The Prescriber e-Letter January 2011, Volume 4, Issue 1 MassHealth Pharmacy Program Pulmonary Hypertension Agents There are three classes of drugs that are FDA approved for the treatment of World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH): prostanoids, endothelin receptor antagonists (ERAs), and phosphodiesterase 5 (PDE5) inhibitors. The consensus guidelines published by the American College of Chest Physicians and the guidelines from the American College of Cardiology Foundation (ACCF) in conjunction with the American Heart Association (AHA) recommend oral therapy with either PDE5 inhibitors or ERAs as first-line agents in patients who are considered lower risk and are not candidates for calcium-channel blockers. These guidelines also recommend intravenous therapy with a prostanoid, epoprostenol, or treprostinil as a first-line agent in patients at higher risk with poor prognostic indexes. Epoprostenol is the preferred treatment for the most severely ill patients and is the only therapy shown to prolong survival. MassHealth has reviewed the PAH agents with respect to appropriate use of generic alternatives. Due to the availability of a generic epoprostenol (Flolan) and ACCF and AHA recommendations that epoprostenol can be used as a first-line agent in patients at higher risk with poor prognostic indexes, MassHealth has determined that all PAH agents with the exception of generic epoprostenol (Flolan) will require prior authorization. The prior-authorization requirement for PAH agents became effective on November 15, 2010. The prior-authorization status of the individual products is outlined below. The following drugs Require PA. The average cost per therapy is listed with each drug. The cost is based on once daily administration. ambrisentan (Letairis) $5,701.50 bosentan (Tracleer) $6,016.50 iloprost inhalation (Ventavis) $5,859.00 sildenafil intravenous (Revatio) $8,819.69 sildenafil oral (Revatio) $1,351.80 tadalafil (Adcirca) $1,122.07 treprostinil inhalation (Tyvaso) $11,833.50–13,266.75 treprostinil injection (Remodulin) $1,237.95– $8,665.65 The following drug is available without PA. The average cost per therapy is listed with the drug. The cost is based on once daily administration. epoprostenol (Flolan)# $2,286.08–$3,639.68 # This is a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the branded Flolan. For weight-based dosing regimens, the cost of therapy was calculated using a 70 kg patient. Thiazolidinedione Update Actos and Avandia are oral thiazolidinedione (TZD) anti-diabetic agents indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). The consensus algorithms for the treatment of T2DM developed by the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) and the American College of Endocrinology/American Association of Clinical Endocrinologists (ACE/AACE) recommend metformin as the cornerstone of therapy. However, the two guidelines differ in their recommendations with regard to the next step in patients not adequately controlled on metformin. ACE/AACE guidelines prefer incretin mimetics and TZDs over sulfonylureas due to increased risk of hypoglycemia. Conversely, the ADA/EASD guidelines consider therapy with incretin mimetics and TZDs to be less well validated than sulfonylureas and recommend their use only in selected clinical settings, when hypoglycemia is particularly undesirable. Both Actos and Avandia carry a black box warning about the risk of congestive heart failure exacerbation and are contraindicated in patients with established New York Heart Association (NYHA) Class III or IV heart failure. MassHealth has reviewed the thiazolidinedione anti-diabetic agents with respect to safety, efficacy, and appropriate use. Due to the availability of less costly alternatives, ADA/EASD and ACE/AACE recommendations that sulfonylureas can be used as a second-line agent in addition to metformin, and the potential for serious cardiac complications in patients with preexisting heart failure, MassHealth has determined that Actos and Avandia will require prior authorization. The prior authorization requirement for Actos and Avandia became effective on January 1, 2011. Drug Availability Avg. monthly price* pioglitazone (Actos) Tablet: 15 mg, 30 mg, 45 mg $144.40–$239.41 rosiglitazone (Avandia) Tablet: 2 mg, 4 mg, 8 mg $82.53–$223.25 *Cost based on once daily administration 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 highlights 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. Recent MassHealth Drug List Updates Drug/Drug Class nonsteroidal anti-inflammatory agents Addition/Deletion/Change Change in PA status; requires PA * diclofenac potassium (Cataflam) * meclofenamate * naproxen (Naprosyn) suspension (>12 years) * naproxen EC (Naprosyn EC) * piroxicam (Feldene) * tolmetin (Tolectin) Rationale Branded Cataflam, Naprosyn suspension, Naprosyn EC, Feldene, Tolectin, and generic meclofenamate require prior authorization. There are more cost-effective alternatives available for the management of the same clinical condition including generic diclofenac sodium, ibuprofen, and naproxen, which are available without PA. Drug/Drug Class acyclovir cream (Zovirax) Addition/Deletion/Change Change in PA status; requires PA >12 years and PA >5 grams/month Rationale Zovirax cream is indicated for the treatment of recurrent herpes labialis in patients 12 years and older. There are more cost-effective alternatives available for the management of the same clinical condition including Denavir (penciclovir) cream, which is available without PA. Drug/Drug Class acyclovir/hydrocortisone (Xerese) Addition/Deletion/Change Addition; requires PA Rationale Xerese is indicated for the treatment of recurrent herpes labialis in patients 12 years and older. There are more cost-effective alternatives available for the management of the same clinical condition including Denavir (penciclovir) cream, which is available without PA. Drug/Drug Class amylase/lipase/protease (Pancrease MT, Pancrecarb, Ultrase) Addition/Deletion/Change Deletion; no longer on MassHealth Drug List Rationale 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. Drug/Drug Class aztreonam (Cayston) Adddition/Deletion/Change Addition; does not require PA Rationale Cayston is indicated to improve respiratory symptoms in patients with cystic fibrosis known to have Pseudomonas aeruginosa in the lungs. Drug/Drug Class cabazitaxel (Jevtana) Addition/Deletion/Change Addition; does not require PA Rationale Jevtana is indicated in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel. Drug/Drug Class chenodiol (Chenodal) Addition/Deletion/Change Addition; requires PA Rationale Chenodal is indicated for patients with radiolucent gallstones when surgery is not an option due to increased surgical risk. There are more cost-effective alternatives available for the management of the same clinical condition including ursodiol products, which are available without PA. Drug/Drug Class clindamycin/tretinoin (Veltin) Addition/Deletion/Change Addition; requires PA Rationale Veltin is indicated for the topical treatment of acne vulgaris in patients 12 years or older. There are more cost-effective alternatives available for the management of the same clinical condition including generic clindamycin and tretinoin, which are available without PA in patients <21 years of age. Drug/Drug Class clobetasol/coal tar (Clobeta Plus Kit) Addition/Deletion/Change Addition; requires PA Rationale Clobeta Plus Kit is indicated for the treatment of psoriasis. There are more cost-effective alternatives available for the management of the same clinical condition such as topical corticosteroids including augmented betamethasone, clobetasol propionate, diflorasone diacetate, and halobetasol, which are available without PA. Drug/Drug Class clonidine (Catapres-TTS Patch) Addition/Deletion/Change Change in PA status; requires PA Rationale Catapres-TTS Patch requires prior authorization. There are more cost-effective alternatives available for the management of the same clinical condition including generic clonidine tablets, which are available without PA. Drug/Drug Class denosumab (Prolia) Addition/Deletion/Change Addition; requires PA Rationale Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. There are more cost-effective alternatives available for the management of the same clinical condition including generic alendronate tablet, which is available without PA. Drug/Drug Class diclofenac powder for solution (Cambia) Addition/Deletion/Change Addition; requires PA Rationale Cambia is indicated for the acute treatment of migraine attacks in adults 18 years of age or older. There are more cost-effective alternatives available for the management of the same clinical condition including other formulations including generic acetaminophen and non-steroidal anti-inflammatory products, which are available without PA. Drug/Drug Class donepezil, orally disintegrating tablet (Aricept ODT) Addition/Deletion/Change Change in PA status; does not require PA Rationale Aricept ODT is indicated for the treatment of Alzheimer-associated dementia. Drug/Drug Class dutasteride/tamsulosin (Jalyn) Addition/Deletion/Change Addition; requires PA Rationale Jalyn is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There are more cost-effective alternatives available for the management of the same clinical condition including generic doxazosin, tamsulosin, and terazosin, which are available without PA. Drug/Drug Class everolimus (Afinitor) 2.5 mg Addition/Deletion/Change Addition; requires PA >30 units/month Rationale Due to comparable pricing between 2.5 mg, 5 mg, and 10 mg tablets, prior authorization is required for quantities of >30 units/30 days of the 2.5 mg and 5 mg tablets to promote dose consolidation. Drug/Drug Class everolimus (Zortress) Addition/Deletion/Change Addition; does not require PA Rationale Zortress is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant. Drug/Drug Class gatifloxacin (Zymaxid) Addition/Deletion/Change Addition; requires PA Rationale Zymaxid is indicated for the treatment of bacterial conjunctivitis. There are more cost-effective alternatives available for the management of the same clinical condition including generic ophthalmic antibiotics, which are available without PA. Drug/Drug Class glipizide/metformin Addition/Deletion/Change Change in PA status; does not require PA Rationale Generic glipizide/metformin combination is now considered a least costly alternative (LCA) and is available without PA. Drug/Drug Class glyburide/metformin Addition/Deletion/Change Change in PA status; does not require PA Rationale Generic glyburide/metformin combination is now considered a least costly alternative (LCA) and is available without PA. Drug/Drug Class influenza virus vaccine (Afluria) Additon/Deletion/Change Addition; does not require PA Rationale Afluria is an influenza virus vaccine indicated for the prevention of influenza virus infection in persons aged 6 months or older. On August 5, 2010, the Advisory Committee on Immunization Practices (ACIP) recommended against its use in children 6 months to 8 years of age due to the increased incidence of fever and febrile seizures. Drug/Drug Class influenza virus vaccine (Agriflu) Addition/Deletion/Change Addition; does not require PA Rationale Agriflu is an influenza virus vaccine indicated for the prevention of influenza virus infection in persons 18 years of age or older. Drug/Drug Class lacosamide solution (Vimpat) Addition/Deletion/Change Addition; requires PA Rationale Vimpat oral solution is indicated for adjunctive therapy in partial- onset seizures in patients aged 17 years or older. There are more cost- effective alternatives available for the management of the same clinical condition including generic carbamazepine suspension, gabapentin solution, lamotrigine tablet, topiramate, valproic acid, and divalproex, which are available without PA. Drug/Drug Class lisdexamfetamine (Vyvanse) Addition/Deletion/Change Change in PA status; requires PA > 60 units/month Rationale Vyvanse is indicated for the treatment of Attention Deficit Hyperactivity Disorder in patients 6 to 17 years old and requires quantity limits to prevent inappropriate overutilization Drug/Drug Class melatonin tablet and solution Addition/Deletion/Change Addition; requires PA>18 years Rationale There are no medications, with the exception of chloral hydrate, that are FDA-approved for the treatment of sleep disorders or insomnia in children. Therefore, MassHealth has determined that melatonin will be available to the pediatric population up to 18 years of age without PA. Drug/Drug Class metformin (Riomet) Addition/Deletion/Change Change in PA status; requires PA >12 years Rationale Riomet solution requires PA for members older than 12 years. There are more cost-effective alternatives available for the management of the same clinical condition including generic metformin, which is available without PA. Drug/Drug Class methylphenidate (Methylin) Addition/Deletion/Change Change in PA status; requires PA >900 ml/month Rationale MassHealth has updated quantity limits on Methylin 5 mg/5 ml oral solution to prevent inappropriate overutilization. Drug/Drug Class methylphenidate transdermal system (Daytrana) Addition/Deletion/Change Change in PA status; requires PA <6 years or >17 years and PA >30 patches/month Rationale Daytrana is indicated for the treatment of Attention Deficit Hyperactivity Disorder in patients 6 to 17 years old and requires PA and quantity limits to ensure treatment is clinically appropriate. Drug/Drug Class miconazole (Oravig) Addition/Deletion/Change Addition; requires PA Rationale Oravig is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. There are more cost-effective alternatives available for the management of the same clinical condition including generic nystatin and clotrimazole, which are available without PA. Drug/Drug Class mometasone/formoterol (Dulera) Addition/Deletion/Change Addition; requires PA Rationale Dulera is indicated for the treatment of asthma in patients 12 years of age or older. There are more cost-effective alternatives available for the management of the same clinical condition including single-agent inhaled corticosteroids, which are available without PA. Drug/Drug Class naproxen/esomeprazole Vimovo) Addition/Deletion/Change Addition; requires PA <60 years Rationale Vimovo is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. There are more cost- effective alternatives available for the management of the same clinical condition including generic naproxen and omeprazole 20 mg capsule, which are available without PA. Drug/Drug Class olmesartan/amlodipine/ hydrochlorothiazide (Tribenzor) Addition/Deletion/Change Addition; requires PA Rationale Tribenzor is indicated for the treatment of hypertension. There are more cost-effective alternatives available for the management of the same clinical condition including generic ACE inhibitors, amlodipine, and hydrochlorothiazide, which are available without PA. Drug/Drug Class omeprazole/sodium bicarbonate Addition/Deletion/Change Addition; requires PA Rationale Omeprazole/sodium bicarbonate combination is indicated for short- term treatment of active duodenal ulcer, active benign gastric ulcer, erosive esophagitis, and treatment of symptoms associated with GERD. There are more cost-effective alternatives available for the management of the same clinical condition including generic omeprazole 10 mg and 20 mg capsules, which are available without PA. Drug/Drug Class ondansetron oral soluble film (Zuplenz) Addition/Deletion/Change Addition; requires PA Rationale Zuplenz is indicated for the prevention of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and post operation. There are more cost-effective alternatives available for the management of the same clinical condition including generic ondansetron 4 mg and 8 mg tablet and orally disintegrating 4 mg tablet formulations, which are available without PA for quantities <15 units/month. Drug/Drug Class ondansetron solution (Zofran) Addition/Deletion/Change Change in PA status; requires PA Rationale Generic and branded Zofran solution require PA for all quantities. There are more cost-effective alternatives available for the management of the same clinical condition including generic ondansetron 4 mg and 8 mg tablet and orally disintegrating 4 mg tablet formulations, which are available without PA for quantities <15 units/month. Drug/Drug Class ondansetron, orally disintegrating tablet (Zofran ODT 4 mg) Addition/Deletion/Change Change in PA status; requires PA >15 units/month Rationale Zofran 4 mg orally disintegrating tablet will no longer require prior authorization for ?15 units/month. Drug/Drug Class palonosetron (Aloxi) Addition/Deletion/Change Change in PA status; requires PA Rationale Aloxi requires prior authorization. There are more cost-effective alternatives available for the management of the same clinical condition including generic ondansetron 4 mg and 8 mg tablet and orally disintegrating 4 mg tablet formulations, which are available without PA for quantities <15 units/month. Drug/Drug Class pitavastatin (Livalo) Addition/Deletion/Change Addition; requires PA Rationale Livalo is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C, apolipoprotein B, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. There are more cost-effective alternatives available for the management of the same clinical condition including lovastatin, pravastatin, and simvastatin, which are available without PA. Drug/Drug Class romidepsin (Istodax) Addition/Deletion/Change Addition; requires PA Rationale Istodax is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. There are more cost-effective alternatives available for the management of the same clinical condition including Zolinza, Actimmune, Intron A, and Targretin, which are available without PA. Drug/Drug Class sacrosidase (Sucraid) Addition/Deletion/Change Change in PA status; requires PA Rationale Sucraid is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency. Sucraid requires PA to ensure treatment is clinically appropriate. Drug/Drug Class scopolamine (Transderm Scop) Addition/Deletion/Change Change in PA status; requires PA Rationale Transderm Scop requires prior authorization. There are more cost- effective alternatives available for the management of the same clinical condition including generic meclizine, which is available without PA along with generic ondansetron 4 mg and 8 mg tablet and orally disintegrating 4 mg tablet formulations, which are available without PA for quantities <15 units/month. Drug/Drug Class tranexamic acid (Lysteda) Addition/Deletion/Class Addition; does not require PA Rationale Lysteda is indicated for the treatment of cyclic heavy menstrual bleeding. Drug/Drug Class trazodone ER (Oleptro) Addition/Deletion/Change Addition; requires PA Rationale Oleptro is indicated for the treatment of major depressive disorder in adults. There are more cost-effective alternatives available for the management of the same clinical condition including generic SSRIs, SNRIs, TCAs, bupropion, and trazodone (excluding 300 mg tablet), which are available without PA. Please send any suggestions or comments to: PrescriberEletter@state.ma.us.