/policies/,/policies/clinical/,/policies/clinical/uw-health-clinical/,/policies/clinical/uw-health-clinical/medications-and-pharmacy/,

/policies/clinical/uw-health-clinical/medications-and-pharmacy/6114.policy

201710299

page

100

UWHC,UWMF,

Policies,Clinical,UW Health Clinical,Medications and Pharmacy

Approval of Core and Patient-Specific Chemotherapy Regimens for the Treatment of Adult Malignancy (6.1.14)

Approval of Core and Patient-Specific Chemotherapy Regimens for the Treatment of Adult Malignancy (6.1.14) - Policies, Clinical, UW Health Clinical, Medications and Pharmacy

6.1.14


UW HEALTH CLINICAL POLICY 1
Policy Title: Approval of Core and Patient-Specific Chemotherapy Regimens for the
Treatment of Adult Malignancy
Policy Number: 6.1.14
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: October 20, 2017

I. PURPOSE

To establish a transparent and safe process to review and approve core and patient-specific chemotherapy
regimens for the treatment of adult malignancy and specific non-malignant conditions (in which
chemotherapy is used), in order to maintain the highest standards of patient safety at our institution.

II. POLICY ELEMENTS

All chemotherapy regimens for the treatment of adult malignancy and specific non-malignant conditions (in
which chemotherapy is used) will be approved by the UW Health Pharmacy and Therapeutics Committee’s
Chemotherapy Council. Core regimens will be reviewed at least every three years.

III. PROCEDURE

A. Core Regimens
i. Members of the relevant disease oriented team (DOT) should discuss and achieve consensus prior
to submission
ii. At least 2 weeks prior to the Chemotherapy Council meeting, the regimen should be submitted
using the approved submission request form to the Chemotherapy Council Chair or their designee
iii. The submission request form will include the following:
a. Regimen title and drugs, dose, route, schedule, cycle length, treatment length (as
necessary)
b. Requesting DOT
c. Disease and disease stage (adjuvant or advanced) in which the treatment is used
d. Justification for use, including, but not limited to:
1. A summary of the supporting data (e.g. type of study; sample size; major
outcomes such as time to progression, disease free survival, overall survival;
dose limiting toxicities; study conclusions; etc.)
A. Supporting data must achieve Level A, Level B, or NSwC (National
Standard of Care with Level C Evidence) level of evidence in order to be
used to support a regimen as a core.
i. Level A (common cancers): Good scientific evidence (Phase
3 data with significant PS and OS data, large Phase 2 data
with significant PS and OS data, and large retrospective
studies with OS and PS definitive benefits) suggests that the
benefits of the clinical service substantially outweigh the
potential risks. Clinicians should offer the service to eligible
patients.
ii. Level B (rare cancers): Scientific evidence (Phase 3 data with
significant PS and OS data, large Phase 2 data with significant
PS and OS data, and large retrospective studies with OS and
PS definitive benefits) suggests that the benefits of the clinical
service outweigh the potential risks. Clinicians should discuss
the service with eligible patients.
iii. NSwC (National Standard with level C evidence, a new
category of evidence for core approval) (Common or rare
cancers): Evidence must be determined to be at least Level C
AND submission must include citation of the protocol in a
National cancer care guideline (e.g., National Comprehensive
Cancer Network [NCCN] or American Society of Clinical
Oncology [ASCO] as a standard of care protocol. Evidence
must suggest that there are benefits provided by the clinical
service, and that the treatment is safe. The purpose of this



UW HEALTH CLINICAL POLICY 2
Policy Title: Approval of Core and Patient-Specific Chemotherapy Regimens for the Treatment of Adult Malignancy
Policy Number: 6.1.14

category is to allow for the approval of core regimens that are
commonly recognized as standard of care, but do not meet
Level A or B evidence
2. The Chemotherapy Council Chair reviews all Core submissions prior to bringing
them to the Council and if the level of evidence is not met, the regimen will be
sent back to the DOT for revision before coming to the Chemotherapy Council.
3. Circumstances in which the regimen might be used (e.g. patients unable to
tolerate a cisplatin based regimen due to poor renal function; following optimal
debulking surgery; patients unable to receive anthracyclines; patients with pre-
existing pulmonary disease; etc.).
e. Citation(s) and full text for the best supporting evidence, no exceptions.
1. Only full text articles may be used as supportive data for a core regimen.
2. Abstracts may not be used as supportive data for a core regimen.
f. Signature of DOT leader and phone or pager number for questions
g. Information necessary to complete the electronic build of the regimen including at a
minimum:
1. Necessary laboratory tests
2. Treatment parameters
3. Required and optional supportive care medications
A. For example, supportive hydration plans as well as plans for supportive
medications such as antiemetics, bone marrow stimulants or
chemoprotectants.
iv. The UW Health Drug Policy Program will review and grade evidence associated with the regimen
submission and provide a limited pharmacoeconomics analysis.
v. The Chemotherapy Council Chair and Secretary will schedule consideration of the submission by
the Chemotherapy Council and communicate the decision to the requesting DOT within one week
of the meeting.
B. Standard Patient-Specific Regimens
i. An attending physician will discuss the plan and obtain approval from at least one other member of
the DOT (preferably the Chair), prior to submission.
ii. The patient-specific regimen submission request form must be completed including the following
information:
a. Regimen (drugs, dose, route, schedule, cycle length, treatment length)
b. Requesting provider
c. The patient’s name, medical record number, date of birth, performance status, diagnosis
and stage
d. The patients weight, body surface area, and area under the curve (if appropriate)
e. Date requested to begin therapy
f. Rationale for the use of the submitted regimen that clearly describes why the provider
wishes to treat with this regimen over other approved regimens and/or clinical trials
1. Evidence of level C or higher to support the regimens.
A. Level A (common cancers): Good scientific evidence (Phase 3 data
with significant PS and OS data, large Phase 2 data, retrospective
studies with OS and PS definitive benefits) suggests that the benefits of
the clinical service substantially outweigh the potential risks. Clinicians
should offer the service to eligible patients.
B. Level B (rare cancers): Scientific evidence (Phase 3 data with
significant PS and OS data, large Phase 2 data, retrospective studies
with OS and PS definitive benefits) suggests that the benefits of the
clinical service outweigh the potential risks. Clinicians should discuss
the service with eligible patients.
C. NSwC (National Standard with level C evidence, a new category of
evidence for core approval) (Common or rare cancers): Evidence
must be determined to be at least Level C AND submission must
include citation of the protocol in a National cancer care guideline
(NCCN, ASCO) as a standard of care protocol. Evidence must suggest
that there are benefits provided by the clinical service, and that the
treatment is safe. The purpose of this category is to allow for the



UW HEALTH CLINICAL POLICY 3
Policy Title: Approval of Core and Patient-Specific Chemotherapy Regimens for the Treatment of Adult Malignancy
Policy Number: 6.1.14

approval of core regimens that are commonly recognized as standard
of care, but do not meet Level A or B evidence
D. Level C: Evidence (Phase 1 data, Phase 3/3 data with significant PS
and OS data, and large retrospective studies with data showing
definitive benefits, may only be PFS benefit) suggests that there are
benefits provided by the clinical service, but the balance between
benefits and risks are too close for making general recommendations.
Clinicians need not offer it unless there are individual considerations.
E. Level D: Available scientific evidence suggests that the risks of the
clinical service outweigh potential benefits. Clinicians should not
routinely offer the service to patients.
i. This evidence will be insufficient for support.
F. Level I: Scientific evidence is lacking, of poor quality, or conflicting,
such that the risk versus benefit balance cannot be assessed. Clinicians
should help patients understand the uncertainty surrounding the clinical
service.
i. This evidence will be insufficient for support.
g. Citation(s) and both full texts and abstracts for phase 2/3 studies and large retrospective
studies and full texts only for phase 1 studies may be submitted as supportive evidence
for this designation.
h. Attending physician approval if an inpatient on the Hematology or Oncology Ward
Services
i. Information needed to complete electronic build for the patient including:
1. Necessary laboratory tests
2. Treatment parameters
3. Required and optional supportive care medications
A. For example, supportive hydration plans as well as plans for supportive
medications such as antiemetics, bone marrow stimulants or
chemoprotectants.
j. The attending physician will submit the completed patient-specific regimen submission
form to the Chemotherapy Council Chair or their designee.
iii. The standard turn-around time for Chemotherapy Council consideration and patient-specific
electronic treatment plan build will be 7 calendar days.
a. In cases where a delay in treatment could lead to patient clinical harm, turn-around time
will be determined on a case-by-base basis balancing need for safety and efficacy review
of the council and electronic build and quality assurance of the regimen against the
potential harm caused by delay in treatment.
1. In cases where a delay is a danger to the patient, the Chemotherapy Council
Chair (or the Vice-Chair if the chair is away) may grant emergency approval to
begin the first cycle of therapy.
2. This permission only applies to the first cycle, and the approval for ongoing
therapy past the first cycle, must still receive Chemotherapy Council approval.
iv. The Chair of the Chemotherapy Council or their designee communicates the decision to the
requesting attending physician within three business days of receipt of the request and will also
notify the physician when the electronic build is completed.
v. Pre-Approved Patient Specific Regimens
a. In rare circumstances, where a regimen does not have sufficient evidence to qualify as a
core regimen, but may be frequently used as a National Standard, the committee may
provide pre-approval as a patient specific with certain patient characteristics.
1. Method of Pre-Approval process:
A. The requesting DOT will submit a request for a Pre-Approved patient
specific regimen to the Chemotherapy Council.
B. There must be evidence of the regimen as a national standard (NCCN,
ASCO, etc.) AND no less than evidence at Level C for the council to
approve such a regimen.
C. The entire council reviews the submission and the data and then a
majority approval in the quorum must be obtained for pre-approved
regimen status.



UW HEALTH CLINICAL POLICY 4
Policy Title: Approval of Core and Patient-Specific Chemotherapy Regimens for the Treatment of Adult Malignancy
Policy Number: 6.1.14

2. Once Pre-Approved Patient Specific status is granted to a regimen, the
requesting physician will submit patient specific request to the Chair who will be
responsible for reviewing the case to ensure the patient qualifies and provide
approval before the regimen will be applied.
3. If the Chair does not approve, the regimen will go through the regular patient
specific submission process.
4. As we continue to develop the new Core regimen approval level of Evidence
NSC (National Standard of Care with Level C evidence) the use of this
designation will likely become unnecessary, except for very rare diseases where
standards exist, but the level of evidence will never reach core status due to
limited case number (for example, use of chemotherapy in the Hemophagocytic
syndrome).
C. Changes to existing core regimens
i. The following changes to an approved core regimen for patient safety and tolerability do not require
Chemotherapy Council approval:
a. Decreasing a dose
b. Discontinuation or removal of a drug from a regimen
c. Lengthening the time between doses/cycles
ii. A new core regimen or a change to an existing core regimen that includes any of the following must
be submitted to and approved by the Chemotherapy Council:
a. Increasing a dose
b. Adding a different cytotoxic, biologic, or immunologic agent to the treatment regimen or
combine regimens
c. Shortening the time between doses/cycles
d. Using a core regimen for a non-approved disease indication
D. Triannual Review Process and Submission of Changes for Core Regimens
i. A process for triannual review will be established to evenly distribute the regimens by DOT
throughout the 3 year period.
a. Members of the relevant DOT are notified of the need for review 6-8 weeks prior to the
submission deadline.
b. The members of the DOT discuss and achieve consensus prior to submission of any
requested change to the Chemotherapy Council.
ii. Both the original/most current submission and electronic treatment plan are reviewed by the DOT
for:
a. Accuracy
b. Safety
c. Supporting evidence for use
d. Supportive care
e. Place in therapy
iii. Revised submissions should be sent to the Chemotherapy Council Chair or designee at least four
weeks prior to the scheduled Chemotherapy Council review date.
iv. The UW Health Drug Policy Program will review and grade evidence associated with the regimen
submission and provide a limited pharmacoeconomics analysis
v. The Chemotherapy Council Chair and Secretary will schedule consideration of the submission by
the Chemotherapy Council and communicate the decision to the requesting DOT within one week
of the meeting.
vi. Actions at the triennial review will include
a. Approve – no changes
b. Approve – with modifications
c. Withdrawal (i.e. remove as available core regimen)
E. Appeals Process (for Core regimen Requests or Patient Specific Regimen Requests)
i. If the treating physician or the DOT disagrees with the Chemotherapy Council’s initial decision, they
may resubmit the regimen with additional justification.
ii. If the treating physician or the DOT disagrees with the Council’s decision on the resubmission, they
may discuss the issue with the Medical Director of the Cancer Center.
iii. The Medical Director of the Cancer Center, if consulted, will discuss the issue with the Chairperson
of the Chemotherapy Council and with others as deemed advisable or necessary (i.e. Ethics,
Administration, etc)



UW HEALTH CLINICAL POLICY 5
Policy Title: Approval of Core and Patient-Specific Chemotherapy Regimens for the Treatment of Adult Malignancy
Policy Number: 6.1.14

iv. The Medical Director of the Cancer Center, the Chair of Chemotherapy Council, Division Head of
Hematology/Oncology and Chair of Pharmacy and Therapeutics Committee will reach a consensus
on a final decision
F. Tracking Process for Identified Core Regimens
i. During the review process, regimens may be selected for tracking based upon any of the following:
a. Expected relatively low therapeutic yield
b. Limited data available
c. Lack of Food and Drug Administration and/or Compendia approval
d. High cost
ii. The Drug Policy Program supports outcome tracking for a defined period of time, and submits
findings to DOT Chair, Chemotherapy Council Chair, and UW Health Pharmacy and Therapeutics
Committee Chair.
iii. Hematology/Oncology fellows participate in the review and communication of data tracking
outcomes. Examples of outcomes include, but are not limited to:
a. Number of patients treated
b. Disease status
c. Time to progression
d. Toxicities
e. Adverse events
f. Cost compared with reimbursement, or other regimens with similar outcomes

IV. COORDINATION

Author(s): Manager, Drug Policy Program
Senior Management Sponsor: Chief Operating Officer
Reviewers: (committees, individuals, or any content experts involved during the revision process)
Approval committees: Chemotherapy Council; Pharmacy and Therapeutic Committee; UW Health Clinical
Policy Committee; Medical Board
UW Health Clinical Policy Committee Approval: August 21, 2017

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospital and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.

V. APPROVAL

Peter Newcomer, MD
Chief Clinical Officer

J. Scott McMurray, MD
Chair, UW Health Clinical Policy Committee

VI. REFERENCES

Several related policies and procedures are developed, coordinated and maintained by the utilizing services.
UW Health Clinical Policy #6.1.1, Chemotherapy Processes: Informed Consent, Ordering, Verification,
Administration, Documentation, and Patient/Family Education
UW Health Clinical Policy #3.4.2, Patient Care Orders

VII. REVIEW DETAILS
Version: Original
Last Full Review: October 20, 2017
Next Revision Due: October 2020
Formerly Known As: Cancer Center policies, Chemotherapy Review Council Description & Submission &
Review Process for Core Chemotherapy Regimens; and Chemotherapy Review Council Submission for
Individualized, Patient-Specific Chemotherapy Regimens