Under some plans, including plans that use an open or closed formulary, Neupro and Zelapar are subject to precertification. If precertification requirements apply Aetna considers Neupro and Zelapar to be medically necessary for those members who meet the following precertification criteria
According to the manufacturer, Neupro and Zelapar can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. A quantity of these drugs will be considered medically necessary as indicated in the table below:
Drug
Maximum Daily Dose/ Dosing Interval
Dosage Strength
Quantity Limits
Neupro
6 mg/ once daily
2 mg,
4 mg,
6 mg
Up to 30 patches in 30 days
Zelapar
2.5mg/ once daily
1.25 mg
Up to 60 tablets in 30 days
For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of Neupro and Zelapar will be considered medically necessary for those members who meet ANY of the following criteria:
Member requires a dose including half tablets(Zelapar ONLY ) OR
Member's dose is being titrated by physician (3-month limit) OR
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Neupro is subject to step-therapy. Aetna considers Neupro to be medically necessary for those members who meet the following step-therapy criteria:
A documented trial of 30 days of carbidopa/levodopa, Mirapex, Requip or Stalevo - covered alternatives on the Aetna Medicare Preferred Drug List.
If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section II below.)
Medical Exception Criteria
Akineton, Cogentin, Eldepryl, Kemadrin, Larodopa, Lodosyn, Neupro, Parcopa, Parlodel, Sinemet, Sinemet CR, Symmetrel, Tasmar and Zelapar are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Akineton, Cogentin, Eldepryl, Kemadrin, Larodopa, Lodosyn, Neupro, Parcopa, Parlodel, Sinemet, Sinemet CR, Symmetrel, Tasmar and Zelapar to be medically necessary for those members who meet any of the following criteria:
For Akineton, Cogentin, Eldepryl, Kemadrin, Larodopa, Lodosyn, Parcopa, Parlodel, Sinemet, Sinemet CR, Symmetrel, Tasmar and Zelapar
A. A documented:
Contraindication to two covered anti-Parkinson agents OR
Intolerance to two covered anti-Parkinson agents OR
Allergy to two covered anti-Parkinson agents OR
Failure of an adequate trial of one month each of two covered anti-Parkinson agents OR
Member is unable to use oral medications (Cogentin inj ONLY)
OR
For Akineton, Kemadrin, Laradopa, Lodosyn, Parcopa and Tasmar
B. Transition of Coverage:
Member is within 90 days of his or her effective date of enrollment
Member is stable on Akineton, Kemadrin, Laradopa, Lodosyn, Parcopa, or Tasmar for 30 days or longer
If applicable, quantity limits, age or gender edits will apply. Approval is valid one year from the date of request.
If the member has been a Medicare member for 91 days or longer and is not residing in a LTC facility then standard precertification, step-therapy, or medical exception criteria will apply.
For Neupro A. A documented:
Contraindication to one of the following covered alternatives: carbidopa/levodopa, Mirapex, Requip or Stalevo OR
Intolerance to of the following covered alternatives: carbidopa/levodopa, Mirapex, Requip or Stalevo OR
Allergy to of the following covered alternatives: carbidopa/levodopa, Mirapex, Requip or Stalevo OR
Failure of an adequate trial of one month of one of the following covered alternatives: carbidopa/levodopa, Mirapex, Requip or Stalevo OR
Member has difficulty swallowing (dysphagia) and requires the transdermal dosage form
Place of Service:
Outpatient
The above policy is based on the following references:
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
Product Package Labeling, Stalevo, Novartis Pharmaceuticals , East Hanover , New Jersey. January 2004.
Product Package Labeling, Drug name 2, drug company, city , state. Date of PI.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
Tan AKY. Current and emerging treatments in Parkinson’s disease. AnnalsAcademyof Medicine 2001;30(2):128-133.
Ahlskog, JE. Parkinson’s disease: Medical and surgical treatment. Movement Disorders 2001; 19(3):579-600.
Gershanik O. Efficacy and safety of levodopa and entacapone in Parkinson’s disease patients suboptimally controlled with levodopa alone, in daily clinical practice: an international, multicentre, open-label study.Prog Neuropsychopharmacol Biol Psychiatry. 2003 Sep;27(6):963-71.
Tuite P, Ebbitt B. Dopamine agonists. Seminars in Neurology 2001; 21(1):9-14.
Olanow CW, Watts RL, Koller WC. An algorithm (decision tree) for the management of Parkinson’s disease (2001): treatment guidelines. Neurology 2001; 56(suppl 5):S1-S88.
Ahskog JE, Muenter M. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Movement Disorders 2001; 16(3):448-458.
Zenzola A, Diroma C, Fraddosio A, Lamberti S, Moramoaroc A, Palagano G, et. al. Efficacy and tolerability of dopamine agonists in a parkinsonian population. Nerol Sci 2001; 22:109-110.
Etminan M, Samii A, Takkouche B, Rochon PA. Increased risk of somnolence with the new dopamine agonists in patients with Parkinson’s disease. Drug Safety 2001; 24(11): 863-868.
Montastruc JL, Desboeuf K, Lapeyre-Mestre M, Senard JM, Rascol O, Brefel-Courbon C. Long-term mortility results of the randomized controlled study comparing bromocriptine to which levodopa was later added with levodopa alone in previously untreated patients with Parkinson’s disease. Movement Disorders 2001; 16(3): 511-514.
Inzelberg R, Carasso RL, Schechtman E, Nisipeanu P. A comparison of dopamine agonists and catechol-o-methyltransferase inhibitors in Parkinson’s disease. Clin Neuropharmacol. 2000; 23(5); 262-266.
Brooks, D J. Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson’s disease: a randomized, placebo controlled, double blind, six month study.J Neurol neurosurg Psychiatry 2003;74:1071-1079.
Larsen, J.P. The tolerability and efficacy of entacapone over 3 years in patients with Parkinson’s disease. European Journal of Neurology 2003, 10: 137-146.
Poewe, Werner MD. The role of COMT inhibition in the treatment of Parkinson disease. Neurology 2004;62(suppl 1):S31-38.
Parkinson Study Group. Entacapone Improves Motor Fluctuations in Levodopa-Treated Parkinson’s Disease Patients.Ann Neurol 1997;42:747-755.
Rinne, U.K., MD. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations.Neurology 1998;51:1309-1314.
Poewe, WH. Efficacy and safety of entacapone in Parkinson’s disease patients with suboptimal Levodopa response: a 6-month randomized placebo-controlled double-blind study in Germany and Austria (Celomen study).Acta Neurol Scand 2002: 105: 245-255.
Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults.Arch Intern Med. 2003;163:2716-24.
Zahn C, Sangl J, Bierman AS, et al. Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29.
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.