Following is a P and T Committee update (from the April 28^th meeting). Starting date for specific programs is 4 May 2015, unless otherwise noted. Please let me know if you have any questions or comments. Don’t forget to check the “New Drug Monitoring Spotlight” section of the website, which provides important monitoring information about newly approved drugs. Also, attached is the updated version of the “Not Stocked, Not Ordered” drug list with the new additions highlighted in red. 

Below is the memo with links to the drug monographs, protocols, and formulary documents. Click to access the full P&T packet for this month, or here to access the P&T packet archive.

blinatumomab (Blincyto) – This new intravenous cancer drug is indicated for treatment of Philadelphia chromosome-negative relapsed or refractory precursor acute lymphoblastic leukemia (ALL), and received FDA accelerated approval. A single cycle consists of 4 weeks of continuous intravenous infusion followed by a 2 week treatment free interval, and a patient may receive up to 5 cycles.  The drug has a complex mechanism and acts as a  CD3 T-cell engager.  There are a wide range of adverse effects related to its use.  Cost is approximately $90,000 per cycle.  This drug was classified as non-formulary, not stocked, and if ever requested for an inpatient, each case will be evaluated individually for need to start as an inpatient, financial issues, transition of care, and other considerations. 

buprenorphine-nalOXone (Bunavail Buccal Film) – This new product is indicated for maintenance treatment of opioid dependence, and use is limited under the Drug Addiction Treatment Act with only certified physicians using it for opioid dependence treatment. It is not used in the initiation phase of therapy. It is available in 3 strengths and is dosed once daily.  Safety issues are similar to other opioids.  The cost ranges from $7 - $14 per day depending on dose.  It was classified as non-formulary, not stocked, and should be interchanged to Suboxone (generic) sublingual tablets in equivalent doses i.e. Bunavail 2.1 mg/0.3 mg buccal film interchanged to Suboxone tablets 4 mg / 1 mg.

eliglustat (Cerdelga) – This drug is indicated for the long term treatment of adults with Gaucher Disease type 1 (GD1), and an enzyme test to determine CYP2D6 metabolic status is required prior to initiation to determine proper dosing. The normal dose is 84 mg orally once – twice daily.  It does interact with other drugs through the CYP 2D6 and 3A 4 pathways.  The cost is $425 - $850 per day depending on dose. It was classified as non-formulary, not stocked, initiation should be deferred to the outpatient setting, and the patient should use their home supply if needed in the hospital.  Rare use is expected.

diosimplex (Vasculera) – This is a bioflavonoid classified as a medical food and used for the management of metabolic processes of chronic venous insufficiency (CVI).  Each tablet contains 600 mg of diosmin glycoside.   Symptoms  of CVI include edema, varicose veins, stasis dermatitis, venous ulcers, and hemorrhoids.  Wm. Nuessle, colo-rectal surgeon, has requested this agent for treatment of specific patients with resistant hemorrhoids.  Studies do show some symptom improvement in selected patients within 1 week. The starting dose is 1 tablet bid – tid, with a maintenance dose of 1 tablet daily.  It was classified as a formulary agent.  The cost of 1 tablet daily is about $2.80, unusual use expected.

mitomycin Ophthalmic Solution (Mitosol) – This is a specially designed kit for preparation and administration of mitomycin doses for ophthalmic use, as an adjunct to ab externo glaucoma surgery. The normal dose is 0.2 mg applied topically at the optic surgery site for 2 minutes, then removed.  The cost of one kit is $359.  The Mitosol dose will be prepared in surgery by the MD or his/her assistant.   Currently, we have been preparing the dose from the 5 mg injectable vial, but will be transitioning to Mitosol after staff education.  Since Mitosol is FDA approved for ophthalmic use, there is better reimbursement for it in the outpatient setting.  Mitosol was classified as a formulary agent.  Initiation of Mitosol use to be announced, pending staff education.

empagliflozin-linaGLIPtin (Glyxambi) – This is a combination of empagliflozin 10 mg or 25 mg with linagliptin 5 mg dosed once daily, as an adjunct to diet/exercise to improve glycemic control in adult type II diabetic patients. Both strengths cost about $12/day.  Glyxambi was classified as non-formulary, not stocked, and the individual drugs should be dispensed and administered separately, as both are on the formulary. 

nalOXone-oxyCODONE Extended Release Tablets (Targiniq ER) – This combination opioid agent is used for management of pain severe enough to require daily, around the clock, long-term opioid treatment. It is formulated in an abuse-deterrent dosage form that is expected to deter misuse and abuse.  It is dosed q 12 hrs, it is available in 3 strengths, and the cost is expected to be from $8 - $20 /day, depending on dose.  It was classified as non-formulary, not stocked, and should be interchanged over to the same dose of oxyCODONE extended release tablets dosed q 12 hrs. 

tirofiban (Aggrastat) – This intravenous 2B/3A inhibitor is indicated for unstable angina/non-ST elevation myocardial infarction (MI), and an unlabeled use is stable ischemic heart disease undergoing elective PCI, and ST elevation MI undergoing primary PCI. The drug has not been used at Huntsville Hospital for several years, in part due to studies favoring other drugs, lack of a specific bolus dose unit, and marketing of oral antiplatelets. Eptifibatide (Integrelin) is a similar drug offering some advantages. Aggrastat was re-classified as a non-formulary, not stocked drug. 

Exaprel MUE in Orthopedics – This project compared orthopedic surgery patients undergoing TKA or THA, and one group received regular PCA narcotic regimen for post-op pain control, the second group received the regular PCA narcotic plus Exparel. Outcomes measured included average daily pain scores, amount of narcotics consumed, post-op walking distance, and ADR occurrences.  There was no difference between the 2 groups in pain scores, narcotics consumed, or ADR occurrences, and the control group did equally well or better with post-op walking distances.  It was approved based on project results, multidisciplinary input and current literature, that Exparel won’t be used in orthopedic surgeries.

enoxaparin (Lovenox) Renal Dose Adjustment Update – The enoxaparin 40 mg subcutaneously once daily dosing regimen is used for prophylaxis in hip replacement and abdominal surgery, in prevention of VTE in pregnancy (unlabeled), and for medical patients with severely restricted mobility during acute illness. It was approved for automatic pharmacist renal adjustment to interchange the dose from 40 mg once daily to 30 mg once daily if the estimated CrCl is < 30 mL/min.

Ferumoxytol (Feraheme) Protocol – The FDA has emphasized a warning that serious, potentially fatal allergic reactions can occur with this intravenous iron product. The new recommendation for administration is give diluted over at least 15 minutes, and monitor the patient post infusion for at least 30 minutes.  The patient should be in a reclined or semi-reclined position during drug administration.   The Outpatient Medical protocol was adjusted to incorporate the new administration recommendations.  

VTE Core Measure – Therapeutic Anticoagulation – In order to meet VTE Core Measure compliance, all patients must be assessed for qualifying for VTE prophylaxis orders or the rationale for no VTE prophylaxis must be documented in the patient care record. CMS does not recognize IV heparin, argatroban, dabigatran, or rivaroxaban doses of 10 mg or less as qualifying for VTE prophylaxis orders, although they may be clinically appropriate.  To meet this measure, it may be documented instead in the patient care record that these patients are receiving therapeutic anticoagulation.  It was requested and approved for pharmacists to be granted the ability to enter the VTE Prophylaxis Order Set, documenting that the patient is currently receiving therapeutic anticoagulation.