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

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1 September rd Quarter Update: Highmark Drug Formulary Enclosed is the 3 rd 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 May 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 September 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 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 (effective April 2007) Actonel 75 mg risedronate sodium An oral bisphosphonate, taken on two consecutive days for a total of two tablets each month for the prevention and treatment of osteoporosis Table 2: Products Not Added * Aerospan HFA flunisolide Asmanex, Azmacort, Flovent, Pulmicort and Qvar are on the formulary. Allegra oral fexofenadine Zyrtec syrup is on the formulary. suspension Altabax retapamulin ointment Mupirocin is on the formulary. Amitiza ** lubiprostone** A chloride channel activator for the treatment of chronic idiopathic constipation. Carac fluorouracil Fluorouracil is on the formulary. Chantix varenicline Bupropion is on the formulary. Duetact pioglitazone/glimepiride Actos and glimepiride are on the formulary. Exubera human insulin (inhalation) Injectable insulin is on the formulary. Flector diclofenac epolamine topical patch Multiple non-steroidal, anti-inflammatory drugs are on the formulary. Invega paliperidone Risperdal, Zyprexa, Seroquel and clozapine OsmoPrep sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP are on the formulary. PEG 3350-KCl-NaBicarb-NaCl-NaSulf is on the formulary. Tekturna aliskiren Multiple antihypertensive agents which act on the renin-angiotensin-aldosterone system (RAAS) are on the formulary. Tyzeka telbivudine Epivir HBV is on the formulary. Vyvanse lisdexamfetamine Multiple formulations of methylphenidate, dexamphetamine and mixed salts of amphetamine are 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 2007 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. **Prior authorization required. See Page 3 for details. 2

3 A. Changes to the Highmark Select/Choice Formulary (continued) Table 3: Products to be Removed* from the Formulary (effective Jan. 1, 2008) Norvasc amlodipine besylate Generic is on the formulary. quinidine gluconate quinidine gluconate Multiple other antiarrhythmic drugs are on the formulary. quinidine sulfate quinidine sulfate Multiple other antiarrhythmic drugs are 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 2007 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. B. Updates to the Prior Authorization Program 1. Tykerb (lapatinib) Effective Aug. 1, 2007, Tykerb (lapatinib) was added to Highmark s Prior Authorization program. Tykerb (lapatinib) is a dual tyrosine kinase inhibitor against epidermal growth factor receptor or EGFR (ErbB1) and HER2 (ErbB2). Stimulation of EGFR and HER2 are associated with cell proliferation and with multiple processes involved in tumor progression, invasion and metastasis. Lapatinib is approved for use in combination with Xeloda (capecitabine) for patients with advanced, metastatic breast cancer that is HER2 positive who have received prior therapy, including an anthracycline, a taxane and trastuzumab (Herceptin ). When a benefit, lapatinib may be approved when all of the following criteria are met: Lapatinib is to be prescribed under the supervision of an oncologist. Lapatinib is to be used in combination with Xeloda (capecitabine) for patients with advanced, metastatic breast cancer that is HER2 positive who have received prior therapy, including an anthracycline, a taxane and trastuzumab (Herceptin). The use of lapatinib for disease states outside its FDA-approved indications should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions. 2. Amitiza TM (lubiprostone) Effective Aug. 1, 2007, the prior authorization criteria for Amitiza (lubiprostone) was revised to allow for use in chronic idiopathic constipation after unsuccessful use of any three other medications (prescription or over the counter) used for the treatment of constipation. When a benefit, coverage for lubiprostone may be approved if members meet the following criteria: Lubiprostone must be used for an FDA-approved indication. Lubiprostone will be approved for use in chronic idiopathic constipation in adult patients (>18 years old) after documented failure of three other medications used for the treatment of constipation. 3. Actimmune (interferon gamma) Effective May 16, 2007, the prior authorization criteria for Actimmune (interferon gamma) was revised to exclude coverage when used for the treatment of Idiopathic Pulmonary Fibrosis. This decision was made in response to recent studies concluding that patients with IPF do not benefit from interferon gamma. (continued) 3

4 B. Updates to the Prior Authorization Program (continued) 3. Actimmune (interferon gamma) (continued) When a benefit, interferon gamma may be approved when either of the following criteria are met: Interferon gamma is to be used for reducing the frequency and severity of serious infections in members with Chronic Granulomatous Disease, OR Interferon gamma is to be used to delay disease progression in members with severe, malignant osteoporosis. Use of interferon gamma for disease states outside of its FDA-approved indications will be denied based on the lack of clinical data to support its effectiveness and/or safety in other conditions. 4. Contraceptive Therapies Effective May 16, 2007, the prior authorization criteria for contraceptive therapies was revised to allow for coverage when used for the treatment of peri-menopausal symptoms. When a benefit, contraceptive therapies may be approved for the following documented diagnoses: Amenorrhea Polycystic ovary disease Endometriosis Hirsutism GI AV malformations Menorrhagia (with complications such as anemia) Acne with documentation of failure with three (3) acne products Concomitant use of Accutane or another known teratogen (Pregnancy category X) Migraine prophylaxis Reduce risk of ovarian cancer in women at risk (nulliparity, positive family history or carrier of BRCA genes) Reduce the risk of endometrial cancer in women at high risk (infertility, obesity and exogenous unopposed estrogen) Fibroid uterus Dysmenorrhea Regulation of menses, cycle control or irregular bleeding Dysfunctional uterine bleeding Peri-menopausal symptoms C. Quantity Level Limit Additions Effective July 1, 2007, the following products were added to Highmark s Quantity Level Limit (QLL) program. Table 4: Additions to the QLL Program (effective July 1, 2007) Brand Name Generic Name Up to 34 Days Supply Limit (Retail) Days Supply Limit (Retail or Mail) Actonel 75 mg risedronate sodium 2 tablets 6 tablets Estrogel 50 gm estradiol 1 metered pump 3 metered pumps 4

5 D. Updates to Highmark s Formulary Policies 1. Non-formulary, Extended-release Products This policy pertains to non-formulary, extended-release products where the same chemical is available on the formulary (Paxil CR, Coreg CR TM, Wellbutrin XL, Proquin XR, Ambien CR TM, Lialda TM, etc.). Effective May 16, 2007, requests for coverage for non-formulary, extended-release products may be approved when all of the following criteria are met: Well-designed studies must demonstrate that the extended-release product has superior clinical efficacy or safety to the same chemical available on the formulary (as determined by the members of the Highmark Pharmacy and Therapeutics Committee upon review of the primary literature) using a clinically measurable parameter (e.g., decreased symptoms, improved quality of life, etc.) Studies supporting safety and superior efficacy must be reproducible outside the academic setting. No exception will be made for requests of non-formulary, extended-release dosage forms if the same chemical is available on the formulary and the sole purpose is to increase patient compliance or patient convenience. E. Retail Exclusivity Program (Self-administered or Oral Biotechnology Drugs) Tykerb and Zolinza were added to Highmark s Retail Exclusivity Program effective Aug. 6, Members who use Tykerb or Zolinza will need to obtain it exclusively from Medmark. Medicare Advantage and BlueRx SM members have the option to obtain this product through Medmark. To simplify this process, physicians can contact Medmark at 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 members. For your convenience, you can search the Highmark Medicare-Approved Select/Choice Formulary online at: Table 1: Products Added (effective April 2007 and June 2007 ) Actonel 75 mg risedronate sodium An oral bisphosphonate, taken on two consecutive days for a total of two tablets each month for the prevention and treatment of osteoporosis Imovax rabies vaccine A vaccine for pre- and post-exposure immunization to rabies virus Je-Vax Japanese encephalitis virus vaccine An inactivated vaccine for the prevention of viral encephalitis (continued) 5

6 A. Changes to the Highmark Medicare-Approved Select/Choice Formulary (continued) Table 2: Products Not Added * Abilify Discmelt aripiprazole orally disintegrating tablets Risperdal, Seroquel, Zyprexa and Zyprexa Zydis are on the formulary. Abilify aripiprazole Haloperidol is on the formulary. injection Aerospan HFA flunisolide Asmanex, Azmacort, Flovent, Pulmicort and Qvar are on the formulary. Allegra oral fexofenadine Fexofenadine tablets are on the formulary. suspension Altabax retapamulin ointment Mupirocin is on the formulary. Amitiza ** lubiprostone** A chloride channel activator for the treatment of chronic idiopathic constipation. Carac fluorouracil Fluorouracil is on the formulary. Chantix varenicline Bupropion is on the formulary. Duetact pioglitazone/glimepiride Actos and glimepiride are on the formulary. Exubera human insulin Injectable insulin is on the formulary. (inhalation) Flector diclofenac epolamine topical patch Multiple non-steroidal, anti-inflammatory drugs are on the formulary. Invega paliperidone Risperdal, Zyprexa, Seroquel, Geodon and clozapine are on the formulary. OsmoPrep sodium phosphate monobasic monohydrate, PEG 3350-KCl-NaBicarb-NaCl-NaSulf is on the formulary. USP, and sodium phosphate dibasic anhydrous, USP Tekturna aliskiren Multiple antihypertensive agents which act on the renin-angiotensin-aldosterone system (RAAS) are on the formulary. Tyzeka telbivudine Epivir HBV is on the formulary. Vyvanse lisdexamfetamine Multiple formulations of methylphenidate, dexamphetamine and mixed salts of amphetamine are 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 2007 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. **Prior authorization required. See Page 7 for details. Table 3: Products Removed* From the Formulary (effective Jan. 1, 2008) Ambien zolpidem tartrate Generic is on the formulary. Norvasc amlodipine besylate Generic 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 2007 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. 6

7 B. Prior Authorization Program 1. Tykerb (lapatinib) Effective Aug. 1, 2007, Tykerb (lapatinib) was added to Highmark s Prior Authorization program for Medicare Advantage and BlueRx SM members. Tykerb (lapatinib) is a dual tyrosine kinase inhibitor against epidermal growth factor receptor or EGFR (ErbB1) and HER2 (ErbB2). Stimulation of EGFR and HER2 are associated with cell proliferation and with multiple processes involved in tumor progression, invasion and metastasis. Lapatinib is approved for use in combination with Xeloda (capecitabine) for patients with advanced, metastatic breast cancer that is HER2 positive who have received prior therapy, including an anthracycline, a taxane and trastuzumab (Herceptin ). When a benefit, lapatinib may be approved when all of the following criteria are met: Lapatinib is to be prescribed under the supervision of an oncologist. Lapatinib is to be used in combination with Xeloda (capecitabine) for patients with advanced, metastatic breast cancer that is HER2 positive who have received prior therapy, including an anthracycline, a taxane and trastuzumab (Herceptin). The use of lapatinib for disease states outside its FDA-approved indications should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions. 2. Amitiza TM (lubiprostone) Effective Aug. 1, 2007, the prior authorization criteria for Amitiza (lubiprostone) was revised for Medicare Advantage and BlueRx SM members to allow for use in chronic idiopathic constipation after unsuccessful use of any three other medications (prescription or over the counter) used for the treatment of constipation. When a benefit, coverage for lubiprostone will be approved if members meet the following criteria: Lubiprostone must be used for an FDA-approved indication. Lubiprostone will be approved for use in chronic idiopathic constipation in adult patients (>18 years old) after documented failure of three other medications used for the treatment of constipation. 3. Actimmune (interferon gamma) Effective May 16, 2007, the prior authorization criteria for Actimmune (interferon gamma) was revised for Medicare Advantage and BlueRx members to exclude coverage when used for the treatment of Idiopathic Pulmonary Fibrosis. This decision was made in response to recent studies concluding that patients with IPF do not benefit from interferon gamma. When a benefit, interferon gamma may be approved when either of the following criteria are met: Interferon gamma is to be used for reducing the frequency and severity of serious infections in members with Chronic Granulomatous Disease, OR Interferon gamma is to be used to delay disease progression in members with severe, malignant osteoporosis. Use of interferon gamma for disease states outside of its FDA-approved indications will be denied based on the lack of clinical data to support its effectiveness and/or safety in other conditions. 7

8 B. Prior Authorization Program (continued) 4. Contraceptive Therapies Effective May 16, 2007, the prior authorization criteria for contraceptive therapies was revised for Medicare Advantage and BlueRx SM members to allow for coverage when used for the treatment of peri-menopausal symptoms. When a benefit, contraceptive therapies will be approved for the following documented diagnoses: Amenorrhea Polycystic ovary disease Endometriosis Hirsutism GI AV malformations Menorrhagia (with complications such as anemia) Acne with documentation of failure with three (3) acne products Concomitant use of Accutane or another known teratogen (Pregnancy category X) Migraine prophylaxis Reduce risk of ovarian cancer in women at risk (nulliparity, positive family history or carrier of BRCA genes) Reduce the risk of endometrial cancer in women at high risk (infertility, obesity and exogenous unopposed estrogen) Fibroid uterus Dysmenorrhea Regulation of menses, cycle control or irregular bleeding Dysfunctional uterine bleeding Peri-menopausal symptoms 5. Orencia (abatacept) Effective July 1, 2007, Orencia (abatacept) was added to Highmark s Prior Authorization program for Medicare Advantage and BlueRx SM members. Abatacept (Orencia) is a fully human soluble fusion protein for the treatment of rheumatoid arthritis. It is a selective T-Cell costimulation modulator. Abatacept blocks both the production of new T-lymphocytes and the production of the chemicals that destroy tissue and cause the symptoms and signs of arthritis. Abatacept is indicated for reducing the signs and symptoms, inducing major clinical response, slowing the progression of structural damage and improving physical function in adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying, anti-rheumatic drugs (DMARDs), such as methotrexate or tumor necrosis factor antagonists (TNF). Abatacept may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. Abatacept is given as an intravenous infusion. Documentation Requirements: Documentation in the medical record must contain a history pertinent to the indications of this policy. In addition, the documentation must support the diagnosis reported and substantiate the medical necessity for administration of this agent. Documentation must be maintained in the patient s medical record and be available upon request. (continued) 8

9 B. Prior Authorization Program (continued) 5. Orencia (abatacept) (continued) Documentation Requirements (continued): The administration of abatacept (Orencia) must be in keeping with the FDA approval and package insert for the drug. For patients continued on abatacept therapy beyond six months, physician documentation, both subjective and objective, of the patient s improvement with therapy is necessary and must be available upon request. C. Updates to Highmark s Formulary Policies 1. Non-formulary, Extended-release Products This policy pertains to non-formulary, extended-release products where the same chemical is available on the formulary (Paxil CR, Coreg CR TM, Wellbutrin XL, Proquin XR, Ambien CR TM, Lialda TM, etc.). Effective May 16, 2007, requests for coverage for non-formulary, extended-release products for Medicare Advantage and BlueRx SM members may be approved when all of the following criteria are met: Well-designed studies must demonstrate that the extended-release product has superior clinical efficacy or safety to the same chemical available on the formulary (as determined by the members of the Highmark Pharmacy and Therapeutics Committee upon review of the primary literature) using a clinically measurable parameter (e.g., decreased symptoms, improved quality of life, etc.) Studies supporting safety and superior efficacy must be reproducible outside the academic setting. No exception will be made for requests of non-formulary, extended-release dosage forms if the same chemical is available on the formulary and the sole purpose is to increase patient compliance or patient convenience. Section III. Miscellaneous Updates A. Zelnorm Withdrawn from the Market Marketing and sales of Zelnorm (tegaserod maleate), a treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation, have been suspended at the request of the Food and Drug Administration. This action was based upon recent clinical data which revealed a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking Zelnorm compared to those taking placebo. These events included myocardial infarction, stroke and unstable angina pectoris. 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. 9

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

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