Section I contains changes to the Highmark Select/Choice Formulary.

Transcription

1 March st Quarter Update: Highmark Drug Formulary Enclosed is the 1 st Quarter 2008 update to the Highmark Drug Formulary and pharmaceutical management procedures. The Formulary and pharmaceutical management procedures are updated on a quarterly basis, and the enclosed changes reflect the decisions made in December 2007 by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. As an added convenience, you can also search the Highmark Drug Formulary online at This function allows you to search by the drug name or therapeutic class. You can also find other helpful information regarding the prescription drug program from our online Resource Center under the Pharmacy/Formulary Information link. (NaviNet users: Simply click on the Resource Center button for quick access to the Pharmacy/Formulary Information link.) Formulary changes will be reflective of both the Highmark Select/Choice Formulary (formerly the Highmark Closed/Incentive Formulary) and the Highmark Medicare-Approved Select/Choice Formulary. For each section, please refer to the header description to obtain information specific to that formulary. Section I contains changes to the Highmark Select/Choice Formulary. Section II contains changes to the Highmark Medicare-Approved Select/Choice Formulary. The Highmark Medicare-Approved Select/Choice Formulary can also be searched online at If you have any questions, contact Provider Service or call Pharmacy Affairs, toll-free, at (over, please)

2 Highmark Drug Formulary Update March 2008 Section I. Highmark Select/Choice Formulary (Formerly Closed/Incentive Formulary) A. Changes to the Highmark Select/Choice Formulary The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the following tables. Please note that since the Highmark Select/Choice Formulary is a complete subset of the Open Formulary, all medications added to the Select/Choice Formulary are automatically added to the Open Formulary. For your convenience, you can search the Highmark Select/Choice Formulary online at An electronic copy of the Highmark Select/Choice Formulary for use with a portable handheld device can be downloaded free by visiting Table 1: Products Added (All products added to the formulary effective immediately unless otherwise noted) Brand Name Generic Name Comments Selzentry maraviroc A chemokine receptor CCR5 antagonist indicated for combination treatment of adults infected with CCR5-tropic HIV-1 Isentress raltegravir An HIV-1 integrase strand transfer inhibitor for treatment-experienced HIV-infected patients Welchol colesevelam Hcl A bile acid binding agent for the treatment of hypercholesterolemia cefdinir cefdinir An oral third-generation cephalosporin Table 2: Products Not Added * Brand Name Generic Name Comments Allegra Oral fexofenadine Fexofenadine tablets are on the formulary. Suspension Atralin Gel tretinoin Tretinoin is on the formulary. CaloMist cyanocobalamin nasal spray Nascobal and cyanocobalamin solution are on the formulary. Exubera insulin human [rdna origin] Injectable insulin is on the formulary. powder for inhalation Soma 250 mg carisoprodol Carisoprodol and cyclobenzaprine are on the formulary. Voltaren Gel diclofenac sodium topical gel Multiple oral NSAIDs are on the formulary. Zingo lidocaine hydrochloride powder for transdermal injection Topical lidocaine is on the formulary. *Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the 2008 Highmark Drug Formulary book. You may also access the form online in Highmark s Provider Resource Center, under Provider Forms; select Miscellaneous Forms from the fly-out menu, and select the form titled Request for Non-Formulary Drug Coverage. Products to be Removed from the Formulary There are no deletions from the Highmark Select/Choice Formulary for this quarter. B. Updates to the Prior Authorization Program 1. Tasigna (nilotinib) Effective March 1, 2008, Tasigna (nilotinib) was added to Highmark s prior authorization program. Tasigna (nilotinib) is FDA approved for the treatment of chronic-phase and accelerated-phase Philadelphia (continued) 2

3 B. Updates to the Prior Authorization Program (continued) 1. Tasigna (nilotinib) (continued) chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior treatment, including Gleevec (imatinib). Tasigna (nilotinib) is a kinase inhibitor and works by inhibiting the proliferation of cells containing the abnormal Philadelphia chromosome. It does this by targeting the production of the Bcr-Abl protein, which is produced only by cells containing this abnormal chromosome. This protein is recognized as the key cause and driver of the overproduction of cancercausing white blood cells in patients with Ph+ CML. Tasigna was specifically designed to target the Bcr- Abl protein more preferentially than Gleevec without adding new mechanisms of action. When a benefit, nilotinib may be approved when all of the following criteria are met: Nilotinib is to be prescribed under the supervision of an oncologist/hematologist, AND Nilotinib is to be used for the treatment of chronic-phase or accelerated-phase Philadelphia chromosome positive (Ph+) CML, in patients who are no longer responding to, or are intolerant to Gleevec (imatinib) therapy. Use of nilotinib for disease states outside of its FDA-approved indications will be denied based on the lack of clinical data to support its effectiveness and safety in other conditions. If approved, authorization may be granted for a period of up to one year. C. Updates to the Managed Prescription Drug Coverage (MRxC) Program 1. Lyrica (pregabalin) Effective Dec. 5, 2007, the Managed Prescription Drug Coverage (MRxC) policy for Lyrica (pregabalin) coverage when used for the treatment of fibromyalgia was modified. When a benefit, coverage for pregabalin for the treatment of fibromyalgia may be approved if members meet the following criteria: The member has a documented diagnosis of fibromyalgia as determined by clinical notes including, but not limited to, confirmation of widespread bilateral pain both above and below the waist for >3 months duration AND the presence of at least 11 of 18 specific tender points AND documented fibromyalgia-related symptoms (e.g., fatigue, sleep disturbance, neurologic symptoms, and/or exercise intolerance), AND The member has a documented trial and failure of at least one additional agent used to treat fibromyalgia (e.g., tricyclic agents, cyclobenzaprine, SSRIs, tramadol). If approved, authorization may be granted for a period of up to one year. 2. Subutex (buprenorphine) and Suboxone (buprenorphine and naloxone) Effective Feb. 1, 2008, the Managed Prescription Drug Coverage (MRxC) policy for Subutex (buprenorphine) and Suboxone (buprenorphine and naloxone) sublingual tablets was revised. As a result of this revision, when a benefit, coverage for Suboxone will be approved if a member meets the following criteria: The prescribed dose of Suboxone does not exceed 90 tablets/30 days. Members who meet the criteria as outlined above will receive automatic authorization at the level of the pharmacy without documentation of additional information. Claims will adjudicate automatically with no prior authorization required. For members who do not meet the criteria above, the dispensing pharmacist will be prompted that prior authorization is required. Prior authorization criteria include the following: The member is being treated for opioid dependence by a physician certified in addiction medicine, AND The patient is enrolled in at least one ancillary service (e.g., psychiatric, counseling, behavioral education), AND The prescribed dose of Suboxone does not exceed 24mg/day. If approved, authorization will be granted for a period of up to one year. 3

4 D. Quantity Level Limit Additions Effective March 1, 2008, the following products were added to Highmark s Quantity Level Limit (QLL) program. Table 3: Additions to the QLL program Brand Name Generic Name Up to 34 Days Supply Limit (retail) Days Supply Limit (retail or mail) EvaMist estradiol spray 1 metered pump 3 metered pumps E. Additions to Highmark s Pharmaceutical Management Procedures 1. Additions to the Specialty Tier Copay Option Effective Feb. 1, 2008, Isentress (raltegravir) and Selzentry (maraviroc) will be added to the specialty tier copay program. Effective March 1, 2008, Somatuline Depot (lanreotide) will be added to the specialty tier copay program. Effective March 1, 2008, Tasigna (nilotinib) will be added to the specialty tier copay program with prior authorization criteria. Effective immediately, Tykerb (lapatinib) will be added to the specialty tier copay program with prior authorization criteria. Section II. Highmark Medicare-Approved Select/Choice Formulary A. Changes to the Highmark Medicare-Approved Select/Choice Formulary The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the following tables. As a reminder, the Highmark Medicare-Approved Select/Choice Formulary applies only to Highmark Medicare Advantage and BlueRx SM members. For your convenience, you can search the Highmark Medicare-Approved Select/Choice Formulary online at Table 1: Products Added (All products added to the formulary effective immediately unless otherwise noted) Brand Name Generic Name Comments Aggrenox aspirin/extended-release dipyridamole A combination anti-platelet agent to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis Isentress raltegravir An HIV-1 integrase strand transfer inhibitor for treatment-experienced HIV-infected patients Selzentry maraviroc A CCR5 receptor antagonist indicated for combination treatment of adults infected with CCR5-tropic HIV-1 Tasigna nilotinib A kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive CML in adult patients resistant to or intolerant to prior therapy that included imatinib Welchol colesevelam Hcl A bile acid binding agent for the treatment of hypercholesterolemia 4

5 Table 2: Products Not Added * Brand Name Generic Name Comments ACAM2000 smallpox vaccine Smallpox vaccine for primary vaccination or revaccination of individuals at high risk for exposure Allegra Oral fexofenadine Fexofenadine tablets are on the formulary. Suspension Atralin Gel tretinoin Tretinoin is on the formulary. Doribax doripenem Merrem is on the formulary. Exubera insulin human [rdna Injectable insulin is on the formulary. origin] powder for inhalation Ixempra ixabepilone Covered under Medicare Part B MyKidz Iron FL iron suspension with Tri-Vitamin/Iron/Fluoride is on the formulary. vitamins A, C, & D, and fluoride Soma 250 mg carisoprodol Chlorzoxazone and methocarbamol are on the formulary. Voltaren Gel diclofenac sodium topical Multiple oral NSAIDs are on the formulary. gel Zingo lidocaine hydrochloride powder for transdermal injection Topical lidocaine is on the formulary. *Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the 2008 Highmark Drug Formulary book. You may also access the form online in Highmark s Provider Resource Center, under Provider Forms; select Miscellaneous Forms from the fly-out menu, and select the form titled Request for Non-Formulary Drug Coverage. Products Removed from the Formulary There are no deletions from the Highmark Medicare-Approved Select/Choice Formulary for this quarter. B. Updates to the Prior Authorization Program 1. Tasigna (nilotinib) Effective March 1, 2008, Tasigna (nilotinib) will be added to Highmark s prior authorization program for Medicare Advantage and BlueRx SM members. Tasigna (nilotinib) is FDA approved for the treatment of chronic-phase and accelerated-phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior treatment, including Gleevec (imatinib). Tasigna (nilotinib) is a kinase inhibitor and works by inhibiting the proliferation of cells containing the abnormal Philadelphia chromosome. It does this by targeting the production of the Bcr-Abl protein, which is produced only by cells containing this abnormal chromosome. This protein is recognized as the key cause and driver of the overproduction of cancer-causing white blood cells in patients with Ph+ CML. Tasigna was specifically designed to target the Bcr-Abl protein more preferentially than Gleevec without adding new mechanisms of action. When a benefit, nilotinib may be approved when all of the following criteria are met: Nilotinib is to be prescribed under the supervision of an oncologist/hematologist, AND Nilotinib is to be used for the treatment of chronic-phase or accelerated-phase Philadelphia chromosome positive (Ph+) CML, in patients who are no longer responding to or are intolerant to Gleevec (imatinib) therapy. Use of nilotinib for disease states outside of its FDA-approved indications will be denied based on the lack of clinical data to support its effectiveness and safety in other conditions. If approved, authorization may be granted for a period of up to one year. 5

6 C. Updates to the Managed Prescription Drug Coverage (MRxC) Program 1. Lyrica (pregabalin) Effective Dec. 5, 2007, the Managed Prescription Drug Coverage (MRxC) policy for Lyrica (pregabalin) coverage when used for the treatment of fibromyalgia was modified for Medicare Advantage and BlueRx SM members. When a benefit, coverage for pregabalin for the treatment of fibromyalgia may be approved if members meet the following criteria: The member has a documented diagnosis of fibromyalgia as determined by clinical notes including, but not limited to, confirmation of widespread bilateral pain both above and below the waist for >3 months duration AND the presence of at least 11 of 18 specific tender points AND documented fibromyalgia-related symptoms (e.g., fatigue, sleep disturbance, neurologic symptoms, and/or exercise intolerance), AND The member has a documented trial and failure of at least one additional agent used to treat fibromyalgia (e.g., tricyclic agents, cyclobenzaprine, SSRIs, tramadol). If approved, authorization may be granted for a period of up to one year. 2. Subutex (buprenorphine) and Suboxone (buprenorphine and naloxone) Effective Feb. 1, 2008, the Managed Prescription Drug Coverage (MRxC) policy for Subutex (buprenorphine) and Suboxone (buprenorphine and naloxone) sublingual tablets was revised for Medicare Advantage and BlueRx members. As a result of this revision, when a benefit, coverage for Suboxone will be approved if a member meets the following criteria: The prescribed dose of Suboxone does not exceed 90 tablets/30 days. Members who meet the criteria as outlined above will receive automatic authorization at the level of the pharmacy without documentation of additional information. Claims will adjudicate automatically with no prior authorization required. For members who do not meet the criteria above, the dispensing pharmacist will be prompted that prior authorization is required. Prior authorization criteria include the following: The member is being treated for opioid dependence by a physician certified in addiction medicine, AND The patient is enrolled in at least one ancillary service (e.g., psychiatric, counseling, behavioral education), AND The prescribed dose of Suboxone does not exceed 24mg/day. If approved, authorization will be granted for a period of up to one year. D. Additions to Highmark s Pharmaceutical Management Procedures 1. Additions to the Specialty Tier Copay Option Effective Feb. 1, 2008, Isentress (raltegravir) and Selzentry (maraviroc) will be added to the specialty tier copay option program for Medicare Advantage and BlueRx members. Effective March 1, 2008, Somatuline Depot (lanreotide) will be added to the specialty tier copay option program for Medicare Advantage and BlueRx members. Effective March 1, 2008, Tasigna (nilotinib) will be added to the specialty tier copay option program with prior authorization criteria for Medicare Advantage and BlueRx members. E. Specialty Drug Tier Program Specialty drugs are very high cost and unique drugs as defined by the Centers for Medicare and Medicaid Services. These drugs may incur a coinsurance based on their negotiated price. Because of this, the cost (continued) 6

7 E. Specialty Drug Tier Program (continued) may vary slightly due to pricing changes in the drug. Drugs in the specialty tier apply to Highmark Medicare Advantage, Highmark BlueRx SM and Highmark Health Insurance Company members. Please refer to the following list for products included in the Specialty Drug Tier program. The Specialty Drug Tier list provided in the 4 th Quarter 2007 Formulary Update was incomplete. The complete current list appears below in Table 3. Table 3: Products Included in the Specialty Drug Tier Program ABELCET HUMIRA REBIF ACCUTANE HUMIRA PEN REGRANEX ACTIMMUNE IMMUNE GLOBULIN REMICADE ACTIQ INCRELEX REVLIMID ADAGEN INFERGEN RIBAPAK ALDURAZYME INNOHEP RIBASPHERE ALFERON N INTRON A RIBATAB ANADROL-50 INVIRASE RIBAVIRIN APOKYN IRESSA RILUTEK APTIVUS ISENTRESS* RISPERDAL CONSTA ARALAST IVEEGAM EN RITUXAN ARANESP KALETRA ROFERON-A ARANESP ALBUMIN FREE KINERET SAIZEN AREDIA KYTRIL SANDOSTATIN ARIXTRA LETAIRIS SANDOSTATIN LAR ATRIPLA LEUKINE SELZENTRY* AVONEX LEUPROLIDE ACETATE SENSIPAR AVONEX ADMINISTRATION PACK LOVENOX SEROSTIM BARACLUDE LUPRON SOMATULINE DEPOT* BETASERON LUPRON DEPOT SOMAVERT BUPHENYL LUPRON DEPOT-PED SORIATANE CARIMUNE MATULANE SPRYCEL CARIMUNE NF NANOFILTERED MEPRON SUCRAID CEREZYME MESNEX SUTENT COLISTIMETHATE SODIUM MYOZYME SYNAREL COLY-MYCIN M PARENTERAL NAGLAZYME TARCEVA COPAXONE NEULASTA TARGRETIN COPEGUS NEUMEGA TASIGNA* CUBICIN NEUPOGEN TEV-TROPIN CYTOVENE NEXAVAR THALOMID D.H.E.45 NIMOTOP TRACLEER DECLOMYCIN NORDITROPIN TRUVADA ELAPRASE NORDITROPIN NORDIFLEX TYGACIL ELITEK *Effective March 1, 2008 NOVANTRONE TYKERB (continued) 7

8 E. Specialty Drug Tier Program (continued) Table 3: Products Included in the Specialty Drug Tier Program (continued) ENBREL NUTROPIN VALCYTE ENBREL SURECLICK NUTROPIN AQ VANCOCIN HCL EPOGEN OCTAGAM VELCADE EXJADE OCTREOTIDE ACETATE VENOGLOBULIN-S FABRAZYME ORENCIA VESANOID FASLODEX ORFADIN VFEND FENTANYL CITRATE ORAL TRA OXANDRIN VFEND IV FENTORA PANGLOBULIN NF VIDAZA FLEBOGAMMA PANRETIN VIRACEPT FORTEO PEGASYS VIVAGLOBIN FRAGMIN PEG-INTRON XOLAIR FUZEON PEG-INTRON REDIPEN ZAVESCA GAMASTAN S/D POLYGAM S/D ZEMAIRA GAMMAGARD LIQUID PREZISTA ZOFRAN GAMMAGARD S/D PROCRIT ZOFRAN IN DEXTROSE GAMUNEX PROGRAF ZOFRAN ODT GENOTROPIN PROLASTIN ZOLADEX GLEEVEC PROLEUKIN ZOLINZA HEPSERA RAPTIVA ZOMETA HUMATROPE REBETOL ZORBTIVE ZYVOX *Effective March 1, 2008 Section III. Miscellaneous Updates A. Prescription Medication Authorization Requests Via NaviNet Providers who need authorizations for prescription medications for their Highmark patients now have the option of using the NaviNet Selection Form for prescription drug authorizations instead of faxing a paper form. The NaviNet Selection Form can be used for any pharmacy authorization request, including nonformulary exception requests, prior authorization or Managed Rx Coverage (MRxC) programs. The NaviNet Selection Form not only saves time, it can also notify providers if a duplicate request has already been received by Highmark and ensures that the patient is an active Highmark member. In addition to the fax and written notification, providers will also receive electronic notification via NaviNet regarding the decision for all requests submitted via the NaviNet Selection Form. More information about the NaviNet Selection Form for prescription drug authorizations is available in the NaviNet New Features section. Go to Customer Service in the upper right toolbar and select NaviNet Customer Care. Then, select Highmark under New Features. In the upper right corner of your screen, select New Feature Archive. Lastly, select the November 16 link for Highmark is a registered mark of Highmark Inc. BlueRx is a service mark of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. Highmark Senior Resources Inc., a subsidiary of Highmark Inc., has a contract with the Federal government to administer Medicare Prescription Drug Coverage in the states of Pennsylvania and West Virginia. NaviNet is a registered trademark of NaviMedix, Inc. NaviMedix, Inc. is an independent company that does not provide Highmark Blue Shield products or services. NaviMedix, Inc. is solely responsible for the products and services that it provides and that are referenced in this bulletin. 8