Guidance for the New HMG-CoA Reductase Inhibitor (Statin) Contract
Department of Defense Pharmacoeconomic Center
April 2003 (updated May 2006)

•  MTF Formulary Guidance
•  Prescribing Guidance for Prescriptions Filled at MTFs
•  Availability of Statins at the TRICARE Mail Order Pharmacy (TMOP) and TRICARE Retail Network   Pharmacies
•  Contract Prices
•  Treat to Goal Chart
•  Dose Equivalency Chart
•  Points of Contact 

Effective Date:  1 May 2003 (Contract will be in effect for one year with an option to extend the terms of the contract for 4 additional one-year periods).

Selected Product:  Simvastatin  (Zocor^®) 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets; Merck & Co., Inc.

MTF Formulary Guidance

• MTFs should consider the following in deciding whether to have any statins in addition to simvastatin on their local formularies:
  
  
  •  Generic lovastatin – A joint DoD/VA contract with Eon Laboratories (contract #V797P-9084) is supposed to provide lovastatin 10 mg for $0.21 per tablet and lovastatin 20 mg and 40 mg for $0.26 per tablet.  However, VA usage of lovastatin has exceeded expectations and Eon is currently unable to supply enough lovastatin to meet the demand. The supply problems are not expected to resolve until mid-summer 2003. Lovastatin products from other companies are not favorably priced.  MTFs should verify the availability of Eon Laboratories’ lovastatin product prior to adding lovastatin to the MTF formulary.
    
    
  •  A non-CYP-3A4 statin – MTFs may choose to add either fluvastatin or pravastatin, but not both, to the MTF formulary, or they may choose to add neither.  Fluvastatin and pravastatin cost more than simvastatin at dosages that lower LDL to the same degree, so usage of fluvastatin or pravastatin should be limited to the relatively small number of patients who have a clinical need to use a statin not extensively metabolized by the cytochrome P450 3A4 isoenzyme system. If an MTF does not have a mechanism to appropriately target the use of the non-CYP-3A4 statins, the MTF should not add either of these drugs to the MTF formulary. Instead, the MTF could continue to use the non-formulary drug request process to provide a non-CYP-3A4 statin to patients who have a bona fide clinical need.

Prescribing Guidance for Statin Prescriptions Filled at MTFs

• New patient starts (patients who have not previously been prescribed a statin) – Simvastatin (Zocor^®) must be used as the first-line statin for all new patients who have a clinical need for a high potency statin unless there is a medical necessity to us a different statin. Examples of medical necessity include:
  
  
  •  Insufficient reduction of LDL-cholesterol after an adequate trial of simvastatin 80 mg
    
    
  •  Patient is on long term therapy with a CYP-3A4 inhibitor or another medication known to interact with simvastatin
    
    
  •  Patient experiences unacceptable side effects with simvastatin
    
    
• As with the previous statin contract, MTFs should purchase and dispense non-contracted statins for patients who have a legitimate medical need to use a statin other than simvastatin.

Availability of Statins at the TRICARE Mail Order Pharmacy (TMOP) and TRICARE Retail Network Pharmacies

• All strengths of simvastatin, generic lovastatin and pravastatin are included on the TMOP Formulary
  
  
• All strengths of atorvastatin, fluvastatin, rosuvastatin, ezetimibe/simvastatin (Vytorin) and all branded lovastatin products are excluded from the TMOP Formulary

**UPDATED INFORMATION**

• In cooperation with Merck, TRICARE Mail Order Pharmacy (TMOP) patients submitting prescriptions for the highest dosage strengths of the non-contract high-potency statins, Vytorin (20/10mg, 40/10mg, 80/10mg), Lipitor (40 & 80mg) and Crestor (20 & 40mg), are no longer subject to Prior Authorization. All other (lower) dosage strengths of these non-contract statins continue to require Prior Authorization before prescription processing and will be strictly reviewed. The history in PDTS of a prescription for the lower strengths of these non-contract statins will no longer automatically authorize the TMOP to fill these prescriptions. More information about the TMOP's process can be found here or on the Formulary Search Tool (www.tricareformularysearch.org)  
  
  
  
• The contract does not affect the availability of statins at TRICARE retail network pharmacies.  All statin products are available at TRICARE retail network pharmacies.

Contract Prices

Treat to Goal Chart 

The PEC has developed a chart to assist prescribers to 'Treat to Goal' by matching statin doses and baseline LDL levels. The chart 'does the math' by identifying the best starting statin dose given a baseline LDL and the patient's LDL goal. It also contains additional information which may be helpful: descriptions of CHD risk factors and patient risk groups, common prescribing information, and typical non-formulary statin request information.

Versions Available:

• Treat to Goal Chart - Adobe Acrobat version (pdf file) - for easy distribution
• Treat to Goal Chart - MS Excel 95 version - can be customized by facilities that would like to include site-specific information. Please note that this file contains separate versions of the front page for color vs. black and white printing.

Points of Contact     

Points of Contact for clinical information/concerns:

David Bretzke, PharmD
DoD Pharmacoeconomic Center
Comm: (210) 295-2782 or DSN: 421-2782
e-mail: David.Bretzke@amedd.army.mil

Last Updated: 9/8/05