jointly provided by: csl...340b enrollment grew steadily before the aca and accelerated after the...

Copyright 2018 National Hemophilia Foundation. All rights are reserved.

CCSC is supported by charitable donations from founding supporter, Shire, and additional support from Bioverativ, CSL Behring,

Genentech, Inc., Novo Nordisk, Inc., and Pfizer Inc.

Jointly provided by:


Introduction

Edmund Pezalla, MD, MPHCEO

Enlightenment Bioconsult, LLC


Learning Objectives

• Describe the current environment and future consequences for Hemophilia Treatment Centers (HTCs)

• Discuss how the HTC model can be positioned for success in the current health care transformation environment

• Identify opportunities for collaborating with payers for the management of bleeding disorders

• Explain how participation in CCSC can foster HTC exposure and sustainability to promote network inclusion and favorable contract negotiations with payers and purchasers


Agenda

340B Update: The Current Environment and Future Consequences for Hemophilia Treatment Centers Johanna Gray Senior Vice PresidentCRD Associates

Health Care Transformation and the HTC Model: Positioning for Success Marisela Trujillo, MSWAdministrative DirectorUniversity of Texas Health Gulf States Hemophilia and Thrombophilia Center

Payer Perspectives and Collaborative Opportunities for the Management of Bleeding DisordersEdmund Pezalla, MD, MPH

CCSC: Charting a Course for Cost‐effective, Improved Outcomes in Hemophilia ManagementKollet Koulianos, MBASenior Director Payer RelationsNational Hemophilia Foundation

Panel Discussion and Audience Q&A


340B Update: The Current Environment and Future Consequences for Hemophilia Treatment Centers

Johanna GraySenior Vice President

CRD Associates


History of 340B Drug Discount Program

• Established in 1992 under the Veterans Health Care Act • HTCs were designated as original covered entities

eligible to participate in program• Allows HTCs to purchase drugs at a discounted price

based on the Medicaid rebate• The Congressional report that accompanied the creation

of 340B in 1992 states that its purpose is to enable eligible providers “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services”

• HTCs report their program income from 340B and use funds in accordance with their grant from HRSA


340B Changes in the ACA Change the Dynamic

ACA expanded hospitals eligible for 340B:Children’s Hospitals, Critical Access Hospitals, Sole Community Hospitals, Free‐standing Cancer Hospitals

Now, more than 1/3 of hospitals in 340B

ACA also reduced DSH payments for hospitals

Hospitals expanding 340B into high‐cost ambulatory care areas by purchasing cancer practices

340B


Eligible Covered Entities/Participants in 340B

Grantees

• Federally Qualified Health Centers• Federally Qualified Health Center Look‐Alikes

• Native Hawaiian Health Centers• Tribal / Urban Indian Health Centers• Ryan White HIV/AIDS Program Grantees• Black Lung Clinics• Comprehensive Hemophilia Diagnostic Treatment Centers that receive grants from HRSA

• Title X Family Planning Clinics• Sexually Transmitted Disease Clinics• Tuberculosis Clinics

Hospitals

• Children’s Hospitals• Critical Access Hospitals• Disproportionate Share Hospitals• Free Standing Cancer Hospitals• Rural Referral Centers• Sole Community Hospitals


340B Enrollment Grew Steadily Before the ACA and Accelerated After the Legislation Was Passed

Source: Avalere analysis of 340B Database of Covered Entities from the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA).

8,035 7,972 8,239 8,6069,193

10,32511,442

12,162 11,926 12,40413,139

14,07614,725

16,572

18,564

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Num

ber o

f 340B SitesHistorical Enrollment in 340B Program, 1998‐2012

(As of July Each Year)


Over Last Few Years, PhRMA, BIO, and Cancer Providers Mount Opposition to 340B

• Changes in health care system mean that program intent has and should change– Limit eligible patients to uninsured or indigent patients

• Concerned with growth in hospitals and use of contract pharmacies

• Need for appropriate oversight and transparency regarding how hospitals earn and spend 340B revenues

• But, manufacturers of hemophilia treatments have been supportive of HTC participation in 340B


340B Reform in Congress – 2017 ‐ 2018

• Congressional Hearings– Both House and Senate – Participants: HRSA/OPA, OIG, GAO, 340B covered entities, PhRMA

• Congressional letters to stakeholders re: use of program income, contract pharmacies, HRSA oversight and regulation

• Energy and Commerce Oversight and Investigations Report with recommendations for policy changes– Mostly focused on hospitals but some ideas could affect HTCs

• Bills introduced in both House and Senate


Energy and Commerce Report Oversight and Investigations Subcommittee Report Recommendations

• “Clarify” the intent of the program; focus on uninsured and low‐income

• Congress should provide HRSA Regulatory Authority• Broaden scope of audits, ensure that audits are equally done

on covered entities and manufacturers, and require contract Rx audits

• Improve transparency– Require all covered entities to track and report savings– Require all covered entities to report level of charity care– Publish ceiling prices

• Develop a new metric to determine hospital eligibility for 340B

• Reduce duplicate discounts in Medicaid Managed Care.• HRSA/OPA should be given the resources to implement

these recommendations


340B Bills Introduced

Numerous bills have been introduced or released:

Bill themes:

• # of individuals prescribed 340B drugs by payer

• total costs and “savings” • Total costs of charity care • % of revenue for physician‐

administered drugs • names of contract pharmacies and

other vendors

HR 4710: 340B PAUSE Act (Reps. Buschon (R‐IN) and

Peters (D‐CA))

S. 2312: HELP Act (Sen. Cassidy (R‐LA))

S. 2453: Ensuring the Value of the 340B Program Act (Sen. Grassley (R‐IA))

15 Bills released before House hearing this

summer

Moratorium on new DSH hospitals and child sites

New requirements for contract pharmacies

New eligibility criteria for hospitals

Requirements for hospitals to annually

report:


2018 Elections – Impact on 340B

• Entire House and a third of Senate up for election– Many predict House could flip majority party– Senate change less clear; slim margin in either case

• Democratic Majority in House would significantly diminish the current drive for 340B legislation

• Senate will continue to work on 340B in a bipartisan manner

• Legislation still possible, but dynamics changing


Trump Administration and 340B

• Drug Pricing Blueprint released on May 11• Some policies that have already been implemented; mostly

request for comments in four categories:1. Increased competition; 2. Better negotiation3. Incentives for lower list prices4. Lowering out‐of‐pocket costs

• Suggests that 340B is a cause of higher drug costs and that changes may be necessary – Blueprint mentions 2018 Medicare Hospital Outpatient cut as a way

to lower costs– Questions the growth of the program, patient definition, ways to

prevent duplicate discounts under Medicaid, reimbursement for 340B drugs in public and private plans


340B Medicare Regulatory Changes

• Funds generated spread among all hospitals

2018 Medicare Hospital Outpatient Prospective Payment System (HOPPS) rule cut reimbursement for 340B drugs from ASP+6% to ASP‐22.5%

• Only applies if bill as hospital outpatient department vs. as pharmacy or physician office• Certain hospitals exempted

Effect on HTCs appears to be very limited so far

Hospital lawsuits to address cuts ongoing

HR 4392 would also stop the cut


Potential Threats from the Trump Administration

• Medicare reimbursement cuts in other settings besides Hospital Outpatient Departments– FY19 Budget proposal included policy that could to allow hospitals that hit certain charity care thresholds to keep some of the money

• Release of a regulations or another Mega Guidance to regulate the program that includes harmful language – Restrictive patient definition – Burdensome Medicaid policies to prevent duplicate discounts– Policies affecting commercial insurance

• How does Trump Administration continue to try to address high drug prices?


How Do These and Future Changes Affect HTCs?

• So far, most debate and policymaker interest/action is focused on hospitals and there is general support for HTCs and other grantees

• Greatest risks for HTCs come from potential for changes related to:– Eligible patient– Audit requirements– Reporting requirements


Summary

• Growing scrutiny of the 340B program could lead to Congressional or Administrative actions affecting covered entities

• Though HTCs are unlikely to be the target of any effort, they should be cognizant of any potential changes related to reimbursement levels or patient eligibility and reporting requirements


Health Care Transformation and the HTC Model: Positioning for Success

Marisela Trujillo, MSWAdministrative Director

University of Texas Health Gulf States Hemophilia and Thrombophilia Center


As Health Care Undergoes Significant Transformation, So Must HTC Operations and Strategies

1982 1990 1996 2003 2010 Present

CA legislation paves the way

for PPOs

NCQA established, PPO enrollment surpasses HMO enrollment

Health Insurance

Portability & Accountability Act (HIPAA)

Medicare Modernization Act (MMA)

Affordable Care Act (ACA)

• Quality Measures • Part D Drug Benefit• Health Savings Accounts (HSAs)

• Pay for Performance

• Clinical Pathways • Palliative Care• Increased Cost Sharing

• Accountable Care Organizations (ACOs)

• Decline of smaller physician practices

• Growth of specialty• Narrow networks

Future• Widespread adoption of outcomes‐based contracting?

• Repeal and replacement of the ACA?

2014

ACA Insurance

Marketplaces


Payer‐led Management Strategies Often Directly Impact Providers, including Those Based in the HTC

• Pay less (value‐based contracting, narrow networks)• Manage more (prior authorization, step edits, etc)• Shift responsibility to the member (copays, deductibles, etc)• Transfer risk to the provider (accountable care organizations [ACOs])• Gain share (pay‐for‐performance)


Behavioral health care‐ Mental health‐ Substance abuse

Primary care‐ Prevention‐ Acute Care‐ Chronic Care

Specialist care

Delivery SystemTransformation andPractice Redesign

Other care

Care Team

PCP

Other licensedhealth care providers

CoordinationCollaborationCommunication

Usual CareFragmented (siloed)Not coordinated

Collaborative CareIntegratedTeam‐based

Patie

nt

As this shift occurs, it is important for HTC personnel to recognize overlapping activities and opportunities for collaboration with health plans

The Current Paradigm of Managed Care is Shifting Toward a Model Similar to that Deployed by HTCs

BH Specialists Specialists


At the Same Time, HTC Sustainability is Facing a Number of Specific Challenges

Challenges Opportunities


Novel Approaches for HTCs May be Necessary as Health Care Landscape Changes

Narrow Networks Accreditation

Value‐based Contracting Data Sharing

Increased Member Cost‐share

Patient Counseling and Advocacy


Facing These Challenges, a Compelling HTC Value Proposition is Necessary

Care Model Outcomes340B

• Characterize hemophilia as a rare, chronic disease requiring expert multidisciplinary care over the course of a lifetime

• Describe the breadth and depth of unbilled ancillary services provided by HTCs

• Describe the evidence supporting improved outcomes associated with comprehensive care delivered by HTCs

• Discuss the implications of improved care quality and outcomes for cost containment

• Conduct a population‐based review process looking at patients in aggregate and comparing to the norm

• Define the role and implications of 340B discount drug pricing• Competitive drug

acquisition costs• Benefits of an integrated

pharmacy model• Explain how HTCs are different from other 340B‐covered entities


HTCs Fill a Critical Niche in the Management of Patients with Bleeding Disorders

Hemop

hilia Chronic, lifelong condition often

diagnosed at birth or in childhoodCharacterized by significant morbidity and mortality

HTCs Offer expert care from a team

of providers trained in the multifaceted clinical and psychosocial issues facing patients with bleeding disorders


The HTC Integrated Care Model Represents an Evidence‐based and Guideline‐recommended Approach for the Management of Bleeding Disorders

Integrated care model should be used over non‐integrated care models

• This recommendation is even more pressing for individuals with inhibitors or individuals at risk for developing inhibitors

A hematologist, specialized hemophilia nurse, physical therapist, and social worker should be part of the integrated care team

• Round‐the‐clock access to a specialized coagulation laboratory is another key component of the integrated care model

Pai M, et al. Haemophilia. 2016;22(Suppl 3):6–16.


The Differential Role and Benefit of 340B Discount Drug Pricing for HTCs

• All of the earnings generated by an HTC is applied toward the provision of high‐quality, comprehensive care to its patients

HTCs are not‐for‐profit entities

• Discounted 340B drug pricing at these HTCs allows for financial resources to be allocated to rigorous follow‐up and patient oversight interventions for which payers are not charged

340B pricing generates critical revenue

• Factor purchased via 340B pricing is often billed at an equivalent or even lower cost to payers than pricing offered through specialty pharmacies with volume‐based contract agreements

Competitive drug acquisition costs can be shared with the payer


HTCs Rely on 340B Income to Support Staffing for Comprehensive Care

Trujillo M, et al. Presented at the WFH 2016 World Congress, July 24‐28, 2016, Orlando, FL.N=31 HTCs with established 340B programs

76%

14%10%

80%

10% 10%

70%

13% 16%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

[90%‐100%] [50%‐90%] [0%‐50%]

% of H

TCs

% of Services Funded by 340B

Percent of Centers by Level of Funding Using 340B Program Income for Care Coordination

Telephone Triage Medical Care Coordination Case Management and Psychosocial Services


10800

12600

7440

3120

960

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0

2000

4000

6000

8000

10000

12000

14000

Hem

atologist

PA/N

P

Nurse

Social W

orker

PT

Ortho

pedist

Encounters

% HTCs with Non‐BillableServices

340B Income Also Supports Staffing for Outpatient and Follow‐up Visits

Trujillo M, et al. Presented at the WFH 2016 World Congress, July 24‐28, 2016, Orlando, FL. N=31 HTCs with established 340B programs

Outpatient and Follow‐Up Visits


The Majority of Centers Support Unbilled Care Coordination and Case Management with 340B Income at the >90% Level

Trujillo M, et al. Presented at the WFH 2016 World Congress, July 24‐28, 2016, Orlando, FL. N=31 HTCs with established 340B programs

Hemophilia Treatment Center Services # of Encounters% of HTCs

Reporting ≥ 90% 340B Funded

Telephone Triage Urgent/Emergent

Annual Mean Encounters per HTC 1,968 76%

Annual Total Encounters 29 HTC 57,072 76%

Medical Care Coordination

Annual Mean Encounters per HTC 2,088 80%


Care Management/Psychosocial/Vocational

Annual Mean Encounters per HTC 960 70%


Patient Education

Annual Mean Encounters per HTC 516 75%



Engaging Payers with Quality and Cost

Payers are well engaged by clearly

evident improvements in outcomes derived from quality care and the avoidance of

morbidity via reduced ED visits/

hospitalizations

Payers have expressed an interest in hearing

about potential savings via improved outcomes/reduced morbidity and

competitive factor pricing in up‐front

discussions

Quality Cost


Improving Hemophilia Outcomes Through Comprehensive Care

• Comprehensive care for hemophilia is defined as the continuous supervision of all medical (including factor replacement utilization) and psychological aspects affecting the patient and family

• Optimal treatment is based on:– Early detection and diagnosis– Prevention and early treatment of bleeding episodes and any complications, particularly

hemophilic arthropathy– Detection and management of inhibitors – Psychosocial and educational support– Monitor for treatment‐related comorbidities – Coordination of care with other providers and payers involved in management of the patient

Ruiz‐Saez A. Hematology. 2012;17(supp1):S141‐143.


Treatment via the HTC Model Results in More Comprehensive Care with Efficiencies that Drive Improved Outcomes

Outcome Data Year Before Program 1975

10th Year of Program 1985

% Increased (+)% Decreased (‐)

Number patients receiving regular comp care 1,333 5,683 + 326%

Number patients on homecare 514 2,517 + 390%

Average days/year lost from work/school 14.5 3.9 ‐ 73%

HRSA. Maternal & Child Health.

Since these initial findings were reported, HTCs have continued to track various measures of care quality, and ongoing initiatives such as the Comprehensive Care Sustainability

Collaborative (CCSC) demonstrate the persistence of data reporting among these providers


Health Benefits of HTC Use and Comprehensive Care

• Use of HTC services is associated with… Greater use of and adherence to self‐infusion

61% of patients perform self‐infusion if they visit an HTC vs 25% of those who do notFewer hospitalizations for bleeding complicationsFewer deaths despite HTCs seeing a greater number of severe patients with complications (HIV/AIDS, hepatitis, etc.)

Soucie JM, et al. Blood. 2000;96:437‐442.


Benefits of Care Delivered Through an HTC: Mortality and Hospitalization

1. Soucie JM, et al. Blood. 2000;96:437‐442. 2. Soucie JM, et al. Haemophilia. 2001;7:198‐206.

1.0

1.4

0

0.5

1

1.5

2

HTC Other Source ofCare

1.0

1.4

0

0.5

1

1.5

2

HTC Other Source ofCare

Relative Mortality1 Relative Number of Hospitalizations2

Relativ

e Risk

Relativ

e Risk

Patients Receiving Care from an HTC Demonstrated a 40% Reduction in Mortality Rate and a 40% Reduction in Hospitalization Rate


HTCs Help Control the Cost of Care

• Many unbilled, ancillary services may be included as part of comprehensive care

• Expert care limits complications– Multidisciplinary team

• Minimizes ED visits• Promotes independence• Complete medical history readily available

– Optimal, collaborative decision making

• Relationships with expert subspecialists• Eligible entity for 340B drug discount program/PHS pricing

PHS = Public Health Service


The Cumulative Benefits of HTC‐delivered Care Have Apparent Clinical as well as Economic Implications for Payers

Total Cost Management

Decreased number of bleeds

Reduced number of infusions

Avoidance of unnecessary ED

visits

Improvement of patient’s quality

of life

Adherence to treatment plan

Proper dosing through assay management


Summary

• US health care has evolved significantly over the past decade, presenting unique challenges and opportunities for HTCs

• In response to these changes, HTCs must rethink current practices and strategies and evolve to meet the changing landscape

• A robust value proposition for HTCs leverages quality improvement and cost management, with a focus on the value of integrated care, the advantages of 340b, and tangible clinical outcomes


Payer Perspectives and Collaborative Opportunities for the Management of Bleeding Disorders

Edmund Pezalla, MD, MPHCEO

Enlightenment Bioconsult, LLC


The Specialty Drug Trend Represents a Pressing Matter for Commercially Insured Populations

Express Scripts. Drug Trend Report. 2018.

5%2%

5%

1% 0%‐2%

2%

6%

0% ‐1%

14% 15%

20% 20%17% 18%

14%

25%

18%

13%

‐5%

0%

5%

10%

15%

20%

25%

30%

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Traditional Specialty


The Specialty Trend Continues to Increase Despite Limited Utilization While Drug Costs Outpace Member Earnings

Pharmaceuticals Strategies Group. Trends in Specialty Drug Benefits. 2018.

Large costs for small populations…It is estimated that specialty medications will account for HALF of total U.S. drug spend by 2020 even though only 1% to 2% of Americans use specialty drugs.

…with no end in sight.Specialty drug spending under the medical benefit has increased 55% since 2011, and double‐digit average specialty trend under the pharmacy benefit has been the norm since 2007.

$52,486AVERAGE TREATMENT

$48,665MEDIAN WAGE

The average annual cost of treatment with a single specialty

drug was $52,486 in 2015.

Median wage in 2016 was $48,665, and median household income in 2016 was $57,617.

vs.


Tools for Managing Specialty Drug Costs

Benefit Design Formulary and Clinical Policy

Innovative Contracting

Provider‐centric Initiatives


Benefit Design

• Some plans have attempted to redefine covered benefits to exclude gene and cell therapy products: this may not be an effective long‐term strategy but in the short‐term it allows plans to scrutinize the requests for treatment more thoroughly and to some extent limits adverse selection

• Patient out‐of‐pocket– Continued growth in high deductible plans– Additional co‐insurance payments (e.g. adding a second or third specialty tier)

• Site of care initiatives to drive utilization to lower cost settings via reduced member cost share


The Current Environment of Member Cost‐Share and Copay Assistance

The use of coinsurance and the prevalence of high‐deductible health plans have risen while the relief offered by copay assistance has been limited


N=299 employer‐based plans of all sizes

The prevalence of high deductible health plans continues to increase, rising from 28% in 2016 to

33% IN2017

When copayment assistance programs are used, less than half of respondents reported that the amount is credited as if the member paid with their own money.

The average coinsurance under the medical benefit is higher than under the pharmacy benefit.

46%32% vs. 29%


Health Care Purchasers Are Driving these Approaches

• A National Business Group on Health (NBGH) survey of 170 large employers representing coverage of 19 million employees and their dependents noted the following:– Nearly half of all companies cited delivery system changes, such as using narrow network delivery models (e.g., accountable care organizations), direct contracting, and high‐performance networks, to shift healthcare costs.

– Nearly 60% plan to use the aforementioned strategies by 2021– However, fewer employers (30%) plan to offer consumer‐directed—or high‐deductible—health plans as the only option for their employees compared to 39% in 2018


Site of Care: Methods to Influence Infusion Site of Care Under the Medical Benefit



42%Yes

(n=255)

58%No

Medical policy directing patients to preferred site of care

26%Yes

(n=247)

74%No

Lower cost‐sharing for preferred site of care


Site of Care: Site of Care Approach During the Past Year Under the Medical Benefit



9%

34%

57%

7%

38%

54%

Modified to encourage use oflower‐cost sites of care

Already encouraged use oflower‐cost sites of care andwas not modified this year

Does not encourage use oflower‐cost sites of care

2016 (n=115)

2017 (n=256)

Significantly higher than comparison year


Formulary and Clinical Policy

• Closed formularies are becoming more common– NDC block until review– Increasing number of excluded drugs

• Narrowing the number of preferred or covered products• More restrictive policies/PA criteria: going beyond the label to consider clinical trial inclusion/exclusion– Restricted patient population– Stopping rules for nonresponse– More rigorous re‐authorization criteria


Tufts Study on Restrictive Coverage

• Across 3,417 decisions, 16% of the 302 drug‐indication pairs were covered the same way by all of the health plans, and 48% were covered the same way by 75% of the plans

• Specifically, 52% of the decisions were consistent with the FDA label, 9% less restrictive, 2% mixed (less restrictive in some ways but more restrictive in others), and 33% more restrictive, while 5% of the pairs were not covered

• Health plans restricted coverage of drugs indicated for cancer less often than they did coverage of drugs indicated for other diseases

• Using multivariate regression, it was found that several drug‐related factors were associated with less restrictive coverage, including indications for orphan diseases or pediatric populations, absence of safety warnings, time on the market, lack of alternatives, and expedited FDA review

Chambers JD, et al. Health Affairs. 2018;37:1041‐1047.


Formulary Exclusion Classes


N=299 employer‐based plans of all sizesBase: Respondents who have formulary exclusions in place. Multiple responses allowed. NA = not asked.

47%

40%

48%

26%

48%

32%

19%16%

11%

20%

9%

60%

49% 47% 46%43%

36%

25% 24% 22%19%

16% 14%

5%

Hepatitis C Inflammatoryconditions

Fertility Multiplesclerosis

Growthdeficiency

Cholesterol Infused/injectableoncology

Lung/breathingdisorders

Oraloncology

HIV Cysticfibrosis

Hemophilia/bleedingdisorders

Other

2016 (n=158) 2017 (n=152) Significantly higher than comparison year

NA NA


Classes Under Consideration for Formulary Exclusion



Base: Respondents who are considering formulary exclusions. Multiple responses allowed. NA = not asked.

45%

38% 37%39%

25%28%

16%

20%

14%

25%

11%

38% 38% 38% 37%34%

29%

25% 25% 25% 25%22% 21%

12%

Hepatitis C Multiplesclerosis

Cholesterol Inflammatoryconditions

Lung/breathingdisorders

Infused/injectableoncology

Growthdeficiency

Hemophilia/bleedingdisorders

HIV Oraloncology

Cysticfibrosis

Fertility Other

2016 (n=110) 2017 (n=102)

NA NA


Innovative Contracting

• Outcomes‐based contracts• Contracts with refunds if patient does not stay on drug for a sufficient period of time

• Limits on plan liability (e.g. if costs exceed expected amounts or number of patients exceed projections)


Value/Outcomes‐Based Contracting May Offer a Potential Incentivefor HTCs to take Exclusive Ownership of Care Management Efforts

Long G, et al. J Med Econ. 2014;17:883‐893.

Increasing Data & Complexity

Value‐Based Contracting

Rebate specific to an indication

Indication‐Based

Rebate paid when two products used in combination

Regimen‐Based

Concessions depend on how ‘well’ the drug works

for a patient/cohort

“Outcomes”Based

Tighter assay management and minimized bleeding episodes/ER utilization are a logical fit for such arrangements

Concessions may depend on volume or share

Traditional Contracting

Flat, Volume or Share‐Based

4%3%2%1%‐

100vials

200vials

ILLUSTRATIVE

Rebate %s forPurchased Brand A

400vials


Value‐Based Contracting in Action for Rare, High‐Cost Diseases

• Patisiran was recently approved to treat polyneuropathy caused by hereditary transthyretin‐mediated (hATTR) amyloidosis

• To help payers cope with the $450,000 annual list price of patisiran, the manufactuer is working with commercial insurance plans to offer value‐based contracts for the therapy

• The contracts will tie the level of reimbursement to patient outcomes:– If patisiran delivers the same benefits in real‐world practice that it did in clinical trials, the manufacturer will receive a higher level of reimbursement

– If the drug does not perform as well, the manufacturer will receive lower reimbursement


Provider‐centric Initiatives

• Increased use of pathways (oncology) and other decision support programs• Cost savings/risk‐sharing arrangements

– IDN– ACO– Medical home– Other


Summary

• Specialty products, including clotting factor concentrate, currently drive the overall drug trend and represent a key target of management efforts on the part of payers

• Benefit design, formulary management, and innovative contracting remain among the most prominent means by which payers manage these agents

• Employer purchasers are driving some of these trends, with increased member cost‐share and narrow networks resulting in a new set of challenges for providers


CCSC: Charting a Course for Cost‐effective, Improved Outcomes in Hemophilia Management

Kollet Koulianos, MBASenior Director Payer RelationsNational Hemophilia Foundation


CCSC: A Hemophilia Quality Improvement and Cost Management Initiative Sponsored by NHF

• Formed in 2014 with a prominent group of HTC directors, clinicians, and administrators along with payer/managed care medical and pharmacy directors

• CCSC’s vision is to augment the sustainability of HTCs through the following:Overcome communication gaps to increase connectivity between payers, purchasers, and providers

Broaden access to extensive hemophilia‐related outcomes data from HTCs

Disseminate rigorous standards of care, quality, and cost management for hemophilia

Improve the recognition of HTC‐derived value

Obtain advanced analytics on a rare, high‐cost disease and gain insight on actionable best practices


Rationale for the CCSC Initiative

• NHF has long since recognized the HTC integrated comprehensive care model as the gold standard of clinical management for patients with rare, chronic bleeding or clotting disorders

• Many HTCs depend on 340B program revenue from the sale of clotting factor replacement products to maintain and grow integrated care programs

• HTCs are challenged to access specialty pharmacy contracts due to current trends:– Factor coverage is increasingly being shifted from the medical to the pharmacy benefit– Pharmacy benefit managers (PBMs) are acquiring their own specialty pharmacies (SPs) and encouraging

plan sponsors to allow the SPs to become the exclusive provider of specialty drugs


CCSC Objectives

• Advance the collaboration between payers, purchasers, and providers to provide high quality hemophilia care to patients that is both effective and reimbursable

• Collect data validating collaborative relationships between payers and HTCs that will ultimately benefit all parties involved, including patients/members

• Implement initiatives throughout the United States between payers, purchasers, and HTCs that support the sustainability of HTCs and the comprehensive care model


CCSC Advisors

Hemophilia AdvisorsShannon Carpenter, MDChildren’s Mercy Kansas City

Miguel A. Escobar, MDUniversity of Texas Health Gulf States Hemophilia and Thrombophilia Center

Amber Federizo, RN, MSN, FNP‐BCHemostasis and Thrombosis Center of Nevada

Jennifer Maahs, RN, PNP, MSNIndiana Hemophilia & Thrombosis Center

Lisa Maiale‐Howell, MSS, LCSWHemostasis and Thrombosis Center at Children's Hospital of Philadelphia

Amy Shapiro, MDIndiana Hemophilia & Thrombosis Center

Michael Tarantino, MDBleeding and Clotting Disorders Institute

Marisela Trujillo, MSWUniversity of Texas Health Gulf States Hemophilia and Thrombophilia Center

Becky Burns Bleeding and Clotting Disorders Institute

Barbara Konkle, MDBloodworks NorthwestUniversity of Washington

Payer AdvisorsMark Godwin, PharmD, AAHIVPUnited Healthcare

James Jorgenson, RPh, MS, FASHPVisante, Inc.

James Kenney, Jr., RPh, MBAHarvard Pilgrim Health Care

Doug Lohkamp, RPh

Maria Lopes, MD, MS Formerly with Magellan Health

Scott McClelland, PharmDFlorida Blue

Edmund Pezalla, MD, MPHEnlightenment Bioconsult

Vanita K. Pindolia, PharmD, BCPS, MBAHenry Ford Health System/Health Alliance Plan of Michigan

Troy RossMid‐America Coalition on Health Care


CCSC Advocates on Behalf of HTCs to Foster Collaboration with Payers and Purchasers Through Various Activities and Materials

Activities

Outreach to payers and purchasers

Surveys

Data‐sharing Pilot Programs

Focus Groups and Advisory Boards

Assistance with Data Collection and Reporting

Materials

Handouts and fact sheets

Publications

Posters

Case Studies

CCSCHemo.com


Recent CCSC Outreach Efforts

Conference or Association Type Date Location Description

Texas Business Group on Health2018 Regional Benefits Forums

Exhibit Booth 8/16/18 Houston, TX Exhibit booth to promote the benefits of CCSC to employers

Hemophilia Drug Development Summit (Boston)

Live Presentation

8/16/18 Boston, MA Presentation to attendees on CCSC vision and purpose

Magellan Specialty Summit Live Presentation

8/22/18 New York, New York Presentation to attendees on CCSC and the value of collaboration

Memphis Business Group on Health Exhibit Booth 8/22/18 Memphis, TN Exhibit booth to promote the benefits of CCSC to employers

The Alliance Annual Business Meeting Exhibit Booth 9/11/18 Madison, WI Exhibit booth to promote the benefits of CCSC to the employer group

Self‐Insurance Institute of America (SIIA) 38thAnnual National Educational Conference & Expo

Exhibit Booth 9/23‐26/18

Austin, TX 3rd year CCSC will be exhibiting at SIIA; provides opportunity to reach self‐insured and reinsurance representatives

Hemophilia Alliance Fall Meeting Presentation 9/23‐25/18

Las Vegas, NV Possible speaking opportunity on agenda at the conference

CBI’s 6th Annual Coupon and Copay Conference

Expert Panel Member

10/2/18 Philadelphia, PA Kollet Koulianos served on an expert panel for the presentation, Explore Current Barriers to Prescription Drug Access and Assistance —Patient Advocacy Perspectives


Copay Accumulator Adjustment Programs

• NHF and CCSC are seen as leaders in educating multiple stakeholders on the unintended consequences of copay accumulator adjustment programs.

• 2018 outreach includes:– Participated in over 30 conference calls, WebEx meetings, and in‐person meetings so far in 2018– At least 10 additional speaking opportunities scheduled through the end of 2018– Invited to serve on several expert panels to represent the patient’s perspective

Educational Webinars• Aids Institute• Bioverativ• Shire• Arthritis Foundation• BIO • Abbvie• Octapharma• MS Society• Better Healthcare Coalition• CSL Behring• Harvard Pilgrim Healthcare• Novo Nordisk, Inc.• New York Hemophilia Alliance

Live Presentations/Expert Panelist/Meetings

• NHF’s Washington Days• Rhode Island State Senate• National Business Group on Health Specialty

Pharmacy Conference• PAN Foundation• United HealthCare• Prime Therapeutics• NEHA Medical Education Meeting• NHF Chapter Training/Pulse on the Road

Regional Meetings/Inhibitor Summits• Midwest Business Group on Health Specialty

Pharmacy Meeting• National Alliance of HealthCare Purchaser

Coalitions

• Florida Bleeding Disorders• Texas State Meeting• CBI• ATHN• PhRma / Bio Accumulator Meeting• Arthritis Foundation• vWD Type III Summit• Mid‐America Coalition on Health

Care


Employer Outreach

• Attending or exhibiting at 10 regional business groups on health• Exhibiting at 3 national employer group conferences• Scheduling educational WebEx programs with regional and national groups• Two employer advisory board meetings were conducted

Greater Philadelphia Business Coalition on Health Opportunities for Managing High‐Cost ClaimantsJuly 12, 2018 from 7:30‐11:30 amConvene Commerce SquarePhiladelphia, PA

Mid‐America Coalition on Health Care August 15, 2018 from 10:00 am‐3:00pmKauffman Foundation Conference CenterKansas City, MO


CCSC Payer Survey on HTCs

• To better determine how CCSC can achieve optimal success, a brief survey was conducted with health care professionals affiliated with a payer– Survey was emailed to IMPACT’s database (non‐payer affiliated responses were excluded)

• The following description was at the beginning of the survey prior to the questions:– A hemophilia treatment center (HTC) is a federally recognized facility providing interdisciplinary care expert in the management of bleeding disorders. The care provided at HTCs is inclusive of clinical, pharmacy, and psychosocial services, much of which is funded via 340B pharmacy revenue and often unreimbursed by payers. The US HTC network is organized and coordinated according to 8 specific regions and includes more than 140 centers distributed across the country as stand‐alone or institutional facilities.


Participant Demographics

31%

24%

19%

11%

6%

6%

5%

0% 10% 20% 30% 40%

Specialty pharmacy

Hospital System

National managed care company

Regional managed care company

Integrated delivery network

Retail pharmacy

Home infusion provider

Percent of Responders

Organization Type39%

21%18%

13%6%

4%

0% 10% 20% 30% 40% 50%

Specialty PharmacistManaged Care Pharmacist

Pharmacy DirectorOther Clinician type (MD, PA, etc.)

Medical DirectorOther


Primary Role

Omitted from survey

23%

13%

18%15%

10%13%

4% 3% 4%

0%

5%

10%

15%

20%

25%

1 to 10 11 to 20 21 to 50 51 to 100 101 to250

251 to500

501 to1,000

Over1,000

Does notapply

Percent o

f Respo

nders

Hemophilia Patients Managed

>11,000 Patients Managed

N=80


Awareness and Perception of HTCs

Yes, 65%

No, 35%

Were you aware of hemophilia treatment centers (HTCs) and the services they

provide prior to reading the description at the beginning of this survey*?

Yes, 94%

No, 2%N/A, 4%

If you were aware of HTCs, do you consider HTCs to be “centers of

excellence” for the management of bleeding disorders?

N=80

*An HTC is a federally recognized facility providing interdisciplinary care expert in the management of bleeding disorders. The care provided at HTCs is inclusive of clinical, pharmacy, and psychosocial services, much of which is funded via 340B pharmacy revenue and often unreimbursed by payers. The US HTC network is organized and coordinated according to 8 specific regions and includes more than 140 centers distributed across the country as stand‐alone or institutional facilities.

N=52


HTC Interaction

10%

24%

11%

24%

31%

0% 10% 20% 30% 40%

Yes, for medical

Yes, for pharmacy

Yes, for both

No

Unsure


Does your organization currently contract with an HTC for medical or pharmacy

services in its network?

If yes, do you recommend that your members with bleeding disorders be seen at the HTC at least once per year?

Yes, 78%

No, 8%Unsure, 14%

N/A, 0%

If no, what is the primary reason your organization does not contract with an HTC for the management of members with bleeding disorders?

Other, 38%

Presently contract with a specialty

pharmacy provider (SPP) for factor replacement products , 31%

Unsure, 15%Unaware of HTCs ,

8%No HTC available in my organization’s immediate geographic area , 8%

N=19

N=36

N=80


Accreditation/Certification for HTCs

Yes, 32%

No, 37%

N/A, 32%

If your organization does not contract with an HTC, would some means of formal accreditation and/or

certification for HTCs change your current approach to contracting with an HTC for the management of

members with bleeding disorders?

Which, if any, of the following accrediting bodies does your organization require certification from for network inclusion for specialty pharmacy services, such as the

dispensation of factor replacement products?

31%

30%

24%

6%

5%

4%

0% 10% 20% 30% 40%

URAC

Unsure

JACHO

Other

N/A

CPPA


2

1

N=19N=80

1. Joint Commission on Accreditation for Healthcare Organizations2. Utilization Review Accreditation Commission3. Center for Pharmacy Practice Accreditation

3


Respondents not aware of HTCs and the services they provide prior to reading the description at the beginning of the survey

Primary Role Title Organization NameSpecialty Pharmacist Pharmacist PFSP Specialty PharmacyManaged Care Pharmacist Managed Care Pharmacist RegenceManaged Care Pharmacist Clinical pharmacist TotalMed Specialty Pharmacist Regional Clinical Pharmacist BriovaRx InfusionOther Clinician type (MD, PA, LCSW, etc.) PA Alliance Rx Walgreens PrimeSpecialty Pharmacist Pharmacy Manager Factor One Source PharmacySpecialty Pharmacist Pharm D Chevy Chase EndoscopyOther Clinician type (MD, PA, LCSW, etc.) Clinical Pharmacist Priority HealthSpecialty Pharmacist PHARMACIST, HOME INFUSION CORAM/CVSManaged Care Pharmacist Senior Clinical Pharmacy Manager CMO, Montefiore Care ManagementSpecialty Pharmacist PharmD IntermountainManaged Care Pharmacist Clinical Pharmacist Health care partners IPAPharmacy Director Pharmacy Manager Lynn Cancer InstituteSpecialty Pharmacist PharmD ConduentSpecialty Pharmacist RXMO Walgreens PharmacySpecialty Pharmacist Clinical pharmacy coordinator NYPBMHManaged Care Pharmacist Pharmacist LTC pharmacySpecialty Pharmacist PharmD HCAMedical Director Medical Director Loma Linda University Medical CtrManaged Care Pharmacist RPh, Staff Pharmacist NuHealthSpecialty Pharmacist RPh Accredo Specialty PharmacyPharmacy Director Director of Clinical Services National CooperativeRxSpecialty Pharmacist Clinical Pharmacist Tower HealthPharmacy Director Pharmacy Director Centene


Respondents whose current approach to contracting with an HTC would change if there was some means of formal accreditation and/or certification

Title OrganizationClinical Pharmacist Priority HealthConsultant Lindon & Lindon, LLCDir Pharmacy Diplomat Specialty Infusion Group Director, Pharmacy COVENTRYPharmD Conduent


New CCSC Fact Sheet and Handout for Employers


Copay Accumulator Adjustment Handout


Copay Accumulator Adjustment Handout (continued)


Assay Management Case Study


Example of Patient Summary Report

Patient ID

Date of Service Drug Cost

per IUDosing Schedule

Patient Weight (kg)

Units/kg (avg)

Target Total Script

Actual Total Dispense

Target v Actual

Deviation

Potential Cost Savings

1 May 2015 ‐Mar 2017 rFactor VIII $1.31 TIW 89.2 44.88 892,000 933,861 +4.69% $277,110

2 Jan 2015 ‐Sep 2016 rFactor VIII $1.31 PRN 92.5 37.83 185,500 199,923 +7.78% $64,230

3 Oct 2015 ‐Jul 2016 rFactor VIII $0.97 3x weekly 21.9 39.72 NA 181,221 NA $4,146

4 May 2015 ‐Feb 2016 rFactor VIII $1.15 2x weekly 27.3 42.85 NA 234,855 NA $39,387

5 Jan 2015 –Jul 2016 rFactor VIII $1.83 Every 4 days 91 62.50 852,000 952,748 +11.65% $301,056

Total Potential Cost Savings with HTC Pricing and +1% Deviation $685,929

Factor VIII was used for this example because it had the most data points.


Individual Patient Cost Savings

$1,218

,572

$975

,885

$941

,461

$0

$250,000

$500,000

$750,000

$1,000,000

$1,250,000

Actual Paid Cost Cost at AverageHTC Price

Cost at AverageHTC Price and+1% Variance

Savings:$242,687 Savings:

$277,110

$260

,016

$208

,920

$195

,786

$0

$100,000

$200,000

$300,000

Actual Paid Cost Cost at AverageHTC Price

Cost at AverageHTC Price and+1% Variance

Savings:$51,097

Savings:$64,230

Patient 1 Patient 2


Inhibitor Case Study

Background• Patient: 32‐year‐old male (110 kg)• Diagnosis: mild hemophilia A with a high

titer inhibitor• Patient was being treated outside the

HTC and received his factor from a specialty pharmacy prior to transitioning to an HTC.

• Patient requests to receive his factor from HTC pharmacy after transitioning his care

Physician prescribes• Infuse factor VIII 125u/kg (±10%) daily

and PRN for breakthrough bleeds– Dispensation (±10%) ranges

• Low ‐ 12,375 u • Target ‐ 13,750 u • High ‐ 15,125 u

• Infuse NovoSeven (VIIa) 8,000 mcg daily and PRN for breakthrough bleeds


Inhibitor Case Study: Initial Cost Analysis

Assay Management Factor VIII

Cost Management Factor VIII and Factor VIIa– HTC dispensed factor VIII at $0.26 per unit below specialty pharmacy*– HTC dispensed factor VIIa at $0.60 per unit below specialty pharmacy*

*Pricing varies across HTCs. Each HTC negotiates own contracts.

Specialty pharmacy dispensed 5%‐10% above target per month

HTC integrated pharmacy dispensed 1%‐4% below target per month


Inhibitor Case Study: Initial Cost Analysis (cont.)

HTC dispensation saved the plan $143,935 per month for factor VIII through more aggressive assay management and shared savings from the 340B in‐house pharmacy*

HTC dispensation saved the plan $144,000 per month for factor VIIa using shared savings from the 340B in‐house pharmacy*



Inhibitor Case Study: Cost Analysis of Medical Management


Within months of transitioning the patient care to the HTC, through testing and education, the physician was able to alleviate the patient’s concerns regarding appropriate dosing that would prevent complications with

managing his inhibitor.

Prescriptions were changed to:–Infuse Factor VIII 75u/kg daily and PRN for bleeding episodes.–Infuse Factor VIIa8,000 mcg PRN as needed for bleeding episodes.

Expert medical management and recommended testing accounted for saving the plan an additional $460,000* through:1. lowering daily factor VIII units by 75%

2. eliminating high cost daily factor VIIa infusions previously 240,000 mcg per month to an average of 32,000 mcg per month


Updated CCSCHemo.com

• New design and layout• Navigation bar by stakeholder• Links to web archives, surveys, upcoming events

• Membership registration and log in • Updated resources

• Including a cost calculator (currently for NHF use only)

• Member‐only access to tools, specific to each member type to be developed


Summary

• CCSC is a quality improvement and cost management initiative involving the input and collaboration of a dedicated group of key HTC and payer stakeholders

• To date, CCSC has generated exposure and advocacy for HTCs through multiple outreach appearances, data collection efforts, surveys, publications/posters, handouts/fact sheets, and web‐based platforms

• Participation in CCSC can foster HTC exposure and sustainability to promote network inclusion and favorable contract negotiations with payers and purchasers


Panel Discussion

Questions and Answers


CCSC is supported by charitable donations from founding supporter, Shire, and additional support from Bioverativ, CSL Behring,

Genentech, Inc., Novo Nordisk, Inc., and Pfizer Inc.

Jointly provided by:

jointly provided by: csl...340b enrollment grew steadily before the aca and accelerated after the...

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