Products Containing Butalbital Combination analgesics containing butalbital are indicated for the relief of symptomatic tension-type headache (TTH). However, the Institute for Clinical Systems Improvement (ICSI) does not recommend the use of agents containing butalbital for the treatment of headaches. Instead, acetaminophen, aspirin, and NSAIDS are recommended for acute treatment of TTH. Amitriptyline and venlafaxine may be appropriate for prophylactic therapy. Additionally, the overuse of products containing butalbital has been associated with cases of rebound headache. Data reported from the American Migraine Prevalence and Prevention study suggests that episodic use of butalbital as infrequently as five days per month may lead to chronic daily headache and medication overuse headache. Based on a recent utilization review conducted by MassHealth, it has been determined that products containing butalbital will have quantity limits to minimize the potential overutilization of these agents. The prior authorization requirement for products containing butalbital was implemented on August 16, 2010. Prior authorization (PA) is required for all of the following products containing butalbital, if the quantity exceeds 60 units/month. Drug Availability butalbital- acetaminophen (Phrenilin, Bupap) Capsule: 50 mg/325 mg, tablet: 50 mg/325 mg, 50 mg/650 mg butalbital- acetaminophen- caffeine (Fioricet) Capsule and tablet: 50 mg/325 mg/40 mg butalbital- acetaminophen- caffeine-codeine (Fioricet with Codeine) Capsule: 50 mg/325 mg/40 mg/ 30 mg butalbital-aspirin- caffeine (Fiorinal) Capsule and tablet: 50 mg-325 mg-40 mg butalbital-aspirin- caffeine-codeine (Fiorinal with Codeine) Capsule: 50 mg-325 mg-40 mg- 30 mg Intravenous Antibiotics for Treatment of MRSA and VRE Intravenous (IV) antibiotics – Cubicin, Zyvox, Synercid, Tygacil, Vibativ, and vancomycin are FDA-approved for the treatment of methicillin-resistant Staphylococcus aureus (MRSA). Zyvox and Synercid are also FDA- approved for the treatment of vancomycin-resistant enterococci (VRE) infections. However, clinical literature indicates that Cubicin and Tygacil also have activity against VRE infections. According to the Infectious Diseases Society of America (IDSA) guidelines, vancomycin is the antibiotic of choice for skin and soft tissue infections caused by MRSA. Vancomycin is also recommended as the agent of choice for MRSA bacteremia, endocarditis, and osteomyelitis. For patients who fail to respond or cannot tolerate vancomycin, Cubicin, Zyvox, Synercid, and Tygacil are all potential treatment options. MassHealth has reviewed the IV antibiotics with activity against MRSA and VRE infections in order to identify safety, efficacy, and appropriate utilization. Due to availability of vancomycin, which is significantly less costly compared to the other parenteral antibiotics, and its place in therapy as a first line in the treatment of MRSA infection, MassHealth has determined that the remaining agents will require prior authorization. The prior authorization requirement for IV antibiotics was implemented on August 16, 2010. The prior authorization status of the individual products is outlined below. Requires PA Avg. cost/therapy* daptomycin (Cubicin) $1,670-$6,681 linezolid (Zyvox) $2,102-$2,943 quinupristin/dalfopristin (Synercid) $4,682 telavancin (Vibativ) $1,139-$2,279 tigecycline (Tygacil) $772-$1,929 Available without PA vancomycin (Vancocin) $205-$307 * The cost provided is for generic drug unless the drug is only available as a brand name. Vancomycin is the only agent available generically. For weight-based dosing regimens, the cost of therapy was calculated using a 70 kg patient. Duration of therapy is that recommended for MRSA treatment. The Prescriber e-Letter is an update designed to enhance the transparency and efficiency of the MassHealth drug prior-authorization (PA) process and the MassHealth Drug List. Each issue will highlight key clinical information and updates to the MassHealth Drug List. The Prescriber E-Letter was prepared by the MassHealth Drug Utilization Review Program and the MassHealth Pharmacy Program. The Prescriber e-Letter October 2010, Volume 3, Issue 3 Recent MassHealth Drug List Updates Drug/Drug Class Addition/Deletion/Change Rationale azithromycin ER (Zmax) Change in PA status; requires PA There are more cost-effective alternatives available for the management of the same clinical conditions including generic azithromycin suspension, which is available without PA. becaplermin (Regranex) Change in PA status; requires PA Regranex previously required prior authorization for quantities greater than 1 tube per month and 3 tubes per lifetime. Effective August 16, 2010, prior authorization is required for all quantities. However, the limit of 3 tubes per lifetime has been removed to allow for greater treatment flexibility. C1 inhibitor, human (Berinert) Addition; MassHealth does not pay for this drug to be dispensed through a retail pharmacy. Only available through the health- care professional who administers the drug Berinert is indicated for the treatment of acute abdominal or facial attacks of Hereditary Angioedema (HAE) in adults and adolescents. MassHealth has determined that this product will be paid for only when obtained through a health-care professional. C1 inhibitor, human (Cinryze) Change in PA status; MassHealth does not pay for this drug to be dispensed through a retail pharmacy. Only available through the health- care professional who administers the drug Cinryze is indicated for the routine prophylaxis against angioedema attacks in adults and adolescents with Hereditary Angioedema (HAE). This agent previously required prior authorization. MassHealth has determined that this product will be paid for only when obtained through a health-care professional. capsaicin (Qutenza) Addition; requires PA Qutenza is a highly concentrated capsaicin patch indicated for the management of neuropathic pain associated with postherpetic neuralgia (PHN). There are more cost-effective alternatives available for the management of the same clinical condition including tricyclic antidepressants (amitriptyline, imipramine, nortriptyline, or desipramine), and gabapentin, which are available without PA. collagenase clostridium histolyticum (Xiaflex) Addition; requires PA Xiaflex is FDA-approved for the treatment of Dupuytren’s contracture in adult patients with a palpable cord. This medication requires PA to ensure treatment is clinically appropriate. cyclosporine (Restasis) Change in quantity limits; requires PA >60 units/month Restasis previously required prior authorization for quantities greater than 64 units/month. Effective August 16, 2010, Restasis requires PA for quantities >60 units/month. denileukin diftitox (Ontak) Addition; requires PA Ontak is FDA-approved for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin-2 receptor. There are more cost-effective alternatives available for the management of the same clinical condition including bexarotene and vorinostat, which are available without PA. dextroamphetamine (ProCentra) Change in quantity limits; requires PA >900 mL/month MassHealth has updated quantity limits on dextroamphetamine (ProCentra) oral solution to prevent inappropriate overutilization. diclofenac (Voltaren Gel) Change in PA status; requires PA >100 grams/month Voltaren Gel previously required prior authorization for all quantities. MassHealth now requires PA for quantities greater than 100 grams per month. diclofenac (Pennsaid) Addition; requires PA The role of topical NSAIDs in the treatment of osteoarthritis has not been fully established. There are more cost-effective alternatives available for the management of the same clinical condition including generic NSAIDs and acetaminophen, which are available without PA. Recent MassHealth Drug List Updates continued on next page The Prescriber e-Letter October 2010, Volume 3, Issue 3 Recent MassHealth Drug List Updates (cont.) Drug/Drug Class Addition/Deletion/Change Rationale ecallantide (Kalbitor) Addition; MassHealth does not pay for this drug to be dispensed through a retail pharmacy. Only available through the health- care professional who administers the drug Kalbitor is a human plasma kallikrein inhibitor approved for the treatment of acute attacks of Hereditary Angioedema. MassHealth has determined that this product will be paid for only when obtained through a health-care professional. ganciclovir (Zirgan) Addition; does not require PA Zirgan is ophthalmic gel indicated for the treatment of acute herpetic keratitis, specifically dendritic ulcers. The agent has similar clinical efficacy compared to the alternative agents for herpetic keratitis, with fewer adverse events than topical acyclovir. hydromorphone, extended release (Exalgo) Addition; requires PA There are more cost-effective alternatives available for the management of the same clinical conditions including long-acting morphine sulfate and short-acting hydromorphone, which are available without PA at daily doses <360 mg. imiquimod (Zyclara) Addition; requires PA Zyclara is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults. There are more cost-effective alternatives available for the management of the same clinical condition including topical fluorouracil and generic imiquimod 5%, which are available without PA. immune globulin (Hizentra) Addition; requires PA Hizentra is a human immune globulin indicated as replacement therapy for primary humoral immunodeficiency (PI). This medication requires PA to ensure treatment is clinically appropriate. levothyroxine (Tirosint) Addition; requires PA There are more cost-effective alternatives available for the management of the same clinical conditions including generic levothyroxine, which is available without PA. loteprednol (Lotemax) Change in PA status; requires PA There are more cost-effective alternatives available for the management of the same clinical conditions including ketotifen, combination vasoconstrictor/antihistamine products, and generic ophthalmic corticosteroids, which are available without PA. mesalamine (Lialda) Change in PA status; does not require PA MassHealth conducted a quality assurance analysis of Lialda, which demonstrated a high rate of appropriate utilization and comparative cost versus other oral mesalamine agents. As a result, it was determined that Lialda will no longer require prior authorization. methyl aminolevulinate (Metvixia) Addition; MassHealth does not pay for this drug to be dispensed through a retail pharmacy. Only available through the health- care professional who administers the drug Metvixia is indicated for treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratoses of the face and scalp in immunocompetent patients. MassHealth has determined that this product will be paid for only when obtained through a health-care professional. methylphenidate (Methylin) Change in quantity limits; methylphenidate (Methylin) 10mg/5mL requires PA >900 ml/month methylphenidate (Methylin) 5mg/5mL requires PA >1800 mL/month Methylin 10 mg/5 mL oral solution was previously on long-term back order, but is currently available. MassHealth has updated quantity limits on Methylin solution to prevent inappropriate overutilization. Recent MassHealth Drug List Updates are continued on the next page. The Prescriber e-Letter October 2010, Volume 3, Issue 3 Recent MassHealth Drug List Updates (cont.) Drug/Drug Class Addition/Deletion/Change Rationale pioglitazone/metformin extended-release (ActoPlus Met XR) Addition; requires PA There are more cost-effective alternatives available for the management of the same clinical condition including Actos and generic metformin single entity agents, which are available without PA. pramipexole (Mirapex) Change in PA status; requires PA Generic pramipexole was recently FDA approved and does not require prior authorization. Therefore, brand-name Mirapex will require prior authorization. pramipexole extended- release (Mirapex ER) Addition; requires PA There are more cost-effective alternatives available for the management of the same clinical condition including generic ropinirole and pramipexole, which are available without PA. risendronate/calcium carbonate (Actonel with Calcium) Deletion; no longer on MassHealth Drug List MassHealth does not pay for drugs that are manufactured by companies that have not signed rebate agreements with the U.S. Secretary of Health and Human Services. sildenafil (Revatio) IV Addition; H symbol - inpatient use only Sildenafil IV is indicated for the treatment of pulmonary arterial hypertension. This drug is available only in an inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through a retail pharmacy or a physician’s office. topiramate Change in PA status; does not require PA Topiramate is now considered a least costly alternative (LCA) and is available without PA. tramadol, orally disintegrating tablet (Rybix ODT) Addition; requires PA There are more cost-effective alternatives available for the management of the same clinical conditions including generic tramadol, which is available without PA. velaglucerase alfa (Vpriv) Addition; requires PA Vpriv is indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease and requires PA to ensure treatment is clinically appropriate. Please send any suggestions or comments to: PrescriberELetter@state.ma.us