Pharmacy Policy Bulletin

Category: Prior Authorization Number: J-30 Subject: Administrative Prior Auth for Medicare Part D Plans Effective Date Begin: May 19, 2010 Effective Date End: Original Date: May 18, 2005 Review Date(s): May 19, 2010 December 2, 2009 December 3, 2008 May 21, 2008 September 5, 2007 September 6, 2006 May 17, 2006 May 18, 2005

Policy Applies to: Medicare only

Background: The following drugs/classes of drugs require prior authorization to determine coverage eligibility under the Medicare Part D benefit.

1. Immunosuppressants - Covered under Part B for a member who has received a Medicare covered organ transplant 2. Intravenous Immune Globulins - Covered under Part B when administered in the home to a member with a diagnosis of primary immunodeficiency disease 3. Methotrexate (oral) - Covered under Part B when used as a part of a cancer chemotherapy regimen 4. Neurokinin 1 (NK1) Receptor Antagonists - Coverage of the oral dosage form under Part B when used in combination with oral formulations of a 5-HT3 antagonist and dexamethasone OR as full replacement for IV anti-emetic therapy for the prevention of nausea and vomiting associated with moderately to highly emetogenic cancer chemotherapy that includes: carmustine, cisplatin, cyclophosphamide, dacarbazine, doxorubicin, epirubicin, lomustine, mechlorethamine, or streptozocin. 5. Home Infusion Therapy– Acute Care Drug. IV Amino Acids, IV Lipids - Coverage under Part B for permanent dysfunction of digestive tract 6. Alpha-1 Antitrypsin Deficiency - Coverage under Part B when furnished incident to a physician service and is not self- administered 7. Agents used for weight gain – Covered under Part D when used to treat AIDS wasting or cachexia; otherwise excluded under Part D benefits. 8. Chorionic gonadotropin – Covered under Part D when used for prepubertal cryptorchidism or hypogonadism secondary to pituitary deficiency in males; otherwise excluded under Part D benefits. 9. Oxsoralen, Oxsoralen Ultra – Covered under Part D when used in the treatment of psoriasis or in the treatment of cutaneous T-cell lymphoma (CTCL); otherwise excluded from Part D benefits.

In addition to the drugs/classes of drugs listed above, claims for drugs/classes of drugs that are usually not self-administered and/or primarily administered incident to a physician service will not process at the pharmacy point of service and will be reviewed for potential coverage under Part D benefits. Such products will be covered under Part D when they are: 1. Self-administered AND/OR 2. Not otherwise administered incident to a physician service AND 3. Are used for an FDA-approved or medically accepted indication not otherwise excluded from Part D. 4. A medically accepted indication is defined as follows:  The use of the drug is supported by any one of these compendia AND the use is NOT listed as “not indicated” in any of the other compendia. i. American Hospital Formulary Service Drug Information ii. Elsevier Gold Standard's Clinical Pharmacology iii. Thomson Micromedex Drug Dex  In those circumstances when the unlabeled use of the drug is not listed in any of the compendia or is listed as insufficient data or investigational, the use of the drug may be supported by clinical research that appears in peer reviewed medical literature. Peer reviewed medical literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts).  Unlabeled uses of the drug may also be considered medically accepted if determined to be the community standard of care and to be medically accepted as safe and effective for the particular use. In order to determine if a drug meets the level of community standard of care, the following may be used:  Peer reviewed medical literature in journals can be used to establish a community level standard of care. To do so, the level of evidence in each article must be determined.  Levels of evidence as defined below will be used use to assess research and to determine a grade of recommendation for a particular medical treatment. These levels are described below: Level 1: Randomized controlled trials/meta analyses Level 2: Cohort studies Level 3: Case controlled studies Level 4: Cross sectional surveys, case reports, or case series Level 5: Expert opinion  If the peer-reviewed literature is a Level 1 study, the use of the drug is considered to be the community standard and the drug may be covered. However, if the peer-reviewed literature is a Level 2, 3, or 4 study, two or more articles by different authoring groups are required to establish the use of the drug as the community standard before the drug may be covered. If the literature is only Level 5, then the drug has not been established as a community standard and will not be covered. If the criteria for approval under Part D are not met, the drug will be able to be reviewed for coverage under a member’s Part B benefit.

Drugs that are determined to be covered under Medicare Part B will be excluded from coverage under the member's Part D Prescription Drug Plan.

Indications and Limitations of Coverage for Chemotherapeutic Regimens

Chemotherapeutic regimens for cancer may be covered under Part D given the following conditions:

 The chemotherapeutic agent (drug) meets the definition of a Part D drug:

"A Part D covered drug is available only by prescription, approved by the Food and Drug Administration (FDA) (or is a drug described under section 1927(k)(2)(A)(ii) or (iii) of the Act), used and sold in the United States, and used for a medically accepted indication (as defined in section 1927(k)(6) of the Act). A covered Part D drug includes prescription drugs, biological products, insulin as described in specified paragraphs of section 1927(k) of the Act, and vaccines licensed under section 351 of the Public Health Service Act. The definition also includes “medical supplies associated with the injection of insulin (as defined in regulations of the Secretary).” We definition also includes “medical supplies associated with the injection of insulin (as defined in regulations of the Secretary).” We define those medical supplies to include syringes, needles, alcohol swabs, and gauze."

 The drug, or use of the drug, is not eligible for coverage under Medicare Part A or Part B. Such circumstances cause the drug to be excluded from the definition of a Part D drug and, therefore, cannot be included in Part D basic coverage.  The drug is NOT administered incident to a physician service.  If the regimen includes an oral chemotherapeutic agent, there is not an infusible version of the drug commercially available.  The drug is being prescribed for an FDA-approved indication or an acceptable unlabeled use (refer to additional conditions for unlabeled use below).

FDA-approved Use for Chemotherapeutic Agents

Cancer chemotherapeutic agents are covered only if all of the following requirements are met:

 Documentation is present to support that the drug is safe and effective and is being administered for an FDA-approved indication.  Documentation in the patient’s medical record supports the medical necessity of administering the chemotherapy drug to that individual patient.

FDA Unlabeled Use for Chemotherapeutic Agents

Cancer chemotherapeutic agents may be covered for use in unlabeled indications given the following conditions:

1) In review of the following compendia, if the use of the chemotherapeutic agent is supported by any one of these compendia AND the use is NOT listed as “not indicated” in any of the other compendia, the agent may be approved.

 American Hospital Formulary Service Drug Information  Elsevier Gold Standard's Clinical Pharmacology  National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium  Thomson Micromedex Drug Dex

2) In those circumstances when the unlabeled use of the chemotherapeutic agent is not listed in any of the compendia or is listed as insufficient data or investigational, the use of the drug may be supported by clinical research that appears in peer reviewed medical literature. Peer reviewed medical literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts).

Coverage will be determined based on the results of peer reviewed medical literature published in the regular editions of the following publications (not to include supplemental editions privately funded by parties with a vested interest in the recommendations of the authors):

American Journal of Medicine Annals of Internal Medicine Annals of Internal Medicine Annals of Oncology Annals of Surgical Oncology Biology of Blood and Marrow Transplantation Blood Bone Marrow Transplantation British Journal of Cancer British Journal of Hematology British Medical Journal Cancer Clinical Cancer Research Drugs European Journal of Cancer (formerly The European Journal of Cancer and Clinical Oncology) Gynecologic Oncology International Journal of Radiation, Oncology, Biology, and Physics Journal of Clinical Oncology Journal of the National Cancer Institute Journal of the National Comprehensive Cancer Network (NCCN) Journal of Urology Lancet Lancet Oncology Leukemia Radiation Oncology The Journal of the American Medical Association The New England Journal of Medicine

3) Unlabeled uses of cancer chemotherapeutic agents may also be considered medically accepted if determined to be the community standard of care and to be medically accepted as safe and effective for the particular use. In order to determine if a chemotherapeutic agent meets the level of community standard of care, the following may be used:

Peer reviewed medical literature in journals other than those journal cited above also can be used to establish a community level standard of care. This literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts). Furthermore, the level of evidence in each article must be determined.

Levels of evidence as defined below will be used use to assess research and to determine a grade of recommendation for a particular medical treatment. These levels are described below:

Level 1: Randomized controlled trials/meta analyses

Level 2: Cohort studies

Level 3: Case controlled studies

Level 4: Cross sectional surveys, case reports, or case series

Level 5: Expert opinion If the peer-reviewed literature is a Level 1 study, the use of that specific chemotherapeutic agent is considered to be the community standard and the agent is covered. However, if the peer-reviewed literature is a Level 2, 3, or 4 study, two or more articles by different authoring groups are required to establish the use of the chemotherapeutic agent as the community standard before the agent will be covered. If the literature is only Level 5, then the chemotherapeutic agent has not been established as a community standard and will not be covered.

4) If the chemotherapeutic agent does not have FDA-approved labeling, the evidence used to make that decision (information in the compendia, established guidelines [for example guidelines developed by the National Comprehensive Cancer Network, American Society of Clinical Oncology], research studies in approved peer-reviewed medical journals, etc.) must be retained. This information must be retained in the patient’s record either as a hard copy of the reference material itself or citations of the reference material. This information must be submitted whenever requested.

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Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.