Non-members present from Catamaran: Leslie Pittman, PharmD, Tracey Lovett, PharmD

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1 TennCare Pharmacy Advisory Committee (PAC Meeting) February 12, 2013 Members in Attendance: Shana Bush, PharmD, Edward Capparelli, MD, Chairman Alan Corley, DPh, Stanley Dowell, MD, Co-Chairman Jeri Fitzpatrick, MD, Vaughn Frigon, MD (TennCare), Lyn Govette, MPAS, PA-C, Ernest Jones, MD, Bryan Leibowitz, PharmD (TennCare), Joel Phares, MD, Michael Polson, PharmD(TennCare), Chris Schwerdt, PharmD, Eleanor Twigg, PharmD Non-members present from Catamaran: Leslie Pittman, PharmD, Tracey Lovett, PharmD INTRODUCTIONS The meeting was called to order by Chairman Alan Corley. Dr. Corley stated that committee members are volunteers, appointed according to public act (TCA ) establishing the Pharmacy Advisory Committee (PAC). Dr. Corley reminded members that conflict of interest statements were included with their packets and are to be signed at the first meeting of each year. Dr. Corley asked members to sign and return disclosure statements. All members should sign part 1 of this document and part 2 if applicable. Dr. Corley asked the members of the Committee to introduce themselves. Dr. Corley welcomed Dr. Vaughn Frigon, Chief Medical Officer of TennCare to the meeting. A brief introduction to the committee was provided by Dr. Frigon regarding his education and past work experience. Lastly, Dr. Frigon encouraged the committee to reach out to him with any suggestions that will assist with improvements in how the upcoming meetings may be conducted. PAC MINUTES The November 20, 2012 PAC meeting minutes were reviewed. Dr. Ernest Jones motioned to approve the minutes as presented. Motion seconded by Lyn Govette. TENNCARE PHARMACY UPDATE Dr. Bryan Leibowitz gave this quarter s TennCare Pharmacy update. Pharmacy Benefit Manager: Magellan was awarded the pharmacy benefit contract. Catamaran will remain on the account until May 31, Dr. Capparelli asked for clarification regarding the process for updating the Preferred Drug Listing and posting of new drugs to the website. o Dr. Pittman stated that new drugs are typically placed as non-preferred, subject to the standard non-preferred criteria. If additional criteria are required, interim criteria may be placed on the agent as a reference for the clinical call center and the State s medical review board. Dr. Corley commented on the format for upcoming meeting formats. One of the suggestions included presenting only on new agents or drug categories where existing guidelines or drug therapies have changed for upcoming meetings, since we currently have general recommendations in place for the drug categories currently listed on the PDL (Preferred Drug List). Dr. Corley informed the committed that the upcoming meetings will follow a different format than typically expected and to expect these upcoming changes. o Dr. Capparelli asked if there have been some changes in the process/policy of posting new drug agents on the PDL.

2 Dr. Leibowitz stated that there have not been any policy changes. New drugs have come available in January and they will be reviewed at the May PAC meeting. Dr. Leibowitz stated that to ensure physicians and patients are aware of any criteria that is currently in place, this information is posted for their purposes. These interim criteria will be brought to the committee for further review at the upcoming meeting. Interim criteria placed on the drug will be decided upon by the State, PBM vendor and may include input from experts in that area. Dr. Pittman reminded the committee that the pharmacy program default is for new agents to reject for PA required. Therefore, criteria are required in order for the call center to review requests for new agents. Dr. Corley commented that in the past this information was sent via ; however this is no longer an option as it is not considered a public meeting. Dr. Capparelli suggested that the interim criteria is sent out to the committees to reflect upon prior to the meeting that the agent will be discussed. Dr. Leibowitz stated that he would get further clarification as to how we can disseminate this information out to the committee. Dr. Capparelli stated that it was his understanding that the new PBM vendor has a different format where there is 1 annual meeting to discuss exceptions to the current PDL. Given the state law where TennCare is scheduled to have quarterly meetings, will there be a change in the number of meetings. o Dr. Leibowitz stated that there will continue to be quarterly meetings for the PAC (Pharmacy Advisory Committee). AE SUBCOMMITTEE Dr. Leslie Pittman reported to the PAC committee there were 5 additions of new drugs to existing categories on the Auto-Exemption (AE) List for 4Q2012. These 5 additions included Synribo, Cometriq, Iclusig, pioglitazone, and pioglitazone-metformin. DRUG CLASS REVIEWS The drug class review section of the meeting consisted of a Catamaran presentation of background information and an overall recommendation for each therapeutic class as well as any proposed clinical criteria, step therapy or quantity limits. This presentation was followed by the Committee s discussion and a vote on the recommendation and any proposed restrictions. For the purpose of the minutes, the section below reflects Catamaran s proposed recommendations, the committee s discussion, and the committee s votes on each recommendation and criteria reviewed. For the complete background information provided by Catamaran, please refer to the February 12, 2013 PAC review packet at: Endocrine & Metabolic Agents Agents for Gout The treatment of gout consists of rapid relief of pain and disability caused by acute gout attacks and the reduction of serum urate levels. All current treatment 2

3 guidelines recommend a NSAID, colchicine, or a corticosteroid for the treatment of an acute gout attack; however the disease can and often will continue to progress unless the serum urate level is normalized. Agents used for the treatment of hyperuricemia are allopurinol, febuxostat, and probenecid. The 2012 ACR guideline recommends either allopurinol or febuxostat as the first-line urate lowering therapy approach for the management of gout, with no preference stated between the two agents. The ACR recommends probenecid as an alternative first-line urate lowering therapy option in patients with a contraindication or intolerance to either allopurinol or febuxostat. Available clinical evidence has demonstrated that colchicine is an effective agent in acute gout attacks and as a prophylactic agent while patients initiate urate lowering therapy. Head-to-head studies that have evaluated febuxostat and allopurinol have demonstrated that febuxostat is more effective in lowering serum urate levels; however in these studies, rates of gout flares were not significantly different between the two agents. Probenecid also has utility as an adjunct to antibiotic therapy; therefore, it is recommended at least colchicine, allopurinol and probenecid should be available for use. Dr. Cappareli asked if the probenecid/colchicine combination product is currently on the market as a brand name product. o Dr. Corley stated that the product was unavailable for a short period of time, but is now available on the market as a generic product. Dr. Capparelli motioned to accept the recommendation. Dr. Jones seconded the motion. Prior Authorization Criteria for Uloric : Uloric will be approved for patients with trial and failure, contraindication, or intolerance to allopurinol. Dr. Jones asked for clarification regarding the Uloric criteria and if it only required trial/failure of allopurinol. o Dr. Pittman stated that since Uloric is a urate lowering drug, it would be inappropriate to ask for trial/failure of 2 agents. Dr. Capparelli stated that sometimes patients may have tried an agent while under the care of a different physician and may state they have tried allopurinol, but no other specifics are available, will this qualify as trial/failure of the agent. o Dr. Pittman stated that there are certain criteria that require trial of the agent within a certain time frame. However, this is not one of those agents and if a provider states the patient has tried/failed allopurinol it will meet the criteria. Discussion continued. Dr. Bush asked if a look back for allopurinol could be implemented. o Dr. Pittman stated she would ask the state. Dr. Jones motioned to accept the PA criteria. Motion seconded and carried. Disease Modifying AntiRheumatic Drugs 3

4 Diseases modifying anti-rheumatic drugs (DMARDs) are the primary initial treatment for rheumatoid arthritis and should be offered as initial therapy to any patient diagnosed with rheumatoid arthritis. The choice of initial agent or combination of agents should be based upon disease duration, activity level, prognostic features and specific patient characteristics. Head-to-head comparisons in medical literature have shown that, at the very least, methotrexate, leflunomide and sulfasalazine have comparable efficacy, while auranofin, hydroxychloroquine and penicillamine may be slightly less efficacious. Each individual DMARD is associated with dangerous adverse effects and all, except sulfasalazine, have black box warnings. The only non-biological DMARDs that the American College of Rheumatology recommends as initial therapy are methotrexate, leflunomide, sulfasalazine or hydroxychloroquine or certain combinations of those drugs. The National Institute for Health and Clinical Excellence guidelines for the management and treatment of rheumatoid arthritis in adults does not favor any particular DMARD as monotherapy, but recommends combination therapy with methotrexate and at least one other DMARD as soon as possible. Due to their relative lower efficacy and lack of endorsement by current clinical guidelines, penicillamine and auranofin can be considered inferior agents in this class. Therefore, it is recommended at least methotrexate, leflunomide, sulfasalazine and hydroxychloroquine should be available for use. Dr. Capparelli stated the presentation of the drug class is very straight forward. However, one concern in general is that the class has been divided based on disease state, which causes some confusion as to exactly where agents (i.e. immunologics vs. non-biologics) would be found on the PDL. o Dr. Pittman stated that both categories are found under the Endocrine Section of the PDL. Dr. Corley stated that in the recommendation we specifically say auranofin is an inferior drug, but list the agent as preferred. Dr. Corley asked if this has occurred in the past. o Dr. Pittman stated that we typically do not list the agent as preferred. However, this agent still has some utilization, so it was left as a preferred drug. Dr. Corley also made comment that some of the brand name products listed are no longer available from wholesalers, such as Azulfadine and Rheumatrex. o Dr. Pittman stated that these agents are still available in the drug file, so will continue to list the agent until they become inactive or obsolete. Dr. Jones inquired as to whether medical conditions outside of rheumatoid arthritis would still be subject to the same PDL rules for this drug category. o Dr. Pittman stated that other medical conditions that use these agents will still be subject to same PDL rules that a patient with rheumatoid arthritis would have to follow to obtain these drugs. Dr. Capparelli motioned to accept the recommendation. Dr. Jones seconded the motion. Quantity Limits Azulfidine Azulfidine EN 8/day 8/day 4

5 sulfasalazine Sulfasalazine EC 8/day 8/day Dr. Fitzgerald motioned to accept the quantity limits as presented. Motion seconded and carried. o Dr. Dowell asked if a note/statement could be placed on the PDL to direct providers to the immunologic class. o Discussion continued. Dr. Pittman stated she would ask the state, but felt sure a note could be added. Oral Mineralocorticoids Fludrocortisone has been used in the treatment of salt-losing congenital adrenal hyperplasia and as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison s disease since Available data demonstrate the therapeutic benefit of utilizing this medication for its sodium- and water-retaining properties. It has been shown to reduce plasma renin activity in congenital adrenal hyperplasia and Addison s disease. Fludrocortisone has also found utility in the treatment of idiopathic orthostatic hypotension. It is recommended fludrocortisone should be available for use. Dr. Capparelli motioned to accept the recommendation. Lyn Govette seconded the motion. Ophthalmic Antihistamines The ophthalmic antihistamines are FDA-approved for the treatment or prevention of the signs and symptoms associated with allergic conjunctivitis. The American Academy of Ophthalmology (AAO) recommends ophthalmic antihistamines as a treatment option for mild allergic conjunctivitis. Additionally, guidelines state medications with dual antihistamine and mast-cell stabilizing properties may be utilized for conditions that are recurrent or persistent, with no preference given to one agent over another. Therefore it is recommended that at least 2 ophthalmic antihistamines are available for use. Dr. Corley asked if the recommendation should state that one of the 2 ophthalmic antihistamine agents should contain both dual antihistamine and mast-cell stabilizing properties. o Dr. Lovett stated that all have the dual properties, except emadastine, but if they wanted to specifically include this in the recommendation, it could be added. o Dr. Corley stated that the recommendation would be fine as presented, if there was currently only one agent without the dual property. Dr. Capparelli inquired about the PDL listing of Bepreve. o Dr. Lovett stated that was a mistake it should be listed on the preferred side only. Dr. Corley inquired as to how ketotifen is covered since it is now an OTC product. o Dr. Lovett stated it is covered on OTC list. 5

6 Dr. Dowell motioned to accept the recommendation. Lyn Govette seconded the motion. Motion carried. Quantity Limits Bepreve / Bepotastine Elestat / epinastine Emadine /emedastine Ketotifen/Zaditor Lastacaft Optivar /azelastine PATADAY PATANOL 10mL per Rx 5mL per Rx 5mL per Rx 10ml per RX 3mL per Rx 6mL per Rx 2.5mL per Rx 5mL per Rx Dr. Jones asked how the quantity limits listed would affect the number of prescriptions per month limits. o Dr. Lovett stated it would only count as 1 prescription and the quantity limits listed are more than enough, as most people who use eye drops, do not properly administer the drops on the first instillation, therefore a small amount of the drug is lost during instillation. Dr. Jones made a motion to accept the quantity limits. Motion seconded and carried. Ophthalmic Mast Cell Stabilizers The ophthalmic mast cell stabilizers are FDA (Food and Drug Administration) approved for the management of signs and symptoms associated with allergic conjunctivitis. The American Academy of Ophthalmology recommend that treatment of allergic conjunctivitis begin with removal of the offending allergens and that pharmacological agents, including ophthalmic mast cell stabilizers, may be useful in treating the associated symptoms. Ophthalmic mast cell stabilizers are usually considered in patients with symptoms that are recurrent or persistent. Clinical guidelines do not give preference to one mast-cell stabilizer over another within the class. However, cromolyn and lodoxamide are the only agents within the class that are FDA approved for the treatment of vernal conjunctivitis. Therefore it is recommended that at least 2 ophthalmic mast stabilizers be available, one of which should be either cromolyn or lodoxamide for treatment of vernal conjunctivitis. Dr. Capparelli inquired about moving this agent to the low utilization category. o Dr. Lovett stated that the category would have to meet both the 100 scripts per year and less than $10,000/year. So this category would not meet those guidelines. o Dr. Pittman stated that with the new process of reviewing drugs, this category will not be re-reviewed unless; there is a change in guidelines or drugs. Dr. Capparelli motioned to accept the recommendation. Lyn Govette seconded the motion. 6

7 Ophthalmic Immunomodulators Cyclosporine ophthalmic emulsion is FDA (Food and Drug Administration) approved to increase tear production in patients with KCS (keratoconjunctivitis sicca). Clinical guidelines consider cyclosporine ophthalmic emulsion to be an appropriate therapy option for patients with moderate dry eye syndrome, treatment of severe atopic KCS, and for patients with atopic KCS who have failed conventional therapy. Additionally, limited clinical trials demonstrate cyclosporine ophthalmic emulsion showed a significant improvement in tear production and dry eye symptoms. The American Academy of Ophthalmology (AAO) recommends treatment options based on disease severity, but do not specifically indicate cyclosporine ophthalmic emulsion as a firstline agent. The American Optometric Association (AOA) recommends use of topical cyclosporine as an alternative to topical corticosteroids in severe atopic keratoconjunctivitis, and may be beneficial in patients with vernal keratoconjunctivitis who have failed conventional therapy. Therefore it is recommended that cyclosporine ophthalmic emulsion is available subject to clinical criteria to ensure appropriate use. Dr. Jones motioned to accept the recommendation. Lyn Govette seconded the motion. Prior Authorization Criteria for Restasis : Restasis will be approved for: Treatment of moderate to severe keratoconjunctivitis sicca (KCS) in patients who have failed at least ONE of the following therapies: o Artificial tears drops or ointments administered at least four times daily o Hydroxypropyl cellulose insert (Lacrisert ) o Punctal plugs Treatment of dry eyes in recipients with Sjogren s disease Recipients using the agent status post corneal transplant Treatment of severe atopic keratoconjunctivitis who have tried and failed at least TWO ophthalmic steroids or have contraindication or intolerance to ophthalmic steroids. Dr. Dowell motioned to accept the recommendation. Dr. Capparelli seconded the motion. The committee inquired as to whether a quantity limit should be placed on the agent, as the product is available as a 60 vial box as well. o Dr. Lovett stated we could investigate the quantity limit and available packages. Ophthalmic Antibiotics Ophthalmic antibiotics are used to treat several ocular infections including blepharitis, conjunctivitis, keratitis and others. Ophthalmic antibiotics are available 7

8 from many drug classes including aminoglycosides, macrolides, polypeptides, quinolones and sulfonamides. Results from head-to-head studies do not consistently show any one ophthalmic antibiotic as significantly more effective than another with regard to bacterial eradication, clinical resolution, clinical response, severity rating or symptom improvement for any indication. Guidelines published by the American Academy of Ophthalmology recommend that blepharitis be treated with ophthalmic bacitracin or ophthalmic erythromycin and note that macrolide antibiotics may have anti-inflammatory activity with regard to the treatment of blepharitis. In addition, the guidelines state that keratitis should be treated with a broad-spectrum ophthalmic antibiotic that may be selected based on the isolated organism, and if no organism is identified, treatment with an ophthalmic fluoroquinolone is recommended. The American Academy of Ophthalmology guideline also notes that fewer gram-positive cocci are resistant to ophthalmic fourth generation fluroquinolones. Therefore, it is recommended at least six ophthalmic antibiotics should be available for use, which should include erythromycin and at least one fourth generation fluroquinolone. Dr. Pittman explained that she combined all the individual class recommendations into this one category recommendation. o Dr. Capparelli stated that it makes more sense to include them all under one category. Dr. Jones inquired as to why both the brand name and generic agents were listed under the preferred side. o Dr. Pittman stated that for this meeting, agents listed with capitalized lettering are brand name agents and agents listed as lower case (or 1 st letter capitalized, but remaining letters lower cased) are classified as generic agents. Therefore, the capitalized letter agents are classified as brand name agents and receive a $2.50 dispensing fee. The lower case generic agents would receive a $3 dispensing fee. o Dr. Capparelli asked if Gentak was listed on the brand as generic list. Dr. Pittman stated the drug is actually considered a generic agent so is listed with the 1 st letter capitalized and all other letters are listed lower case. Dr. Capparelli motioned to accept the recommendation. Dr. Jones seconded the motion. Ophthalmic Antibiotic/Steroid Combinations Ophthalmic antibiotic steroid combination products are indicated for the treatment of steroid-responsive ocular inflammatory conditions where the presence or risk of a superficial bacterial ocular infection exists. Results from head-to-head studies do not consistently show any one ophthalmic antibiotic steroid combination product as significantly more effective than another with regard to symptom improvement or reduction of postoperative inflammation. Clinical guidelines do not differentiate between the available agents within this class. However, agents differ in their FDAapproved ages with only tobramycin/dexamethasone and neomycin/polymyxin B/dexamethasone approved for use in patients down to 2 years of age. Therefore, it is recommended at least three ophthalmic antibiotic steroid combination products should be available for use, with at least one of these being an ointment formulation 8

9 and one approved for use in patients down to 2 years of age. Additionally, given that loteprednol is associated with a lower increase in IOP than other ophthalmic steroids, tobramycin/loteprednol should be available for those patients in whom increased IOP is a concern. Dr. Schwerdt asked if the Tobradex suspension is currently on the Brand as Generic list. o Dr. Pittman stated that this suspension product is on the Brand as Generic list. Dr. Jones motioned to accept the recommendation. Lyn Govette seconded the motion. Prior Authorization Criteria for Zylet Zylet will be approved if the recipient has a contraindication or intolerance to any two of the preferred ophthalmic antibiotic/steroid combination products, OR if there are concerns over a potential increase in intra-ocular pressure (IOP) with other steroids (i.e. glaucoma, recipient is pre or post cataract surgery and a known steroid-responder, etc.). Lyn Govette made a motion to accept the quantity limits. Dr. Jones seconded the motion. Ophthalmic Antivirals Keratitis, or corneal infection and inflammation, caused by herpes simplex virus (HSV) is a common and major cause of blindness. Ophthalmic antiviral agents are one treatment option for ocular HSV; currently available agents include trifluridine and ophthalmic ganciclovir. Currently there are no head-to-head clinical trials of ophthalmic ganciclovir and ophthalmic trifluridine. However, both agents have established safety and efficacy in the treatment of keratitis. The current clinical guidelines from the American Academy of Ophthalmology for the treatment of HSV conjunctivitis state that ophthalmic trifluridine, ophthalmic ganciclovir and oral acyclovir are potential treatment options, the guidelines do not give preference to one agent over another. Therefore it is recommended that at least one ophthalmic antiviral agent be available for use. Additionally, ophthalmic ganciclovir should be available for patients less than 6 years of age. Dr. Capparelli motioned to accept the recommendation. Dr. Dowell seconded the motion. Clinical Criteria for Zirgan o Prior Authorization not required for patients less than 6 years of age. 9

10 Dr. Corley made note that the Clinical Criteria should be changed to read Prior Authorization for Zirgan. o Dr. Pittman confirmed that it should be changed and will be corrected. Dr. Capparelli asked if a lookback in the system to check the patient s age. o Dr. Pittman replied a lookback is currently in place that will allow the claim to pay at POS for children less than 6 years of age without calling for a prior authorization Dr. Jones motioned to accept the prior authorization criteria as presented. Motion seconded and carried. Ophthalmic Beta Blockers Glaucoma manifests initially as visual field loss and may progress to blindness. Intraocular Pressure (IOP) is the one major risk factor for glaucoma that is treatable. Clinical evidence suggests that lowering IOP inhibits or reduces the progression of optic nerve damage. Head-to-head trials in the ophthalmic beta-blocker class involving patients with open-angle glaucoma or ocular hypertension show that all treatments are efficacious in decreasing IOP from baseline. However, various results were seen when groups were compared to each other. The American Academy of Ophthalmology and American Optometric Association clinical guidelines recommend ophthalmic beta blockers and prostaglandin analogues as first-line therapy agents in patients with elevated IOP. Combination or monotherapy with agents from an alternative pharmacologic class is recommended for patients that experience intolerable adverse events or who do not achieve the optimal IOP reduction with firstline agents. Additionally, guidelines do not specifically differentiate between the agents. Therefore, it is recommended that at least 2 ophthalmic beta blockers are available for use. Dr. Capparelli motioned to accept the recommendation. Dr. Dowell seconded the motion. Ophthalmic Carbonic Anhydrase Inhibitors All ophthalmic carbonic anhydrase inhibitors are indicated for use in the treatment of increased IOP due to open-angle glaucoma or ocular hypertension. The combination product, dorzolamide hydrochloride/timolol maleate, is indicated for use in patients with ocular hypertension or open-angle glaucoma who had insufficient response to ophthalmic beta-blocker monotherapy. Ophthalmic carbonic anhydrase inhibitors are recommended as a second line therapy option in patients who have not achieved a target IOP reduction or developed an intolerable adverse event with an ophthalmic beta-blocker or an ophthalmic prostaglandin analogue. Clinical trials demonstrate that ophthalmic carbonic anhydrase inhibitors are a viable treatment option for the management of intraocular pressure (IOP), therefore it is recommended that at least one carbonic anhydrase inhibitor is available for use. 10

11 Dr. Capparelli motioned to accept the recommendation with modification that a sentence is added that will allow in addition to 1 carbonic anhydrase inhibitor (CAI), 1 combination product be available for use as well. Dr. Jones seconded the motion. Motion carried. Quantity Limits AZOPT 3/month(billing units of 5) 2/month (billing units of 10 & 15) 15ml/month Dorzolamide 30 ml/month 10ml/month Trusopt dorzolamide HCL/timolol maleate 20 ml/month 10ml/month COSOPT COSOPT PF 60 vials Dr. Lovett reminded the committee that the ophthalmologist, who reviewed the recommendations and quantity limits, suggested decreasing the Azopt quantity limit to 10mL/month. Dr. Lovett explained the product is available in 2 package sizes, 10mL and 15mL bottle sizes. The quantity limit was set at 15mL/month to allow a claim to pay at POS if the patient was dispensed this bottle size. o Dr. Phares asked for clarification on the number of drops per ml. o Dr. Corley stated that in general there is 20 drops per ml. Dr. Schwerdt made a motion to accept the quantity limits as presented. Lyn Govette seconded and carried. Ophthalmic Mydriatrics & Mydriatric Combos Atropine sulfate, cyclopentolate, homatropine, scopolamine and tropicamide are ophthalmic mydriatics FDA approved for the induction of cycloplegia and mydriasis. These agents are most commonly used topically in the examination of the eye and during ophthalmic procedures. They also may be used in the management of inflammatory conditions of the eye to treat uveitis and in strabismus. There is limited clinical trial data regarding the safety and efficacy of the ophthalmic mydriatics; however, these agents are established treatment options. The combination mydriatic agent is typically reserved to enhance mydriasis in patients who respond poorly to single entity agents. Therefore, it is recommended that at least 2 ophthalmic mydriatic agents are available for use. Dr. Capparelli motioned to accept the recommendation. Lyn Govette seconded the motion. Miscellaneous Agents for IBS Lubiprostone and linaclotide are FDA-approved for the treatment of chronic idiopathic constipation as well as constipation-predominant IBS. Both agents have demonstrated efficacy for their FDA-approved indications in placebo controlled trials. 11

12 To date, these agents have not been directly compared to therapies which are recognized as first-line treatment strategies for constipation; therefore they are typically reserved for patients in whom other approaches have been unsuccessful. Current clinical guidelines include lubiprostone and linaclotide as treatment options when therapy with dietary management, stopping or reducing constipation-inducing medications, and treatment with laxatives have been unsuccessful. Due to the number of other treatment options available for the management of constipation that have established safety profiles and are recognized as first-line agents, it is recommended that agents in this class are subject to prior authorization. Dr. Dowell motioned to accept the recommendation. Lyn Govette seconded the motion. Prior Authorization Criteria for Amitiza Approval for Amitiza will be granted upon documentation of: Diagnosis of idiopathic chronic constipation or constipation predominate irritable bowel syndrome (IBS), AND Trial and failure of at least TWO other laxatives (bulk, osmotic, or stimulant) ONE agent from TWO of the following classes: Osmotic laxatives Bulk-forming laxatives Stimulant laxatives OR Diagnosis of constipation predominate irritable bowel syndrome (IBS) in female, AND Trial and failure of at least TWO other laxatives (bulk, osmotic, or stimulant) ONE agent from TWO of the following classes: Osmotic laxatives Bulk-forming laxatives Stimulant laxatives Lyn Govette asked for clarification regarding males with IBS-constipation dominant. o Dr. Pittman stated that the agent is FDA approved for females with constipation dominant IBS. However, Dr. Pittman stated that the agent is approved for males and females with idiopathic chronic constipation. Dr. Jones asked if diet could be added to the criteria as it plays a huge part in managing the condition. o Dr. Pittman stated that her only concern would be documentation of this requirement. Dr. Jones stated this would fall in the same category of requiring use of an OTC laxative product. Dr. Pittman stated this would be correct and there are limitations on obtaining documentation of these types of requirements. Dr. Capparelli made a comment that the diet requirement is technically not considered an agent. Dr. Pittman stated 12

13 that initiating a modified diet is definitely would fall within the clinical guidelines. Dr. Phares felt this would fall along the lines of dictating medical practice and would be difficult to monitor. Discussion continued. Dr. Capparelli motioned to accept the prior authorization criteria as presented. Lyn Govette seconded the motion. Motion carried. Prior Authorization Criteria for Linzess Approval for Linzess will be granted upon documentation of: Diagnosis of idiopathic chronic constipation or constipation predominate irritable bowel syndrome (IBS), AND Trial and failure of at least TWO other laxatives (bulk, osmotic, or stimulant) ONE agent from TWO of the following classes: Osmotic laxatives Bulk-forming laxatives Stimulant laxatives Dr. Capparelli made note that in the presentation it was stated that this agent is contraindicated in patients less than 6 years of age and should be avoided in patients between the ages of 6-17 years old. Dr. Capparelli felt that this age restriction was important and should be included in the criteria. o Dr. Pittman stated she could definitely include this for patients less than 6 years of age since the age restriction is a contraindication. However, for the other age group it is listed as a precaution or warning. The Black Box warning is only for patients less than 6 years of age. Dr. Pittman stated a note could be placed for the other age group. Dr. Capparelli made a motion to accept the prior authorization criteria with modification to add the following Approval for Linzess will be granted for patients 6 and up upon documentation. And to add the Note: Use should be avoided in patients 6-17 years of age. Dr. Jones seconded the motion. Quantity Limits Amitiza Linzess 2/day 1/day Dr. Capparelli made a motion to accept the quantity limits as presented. Dr. Jones seconded the motion. Prior Authorization Criteria for Promacta : 13

14 Approval will be granted if ALL of ONE the following criteria are met: Diagnosis of idiopathic thrombocytopenia purpura (ITP), AND Documentation of failure or insufficient response to adequate treatment with corticosteroids AND immunoglobulins, OR ITP-related splenectomy, AND Documentation that patient s thrombocytopenia and clinical condition puts the patient at increased risk of bleeding. Diagnosis of thrombocytopenia in patient with chronic hepatitis C, AND o Patient receiving (or planning to initiate) interferon-based anti-viral therapy Dr. Capparelli asked for clarification on the last bullet point. o Dr. Pittman stated that the last bullet point listed in italics is new to the current criteria in place today. Dr. Capparelli motioned to accept the prior authorization criteria. Lyn Govette seconded the motion. Prior Authorization Criteria for Exjade Exjade will be approved for recipients two years of age and older who meet ALL of the following criteria: Diagnosis of chronic iron overload due to blood transfusions, AND o Serum ferritin > 1,000 mcg/l, OR o Liver iron concentration between 3.2 and 7 mg Fe/g dw L Diagnosis of non-transfusion-dependent thalassemia (NTDT) in patients aged 10 & older, AND o Serum ferritin > 1,000 mcg/l, OR o Liver iron concentration between 3.2 and 7 mg Fe/g dw L Exjade will not be approved for recipients with creatinine clearance less than 40 ml/min or for recipients with platelet count less than 50x109/L. Note: It is recommended that if the serum ferritin is consistently < 500mcg/L therapy should be stopped; however, this may be up to the prescriber s discretion in his/her experience of treating patients with iron-overload. Dr. Pittman informed the committee that the criteria list two years of age and older in the 1 st sentence, but should be moved to the 1 st bullet point so as to read like the second bullet point for patients aged 10 & older. o Dr. Capparelli made note that the 1 st sentence should be modified as well. Dr. Pittman agreed the first sentence should read One of and the 1 bullet point should contain the age clarification. Dr. Capparelli motioned to accept the prior authorization criteria with modification that two years of age and older is removed and ALL of is replaced with One of. Also the following will be added to the 1 st bullet point Diagnosis of chronic iron overload blood transfusions in 2 years of age and older Dr. Dowell seconded the motion. 14

15 Motion carried. Dr. Capparelli asked to make one clarification regarding the immunologic class; these agents are currently not listed under the endocrine section. They are listed as a separate class following the GI agents. Dr. Capparelli also recommended that musculoskeletal agents are grouped together under one musculoskeletal drug category on the PDL. o Dr. Pittman stated this request will be further discussed with the state. REVIEW OF NOVEMBER PAC MEETING DECISIONS SXC reviewed TennCare s decisions from the November 20, 2012 meeting. In the interest of time, decisions were presented only for those classes in which TennCare did not accept the Committee s recommendations. Page 10 Diabetes: Insulins: PAC approved the recommendation as modified to add sentence that one concentrated insulin formulation should be available for use. PAC also voted to add a sentence to the recommendation that due to longacting basal insulin formulations not being interchangeable, in the event agents are moved to non-preferred status, grandfathering would be in place for current users. TennCare accepted the recommendation as modified to include the sentence that once concentrated insulin formulation should be available for use. However, the request for grandfathering will be noted for future reference, but will not be included within the recommendation as it falls outside of the prevue of the committee. o o Dr. Capparelli asked for clarification on the decision regarding grandfathering. Dr. Capparelli felt that this request fell within the prevue of the committee given that it focuses on a clinical issue. Dr. Pittman noted that grandfathering has never before been placed into grandfathering. Dr. Capparelli voiced objection to the last part of the statement. Discussion continued. o Dr. Pittman recommended that the following however, this will not.prevue of the committee will be removed from the statement. o Dr. Capparelli agreed he would be fine with the final decision based on that modification. Dr. Leibowitz agreed to the change. Page 11 Insulin Pens: PAC approved the prior authorization criteria as clarified to state one of the following criteria and i.e. should be changed to e.g. Additionally, PAC suggested the following: supplemental messaging at POS, member disruption and provider notice letters sent regarding change, a 6 month grandfathering period for current users and web PA if possible. TennCare accepted PAC s recommendation. Supplemental messaging at POS, targeted provider notice letters and a 60 day grandfathering period for current users will be implemented as well. o Dr. Jones asked when the 60 day grandfathering begins and inquired as to when letters were sent out. Dr. Jones stated that he did not receive a letter regarding this issue and has patients that receive these agents. o Dr. Pittman stated the 60 day grandfathering began January 1, The notice letters went out in December. Dr. Pittman stated that a check will be made to see if you were included on the letter notification. Page 31 DPP-4 Inhibitors: PAC approved the recommendation as modified to read: At least one DPP-4 inhibitor agent is available without criteria or restriction. TennCare did not accept PAC s recommendation. Clinical guidelines clearly state that metformin is the mainstay of therapy for most patients; 15

16 therefore, DPP-4 inhibitors will be subject to prior authorization. PAC approved the prior authorization criteria as presented by PAC and requested the lookback for metformin is noted on the public document. TennCare accepted PAC s recommendation; however, lookback will not be noted on the public document. Page 32 DPP-4 Inhibitors: PAC approved the criteria as presented by PAC and requested the lookback for metformin is noted on the public document. TennCare accepted PAC s recommendation; however, lookback will not be noted on the public document. o Dr. Capparelli commented on the AACE/ACE guidelines on what to use following metformin, the DPP-4s are located at the same level of other agents, so would be considered a therapy option following metformin. Dr. Pittman stated the criteria only ask for trial/failure of metformin or the patient can use an alpha-glucosidase inhibitor, sulfonylurea or TZD the other agents if there is a contraindication, adverse reaction or intolerance to metformin. Page 37 Prior Authorization Criteria for Bydureon: PAC approved the prior authorization criteria as modified to change the 3 month trial duration to a 2 week trial duration. TennCare accepted PAC s recommendation; however, TennCare accepted PAC s recommendation to have a long-acting incretin mimetic available and Bydureon is being added as a preferred agent, therefore, this bullet point is being removed from the criteria. Page 50 Unfractionated heparin: PAC asked to check if unfractionated heparin should be listed in the injectable anticoagulant category. Unfractionated heparin is currently on the covered injectables list and will be added as a preferred agent in this category. Public testimony speaker was not available at the close of the meeting. However, accomodations will be made to allow the speaker to address PAC members who remain during lunch. Next Meeting will be May 16, 2013 at the Nashville Public Library 1Q2013 committee agenda was completed prior to lunch. Meeting adjourned. 16

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