June 2007 2 nd Quarter Update: Highmark Drug Formulary Enclosed is the 2 nd Quarter 2007 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 March 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 http://highmark.formularies.com. 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 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 http://highmark.medicare-approvedformularies.com. If you have any questions, contact Provider Service or call Pharmacy Affairs, toll-free, at 1-800-600-2227. (over, please)
Highmark Drug Formulary Update June 2007 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 tables below. 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 http://highmark.formularies.com. An electronic copy of the Highmark Select/Choice Formulary for use with a portable handheld device can be downloaded free by visiting www.epocrates.com. Products Added There were no additions to the Highmark Select/Choice Formulary for this quarter. Table 1: Products Not Added * Amrix cyclobenzaprine extended Cyclobenzaprine is on the release Elestrin estradiol gel Climara patches, Vivelle patches, estradiol tablet and estradiol patches are on the Lialda mesalamine Asacol, Pentasa, Colazal, mesalamine suppositories and mesalamine enemas are on the Nitromist nitroglycerin lingual spray Nitrolingual aerosol solution and nitroglycerin sublingual tablets are on the Olux-E clobetasol 0.05% foam Multiple topical corticosteroids are on the Omnaris ciclesonide Nasonex, Rhinocort Aqua and fluticasone propionate are on the Pylera biskalcitrate/metronidazole/ tetracycline Metronidazole and tetracycline are on the Veregen kunecatechins Condylox and Aldara are on the Zegerid with mag omeprazole/sodium bicarbonate/magnesium hydroxide Protonix, Nexium and omeprazole are on the Ziana clindamycin 1.2%/tretinoin 0.025% Multiple topical products containing either tretinoin or clindamycin are on the Table 2: Products to be Removed* From the Formulary (effective Jan. 1, 2008) Ditropan XL oxybutinin Generic is on the Zofran ondansetron Generic is on the 2
B. Updates to the Prior Authorization Program 1. Humira (adalimumab) Effective March 7, 2007, the prior authorization criteria for adalimumab was revised to include approval criteria for ankylosing spondylitis and Crohn s Disease. When a benefit, adalimumab may be approved when the following criteria are met: The member should be under the supervision of a rheumatologist or gastroenterologist, AND Adalimumab is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderate to severe active rheumatoid arthritis AND the member has tried and experienced an inadequate response to at least one DMARD, OR Adalimumab is to be used in reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis, OR Adalimumab is to be used in reducing the signs and symptoms of patients with ankylosing spondylitis, OR Adalimumab is to be used in reducing the signs and symptoms of patients with Crohn s Disease who have failed two alternative therapies or monotherapy with Remicade, AND The member is currently not using another biological DMARD [i.e., etanercept (Enbrel ), anakinra (Kineret ), etc.]. If approved, authorization may be granted for a period of up to one year. 2. Sutent (sunitinib) Effective March 7, 2007, the prior authorization criteria for sunitinib was revised to allow for first-line use in the treatment of renal cell carcinoma (RCC). When a benefit, sunitinib may be approved when all of the following criteria are met: Sunitinib is to be prescribed under the supervision of an oncologist/hematologist. Sunitinib is to be used for the treatment of documented c-kit expressing gastrointestinal stromal tumors (GIST) after documented failure or intolerance to imatinib (Gleevec ), OR Sunitinib is to be used for the treatment of RCC. Use of sunitinib 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 up to one year. C. Quantity Level Limit (QLL) Program Additions Effective March 7, 2007, the following product was 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) Seasonique Levonorgestrol/ethinyl estradiol 1 extended-cycle tablet dispenser 35-90 Days Supply Limit (Retail or Mail) 1 extended-cycle tablet dispenser 3
D. Updates to Highmark s Formulary Policies 1. Selective Serotonin and Norepinephrine Reuptake Inhibitors (SSNRI) Effective March 7, 2007, Highmark s Selective Serotonin and Norepinephrine Reuptake Inhibitors (SSNRI) policy was updated to allow for coverage of non-formulary SSNRIs in the following situations: The member must have a documented diagnosis of diabetic neuropathy, OR The member must have a documented diagnosis of any other neuropathy and have tried and failed one formulary agent, OR Effexor or Effexor XR and one other antidepressant, OR three other antidepressants, OR The member must have a documented diagnosis of generalized anxiety disorder and have tried and failed two alternative anti-anxiety agents. 2. Aromasin (exemestane) Aromasin is indicated for the adjuvant treatment of postmenopausal women with estrogen receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to Aromasin for completion of a total of five consecutive years of adjuvant hormonal therapy. Aromasin is also indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. Effective March 7, 2007, requests for coverage for exemestane may be approved for members with a Select (closed) formulary design when both of the following criteria are met: The agent must be used for an FDA-approved indication. The patient must have tried and failed at least one formulary product within the same therapeutic category (aromatase inhibitors). E. Additions to Highmark s Pharmaceutical Management Procedures 1. Additions to the Specialty Tier Copay Option Effective June 1, 2007, Tykerb (lapatinib) was added to the Specialty Tier Copay Option 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: http://highmark.medicare-approvedformularies.com. Table 1: Products Added (effective March 7, 2007, unless otherwise noted) Eraxis anidulafungin An I.V. echinocandin antifungal for the treatment of Candidemia, Esophageal Candidiasis and other forms of Candida infections (intra-abdominal abscess and peritonitis). (continued) 4
A. Changes to the Highmark Medicare-Approved Select/Choice Formulary (continued) Table 2: Products Not Added * Amrix cyclobenzaprine extended release This medication has been identified as a drug to avoid in the elderly. Cancidas caspofungin Eraxis is on the Elestrin estradiol gel Climara patches, Vivelle patches, estradiol tablet and estradiol patches are on the Lialda mesalamine Asacol, Pentasa, Colazal, mesalamine suppositories and mesalamine enemas are on the Mycamine micafungin sodium Eraxis is on the Nitromist nitroglycerin lingual spray Nitrolingual aerosol solution and nitroglycerin sublingual tablets are on the Olux-E clobetasol 0.05% foam Multiple topical corticosteroids are on the Omnaris ciclesonide Nasonex and fluticasone propionate are on the Orencia abatacept Available upon failure of formulary alternative (Humira or Enbrel ). Pylera biskalcitrate/metronidazole/ tetracycline Metronidazole and tetracycline are on the Veregen kunecatechins Condylox and Aldara are on the Zegerid with mag omeprazole/sodium bicarbonate/magnesium hydroxide Protonix, Nexium and omeprazole are on the Ziana clindamycin 1.2%/tretinoin 0.025% Multiple topical products containing either tretinoin or clindamycin are on the Table 3: Products to be Removed* From the Formulary (effective Jan. 1, 2008, unless otherwise noted) Zofran ondansetron Generic is on the B. Prior Authorization Program 1. Cymbalta (duloxetine) Effective March 7, 2007, the prior authorization criteria for duloxetine (Cymbalta ) for Medicare Advantage and BlueRx SM members was revised to allow for coverage in the following situations: The member must have a documented diagnosis of diabetic neuropathy, OR The member must have a documented diagnosis of any other neuropathy and have tried and failed one formulary agent, OR (continued) 5
B. Prior Authorization Program (continued) 1. Cymbalta (duloxetine) (continued) Effexor or Effexor XR and one other antidepressant, OR three alternative antidepressant agents, OR The member must have a documented diagnosis of generalized anxiety disorder and have tried and failed two alternative anti-anxiety agents. Approvals will be granted for the life of the member. 2. Humira (adalimumab) Effective March 7, 2007, the prior authorization criteria for adalimumab for Medicare Advantage and BlueRx SM members was revised to include approval criteria for ankylosing spondylitis and Crohn s Disease. When a benefit, adalimumab may be approved when the following criteria are met: The member should be under the supervision of a rheumatologist or gastroenterologist, AND Adalimumab is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderate to severe active rheumatoid arthritis AND the member has tried and experienced an inadequate response to at least one DMARD, OR Adalimumab is to be used in reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis, OR Adalimumab is to be used in reducing the signs and symptoms of patients with ankylosing spondylitis, OR Adalimumab is to be used in reducing the signs and symptoms of patients with Crohn s Disease who have failed two alternative therapies or monotherapy with Remicade, AND The member is currently not using another biological DMARD [i.e., etanercept (Enbrel), anakinra (Kineret), etc.]. If approved, authorization may be granted for a period of up to one year. 3. Sutent (sunitinib) Effective March 7, 2007, the prior authorization criteria for Sutent (sunitinib) for Medicare Advantage and BlueRx members was revised to allow for first-line use in the treatment of renal cell carcinoma (RCC). When a benefit and prescribed under the supervision of an oncologist/hematologist, Sutent may be approved when one of the following criteria is met: Sunitinib is to be used for the treatment of documented c-kit expressing gastrointestinal stromal tumors (GIST) after documented failure or intolerance to imatinib (Gleevec ), OR Sunitinib is to be used for the treatment of RCC. Use of sunitinib for disease states outside of its FDA-approved indications should 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 up to one year. 6
C. Updates to Highmark s Formulary policies 1. Aromasin (exemestane) Aromasin is indicated for the adjuvant treatment of postmenopausal women with estrogen receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to Aromasin for completion of a total of five consecutive years of adjuvant hormonal therapy. Aromasin is also indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. Effective March 7, 2007, requests for coverage for exemestane may be approved for Medicare Advantage and BlueRx members when all of the following criteria are met: The agent must be used for an FDA-approved indication. The patient must have tried and failed at least one formulary product within the same therapeutic category (aromatase inhibitors). D. Additions to Highmark s Pharmaceutical Management Procedures 1. Additions to the Specialty Tier Copay Option Effective July 1, 2007, Orencia (abatacept) will be added to the Specialty Tier Copay Option program with prior authorization criteria (pending approval by CMS) for BlueRx SM members. Effective June 1, 2007, Tykerb (lapatinib) was added to the Specialty Tier Copay Option program with prior authorization criteria for BlueRx members. 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. 7