the
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer.

Voting Questions

For all voting questions, the health outcomes of interest are: overall
survival, control of disease-related symptoms, and the avoidance or
minimization of the burdens to patients associated with anticancer
therapy. The comparator is the management that the patient would
otherwise have received. 

For the voting questions, use the following scale identifying level of
confidence - with 1 being the lowest or no confidence and 5 representing
a high level of confidence.

1
Low
confidence

2

3
Intermediate
confidence

4

5
High confidence

1.	How confident are you that there is adequate evidence to
determine whether or not the use of autologous cellular immunotherapy
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant prostate cancer significantly improves:

	1.	Overall survival?

1

2

3

4

5

	2.	Control of disease-related symptoms?

1

2

3

4

5

	3.	Avoidance or minimization of the burdens associated with
anticancer therapy while maintaining overall survival and control of
disease-related symptoms?

1

2

3

4

5

Note: Questions 2 -6 should be addressed only for those outcomes under
question 1 where the panel is confident that there is at least
intermediate confidence (mean vote of 2.5) that there is adequate
evidence to make the determination of improvement.

2.	How confident are you that there is adequate evidence to
conclude that autologous cellular immunotherapy treatment significantly
improves overall survival in patients with asymptomatic or minimally
symptomatic metastatic castrate resistant prostate cancer?

1

2

3

4

5

3.	How confident are you that there is adequate evidence to
conclude that autologous cellular immunotherapy treatment significantly
improves control of disease-related symptoms in patients with
asymptomatic or minimally symptomatic metastatic castrate resistant
prostate cancer?

1

2

3

4

5

4.	How confident are you that there is adequate evidence to
conclude that autologous cellular immunotherapy treatment significantly
improves the avoidance of the treatment burdens (e.g., access, delivery,
or side-effects) associated with anticancer therapy in patients with
asymptomatic or minimally symptomatic metastatic castrate resistant
prostate cancer?

1

2

3

4

5

5.	How confident are you that these conclusions are generalizable
to unlabeled use in:

	1.	Patients whose prostate cancer has not metastasized?

1

2

3

4

5

	2.	Patients who have metastatic, castrate resistant disease
and symptoms more severe than minimally symptomatic?

1

2

3

4

5

	3.	Patients who have metastatic prostate cancer but who
have not failed hormonal therapy?

1

2

3

4

5

6.	How confident are you that these conclusions are generalizable
to:

	1.	Community based settings?

1

2

3

4

5

	2.	Patients belonging to demographic groups that may have
been under-represented in the enrolled clinical trial populations?

1

2

3

4

5

Discussion Questions

7.	Do you believe that there is adequate evidence to identify
patients who are more likely or less likely to respond favorably to
autologous cellular immunotherapy treatment based on pretreatment
evaluation of any of the following factors?

	1.	Site(s) or number of metastasis(es) as detected by
imaging studies
	2.	Gleason score
	3.	Alkaline phosphatase (U/L)
	4.	Hemoglobin (g/dL)
	5.	Serum LDH (U/L)
	6.	Serum PSA (ng/mL)
	7.	Pain associated with metastatic, castrate-resistant
prostate cancer
	8.	Other

8.	What significant evidence gaps exist regarding the health
outcomes attributable to autologous cellular immunotherapy treatment? 

	1.	For the FDA-labeled indication?
	2.	For off-label uses?

9.	What clinical study designs would adequately address any
evidence gaps?