Transcript Drug development cycle - University of Massachusetts Medical School

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The contents of this module are accurate at the
timeMaster
of publication.
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Case
Your patient does not get relief from the
generic medication you prescribed
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You
trytotoedit
substitute
medication
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style from
another class that is only available in a
name brand
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Organizational
Influences
on
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Objectives
Review the principles of evidence-based
formulary development
Describe how pharma influences
organizations
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Describe and examine the impact of
organizational influences on prescribing
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Identify
ways forsubtitle
prescribers
to
address organizational influences
Communicate relevant issues for patient care
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Case
You complete the prior authorization (PA)
paperwork
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Patient gets the name brand
medication, but at a higher co-pay
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The patient wonders why this is true, how
these decisions are made, if one is really
better than the other
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Organizational Influences
– Home institution
– Insurances
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– Government
– Professional
societies
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– Pharmaceutical companies and chains
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Some Formulary Characteristics
Pros
• Reduce cost
• Improve quality
• Simplify
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Cons
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• Confusion
• Frustration
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Principles of Evidence-Based
Drug Formularies
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Garber, AM. Health Affairs. 2001;20(5):62-82; Simon GE, et al. J Gen Intern Med. 2005;20:964-968.
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The Preferred Formulary Statins from 4 Large
Pharmacy Benefit Managers (PBMs)
Brand Drugs
(manufacturer)
Crestor Lescol/XL
(Astra) (Novartis)
PBMs
Generic
Lipitor
(Pfizer)
Pravachol
(BMS)
X
X
Zocor
(Merck)
Lovastatin
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Aetna
Caremark
X
X
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Express Scripts
Medco
X
X
X
X
X
X
X
Federal Trade Commission. Pharmacy benefit managers: ownership of mail-order pharmacies. 2005, Aug. Available at:
http://www.ftc.gov/reports/pharmbenefit05/050906pharmbenefitrpt.pdf Accessed March 15, 2007.
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Players in the U.S. Commercial Drug Supply Chain
Premium
CONSUMER
Member Cost Share or
Payment for Drug if Cash Pay
Negotiated
Payment
EMPLOYER/PLAN
SPONSOR OR
HEALTH INSURER
Payment Flow
Rebate Flow
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PHARMACY
BENEFITS
MANAGER
PHARMACY
(Retail, Mail-order)
Product Flow
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DRUG
MANUFACTURER
Prompt Pay
Volume
Discounts
Negotiated
Payment
DRUG
WHOLESALER/
DISTRIBUTER
Kaiser Family Foundation. Follow the pill: understanding the U.S. commercial pharmaceutical supply chain. 2005. Available
at: http://www.kff.org/rxdrugs/7296.cfm Accessed October, 2006.
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Conflicting Formularies
Out-Patient
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Hospital-Based
Formulary
X
=
Formulary
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This may be frustrating and confusing…
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Preferred Formulary Status Influences
Medication Use
Patient Response to Change in the Formulary’s Preferred Statins
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Patients whose Statin Remained Preferred
4.0%
Discontinued Use of All Statins
9.1%
Patients whose Statin Lost Preferred Status
8.0%
Sw itched to a Preferred Drug
48.5%
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88.0%
Remained on Drug
42.4%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Huskamp HA, et al. N Engl J Med. 2003;349(23):2224-2232.
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Formularies
Pros
• Contain costs
• Easy access to
Cons
proven
meds
• Subject
change
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• Prescribers waste time
• Allows for quality
control and
• Patients waste time
and money
improvement
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• Patient safety is
compromised
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Government Influences
U.S. Department of
Health
and Human Services
Food and Drug
Administration
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Center for Biologics
Evaluation and
Research
Center for Devices
and Radiological
Health
Center for Drug
Evaluation and
Research
Center for Food Safety
and Applied Nutrition
Center for Veterinary
Medicine
National Center for
Toxicological Research
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Food and Drug Administration. Available at: www.fda.gov Accessed February 27, 2008.
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Government Influences
Provides oversight of the Medicaid rebate
program and anti-kickback statutes
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Rebateto
program
that Medicaid
pricing equals all other formulary programs
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Rebate
strong financial
incentive for pharmaceutical companies to
hide pricing concessions
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Non-Government Influences
on Prescribing
Institute of Medicine (IOM)
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Institute of Medicine Reports
Addressing the FDA’s resource challenges
Strengthening the scientific base of the agency
Integrating pre and post market review
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post market safety monitoring
Conducting confirmatory drug safety and efficacy
studies
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Enhancing the value of clinical trial registration
IOM Reports
Enhancing the FDA’s post market regulation and
enforcement
Institute of Medicine of the National Academies. Challenges for the FDA: the future of drug safety - workshop summary.
Available at: http://www.iom.edu/CMS/3740/24155/45823.aspx Accessed March 11, 2008.
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National Pharmacy Influence
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Patient Programs
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Professional Societies and Expert
Panels
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PhRMA Code on Interactions with
Healthcare Professionals
Not interfere
with the
independence
of a
Focus
on informing
healthcare
professionals
Intended
to benefit
patients
and
to
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Support
medical
research
and
education
healthcare
professional’s
prescribing
practices
about products by providing scientific and
enhance the practice of medicine
educational information
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Pharmaceutical Research and Manufacturers of America (PhRMA). Code on interactions with healthcare professionals.
2008. Available at: http://www.phrma.org/code_on_interactions_with_healthcare_professionals/ Accessed February 12, 2008.
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Choudry NK. J Am Med Assoc. 2002;287(5):612-617.
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Do you think this had an impact on
their recommendations?
(Please enter your answer below)
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What can we do?
(Please enter your answer below)
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Institutional Responses
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Links active as of: August 21, 2008.
http://med.stanford.edu/coi/siip/policy.html
http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Policy%20on%20Vendor%20Relationships.pdf
http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Device%20Companies.pdf
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Key Points
– Formularies are developed with available
evidence and influenced by pharmaceutical
company pricing and market forces
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Prescribers
shouldMaster
use available
evidence
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guide prescribing
– Government agencies, private organizations
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and academic health centers have started to
question prescriber-industry relationships
– Discuss prescribing decisions with patients
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Recommendations
Get involved with professional societies
Give feedback to or serve on Pharmacy and
Therapeutics Committee
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Talk to to
youredit
patients
about prescribing
Help patients identify appropriate resources
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Consider
cost generic
programs/sample centers
Promote communication during transitions of
care
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References

Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the
pharmaceutical industry. J Am Med Assoc. 2002;287(5):612-617.

Federal Trade Commission. Pharmacy benefit managers: ownership of mail-order pharmacies. 2005, Aug.
Available at: http://www.ftc.gov/reports/pharmbenefit05/050906pharmbenefitrpt.pdf Accessed March 15,
2007.

Food and Drug Administration. Available at: www.fda.gov. Accessed February 27, 2008.

Garber AM. Evidence-based coverage policy. Health Affairs. 2001;20(5):62-82.

Huskamp HA, Deverka PA, Epstein AM, Epstein RS, McGuigan KA, Frank RG. The effect of incentive-based
formularies on prescription-drug utilization and spending. N Engl J Med. 2003;349(23):2224-2232.

Institute of Medicine of the National Academies. Pray L, Robinson S (Rapporteurs). Challenges for the FDA:
the future of drug safety - workshop summary. Forum on Drug Discovery, Development, and Translation.
Board on Health Sciences Policy. 2007; The National Academies Press: Washington, D.C. Available at:
http://www.iom.edu/CMS/3740/24155/45823.aspx Accessed March 11, 2008.

Kaiser Family Foundation. Follow the pill: understanding the U.S. commercial pharmaceutical supply chain.
2005. Available at: http://www.kff.org/rxdrugs/7296.cfm Accessed October, 2006.

Pharmaceutical Research and Manufacturers of America (PhRMA). Code on interactions with healthcare
professionals. 2008. Available at: http://www.phrma.org/code_on_interactions_with_healthcare_professionals/
Accessed February 12, 2008.

Simon GE, Psaty BM, Hrachovec JB, Mora M. Principles for evidence-based drug formulary policy. J Gen
Intern Med. 2005;20(10):964-968.
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References - Policies

Partners HealthCare. Policy on interactions with pharmaceutical and medical device companies. Available at:
http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Device%20Companies.pdf
Accessed August 21, 2008.

Stanford School of Medicine. Policy and guidelines for interactions between the Stanford University School of
Medicine, the Stanford Hospital and Clinics, and Lucile Packard Children's Hospital with the pharmaceutical,
biotech, medical device, and hospital and research equipment and supplies industries ("Industry"). Available
at: http://med.stanford.edu/coi/siip/policy.html Accessed August 20, 2008.

UMass Memorial Medical Center. Policy Manual. # 1143 Policy on Vendor Relationships. Effective Date:
7/1/2008. Available at:
http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Policy%20on%20Vendor%20Re
lationships.pdf Accessed August 18, 2008.
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Resources
•
•
Consumer Reports Best Buy Drugs
http://www.consumerreports.org/health/best-buy-drugs/index.htm
•
•
Institute of Medicine Reports
http://www.iom.edu/cms/2955.aspx
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•
Journal Watch
http://www.jwatch.org/
•
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Medical Letter
http://www.medicalletter.org/
•
•
Medline (through the U.S. National Library of Medicine)
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed
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Attorney General Consumer and Prescriber Education Grant Program Initiated Resources
•
•
http://www.rxfacts.org/
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Georgetown University
http://www.pharmedout.org/
•
MGH Institute of Health Professionals
http://www.perxinfo.org/perx.html
•
University of Kentucky
http://www.cecentral.com/
•
University of North Carolina, Chapel Hill
http://harryguess.unc.edu/
•
University of Massachusetts Medical School/
Meyers Primary Care Institute
http://www.umassmed.edu/meyers/index.aspx
Brigham & Women's Hospital
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Resources
Institutions with Available Policies
 Partners HealthCare

http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Devic
e%20Companies.pdf
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 Stanford School of Medicine

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http://med.stanford.edu/coi/siip/policy.html
 UMass Memorial Health Care

http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Po
licy%20on%20Vendor%20Relationships.pdf
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Resources
Additional Learning Modules in This Series
 Communicating with Patients
 Evidence-Based Medicine (EBM)
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 Pharmaceutical Development and Regulation
 Pharmaceutical Marketing
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subtitle style (PR)
 Provider-Pharmaceutical
Communication
 Links to Web-Access and Downloadable Versions Available at:
http://www.umassmed.edu/meyers/index.aspx
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Questions
1. Evidence-based formularies are intended to reduce cost, improve quality
and simplify medication delivery.
A. True
B. False
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Answer
1. A: True.
The goals of an evidence-based formulary are to support cost-effective,
quality care by promoting the use of a limited number of medications that
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have proven effective for specific diseases. This practice should also
simplify delivery as prescribers may become more familiar with a smaller
number of medications, and institutional pharmacies may not need to
maintain large
inventories.
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to edit
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Questions
2. Efficacy data is the only factor pharmacy benefits managers use in
determining preferred formulary status for drugs.
A. True
B. False
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Answer
2. B: False.
In an ideal world formularies would be based on clear evidence to support
appropriate decision-making for patients. In practice they are influenced by
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several factors. For one thing, clear evidence is not always adequate to
make these decisions. Additionally, the business of medicine involves pricing
of medications and contractual agreements between pharmaceutical makers
and pharmacy
benefitto
mangers,
in somesubtitle
cases providers
attempt to
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maintain autonomy in decision making by influencing formulary decisions.
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Questions
3. Differences between hospital-based formularies and outpatient
pharmaceutical benefits are likely to contribute to patient confusion about their
medications or medication errors.
A. True
B. False
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Answer
3. A: True.
For example, your patient may be discharged home on a medication despite
the fact that it might not be covered by your patient’s outpatient pharmacy
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benefit, or could require a larger co-payment. This may be frustrating for
your patients and you as you work through the system to determine whether
you will change the medication to one covered by your patient’s insurer for
outpatient treatment,
a prior authorization
In some cases
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a patient might be discharged on a me-too medication that may be different
from what they already have at home. This could cause confusion and
increased side effects and risks from unintentional double dosing.
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Questions
4. The Institute of Medicine (IOM) is a branch of the US government.
A. True
B. False
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Answer
4. B: False.
The Institute of Medicine is a private, non-governmental organization. It is
largely composed of unpaid volunteer experts who author reports based on
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evidence and is free from many of the constraints of governmental
organizations.
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Questions
5. In a NEJM study of patients whose statin lost preferred formulary status,
nearly 50% of patients switched to the preferred drug showing the impact of
formulary decision-making on prescribing.
A. True
B. False
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Answer
5. A: True.
Additionally 9% stopped using statins altogether only 42% remained on the
old drug. This study clearly shows that formulary decisions can drive
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prescribing.
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Questions
6. A number of major US pharmacy chains now offer some generic
medications at low prices to the consumer. This may aid patient compliance
with medications, and influence prescribing.
A. True
B. False
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Answer
6. A: True.
To our knowledge there have been no detailed studies of this practice, but
anecdotal evidence suggests that providers may direct patients to these
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locations to fill prescriptions. This may support use of cost-effective generics
and patient compliance, which may also influence prescribing.
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Questions
7. The US Government’s rebate program requires that Medicaid pricing equals
that of other formulary programs. This is designed to maintain pricing equity,
but may provide an incentive for pharmaceutical companies to hide pricing
concessions to other groups.
A. True
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to edit Master title style
B. False
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Answer
7. A: True.
This is designed to maintain pricing equity, but may provide an incentive for
pharmaceutical companies to hide pricing concessions to other groups.
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Questions
8. Many pharmaceutical companies provide patient support programs that
include coupons for trials of drugs, low cost medication programs for low
income patients, and freely accessible information regarding diseases and
treatments. These programs may help patients, and may influence prescribing.
A. True
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B. False
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Answer
8. A: True.
These programs may help patients, and may influence prescribing.
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Questions
9. Prescribing can be influenced by which of the following organizational
mechanisms:
A.
B.
C.
D.
E.
Institutional pharmacy and therapeutics committees.
Clinical pathways developed by professional societies.
Insurance company tiering processes.
Pharmaceutical company pricing and marketing practice.
All of the above.
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Answer
9. E: All of the above.
Clinicians should be aware of these influences when making decisions to
ensure that they are prescribing appropriately.
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Questions
10. The PhRMA code on interactions with healthcare professionals states that
pharmaceutical representatives should focus on informing healthcare
professionals about products by providing scientific and educational
information.
A. True
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B. False
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Answer
10. A: True.
Some pharmaceutical companies are further adjusting their support of CME
and physician outreach even as this presentation is under preparation.
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Clinicians should be aware of potential bias in all sponsored educational
programs, and integrate this into their clinical decision-making. Please see
our module on communication with pharmaceutical representatives for
additional information.
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Questions
11. Did completing this module help you to understand the principles of
evidence-based formulary development?
A. Yes, definitely
B. Yes, probably
C. Probably not
D. Definitely not
E. Not sure
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12. Would you recommend this training module to a colleague?
A. Yes, definitely
B. Yes, probably
C. Probably not
D. Definitely not
E. Not sure
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Questions
13. Will you do anything differently in your practice as a result of this training
module?
A. Yes, definitely
B. Yes, probably
C. Probably not
D. Definitely not
E. Not sure
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14. Please tell us about any changes you are considering or planning:
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