P&T Committee Meeting Minutes (GHP Family Business) September 17, 2013

Transcription

1 P&T Committee Meeting Minutes (GHP Family Business) September 17, 2013 Present: Bret Yarczower, MD, MBA, Chair Ali Akram, Pharm.D. MBA Kristen Bender, Pharm.D. Keith Boell, DO Holly Bones, Pharm.D. - via phone Kimberly Clark, Pharm.D. Jamie Dodson, RPh Michelle Holt-Macey, Pharm.D. via phone Kristi Juskiewicz, Pharm. D. via phone Steven Kheloussi, Pharm.D. via phone Phillip Krebs, R.EEG T. Lisa Mazonkey, RPh Daniel McConnell, Pharm.D., RPh Sean Ordway, Pharm.D. - Resident Jonas Pearson, MS, RPh Gino Raineri, Pharmacy Student Tricia Russell, Pharm.D. Kristen Scheib, Pharm. D. via phone Richard Silbert, MD - via phone Leah Smith, Pharm.D. Michael Spishock, RPh Todd Sponenberg, Pharm.D., RPh via phone Kevin Szczecina, RPh Steve Tracy, Pharm.D.- via phone Lori Zaleski, RPh via phone Absent: Charles Baumgart, MD, MBA Beverly Blaisure, MD excused Fred Bloom, MD Dorothy Fisher, MD Tricia Heitzman, Pharm.D. Peter Mikhail, Pharm.D., MBA, Secretary David Rolston, MD Ray Roth, DO, MBA James Schuster, MD William Seavey, Pharm.D. Call To Order: Bret Yarczower called the meeting to order at 1:07 p.m., Tuesday, September 17, Review and Approval of Minutes: Ali Akram submitted typographical changes to update the minutes from July 16, Bret Yarczower asked for a motion or approval to accept the July 16, 2013 minutes as amended. Jamie Dodson accepted the motion, and Lisa Mazonkey seconded the motion. None were opposed.

2 DRUG REVIEWS: SIRTURO (bedaquiline) Kimberly Clark Kimberly Clark provided a review of Sirturo to the committee for consideration as a pharmacy benefit. Sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults ( 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Formulary alternatives include amoxicillin-clavulanic acid, clarithromycin, ethambutol, isoniazid, levofloxacin, pyrazinamide, rifampin and Zyvox (requires prior authorization. A. Proposed Clinical Recommendations: Based on the potential for serious adverse reactions and specialists recommendations, it is recommended that this medication be non-formulary for GHP Family with a prior authorization to ensure appropriate utilization. The following prior authorization criteria should apply: Prescription is written by a physician specializing in infectious disease AND Medical record documentation of age 18 years AND Medical record documentation of resistance to isoniazid AND rifampin AND Medical record documentation that an effective treatment regimen cannot be attained with other available treatment options AND Medical record documentation that Sirturo is being prescribed in combination with at least 3 other drugs to which the patient s MDR-TB isolate had been shown to be susceptible in vitro Approval will be given for a total duration of 24 weeks. A 34 day supply limit per fill will apply. A quantity limit of 56 tablets will be applied to the first fill. Subsequent fills will be for a quantity of 24 tablets. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, Special Population Precautions and Specialist Input were discussed. Clinical Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Sirturo not be added to the GHP Family formulary.

3 Financial Discussion: No comments or questions. Financial Outcome: Jamie Dodson made a motion to accept the recommendations as written. Ali Akram accepted the motion. None were opposed. B. Approved Recommendations: Sirturo will not be added to the GHP Family formulary. The following prior authorization criteria will apply to non-formulary exception requests: Prescription is written by a physician specializing in infectious disease AND Medical record documentation of age 18 years AND Medical record documentation of resistance to isoniazid AND rifampin AND Medical record documentation that an effective treatment regimen cannot be attained with other available treatment options AND Medical record documentation that Sirturo is being prescribed in combination with at least 3 other drugs to which the patient s MDR-TB isolate had been shown to be susceptible in vitro If approved, approval will be given for a total duration of 24 weeks. A 34 day supply limit per fill will apply. A quantity limit of 56 tablets will be applied to the first fill. Subsequent fills will be for a quantity of 24 tablets. SUCLEAR Ali Akram (Sodium sulfate, potassium sulfate and magnesium sulfate oral solution; and PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) Ali Akram provided a review of Suclear to the committee for consideration as a pharmacy benefit. Suclear is indicated for cleansing of the colon as a preparation for colonoscopy in adults. GHP Family formulary alternatives include Peg-3350 with Electrolytes, Polyethylene Glycol-3350, sodium chloride/nahco3/kcl/peg A. Proposed Clinical Recommendations: It is recommended that Suclear not be added to the GHP Family formulary. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed. Clinical Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Lisa Mazonkey seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Suclear not be added to the GHP Family formulary.

4 Financial Discussion: No comments or questions. Financial Outcome: Lisa Mazonkey made a motion to accept the recommendations as written. Kevin Szczecina seconded the motion. None were opposed. B. Approved Recommendations: Suclear will not be added to the GHP Family Formulary OSPHENA (ospemifene) Kimberly Clark Kimberly Clark provided a review of Osphena to the committee for consideration as a pharmacy benefit. Osphena is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Premarin Cream is a formulary alternative for GHP Family members. A. Proposed Clinical Recommendations: Osphena is the first and only FDA-approved non-estrogen oral product that reverses the physical changes of the vagina (superficial cells and parabasal cells, and ph) and significantly relieves moderate to severe painful intercourse due to menopause. However, based on the availability of a formulary alternative with similar efficacy and longer term safety data, it is recommended that Osphena be non-formulary for GHP Family. The following prior authorization criteria should apply: Medical record documentation of a diagnosis of moderate to severe dyspareunia caused by vulvovaginal atrophy AND Medical record documentation of contraindication to, intolerance to, or therapeutic failure on Premarin Cream Quantity Limit: 1 tablet per day Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed. Clinical Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Osphena not be added to the GHP Family formulary. Financial Discussion: No comments or questions. Financial Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed.

5 B. Approved Recommendations: Osphena will not be added to the GHP Family formulary. The following prior authorization criteria will apply to non-formulary exception requests: Medical record documentation of a diagnosis of moderate to severe dyspareunia caused by vulvovaginal atrophy AND Medical record documentation of contraindication to, intolerance to, or therapeutic failure on Premarin Cream) Quantity Limit: 1 tablet per day MEKINIST (trametinib) Ali Akram Ali Akram provided a review of Mekinist to the committee for consideration as a pharmacy benefit. Mekinist is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. Mekinist is not indicated for the treatment of patients who have received prior BRAF-inhibitor therapy. There are no formulary alternatives available. A. Proposed Clinical Recommendations: It is recommended that Mekinist be added to the GHP Family formulary. It is recommended that the following prior authorization criteria be applied: Must be prescribed by oncologist or dermatologist AND Medical record documentation of unresectable or metastatic melanoma AND Medical record documentation of FDA-approved test documenting the presence of the BRAF V600E or V600K mutations AND Medical record documentation of no prior therapeutic failure with a BRAF inhibitor therapy (Zelboraf (vemurafenib), Tafinlar (Dabrafenib)) or MEK inhibitor therapy such as Mekinist Q/L: 1mg and 2 mg: 30 tablets per 30 days, 0.5mg: 90 tablets per 30 days. PA: Each treatment period will be defined as 6 months. Re-review will occur every 6 months. Mekinist will no longer be considered medical necessary if there is medical record documentation of disease progression. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, Special Population Precautions and Specialist Input were discussed. Clinical Outcome: Dan McConnell made a motion to accept the recommendations as amended. Leah Smith seconded the motion. None were opposed.

6 Proposed Financial Recommendations: It is recommended that Mekinist be added to the GHP Family Formulary. Financial Discussion: No questions or comments. Financial Outcome: Kim Clark made a motion to accept the recommendations as written. Jamie Dodson seconded the motion. None were opposed. B. Approved Recommendations: Mekinist will be added to the GHP Family Formulary. The following prior authorization criteria will apply: Must be prescribed by oncologist or dermatologist AND Medical record documentation of unresectable or metastatic melanoma AND Medical record documentation of FDA-approved test documenting the presence of the BRAF V600E or V600K mutations AND Medical record documentation of no prior therapeutic failure with a BRAF inhibitor therapy (Zelboraf (vemurafenib), Tafinlar (Dabrafenib)) or MEK inhibitor therapy such as Mekinist Q/L: 1mg and 2 mg: 30 tablets per 30 days, 0.5mg: 90 tablets per 30 days. PA: Each treatment period will be defined as 6 months. INVOKANA (canagliflozin) Kimberly Clark Kimberly Clark provided a review of Invokana to the committee for consideration as a pharmacy benefit. Invokana is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Formulary alternatives for GHP Family members include: glimepiride, glipizide IR, glipizide XL, glipizide-metformin, glyburide, metformin, and pioglitazone (requires step therapy). A. Proposed Clinical Recommendations: It is recommended that Invokana not be added to the GHP Family formulary and requests should be reviewed using the following criteria: Medical record documentation of a diagnosis of type II diabetes mellitus AND Medical record documentation of age 18 years AND Medical record documentation a egfr 45 ml/min/1.73 m 2 AND Medical record documentation of therapeutic failure on, intolerance to, or contraindication to metformin and either a sulfonylurea OR pioglitazone A quantity limit of 1 tablet per day will apply Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique

7 Therapeutic Features, Recommendations of National Agencies and Organizations, Special Population Precautions and Specialist Input were discussed. It was suggested that the formulary alternative criteria be changed to Medical record documentation of therapeutic failure on, intolerance to, or contraindication to 2 other formulary medications, one of which must be metformin. Clinical Outcome: Kevin Szczecin made a motion to accept the recommendations as amended. Leah Smith seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Invokana not be added to the GHP Family formulary. Financial Discussion: No comments or questions. Financial Outcome: Leah Smith made a motion to accept the recommendations as written. Lisa Mazonkey seconded the motion. None were opposed. B. Approved Recommendations: Invokana will not be added to the GHP Family formulary and will require prior authorization. The following criteria will apply to exception requests: Medical record documentation of a diagnosis of type II diabetes mellitus AND Medical record documentation of age 18 years AND Medical record documentation a egfr 45 ml/min/1.73 m 2 AND Medical record documentation of therapeutic failure on, intolerance to, or contraindication to 2 other formulary medications, one of which must be metformin NOTE: Invokana 300 mg is only approved for members with an egfr 60 ml/min/1.73 m2. If Invokana is approved for members with an egfr of 45 to 60 ml/min/1.73 m2, the GPID for Invokana 100 mg should be utilized to enter the authorization into MedImpact A quantity limit of 1 tablet per day will apply. DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) Ali Akram Ali Akram provided a review of Diclegis to the committee for consideration as a pharmacy benefit. Diclegis is a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. There are no GHP Family formulary alternatives available with the same indication. A. Proposed Clinical Recommendations: It is recommended that the following prior authorization criteria apply to exception requests for Diclegis:

8 Medical record documentation of nausea and vomiting of pregnancy in adult women 18 years of age or older and 7 to 14 weeks gestation who have attempted and failed conservative management* *Conservative management: Dietary and lifestyle modifications. These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea. Q/L: 4 tablets per day. PA: Authorization duration will be for 4 (four) weeks. Another PA would have to be obtained for treatment beyond 4 (four) weeks. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed Clinical Outcome: Lisa Mazonkey made a motion to accept the recommendations as written. Kim Clark seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Diclegis not be added to the GHP Family formulary. Financial Discussion: No comments or questions. Financial Outcome: Leah Smith made a motion to accept the recommendations as written. Kevin Szczecina seconded the motion. None were opposed. B. Approved Recommendations: Diclegis will not be added to the GHP Family formulary. The following criteria will apply: Medical record documentation of nausea and vomiting of pregnancy in adult women 18 years of age or older and 7 to 14 weeks gestation who have attempted and failed conservative management* *Conservative management: Dietary and lifestyle modifications. These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea. Q/L: 4 tablets per day. PA: Authorization duration will be for 4 (four) weeks. Another PA would have to be obtained for treatment beyond 4 (four) weeks.

9 LIPTRUZET (ezetimibe and atorvastatin) Kimberly Clark Kimberly Clark provided a review of Liptruzet to the committee for consideration as a pharmacy benefit. Liptruzet is indicated, in addition to diet, to reduce elevated total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), Apolipoprotein (Apo) B, triglycerides (TG), and non-high density lipoprotein cholesterol (HDL-C), and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Liptruzet is also indicated, in addition to diet, to reduce elevated total- C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipidlowering treatments. Formulary alternatives for GHP Family members include: atorvastatin, lovastatin, pravastatin, simvastatin, and Zetia. A. Proposed Clinical Recommendations: It is recommended that Liptruzet be non-formulary requiring a prior authorization. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed Clinical Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Liptruzet be non-formulary. Prior authorization requests should be reviewed with the following criteria: Medical record documentation of contraindication to, therapeutic failure on or intolerance to: o All equipotent, generic, formulary statins in combination with Zetia Financial Discussion: No comments or questions. Financial Outcome: Ali Akram made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. B. Approved Recommendations: Liptruzet will not be added to the GHP Family formulary. The following criteria will apply: Medical record documentation of contraindication to, therapeutic failure on or intolerance to: o All equipotent, generic, formulary statins in combination with Zetia SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) Ali Akram

10 Ali Akram provided a review of Simbrinza to the committee for consideration as a pharmacy benefit. Simbrinza is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. GHP Family formulary alternatives include brimonidine, and dorzolamide. A. Proposed Clinical Recommendations: It is recommended that Simbrinza be added to the formulary. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed Clinical Outcome: Lisa Mazonkey made a motion to accept the recommendations as written. Phil Krebs seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Simbrinza be added to the GHP Family formulary. Financial Discussion: No comments or questions. Financial Outcome: Jamie Dodson made a motion to accept the recommendations as written. Kevin Szczecina seconded the motion. None were opposed. B. Approved Recommendations: Simbrinza will be added to the GHP Family formulary. TECFIDERA fumarate) Kimberly Clark (dimethyl Kimberly Clark provided a review of Tecfidera to the committee for consideration as a pharmacy benefit. Tecfidera is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). The formulary alternatives for GHP Family members are Avonex, Betaseron, Copaxone, Gilenya and Rebif. A. Proposed Clinical Recommendations: Based on available clinical data and experience it is recommended that Tecfidera be non-formulary with the following prior authorization criteria: Prescription is written by a neurologist AND Patient has a diagnosis of relapsing form of multiple sclerosis AND Therapeutic failure on, intolerance to, or contraindication to Interferon Disease Modifying Therapy (Betaseron, Avonex or Rebif) AND Copaxone A quantity limit of 60 capsules per 30 days will be applied to the 240 mg capsules.

11 A quantity limit of 14 capsules per 7 days will be applied to the 120 mg capsules. A quantity limit of 60 capsules per 30 days will be applied to the starter pack. As a specialty medication, members will be limited to a 34 day supply per fill. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology/MOA, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, Special Population Precautions and Specialist Input were discussed. Clinical Outcome: Kevin Szczecina made a motion to accept the recommendations as amended. Jamie Dodson seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Tecfidera not be added to the GHP Family formulary. Financial Discussion: No comments or questions. Financial Outcome: Leah Smith made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. B. Approved Recommendations: Tecfidera will not be added to the GHP Family formulary. The following prior authorization criteria will apply to requests: Prescription is written by a neurologist AND Patient has a diagnosis of relapsing form of multiple sclerosis AND Therapeutic failure on, intolerance to, or contraindication to Interferon Disease Modifying Therapy (Betaseron, Avonex or Rebif) AND Copaxone A quantity limit of 60 capsules per 30 days will be applied to the 240 mg capsules. A quantity limit of 14 capsules per 7 days will be applied to the 120 mg capsules. A quantity limit of 60 capsules per 30 days will be applied to the starter pack. As a specialty medication, members will be limited to a 34 day supply per fill. FAST FACTS LATUDA (lurasidone hydrochloride) Ali Akram Ali Akram provided a fast facts review of a new indication for Latuda. Latuda is now indicated for depressive episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate

12 Recommendations: Recommend adding the indication with the following additional criteria to the existing approved criteria: Medical record documentation of a diagnosis of depressive episodes associated with Bipolar I Disorder (bipolar depression), AND Medical record documentation of therapeutic failure on, intolerance to, or contraindication to Quetiapine and olanzapine and fluoxetine used in combination Discussion: Dr. Silbert voiced concern about requiring failure on olanzapine and fluoxetine used in combination. The fluoxetine in the two drug combination could cause patients who are predisposed to manic swings to become manic. Outcome: It was decided to seek specialist input and review in November. AMITIZA (lubiprostone) Kimberly Clark Kimberly Clark provided a fast facts review of a new indication for Amitiza. Amitiza is a chloride channel activator now indicated for the treatment of opioid-induced constipation in adults with chronic, non-cancer pain. Recommendations: Amitiza is currently non-formulary for GHP Family. Considering there are several formulary agents available there are no formulary changes recommended at this time. Discussion: No comments or questions. Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Jamie Dodson seconded the motion. None were opposed. XGEVA (denosumab) Ali Akram Ali Akram provided a fast facts review of a new indication for Xgeva. Xgeva is now indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity Recommendations: Xgeva is currently listed as a medical benefit for GHP Family and the following will be added to the policy: Medical record documentation of treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity Discussion: No comments or questions. Outcome: Jamie Dodson made a motion to accept the recommendations as written. Lisa Mazonkey seconded the motion. None were opposed.

13 PRISTIQ/OLEPTRO Kimberly Clark Kimberly Clark presented an update to the Pristiq and Oleptro policies to the committee for review. Currently, Pristiq and Oleptro are non-formulary for GHP Family. It was recommended that the policies be changed as follows: Pristiq- Medical record documentation of therapeutic failure on, intolerance to, or contraindication to a least one medication from three antidepressant classes, one of which must be venlafaxine extended release or venlafaxine Oleptro- Medical record documentation of therapeutic failure on, intolerance to, or contraindication to a least one medication from three antidepressant classes, one of which must be trazodone Discussion: No comments or questions. Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. PROMACTA Tricia Russell Tricia Russell presented an update to the Promacta policy to the committee for review. Recommend the updated criteria be: Medical record documentation of a diagnosis of chronic immune (idiopathic) thrombocytopenic purpura (ITP) AND Medical record documentation of a therapeutic failure on, or contraindication to, corticosteroids, immunoglobulins, or splenectomy AND Symptomatic ITP with bleeding symptoms OR a platelet count of less than 20,000/µL and an increased risk of bleeding AND Prescription is written by a Hematologist OR Medical record documentation of a diagnosis of chronic hepatitis C and plan to initiate or continue interferon-based therapy AND

14 Prescription is written by a Gastroenterologist, Hematologist, Hepatologist, or Infectious Disease specialist AND A platelet count of < 50,000/µL AUTHORIZATION DURATION: If approved, the authorization will be for a time period of 1 year. Discussion: No comments or questions. Outcome: Dan McConnell made a motion to accept the recommendations as written. Kimberly Clark seconded the motion. None were opposed. ACTEMRA/AMEVIVE/STELARA Kimberly Clark Kimberly Clark presented an update to the Actemra, Amevive, and Stelara policies to the committee for review. Amevive has been discontinued by the manufacturer and therefore the medical policy fort his drug can probably be retired. Currently, the prior authorization criteria for Actemra and Stelara state that the member must have a therapeutic failure on, contraindication to, or intolerance to Enbrel and Humira or Remicade prior to approval. Considering that approval of Remicade is contingent upon therapeutic failure on, contraindication to, or intolerance to Humira and Enbrel, it is recommended to remove Remicade from the policy criteria and require therapeutic failure on, contraindication to, or intolerance to Humira and Enbrel. Discussion: No questions or comments. Outcome: Dan McConnell made a motion to accept the recommendations as written. Lisa Mazonkey seconded the motion. None were opposed. GHP Family Policy Updates: Kevin Szczecina presented the following policies for committee review: Policy # Drug Aranesp 901.0F Epogen Procrit F Zyvox Growth Hormone F Genotropin Norditropin Nordiflex F Enbrel F Humira

15 Suboxone F Subutex (Buprenorphine Hydrochloride Sublingual) F Modafinil F Tykerb F Xifaxan F Oral Vancomycin Capsules F Targretin Intermezzo F Lunesta Rozerem Zolpidem ER F Tazorac Gel F Tazorac Cream F Symbyax F Ranexa F Tekturna Valturna F Tradjenta F Sabril F Saphris F Bromday F Nexiclon XR F Masks, Spacers for MDI F Livalo Crestor F Ferriprox Exjade F Korlym F Sklice F Onfi F Acthar F Tudorza Pressair F Binosto F Aubagio F Xeljanz F Xarelto Prior authorization of Epogen, Procrit, or Aranesp will be made for members for the following indications when all of the indication specific criteria are met:

16 Treatment of symptomatic anemia of chronic renal insufficiency, chronic renal failure, including end stage renal disease either requiring or not requiring dialysis when all of the following criteria are met: o To achieve and maintain a hemoglobin level of gm/dl; and o Ferritin greater than or equal to 100 ng/ml or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron 2. Treatment of symptomatic anemia in zidovudine-treated HIV infected insured individuals when all of the following criteria are met: Endogenous erythropoietin levels of 500 MU/mL or less; and Ferritin greater than or equal to 100 ng/ml or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron; and Zidovudine doses of 4200 mg or less per week; and To achieve and maintain a hemoglobin level of gm/dl Treatment should not last longer than 3 months following the discontinuation of zidovudine 3. Treatment of symptomatic anemia associated with hepatitis C caused by the effect of administered chemotherapy when all of the following criteria are met: Anemia is due interferon alpha and ribavirin or peginterferon alpha and ribavirin therapy; and Ferritin greater than or equal to 100 ng/ml or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron; and To achieve and maintain a hemoglobin level of gm/dl 4. Treatment of anemia in non hematologic malignancy (on chemotherapy) Insured individual is currently on anemia-inducing chemotherapy or has received anemia-inducing chemotherapy in the previous 3 months; and Ferritin greater than or equal to 100 ng/ml or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron; and To achieve and maintain a hemoglobin level of gm/dl Treatment should be discontinued when hgb level is equal to or greater than 12 gm/dl 5. Treatment of symptomatic anemia secondary to myelodysplastic syndrome (MDS) when all of the following criteria are met: To achieve and maintain a hemoglobin level of gm/dl; and Ferritin greater than or equal to 100ng/dL or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron; and Baseline endogenous erythropoietin levels of 500 MU/mL or less (NCCN Clinical Practice Guidelines in Oncology-Myelodyspastic Syndromes v2.2010) Treatment should be discontinued when hgb level is equal to or greater than 12 gm/dl Note: If ferritin level is < 20ng/dL, the member should receive iron supplement If ferritin level is between ng/dL, the bone marrow iron stores should be evaluated in order to determine the need for iron supplementation. Assessment of insured individuals with no response to therapy should be performed at 4 weeks for epoetin alfa and six weeks for darbepoetin 6. Treatment of symptomatic anemia of chronic disease when all of the following criteria are met:

17 To achieve and maintain a hemoglobin level of gm/dl; and Ferritin greater than or equal to 100ng/dL or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron ; and 1. Insured individual has a severe comorbidity (e.g. severe angina, pulmonary disease, heart failure, cerebrovascular disease causing transient ischemic attacks, lymphoma, myeloma, etc.); OR 2. Insured individual s anemia is manifested by impairments such as, but not limited to, exercise intolerance, tachycardia or shortness of breath with minimal activity, or inability to perform activities of daily living 7. Reduction of allogeneic blood transfusion in anemic insured individuals undergoing surgery when all of the following criteria are met: To achieve and maintain a hemoglobin level of gm/dl; and Ferritin greater than or equal to 100ng/dL or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron; and Anemia is related to a chronic disease state (not acute blood loss); and Insured individual is scheduled to undergo elective, non-cardiac, non-vascular surgery in which anticipated blood loss is greater than 2 units and the need for allogeneic blood transfusion is anticipated. Note: Erythropoietin therapy (epoetin alfa) is not indicated for anemic patients who are able and willing to donate autologous blood. 8. Treatment of anemia in multiple myeloma To achieve and maintain a hemoglobin level of gm/dl; and Ferritin greater than or equal to 100ng/dL or transferrin level saturation greater than or equal to 20% or a history of chelation therapy for iron; and; Documentation of chemotherapy, or Documentation of transfusion dependence; or Documentation of renal insufficiency For All Indications: For continuation of therapy, a repeat hgb should be submitted after 3 months of therapy. For initiation or continuation of therapy, a ferritin level no greater than 3 months old and/or transferrin saturation level no greater than 6 months old should be submitted. In individuals whose Hgb is greater than or equal to 12gm/dL or rises by 1gm/dl in any two-week period, additional doses should be reduced. When erythropoietin or darbepoetin therapy is approved, the prior authorization will be defined as a period of three months. Subsequent authorizations will be considered based on the above criteria. EXCLUSIONS:

18 Erythropoietin and Darbepoetin therapy is not covered for the following conditions because current clinical data indicates that erythropoietin stimulating agents have been shown to impart either a deleterious effect on the underlying disease, or that the underlying disease increases the risk of adverse effects related to use of erythropoietin stimulating agents. These conditions include: Anemia of cancer not related to cancer treatment; Anemia associated only with radiotherapy; Anemia due to cancer treatment in insured individuals with uncontrolled hypertension; Anemia associated with the treatment of acute and/or chronic myelogenous leukemias (CML or AML), or erythroid cancers; Anemia in cancer or in cancer treatment due to folate deficiency, iron deficiency, vitamin B-12 deficiency, bleeding, hemolysis, or bone marrow fibrosis; Prophylactic use of erythropoietin stimulating agents to prevent chemotherapy-induced anemia; Prophylactic use of erythropoietin stimulating agents to reduce tumor hypoxia; Erythropoietin-type resistance due to neutralizing antibodies In insured individuals with an Hgb of greater than or equal to12 gm/dl erythropoietin or darbepoetin therapy will not be covered according to FDA recommendations. Erythropoietin or darbepoetin therapy is not approved by the FDA for the treatment of insured individuals with a diagnosis of cancers who are not on chemotherapy or who are past the 3 month chemotherapy wash-out period. Coverage of Zyvox will be restricted to those who meet one of the following criteria: 1. Medical record documentation of Vancomycin-Resistant Enterococcus (VRE) faecium infection which has been diagnosed and documented with Infectious Disease consultation. 2. Medical record documentation of a diagnosis of nosocomial pneumonia caused by Methicillin Resistant Staphylococcus Aureus (MRSA) or Multidrug-resistant Strains of Streptococcus Pneumoniae (MDRSP) which has been diagnosed and documented with Infectious Disease consultation. 3. Medical record documentation of a diagnosis of complicated skin and structure infections caused by MRSA which has been diagnosed and documented with Infectious Disease consultation. 4. Medical record documentation of a diagnosis of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) which has been diagnosed and documented with Infectious Disease consultation. 5. Medical record documentation of a diagnosis of Community-acquired pneumonia caused by Multidrug-resistant strains of Streptococcus Pneumoniae (MDRSP), including cases with concurrent bacteremia. Prior authorization of human growth hormone will be made for members of Geisinger Health Plan who meet the following criteria: For Genotropin and Norditropin: 1.) Medical record documentation of use for an FDA approved indication

19 For all other Growth Hormone Agents: 2.) Medical record documentation of use for an FDA approved indication AND 3.) Medical record documentation of therapeutic failure on, intolerance to, or contraindication to Genotropin* AND Norditropin* (if applicable) FDA Approved Indications: Growth failure associated with chronic renal insufficiency: (Nutropin and Nutropin AQ) Growth failure associated with Noonan syndrome: (Norditropin) Growth failure associated with Prader-Willi syndrome: (Genotropin and Omnitrope) Growth failure associated with Turner syndrome: (Accretropin, Genotropin, Humatrope, HumatroPen, Norditropin, Omnitrope, Nutropin, and Nutropin AQ) Growth failure in children: (Accretropin, Genotropin, Humatrope, HumatroPen, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin) For children born small for gestational age (SGA) who fail to manifest catch-up growth by 2 years of age: (Genotropin and Omnitrope). For the treatment of children with short stature born SGA with no catch-up growth by 2 to 4 years of age: (Humatrope and Norditropin) Growth hormone deficiency in adults: (Genotropin, Humatrope, HumatroPen, Norditropin, Nutropin, Nutropin AQ, Omnitrope, and Saizen) HIV patients with Wasting or Cachexia: (Serostim) Idiopathic short stature: (Genotropin, Humatrope, HumatroPen, Omnitrope, Nutropin, and Nutropin AQ) Short bowel syndrome: (Zorbtive) Short stature homeobox-containing gene (SHOX) deficiency: (Humatrope, HumatroPen) Continued Authorization: Authorization for Growth Hormone will be for a time period of one year. Continuation of coverage will be provided based on medical record documentation to determine if there is appropriate follow up care with the physician, if any endpoint criteria are met, or if any major change in clinical status has occurred. Prior authorization of Enbrel* (which is self-administered) will be made for members who meet the following criteria: For treatment of adult rheumatoid arthritis:

20 1. Medical record documentation of a diagnosis of rheumatoid arthritis (made in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis) and 2. Must be prescribed and administered by a rheumatologist and 3. Member must be 18 years of age and 4. Medical record documentation of the number of swollen or tender joints prior to initiating etanercept therapy. Member must have a minimum documented joint count of A. Greater than four (4) swollen or tender joints based on a 28 joint count or B. Greater than six (6) swollen or tender joints based on a joint count and 5. Medical record documentation of an inadequate response to a minimum 4 month trial of methotrexate or other DMARD if member is unable to tolerate methotrexate or methotrexate is contraindicated. For treatment of adult rheumatoid arthritis: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of improvement in signs and symptoms of rheumatoid arthritis that must include the number of swollen or tender joints on six (6) months of etanercept therapy is required. After the initial six (6) month approval, subsequent approvals for coverage will be for a duration of one (1) year. Reevaluation of coverage will be every one (1) year requiring medical record documentation of improvement in the signs and symptoms of rheumatoid arthritis and must include the number of swollen or tender joints while on etanercept therapy. For treatment of polyarticular course juvenile ( 2 years of age) or juvenile rheumatoid arthritis: 1. Member is at least 2 years of age. 2. Enbrel is being prescribed by a rheumatologist. 3. Medical record documentation of a diagnosis of moderate to severely active polyarticular juvenile idiopathic arthritis or juvenile rheumatoid arthritis with at least 5 swollen or tender joints, or an elevated ESR or CRP, or another poor prognostic feature 4. Medical record documentation of an adequate trial (3 months each) of NSAID therapy AND methotrexate therapy or other DMARD if methotrexate therapy is contraindicated. For treatment of polyarticular course juvenile ( 2 years of age) or juvenile rheumatoid arthritis: If approved, the initial approval period will be for six (6) months. For continuation of coverage, medical record documentation is required of continued improvement on or Enbrel therapy. Subsequent approvals will be for one (1) year. For the treatment of Psoriatic Arthritis: 1. Medical record documentation of a diagnosis of moderately to severely active psoriatic arthritis which must include the following: o Documentation of at least three swollen joints and at least three tender or painful joints AND o Documentation of either active psoriatic lesions or a documented history of psoriasis AND 2. Must be prescribed by a rheumatologist AND 3. Member must be 18 years of age AND

21 4. Medical record documentation of intolerance to or failure to respond to a minimum 4 month trial of methotrexate or sulfasalazine. If methotrexate and sulfasalazine are contraindicated, therapy with an alternative DMARD is required. For Treatment of Psoriatic Arthritis: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of improvement in the signs and symptoms of psoriatic arthritis that must include the number of swollen or tender joints on six (6) months of etanercept therapy. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year requiring medical record documentation of improvement in the signs and symptoms of psoriatic arthritis and must include the number of tender or swollen joints while on etanercept therapy. For the treatment of ankylosing spondylitis: 1. Medical record documentation of a diagnosis of ankylosing spondylitis 2. Must be prescribed by a rheumatologist 3. Physician documentation of a therapeutic failure on, contraindication to, or intolerance to an adequate trial of at least two (2) NSAIDS. Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of improvement in the signs and symptoms of ankylosing spondylitis on six (6) months of etanercept therapy is required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year requiring medical record documentation of improvement in the signs and symptoms of ankylosing spondylitis while on etanercept therapy. For the treatment of moderate to severe Plaque Psoriasis: 1. Prescription must be written by a dermatologist and 2. Member must be 18 years of age and 3. Medical record documentation of a diagnosis of moderate to severe plaque psoriasis characterized by 10% of body surface area involved or disease involving the palms of hands or soles of feet that impairs activities of daily living. 4. Medical record documentation of a therapeutic failure on, intolerance to, or contraindication to topical corticosteroids AND an adequate trial of at least one form of systemic therapy (two to three months) or phototherapy. For Treatment of Moderate to Severe Plaque Psoriasis: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of improvements in signs and symptoms of psoriasis on six (6) months of etanercept therapy is required. After the initial 6 month approval, subsequent approvals will be for a duration of 1 year, requiring medical record documentation of improvement in the signs and symptoms of psoriasis while on etanercept therapy.

22 *QUANTITY LIMITS: 8 syringes per 28 days, all strengths For Adult Rheumatoid Arthritis Prior authorization of BIWEEKLY (every other week) administration of Humira** (which is selfadministered) will be made for members who meet all the following criteria: 1. There is medical record documentation of a diagnosis of rheumatoid arthritis (made in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis) AND 2. There is medical record documentation that Humira is being prescribed by a rheumatologist AND 3. There is medical record documentation of an inadequate response to a minimum 4 month trial of methotrexate or other DMARD if methotrexate is not tolerated or contraindicated AND 4. Medical record documentation of the number of swollen or tender joints prior to initiating adalimumab therapy. Member must have a minimum documented joint count of: Greater than four (4) swollen or tender joints based on a 28 joint count OR Greater than six (6) swollen or tender joints based on a joint count AND 5. Member is at least 18 years of age. Prior authorization of WEEKLY administration of Humira** (which is self-administered) will be made for members who meet the following criteria: 1. There is medical record documentation of a diagnosis of rheumatoid arthritis (made in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis) AND 2. There is medical record documentation that Humira is being prescribed by a rheumatologist AND 3. Member is at least 18 years of age AND 4. There is medical record documentation of an inadequate response to a minimum 4 month trial of methotrexate or other DMARD if methotrexate is not tolerated or contraindicated AND 5. There is medical record documentation of a contraindication to, intolerance to, or therapeutic failure on BIWEEKLY (every other week) administration of Humira AND 6. Medical record documentation of the number of swollen or tender joints prior to initiating adalimumab therapy. Member must have a minimum documented joint count of: Greater than four (4) swollen or tender joints based on a 28 joint count OR Greater than six (6) swollen or tender joints based on a joint count For biweekly or weekly administration: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of improvement in signs and symptoms of rheumatoid arthritis that must include the number of swollen or tender joints on six (6) months of adalimumab therapy is required. After the initial six (6) month approval, subsequent approvals for coverage will be for a duration of one (1) year. Reevaluation of coverage will be every one (1) year requiring medical record documentation of improvement in the signs and symptoms of rheumatoid arthritis and must include the number of swollen or tender joints while on adalimumab therapy. For treatment of polyarticular course juvenile ( 4 years of age) or juvenile rheumatoid arthritis: 1. Member is at least 4 years of age.

23 2. Humira is being prescribed by a rheumatologist Medical record documentation of an adequate trial (3 months each) of NSAID therapy AND methotrexate therapy or other DMARD if methotrexate therapy is contraindicated Medical record documentation of a diagnosis of moderate to severely active polyarticular juvenile idiopathic arthritis or juvenile rheumatoid arthritis (i.e. at least 5 swollen or tender joints, or an elevated ESR or CRP, or another poor prognostic feature - ACR 2011 Recommendations for the Treatment of JIA). For bi-weekly administration: If approved, the initial approval period will be for six (6) months. For continuation of coverage, medical record documentation is required of continued improvement on Humira therapy. Subsequent approvals will be for one (1) year. For Psoriatic Arthritis Prior authorization of BIWEEKLY (every other week) administration of Humira** (which is selfadministered) will be made for members who meet all the following criteria: 1. Medical record documentation of a diagnosis of moderately to severely active psoriatic arthritis which must include the following: Documentation of at least three swollen joints and at least three tender or painful joints AND Documentation of either active psoriatic lesions or a documented history of psoriasis 2. Must be prescribed by a rheumatologist 3. Member must be 18 years of age 4. Medical record documentation of intolerance to or failure to respond to a minimum 4 month trial of methotrexate or sulfasalazine. If methotrexate and sulfasalazine are contraindicated, therapy with an alternative DMARD is required. Prior authorization of WEEKLY administration of Humira** (which is self-administered) will be made for members who meet all the following criteria: 1. Medical record documentation of a diagnosis of moderately to severely active psoriatic arthritis which must include the following: Documentation of at least three swollen joints and at least three tender or painful joints AND Documentation of either active psoriatic lesions or a documented history of psoriasis 2. Must be prescribed by a rheumatologist 3. Member must be 18 years of age 4. Medical record documentation of intolerance to or failure to respond to a minimum 4 month trial of methotrexate or sulfasalazine. If methotrexate and sulfasalazine are contraindicated, therapy with an alternative DMARD is required. 5. Medical record documentation of a therapeutic failure on every other week dosing of adalimumab For biweekly or weekly administration: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of improvement in signs and symptoms of rheumatoid arthritis that must include the number of swollen or tender joints on six (6) months of adalimumab therapy is required. After the initial six (6) month approval, subsequent approvals for coverage will be for a duration of one (1) year. Reevaluation of coverage will be every one (1) year requiring medical record documentation of improvement in the signs and symptoms of rheumatoid arthritis and must include the number of swollen or tender joints while on adalimumab therapy.

24 For Ankylosing Spondylitis Prior authorization of BIWEEKLY (every other week) administration of Humira** (which is selfadministered) will be made for members who meet all the following criteria: 1. Must be prescribed by a rheumatologist 2. Must be 18 years of age or older 3. Physician documentation of a therapeutic failure on, contraindication to, or intolerance to an adequate trial of at least two (2) NSAIDS. For biweekly administration: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of clinical or sustained improvement in the signs and symptoms of ankylosing spondylitis on six (6) months of adalimumab therapy is required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year requiring medical record documentation of clinical or sustained improvement in the signs and symptoms of Crohn s disease while on adalimumab therapy. For Crohn s Disease Prior authorization of BIWEEKLY (every other week) administration of Humira** (which is selfadministered) will be made for members who meet all the following criteria: 1. Must be prescribed by a gastroenterologist 2. Must be 18 years of age or older 3. Medical record documentation of a diagnosis of moderately or severely active Crohn s disease with failure on, intolerance to, or contraindication to aminosalicylates, corticosteroids, and immunomodulators (e.g. azathioprine and 6-mercaptopurine). For biweekly administration: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of clinical or sustained improvement in the signs and symptoms of Crohn s disease on six (6) months of adalimumab therapy is required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year requiring medical record documentation of clinical or sustained improvement in the signs and symptoms of Crohn s disease while on adalimumab therapy. For the treatment of moderate to severe Plaque Psoriasis: Prior authorization of BIWEEKLY (every other week) administration of Humira** (which is selfadministered) will be made for members who meet all the following criteria: 1. Prescription must be written by a dermatologist and 2. Member must be 18 years of age and 3. Medical record documentation of a diagnosis of moderate to severe plaque psoriasis characterized by

25 10% of body surface area involved or disease involving the palms of hands or soles of feet that impairs activities of daily living. 4. Medical record documentation of a therapeutic failure on, intolerance to, or contraindication to topical corticosteroids AND an adequate trial of at least one form of systemic therapy (two to three months) or phototherapy. Prior authorization of WEEKLY administration of Humira** (which is self-administered) will be made for members who meet all the following criteria: 1. Prescription must be written by a dermatologist and 2. Member must be 18 years of age and 3. Medical record documentation of a diagnosis of moderate to severe plaque psoriasis characterized by 10% of body surface area involved or disease involving the palms of hands or soles of feet that impairs activities of daily living. 4. Medical record documentation of a therapeutic failure on, intolerance to, or contraindication to topical corticosteroids AND an adequate trial of at least one form of systemic therapy (two to three months) or phototherapy. 5. Medical record documentation of a therapeutic failure on every other week dosing of adalimumab For weekly or biweekly administration: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of improvements in signs and symptoms of psoriasis on six (6) months of adalimumab therapy is required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year, requiring medical record documentation of improvement in the signs and symptoms of psoriasis while on adalimumab therapy. For Ulcerative Colitis Prior authorization of BIWEEKLY (every other week) administration of Humira** (which is selfadministered) will be made for members who meet all the following criteria: 1. Medical record documentation of a diagnosis of moderate to severe ulcerative colitis AND 2. Must be prescribed by a gastroenterologist AND 3. Must be 18 years of age or older AND 4. Medical record documentation of a diagnosis of moderately or severely active ulcerative colitis with failure on, intolerance to, or contraindication to azathioprine or 6-mercaptopurine (6-MP) For biweekly administration: Approval will be given for an initial duration of six (6) months. For continuation of coverage, medical record documentation of clinical or sustained improvement in the signs and symptoms of ulcerative colitis on six (6) months of adalimumab therapy will be required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year requiring medical record documentation of clinical or sustained improvement in the signs and symptoms of ulcerative colitis while on adalimumab therapy. **QUANTITY LIMITS: For Crohn s Starter Kit, 6 syringes per 28 days, for all others, 4 syringes per 28 days.

26 Prior authorization of Suboxone and Subutex (buprenorphine) will be made for members who meet all of the following criteria: 1. There is medical record documentation of a diagnosis of opioid dependence. 2. The prescribing physician is participating with the GHP or Behavioral Health network and has obtained the necessary waiver to be eligible to prescribe buprenorphine/suboxone. If the drug is prescribed by a Behavioral Health provider, that provider needs to have a signed agreement with one of the BH- MCOs. If the prescriber is not in the GHP or BH-MCO network, GHP Family will work with the member through the Special Needs Unit to ensure the member is redirected to an in-plan physician. 3. For re-authorization, the member must be adherent to buprenorphine or buprenorphine/naloxone therapy and must not be using opiates. This must be verified by urine drug screen (dated within 28 days of request date) for all controlled substances, including opiates and buprenorphine. The presence of controlled substances other than buprenorphine must be addressed. 4. If on buprenorphine and buprenorphine/naloxone therapy for > 1 year with doses > 8mg, documentation of attempted dose reduction or of a reason why dose reduction was not attempted is required. 5. Buprenorphine/naloxone must be used unless there is medical record documentation of a contraindication to, or intolerance to buprenorphine/naloxone (ex. use in pregnancy/breast feeding). 6. Member must be initially referred to and actively involved in formal counseling with a licensed behavioral health provider. Must provide the name of counselor and/or facility or rationale for nonparticipation. 7. Form and attestation must be completed by prescriber at each interval. If approved, initial authorization duration will be for 3 months. Subsequent authorizations, if approved, will be for 6 months. QUANTITY LIMIT: 30 day supply per fill Appendix A: Buprenorphine (Subutex ) and buprenorphine/naloxone (Suboxone ) Prior Authorization Request Form For assistance, please call or fax completed form to Patient Name: Medical documentation may be requested. This form will be returned if not completed in full. Patient Information Prescriber Information Prescriber Name: