July 6, 2010

Dear Providers,

The Pharmacy and Therapeutics Committee has approved the following changes. Effective 7/1/2010, the Health Plan of San Joaquin Drug Benefit for Medi-Cal Managed Care, Healthy Families and Healthy Kids will change.

Formulary Status Changes:

1. Biologicals for Rheumatoid Arthritis (RA) is restricted to patients with one or more of the following: (1) hypersensitivity, intolerance, or contraindication to MTX or leflunomide, (2) inadequate response to MTX or leflunomide for 6 months, (3) documented evidence of high disease activity for at least 3 months since diagnosis, or (4) documented evidence of poor prognostic features at any time since diagnosis. Concomittant therapy with DMARD (MTX, Arava, I etc.) is required.

   First line biologicals:	Humira (Adalimumab) - preferred, Enbrel (Etanercept)
   Second line biologicals:	Remicade(Infliximab) with max dose of 8 mg/kg, Simponi (Golimumab) with max dose of 50 mg SubQ q4wk
   Third line biologicals:	Orencia (Abatacept), Rituxan (Rituximab), Actemra (Tocilizumab)
   Special situations:	Cimzia (certolizumab) for in pregnant women with RA who are unable to discontinue TNF-á inhibitor during pregnancy. Kineret (anakinra) for febrile rheumatoid arthritis with no response to one TNF-á inhibitor

2. Biologicals for Chronic Plaque Psoriasis is restricted to patients with moderate to severe chronic plaque psoriasis (> 10%BSA) or psoriatic arthritis in patients > 18 yo with documented inadequate response, intolerance, hypersensitivity or contraindication to methotrexate AND ultraviolet (UV) therapy.

   First line biological:	Humira (Adalimumab) - preferred, Enbrel (etanercept) Remicade (Infliximab) for severe pustular psoriasis and erythrodermic psoriasis
   Second line biological:	Infliximab (Remicade)
   Third line biological:	Stelara (ustekinumab)

3. Renagel (sevelamer hydrochloride) is a second line therapy with PA for patients who have one or more of the following: (1) hyperphosphatemia despite maximum recommended doses of calcium-based binders (1500 mg/day elemental calcium); (2) hypercalcemia (corrected serum calcium > 10.2 mg/dl), either pre-existing or secondary to calcium-based binders; (3) plasma PTH levels < 150 pg/ml; or (4) documentation of vascular and/or soft tissue calcification.

4. Renvela tablet (sevelamer carbonate) is a second line therapy with PA for patients who have one or more of the following: (1) hyperphosphatemia despite maximum recommended doses of calcium-based binders (1500 mg/day elemental calcium); (2) hypercalcemia (corrected serum calcium > 10.2 mg/dl), either pre-existing or secondary to calcium-based binders; (3) plasma PTH levels < 150 pg/ml; or (4) documentation of vascular and/or soft tissue calcification.

5. Renvela Powder (sevelamer carbonate) is a second line therapy with PA for patients who meet the criteria for use of sevelamer carbonate tablets AND have a documented inability to swallow sevelamer tablets.

6. Fosrenol (lanthanum) is a third line therapy with PA for patients with treatment failure of sevelamer hydrochloride or sevelamer carbonate.

7. Intuniv (guanfacine ER) is a third line agent with PA, after treatment failure of long-acting stimulants, and Strattera.

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