Risk Sharing in Drug Development
-
Upload
keaton-powers -
Category
Documents
-
view
23 -
download
1
description
Transcript of Risk Sharing in Drug Development
![Page 1: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/1.jpg)
Risk Sharing inDrug Development
Richard Malcolm, Ph.D.CEO, Acurian
September 15, 2011 | BIOCOM
![Page 2: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/2.jpg)
Risk Sharing Defined
• A method in which the cost of the consequences of a risk is distributed among several participants (e.g. syndication)
• Business management method whereby the financial consequences of a risk are distributed among both vendor and client
2
![Page 3: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/3.jpg)
Objectives of Risk Sharing
• Ensure all parties have an aligned interest to the ultimate success of a venture– Shared accountability
• Put the vendor(s) “in the boat” with the sponsor
3
![Page 4: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/4.jpg)
General Background
• First appeared in centralized patient recruitment in the 1990s
• Soon disappeared due to declining demand • Made a comeback in past several years • Increasingly common requirement in patient
recruitment & retention contracts • Applicable to virtually any drug development service,
not just patient recruitment
4
![Page 5: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/5.jpg)
Types of Risk Sharing
• None• Partial• Complete• Total
5
![Page 6: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/6.jpg)
Patient Recruitment Example
• Phase IIb study of drug X in generalized anxiety disorder
• Recruitment vendors receive RFP from drug company to provide recruitment/enrollment services
• Services requested include mix of radio/TV ads, internet recruiting & direct mail
6
![Page 7: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/7.jpg)
None: Time & Materials
• Time (people)– Project manager $/hour– Web developer $/hour– Creative director $/hour
• Materials (things)– TV production $/commercial– TV airtime $/station/market– Call center $/call– Printing & postage $/letter
7
Buyer pays for all fees
regardless of results
Buyer pays for all fees
regardless of results
RISK
Buyer Seller
![Page 8: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/8.jpg)
Partial: Non-Pass Through
• Time (people)– Project manager $/hour– Web developer Results-based– Creative director Results-based
• Materials (things)– TV production $/commercial– TV airtime $/station/market– Call center $/call– Printing & postage $/letter
8
Buyer pays for all pass
through costs
Buyer pays for all pass
through costs
Buyer pays for some costs based upon
results
Buyer pays for some costs based upon
results
RISK
Buyer Seller
![Page 9: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/9.jpg)
Complete: Non-Pass Through
• Time (people)– Project manager Results-based– Web developer Results-based– Creative director Results-based
• Materials (things)– TV production $/commercial– TV airtime $/station/market– Call center $/call– Printing & postage $/letter
9
Buyer pays for all pass
through costs
Buyer pays for all pass
through costs
Vendor compensated for staff only upon delivery
of results
Vendor compensated for staff only upon delivery
of results
Buyer pays for all pass
through costs
Buyer pays for all pass
through costs
RISK
Buyer Seller
![Page 10: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/10.jpg)
Total: Price Per Unit
• Time (people)– Project manager Results-based – Web developer Results-based – Creative director Results-based
• Materials (things)– TV production Results-based – TV airtime Results-based – Call center Results-based – Printing & postage Results-based
10
Buyer pays no fees, only for
units produced
based on pre-negotiated unit price
Buyer pays no fees, only for
units produced
based on pre-negotiated unit price
RISK
Buyer Seller
![Page 11: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/11.jpg)
Payment Markers (Units)
• For this metric to be successful, it must: represent a reasonable level of vendor performance be considered as a fair assessment of performance (by sponsor &
vendor alike)
• Key patient recruitment agreement metrics: pre-screened referral screened referral randomized subject
11
![Page 12: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/12.jpg)
None: Costing Example • Time (people)
– Project manager $200/hour x 100 hours = $20,000 – Web developer $90/hour x 100 hours = $9,000– Creative director $150/hour x 100 hours = $15,000
TOTAL FOR TIME = $44,000
• Materials (things)– TV production $15,000/commercial = $15,000– TV airtime $40,000/week x 6 weeks = $240,000– Call center $15/call x 600 calls = $9,000– Printing & postage $1.75/letter x 100,000 letters = $175,000
TOTAL FOR MATERIALS = $439,000
Vendor projects that these costs will result in 100 randomized patients
12
![Page 13: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/13.jpg)
So….No Risk Share Means:TOTAL FOR TIME = $44,000+ TOTAL FOR MATERIALS = $439,000 = $483,000 paid regardless of vendor results
Vendor has no fees tied to results. Buyer bears 100% of the risk.
Cost per patient depends on vendor’s performance against $483,000. For example:
100 patients randomized Sponsor pays $4,830/patient50 patients randomized Sponsor pays $9,660/patient10 patients randomized Sponsor pays $48,300/patient
13
![Page 14: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/14.jpg)
Partial: Costing Example • Time (people)
– Project manager $200/hour x 100 hours = $20,000 – Web developer $90/hour x 100 hours = Tied to results– Creative director $150/hour x 100 hours = Tied to results
TOTAL = $20,000 + $24,000 if commitments are met
• Materials (things)– TV production $15,000/commercial = $15,000– TV airtime $40,000/week x 6 weeks = $240,000– Call center $15/call x 600 calls = $9,000– Printing & postage $1.75/letter x 100,000 letters = $175,000
TOTAL FOR MATERIALS = $439,000 Vendor projects that these costs will result in 100 randomized patients
14
![Page 15: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/15.jpg)
So….Partial Risk Share Means:TOTAL FOR TIME = $20,000 + $24,000 if 100 rands delivered+ TOTAL FOR MATERIALS = $439,000 = $459,000 paid even if vendor fails / $483,000 if vendor succeeds
Vendor has only $24,000 tied to results. Buyer bears 95% of the risk.
Cost per patient depends on vendor’s performance against $459,000. Vendor receives +$24,000 upon delivery of 100 rands. For example:
100 patients randomized Sponsor pays $4,830/patient50 patients randomized Sponsor pays $9,060/patient10 patients randomized Sponsor pays $45,300/patient
15
![Page 16: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/16.jpg)
Complete: Costing Example • Time (people)
– Project manager $200/hour x 100 hours = Tied to results– Web developer $90/hour x 100 hours = Tied to results– Creative director $150/hour x 100 hours = Tied to results
TOTAL FOR TIME = $44,000 in staff fees tied to results
• Materials (things)– TV production $15,000/commercial = $15,000– TV airtime $40,000/week x 6 weeks = $240,000– Call center $15/call x 600 calls = $9,000– Printing & postage $1.75/letter x 100,000 letters = $175,000
TOTAL FOR MATERIALS = $439,000
Vendor projects that these costs will result in 100 randomized patients
16
![Page 17: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/17.jpg)
So….Complete Share Means:TOTAL FOR TIME = $0 fixed. $44,000 tied to delivery of 100 rnads+ TOTAL FOR MATERIALS = $439,000 = $439,000 paid even if vendor fails / $483,000 if vendor succeeds
Vendor has only $44,000 Results-based. Buyer bears 90% of the risk.
Cost per patient depends on vendor’s performance against $439,000. Vendor receives +$44,000 upon delivery of 100 rands. For example:
100 patients randomized Sponsor pays $4,830/patient10 patients randomized Sponsor pays $43,900/patient
17
![Page 18: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/18.jpg)
Total: Costing Example • Time (people)
– Project manager $200/hour x 100 hours = $20,000 – Web developer $90/hour x 100 hours = $9,000– Creative director $150/hour x 100 hours = $15,000
TOTAL FOR TIME = $44,000
• Materials (things)– TV production $15,000/commercial = $15,000– TV airtime $40,000/week x 6 weeks = $240,000– Call center $15/call x 600 calls = $9,000– Printing & postage $1.75/letter x 100,000 letters = $175,000
TOTAL FOR MATERIALS = $439,000
Vendor projects that these costs will result in 100 randomized patients - payment is tied to projected outcome rather than any activity.
18
![Page 19: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/19.jpg)
So….Total Risk Share Means:TOTAL FOR TIME = $44,000+ TOTAL FOR MATERIALS = $439,000 = $483,000
$483,000 / 100 randomizations = $4,830 per patient
Buyer pays a fixed $4,830 for 1-100 patients. No other fees may be invoiced.
Invoicing occurs only on randomization.
19
![Page 20: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/20.jpg)
Comparison of Each Risk Share
20
Risk to Vendor Price Type Minimum Cost Per Patient* (100 patients)
Maximum Cost Per Patient *
(1 patient)
None(T&M)
0% Variable $4,830 $483,000
Partial 5% Variable $4,830 $459,000
Complete 10% Variable $4,830 $439,000
Total 100% Fixed $4,830 $4,830
*Assuming full budget spent
![Page 21: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/21.jpg)
Penalties & Incentives
• Risk-share contracts can also contain special performance provisions that govern budget variance
• Carrot: Vendor has monetary incentive to out perform contract terms
• Stick: Vendor has monetary punishment if it underperforms contract terms
• Risk is generally tilted toward the vendor as the monetary penalties are harder to absorb
21
![Page 22: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/22.jpg)
Milestones or Units?
• Will achieving the payment markers constitute success?
• Is there a time requirement (e.g. Do patients need to be enrolled in a specific time?)
22
![Page 23: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/23.jpg)
Changes in Pricing Assumptions
• Protocol amendment• Drug availability • Number of active sites • Early termination of contract
23
![Page 24: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/24.jpg)
• Vendor bid strategy is to make per patient price appear lower, but consider how each bidder ascertains their per patient price in a 1,000-person study:
24
The “All Patients” Trick
![Page 25: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/25.jpg)
• Two specialty recruitment vendors bidding against each other• One vendor uses a partial risk share, the other uses a total risk share• The partial risk share budget is based on a prediction while the total risk share is a contract that
is governed by the vendor meeting performance metrics (randomized patients)
25
The “Risk Share” Trick
![Page 26: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/26.jpg)
Conclusions
• Risk sharing can be beneficial to both sponsors & vendors• Terms, conditions & units need to be well thought out • Patient enrollment contracts should consider both vendor
costs & pass-through (to be apples-to-apples)• Consideration should be given to impact of changes in
conditions or terms• Results-based pricing greatly improves outcomes for sponsors
26
![Page 27: Risk Sharing in Drug Development](https://reader036.fdocuments.in/reader036/viewer/2022081519/56813659550346895d9de42f/html5/thumbnails/27.jpg)
Thank you.