December Remove metronidazole 0.75% lotion from Formulary

December 2013 The following changes to the Neighborhood formulary were recently approved by the Pharmacy and Therapeutics (P&T) Committee. These chang...
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December 2013 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/Drug Name

Strategy or Medications Added or Modified

Rationale

2013 Comprehensive Class Review: Anti-obesity Preparations - Phentermine - Alli® (orlistat) - Belviq® (lorcaserin) - Qsymia® (phentermine; topiramate)

Alli and phentermine are now firstline anti-obesity drugs. All antiobesity drugs, including Alli and phentermine, require Prior Authorization.

Neighborhood criteria for weight loss agents do not specify preferred first-line drugs. There are now two brand nameonly weight loss drugs available (i.e. Belviq and Qsymia); both brand name-only drugs are very expensive compared to alternative Formulary agents, phentermine and Alli. Belviq and Qsymia do not offer a clinical advantage over Formulary agents.

2013 Comprehensive Class Review: All Other Dermatologicals - Metronidazole 0.75% lotion

Remove metronidazole 0.75% lotion from Formulary.

Metronidazole 0.75% lotion is significantly more expensive than both metronidazole 0.75% cream and metronidazole 0.75% gel. The lotion does not have a clinical advantage over the cream or gel. Metronidazole 0.75% lotion is available through the Prior Authorization process.

2013 Comprehensive Class Review: Androgens - Androgel® 1%, 1.62% (testosterone) - Axiron® (testosterone) - Fortesta® (testosterone) - Testim® (testosterone)

When authorized, limit all nonFormulary topical testosterone preparations to 1 box or 1 metered dose pump.

Non-Formulary testosterone preparations require Prior Authorization following failure of testosterone cypionate or testosterone enanthate injection. Rationale must be provided for quantities greater than 1 box or 1 metered dose pump.

2013 Comprehensive Class Review: Antiparasitics - Spinosad (Natroba®) - Malathion (Ovide®)

Add spinosad and malathion to the Formulary as 2nd line head lice treatments. Spinosad and malathion are available through the Prior Authorization process following failure of a 3 treatment cycle (day 0, 7, and 13-15) of firstline drugs permethrin or pyrethrins shampoo.

Natroba®, indicated in patients aged ≥4 years, is now available generically as spinosad. Malathion is indicated in patients aged ≥6 years. First-line drugs, OTC permethrin and pyrethrins shampoo, are indicated in patients aged ≥2 months. OTC permethrin and pyrethrins shampoo do not require Prior Authorization. Spinosad and malathion are available through the Prior Authorization process following failure of ≥1 first-line agent. Requests for all other non-Formulary head lice treatments require Prior Authorization following failure of ≥1 first-line agent and ≥1 second-line agent.

December 2013

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December 2013 Therapeutic Class/Drug Name 2013 Comprehensive Class Review: Anti-ulcer Preps / GI Preps - Rabeprazole (Aciphex®) - Helidac® (bismuth subsalicylate; metronidazole; tetracycline) - Pylera® (bismuth subcitrate potassium; metronidazole; tetracycline)

2013 Comprehensive Class Review: Antispasmodics - Oxytrol® For Women (oxybutynin transdermal)

December 2013

Strategy or Medications Added or Modified

Rationale

Rabeprazole (Aciphex) to be added to Formulary as a second-line proton pump inhibitor, available following failure of both omeprazole (twice-daily dosing) and pantoprazole.

Aciphex is now available generically as rabeprazole. The average cost/Rx of rabeprazole is very inexpensive compared to alternative non-Formulary proton pump inhibitors (PPIs). Rabeprazole and lansoprazole are both second-line PPIs following failure of omeprazole (twicedaily dosing) and pantoprazole. Requests for non-Formulary PPIs require failure of all first- and second-line drugs. NonFormulary PPIs do not offer a clinical advantage over alternative Formulary drugs.

Criteria for H. pylori treatment packs (Helidac, Pylera) to require failure of triple therapy. Sequential and concomitant therapies are alternative therapies available to triple therapy. Triple therapy includes amoxicillin; clarithromycin; omeprazole and amoxicillin; clarithromycin; lansoprazole. Sequential and concomitant therapies both consist of a combination of PPI; amoxicillin; clarithromycin; metronidazole.

The American College of Gastroenterology Clinical Guidelines on H. pylori infection and the Maastricht Consensus Report (MCR) both recommend the use of triple therapy for 14 days duration as first-line therapy. Both guidelines recommend the use of metronidazole in place of amoxicillin if there is a penicillin allergy. Quadruple therapies are to be reserved for patients who have previously been treated with a macrolide antibiotic or those with a true penicillin allergy and not a candidate for metronidazole. Helidac and Pylera are used in combination with a PPI (e.g. omeprazole) as quadruple therapy for treatment of H. pylori.

Add over-the-counter (OTC) Oxytrol For Women to Formulary as the second-line antimuscarinic available for the treatment of overactive bladder (OAB). OTC Oxytrol will be available following failure of oxybutynin immediaterelease (IR). All non-Formulary overactive bladder (OAB) agents to require failure with both Oxytrol and oxybutynin IR.

Oxytrol became available OTC in September 2013 and is very inexpensive compared to non-Formulary antimuscarinics. The OTC and Rx-only Oxytrol are the same strength and have the same directions (applied twice-weekly). Oxytrol is the Formulary long-acting antimuscarinic available for those who have failed oxybutynin immediate-release. Oxybutynin immediate-release tablets and syrup are first-line OAB therapy available on Formulary, without restrictions. Page 2 of 7

December 2013 Therapeutic Class/Drug Name 2013 Comprehensive Class Review: Antivirals - Valacyclovir

Strategy or Medications Added or Modified

Rationale

Valacyclovir to be available as second-line agent following failure of acyclovir. Valacyclovir to have parity status with famciclovir.

Valacyclovir and famciclovir are now both second-line agents following failure of acyclovir. There are no clinical advantages of either agent over the other. Valacyclorvir and famciclovir are both available following failure of acyclovir or through the Prior Authorization process.

Valcyte® (valganciclovir) to be reviewed formally at the next P&T Committee meeting in March 2014.

Criteria to be created for Valcyte® and reviewed at the March 2014 P&T Committee meeting.

2013 Comprehensive Class Review: Cephalosporins - Cefpodoxime

Remove cefpodoxime from Formulary.

Cefpodoxime is very expensive compared to cefdinir, which is an alternative 3rd generation cephalosporin antibiotic. Cefdinir carries all of the indications of cefpodoxime. Cefdinir is available following failure of amoxicillin, generic macrolide, cefprozil suspension, cefuroxime tablets, or sulfamethoxazole/trimethoprim or through the Prior Authorization process. Cefpodoxime is available through the Prior Authorization process.

2013 Comprehensive Class Review: Erythromycins - Erythromycin base

Remove erythromycin base from Formulary.

Erythromycin ethylsuccinate is available on Formulary, without restrictions. Erythromycin base is very expensive compared to erythromycin ethylsuccinate. Erythromycin base does not offer clinical advantage over erythromycin ethylsuccinate.

2013 Comprehensive Class Review: Narcotic Analgesics - Non-Formulary fentanyl preparations (Abstral®, Fentora®, Lazanda®, Onsolis®, Subsys® and fentanyl citrate lozenge)

All non-Formulary fentanyl preparations to be reviewed formally at the next P&T Committee meeting in March 2014.

Criteria to be created for all nonFormulary fentanyl preparations and reviewed at the March 2014 P&T Committee meeting.

Therapeutic Class/Drug December 2013

Strategy or Medications

Rationale Page 3 of 7

December 2013 Name

Added or Modified

2013 Comprehensive Class Review: Non-narcotic Analgesics - butalbital-acetaminophencaffeine 50mg-325mg-40mg capsule

Remove butalbital-acetaminophencaffeine 50mg-325mg-40mg capsule from Formulary.

The butalbital-acetaminophen-caffeine 50mg-325mg-40mg tablet is on Formulary, without restrictions. The capsule dosage form is very expensive compared to the tablet. The capsule does not offer a clinical advantage over the tablet.

2013 Comprehensive Class Review: Penicillins - Amoxicillin; clavulanic acid 250mg-62.5mg/5ml suspension - Amoxicillin; clavulanic acid 400mg-57mg chew tablet

Remove amoxicillin; clavulanic acid 250mg-62.5mg/5ml suspension and amoxicillin; clavulanic acid 400mg-57mg chew tablet from Formulary.

Amoxicillin; clavulanic acid 250mg62.5mg/5ml suspension and amoxicillin; clavulanic acid 400mg-57mg chew tablet carry significantly higher average costs/dose than other amoxicillin; clavulanic acid strengths/dosage forms. Amoxicillin; clavulanic acid 400mg57mg/5ml and 600mg-42.9mg/5ml suspensions are available on Formulary, without restrictions. 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. The 250mg62.5mg/5ml suspension provides a higher clavulanic acid dose.

2013 Comprehensive Class Review: Sedative Nonbarbiturate

Update approval criteria for nonFormulary sedative hypnotics to require failure of zolpidem, zalepon and ≥1 benzodiazepine. Require reason for failure of drug to be inadequate outcome (failure to achieve sleep onset versus sleep maintenance) or intolerance (e.g. side effects).

Formulary sedative hypnotics are significantly less expensive than nonFormulary alternatives (e.g. Lunesta® or zolpidem extended-release). Zolpidem extended-release is significantly less expensive than Lunesta. Sedative hypnotics differ in the ability to help patients go to sleep versus stay asleep. Non-Formulary agents are available through the Prior Authorization process following failure of zolpidem, zaleplon and ≥1 benzodiazepine. There is consideration for the reason of failure of Formulary agents.

December 2013

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December 2013 Therapeutic Class/Drug Name

Strategy or Medications Added or Modified

Rationale

2013 Comprehensive Class Review: Tetracyclines - Tetracycline

Remove tetracycline from Formulary.

Tetracycline capsules are very expensive compared to Formulary alternatives. Tetracycline does not offer a clinical advantage over Formulary alternatives. Tetracycline capsules are available through the Prior Authorization process.

Adrenergics - Auvi-Q® (epinephrine)

Do not add Auvi-Q (epinephrine) to Formulary.

Auvi-Q is the newest epinephrine autoinjector that is used for the treatment of anaphylaxis. Auvi-Q is more expensive than Formulary alternatives, Epi-Pen® and epinephrine auto-injector. Auvi-Q does not offer a clinical advantage compared to Formulary alternatives.

Antiarthritics - Oxaprozin - Zorvolex® (diclofenac) - Diclofenac sodiummisoprostol delayedrelease tablet (Arthrotec®) - Duexis® (famotidine; ibuprofen) - Oxtrexup® (methotrexate) - Humira® (adalimumab) - Enbrel® (etanercept)

Remove oxaprozin from Formulary.

Oxaprozin is very expensive compared to alternative Formulary non-steroidal antiinflammatory drugs (NSAIDs), such as meloxicam, naproxen and ibuprofen. Oxaprozin does not offer a clinical advantage over alternative Formulary NSAIDs. Oxaprozin is available through the Prior Authorization process.

Do not add Zorvolex to Formulary.

Zorvolex does not offer a clinical advantage over Formulary NSAIDs.

Do not add diclofenac sodiummisoprostol delayed-release tablets to Formulary.

Proton pump inhibitors may be added to NSAIDs to reduce the risk of GI complications. Formulary PPIs are omeprazole, pantoprazole, Prevacid 24HR and rabeprazole.

December 2013

Do not add Duexis to Formulary.

Duexis is a combination tablet of ibuprofen and famotidine. Both components of Duexis are available generically and are on Formulary, without restrictions.

Do not add Oxtrexup to Formulary.

Methotrexate tablets and intramuscular injectable is available on Formulary. Oxtrexup does not offer a clinical advantage over methotrexate tablets or IM injection. Page 5 of 7

December 2013 Therapeutic Class/Drug Name

Strategy or Medications Added or Modified

Antiarthritics (continued)

Update Humira criteria for approval to include diagnosis of ulcerative colitis. Humira approval criteria for UC require diagnosis of moderately to severely active UC and failure of conventional therapy (e.g. mesalamines, steroids, sulfasalazine, azathioprine or methotrexate) due to inadequate response and/or intolerance.

Humira was approved in September 2012 for use in the treatment of moderately to severely active ulcerative colitis (UC) in adults who have had inadequate response to immunosuppressants (i.e. corticosteroids, azathioprine or 6mercaptopurine).

Update Enbrel and Humira approval criteria for diagnosis of newly diagnosed mild to moderately severe rheumatoid arthritis (RA). Updated criteria requires failure of adequate dose and appropriate duration (≥3 months) of methotrexate AND failure of adequate dose and appropriate duration (≥3 months) of methotrexate taken in combination with ≥1 other nonbiologic disease modifying antirheumatic drug (DMARD) as double or triple DMARD therapy.

The American College of Rheumatology (ACR) guidelines support the use of methotrexate and at least 1 other nonbiologic DMARD prior to moving to biologic DMARD therapy in patients newly diagnosed with RA who have mild or moderate disease activity.

Rationale

Cold & Cough Preparations

There were no recommendations for this class.

Linzess® (linaclotide)

Do not add Linzess to Formulary. Medical necessity criteria have been developed.

Linzess is not a member of a protected class.

Medical necessity criteria developed for Linzess requires a diagnosis of chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C) and; failure of a recent trial of adequate dose and appropriate duration of polyethylene glycol and at least one other agent (lactulose, senna, and/or bisacodyl) due to inadequate response or intolerance.

Linzess is parity status with Amitiza®. Amitiza carries both of the FDA approved indications for Linzess. Linzess is indicated in the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. There have not been studies demonstrating clinical superiority of Linzess over alternative Formulary agents.

December 2013

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December 2013 Therapeutic Class/Drug Name Uceris® (budesonide extended-release)

Xeljanz® (tofacitinib)

Strategy or Medications Added or Modified

Rationale

Do not add Uceris to Formulary. Medical necessity criteria have been developed.

Uceris is not a member of a protected class.

Medical necessity criteria developed for Uceris requires diagnosis of active, mild to moderate ulcerative colitis (UC) and; therapy used for induction of remission and; failure of an oral aminosalicylate and; requirement of hydrocortisone enema, hydrocortisone suppositories and mesalamine enema to induce remission if patient is diagnosed with distal disease. If criteria are met, Uceris will be approved for no more than 2 months.

Uceris is indicated in induction of remission in patients with active, mild to moderate UC and is not intended for longterm use or maintenance therapy. The American College of Gastroenterology 2010 guidelines for treatment of UC recommends the use of topical mesalamine, topical steroids and oral aminosalicylates as first-line options for the induction of remission in mild to moderate distal UC. Oral steroids are to be used following failure of combination therapy of oral aminosalicylates and topical therapy. Once stabilized, evaluation must be done for maintenance treatment. Uceris does not provide a clinical advantage compared to alternative Formulary agents.

Do not add Xeljanz to Formulary. Medical necessity criteria have been developed.

Xeljanz is not a member of a protected class.

Medical necessity criteria developed for requires a diagnosis of moderately to severely active RA in adult patients, failure of adequate dose and appropriate duration of methotrexate and at least one biologic DMARD (e.g. Enbrel, Humira). Initial and renewal requests require documentation of appropriate laboratory monitoring. If criteria are met, initial requests will be approved for 3 months. Renewal requests will be authorized for 9 months.

Xeljanz is indicated in the treatment of moderately to severely active RA in adult patients. The American College of Rheumatology (ACR) guidelines supports the use of DMARD monotherapy (e.g. methotrexate) or combination therapy as first-line therapy in the treatment of moderately to severely active RA, depending on prognosis features. Biologic DMARDs may be used following failure of combination non-biologic DMARD therapy. Xeljanz does not offer a clinical advantage over Formulary biologic DMARDs available.

Please call the Pharmacy Help Desk at 1-401-459-6020 for pharmacy authorization requests or for further information on 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.

December 2013

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