pharmaceutical sampling strategy, compliance and future trends

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www.exlpharma.com Pharmaceutical Sampling Strategy Trends & Compliance Content summarized from 5 th Sampling Strategies Conference, October, 2009

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With increased use and scrutiny of drug samples by pharmaceutical industry, this presentation outlines some current updates, compliance issues and future trends. An effective drug sampling program can really make an impact on a pharmaceutical company brand and lead to increased patient starts.

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Page 1: Pharmaceutical Sampling Strategy, Compliance and Future Trends

www.exlpharma.com

Pharmaceutical Sampling Strategy Trends &

Compliance

Content summarized from 5th Sampling Strategies Conference, October, 2009

Page 2: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Industry Sales Force Trend• Reps say they need samples to see

doctors….how important are rep calls?• In some studies:

– 65% of sales calls result in samples being dropped off by a rep without the rep speaking with an MD

– 93% of sales calls last less than 2 minutes– Sales force sizes doubled from 1998 to 2006, while # of

MDs increased only 15%– Industry analysts predict aggregate of 10% sales force

reduction per year over next 3 years• From 98,000 reps in 2007 to 60,000 by 2010

2Source; ZS Associates

Page 3: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Continuum of Adherence = ROI

3

Identification Initiation Compliance Persistence

100% ofthoseDx

60% receive1st Rx

40% refill once

20% refill twice

10% refill >2X

The greatest ROI opportunity for most brands (and best patient outcomes) is to focus on improving the continuum of adherence.

Source: NEJM

MDPatientVisit

MDPatientFol UpVisit

6+ Months

Reps

Samples

Page 4: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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The Role of SamplesSamples Matter to Physicians

Encourage New Starts

Facilitate Titration

Promote Adherence

Samples are a key component to product adoption and compliance.

Samples are a Tool to… Samples Are Not…

Substitute for PAP

Substitute for Promotions

“One Size Fits All” Strategy

Page 5: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Goal of Sampling in Today’s Environment

• Patient focus for physician– Test efficacy and tolerability with the appropriate patient

• Sales & Marketing– Improve the quality of care for the appropriate patient while driving new starts and

scripts

Page 6: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Risk of Inappropriate Sampling• Under-sampling

– Patient does not receive therapy– Physician is not able to gain experience with patient trials– Company is not getting appropriate exposure for drug

• Over-sampling– Cannibalize sales – Unauthorized Patient Assistance Program

• Expensive and inefficient method

– Potential for rep or physician product diversion• FDA & DEA investigation

• Who is responsible for intelligent sampling???

• EVERYONE!

Page 7: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Sample Model Alternatives

Sales Reps are the primary distribution vehicle and maintain decision authority on inventory management and allocation

Sales Reps are the primary distribution vehicle while HQ provides prescriptive inventory management and HCP allocation guidance

Direct sample send is used for steady state; reps manage closet and collect signatures; some reps may carry full time or in exception cases

Direct sample send is used for all sample distribution; reps focus on message delivery and process sample requests.

Benefits•Rep carry may improve HCP access

•Immediate HCP sample needs filled

•HCPs prefer this model

Drawbacks•High operational cost

•May lead to over / under sampling

•Coverage challenges

Drawbacks•High operational cost

•Coverage challenges

Drawbacks•Ramp up to sample is time/cost intensive

•Could be higher ops cost than current model

Drawbacks•Field disruption

•Customers do not prefer this model

•Freight increases

Sampling Models

Sales Rep Driven

HQ Driven Rep-Carry / Rep Directed

Rep-Carry /HQ Directed

Hybrid Rep-Carry / DTP

Direct to Physician

Benefits•Rep carry may improve HCP access

•Immediate HCP sample needs filled

•Reduces inventory, optimizes HCP allocation

Benefits•Rep carry for launch drives uptake

•Reduces inventory, optimizes HCP allocation

Benefits•Lower overall costs

•Reduces inventory, optimizes HCP allocation

•Better HCP coverage

•Reduces compliance concerns

Page 8: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Rep Value vs. Sample Value

Product Launch Growth Mature Product

Product Life Cycle

High Rep Value• Consistent message• New information• Physician gains comfort with prescribing• Supplies Samples for trial

Greater access to physician

Moderate Rep Value• Physician knows product• Physician prescribing• New indications & info• Supplies Samples for trial

Physician Access reduced

Low Rep Value• Message fatigue• Physician prescribing entrenched• Supplies Samples

Physician access for signature

Page 9: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Keys to Successful Sampling

• Planning

• Collaboration

• Communication

• Analysis

• Monitoring

• TRAINING

Page 10: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Sample Monitoring of the Field • How do you determine if reps are sampling appropriately?

– Analysis of scripts vs samples at a minimum

• Data to consider when developing guidelines & reports

– Product specific sampling quantities – Physicians in call plan receiving samples– Average monthly samples dispersed over 12 months– Average monthly scripts filled over 12 months– Who are the reps calling on these physicians– How often you review

• What do you do about the physicians outside of guidelines?

– Counsel physicians on sampling and other sampling mechanisms

Page 11: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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How do you stay up-to-date?• Attend conferences to stay updated

• Compliance audits – risk assessments or gap analysis

• Networking

• When a problem arises?

• Vendors

Page 12: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Samples Marketplace• Samples strategy more and more integrated across personal and

non personal promotion Sales Rep delivers samples - SFA tools needs to be integrated into

overall Pharma company marketing platform Direct Samples targeting and enrollment

– Direct mail – Fax– Telemarketing– Online– Mobile (coming soon)

• Physicians are open to multiple channels for accessing samples directly and see online (and potentially mobile) as more accessible and efficient for them

Page 13: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Pharma Challenges and Opportunities in eSampling

Allocation & Targeting – impacting marketing, compliance and legal– Open Program approach – any called on prescriber can access

samples– Targeted Approach – Marketing targets specific prescribers

Electronic samples closet – buy or build model– Buy - several eSample closet providers available

• J. Knipper and Co – MySampleCloset.com• MedManage –medmanagesystems.com• One Eleven Interactive – 111 interactive.com

– Build – do companies have expertise to build a customer friendly and compliant system?

• Option: hire eSamples closet provider as a consultant for in house development and build

Page 14: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Pharma Challenges and Opportunities in eSampling

Customer Facing– Develop Customer Experience Strategy and execute

on it

– Authentication and authorization

– Promote eSample availability

Infrastructure support – IT/ systems/operations– Centralized hub for all HCP activities

– Samples business rules across company

– Real time support

– Prescriber validation

Page 15: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Pharma Challenges and Opportunities in eSampling

Business Processes and Analytics– Legal, Medical and Regulatory – centralized and consistent

review standards and practices across all brands– Measurement – market research and campaign analytics

integrated across personal and non personal promotion– Determining allowable cost per HCP/prescriber– Include promotional communications in direct sample packages– Sales force involvement – integrate sample drop for sales rep

and direct programs

Page 16: Pharmaceutical Sampling Strategy, Compliance and Future Trends

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Summary• For access to additional presentations or case

study information, please visit www.exlpharma.com and search for our Sampling Strategy conference

• Also, our 6th Sampling Strategy conference is taking place October 25-26th at the Lowes Hotel in Philadelphia, for more information, please click the following link: http://www.exlpharma.com/events/6th-sampling-strategies-and-alternatives