the provision of chemotherapy in hospice john w. finn md, faahpm chief medical director hospice of...

The Provision of ChemotherapyThe Provision of Chemotherapy in Hospice in Hospice

John W. Finn MD, FAAHPMChief Medical Director

Hospice of Michigan

Terri L. Maxwell APRN, BC-PCMDirector of Research, excelleRx, Inc.

Doctoral Candidate, University of Pennsylvania

DisclaimerDisclaimer

• The information and the materials included in this presentation are intended for educational use.

• Review or discussion of any agent does not alter in any way the conditions for use contractually agreed upon and outlined in the Hospice Pharmacia Medication Use Guidelines.

• This program will not be a focus on the Medication Use Guidelines and is intended for educational purposes.

The Provision of Chemotherapy in Hospice:The Provision of Chemotherapy in Hospice:When is it Palliative?When is it Palliative?

John W. Finn MD, FAAHPM

Chief Medical Director

Hospice of Michigan

Hospice of MichiganHospice of Michigan

• Not-for-profit since 1980• Statewide (17 program sites) through merger in 1994• 20-25% of hospice care provided in Michigan• Census 850-900 patients daily• Serve approximately 7,000 pts/families/yr• Increasingly competitive hospice market• Commitment to care for all• Development raises approximately $6 million/yr

Palliative ChemotherapyPalliative Chemotherapy

• Definitions • Palliative CTX (incurable malignancy)

Patient/Family – hoped-for disease ‘cure’

Medical Oncologist – disease control

Hospice Team – symptom control

“Is it palliative?”


“Is it palliative?”

Palliative Chemotherapy…is allowed under the HMB

One of several “special modalities” listed, provided the intent of treatment is palliative – not curative.

No additional MCR payment may be made regardless of cost of the service.

Better Questions: “Is the patient terminal?”

“How are the needs of this pt/family best met?

HMB Eligibility and Coverage


• Cytotoxic TherapyIndiscriminate cellular poisonsDamage DNA, cellular machineryCancer cells vs. normal cells

• Targeted TherapyBiotechnologic attack on the cancer cellLess toxic (sometimes oral)Considerably more expensive


• Cytotoxic Therapy

Primary effect – shrink tumor (CR,PR)

Secondary effect – reduce tumor-related Sx

improve HR QOL

disease-free survival

overall survival



Balance benefit vs. likelihood of toxicity(toxicity>>>benefit when KPS <50% or ECOG <3)

(avoid treating pts with multiple co-morbidities, lacking social supports) (age by itself is not a factor)

Balance tumor responsiveness vs. pt’s health(tx poorly responsive cancers in only otherwise healthy pts)

Most effective chemotherapy is given first(second, third, fourth-line CTX is increasingly less effective)



Subjective response predictive of objective response (i.e. decrease pain, imp. KPS)

Converse is likewise true (i.e. inc. pain, dec. KPS implies CTX is not working)

Exception to the rule: tumor responds, but pt doesn’t(i.e. in spite of objective response, pt’s health spirals downward)


• Cytotoxic Therapy (oral examples)

Emcyt (estramustine) 140 mg caps

Hydrea (hydroxyurea) 500 mg caps

Temodar (temozolomide) 5,10,100,250 mg caps

Xeloda (capecitabine) 150, 500 mg tabs


• Targeted Therapy

Newer agents

May benefit Sx, QOL, KPS without evidence of tumor shrinkage or enhanced survival (so-called ‘clinical benefit’)

Change of tumor microenvironment(dec. cytokines/neurotransmitters, dec. angiogenesis)

Ellison,Chevlen,Palliative Chemotherapy, in Berger,Portenoy,Weisman,2cd Ed., P and P of PC&SO,Ch.50, Lippincott, Wms, Wilkins, 1998


• Targeted Therapy (oral examples)

Gleevec (imatinib) 100, 400mg tabs

Irresa (gefitinib) 250, 500 mg tabs

Tarceva (erlotinib) 25, 50,150 mg tabs


• ‘Open Access’ Rationale

Cancer patients and families need improved access to hospice services.Though hospice utilization for those with cancer is good, the timeliness is not (decreasing LOS)Cancer patients and families access hospice very late in the course of illness.Newer therapeutic options are delaying hospice admission, making matters worse.


(Hospice’s Pandora’s Box)

Open Access

or

Open Checkbook?


• Aggressiveness of Cancer Care at EOL(MCR pts with Ca Lung, Breast, Colorectal, Other GI Malignancies from 1993-1996)

Inc CTX in last 2 weeks of life (13.8% - 18.5%)

Inc ER, Hospitalization, ICU days

Inc hospice utilization (28.3% - 38.8%)

Inc hospice LOS < 72 hrs (14.3% - 17%)

Earle CC, J Clin Oncol, Jan 15, 2004

Earle CC, Proc. ASCO 2006 (#6004)


• Proposed Quality Indicators

<10% pts receive CTX in last 14 days of life

<2% start new CTX in last 30 days of life

<4% have multiple hospitalizations, or ER visits, or admission to ICU in last month of life

<17% die in acute care institution

At least 55% pts receive hospice services before death

<8% with hospice LOS <3 days

Earle CC, International J for Quality in Health Care 2005;17(6):505-509


• Quality Oncology Practice Initiative (QOPI)

Preliminary report on EOL measures

Pilot phase (Summer 2005)

Voluntary quality self-assessment

Semi-annual chart abstraction on secure web-based application

455 charts abstracted from 22 practices

Simone JV, Proc ASCO 2006 (#8573)


• Quality Oncology Practice Initiative (QOPI)

Was pain addressed on either of the last two visits prior to death? 85%

Was pain rated numerically? 41%

Was pt enrolled in a hospice program? 62%

Was pt enrolled in hospice at least 7 days before death? 77%

Was the pts last dose of chemotherapy given within 14 days prior to death? 12%

Simone JV, Proc ASCO 2006 (#8573)


• Quality Cancer Care (10 goals)Consensus Statement of ASCO and ESMO

#7 Multi-disciplinary Cancer Care…integration of pc experts, as well as oncology nurses, and social workers…access to counseling for their psychosocial, nutritional and other needs.

#10 Pain Management, Supportive, and Palliative Care…access to optimal palliative care and counseling with respect to end-of-life issues.

J Clin Oncol, July 20, 2006


• Improving End-Of-Life Care

“the MHB severely limits the availability of the quantity and quality of care to beneficiaries who would benefit from end-of-life care…”

(‘terrible choice’ of either/or vs. both/and)

NIH State of the Science Conference Dec 6-8, 2004, Bethesda, Maryland

http://consensus.nih.gov


• Need for IntegrationPC/Supportive Oncology + Hospice

Aggressive palliative treatments along with the supportive services hospice provides to patient, family.

“a new model of interaction…one that emphasizes cooperation rather than conflict… that keeps the focus on the suffering patient.”

Spiess, AAHPM Bulletin, Fall 2005


• Chemotherapy Use Among Hospice Cancer Patients at LifePath Hospice and PC, Inc.18 patient (plus matched controls)- tended to be more recently diagnosed- fewer hospitalizations while on hospice- better self reported outcomes from treatment- reported slightly more symptoms- had lower symptom distress rating scores (MSAS)- QOL similar in both groups (HQLI)

Schonwetter RS, J Pall Med, Feb 2005


• New Models of Concurrent CareProject Safe Conduct

Ireland Cancer Center/Hospice of Western Reserve

Simultaneous CareUC-Davis (Phase I & II agents) NCI Study

Project ENABLENorris Cotton CC/Dartmouth Hitchcock Med Ctr.

Palliative Care ProjectUniversity of Michigan CCC/Hospice of Michigan


• Collaborative Care Management (CCM)

Hospice of Michigan

Care Collaboration “Triggers”

(CTX,XRT,CT/MRI,HD,TPN,Tf,Vent,liq.O2,other)

Admission Delay

HMD consults with Referring Doc

Negotiate a palliative treatment POC

(what has pt/family been told/expectations?)

(timeline, endpoints, monitoring, follow-up)


• Collaborative Care Management (CCM) (all “triggers”)

Admit with proposed tx plan 25%

Admit with modified tx plan 60%

Admit without trigger tx <10%

Delay 5%

Do not admit 1%



Customer Focus/Referral Source friendly

Preferred by Medical Oncologists

Sense of Goodwill in the Community

Market Differentiation

Development Opportunity

Hope (psych. distress, non-abandonment)



Reduction in Use and Cost of TherapeuticsLess Team ‘Distress’Appreciated by Most Referring Docs (not all) Perceived by Pt/Family as a QOL IssueA Few Questions by Fiscal Intermediary


• Concluding Remarks

Pragmatic Approach to Pall. Chemotherapy in HospiceOffer Guidance - Collaborative ManagementHospice Medical Director as Active Participant in POCTreatment Decisions Individualized to the Pt/FamilyTimeframe and End-Points Determined Pre-Admission

Terri L. Maxwell APRN, BC-PCM

Director of Research, excelleRx, Inc.

Doctoral Candidate, University of Pennsylvania

The Provision of Chemotherapy The Provision of Chemotherapy in Hospice: in Hospice:

An Analysis of Hospices and Hospice PatientsAn Analysis of Hospices and Hospice Patients

Theoretical FrameworkTheoretical FrameworkHospice AccessHospice Access

• Many factors limit access to and utilization of hospice

services, but governmental regulations are especially limiting.

• The Medicare Hospice Benefit enacted in 1982:

– Was based upon the notion that care shifts in some linear

fashion at the end of life (EOL) and that the goals of

therapy are easily distinguished as cure-focused or

palliative and

– Often compel patients and providers to choose between

receiving disease-modifying therapies and hospice care.

Theoretical FrameworkTheoretical FrameworkChemotherapy Treatment AdvancesChemotherapy Treatment Advances

• Since the 1990s, there has been a growth in the

development of nondebilitating palliative chemotherapy

agents, making continuing treatment more acceptable

for patients.

• The availability of these less toxic therapies is

considered an important factor in patients’ decisions to

postpone the election of hospice care and for physicians

to delay hospice referral.


Palliative chemotherapy has been defined as “the use of antineoplastic medications to affect the cancer and to reduce the adverse signs and symptoms caused either directly or indirectly by the malignant disease process.”*

Using this definition, palliative chemotherapy could be allowable under Medicare guidelines.

*Ellison, 1998

The Chemotherapy Dilemma for HospicesThe Chemotherapy Dilemma for Hospices

• Hospice programs are faced with making decisions about

enrolling patients receiving palliative agents that are not

being used to cure the terminal diagnosis, but rather to

decrease symptoms associated with the disease.

• Not all hospices view chemotherapy (even palliative) as

hospice appropriate.

• Current reimbursement rates make it difficult for most

hospices to cover the costs associated with chemotherapy

Examples of Palliative Chemotherapy CostsExamples of Palliative Chemotherapy Costs

• Based upon a 150 lb 5’6” female*

– Gefitinib (Iressa )- $60 per day (taken daily)

– Capecitabine (Xeloda )- $108 per day (taken

daily for 2 weeks, then one week off and then

cycles repeats)

– Temozolomide (Temodar )- $61 per day (taken

for 5 days in 28-day cycles)

*Costs per www.drugstore.com

Background/SignificanceBackground/Significance

• Chemotherapy has been identified as a barrier to hospice

enrollment, which affects overall hospice utilization and

hospice length of stay (LOS).

• Hospice LOS is declining; In 2004, 35% of all patients

served by hospice died in 7 days or less.

– The median LOS has declined from 29 days in 1995 to

22 days in 2004 .

Implications of HospiceImplications of Hospice LOSLOS

• Changes in LOS have important implications for patients,

their caregivers, and hospices

– Shorter LOS:

• Means hospices have a greater proportion of high-cost days,

which has contributed to budget shortfalls for many programs.

• Increases the burden on hospice staff and family members.

• Decreases the time hospice has to provide care.

• Decreases caregiver satisfaction with hospice services.

Study PurposeStudy Purpose

1. To determine if hospice organizational characteristics are

associated with the provision of chemotherapy in

hospice.

2. To examine differences between chemotherapy and non-

chemotherapy patients in hospice, especially with respect

to hospice length of stay.

Research DesignResearch Design

• Exploratory, descriptive correlational design using secondary analysis

of patients admitted to hospices receiving medication management

from Hospice Pharmacia.

• Sample-

– Patients with a diagnosis of brain, breast or lung cancers receiving

FDA-approved oral palliative agents specific to their diagnoses:

temozolomide (Temodar), capecitabine (Xeloda) and gefitinib

(Iressa), respectively.

– Admitted to hospice on or after 1/01/03 and discharged or

deceased by 6/30/05.

• Study was approved by University of Pennsylvania IRB

MethodsMethods

• excelleRx and the excelleRx database

– excelleRx provides pharmacy services to >800 hospice

programs and approx. 30% of all US hospice patients

through its Hospice Pharmacia (HP) business unit. Avg

daily census >75,000 patients.

– Hospice programs that contract with HP are nationally

representative of other hospice programs.

– Data is collected longitudinally as part of the care process

that occurs when hospice nurses call pharmacists with

requests for medication consultation or medication changes.

Variables of InterestVariables of Interest

• Patient Variables– Gender

– Age

– Race/ethnicity

– Diagnosis

– Chemotherapy received

– Discharge disposition (alive vs. deceased)

– Hospice LOS

• Hospice Variables

– Size (based upon average

daily census for 2Q‘05 or

last available quarter)

– Profit status

– Geographic region

Study FindingsStudy Findings

Patient DemographicsPatient Demographics

• Age on admission to hospice

– Mean age- 70 yrs

• Ethnicity

– Caucasian- 79%

– Non-Caucasian- 12% (8.4%

Black)

– Unknown- 11%

• Discharge status

– Deceased (87.2%)

– Discharged alive (12.8%)

• Diagnoses

– Brain cancer- 8%

– Breast cancer- 18%

– Lung cancer- 74%

• Length of stay

– Mean- 41 days

– Median- 19 days

– 26% LOS < 7 days

N= 58,154

ChemotherapyChemotherapy

• 1,114 (2%) patients received chemotherapy

• Chemotherapy received:

– Gefitinib (Iressa) (n= 911)

– Temozolomide (Temodar) (n= 87)

– Capecitabine Xeloda (n= 116)

Characteristics of Patients Receiving Characteristics of Patients Receiving Chemotherapy in HospiceChemotherapy in Hospice

NO-CHEMO CHEMO P value

Age (mean) 70 yrs 66 yrs P < 0.001

Gender Female 55.8% 52.1% P = 0.012**

Male 44.2% 47.9%

Ethnicity* Caucasian 87.2% 86.3% P = 0.698

Non-Caucasian 12.8% 13.9%

Pt Status Deceased 87.2% 86.1% P = 0.272

Discharged 12.8% 14%

*Excludes Unknown** Non-significant after breast ca dx removed

LOS Differences for Patients Receiving LOS Differences for Patients Receiving Chemotherapy Chemotherapy

No ChemotherapyMean

Median

ChemotherapyMean

MedianP value*

All patients 40.7 days19.0 days

53.8 days28.0 days

< 0.001

Lung cancer 39.4 days18.0 days

48.4 days26.0 days

< 0.001

Breast cancer 44.0 days19.0 days

76.4 days35.5 days

< 0.001

Brain cancer 45.0 days24.0 days

83.7 days40.5 days

< 0 .001

* Bivariate analyses of chemo vs. no-chemo using Mann Whitney test

Characteristics of Hospice SampleCharacteristics of Hospice Sample

• N=544 hospices

• 237/544 hospices provided

chemotherapy (43.6%)

• Of those who provided

chemotherapy, a range of 1 to

62 patients received these

agents

Variable Frequency (%)

Average daily census

Small (<50)

Medium (50-200) Large (>200)

318 (58.5%)

200 (36.8%)

26 (4.8%)

Region of country South

Northeast

Midwest

West

189 (33.8%)

138 (25.4%)

146 (26.8%)

76 (14.0%)

Profit status

Not-for-profit

For-profit

373 (68.8%)

171 (31.4%)

Chemotherapy

No

Yes

307 (56.4%)

237 (43.6%)

Characteristics of Hospices Providing Characteristics of Hospices Providing Chemotherapy (N=237)Chemotherapy (N=237)

Variable N (%) providing chemotherapy

P value

Average daily census Small <50 Medium 50-200 Large >200

93 (29.2%)123 (61.2%)23 (88.5%)

<0.001

Region of country South Northeast Midwest West

86 (46.7%)67 (48.6%)48 (32.9%)36 (47.4%)

0.025

Profit status Not-for-profit For-profit

193 (51.7%)44 (25.7%) <0.001

Likelihood of Providing ChemotherapyLikelihood of Providing Chemotherapy

• Logistic regression analyses, controlling for hospice size, profit status,

and region, were used to assess the likelihood of being a

chemotherapy provider.

• In the model including ADC, profit status, and region, not-for-profit

hospices were almost 5 times more likely to provide chemotherapy

compared to for-profit programs, independent of size and region.

• Controlling for profit status and region, small and medium-sized

hospices were much less likely to offer chemotherapy compared to

large hospices.

• Region did not independently add to the prediction of which hospices

were chemotherapy providers.

Summary of Study FindingsSummary of Study Findings• A significant number of hospices are providing oral chemotherapy.

• Large programs and not-for-profit hospices are more likely to provide

chemotherapy compared to small and for-profit organizations.

• Patients who received chemotherapy were on average, younger than the

non-chemotherapy group but were no more likely to be discharged from

hospice alive.

• Chemotherapy patients

– were in hospice on average 2 weeks longer than those who did not receive

chemotherapy,

– were less likely to have short stays of a week or less, and

– were more likely to be enrolled for at least 2 months.

DiscussionDiscussion

• Longer hospice LOS may indicate improved access for patients who

do not need to wait until all therapies are discontinued before entering

hospice.

• Larger hospices may have a financial advantage enabling them to be

able to provide chemotherapy based upon “economy of scale”

principles.

• Not-for-profit hospices are more likely to provide chemotherapy

– Other studies* have found that for-profit hospices provide fewer

non-core services compared to not-for-profit programs, most likely

related to differences in business-focused goals associated with

profits and efficiencies. *Carlson et al, 2004; McCue & Thompson, 2006

Study ImplicationsStudy Implications

• Greater availability of less toxic chemotherapy coupled with increased

acceptance of their use late in the illness is prompting a growing

number of hospices to selectively admit patients on chemotherapy.

• Hospices differ in their ability and willingness to provide these

therapies based upon size and profit status.

• Providing chemotherapy appears to result in earlier referral to hospice,

with fewer patients having very short stays.

• The current payment system is not well designed to support hospices

that elect to provide chemotherapy. A change in Medicare’s payment

system that explicitly recognizes palliative chemotherapy may increase

access to hospice services for patients who elect to continue treatment.

Strengths/Limitations of the StudyStrengths/Limitations of the Study

• Strengths

– Dataset contained actual prescribing information

– Able to examine large numbers of hospices and patients (reduces site effect and better enables detection of differences across groups)

– Data is relatively current

– Included all patients regardless of age

• Limitations

– Data are not collected for study purposes, so some data elements (especially related to therapy outcomes or hospice admission protocols) are not available

– Data was missing for some variables (e.g., 11% race is missing)

– Findings may not be generalizable beyond selected diagnoses

Implications for Future ResearchImplications for Future Research

• The value of providing chemotherapy in hospice has not

yet been adequately described or measured.

• Organizational-level barriers to providing chemotherapy in

hospice are still not understood, especially with regards to

financial constraints.

Implications for Future Research (con’t)Implications for Future Research (con’t)

• More data are needed to better understand patients and

families preferences for treatment options and symptom

management and support at the end of life, and factors

influencing decisions to continue chemotherapy and accept

hospice care.

• Future studies should also evaluate the total costs for

patients both on and off chemotherapy to determine the

cost-effectiveness (or lack thereof) of these therapies.

Thank you for your time and participation!Thank you for your time and participation!

Questions???Questions???

For further information about this presentation, please contact:

Terri [email protected]

215-282-1789

mailto:[email protected]

the provision of chemotherapy in hospice john w. finn md, faahpm chief medical director hospice of...

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