Enclosed is the 4th Quarter 2009 update to Highmark’s Medicare-Approved Select/Choice Formulary and related pharmaceutical management procedures. Highmark’s Medicare-Approved Select/Choice Formulary applies to all members enrolled in Highmark’s Medicare Advantage FreedomBlueSM PPO product offered in partnership with Blue Cross of Northeastern Pennsylvania® (BCNEPA) in the BCNEPA service area. The formulary also applies to all members enrolled in Highmark’s Medicare Prescription Drug plan, BlueRxSM. Highmark’s Medicare-Approved Select/Choice Formulary and related pharmaceutical management procedures are updated on a quarterly basis, based on recommendations made by Highmark’s Pharmacy and Therapeutics Committee and within the guidelines established by the Centers for Medicare and Medicaid Services (CMS). On an ongoing basis, Highmark, in partnership with BCNEPA, will provide you with quarterly updates regarding formulary changes. Please watch your mail for these important quarterly updates. The enclosed changes reflect the decisions made in September 2009 by Highmark’s Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. As an added convenience, you can search the Highmark Medicare-Approved Select/Choice Formulary online at http://highmark.medicare-approvedformularies.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 on Highmark’s online Provider Resource Center. Simply visit www.highmarkblueshield.com, click on the Providers tab at right near the top of the page and then look under the Pharmacy/Formulary Information link. (If you have access to Highmark’s NaviNet® system, simply click Resource Center at left on the Plan Central welcome page to access the Pharmacy/Formulary Information link.) Additionally, an electronic copy of the formulary for use with a portable handheld device can be downloaded free by visiting www.epocrates.com. If you have any questions regarding this Special Bulletin or Highmark’s Medicare-Approved Select/Choice Formulary, please contact your Provider Relations representative. *PLEASE NOTE: This formulary doesn’t apply to members enrolled in BCNEPA’s traditional Medicare products. Highmark is a registered mark of Highmark Inc. Blue Shield and the Shield symbol are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. BlueRx and FreedomBlue are service marks of the Blue Cross and Blue Shield Association. 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 NaviNet, Inc. NaviNet, Inc. is an independent company that provides a secure, Web-based portal between providers and health care insurance plans. (over, please) Highmark Medicare-Approved Formulary Update November 2009
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 BlueRxSMmembers and to members of Highmark’s Medicare Advantage FreedomBlueSM PPO product. For your convenience, you can search the Highmark Medicare-Approved Select/Choice Formulary online at http://highmark.medicare-approvedformularies.com. Table 1: Products Added (All products added to the formulary effective immediately unless otherwise noted) Brand Name Generic Name Comments
A once-daily phosphodiesterase-5 (PDE-5) inhibitor for Pulmonary Arterial Hypertension (PAH). Colchicine is for the treatment of acute gout
angiotensin receptor blocker-thiazide diuretic for the treatment of hypertension.
A fully human monoclonal antibody that selectively blocks IL-1ß for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS).
A selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia.
A prostacyclin analogue indicated to increase walk distance in patients with WHO Group I pulmonary arterial hypertension and NYHA Class III symptoms.
A non-neurotoxic prescription product for treating head lice.
Table 2: Products Not Added* Brand Name Generic Name Comments
Clindamycin and benzoyl peroxide topical preparations are on the formulary.
Ciprofloxacin and ofloxacin ophthalmic solutions are on the formulary.
Ketorolac injection is on the formulary.
Ofloxacin otic solution 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 2009 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center; under Provider Forms, select Miscellaneous Forms, and select the link titled Request for Drug Coverage from Pharmaceutical Management Program.
Changes to the Highmark Medicare-Approved Select/Choice Formulary (continued) Table 2: Products Not Added* (continued) Brand Name Generic Name Comments
An intravenous (IV) dihydropyridine calcium
Multiple short-acting narcotic agonists are on the formulary.
Maxalt ® and sumatriptan are on the formulary.
Fibrinogen Concentrate indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency.
An injectable agent for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain.
An injectable agent indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the IL-2 receptor.
An injectable iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).
Actos® and metformin 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 2009 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center; under Provider Forms, select Miscellaneous Forms, and select the link titled Request for Drug Coverage from Pharmaceutical Management Program. Table 3: Products to be Removed* From the Formulary (effective January 1, 2010) Brand Name Generic Name Comments Changes to the Highmark Medicare-Approved Select/Choice Formulary (continued) Table 3: Products to be Removed* From the Formulary (effective January 1, 2010) (continued) Fludara®
calcitonin (salmon) nasal spray 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 2009 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center; under Provider Forms, select Miscellaneous Forms, and select the link titled Request for Drug Coverage from Pharmaceutical Management Program. B. Updates to the Prior Authorization Program
Effective November 1, 2009, Adcirca™ (tadalafil) was added to Highmark’s Pulmonary Arterial Hypertension policy for Medicare Advantage and BlueRxSM members. When a benefit, tadalafil may be approved when all of the following criteria are met:
1. A diagnosis of pulmonary hypertension is substantiated by results from Doppler echocardiography and/or direct measurement of pulmonary arterial pressure. Pulmonary arterial hypertension is defined as a mean pulmonary arterial pressure of > or = 25 mmHg, with a pulmonary capillary wedge pressure of < 15 mmHg AND 2. Tadalafil is to be prescribed under the supervision of a cardiologist or pulmonologist AND 3. Tadalafil is to be used for the treatment of pulmonary arterial hypertension (WHO Group I) to increase exercise ability AND 4. Tadalafil may be used alone or in combination with calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, diuretics, digoxin, and anticoagulants, but will not be covered when used concomitantly with bosentan (Tracleer™), ambrisentan (Letairis™), sildenafil (Revatio™), epoprostenol sodium (Flolan®), treprostinil sodium (Remodulin™, Tyvaso™), or iloprost (Ventavis®), due to the lack of clinical data to support combination therapy with these agents.
Adcirca™ (tadalafil) (continued)
As there is no established criterion or algorithm for the transitioning of patients from one PAH drug product to another (e.g., sildenafil to bosentan), the use of two agents concomitantly may be authorized for a period of up to one month to accommodate potential overlapping titration schedules when changing therapy from one drug product to another. As stated in #4 above, coverage will not be provided for the use of two agents (bosentan, ambrisentan, sildenafil, epoprostenol, iloprost, treprostinil) as maintenance combination therapy for PAH. Use of tadalafil 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. Duration of authorization: If approved, authorization may be granted for a period of up to one year. 2.
Onsolis™ (fentanyl buccal soluble film)
Effective November 1, 2009, Onsolis™ (fentanyl buccal soluble film) was added to Highmark’s Oral Transmucosal Fentanyl Citrate Policy for Medicare Advantage and BlueRxSM members. When a benefit, oral transmucosal fentanyl citrate may be approved when the following criteria are met:
For the management of breakthrough cancer pain in patients who are currently receiving and are tolerant to long-acting opioid therapy.
Upon approval, coverage will be limited to 120 units total (Fentora or Actiq or Onsolis) per 25 days. If more units are required on a daily basis for the management of breakthrough cancer pain, an increase in the around-the-clock opioid dose for persistent pain should be considered.
Oral transmucosal fentanyl citrate should not be used for acute pain conditions, chronic pain conditions which are not related to cancer, or in situations involving chronic pain in which the patient is not receiving maintenance doses of long-acting opioid analgesics. Duration of Authorization: If approved, authorization may be granted for a period of up to one year.
C. Additions to Highmark’s Pharmaceutical Management Procedures
Additions to the Specialty Tier Copay Option
Effective November 1, 2009, Firmagon® (degarelix) was added to the specialty tier copay program for Medicare Advantage and BlueRxSM members. Effective November 1, 2009, Adcirca™ (tadalafil) and Onsolis™ (fentanyl buccal soluble film) were added to the specialty tier copay program with prior authorization criteria for Medicare Advantage and BlueRxSM members. D. Specialty Drug Tier Program
Specialty drugs are very high-cost and unique drugs as defined by the Centers for Medicare & Medicaid Services. These drugs may incur a coinsurance based on their negotiated price. Because of this, the cost may vary slightly due to pricing changes in the drug. Drugs in the specialty tier apply to Highmark Medicare Advantage and BlueRx members. Please refer to the following list for products included in the Specialty Drug Tier program.
Specialty Drug Tier Program (continued) Table 4: Products Included in the Specialty Drug Tier Program Specialty Drug Tier Program (continued) Table 4: Products Included in the Specialty Drug Tier Program (continued) ELAPRASE
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