Exclusion Criteria. Required Medical Documentation. Specified reasons for denial (if any), other than not meeting criteria requirements.

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1 Partnership HealthPlan of California: New and Revised, 3nd Quarter P & T 2016 Effective 10/1/2016 Generic substitution required when there is an FDA approved generic equivalent; additional criteria apply for brand name requests per PHC Policy MPRP4033 HEADING Drug/PA Group Products Included in Group Covered Uses Restriction Restriction Requirements DEFINITION For PHC Internal use, used for grouping drugs with like criteria. Drugs covered by the same TAR criteria. Trade names, strengths, dosage forms are for example only. apply to the active ingredient entity, unless separate criteria exist for different strengths/forms of same drug. Indications for which PHC will consider prior authorization based on the stated criteria. uses may require additional documentation of safety, efficacy & medical necessity. Specified reasons for denial (if any), other than not meeting criteria requirements. Documents to be submitted with the TAR for clinical review. Absence of these documents will result in delay or denial of the request. Any age limit or CCS screening associated with the drug. specialty requirement for TAR consideration, if any. The maximum duration of TAR approval before renewal is required, when all criteria are met. Less than the maximum may be authorized when additional clinical information is required. criteria and notations not included elsewhere. This page is for general information only, to assist with interpretation of the TAR/PA criteria. Please review the information above if you are unfamiliar with this criteria format. New & revised criteria begin on the next page. Benzyl Alcohol 5% (Ulesfia) Lipase-Amylase-Protease 10.44K-39.15K-39.15K, 30.88K-78.30K-78.30K (Viokace) Lipase-Amylase-Protease 8.0K-28.75K-30.25K, 16.0K- 57.5K-60.5K (Pertzye) Naloxegol Oxalate (Movantik) Methylnaltrexone Bromide (Relistor) Omalizumab (Xolair) Mebendazole (Emverm) Roflumilast (Daliresp) Crotamiton 10% (Eurax)

2 Benzyl Alcohol 5% (Ulesfia) Pediculicides Covered Uses Treatment of head lice (pediculus humanus capitis) infestation Required Medical Clinical documentation supporting confirmed diagnosis of live lice along with proper nonpharmacologic measures being in place for reinfestation may be required for repeat treatment requests. 6 months and older None 1 time authorization per infestation Must have T/F of 3 formulary agents, one of which must be a first line formulary product and 2 of which must be 2 nd line formulary/step products. First line formulary Permethrin (1% or 5%, Nix) or Pyrethrins (Rid); 2 nd line formulary/step Malathion lotion (Ovide), Spinosad suspension (Natroba), and Ivermectin lotion (Sklice). MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 2 of 9

3 Lipase-Amylase-Protease 10.44K-39.15K-39.15K, 30.88K-78.30K-78.30K (Viokace) Lipase-Amylase-Protease 8.0K-28.75K-30.25K, 16.0K-57.5K-60.5K (Pertzye) Covered Uses Pancreatic Viokace: Enzymes Adult members with exocrine pancreatic insufficiency caused by chronic pancreatitis or pancreatectomy, used in conjunction with a PPI. s: Members with functional pancreatic insufficiency or pancreatic insufficiency secondary to cystic fibrosis, chronic pancreatitis or pancreatectomy. Pertzye, Viokace: Reason(s) why Creon, Pancreaze or Zenpep cannot be used. Current Weight Note: Dose is weight based but dose should also be proportionate to a patient s estimated gastric volume; therefore there is an expected maximum dose for the morbidly obese. That is, the dose would not be linear with total body weight. Viokace: Not FDA approved for pediatric use. 0-20: CCS screening/ referral processes apply. Up to 12 month per Prior Auth TAR must include documented history of therapeutic failure or intolerance to the preferred pancreatic enzymes (Creon, Pancreaze, and Zenpep). Note: Members on Viokace are to also be on PPI. Any pancreatic enzyme request (formulary or non-formulary, for functional pancreatic insufficiency or other chronic pancreatic insufficiency not due to CF, chronic pancreatitis or pancreatectomy: Specialist consult notes including confirmation of diagnosis (other etiologies ruled out), medical justification for pancreatic enzyme supplementation and dose requested (abdominal symptoms, nutritional intake, weight, growth (children), stool character, fecal fat). Requests must include appropriate labs or imaging studies to confirm diagnosis (fecal elastase measurement, endoscopic US, secretin pancreatic function test). MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 3 of 9

4 Mebendazole 100mg tablets (Emverm) Covered Uses Mebendazole Intestinal infections with roundworm, hookworm, whipworm or pinworm. Pinworm: Medical records supporting diagnosis and adequate trial of first line/formulary alternative(s). None Pinworm Single dose for initial request. infections 3 days (6 tablets) for initial request. Members with intestinal infections of hookworm, roundworm or whipworm: 1. Initial TAR approval will be limited to 3 days for initial treatment (6 tablets). 2. A second course of treatment may be approved with confirmed continued infection. Members with pinworm: 1. Must have had adequate trial of pyrantel pamoate documented in in claims or in the medical record (2 doses 2 weeks apart is recommended by the CDC). 2. Must have documentation of active continued infection which failed treatment with pyrantel pamoate (rather than reinfection due to poor infection control measures. A second course may be approved if confirmation of continued infection is submitted. MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 4 of 9

5 Naloxegol Oxalate tablets (Movantik) Covered Uses Opioid antagonist Treatment of opioidinduced constipation (OIC) in adults. May be used off-label for members with refractory OIC who are being treated for chronic cancer pain For Renewals: Clinic documentation that member experienced clinically significant benefit after an adequate therapeutic trial (minimum 1 week). 18 years of age or older None Naïve to treatment: up to 15 day supply to determine response. Initial Renewal: 12 months with documentation of efficacy. Re: Appropriate use: Discontinue naloxegol if opioids are discontinued Limited to adult members receiving chronic opioid treatment and:. OIC with diagnosis of ACTIVE cancer -OR-.. Diagnosis of opioid induced constipation with non-cancer chronic pain AND (OIC) Member must have tried and failed a stool softener (docusate) plus a stimulant laxative such as sennosides (Ex-Lax, Senokot or bisacodyl). Failed/intolerant to at least one other laxative, such as lactulose or polyethylene glycol (Miralax). Failed/intolerant to at least one saline laxative, such as milk of magnesia, magnesium citrate or Fleet Phospho-Soda MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 5 of 9

6 Methylnaltrexone Bromide (Relistor) Opiate antagonist Covered Uses 1. Treatment of refractory opioid-induced constipation (OIC) in adult patients with advanced illness (receiving palliative care) who have an inadequate response to conventional laxative regimens. 2. Treatment of refractory opioid -induced constipation in adult patients with chronic non-cancer pain. Weight of patient (Weight based dosing) 18 years and older Initial authorization will be for up to 2 months. Subsequent authorization (an additional 2 months) will be based on physician documentation of efficacy. Authorization will be limited to a maximum of 4 months therapyuse of Relistor beyond four months has not been studied. Use is limited to members receiving chronic opioid treatment and: 1. Diagnosis of OIC and ACTIVE cancer, with trial and failure of Naloxegol (Movantik), OR 2. Diagnosis of OIC with noncancer chronic pain AND a. Trial and failure or contraindication to a minimum of three standard laxative agents These include contact cathartic stimulant (e.g. senna) w/ or w/o stool softener, osmotic (e.g. lactulose and PEG) AND b. Failure or inadequate response to oral nonformulary agents Lubiprostone (Amitiza) and Naloxegol (Movantik)* *Non-Formulary, TAR required. Note that members with OIC due to methadone are not required to have trial of lubiprostone. MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 6 of 9

7 Omalizumab (Xolair) Anti- Asthmatic Monoclonal Antibody Covered Uses Chronic idiopathic urticaria. Acute urticaria Allergist or 12 years and dermatologist clinic older notes with documented: (1) Confirmed diagnosis of chronic idiopathic urticaria, defined as hives for 6 weeks or more. (2) Response to first line, Stepwise approach to treatment with high dose H1 antihistamine along with H2 antihistamine (H2 blocker) and leukotriene receptor antagonist such as montelukast Allergist or dermatologist Initial: 3 months. Renewal: 6 months. of compliant trial of a minimum of 4 weeks (per antihistamine tried) and failure to a minimum of 2 high dose (up to 4 times the normal dose) antihistamines, one of which must be levocetirizine AND either an H2 blocker or a leukotriene receptor antagonist (montelukast/singulair) Compliance to be confirmed per patient claims or fill history. Diagnosis of chronic urticaria that does not specifically include idiopathic chronic urticaria will be reviewed on a case by case basis. Initial approval for 3 months. Renewal will require clinical documentation of benefit with current therapy. Renewal approval for up to 6 months with clinical documentation noting benefit. If benefit is noted, may ask provider upon renewal after initial 6-9 months of treatment either for decrease in dose to 150mg per month or consider 300mg every 6 weeks. MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 7 of 9

8 Roflumilast (Daliresp) Phosphodiesterase-4 Enzyme Inhibitor Covered Uses COPD associated with chronic bronchitis Most recent FEV1 percent predicted. Confirmed diagnosis of COPD associated with chronic bronchitis. Clinic notes with documentation of 2 or more exacerbations which required systemic steroids with or without urgent heath care needs OR emergency department visit OR exacerbations requiring hospitalization within the past year. Initial renewal: of improvement with symptoms such as reduced exacerbations, improved dyspnea. Monitor compliance with maintenance bronchodilator therapy 18 years and older None 12 months New starts: FEV1 < or = 50% predicted. of 2 of more exacerbations within the past year. Compliant use of maximized maintenance therapy of long acting bronchodilators (e.g. long acting beta agonist/long acting glucocorticoid +/- long acting anticholinergic agonist). May consider recommendation for use of a spacer for MDI (e.g., Symbicort). Initial renewal: of improvement with symptoms such as reduced exacerbations, improved dyspnea. Monitor compliance with maintenance bronchodilator therapy. MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 8 of 9

9 Crotamiton 10% (Eurax) Scabicides Covered Uses Treatment of scabies (Sarcoptes scabiei) infestation and related pruritus Non-FDA approved use (e.g. head lice) Clinical 18 years and None Limited to 2 Requires clinical documentation older fills per documentation of treatment confirming treatment failure with recommended diagnosis and authorization use/doses of formulary treatment failure of permethrin 5% cream preferred (Elimite) and oral ivermectin alternatives. (Stromectol) tablets for classic scabies (concurrent use and failure of both agents required for treatment of crusted scabies). MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 9 of 9