Subject: Anti-Parkinson Agents

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	amantadine
C	Atamet™ (carbidopa with levodopa)
C	benztropine
C	bromocriptine
C	carbidopa/levodopa
C	ropinirole
C	selegiline
C	trihexyphenidyl
C	Azilect®  (rasagiline)
C	COMTan®  (entacapone)
C	Mirapex®  (pramipexole)
C	Stalevo®  (carbidopa/ levodopa/entacapone)
CS	Apokyn®  (apomorphine hcl)
NC	Akineton®  (biperiden)						X	X
NC	Cogentin®  (benztropine)						X
NC	Eldepryl®  (selegiline)						X
NC	Kemadrin®  (procyclidine)						X	X
NC	Lodosyn®  (carbidopa)						X	X
NC	Parcopa®  (carbidopa/ levodopa orally disintegrating tablet)						X	X
NC	Parlodel®  (bromocriptine)						X
NC	Requip®  (ropinirole)						X
NC	Requip XL®  (ropinirole)			X		X	X
NC	Sinemet®  (carbidopa/ levodopa)						X
NC	Sinemet CR®  (carbidopa/ levodopa CR)						X
NC	Symmetrel®  (amantadine)						X
NC	Tasmar®  (tolcapone)						X	X
NC	Zelapar®  (selegiline orally disintegrating tablet)			X			X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Requip XL and Zelapar is subject to precertification.   If precertification requirements apply Aetna considers Requip XL and Zelapar to be medically necessary for those members who meet the following precertification criteria:

A.  Quantity Limits:  According to the manufacturer, Requip XL  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
Requip XL	24 mg/Once daily	2 mg	Up to 30 tablets in 30 days
Requip XL	24 mg/Once daily	4 mg	Up to 150 tablets in 30 days
Requip XL	24 mg/Once daily	6 mg	Up to 120 tablets in 30 days
Requip XL	24 mg/Once daily	8 mg	Up to 90 tablets in 30 days
Requip XL	24 mg/Once daily	12 mg	Up to 60 tablets 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 will be considered medically necessary for those members who meet ANY of the following criteria:

• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
  



2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Requip XL  is subject to step-therapy.  Aetna considers Requip XL to be medically necessary for those members who meet the following step-therapy criteria:

Requip XL
A documented trial of one month of ropinirole or Requip.

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 III below.)


3. Medical Exception Criteria

Akineton, Cogentin, Eldepryl, Kemadrin, Lodosyn, Parcopa, Parlodel, Requip, Requip XL, 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, Lodosyn, Parcopa, Parlodel, Requip, Requip XL, 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, Lodosyn, Parcopa, Sinemet, Sinemet CR, Symmetrel, Tasmar and Zelapar -- A ONLY    

For Akineton, Kemadrin, Lodosyn, Parcopa and Tasmar - A OR B
  
A.  A documented:

• Contraindication to two preferred anti-Parkinson agents OR
• Intolerance to two preferred anti-Parkinson agents OR
• Allergy to two preferred anti-Parkinson agents OR
• Failure of an adequate trial of one month each of two preferred anti-Parkinson agents OR
• Member is unable to use oral medications (Cogentin inj ONLY)
  OR

For Akineton, Kemadrin, Lodosyn, Parcopa and Tasmar

B. Transition of Coverage:

• Member is within 90 days of his or her effective date of enrollment

If applicable, quantity limits, age or gender edits will apply.  Approval is valid through the end of the calendar year.

If the member has been a Medicare member for 91 days or longer standard precertification, step-therapy, or medical exception criteria will apply.

For Parlodel

A.  A documented:

• Contraindication to the generic equivalent, bromocriptine, OR
• Intolerance to the generic equivalent, bromocriptine OR
• Allergy to the generic equivalent, bromocriptine OR
• Failure of an adequate trial of one month of the generic equivalent, bromocriptine

For Requip

A.  A documented:

• Contraindication to the generic equivalent, ropinirole, OR
• Intolerance to the generic equivalent, ropinirole, OR
• Allergy to the generic equivalent, ropinirole, OR
• Failure of an adequate trial of one month of the generic equivalent, ropinirole.

For Requip XL

A documented:

• Contraindication to ropinirole or Requip, OR
• Intolerance to ropinirole or Requip OR
• Allergy to ropinirole or Requip OR
• Failure of an adequate trial of one month of ropinirole or Requip
  

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Tan AKY. Current and emerging treatments in Parkinson's disease. Annals Academy of Medicine 2001;30(2):128-133.
8. Ahlskog, JE. Parkinson's disease: Medical and surgical treatment. Movement Disorders 2001; 19(3):579-600.
9. 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.
10. Tuite P, Ebbitt B. Dopamine agonists. Seminars in Neurology 2001; 21(1):9-14.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. Poewe, Werner MD. The role of COMT inhibition in the treatment of Parkinson disease. Neurology 2004;62(suppl 1):S31-38.
20. Rinne, U.K., MD.  Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations.  Neurology 1998;51:1309-1314.
21. 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.
22. 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.
23. 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.

May 08, 2009