TennCare Pharmacy Advisory Committee (PAC Meeting) August 30, 2012

TennCare Pharmacy Advisory Committee (PAC Meeting) August 30, 2012 Members in Attendance: Shana Bush, PharmD, Edward Capparelli, MD, David Collier, MD (TennCare), Chairman Alan Corley, DPh, Vice-Chair Jeri Fitzpatrick, MD, Lyn Govette, MPAS, PA-C, Bryan Leibowitz, PharmD (TennCare), Carol Minor, Joel Phares, MD, Michael Polson, PharmD(TennCare), Chris Schwerdt, 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 71-5-2401) establishing the Pharmacy Advisory Committee (PAC) and have signed conflict of interest statements. Dr. Corley stated no conflicts of interest had been disclosed. Dr. Corley asked the members of the Committee to introduce themselves. Dr. Corley welcomed TennCare Director of Pharmacy, Bryan Leibowitz to the meeting. Dr. Leibowitz gave a formal introduction to the Committee. PAC MINUTES The May 24, 2012 PAC meeting minutes were reviewed. Lyn Govette motioned to approve the minutes as presented. Motion seconded and carried. TENNCARE UPDATE Dr. David Collier gave this quarter s TennCare update. TennCare Standard Spend Down (SSD): The 5 th round of enrollment opportunity is set for September 13, 2012 beginning at 6 PM CST. Interested applicants may call 1-866-358-3230 to request an application. Operators will close the phone lines once 2,500 applicant calls have been received. In the past, this cut-off limit has been reached approximately 1 hour after the initial opening of the phone lines. o SSD serves a limited number of people who are not otherwise eligible for Medicaid, but are 21 and over, not pregnant, US citizen or legal resident, Tennessee resident, not incarcerated, 65 years of age or older, blind, disabled (as determined by social security), or the caretaker relative of a Medicaid eligible child and who have enough unreimbursed medical bills to allow them to spend down their income to the State s Medically Needy Income Standard (MNIS). The applicant volume limits are placed on each open enrollment opportunity as the applications must meet the proper processing requirements and time frames set by the federal government to ensure timely processing. ICD-10 Implementation: Last week, CMS (Centers for Medicare & Medicaid Services) announced the final rule that delays the ICD-10 implementation compliance date for 1 year, which sets the date to October 1, 2014. The Electronic Health Record (EHR) Provider Incentive Program Update: Tennessee is doing quite well with the incentive program. In year one, 2,097 eligible providers (EP) were paid a total of $44,228,340 with $586,500 paid to 69 eligible providers in year two. Eligible hospitals (EH) that participated in the incentive

program for year one, a total of $45,764,040 was distributed to 67 eligible hospitals (EH). In the second year $1,283,296 was paid to 5 eligible hospitals. TENNCARE PHARMACY UPDATE Dr. Collier gave this quarter s TennCare Pharmacy update. TennCare s Pharmacy Benefit Magnager (PBM): TennCare's Pharmacy Benefits Manager, SXC Health Solutions, Inc. has merged with Catalyst Health Solutions to become Catamaran. o This company merge will not affect TennCare s current contract, but the merge will affect email addresses of former SXC employees. It was noted that Dr. Capparelli joined the committee members for the meeting. Pharmacy Benefit Manager RFP (Request for Proposal)- The pharmacy benefit manager RFP has been released for bids, as the current contract expires May 31, 2013. The state anticipates that the new contract will be signed by November 2012. Implementation and/or transition will begin in December 2012, based on who will be awarded the contract. The Go-live date for the new contract is set for June 1, 2013. Dr. Capparelli stated that last year s budget had 10 million dollars set aside for smoking cessation that was listed as a separate line item in the budget and asked for an update on the smoking cessation agents as of June 30, 2012 as to how much was spent and the amount of the remaining funds. o Dr. Collier stated that he did not have the answer to this question. Dr. Leibowitz stated that he was aware that 10 million dollars had been allocated but did not have the exact numbers available at this time, but could definitely check on the request. o Dr. Capparelli voiced concern that if the money is not fully utilized over the 2 years then there is a possibility that a situation may arise when the funds are no longer allocated for this purpose. Dr. Capparelli stated that the modeling for the budget line item included the prescription limits to prevent over spending of the allocated funds. Dr. Capparelli suggested that if the funds appear to be underutilized then perhaps these agents could be removed from the script limit requirement. Then implementation of an educational component which informs providers and members about the smoking cessation program benefit. Dr. Leibowitz reiterated that he would check on the financial aspects of the smoking cessation agents. o Dr. Phares asked if a huge portion of the funds are not be utilized will it be possible to allow Chantix availability through the county health departments for uninsured patients at no or low cost. Dr. Capparelli commented that at one time in the past these agents were made available through the health clinic, but due to reasons unknown, possibly lack of advertising, many of the products were wasted. Dr. Capparelli asked Dr. Collier if he knew whether the funds could be allocated to other groups or organizations that work with uninsured patients. Dr. Collier commented that this question would be more appropriate for the CFO (Chief Financial Officer) of TennCare as to how the money could be allocated and could check on this request. 2

AE SUBCOMMITTEE Dr. Leslie Pittman reported to the PAC committee there were 2 additions of new drugs to existing categories on the Auto-Exemption (AE) List for 2Q2012. These 2 additions included Perjeta and Kyprolis. 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 August 30, 2012 PAC review packet at: https://tnm.providerportal.sxc.com/rxclaim/tnm/pac%20packet%20083012.pdf Miscellaneous Agents Oral Iron Chelators Deferasirox and deferiprone are orally active chelating agents that have an affinity for iron. Deferasirox is FDA-approved for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. Deferiprone is FDA-approved for the treatment of patients with transfusional iron overload due to thalassemia syndromes. Both oral iron chelators have demonstrated safety and efficacy in the management of iron overload based on a reduction in ferritin levels; however, both agents also carry black box warnings regarding their use. Due to their specific FDAapproved indications as well as significant safety concerns, it is recommended all agents in this class should be subject to clinical criteria. Dr. Capparelli motioned to accept the recommendation. Lyn Govette seconded the motion. Motion carried. Clinical Criteria for Exjade 3

Exjade will be approved for recipients two years of age and older who meet ALL of the following criteria: have diagnosis of chronic iron overload due to blood transfusions. The type of anemia should be noted (i.e. Diamond-Blackfan anemia, Myelodyspastic syndrome, sickle cell anemia, β- thalassemia). Diagnosis of chronic iron overload due to blood transfusions, AND Therapy should be initiated when: Patient has received approximately 100mL/kg of PRBC, AND Serum ferritin concentration is consistently > 1,000 mcg/l, OR Liver iron concentration between 3.2 and 7 mg Fe/g dw L o o This should be documented prior to the first approval. Serum ferritin should be monitored monthly and documented upon prior authorization request for subsequent renewals. Exjade will not be approved for recipients with creatinine clearance less than 40 ml/min or for recipients with platelet count less than 50x10 9 /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. Corley inquired about the levels listed for ferritin in the clinical criteria section which lists 1,000 mcg/l verses the level listed under the Study of Thalassemia and Hemoglobinopathies as 1,000 μg/dl. o Dr. Pittman stated the correct notation will be verified. Dr. Capparelli commented that statements removed from the criteria should provide better clarification for both providers and call center personnel and appreciated the changes. Dr. Capparelli made the motion to approve the criteria. Motion seconded and carried. Clinical Criteria for Ferriprox Ferriprox will be approved for recipients who meet ALL of the following criteria: Recipient must be > two years old and have diagnosis of chronic iron overload due to blood transfusions. The type of anemia should be noted (i.e. Diamond-Blackfan anemia, Myelodyspastic syndrome, sickle cell anemia, β-thalassemia). Therapy should be initiated when: Diagnosis of transfusional iron overload due to thalassemia syndromes, AND Patient has received approximately 100mL/kg of PRBC, AND Serum ferritin concentration is consistently > 1000mcg/L, OR Liver iron concentration between 3.2 and 7 mg Fe/g dw L o o This should be documented prior to the first approval. Serum ferritin should be monitored monthly and documented upon prior authorization request for subsequent renewals. 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 stated the serum ferritin level notation will be verified as well for the Ferriprox clinical criteria. Lyn Govette made the motion to approve the criteria. Motion seconded and carried. Endocrine & Metabolic Agents 4

Growth Hormone Agents Growth hormone (GH) affects many metabolic processes including cells of internal organs, skin, bones, blood and connective tissues. Somatropin is available as a recombinant human GH and is Food and Drug Administration (FDA) approved for use in patients with growth hormone deficiency (GHD) and a variety of pediatric conditions associated with a failure in growth, including chronic kidney disease, Turner syndrome, small for gestational age (SGA), Prader-Willi syndrome, mutations in the Short Stature Homeobox gene (SHOX) and Noonan syndrome. Somatropin growth hormone products differ in their FDA approved indications and recommended doses but clinical evidence has shown these agents exhibit similar efficacy and safety. Clinical guidelines from the American Association of Clinical Endocrinologists (AACE) state there is no evidence that one agent is more advantageous over another and do not differentiate between the various GH products. Therefore, all agents within the class can be considered therapeutic alternatives to one another. Additionally, given the potential for misuse and high cost of these agents, it is recommended that the growth hormone agents be subject to clinical criteria to ensure appropriate use. Dr. Capparelli commented that this class has been reviewed approximately 3 times since he has been on the board and making note that certain agents have specific FDA approved indications, each previous review of the growth hormone agents has determined there is no clinical evidence that indicates differences within the growth hormone agent class. As a result of this information, it was decided that a single growth hormone agent product would be listed as preferred which required 96% of the patients being moved to another drug despite opposition from some endocrinologists and it appears this change was pretty successful. Dr. Capparelli stated that his only concern is in regard to patients who experienced some juggling around of agents due to specific dosing issues that were not easily accommodated by the currently available pen devices. Dr. Capparelli agreed with the recommendation that the growth hormone agents are therapeutically the same but asked TennCare to consider not making any current product PDL changes that would require a large percentage of patients to be moved to a different product. Dr. Capparelli motioned to approve the recommendation as read. Motion seconded and carried. Clinical Criteria for Growth Hormone Agents 5

For patients <= 21 years old: will be approved if ANY of the following criteria are met: Patient has a diagnosis of short stature associated with Turner s Syndrome, Noonan Syndrome or mutations of the Short Stature Homeobox (SHOX) gene Patient has a diagnosis of Prader-Willi Syndrome; Patient has evidence of hypothalamic-pituitary disease or structural lesions/trauma to the pituitary, including pituitary tumor, pituitary surgical damage, trauma, or cranial irradiation and meets any of the following: o Failed a GH stimulation test (peak GH level <10ng/mL) o Documented low IGF-1 level (below normal for patient s age) o Has deficiencies in 3 or more pituitary axes Patient has chronic renal insufficiency (CrCl < 30mL/min/1.73m2) Patient is a newborn infant and has evidence of hypoglycemia AND either a low GH level (<20 ng/ml) or a low for age IGF-1/IGF Binding Protein #3 level Patient has failed two GH stimulation tests (defined as peak GH level < 10 ng/ml), OR has failed one GH stimulation test and has a documented low IGF-1 level based on age normal values. o Continuation of GH therapy will be approved only if height velocity is within range of normal for patient s age or bone age. o Therapy will not be approved once epiphyseal fusion occurs. o For recipients who have been on GH prior to the start of this edit, the requirement for 2 stimulation tests will be waived. Diagnosis of Small for Gestational Age (SGA) or Intrauterine Growth Retardation (IGR), > 2 years old, and has a height at least 2 standard deviations below the population mean for age Patient has a diagnosis of HIV/AIDS wasting/cachexia Patient has short bowel syndrome and is receiving specialized nutrition support. NOTE: GH therapy will NOT be approved for idiopathic short stature. Patients > 21 years old: will be approved for ANY of the following: Patient has evidence of hypothalamic-pituitary disease or structural lesions/trauma to the pituitary, including pituitary tumor, pituitary surgical damage, trauma, or cranial irradiation (can be diagnosed either in childhood or adulthood) AND meets any one of the following: o Failed at least one GH stimulation test o Has at least one documented low IGF-1 level o Has deficiencies in 3 or more pituitary axes NOTE: For recipients diagnosed in childhood with hypothalamic-pituitary disease or structural lesions/trauma to the pituitary who have a past history of GH use, no retesting is necessary. Failure of two GH stimulation tests (peak GH level < 5 ng/ml) or failure of one GH stimulation test and documented low IGF-1 Patient has a diagnosis of HIV/AIDS wasting/cachexia Patient has short bowel syndrome and is receiving specialized nutrition support. Dr. Capparelli inquired as to whether the proposed changes to the clinical criteria would prevent a patient who has moved to Tennessee and has become eligible for TennCare from receiving the drug. o Dr. Pittman stated there were 2 different pathways to receive a prior authorization (PA), which includes an initial request and a renewal request. So patients coming from a different state would be handled under the renewal pathway. The renewal requests have slightly different questions and would be handled differently in regards to the tests that have been performed. Dr. Pittman stated that removing this bullet point 6

from the criteria does not change the questions on the specific pathways used. This would only affect the public criteria that is posted. Dr. Capparelli motioned to approve the criteria as read. Motion seconded and carried. Insulin-Like Growth Factor-1 Increlex (mecasermin) is the only recombinant human insulin-like growth factor-1 (IGF-1) and is FDA approved for the treatment of growth failure in pediatric patients with severe primary IGF-1 deficiency and in those with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Although there are no consensus guidelines on the management of primary IGF-1 deficiency, the literature supports the use of IGF-1 in the FDA-approved indications. Therefore it is recommended mecasermin should be subject to clinical criteria to ensure appropriate use. Dr. Capparelli motioned to approve the recommendation. Motion seconded by Lyn Govette Motion carried. Clinical Criteria for Increlex (mecasermin) Will be approved for patients <21 years old with a diagnosis of: Growth failure due to severe primary IGF-1 deficiency (documentation of low-igf-1 must be provided), OR Growth hormone gene deletion in a patient who has developed neutralizing antibodies to growth hormone (GH). Note: Will not be approved for individuals with closed epiphyses Dr. Capparelli asked if it would be prudent to say growth hormone deficiency in a patient who has developed neutralizing antibiodies verses growth hormone gene deletion. In the previous discussion of growth hormone, gene deletion is never mentioned. o Dr. Lovett stated that the FDA approval should specifically state growth hormone gene deletion. o Dr. Capparelli asked if mecasermin could be used for patients with growth hormone deficiency in which knowledge of IFG-1 deficiency is unknown. Dr. Lovett stated no, the agent would not be used in patients with just growth hormone deficiency. Dr. Pittman reiterated that the FDA approval is specifically for the growth hormone gene deletion. o Dr. Capparelli asked if there were specific tests available to determine if a patient has a growth hormone gene deletion. Dr. Lovett stated that genetic testing would be done to determine if a person has a growth hormone gene deletion. In the MedMetrics full class review, it specifically states that this agent should not be used in patients who just have growth hormone deficiency. Dr. Lovett stated that review of the claims from last quarters only indicates 20 claims were submitted for the agent, which may be indicative that only patients with the growth hormone gene deletion are actually receiving the agent. 7

o Dr. Polson stated there are currently 2 genetic tests available to detect growth hormone deletions. Dr. Capparelli motioned to approve the clinical criteria as presented. Motion seconded by Dr. Phares. Motion carried. Agents for Acromegaly Acromegaly is a long-term condition characterized by growth hormone (GH) hypersecretion, multisystem-associated morbidities, increased mortality and is most commonly caused by a GH secreting adenoma. Treatment goals include normalization of biochemical variables, reversal of mass effects of the tumor, minimizing long-term mortality risk, improving signs, symptoms and comorbidities of the disease. All of the acromegaly agents are Food and Drug Administration (FDA)- approved for the treatment of acromegaly in patients who have had an inadequate response to or cannot tolerate surgery or radiotherapy. Furthermore, octreotide and pegvisomant are approved for use in acromegalic patients who have failed or who cannot tolerate other medical therapies. Octreotide has an additional FDA-approved indication for use as symptomatic treatment of neuroendocrine carcinomas. The AACE guidelines for acromegaly recommend somatostatin analogs as first-line pharmacologic therapy, with pegvisomant reserved for individuals who fail to respond to somatostatin analogs. Based on this information, pegvisomant should be considered second-line therapy behind the somatostatin analogs. Dr. Capparelli motioned to approve recommendation as presented. Lyn Govette seconded the motion. Motion carried. Bone: Bisphosphonates In general, the bisphosphonates are FDA-approved for the prevention and/or treatment of osteoporosis in postmenopausal women, in men, and in patients taking prolonged courses of glucocorticoids; however, some agents are also approved for the treatment of Paget s disease. Data from trials specifically examining fractures indicates that the use of bisphosphonates is efficacious and significantly lowers the risk, in both men and women, of developing fractures in both vertebral and nonvertebral areas. Based on the available evidence, and due to a lack of conclusive head-to-head data, it is unknown whether one bisphosphonate is more efficacious for the treatment and prevention of osteoporosis. While not all clinical guidelines for osteoporosis recommend a preferred medication and/or medication class, the American Association of Clinical Endocrinologist and the North American Menopause Society recommend bisphosphonates as first-line therapy for the treatment of osteoporosis in postmenopausal women. Bisphosphonates are generally recognized as first-line therapy for the prevention and treatment of osteoporosis, including postmenopausal and glucocorticoid-induced osteoporosis due to the good quality evidence supporting their use for reducing the risk of vertebral, non-vertebral, and hip fractures. Therefore, it is recommended at least one bisphosphonate should be available for use, which should be approved for use in men, postmenopausal women and for the treatment of Paget s Disease. 8

Dr. Capparelli asked if the criteria should include a statement for prolonged corticosteroid use for patients who may not fall in the postmenopausal women category. o Dr. Pittman stated a statement could be added, but the agents currently do not have clinical criteria placed on them. The current recommendation wording ensures the agent chosen as preferred would include all 3 categories of patients. Therefore this refers to either alendronate or risendronate that would have to be chosen as the preferred agent. Dr. Pittman further clarified that she wanted to ensure that the preferred agent chosen would not be an agent FDA approved only for Paget s disease. Dr. Capparelli motioned to approve the recommendation as presented. Motion seconded by Shana Bush Motion carried. Quantity Limits: alendronate Actonel Atelvia Boniva Fosamax Fosamax Plus D ibandronate Skelid 5mg, 10 mg, 40 mg: 1 per day 35 mg, 70 mg: 4 per 28 days 5 mg, 30 mg: 1 per day 35 mg: 4 per 28 days 75 mg: 2 per month 150 mg: 1 per month 4 per 28 days 1 per month 5mg, 10 mg, 40 mg: 1 per day 35 mg, 70 mg: 4 per 28 days 4 per 28 days 1 per month 2 per day Dr. Pittman stated that due to a new effervescent alendronate agent, Bonista becoming available on this past Friday, the quantity limit was not included in the PAC packet. However, the agent was added to the proposed quantity limits presented today and reflected on the current slide for a vote from the committee. The quantity limits presented for Bonista are 4 per 28 days as this agent is formulated to be taken on a weekly basis. Additionally, the other new agents presented today with quantity limits in this class includes Atelvia with a quantity limit of 4 per 28 days and Skelid listed with a quantity limit of 2 per day. Dr. Schwerdt asked if Fosamax oral solution was no longer available. Dr. Corley stated that many patients were switched over as a result of the agent not being available and has not seen the product return to the market. Dr. Pittman concurred and stated that she believes the agent was discontinued. Motion made to approve the quantity limits as presented. Motion seconded and carried. Bone: SERMs 9

Raloxifene is FDA-approved for the prevention and treatment of osteoporosis in postmenopausal women, as well as for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women with osteoporosis who are at high risk for invasive breast cancer. Clinical trial data demonstrates that raloxifene significantly increases bone mineral density in postmenopausal women with osteoporosis as well as reducing vertebral fractures; however, raloxifene has not demonstrated a reduction in non-vertebral and hip fractures. Current clinical guidelines recommend that all drugs FDA-approved for use in osteoporosis are appropriate treatment options; however, the bisphosphonates are generally recognized as first-line therapy. Raloxifene is recognized as a potential treatment option for the prevention and treatment of osteoporosis, but generally is recommended as second- or third-line therapy for treatment of postmenopausal osteoporosis. According to the National Comprehensive Cancer Network, raloxifene is recognized as a potential option to reduce the risk of breast cancer; however, tamoxifen is a superior choice for most postmenopausal women. While not considered first line therapy, raloxifene is an effective treatment option for osteoporosis in postmenopausal females. In order to provide treatment options for osteoporosis with differing mechanisms of action, it is recommended raloxifene should be available for use. Dr. Capparelli commented that in his practice, this agent worked well for 2 groups of patients, those who could not comply with the prolonged standing requirement of bisphosphonates and in women with a 1 st line family history of breast cancer and required treatment but were not good candidates for treatment with tamoxifen. The drug has a special niche for those women who have a family history of breast cancer in addition to a diagnosis of osteoporosis as well. Dr. Capparelli motioned to approve the recommendation as presented. Lyn Govette seconded the motion. Motion carried. Quantity Limits: Evista 1 per day Lyn Govette motioned to approve the quantity limits presented. Dr. Bush seconded the motion. Motion carried. Bone: Calcitonin Injectable calcitonin-salmon is FDA-approved for the early treatment of hypercalcemic emergencies, for the treatment of symptomatic Paget s disease of bone, and for the treatment of postmenopausal osteoporosis in women. Nasal calcitonin-salmon is only approved for the treatment of postmenopausal osteoporosis. Overall, there is a lack of substantial clinical trial data for this medication class as clinical trials are limited by small sample size and design. There is also a lack of substantial head-to-head data comparing calcitonins to other established osteoporosis treatments; however, available data supports the use of first- and second-line osteoporosis therapies over calcitonin for increasing bone mineral density. Current clinical guidelines recommend that all drugs FDA-approved 10

for use in osteoporosis are appropriate treatment options; however, the bisphosphonates are generally recognized as first-line therapy. Calcitonins are recognized as a potential option for the treatment of osteoporosis, and have fair quality evidence to support their use in reducing vertebral fractures; they have not demonstrated a reduction in non-vertebral and hip fractures. Current guidelines from the American Association of Clinical Endocrinologists recommend calcitonin as a last line therapy for the treatment of postmenopausal osteoporosis. Due to the lack of substantial trial data and given that calcitonin is considered a last line therapy for the treatment of postmenopausal osteoporosis, it is recommended calcitonin should be subject to clinical criteria. Dr. Corley asked that the Miacalcin nasal spray and injection be listed separately on for clarification purposes since it is mentioned separately in the clinical criteria and quantity limits. o Dr. Pittman agreed this could be listed separately on the PDL. Dr. Capparelli motioned to accept the recommendation. Motion seconded and carried. Quantity Limits: calcitonin-salmon nasal spray Fortical Miacalcin nasal spray Miacalcin injection 2 per month (billing units of 3.7 ml) 3.7 ml/30 days 2 per month (billing units of 3.7mL) 3.7 ml/30 days 2 per month (billing units of 3.7mL) 3.7 ml/30 days 1 ml/day Dr. Pittman stated that the quantity limits have been changed to allow only 1 bottle as this is considered a 1 month supply. Dr. Bush asked if the quantity limits were coded as an exact 30 days or does it hit a refill threshold. o Dr. Pittman stated it is coded to allow a refill every 26 days. Lyn Govette motioned to accept the quantity limit changes. Motion seconded and carried. Clinical Criteria for Fortical Fortical will be approved for patients meeting ALL of the following criteria: Diagnosis of osteoporosis in postmenopausal women greater than five years postmenopause, AND Trial and failure, contraindication or intolerance to BOTH bisphosphonates AND raloxifene. Lyn Govette motioned to accept the clinical criteria. Dr. Phares seconded the motion. Motion carried. Clinical Criteria for Miacalcin nasal spray & calcitonin-salmon nasal spray 11

Will be approved for patients meeting ALL of the following criteria: Diagnosis of osteoporosis in postmenopausal women greater than five years postmenopause, AND Trial and failure, contraindication or intolerance to BOTH bisphosphonates AND raloxifene, AND Trial and failure, contraindication or intolerance to preferred agents Dr. Capparelli stated that prior to bisphosphonates coming to the market. The nasal spray was utilized quite frequently to treat chronic low back pain in postmenopausal women. It appears anecdotally, this was helpful for osteoporotic patients with chronic low back pain and had a fairly good success rate in treating postmenopausal women with low back pain. o Lyn Govette asked for clarification regarding whether a patient with a diagnosis of osteoporosis could receive the drug. Dr. Pittman confirmed that if they have a diagnosis of osteoporosis they could receive the drug. Lyn Govette motioned to approve the clinical criteria as presented. Dr. Capparelli seconded the motion. Motion carried. Clinical Criteria for Miacalcin injection Will be approved for patients meeting ONE of the following criteria: Diagnosis of Paget s disease of the bone, OR Diagnosis of osteoporosis in postmenopausal women greater than five years postmenopause, AND Trial and failure, contraindication or intolerance to BOTH bisphosphonates AND raloxifene, AND Trial and failure, contraindication or intolerance to preferred agents Dr. Pittman stated the use of Miacalcin injection for hypercalcemia was not added as this would not be considered an outpatient treatment. Dr. Capparelli motioned to approve the clinical criteria. Dr. Bush seconded the motion. Motion carried. Bone: Parathyroid Hormone Teriparatide is a recombinant human parathyroid hormone and has the same physiological actions on bone and kidney as endogenous parathyroid hormone. Teriparatide is FDA-approved for use in patients at high risk for fracture specifically to increase bone mass in men with primary or hypogonadal osteoporosis, for the treatment of patients with glucocorticoid-induced osteoporosis, and for the treatment of postmenopausal women with osteoporosis. Clinical trials evaluating the safety and efficacy of teriparatide in FDA-approved indications demonstrate that bone mineral density (BMD) is consistently increased; however, the safety and efficacy of teriparatide have not been evaluated beyond two years of treatment, and a treatment duration greater than two years in a patient s lifetime is not recommended. Current clinical guidelines recommend that all drugs FDA-approved for use in osteoporosis are appropriate treatment options; however, the bisphosphonates are generally 12

recognized as first-line therapy for the prevention and treatment of osteoporosis, including postmenopausal and glucocorticoid-induced osteoporosis. With regards to parathyroid hormones, guidelines recommend teriparatide as a potential option for the prevention and treatment of osteoporosis, but generally recommend that it be reserved for patients at very high fracture risk or in patients who have failed first-line bisphosphonate therapy. Due to the lack of long term outcomes data and safety concerns, it is recommended that teriparatide be subject to clinical criteria. Dr. Capparelli commented that this agent produces physiological effects that the bisphosphantes cannot produce, this agent restructures and remolds the bone matrix, which is phenomenal. Dr. Capparelli stated the concern with Forteo is that you may use the agent in a patient who is now 50 years old, if that person lives to be 70 you no longer have this treatment option available therefore agreed with the clinical criteria presented. o Dr. Pittman concurred with Dr. Capparelli s thoughts and stated that once the patient receives 2 years of treatment with teriparatide, the patient is no longer eligible to receive the drug again and should be reserved for high risk patients. Dr. Capparelli asked if the agent was designed to be effective for any type of fracture or for a specific type of fracture, such as spine fractures. o Dr. Pittman stated this was not specifically addressed in the class review. However, the guidelines state it increases bone mineral density (BMD) at the lumbar spine, total hip and femoral neck, so has both vertebral and non-vertebral effects. Dr. Capparelli motioned to approve the recommendation. Motion seconded and carried. Clinical Criteria for Forteo : Will be approved for individuals at high risk for fracture, with a T-score at or below -2.5 SD, who: Have experienced an insufficient response or intolerance to an adequate trial of a bisphosphonate, or have a contraindication to bisphosphonate use, PLUS a history of osteoporotic fracture, AND Have been screened and found not to have pre-existing hyperparathyroidism. Note: The safety and efficacy of teriparatide has not been evaluated beyond 2 years of treatment. Consequently, use of the drug for more than 2 years is not recommended. Dr. Pittman stated that the only change was the reference to the T-score which previously read below -2.0 SD (standard deviation)and has been changed to say at or below -2.5 SD, which technically defines a patient as being osteoporotic. Dr. Capparelli asked if the statement individuals at high risk for fracture could be defined and if the note applied to the criteria could be changed to read use of the drug for more than 2 years will not be approved. o Dr. Pittman stated this was listed this way intentional, but this could be defined as there is a risk rating scale that could classifies a person s risk level, but this would make it harder for a patient to receive the drug. Dr. Pittman stated the note could be changed to read use beyond 2 years is not recommended and will not be approved. Dr. Capparelli motioned to approved the clinical criteria with modification to the note that indicates it will not be approved beyond 2 years. 13

Motion seconded and carried. Hormones: Oral Progestins The oral progestin agents are Food and Drug Administration (FDA) approved for a variety of clinical conditions. The FDA approved indications include prevention of endometrial hyperplasia in postmenopausal women receiving conjugated estrogens (medroxyprogesterone, progesterone), palliative treatment of advanced breast and endometrium cancer (megestrol tablet), treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology (medroxyprogesterone, norethindrone), treatment of human immunodeficiency virus (HIV)-related wasting (megestrol suspension), treatment of endometriosis (norethindrone), and treatment of secondary amenorrhea (medroxyprogesterone, norethindrone & progesterone). In general the benefits and efficacy of hormonal therapy for these indications are well established. The American Society for Reproductive Medicine guidelines state oral contraceptives, progestogens, danazol, gonadotropin-releasing hormone agonists, and anti-progestogens have all been utilized as medical treatments for endometriosis. However, there is no substantial evidence to support the superiority of one medical treatment over another and treatment decisions require individualization. Additionally, clinical trials do not differentiate between the agents within the class in regards to safety and efficacy. Therefore, it is recommended that at least megestrol plus 2 other agents be available. Dr. Capparelli commented on megestrol suspension noting its sole FDA indication is for treatment of HIV related wasting, but has found the agent very effective for treating wasting/anorexic symptoms due to a variety of other reasons, such as cancer and appreciated the fact that no criteria has been placed on the drug that would restrict use of the agent. o Dr. Lovett stated that many of the cases outside of the FDA approved indication come through appeals and most are approved for use in wasting/cachexia situations due to other causes. Dr. Capparelli motioned to approve the recommendation. Motion seconded and carried. Quantity Limits megestrol acetate Megace Megace ES 600mL/month 600mL/month 150mL/month Dr. Chris Schwerdt inquired as to how the quantity limit will be coded, as the suspension comes in 240ml bottles and voiced concern to ensure the coding would allow full bottles versus splitting of the 240ml bottles. o Dr. Pittman stated that typically it is coded on a per day basis. In this case it should be coded as 20ml per day. Dr. Lovett stated we can verify the quantity limit coding to ensure it is coded as a daily limit. Dr. Capparelli motioned to approve the quantity limit. Motion seconded and carried. 14

Clinical Criteria for Megace ES Will be approved for individuals meeting one of the following criteria: Inability to swallow the 10mL (400mg) or 20mL (800mg) dose Intolerance to the original formulation Dr. Capparelli asked if anyone has ever met the criteria for the second bullet point. Dr. Capparelli voiced concern that this may allow someone to receive a branded agent versus using the generic megesterol formulation. o Dr. Pittman stated that usually when this statement is included it refers to a filler or excipient that the patient cannot tolerate. Dr. Capparelli motioned to accept the criteria with modification that the 2 bullet point is removed. Lyn Govette seconded the motion. Motion carried. Clinical Criteria for Aygestin (norethindrone) Will be approved for patients with a diagnosis of endometriosis Dr. Corley inquired as to why we allowed this indication and not for the others. o Dr. Lovett stated this agent is FDA approved for treatment of endometriosis and since this was moved to the NP side criteria was placed on the agent to allow use for patients with this diagnosis. Dr. Bush asked if a diagnosis approval could be used for this agent at point-ofsale. o Dr. Lovett stated the ICD-9 edit could be discussed with the state to see if this is an option. Dr. Capparelli motioned to accept the clinical criteria. Lyn Govette seconded the motion. Motion carried. Hormones: Oral, Transermal & Vaginal Estrogens Estrogens are FDA (Food and Drug Administration) approved for the treatment of moderate to severe vasomotor symptoms due to menopause, vulvar and vaginal atrophy, palliative treatment of metastatic breast cancer and advanced prostate cancer, as well as for the prevention of postmenopausal osteoporosis. The North American Menopause Society recognizes estrogen therapy, with or without progesterone, as the most effective treatment for menopause-related vasomotor symptoms and clinical data supports the use of estrogen for the treatment of moderate to severe vasomotor symptoms associated with menopause. Furthermore, clinical guidelines do not prefer one estrogen agent over the other and stress that decisions should be made on an individual basis. However, the AACE (American Association of Clinical Endocrinologists) guidelines state transdermal estrogen products may be considered to avoid the hepatic first-pass effect of oral estrogen agents. The guidelines also support the use of vaginal estrogen agents when minimal systemic absorption is desired or when hormonal therapy is utilized 15

primarily for urogenital atrophy. Therefore given that hormonal therapy should be determined on an individual basis, it is recommended that at least one oral, one transdermal and one vaginal product be available for use to allow product selection among the various formulations. Dr. Lovett stated the oral, transdermal and vaginal agents were combined for the purpose of the class review, but will be listed separated by category on the public PDL listing. Dr. Pittman stated that estradiol TDS and Climara were flipped on the drug listing. Climara TDS is now preferred and will be added to the Brand as Generic list. Dr. Capparelli motioned to accept the recommendation as presented. Dr. Bush seconded the motion. Motion carried. Quantity Limits Alora Climara estradiol TDS Estraderm Menostar Premarin Vaginal Cream Vivelle-Dot 8/month 4/month 4/month 8/month 4/month 3/month 8/month Dr. Corley stated the Premarin vaginal cream has recently changed package size from a 42.5 gram tube to a 30 gram tube and inquired as to whether this would affect the proposed quantity limit. o Dr. Lovett stated the billing units and maximum daily dosage will be verified. Dr. Capparelli motioned to accept the quantity limits with verification of the quantity limit on Premarin vaginal cream. Dr. Phares seconded the motion. Motion carried. Hormones: Oral & Transdermal Estrogen/Progestins The oral and transdermal estrogen/progestin agents are Food and Drug Administration (FDA)-approved for the prevention of postmenopausal osteoporosis, treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause and treatment of moderate to severe vasomotor symptoms due to menopause. Specifically, transdermal estradiol/norethindrone is the only agent in the class that is FDA-approved for the treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Current clinical guidelines support the use of estrogen and progestins for the treatment of moderate to severe vasomotor symptoms and other symptoms associated with menopause; stating it is the most effective treatment for vasomotor symptoms. However, due to potential risks associated with EPT, the decision to use EPT for management of menopausal symptoms should be assessed on an individual basis. Although guidelines do not prefer one estrogen/progestin agent over another, the AACE (American Association of Clinical Endocrinologists) guidelines state transdermal hormonal preparations may be considered to avoid the hepatic first-pass effect of oral preparations. Therefore it 16

is recommended that at least two oral estrogen/progestin agents be available for use. Additionally, to allow for treatment of estrogen deficiency secondary to other conditions, at least one transdermal estrogen/progestin agent should also be available. Dr. Capparelli motioned to accept the recommendation as presented. Dr. Phares seconded the motion. Motion carried. Quantity Limits Climara Pro Combipatch PremPhase PremPro 4/month 8/month 28 tablets/month 28 tablets/month Dr. Corley asked if the PremPhase and PremPro quantity limits should be listed as a daily limit as they are to be taken once daily. o Dr. Lovett stated this could be coded as a daily limit. Dr. Schwerdt asked how the quantity limits affect the 5 script limit. o Dr. Corley stated that it could affect the script limits and most people take a 2-3 day break. Dr. Lovett stated that this particular agent is not on the attestation limits but the thinking is that other agents that the patient may be taking that are on the attestation list can be substituted, which will allow the patient to bypass the five script limit. o Dr. Capparelli commented that the attestation process could be time consuming. Lyn Govette reported that the process is very effortless with the new IVR functionality that faxes the Attestation request document to the provider on demand within 10 minutes. Dr. Capparelli stated that you still have to spend approximately 15 minutes to complete and fax the form back for approval. o Dr. Corley asked if this drug could be given a dose titration override. Dr. Pittman stated the dose titration override is only applicable if the claim is submitted within 21 days of the first claim and since the submittal of this claim would be outside of this time frame it wouldn t work. Dr. Corley stated that he hasn t had a lot of patients to complain about not receiving the agent as a result of script limits. persued. Dr. Capparelli motioned to approve the quantity limits with the modification that PremPhase and PremPro quantity limits are changed to a 1 per day quantity limit. Motion seconded and carried. Hormones: LHRH Nafarelin acetate is FDA (Food and Drug Administration) approved for the management of endometriosis, including pain relief and reduction of endometriotic lesions. Clinical guidelines indicate both surgical and medical treatments are effective for endometriosis and do not establish one treatment option over the other. The American Society for Reproductive Medicine guidelines list gonadotropin- 17

releasing hormone agonist as a drug option along with other agents for the treatment of endometriosis. Additionally, nafarelin acetate is FDA approved for the treatment of central precocious puberty in children of both sexes. Therefore it is recommended that nafarelin acetate be available for use. Dr. Capparelli motioned to approve the recommendation. Motion seconded and carried Dr. Capparelli commented that the claims data shows that only 2 claims for this agent were submitted during the last quarter. Given the low utilization, this agent is probably being utilized for precocious puberty. Dr. Capparelli motioned to move the agent to the low utilization category. Dr. Corley explained that the low utilization category includes those classes that have less than 100 claims and a cost less than $100,000 per year. Classes in this category do not have to be reviewed again unless something changes in the category that requires it to be reviewed. Motion seconded and carried. Hormones: Adrenocorticotroic Corticotropin, a natural porcine ACTH, is FDA approved for the treatment of infantile spasms as well as a variety of glucocorticoid-responsive disorders. Current clinical guidelines recommend ACTH as first-line therapy for the treatment of infantile spasms. For all other FDA-approved indications, consensus guidelines generally recommend the use of intravenous or oral glucocorticoids when glucocorticoid therapy is warranted. Therefore, it is recommended corticotropin should be available for use in the treatment of infantile spasms and should be subject to step therapy for all other indications.. Dr. Capparelli made a motion to accept the recommendation. Lyn Govette seconded the motion. Motion carried. Quantity Limits: H.P. Acthar 1 ml/day Dr. Capparelli inquired about the 6ml quantity listed on the cost data information and if the proposed quantity limit was appropriate. o Dr. Pittman stated the daily quantity limit was placed to prevent misbilling. Dr. Pittman clarified the strength and billing units can be confusing which causes some claims to be submitted with an incorrect dispensed quantity. Dr. Phares made a motion to accept the quantity limit presented. Dr. Bush seconded the motion. Motion carried. Clinical Criteria for H.P. Acthar 18

Corticotropin will be approved only for recipients who are self-administering and meet ONE of the following criteria: Difficulty swallowing or inability to absorb oral medications Contraindication or intolerance to oral AND injectable glucocorticoids Diagnosis of infantile spasms Dr. Pittman explained that the are self-administering and was removed as this agent was added to the covered injectable list in 2010. The first bullet point was also removed from the criteria as well. Dr. Capparelli made a motion to accept the clinical criteria with the proposed changes. Lyn Govette seconded the motion. Motion carried. The Committee was dismissed for Lunch break. Attendance after lunch: all committee members returned. Hormones: Thyroid Thyroid hormone replacement therapy with the thyroid agents is the mainstay of treatment for patients with hypothyroidism, and will be administered lifelong for the majority of patients. All of the thyroid hormones have similar FDA-approved indications and safety profiles. Current clinical guidelines state that levothyroxine is the treatment of choice for the management of hypothyroidism and that in general, desiccated thyroid hormone, combinations of thyroid hormones, or triiodothyronine should not be used as replacement therapy. Clinical trial data demonstrate that combination T3 and T4 treatment is not associated with consistent clinical benefits over monotherapy with levothyroxine. Liothyronine may be useful prior to treatment of thyroid cancer with radioactive iodine, because patients can be withdrawn from liothyronine for shorter periods of time. Therefore, it is recommended at least levothyroxine and liothyronine should be available for use in patients with hypothyroidism. Dr. Capparelli voiced concerned regarding the statement about bioequivalence and stated that it becomes hard to manage patients if the patient receives a different manufacturer brand each time the drug is filled. o Dr. Pittman clarified that the guidelines specifically address this issue and advocate the use of brand name agents to be used throughout therapy. o Dr. Capparelli inquired as to which agent would be considered brands. Dr. Pittman clarified which agents on the drug listing were considered true brands. Dr. Capparelli asked if the Synthroid would count against the 2 brand script limit whereas Levoxyl would not count. Dr. Pittman agreed. o Dr. Capparelli asked if a prescription was written for Levoxyl would the patient receive the same drug each time. 19