Rationale Modified 2014 Comprehensive Class Review: Anesthetic Local Topical

Transcription

1 The following changes to the Neighborhood formulary were recently approved by the Pharmacy and Therapeutics (P&T) Committee. These changes are effective immediately unless otherwise indicated. Therapeutic Class/ Anesthetic Local Topical Implement a quantity limit restriction on both lidocaine 5% ointment and lidocaine-hc 3-0.5% cream of 1 tube per prescription. Both high doses of lidocaine and short dosing intervals of lidocaine can be associated with serious adverse events. Lidocaine 5% ointment and Lidocaine-HC 3-0.5% cream are very expensive. The implementation of a quantity limit - Lidocaine 5% oint - Lidocaine-HC 3-0.5% - Lidocaine 5% oint: 35.44g per prescription promotes appropriate utilization and limits the potential for waste. crm - Lidocaine-HC 3-0.5% crm: 28.35g per prescription Anesthetic Local Topical - Voltaren gel - Salsalate tablet Anticonvulsants - Diazepam rectal gel Add Voltaren topical gel to Formulary as a preferred brand; require Step-Therapy with all Formulary NSAIDS meloxicam, naproxen and ibuprofen. Implement quantity restriction of 100g per prescriptions. Remove salsalate from Formulary; require Prior Do not grandfather members. Implement a quantity limit restriction on diazepam rectal gel of 2 units (i.e. 4 doses) per prescription. Do not implement a limit on the number of prescriptions a patient can receive. There is currently no topical non-steroidal anti-inflammatory (NSAID) on Formulary and there is no generic topical NSAID indicated in the treatment of osteoarthritis (OA). The addition of Voltaren gel to Formulary with Step-Therapy required offers those patients diagnosed with OA who cannot obtain adequate outcome with oral NSAIDs an alternative option in therapy. Voltaren gel is significantly less expensive than alternative non-formulary topical agents for the treatment of OA. Alternative non-formulary topicals have not been shown to be clinically superior to Voltaren gel. Voltaren gel is available in 100gram tubes. Salsalate is a non-acetylated NSAID indicated in the treatment of rheumatoid arthritis and OA. Meloxicam, ibuprofen and naproxen are NSAIDs available on the Formulary, unrestricted. Acetaminophen and aspirin are also covered. Salsalate does not provide a clinical advantage over available Formulary alternatives. Salsalate is associated with low utilization and increased cost compared to Formulary alternatives. Diazepam rectal gel is indicated as adjunctive treatment of seizures other than status epilepticus in selected, refractory patients with partial or generalized tonic-clonic seizures who require intermittent use to control bouts of increased seizure activity. For one event, up to two doses of diazepam rectal gel may be used; no more than one episode every 5 days and no more than five episodes per month may be treated. Each dispensed unit of diazepam rectal gel contains two doses. The implementation of a quantity limit is designed to limit potential for waste, and not to limit access to the medication. The diazepam rectal gel quantity limit is similar to that of other life-saving medications, such as epinephrine autoinjector pens. Quantities of diazepam rectal gel in excess of 2 units are available through the Prior Authorization process, if Page 1 of 14

2 Antihistamines - Azelastine eye drops - Levocetirizine tablet Add azelastine eye drops to Formulary; require Step-Therapy with both ketotifen eye drops and cromolyn sodium eye drops. Azelastine and ketotifen eye drops are indicated in the treatment of ocular pruritus associated with allergic conjunctivitis in patients aged 3 years and up. Cromolyn eye drop is indicated in patients older than 4 years for the treatment of allergic ocular disorders. The addition of azelastine eye drop with Step-Therapy required provides patients with alternative treatment options for ocular pruritus associated with conjunctivitis. Azelastine eye drop is significantly less expensive than alternative non-formulary options. Antinaeuseants - Prochlorperazine supp. Antineoplastics - Tamoxifen citrate tablet Add levocetirizine tablet to Formulary; unrestricted. Implement quantity limit on prochlorperazine suppositories of 12 per prescription. Remove sex restriction on tamoxifen citrate. Levocetirizine is FDA approved for the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in patients aged 6 years. The average cost per dose is now comparable to alternative Formulary second generation antihistamines. Prochlorperazine suppositories are indicated in the treatment of nausea/vomiting and short-term treatment of nonpsychiatric related anxiety and dosed twice-daily in adults. Prochlorperazine suppository is a treatment option for those patients who cannot tolerate oral therapy. The average cost per prescription has increased significantly for prochlorperazine suppositories over the last year. Quantities of prochlorperazine suppository in excess 12 are available through the Prior Authorization process, if medically necessary. Tamoxifen citrate is FDA approved for the treatment of breast cancer and breast cancer prophylaxis. Both female and male patients are affected by these diagnoses. Removal of the sex restriction on tamoxifen citrate prevents delays and gaps in therapy. Page 2 of 14

3 Antiparasitics - Ivermectin (Stromectol ) tablet - Head Lice Treatment Medical Necessity Criteria Add oral ivermectin to Formulary as a 2 nd -line agent that is available through the Prior Authorization process. Update Head Lice Treatment Medical Necessity Criteria (MNC) for non-formulary agents to require failure of at least one 2 nd -line agent. Second-line agents are oral ivermectin tablet, spinosad and malathion. Oral ivermectin is now available generically as of November Oral ivermectin is used off-label and is recommended by the Centers for Disease Control (CDC) as a treatment option for head lice in adult and pediatric patients aged 2 years and older ( 15kg). Second-line oral ivermectin is another option for those patients who are unable to achieve an adequate outcome with first-line OTC products (pyrethrins/permethrin). Oral ivermectin does not provide a clinical advantage over OTC permethrin and pyrethrins. Head lice MNC require failure of a 3 treatment-cycle of 1 st - line agents, OTC pyrethrins/ permethrin products. Secondline agents available following failure of a recent 3 treatment cycle of first-line agents are oral ivermectin, topical malathion and spinosad. Non-Formulary head lice treatments require recent failure both a 1 st -line agent and at least one 2 nd -line agent. The American Academy of Pediatrics clinical practice guidelines for the treatment of head lice recommends OTC products permethrin and pyrethrins as first-line agents. Neighborhood covers OTC permethrin/pyrethrins products without Prior Authorization required. Non-Formulary agents do not provide a clinical advantage over 1 st - and 2 nd - line agents. Non-Formulary agents are significantly more expensive than 1 st - and 2 nd -line options. Non-Formulary Second-line and non-formulary head lice agents are available through the Prior Authorization process, if medically necessary. Antispasmodic & Anticholinergics: - Oxybutynin extendedrelease (ER) tablet - Trospium immediaterelease (IR) tablet Add oxybutynin ER and trospium IR to Formulary as 2 nd -line overactive bladder (OAB) agents; require Step-Therapy with 1 st -line OAB agents, oxybutynin immediaterelease (IR) and OTC Oxytrol Patch. Oxybutynin ER and trospium IR are both indicated in the treatment of urgency, frequency, and urge urinary incontinence (includes neurogenic bladder). Oxybutynin ER is an oral long-acting OAB agent with the additional indication for treatment of detrusor overactivity associated with a neurological condition in pediatric patients 6 years and older. Trospium does not cross the blood-brain-barrier and thus is associated with fewer CNS-related side effects (e.g. dizziness, drowsiness). Oxybutynin ER and Trospium IR both provide those patients unable to gain control on oxybutynin IR and OTC Oxytrol patch an additional option in therapy. The average cost per day for each oxybutynin ER and trospium IR has decreased significantly since becoming available generically. Alternative non-formulary OAB agents do not provide a clinical advantage over 1 st - and 2 nd -line Formulary OAB agents. Alternative non-formulary agents continue to be available through the Prior Authorization process, if Page 3 of 14

4 Antiulcer /GI Preps - Cimetidine 200mg tablet (Rx-only version) - Cimetidine liquid Remove cimetidine 200mg (Rx-only) from Formulary. Remove cimetidine liquid from Formulary; require Prior Over-the-counter (OTC) cimetidine 200mg tablet is covered on the Neighborhood Formulary, unrestricted. Cimetidine 200mg (Rx-only tablet) is associated with low utilization and increased cost compared to OTC cimetidine 200mg tablet. Ranitidine liquid is available on Formulary, unrestricted. Ranitidine and cimetidine are both histamine H2-receptor antagonists indicated in the treatment of gastroesophageal reflux disease (GERD) and gastric and duodenal ulcers. Ranitidine is indicated in patients infant age and older; cimetidine is indicated in neonates and older. Cimetidine is a known inhibitor of many CYP450 enzymes; thus, it is known to have many severe drug-drug interactions. Cimetidine liquid is associated with low utilization and increased cost compared to Formulary alternatives. Cimetidine liquid is available through the Prior Authorization process, if CNS Stimulants - Methylphenidate CD (Metadate CD ) - Non-Formulary Stimulant Medical Necessity Criteria Durable medical equipment (DME) supplies Drugs used for cosmetic purposes Add methylphenidate CD to Formulary, unrestricted. Update non-formulary stimulant Medical Necessity Criteria (MNC) to require failure of an appropriate dose and duration of at least one amphetamine product and methylphenidate CD due to inadequate outcome and/or intolerance. Remove all DME supplies (i.e. Depends, blood pressure monitor, thermometer, heating pads) from Formulary during grace period and thereafter. Remove all drugs used for cosmetic purpose from Formulary during grace period and thereafter. Methylphenidate CD extended-release is an oral, once-daily, capsule indicated in the treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy. Methylphenidate CD extended-release capsules have a biphasic release mechanism that allows for drug to be release over both short- and long-term timeframes throughout the day. Methylphenidate CD capsules may be opened and sprinkled on cool, soft foods, such as applesauce for easier administration. The addition of methylphenidate CD to the Formulary provides patients an alternative treatment option for those who require a long-acting methylphenidate product and who are unable to obtain optimal outcomes with a current alternative Formulary agent. Other stimulants covered on Formulary, unrestricted, include generics for Ritalin SR, Metadate ER, Adderall XR and Dexedrine Spansule. Methylphenidate CD is significantly less expensive than alternative non-formulary long-acting methylphenidates, such as generics for Concerta, Focalin XR and Ritalin LA. Non-Formulary stimulants continue to be available through the Prior Authorization process, if These products are available to patients under the DME benefit. The removal of these products from the pharmacy benefit is to prevent double-billing. Drugs for cosmetic purposes are an excluded Medicaid benefit per the state of Rhode Island. Page 4 of 14

5 Electrolytes & Miscellaneous Nutrients - Potassium Chloride ER 10meq capsule (Micro- K ) Remove Potassium chloride ER 10meq capsule from Formulary; require Prior Potassium chloride 10meq ER tablet (K-DUR ) is available on Formulary, unrestricted. Potassium chloride ER tablet may be dissolved in 4 ounces of water or cut in half for easier administration. Potassium chloride ER capsule does not provide a clinical advantage over the capsule dosage form. The capsule is significantly more expensive than the tablet dosage form. Potassium chloride ER 10meq capsule continues to be available through the Prior Authorization process, if Enzymes - Zenpep Fluorides - Fluor-A-Day General Antibacterials & Antiseptics - Formaldehyde Laxatives - Amitiza - Linzess Remove Zenpep from Formulary; require Prior Remove Fluor-A-Day from Formulary. Remove formaldehyde from Formulary. Update Medical Necessity Criteria (MNC) for Amitiza to require failure of Linzess for treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Do not remove Prior Authorization requirement on Linzess. Updated MNC for Amitiza to require that the patient is being treated for CIC or IBS-C; recent failure of an appropriate dose and duration of polyethylene glycol powder due to inadequate response or intolerance; recent failure with lactulose, senna and/or bisacodyl due to inadequate response or intolerance; and recent failure of appropriate dose and duration of Linzess. Creon is available on Formulary, unrestricted. Creon and Zenpep both contain the active ingredient pancrealipase. Zenpep does not carry a unique indication; nor does it offer a clinical advantage over Creon. Zenpep is associated with an increased cost compared to Formulary alternatives. Generic fluoride tablet is available on Formulary, unrestricted. Fluor-A-Day is a brand name fluoride tablet that does not offer a clinical advantage over alternative Formulary agents. Flour-A-Day is associated with an increased cost compared to Formulary alternatives. Formaldehyde was previously removed from the Neighborhood Formulary by the P&T Committee due to safety concerns. The removal of formaldehyde is to reinforce previous Formulary changes. None of the formaldehyde prescriptions dispensed were compounded prescriptions. Linzess and Amitiza are both indicated in the treatment of CIC and IBS-C. Linzess is dosed once-daily; Amitiza is dosed twice-daily. Amitiza does not provide a clinical advantage over Linzess. Linzess is associated with a reduction in pill burden for the patient and cost-savings compared to Amitiza. Both Linzess and Amitiza are available through the Prior Authorization process, if Page 5 of 14

6 Nonnarcotic Analgesics - Sumatriptan injection kits - Ketorolac tablet - Rizatriptan orally disintegrating tablet (ODT) - Butalbital-ASA-caffeine tablet Implement a quantity restriction on sumatriptan injection kits of 1 kit per 365 days. Maintain current quantity limit on sumatriptan injection refills cartridges of 3 refill cartridge packs (6 doses) per 30 days. Sumatriptan injection is available in two strengths, 6mg/0.5ml and 4mg/0.5ml. Sumatriptan injection is available as a kit and refill cartridges. Each kit includes 2 prefilled syringes and an autoinjector pen. The autoinjector pen may be used for future injections with refill cartridge packs. The implementation of a kit quantity limit is to limit the potential for waste when patients already have received an auto-injector pen. One kit is significantly more expensive than one refill cartridge pack. There continues to be a quantity limit in place for the sumatriptan injection refill cartridges of 3 packs per 30 days. Each refill pack contains two doses. Other Antibiotics - Ofloxacin tablet Implement a day supply limit on ketorolac tablet of 5 days. Require Prior Authorization for ketorolac prescriptions in excess of a 5 day supply. Add Rizatriptan ODT as a secondline Formulary agent; require Step- Therapy with 1 st -line triptans, sumatriptan and rizatriptan tablets. Maintain current quantity limit on rizatriptan ODT of 9 tablets per 30 days. Remove Butalbital-ASA-caffeine tablet from Formulary. Remove ofloxacin tablet from Formulary; require Prior Due to associated safety risks, ketorolac therapy is not to exceed 5 days according to product labeling required by the FDA. Ketorolac therapy extended beyond 5 days is available through the Prior Authorization process, if medically necessary. Rizatriptan ODT provides an additional option to those patients requiring triptan therapy, but who are unable to swallow a tablet. The maximum dosage limit of rizatriptan is 30mg per day; safety of treating more than 4 headaches in a 30 day period has not been established. Rizatriptan ODT does not provide a clinical advantage over 1 st -line triptans. Rizatriptan ODT is more expensive than 1 st -line agents, but offers cost-savings when compared to non-formulary alternatives. Butalbital-ASA-caffeine tablet has been discontinued by manufacturers and is no longer available. Ofloxacin is a fluoroquinolone antibiotic. Ofloxacin does not provide a clinical advantage over alternative Formulary oral fluoroquinolones, levofloxacin and ciprofloxacin. Ofloxacin is associated with low utilization and increased cost compared to Formulary alternatives. Ofloxacin continues to be available through the Prior Authorization process, if Page 6 of 14

7 Other Antihypertensives - Benazepril-HCTZ tablet - Valsartan-HCTZ tablet Remove benazepril-hctz from Formulary; require Prior Add valsartan-hctz to Formulary as second-line agent; require Step- Therapy with losartan-hctz. Benazepril and hydrochlorothiazide (HCTZ) are both available separately on the Formulary. The combination product is significantly more expensive than the cost of the individual components, when taken separately. Valsartan-HCTZ is a combination tablet of angiotensin receptor blocker (ARB) valsartan and diuretic HCTZ. Valsartan-HCTZ is indicated in the treatment of hypertension. Alone, valsartan is indicated in the treatment of hypertension, heart failure and reduction of cardiovascular mortality. The addition of valsartan-hctz provides patients unable to achieve an adequate outcome with losartan-hctz an additional treatment option for treatment of cardiovascular diagnoses. Alternative non-formulary agents do not provide a clinical advantage over valsartan-hctz. Valsartan-HCTZ is significantly less expensive than alternative non-formulary agents, but continues to be more expensive than losartan-hctz. Penicillins - Amoxicillin TRpotassium clavulanate (CLV) 250mg-125mg tablet - Amoxicillin 500mg tablet Probiotics (all) Remove amoxicillin TR- potassium clavulanate (CLV) 250mg-125mg tablet from Formulary; require Prior Remove Amoxicillin 500mg tablet from Formulary. Remove all probiotics from Formulary during grace period and thereafter. Amox-tr-K clv 250mg-125mg tablet does not carry a unique indication compared to Formulary alternatives, such as alternative strengths and dosage forms of amox tr-k clv. Amox tr-k clv 250mg-125mg is dosed every 8 hours; whereas amox-tr-k clv 500mg-125mg is dosed every 12 hours. Amox-tr-K clv 500mg-125mg is associated with a decrease in pill burden for patients and increased cost savings compared to Amox tr-k clv 250mg-125mg. For pediatric patients, amoxicillin-clavulanic acid is dosed according to the amoxicillin component, which typically results in a higher dose of clavulanic acid than needed for the treatment of infection and contributes to increased unnecessary gastrointestinal side effects. Amox-tr-K clv 250mg-125mg tablet is available through the Prior Authorization process, if Amoxicillin 500mg capsule is available on Formulary, unrestricted. There is no clinical advantage of the tablet dosage form over the capsule. Amoxicillin 500mg tablet is more expensive than the capsule. Probiotics are an excluded Medicaid benefit per the State of Rhode Island. Page 7 of 14

8 Psychostimulantsantidepressants - Duloxetine - Nuvigil Add duloxetine to Formulary; do not require Prior Implement a quantity restriction on all duloxetine strengths of 30 capsules per 30 days. Duloxetine is a once-daily treatment option for depression, diabetic neuropathy, fibromyalgia, generalized anxiety disorder (GAD) and musculoskeletal pain. The addition of duloxetine to Formulary enables patients to have access to a drug that is FDA approved for the treatment of both fibromyalgia and diabetic neuropathy. Duloxetine is significantly less expensive than non-formulary alternatives, such as Lyrica, Savella and brand name antidepressants. Twice-daily dosing of duloxetine is available through the Prior Authorization process. Update Lyrica and Savella Medical Necessity Criteria to require failure of duloxetine plus at least one other agent, both at an adequate dose and for an appropriate duration, for treatment of diabetic neuropathy and fibromyalgia, as indicated. Lyrica is indicated in the treatment of neuropathic pain (including peripheral diabetic neuropathy, post-herpetic neuralgia, and pain associated with spinal cord injury), fibromyalgia and partial seizures. Savella, serotonin norepinephrine reuptake inhibitor (SNRI), is indicated in the treatment of fibromyalgia. Lyrica and Savella have not been shown to demonstrate a clinical advantage over duloxetine for the treatment of diabetic neuropathy and fibromyalgia. 0Lyrica and Savella continue to be available through the prior authorization process, if Systemic Contraceptives - Take Action 1.5mg tablet Update Nuvigil Medical Necessity Criteria to require failure of modafinil due to inadequate outcome and/or intolerance. Add Take Action 1.5mg tablet to Formulary; do not require Prior Nuvigil is the R-enantiomer of modafinil. Nuvigil does not carry a unique indication or provide a clinical advantage compared to modafinil. Modafinil is now available at an increased cost savings compared to Nuvigil. Both modafinil and Nuvigil continue to be available through the Prior Authorization process. Take Action 1.5mg tablet contains the same drug at the same dose as Plan B One-Step. Plan B One-Step generics are covered on Formulary, unrestricted. Take Action is stocked at some of Neighborhood's local, in-network pharmacies. Take Action 1.5mg tablet is not more expensive than other Plan B One-Step generics covered by Neighborhood. Page 8 of 14

9 Topical Nasal & Otic Preparations - Azelastine (Astelin ) Add azelastine nasal spray to Formulary; require Step-Therapy with at least one 1 st -line nasal steroid and at least one oral second generation antihistamine. Azelastine is an antihistamine nasal spray indicated in the treatment of allergic rhinitis (seasonal) and vasomotor rhinitis. First-line steroid nasal sprays covered are fluticasone nasal spray and Nasacort 24HR, which are indicated for treatment of allergic rhinitis (perennial or seasonal) and allergic rhinitis symptoms, respectively. Oral second generation antihistamines covered include cetirizine, levocetirizine, loratadine and fexofenadine. The addition of azelastine nasal spray with Step-Therapy required offers an alternative therapy option for those patients unable to achieve adequate outcomes using a nasal steroid and an oral antihistamine. Azelastine nasal spray is significantly less expensive than alternative non-formulary nasal sprays, but is not yet cost comparable to 1 st -line nasal steroids and second generation antihistamines. Xolair (omalizumab) Diagnostics Do not add Xolair to Formulary. Create Medical Necessity Criteria (MNC) for diagnosis of chronic idiopathic urticaria (CIU). Xolair MNC for the treatment of CIU to require that the patient is at least 12 years of age; under the care of an allergist; experiencing symptoms of idiopathic urticaria for at least 6 consecutive weeks; known triggers and physician factors have been removed; recent failure of second generation antihistamine monotherapy with a with dose advancement; recent failure of combination therapy with two second generation antihistamines; recent failure of adjunct therapy with a potent antihistamine at bedtime with dose advancement, as tolerated; and the prescriber is aware of the labeled boxed warning for Xolair. There were no recommendations for this class. Xolair is indicated in the treatment of allergic asthma and CIU. Neighborhood has previously reviewed Xolair and has Medical Necessity Criteria for use in the treatment of allergic asthma. In March 2014, Xolair was FDA approved for the treatment of CIU in patients aged 12 years and older. Unlike treatment for allergic asthma, Xolair is not dosed according to serum IgE (free or total) level or body weight when treating CIU. CIU is defined as the occurrence of daily urticaria symptoms for at least 6 weeks from no obvious cause despite treatment. Practice parameter guidelines for the treatment of CIU were published in the J Allergy Clin Immunology in May The practice parameter guidelines recommend that step one in treating CIU is the use of a second generation antihistamine and the avoidance of all triggers. Options for the next step in therapy include dose advancement of a second generation antihistamine; combination therapy with two second generation antihistamine; addition of an H2 antagonist; addition of a leukotriene receptor antagonist (LTRA); and addition of a first generation antihistamine at bedtime. Step three in treatment is dose advancement of a first generation antihistamine, as tolerated. Xolair is the last option in therapy and is an alternative to cyclosporine. The incremental clinical benefit of H2 antagonist or LTRA addon therapy (as recommended in step 2) has not been demonstrated in clinical trials. Xolair contains a boxed warning for risk of anaphylaxis. Xolair is available through the Prior Authorization process, if Xolair is not a member of a protected class. Page 9 of 14

10 Diabetic Therapy - Jentadueto - Janumet XR - Nesina - Oseni - DPP-4 inhibitor Medical Necessity Criteria (MNC) - Tanzeum TM - Trulicity TM - GLP-1 agonist MNC - Farxiga TM - Invokamet TM - Jardiance - Xigduo TM XR - SLGT2 inhibitor MNC - Pioglitazone-glimepiride - Pioglitazone-metformin Humulin R U-500 vial Do not add Jentadueto, Janumet XR, Nesina and Oseni to Formulary; apply DPP-4 inhibitor MNC to all new DPP-4 inhibitors. DPP-4 inhibitor MNC requires a recent failure of metformin (up to a dose of 2 grams per day; and recent failure of an adequate dose and duration of a sulfonylurea. Do not add Tanzeum and Trulicity to Formulary; apply current GLP-1 agonist MNC for all GLP-1 agonists. GLP-1 agonists MNC require that the patient is aged 18 years or older; recent failure of with metformin (up to a dose of 2 grams per day; recent failure of an adequate dose and duration of a sulfonylurea; and that the patient is not a candidate for addition of thiazolidinedione or insulin therapy. Do not add Farxiga, Invokamet, Jardiance and Xigduo XR to Formulary; apply Invokana MNC to all SGLT2-inhibitors products. SGLT2 inhibitor products MNC to require that the patient is diagnosed with type II diabetes mellitus (T2DM); has a recent failure of metformin (up to a dose of 2 grams per day); and recent failure of an adequate dose and duration of a sulfonylurea. The American Diabetes Association (ADA) recommends metformin as the preferred first-line therapy for type II diabetes mellitus (T2DM). Insulin is to be considered as monotherapy or as add-on therapy at the onset of newly diagnosed fragile patients. The chosen first pharmacologic therapy (e.g. metformin, insulin) must be titrated to the maximum tolerated dose prior to adding a second drug. Hemoglobin A1c levels are to be re-evaluated once there has been at least 3 months of drug adherence. DPP-4 inhibitors, GLP-1 agonists and SGLT2 inhibitors are significantly more expensive than Formulary diabetes therapy options and have not been shown to provide a clinical advantage. DPP-4 inhibitors, GLP-1 agonists and SGLT2 inhibitors are available through the Prior Authorization Process, if Pioglitazone, glimepiride and metformin are all available on Formulary, unrestricted. The combination products are significantly more expensive than the cost of component separately. Humulin R U-500 is a highly concentrated form of Humulin R U-100. Humulin R-500 is only intended for use in those patients using large quantities of insulin per each dose which would require multiple injections of Humulin R U-100. Stability of Humulin R can only be guaranteed for 31 days once a vial has been opened, which can result in unnecessary waste. Humulin R U-500 is associated with a high potential for adverse effects caused by dosing errors. Humulin R U- 500 is available through the Prior Authorization process, if Do not add Pioglitazone-glimepiride and pioglitazone-metformin; require Prior Remove Humulin R U-500 vial from Formulary; require Prior Page 10 of 14

11 Miscellaneous: Immunosuppressants - Sirolimus - Mycophenolic acid delayed-release (DR) tablet - Liquid oral immunosuppressants: o Cyclosporine o Mycophenolate o Rapamune o Sandimmune Add generic sirolimus tablet to Formulary, unrestricted. Remove brand name Rapamune tablet from Formulary. Remove mycophenolic acid DR tablet from Formulary; require Prior Sirolimus tablet is now available generically in all strengths. The State of RI has a generics-first mandate which requires that a patient fail generic prior to brand name. Rapamune does not provide a clinical advantage over the generic form. Sirolimus is significantly less expensive than Rapamune. Mycophenolic acid DR tablet does not carry a unique indication compared to mycophenolate mofetil and both have comparable efficacy. Mycophenolic acid DR is associated with an increased cost compared to mycophenolate mofetil. Mycophenolate mofetil is available on Formulary, unrestricted. Mycophenolic acid DR is available through the Prior Authorization process, if All Other Dermatologicals & Topical Glucocorticoids - Desonide 0.05% cream - Fluocinolone 0.025% cream, ointment - Clobetasol 0.05% gel - Salicylic acid 6% cream kit - Mometasone furoate 0.1% ointment - Calcipotriene cream Medical Necessity Criteria (MNC) - Tretinoin MNC Implement an age restriction on all oral liquid immunosuppressants; require Prior Authorization for all patients 18 years and older. Implement Step-Therapy requirement for desonide 0.05% ointment and fluocinolone 0.01% cream; require a recent trial of hydrocortisone ointment and cream, respectively. Remove desonide 0.05% cream from Formulary; require Prior Remove fluocinolone 0.025% cream and ointment from Formulary; require Prior Remove clobetasol 0.05% gel from Formulary; require Prior Remove salicyclic acid 6% cream (kit) from Formulary. Add betamethasone dp aug 0.05% gel and mometasone furoate 0.1% ointment to Formulary, unrestricted. Oral liquid immunosuppressants are significantly more expensive than tablet/capsule dosage forms. Oral liquid immunosuppressants continue to be available to pediatric patients; adults 18 years and older may access these oral liquids through the Prior Authorization Process, if medically necessary. Desonide 0.05% ointment, desonide 0.05% cream, fluocinolone 0.01% cream are low potency steroids. These low potency steroids are significantly more expensive and do not provide a clinical advantage over alternative low potency and very low potency steroids that are Formulary, unrestricted. Fluocinolone 0.025% cream and fluocinolone 0.025% ointment are medium potency steroids. These medium potency steroids are significantly more expensive do not provide a clinical advantage over alternative medium potency steroids that are Formulary, unrestricted. Clobetasol 0.05% gel is a very high potency steroid that is significantly more expensive and does not provide a clinical advantage over to alternative very high potency steroids that are Formulary. Salicyclic acid 6% cream (kit) comes in a combination package with a soap-free cleanser. Cleansers are an excluded Medicaid benefit according to the state of RI. Salicyclic 6% cream continues to be available under the product labeled Salacyn 6% cream. Salacyn 6% cream is significantly less expensive than the combination kit product. Page 11 of 14

12 All Other Dermatologicals & Topical Glucocorticoids (continued) Update calcipotriene cream MNC to not require failure of calcipotriene ointment or solution. Update tretinoin MNC to allow for treatment of molluscum contagiosum. Updated tretinoin MNC to require that the patient is less than 45 years of age; or being treated for acne vulgaris; or precancerous or cancerous skin lesions; or molluscum contagiosum. Prior Authorization is not required for patients less than 45 years of age. Mometasone furoate ointment is a medium potency steroid. The addition of mometasone furoate ointment provides patients additional options in steroid therapy. Betamethasone dp aug 0.05% gel is a very high potency steroid. The addition of betamethasone dp aug 0.05% gel provides patients additional options in steroid therapy. Calcipotriene cream MNC previously required failure of the generic ointment or solution. Now that calcipotriene is available generically, there is no cost savings associated with preferring the ointment and solution dosage forms over the cream. Implement a quantity limit restriction on all acne products of one small tube per 30 days. Tretinoin topical therapy is prerequisite for imiquimod 5% cream in the treatment of molluscum contagiosum. Updated tretinoin MNC allows for treatment of molluscum contagiosum. Aubagio (teriflunomide) Do not add Aubagio to Formulary. Medical Necessity Criteria (MNC) has been developed. Aubagio MNC to require that the patient is an adult ( 18 years of age) being treated for a relapsing form of multiple sclerosis (MS) and is currently under the care of a neurologist; Aubagio is not being used as add-on therapy to another disease-modifying agent; patient has a documented failure, contraindication, or intolerance to at least one form of interferon and Copaxone ; patient does not have hepatic impairment as demonstrated by liver enzyme laboratory tests. Renewal for continuation of therapy is dependent on documented improvement in symptoms and lack/decrease of relapses. Topical acne products are to be used sparingly when applied. A quantity limit on all topical acne preparations will promote appropriate utilization of topical acne products and limit any unnecessary waste. Aubagio is indicated in the treatment of relapsing forms of MS. Aubagio has not demonstrated a clinical advantage over Formulary alternative agents for treatment of MS, such as Avonex, Extavia and Copaxone. Aubagio as adjunct therapy to another MS disease modifying agent has not demonstrated improved outcomes. Aubagio is contraindicated in patients with hepatic impairment. Aubagio is available through the Prior Authorization process, if Aubagio is not a member of a protected class. Page 12 of 14

13 Tecfidera (dimethyl fumarate) Do not add Tecfidera to Formulary. Medical Necessity Criteria (MNC) has been developed. Tecfidera MNC to require that the patient is an adult ( 18 years of age) being treated for a relapsing form of multiple sclerosis and is currently under the care of a neurologist; and Tecfidera is not being used as addon therapy to another diseasemodifying agent; patient has a documented failure, contraindication, or intolerance to at least one form of interferon and Copaxone ; complete blood count (CBC) has been drawn within six months prior to initiation of therapy and has lymphocyte count within normal limits (due to the risk of lymphopenia); and there is no active or chronic infection at the time of initiation of Tecfidera therapy. Renewal for continuation of therapy is dependent on documented improvement in symptoms and lack/decrease of relapses. Tecfidera is indicated in the treatment of relapsing forms of MS. Tecfidera has not demonstrated a clinical advantage over Formulary alternative agents for the treatment of MS, such as Avonex, Extavia and Copaxone. Tecfidera as adjunct therapy to another MS disease modifying agent has not demonstrated improved outcomes. Patients treated with Tecfidera are advised to have routine lab testing done prior to therapy initiation and must be evaluated for any potential chronic infections at the time of therapy initiation. Tecfidera is available through the Prior Authorization process if Tecfidera is not a member of a protected class. Ampyra (dalfampridine) Update Ampyra Medical Necessity Criteria (MNC) to allow for patients who no longer benefit from a disease modifying agent for multiple sclerosis to access Ampyra if all other criteria are met. Ampyra MNC requires that the patient is an adult ( 18 years of age) being treated for multiple sclerosis (MS) and under the care of a neurologist; currently being treated with a disease-modifying agent for treatment of MS, if appropriate; ambulatory and does not require a wheelchair for mobility; documented Timed 25 Foot Walk (T25FW) completed within 8 to 45 seconds; creatinine clearance >50ml/min; and no history of seizures. Ampyra MNC previously required that all eligible MS patients be receiving concurrent therapy with a disease modifying agent. In clinical trials, the safety and efficacy Ampyra was evaluated in patients diagnosed with MS, the majority of whom were diagnosed with relapsing forms and on concurrent therapy with a disease modifying agent for the treatment of MS. A patient diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) may come to a point in his/her disease progression at which there is no longer any benefit provided by a disease modifying agent. In such cases, updated criteria do not require that the patient be currently on a disease modifying agent if all other criteria are met. Updated Ampyra MNC increases drug access to those SPMS patients who no longer benefit from a disease modifying agent but meet all other criteria. Ampyra continues to be available through the Prior Authorization process, if Ampyra is not a member of a protected class. Page 13 of 14

14 Acetaminophen: Maximum Allowable Quantity Limit Implement a maximum allowable quantity limit across all acetaminophen-containing products of 4 grams per day. Neighborhood s current maximum allowable quantity on any one acetaminophen-containing product is 3 grams per day. This is in line with the FDA recommended total daily dose of acetaminophen. The new acetaminophen maximum allowable quantity limit of 4 grams per day across all acetaminophen-containing products further supports safe and appropriate use of acetaminophen. Please call the Pharmacy Help Desk at for pharmacy authorization requests or for further information related to the Neighborhood formulary. Explanation of Terms Products listed as added are available to most Neighborhood members at zero copay, if restrictions apply they will be indicated on this form and in the electronic formulary. Drugs may be limited to certain age groups (an AGE EDIT), by demonstrating prior therapies have been attempted (a STEP EDIT), in quantity allowed per 30 days (a QUANTITY LIMIT), or by requiring precertification for use from NHPRI (a PRIOR AUTHORIZATION). Products listed as removed are no longer available to Neighborhood members and are considered non-formulary or benefit exclusions. Physicians may requests these products via the medical necessity request process only. Page 14 of 14