Generic Name

ND= no data available, TN= treatment-naïve, TE= treatment-experienced, N= nausea, D= diarrhea, V= vomiting, HA= headache, R= rash Updated by: Cristina Gruta, PharmD (11/2019) **Renal and hepatic dosing of antiretrovirals is mostly based on product package insert (except QD dosing of ZDV). The DHHS guidelines on antiretroviral agents in HIV-infected adults may indicate other dosing strategies. Cobicistat is a pure pharmaco-enhancer with no HIV activity

• Provider has indicated that there is no worsening of disease from baseline after treatment with belimumab. • Bristish Isles Lupus Assessment Group (BILAG) Classic Index that measures organ specific changes in disease activity in the past 28 days that indicates no new BILAG A score and no more than one new BILAG B score compared with baseline. • No worsening of disease activity requiring intensification of therapy with high-dose steroids or immunosuppressants. • Experienced a dose reduction of steroid therapy.
If yes, approve for 6 month.
If no, do not approve. If no, do not approve. 6. Is abnormal muscle tone causing functional impairment or expected to result in joint contracture? If yes, continue to #7. If no, do not approve. 7. Has the member tried and failed or have contraindications to conventional nonpharmacologic treatment including physical therapy, splinting, bracing, or biofeedback which has been ineffective or cannot be maximized secondary to significant contracture? If yes, continue to #8. If no, do not approve. 8. Has the member tried and failed two oral pharmacologic agents, such as baclofen, dantrolene, tizanidine, and benzodiazepines? If yes, continue to #9. If no, do not approve. 9. Approve for 12 months.
Renewal Criteria: 1. Has the member met treatment goals on the current dose, including but not limited to the following?
• Decrease in severity of abnormal movements or contractures such as head positioning, improved range of motion, or decreased spasticity • Decrease in pain • Decrease in disability, such as enhanced motor ability and functional skills, improved execution of tasks, or improvement in activities of daily living. If yes, approve for 12 months. If no, continue to #2.
2. Has the provider requested dose optimization or toxin change? If yes, continue to #3. If no, do not approve.
3. Approve for 6 months. Brand Name Sublocade (long-acting buprenorphine injection) Created: 5/10/18. *** Nonformulary on outpatient benefit. PA required for medical benefit *** Note: In accordance with Oregon Law, starting 1/1/20 CareOregon will cover MAT in the first 30 days without clinical prior authorization. For Sublocade, this applies only through the medical benefit. CareOregon discourages starting Sublocade under this policy as criteria will still be applied to future doses and will likely require a therapy change for the member. CareOregon strongly recommends using generic Suboxone or buprenorphine to start MAT while the PA for Sublocade is requested. 3. Has the member been evaluated for triggers of HAE attacks and is maximally managed for avoidance of those triggers (such as stress, hormonal changes, dental surgery, trauma, medications including ACE inhibitors and estrogen)? If yes, continue to #4. If no, do not approve. 4. Has the member failed treatment with androgen therapy (i.e. danazol)? If yes, continue to #5. If no, do not approve and recommend a trial of danazol.
5. Is treatment with acute, abortive therapy an option for this member (Firazyr,Berinet)?
If yes, do not approve If no, continue to #6. . 6. Review case with medical director for consideration of approval.
Renewal criteria: 1. Has there been at least a 50% reduction in the number of angioedema attacks, significant improvement in the severity and duration of attacks, and clinical documentation of functional improvement? If yes, approve previous qty as above x      6. Has the provider submitted an acceptable, medical rationale for why meal time insulin cannot be used? If yes, approve for 6 months. If no, deny for criteria not met. Myeloid growth factors (MGFs) are indicated for the prevention of neutropenic fever -not for the prevention of neutropenia itself. Neutropenia is an expected side effect of many antineoplastic drugs and chemotherapy regimens. MGFs reduce the duration of neutropenia, not the magnitude (known as the nadir). Clinical practice guidelines (NCCN, ESMO, ASCO) adopt the same stance regarding when prophylaxis with MGFs is appropriate using evidence-based recommendations. MGFs are also generally not recommended for the treatment of febrile neutropenia.
• Indicated when the risk of febrile neutropenia is > 20% • Indicated when the risk of febrile neutropenia is 10-20% plus a risk factor • Indicated when a patient experienced febrile neutropenia with a previous chemotherapy regimen • MGF's may still be appropriate in cases where the risk of febrile neutropenia is <10% but clinicians should be providing justification in these cases   5. Does the member meet one of the following criteria?
• Hypogammaglobulinemia defined as serum IgG concentration less than 400 mg/dL. • Recurrent serious bacterial infections, defined as two or more infections such as bacteremia, meningitis, or pneumonia in a 1-year period. • Failure to form antibodies to common antigens, such as measles, pneumococcal, and/or Haemophilus influenzae type b vaccine. • Living in areas where measles is highly prevalent and who have not developed an antibody response after two doses of measles, mumps, and rubella virus vaccine live. • HIV-infected children who are exposed to measles (single dose indicated).
• HIV-infected children with chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy. If yes, approve for up to 12 months. If no, do not approve. 2. Does the member require treatment based on one of the following conditions? a. Previously delivered an infant with autoimmune thrombocytopenia. b. Platelet count of less than 10 x 10 9 /L during the third trimester c. Platelet count of less than 30 x 10 9 /L associated with bleeding d. Platelet count of less than 75 x 10 9 /L at time of delivery, to achieve minimum platelet counts recommended to undergo the procedures e. Past history of splenectomy.

HIV, Pediatric
If yes, continue to #3. If no, do not approve. 2. Does the member require acute treatment under one of the following conditions? a. Platelet count less than 20 x 10 9 /L, considered to be at risk for bleeding b. Platelet count less than 30 x 10 9 /L with acute bleeding c. Member is preparing to undergo surgery, such as a splenectomy, with platelet count less than 75 x 10 9 /L. If yes, continue to #4. If no, do not approve.
3. Are the platelet counts persistently at or below 20 x 10 9 /L? If yes, continue to #4. If no, do not approve.

Quantity Limit Explanation:
According to product labeling, the safety and effectiveness of treating more than 4 headaches in a 30-day period with sumatriptan (oral and nasal spray), naratriptan, rizatriptan, frovatriptan, almotriptan, and zolmitriptan nasal spray have not been established.

Medical Necessity Quantity exception criteria:
1. Is the request for more than 4 treatment days per month? If yes, do not approve and recommend reevaluation of migraine prophylaxis.
Prophylaxis indications: a. 2 or more attacks per month that produce disability that lasts 3 or more days per month b. Contraindication or failure of acute treatments c. Use of abortive medication more than twice per week d. Presence of uncommon migraine (hemiplegic migraine, prolonged aura, migrainous infarction). 6. Has the member reached treatment goals such as: • Symptom control, such as reduction in diarrhea episodes or carcinoid symptoms • Tumor control and disease stabilization If yes, approve for 12 months.
If no, do not approve. .

Opioids PA criteria
The following criteria apply to all reviews including PA required, Quantity limit exceeded, and formulary exception.   • Severe trauma resulting in increased metabolic need (e.g., severe burn, major bone fracture), or • Malabsorption difficulty (e.g., Crohn's disease, short-gut syndrome, bowel resection, fistula, gastric bypass, cystic fibrosis, renal dialysis, dysphagia, achalasia), or • Diagnosis that requires additional calories (cancer, AIDS,Pulmonary insufficiency MS, ALS, Parkinson's, cerebral palsy, Alzheimer's) *Weight loss criteria may be waived if body weight is being maintained by supplements due to member's medical condition (e.g., renal failure, AIDS) If yes, approve for life. If no, do not approve.

Age < 6 years:
1. Is the nutritional supplement to be administered via enteral tube feeding (e.g. G-tube, NG-tube)? If yes, close request If no, continue to #2. 7. Does the member have a nutritional deficiency identified by any ONE of the following? • Total protein < 5.6g/dl or Albumin < 3.4g/dl, or • Registered dietician assessment in the past 3 months indicates sufficient caloric/protein intake is not attainable through regular, liquified or purified foods. If yes, approve x 12 months.
If no, continue to #8.
8. Does the member meet ONE of the following criteria?
If no, do not approve. The following are based off the American Academy of Pediatrics 2014 Synagis Guidelines: 1. Does the member meet ANY of the following? a. Current age** < 12 months at the start of RSV season and gestational age <29 weeks, 0 days, or b. Preterm infants who develop Chronic lung disease (CLD) of prematurity defined as birth at gestational age of <32 weeks, 0 days' gestation and a requirement for >21% oxygen for at least 28 days after birth AND one of the following: i. Current age <12 months**; OR ii.
Current age 12-24 months** AND continued medical need for supplemental oxygen, chronic corticosteroids, or diuretic therapy during the 6 month period before the start of the RSV season c. Current age < 12 months** with hemodynamically significant congenital heart disease (CHD) and at least one of the following: i. acyanotic heart disease who are receiving medication to control CHF and will require cardiac surgical procedures or ii.
moderate to severe pulmonary hypertension, or d. Current age ≤ 12 months** with congenital abnormalities of the airway or neuromuscular disease that impairs the ability to clear secretions from the upper airways. , or e. Age less than 24 months** who will be profoundly immunocompromised during RSV season (such as chemotherapy, or post solid organ or stem cell transplant) If yes, continue to #2. If no, deny. ** All referenced ages above are as of start of season.
2. Approve Synagis at a dose of 15mg/kg for up to a maximum of 5 total monthly doses until March 31 (projected end of RSV season). Qualifying infants born during RSV season may require fewer doses. If any infant or young child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, monthly prophylaxis should be discontinued. 4. Has the provider documented a treatment protocol that specifies that Mozobil will only be used in case of mobilization failure in order to salvage the attempt in one of these clinical scenarios? a. Peripheral blood CD34+ counts plateaued at < 10 × 10 9 /L or declined without reaching a maximum of 10 × 10 9 /L after recovery of white blood cell counts following chemotherapy b. The number of CD34+ cells collected was < 0.3 × 10 6 per kilogram of body weight per day for 2 consecutive days c. A progressive decline in daily collection yield.
If yes, continue to #5 If no, do not approve. 8. Is there attestation that the patient and provider will comply with all case management interventions to promote the best possible outcome for the patient and adhere to monitoring requirements required by the Oregon Health Authority, including measuring and reporting of a post-treatment viral load?

Will
Case management includes assessment of treatment barriers and offer of patient support to mitigate potential barriers to regimen adherence as well as facilitation of SVR12 13. Is the prescribed regimen for the retreatment after failure of a DAA due to noncompliance or lost to follow-up? If yes, review with medical director. If no, continue to #14 14. Is the prescribed drug regimen a recommended regimen based on the patient's genotype, treatment status (retreatment or treatment naïve) and cirrhosis status (see Table 1 6. Is the member new to CareOregon and already receiving testosterone replacement for at least 6 months or an existing member with documented use of testosterone replacement for at least 6 months? If yes, continue to #8. If no, continue to #7. 7. Has the member had TWO morning (between 8 a.m. to 10 a.m.) tests (at least 1 week apart) at baseline demonstrating low testosterone levels as defined by the following criteria? Total serum testosterone level less than 300ng/dL (10.4nmol/L); OR Total serum testosterone level less than 350ng/dL (12.1nmol/L) AND free serum testosterone level less than 50pg/mL (or 0.174nmol/L). If yes, continue to #8. If no, do not approve.
• Exceptions: o New starts:  Moderate to severe plaque psoriasis with or without psoriatic arthritis: Eight syringes in the first 28 day fill then two syringes every four weeks continuing for initial 3 month approval only. Enbrel: • Four syringes per 28 days all strengths.
• Exceptions: o New starts:  Moderate to severe plaque psoriasis: Eight syringes per 28 days are authorized for the initial 3 month approvalHumira: • Two syringes per 28 days all strengths.
• Exceptions: o New starts:  Crohn's Disease or ulcerative colitis: One Crohn's starter pack for a 28 day supply at initiation will be authorized  Moderate to severe plaque psoriasis: One psoriasis starter pack for a 28 day supply at initiation will be authorized.  Ulcerative colitis: One Crohn's starter pack or equivalent for a 28 day supply at initiation will be authorized.  Uveitis: One psoriasis starter pack or equivalent for a 28 day supply at initiation will be authorized. o Hidradenitis suppurativa: Four syringes per 28 days at initiation will be authorized Infliximab: • 5mg/kg every 8 weeks.
• Exceptions: o New starts:  For all diagnoses, up to 5mg/kg on weeks 0, 2, and 6 at initiation will be authorized (8 doses over 12 months). o At least 12 weeks after initiation, quantity limit exceptions require documentation of medical necessity. Interval changes AND dose increases will not be approved at the same time in the same request. Siliq: • Two syringes per 28 days • Exceptions: o New starts:  Moderate to severe plaque psoriasis: Three syringes for a 28 day supply for the first fill Simponi Aria: • 2mg/kg every 8 weeks.
• Exceptions: o Crohn's Disease: One 90mg syringe every 8 weeks after induction o New starts:  Psoriatic arthritis and moderate to severe plaque psoriasis: Induction doses of one 45mg syringe will be authorized for new starts for 0 and 4 weeks on separate fills. o Moderate to severe plaque psoriasis with or without psoriatic arthritis: one 90mg syringe every 12 weeks only after failure of 3 months of 45mg dosing. Taltz: • One 80mg syringe every 28 days.
• Exceptions: o New starts:  Plaque psoriasis with or without psoriatic arthritis: • Three syringes for a 28 day supply, then • Two syringes per 28 days for initial 3 month approval.  Psoriatic arthritis: • Three syringes for a 28 day supply for first fill. Tremfya: • One syringe 100mg/ml syringe every 8 weeks.