confidential – internal celgene use only veterans …veterans health administration (vha) overview...

Veterans Health Administration (VHA) Overview and FAQs

Confidential – Internal Celgene Use Only

July 2015 US-ABR150053(1)

This backgrounder provides an overview of the VHA system, including information on the organizational structure, patient demographics, and VHA guidelines surrounding interactions with affiliated healthcare providers



For Celgene internal use only.

Intended for sales educational training ONLY.

Use of this presentation in sales or promotional detailing is prohibited.

CONFIDENTIAL

Contents


Veterans Health Administration (VHA) Overview

Frequently Asked QuestionsSystem Organization Interactions●  How does working within the VHA differ from working within

other networks?

●  What is the organizational structure of a typical VHA medical center?

●  What is the relationship between teaching institutions and the VHA?

●  What is a VISN?

●  What is the VA National Formulary (VANF)?

●  What are the implications of the VANF for Celgene products?

●  What is the formulary approval process?

●  What is the process for getting a non-formulary drug for a patient?

●  What are VHA Drug Monographs and Criteria-for-Use documents (CFUs)?

●  What are the implications of national and local CFUs?

●  What are the access implications if a product is not on the VA National Formulary?

●  Are the physicians employed by the federal or state government?

●  Are all VHA clinicians held to the same restrictions as VHA physicians?

●  Can a VHA physician be trained as a speaker and provide promotional talks on behalf of Celgene?

●  What are the rules and guidelines on VHA providers attending Celgene speaker programs?

●  What if a VHA employee attends a Celgene speaker program?

●  Can promotional materials or disease state materials be left at a VHA facility?

●  Can speaker programs (outside of speaker direct) be conducted within the VHA?

●  Would it be allowable to host a CME program specifically for the VHA?

●  What types of patients receive care at VHA facilities?

●  Are VHA patients eligible to enroll into CPS?

Key Contacts

1

2

3


VETERANS HEALTH ADMINISTRATION (VHA) OVERVIEW



The VHA is the largest integrated healthcare system in the US1

●  Each year, the VHA provides comprehensive care to over 8.3 million veterans1


1.  Veterans Health Administration. VHA Web site. About VHA. Available at: http://www.va.gov/health/aboutVHA.asp#datasource. Accessed February 20, 2015. 2.  US Department of Veterans Affairs. Quickfacts: Department of Veterans Affairs Statistics at a Glace. Available at:

http://www.va.gov/vetdata/docs/Quickfacts/Homepage_slideshow_09_30_14.pdf. Accessed February 20, 2015.

56

131

150

300

819 VA Community-Based Outpatient Clinics

VA Vet Centers

VA Hospitals

VA National Cemeteries

Veterans Benefits Administration Regional Offices

Oncologists are based primarily in larger, full-service medical centers

Number of Facilities2


A substantial portion of US HCPs have experience with the VHA


of physicians rotate through the VHA for training1

60%

● There is a considerable overlap of physicians working with both VHA and academic centers1

—  Approximately 70% of VHA physicians have a faculty appointment at a US medical school

● The VHA is a major provider of graduate medical training and CME1

1.  Association of American Medical Colleges. The VA and Academic Medicine: Partners in Health Care, Training, and Research. Available at: https://www.aamc.org/download/385612/data/07182014.pdf. Accessed February 20, 2015.

2.  US Department of Veterans Affairs. VA Physician Brochure. Available at: http://www.vacareers.va.gov/assets/common/print/Physician_Brochure.pdf. Accessed February 20, 2015.

physicians are employed by the VHA2

>14,000


VHA decision making happens at multiple tiers

Lower tiers do have some level of decision-making power, such as creating local Criteria-for-Use guidelines, but must adhere to national guidelines

Decisions made at the national level (eg, products on formulary and national Criteria-for-Use guidelines) must be honored at other levels

VISN level (Veterans Integrated Service Networks) 23 Regional VISNs

Local VHA clinics


National-level decisions are passed down

Department of Veterans Affairs

Veterans Affairs National Formulary

(VANF)

US military veterans obtain healthcare via two systems: the VHA and Tricare


These are different systems

1.  US Department of Veterans Affairs. At-A-Glance Pocket Card. Fiscal Year 2015, First Quarter 20. Available at: http://www.va.gov/vetdata/docs/pocketcards/fy2015q1.pdf. Accessed February 20, 2015.

The federal government, through the VHA and the DoD, provides healthcare for veterans, current armed service members, as well as their family members

US Veteran Population

~22 Million1

●  US military veterans who meet specific criteria

●  Service-disabled veterans only

●  Administered by the Veterans Administration (VA)

●  Active service members and veterans who don’t qualify for the VHA

●  Administered by the DoD

VHA

TRIC

AR

E


Malignancy incidence among US Veterans


1. Zullig LL et al. Cancer incidence among patients of the U.S. Veterans Affairs Health Care System. Mil Med. 2012;177:693-701. 2. Lung Cancer Alliance. Lung Cancer as It Affects Veterans and Military. Lung Cancer Alliance web site. Available at:

http://www.lungcanceralliance.org/special-features/special-focus-on-veterans-and-lung-cancer/lung-cancer-and-wartime-exposure.html. Accessed July 28, 2015. 3. Campling BG et al. A population-based study of lung carcinoma in Pennsylvania: comparison of Veterans Administration and civilian populations. Cancer.

2005;104:833-840. 4. Data on file. Celgene Inc. 5. Zhong F. Systemic treatment outcomes of metastatic pancreatic cancer. Fed Pract. 31:49-52.

The VHA serves an older, predominantly male subset of the US population1

Lung Cancer

●  Lung cancer is the second most common cancer diagnosed among male and female veterans1

●  Incidence of lung cancer is higher among veterans than in the civilian population2,3

●  An estimated 40% of VHA NSCLC patients are of squamous histology, versus a national average of 24%4

●  The VHA has not instituted a screening process for lung cancer1

●  VHA patients diagnosed with lung cancer have more frequent and more severe lung disease

Pancreatic Cancer5

●  Some studies suggest increased risk of pancreatic cancer among some subsets of veterans (eg, obese, hepatitis C infection, diabetes)

Breast Cancer1

●  Breast cancer is the most common malignancy diagnosed in female veterans, accounting for approximately 30% of female cancers

●  Women currently make up approximately 15% of the US veteran population

●  The proportion of women veterans is growing


FREQUENTLY ASKED QUESTIONS



SYSTEM ORGANIZATION

Frequently Asked Questions:


FAQs: System Organization (cont’d)


What are important factors to be aware of when working within the VHA?Q

●  Access decisions for pharmaceuticals are primarily made at the national level ●  Oncologists are based primarily in larger full-service medical centers ●  Pharmacy directors pay close attention to chemotherapy because it is a

significant cost

A


What is the organizational structure of a typical VHA medical center?Q

A

Credentialing Performance Improvement

Director

EEO

Public Affairs

Chief of StaffAssociate Director Patient Care Services

● Fiscal ● Business ● HR ● Security ● Resources ● Nutrition ● Etc

● Emergency Prep

● Safety ● Fire ● Etc

Patient Safety

● ACOS/ ACHA

● ACOS/ R&D

● Makes local formulary decisions for departments including:

● Oncology ● Radiation ● Surgical ● Medical ● Etc

● Nursing ●  Infection Control ● SPD ● Learning Systems

PHARMACY

Compliance



Workforce Development


1.  Association of American Medical Colleges. The VA and Academic Medicine: Partners in Health Care, Training, and Research. Available at: https://www.aamc.org/download/385612/data/07182014.pdf. Accessed February 20, 2015.

What is the relationship between teaching institutions and the VHA?Q

A

●  Many are physically attached ●  Affiliated VHA clinics and teaching institutions have separate formularies ●  Most residents and fellows will spend time within a VHA medical center or

outpatient clinic

92% of US medical schools (130 of 141) are affiliated with a VHA facility1



1.  Veterans Health Administration. VHA Web site. Locations. Available at: http://www.va.gov/directory/guide/division.asp?dnum=1. Accessed February 20, 2015. 2.  Department of Veterans Affairs. Veterans Health Administration. VHA Formulary Management Process. VHA Handbook 1108.10. Washington, DC. 2012. Available at:

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2417. Accessed February 20, 2015.

What is a VISN?Q

A ●  VISN = Veterans Integrated Service Network

●  Each VHA medical center, community-based outpatient clinic, or other facility falls within a VISN

●  VISN Formulary Committees and Pharmacy Executives affect local access2

—  Enforce VHA formulary decisions

—  Analyze non-formulary drug data

—  Ensure a non-formulary approval process is in place

There are 23 VISNs across the US1



Department of Veterans Affairs. Veterans Health Administration. VHA Formulary Management Process. VHA Handbook 1108.10. Washington, DC. 2012. Available at: http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2417. Accessed February 20, 2015.

What is the VA National Formulary (VANF)?Q

A ●  The VANF dictates the drugs and supplies that must be available for prescriptions at all VHA facilities

In September 2009, all VISN and local VHA clinic formularies were eliminated

VANF objectives include:

● Uniform reliance on evidence-based drug evaluations

●  Improved patient safety

VANF inclusion is:

● Highly restricted

● Highly cost sensitive



U.S. Department of Veterans Affairs website. VA National Formulary by class, June 2015. Available at: http://www.pbm.va.gov/nationalformulary.asp. Accessed July 28, 2015.

What are the implications of the VANF for Celgene products?Q

A ●  ABRAXANE is not currently included on the VANF, while other taxanes are included

●  However, local CFU, community standards of care, and NCI Guidelines influence treatment choices

●  Therefore ABRAXANE may be prescribed at local VHA medical centers

Current status of taxanes on the VANF

Docetaxel ✔ Solvent-based paclitaxel ✔ ABRAXANE ✖



VistA = Veterans Health Information Systems and Technology Architecture (VistA)

What is the formulary approval process? Q

A ●  Almost all branded oncology drugs are currently off the VANF

What is the process for getting a non-formulary drug for a patient? Q

A ●  There is a non-formulary request form on the VistA system (EMR) ●  Once the form is completed, it is sent directly to Pharmacy. The process may be

more streamlined at some VHA clinics and less so at others ●  For non-formulary drugs, including ABRAXANE:

—  Some local and VISN level Pharmacy Directors may make it more challenging to access certain drugs




What are VHA Drug Monographs and Criteria-for-Use documents?Q

A

Monographs and VHA national criteria-for-use documents are freely available to the public and available online

Drug Monographs

●  Monographs are independently written (without industry input) by subject matter experts within the VHA’s Pharmacy Benefits Management (PBM)

●  Current editions of monographs are acquired, catalogued, classified, and maintained in support of the patient care, education, research, and management activities of the VHA

Criteria-for-Use (CFU)

●  A CFU is a set of clinical criteria developed by the VHA at the national level that describes how certain drugs may be used

●  National CFUs may exist for drugs on the VANF ●  Local CFUs may allow for use of drugs not on the VANF



What are the implications of national and local CFUs?Q

A ●  Once a national CFU is in place, VHA leadership assumes it will be followed

●  A national or local CFU does not ensure that a drug is automatically in the local VHA’s ordering system

—  Each local VHA medical center maintains its own separate ordering system

•  The local ordering system will include the drug once an initial order is made

●  If a drug is not available via the VANF, local CFUs can influence product availability within a single clinic



What are the access implications if a product is not on the VA national formulary?Q

A Drugs that are given despite their lack of inclusion on the VANF are considered “off formulary” ●  Each VISN has some discretion to approve off-formulary drugs and employs a VISN

Pharmacy Executive ●  VHA clinics may fill prescriptions for drugs not on VANF or the VISN formulary ●  Prescriptions may be filled via the non-formulary request process

— Use at the VHA clinic level is influenced by both national and local Criteria-for-Use (CFU) guidelines

— Barriers to access will vary depending on the local VHA clinic and the Pharmacy Director


Commercially available products that are not on the VANF may be made available at the VISN or VHA clinic level


INTERACTIONS

Frequently Asked Questions:


FAQs: Interactions (cont’d)


Are the physicians employed by the federal or state government? Q

●  Staff physicians operating within the VHA are federal employees

●  Food and gifts are heavily restricted by law

●  Rules regarding federal employees remain in effect when interacting with these physicians in other settings (eg, in an academic institution)

A

Refer to the VHA Handbook for more specifics:http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2852



Are all VHA clinicians held to the same restrictions as VHA physicians?Q

A

Can a VHA physician be trained as a speaker and provide promotional talks on behalf of Celgene?Q

A

●  Yes: Any clinician who is practicing in a VHA facility, even if they practice elsewhere, must abide by the VHA Rules, Regulations and Formulary Process

●  This applies to nurses, pharmacists, PAs, NPs, and fellows (if tied to a teaching institution) as well as to physicians

●  Yes, they can, but only on their own time ●  Rules regarding meals and gifts remain in effect



What are the rules and guidelines on VHA providers attending Celgene speaker programs?Q

A ●  You must receive permission from the facility’s Pharmacy Director before you invite VHA providers

●  VHA providers can attend (or speak at) dinner programs, however the meal must be valued at less than $201

—  Importantly, the total value of items (including reprints)/meals received by the VHA provider from Celgene (not just a single sales representative) cannot exceed $50 in a calendar year

1.  Department of Veterans Affairs. Veterans Health Administration. Promotion of Drugs and Drug-Related Supplies by Pharmaceutical Representatives. VHA Handbook 1108.10. Washington, DC. 2012. Available at: http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2852. Accessed February 20, 2015.



What if a VHA employee attends a Celgene speaker program? Q

A ●  As federal employees, they are aware of the rules regarding accepting meals ●  The program is open to them, and they are welcome ●  If the employee chooses to attend and eat, it is his/her choice ●  There is no requirement that the meeting sponsor inform them of the rules ●  Celgene will report the value of the meal provided to the employee if required by federal or

state transparency laws, such as the Sunshine Act (applicable to US physicians)



Can speaker programs (outside of speaker direct) be conducted within the VHA?Q

A ●  Only if it is approved by the Pharmacy Director of the facility ●  In general, Pharmacy Directors will not allow presentations on or discussions of:

—  Non-formulary drugs —  Drugs not specified on a CFU


Can promotional materials or disease state materials be left at a VHA facility?Q

A ●  Materials must be non-branded ●  Materials must be approved by the Pharmacy Director of the facility ●  In general, Pharmacy Directors will not allow distribution of materials relating to drugs

that are not on formulary


What types of patients receive care at VHA facilities? Q

A ●  For the purposes of VHA health benefits, a person who served in active military service and was discharged or released under conditions other than dishonorable is a veteran

—  Some veterans may choose to use health benefits, such as private insurance, for which they are eligible

●  The number of veterans who can be enrolled in the VHA and level of coverage is determined by federal funding

●  Enrollment priority groups ensure certain groups of veterans are able to be enrolled before others

—  Eg, veterans who are more than 50% disabled or determined to be unemployable have top priority, and those with high incomes may have lower priority

Veterans Health Administration. VHA Web site. Priority Groups Table. Available at: http://www.va.gov/healthbenefits/resources/priority_groups.asp. Accessed February 20, 2015.

Refer to the VHA Website to find information on the 8 enrollment priority groups:http://www.va.gov/healthbenefits/assets/documents/publications/IB-10-441_enrollment_priority_groups.pdf



Are VHA patients eligible to enroll into CPS? Q

A

●  However, CPS is rarely utilized by VHA patients because:

—  VHA coverage is excellent and requires minimal copays, if any

—  The VHA is the last payer, after Medicare and Medicaid

—  Many VHA patients also have Medicare or Medicaid

Yes, they are eligible!


Key Contacts

●  For more information or to address additional questions, please contact the Celgene Federal Markets Team


Elizabeth MorseVHA

[email protected]

Howard CrawfordDoD

[email protected]


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