MEDICAL POLICY
POLICY TITLE
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
POLICY NUMBER
MP-2.189
Original Issue Date (Created):
2/1/2016
Most Recent Review Date (Revised): 9/27/2016
Effective Date:
POLICY
RATIONALE
DISCLAIMER
POLICY HISTORY
1/1/2017
PRODUCT VARIATIONS
DEFINITIONS
CODING INFORMATION
DESCRIPTION/BACKGROUND
BENEFIT VARIATIONS
REFERENCES
I. POLICY
Duopa enteral suspension is a combination of carbidopa (an aromatic amino acid
decarboxylation inhibitor) and levodopa (an aromatic amino acid) which is medically necessary
for the treatment of motor fluctuations when the ALL the following criteria are met:
Medication is prescribed by a neurologist or a movement disorder specialist
Patient with Hoehn and Yahr Stage ≥ IV disease (see definitions)
 L-dopa responsive with clearly defined periods of symptom control
 Experiences periods of persistent motor complications with onset of disabling
symptoms for a minimum of 3 hours/day, despite medical therapy with levodopacarbidopa, and at least one other class of anti-PD therapy (i.e. catechol-omethyltransferase (COMT) inhibitor or monoamine oxidase inhibitors (MAO-B)
inhibitor)
 No contraindications to treatment with Duopa such as (but not limited to) one of the
following:
o Concomitant use of nonselective monoamine oxidase (MAO) inhibitor (e.g.,
phenelzine and tranylcypromine) or have recently (within 2 weeks) taken a
nonselective MAO inhibitor.
o Previous allergic reaction to the medication
Cross-reference:
NA
II. PRODUCT VARIATIONS
TOP
This policy is applicable to all programs and products administered by Capital BlueCross unless
otherwise indicated below.
BlueJourney HMO*
BlueJourney PPO*
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MEDICAL POLICY
POLICY TITLE
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
POLICY NUMBER
MP-2.189
* Refer to Durable Medical Equipment Regional Carrier (DME MAC A) Region JA Noridian
Healthcare Solutions, LLC Local Coverage Determination (LCD) L33794 External Infusion
Pumps.
III. DESCRIPTION/BACKGROUND
TOP
Parkinson's disease is a progressive and chronic movement disorder characterized by tremor,
muscle rigidity, slowness of movement and difficulty with balance. It is classified as a movement
disorder resulting from the loss of dopamine-producing brain cells. The motor symptoms of
Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in
the brain are lost and symptoms continue to worsen slowly over the course of time. While there
is no known cure for the disease, there are treatments available to help reduce symptoms.
As Parkinson's disease progresses, patients may experience fluctuations from an "on" state to an
"off state," during which they are slower, stiffer and experience more difficulty moving. Patients
may also experience dyskinesias (involuntary movements). The spontaneous emptying of the
stomach becomes delayed and unpredictable, which can affect the timing of when orally
administered medicines leave the stomach and are absorbed in the small intestine. DUOPA
provides patients with the same active ingredients as orally-administered carbidopa and levodopa
immediate release, but is delivered in a suspension that goes directly into the small intestine via a
tube placed by a percutaneous endoscopic gastrostomy procedure with jejunal extension (PEGJ). This type of administration is intended to bypass the stomach.
In the United States, it is estimated that 60,000 new cases of Parkinson's disease are reported
each year, adding to as many as 1 million people who currently have the disease.
On January 12, 2015 The U.S. Food and Drug Administration (FDA) has approved AbbVie's
(NYSE: ABBV) DUOPA™ (carbidopa and levodopa) enteral suspension for the treatment of
motor fluctuations for people with advanced Parkinson's disease. DUOPA is administered using
a small, portable infusion pump that delivers carbidopa and levodopa directly into the small
intestine for 16 continuous hours via a procedurally-placed tube.
DUOPA was approved by the FDA as an orphan drug, a designation granted to products
intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in
the U.S.
IV. RATIONALE
TOP
The efficacy of DUOPA was established in a randomized, double-blind, double-dummy, activecontrolled, parallel group, 12-week study (Study 1) in patients with advanced Parkinson's
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MEDICAL POLICY
POLICY TITLE
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
POLICY NUMBER
MP-2.189
disease who were levodopa-responsive and had persistent motor fluctuations while on treatment
with oral immediate-release carbidopa-levodopa and other Parkinson's disease medications.
Patients were eligible for participation in the studies if they were experiencing 3 hours or more of
“Off” time on their current Parkinson's disease drug treatment and they demonstrated a clear
responsiveness to treatment with levodopa. Seventy-one (71) patients enrolled in the study and
66 patients completed the treatment (3 patients discontinued treatment because of adverse
reactions, 1 patient for lack of effect, and 1 patient for non-compliance).
Patients enrolled in this study had a mean age of 64 years and disease duration of 11 years. Most
patients (89%) were taking at least one concomitant medication for Parkinson’s disease (e.g.,
dopaminergic agonist, COMT-inhibitor, MAO-B inhibitor) in addition to oral immediate-release
carbidopa-levodopa. Thirty nine percent of patients were taking two or more of such
concomitant medications.
Patients were randomized to either DUOPA and placebo capsules or placebo suspension and
oral immediate-release carbidopa-levodopa 25/100 mg capsules. Patients in both treatment arms
had a PEG-J device placement. DUOPA or placebo-suspension was infused over 16 hours daily
through a PEG-J tube via the CADD®-Legacy 1400 model ambulatory infusion pump. The
mean daily levodopa dose was 1117 mg/day in the DUOPA group and 1351 mg/day in the oral
immediate-release carbidopa-levodopa group.
The clinical outcome measure in Study 1 was the mean change from baseline to Week 12 in
the total daily mean “Off” time, based on a Parkinson's disease diary. The "Off" time was
normalized to a 16-hour awake period, based on a typical person's waking day and the daily
infusion duration of 16 hours. The mean score decrease (i.e., improvement) in “Off” time from
baseline to Week 12 for DUOPA was significantly greater (p=0.0015) than for oral immediaterelease carbidopa-levodopa. Additionally, the mean score increase (i.e., improvement) in “On”
time without troublesome dyskinesia from baseline to Week 12 was significantly greater
(p=0.0059) for DUOPA than for oral immediate-release carbidopa-levodopa. The treatment
difference (DUOPA – oral immediate release carbidopa-levodopa) for decrease in “Off” time
was approximately 1.9 hours and the treatment difference for the increase in “On” time without
troublesome dyskinesia was approximately 1.9 hours. Results of Study 1 are shown in Table 4.
Table 4. Change from Baseline to Week 12 in "Off" Time and in "On" Time Without
Troublesome Dyskinesia in Patients with Advanced Parkinson’s Disease
Treatment Group
Baseline
LS Mean Change from Baseline at
(hours)
Week 12
(hours)
"Off" time
Oral immediate-release
6.9
-2.1
carbidopa-levodopa
DUOPA
6.3
-4.0*
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MEDICAL POLICY
POLICY TITLE
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
POLICY NUMBER
MP-2.189
Treatment Group
Baseline
(hours)
LS Mean Change from Baseline at
Week 12
(hours)
"On" time without troublesome dyskinesia
Oral immediate-release
8.0
carbidopa-levodopa
DUOPA
8.7
LS Mean Change from Baseline based on Analysis of Covariance
(ANCOVA). *=Statistically Significant.
2.2
4.1*
Figure 2 shows results over time according to treatment for the efficacy variable (change from
baseline in “Off” time) that served as the clinical outcome measure at the end of the trial at 12
weeks.
DUOPA
(N )
35
33
34
35
35
35
33
35
(N )
31
27
29
31
30
26
30
31
O r a l Im m e d la te ca rb id o p a le v o d o p a
Figure 2. Change in “Off” Time Over 12 Weeks.
V. DEFINITIONS
TOP
HOEHN AND YAHR STAGES OF DISEASE
1. Stage One
1. Signs and symptoms on one side only
2. Symptoms mild
3. Symptoms inconvenient but not disabling
4. Usually presents with tremor of one limb
5. Friends have noticed changes in posture, locomotion and facial expression
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MEDICAL POLICY
POLICY TITLE
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
POLICY NUMBER
MP-2.189
2. Stage Two
1. Symptoms are bilateral
2. Minimal disability
3. Posture and gait affected
3. Stage Three
1. Significant slowing of body movements
2. Early impairment of equilibrium on walking or standing
3. Generalized dysfunction that is moderately severe
4. Stage Four
1. Severe symptoms
2. Can still walk to a limited extent
3. Rigidity and bradykinesia
4. No longer able to live alone
5. Tremor may be less than earlier stages
5. Stage Five
1. Cachectic stage
2. Invalidism complete
3. Cannot stand or walk
4. Requires constant nursing care
VI. BENEFIT VARIATIONS
TOP
The existence of this medical policy does not mean that this service is a covered benefit under
the member's contract. Benefit determinations should be based in all cases on the applicable
contract language. Medical policies do not constitute a description of benefits. A member’s
individual or group customer benefits govern which services are covered, which are excluded,
and which are subject to benefit limits and which require preauthorization. Members and
providers should consult the member’s benefit information or contact Capital for benefit
information.
VII. DISCLAIMER
TOP
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical
advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of
members. Members should discuss any medical policy related to their coverage or condition with their provider
and consult their benefit information to determine if the service is covered. If there is a discrepancy between this
medical policy and a member’s benefit information, the benefit information will govern. Capital considers the
information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law.
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MEDICAL POLICY
POLICY TITLE
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
POLICY NUMBER
MP-2.189
VIII. CODING INFORMATION
TOP
Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The
identification of a code in this section does not denote coverage as coverage is determined by the
terms of member benefit information. In addition, not all covered services are eligible for separate
reimbursement.
Covered when medically necessary:
HCPCS
Code
J7340
Description
Carbidopa 5 mg/levodopa 20 mg enteral suspension
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses.
ICD-10-CM
Diagnosis
Description
Code*
G20
Parkinson's disease
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses.
IX. REFERENCES
TOP
AbbVie Announces U.S. FDA Approval of DUOPA™ (carbidopa and levodopa) Enteral
Suspension for the Treatment of Motor Fluctuations in Patients with Advanced Parkinson's
Disease Jan. 12, 2015 /PRNewswire.[Website]: http://www.prnewswire.com/newsreleases/abbvie-announces-us-fda-approval-of-duopa-carbidopa-and-levodopa-enteralsuspension-for-the-treatment-of-motor-fluctuations-in-patients-with-advanced-parkinsonsdisease-300018802.html. Accessed August 12, 2016.
Prescribing Information DUOPA (carbidopa and levodopa) enteral suspension [Website]:
http://www.rxabbvie.com/pdf/duopa_pi.pdf#page=1. Accessed August 12, 2016.
Carbidopa and levodopa: Drug information: Lexicomp® In: UpToDate Online Journal [serial
online]. Waltham, MA: UpToDate; Copyright 1978-2015. [Website]: www.uptodate.com
Accessed August 12, 2016.
Other Sources:
Centers for Medicare and Medicaid Services (CMS) Medicare Benefit Policy Manual.
Publication 100-02. Chapter 15. Section 50.4.2. Unlabeled Use of Drug. Effective 10/01/03.
[Website]: http://www.cms.gov/manuals/Downloads/bp102c15.pdf . Accessed August 12,
2016.
Durable Medical Equipment Regional Carrier (DME MAC JA) Region JA Noridian Healthcare
Solutions, LLC Local Coverage Determination (LCD) L33794 External Infusion Pumps.
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MEDICAL POLICY
POLICY TITLE
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
POLICY NUMBER
MP-2.189
Effective 7/1/16. [Website]: http://www.medicarenhic.com/dme/mrlcdcurrent.aspx. Accessed
August 12, 2016.
X. POLICY HISTORY
MP 2.189
TOP
CAC 9/29/15 New policy. Duopa is medically necessary when criteria are
met. Added Medicare variation to reference NHIC LCD L33794. Policy
coded. New 2016 code added and NOC code (J7799) removed.
7/8/16 Administrative posting. Changed Medicare DME carrier from NHIC
to Noridian.
CAC 9/27/16 Consensus. No change to policy statements. References and
rationale reviewed. Variation reformatted.
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company®,
Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent licensees of the BlueCross BlueShield
Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies.
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