Following is a P and T Committee update (from the June 25^th meeting).  Starting date for specific programs listed below is July1^st, 2013, unless otherwise noted.  This information should soon be available in the formulary notebooks, the formulary website, and Formulary One-Source.  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.

dimethyl fumarate (Tecfidera) – This new oral drug is indicated for relapsing forms of multiple sclerosis (MS), and acts by attenuating oxidative stress and reducing the inflammatory response.  It is dosed BID, has a relatively good safety profile, and costs about $145/day.  It will be used as chronic outpatient therapy and patients are expected to come into the hospital on the drug.  Tecfidera was classified as a formulary agent, infrequent inpatient use is expected.

omacetaxine (Synribo) – This new injection is indicated for resistant CML and is given subcutaneously BID.  The induction dose phase involves administration for 14 consecutive days of a 28 day cycle, and the drug is given for 7 consecutive days of a 28 day cycle for maintenance therapy.  The most serious adverse event involves myelosuppression, and there are dosage adjustments if serious myelosuppression occurs.  The drug costs about $2,000 per day.  Rare inpatient use is expected, in most cases for inpatients the drug is expected to be discontinued by the physician during hospitalization.  Synribo was classified as non-formulary, not stocked.

balsalazide (Giazo) - This is a new formulation of balsalazide, a derivative of mesalamine (5-ASA) used for mild-moderate cases of ulcerative colitis.  The drug is available in 1.1 gram tablets, and generally dosed as 3.3 grams BID.  Colazal is a balsalazide product available in 750 mg capsules and already on the mesalamine product formulary, and is less expensive than Giazo.  Giazo was classified as non-formulary, not stocked, and an automatic interchange to a similar dose regimen of Colazal was approved.  For example, Giazo 3.3 grams BID should be converted to Colazal 2.25 grams TID.

mesalamine (Delzicol) – Asacol 400 mg delayed-release tablets have been discontinued by the manufacturer;  instead, they are now marketing a product called Delzicol, which is available in 400 mg capsule form.  Delzicol is equivalent to Asacol on a 1 mg : 1 mg basis, so Delzicol will take the place of Asacol 400 mg as a formulary agent.

teduglutide (Gattex) – This new parenteral agent is indicated for therapy of  short bowel syndrome for patients on total parenteral nutrition.  The goal of therapy is to reduce TPN requirements, and if possible get the patient off of TPN.  The drug is an analog of glucagon-like peptide-2 (GLP-2) which increases intestinal and portal blood flow and inhibits gastric acid secretion.  Results are increased absorption of nutrients through the GIT.  In one study, after 24 weeks and 52 weeks, 63% and 72% of patients had at least a 20% reduction in TPN volume, respectively, and 7% of patients were completely weaned off of TPN.  The drug costs $800/day or about $24,000/month.  There is a REMS program that requires physician education and certification to prescribe Gattex, due to concerns regarding GI adverse effects, including neoplasms.   Rare inpatient use is expected.  Gattex was classified as non-formulary, not stocked, initiation should be deferred to the outpatient setting, if needed during hospitalization, the patient should use their own supply.

pasireotide (Signifor) – This injectable agent is a somatostatin analog indicated for treatment of Cushing’s disease for whom pituitary surgery is not an option. It is administered subcutaneously BID and can cause various adverse effects. It costs almost $500 daily, and is supplied only through specialty pharmacies, the hospital cannot order this drug.  Signifor was classified as non-formulary, not stocked, and if needed for an inpatient, they will have to use their home supply.  Initiation should be deferred to the outpatient setting.

citalopram (CeleXA) / escitalopram (Lexapro)– Currently there is an automatic interchange program in place with a switch from escitalopram to citalopram unless “no substitution” is written.  This was based on similar safety and efficacy profiles, and a large cost difference between generic citalopram and brand-named Lexapro.  Escitalopram is now generic with a lower price also.  The adverse effects are similar, and both drugs can cause QTc prolongation particularly with larger doses.  There has been more publicity on this issue with citalopram recently, and this alert has been moved to the precautions/warning section in the citalopram PI;  for escitalopram, QTc prolongation is still listed in the adverse reaction section.  Based on similar costs, it was recommended through the psychiatry department, and approved by the P and T Committee, that the automatic interchange be discontinued.   A program adjustment will be made in ICare. 

Erythromycin Topical Ointment – This product is mainly used for acne, and hospital use has been extremely low.  However, there have been medication errors related to the confusion of the ophthalmic ointment versus the regular topical ointment.  Therefore, it was recommended and approved to remove the topical ointment product from the formulary, to avoid these medication errors. 

Carbapenem Update – Due to the manufacturer discontinuing the national Doribax contract, our cost of doripenem will increase significantly. Meropenem (Merrem) is a viable alternative agent, has had no recent drug supply issues, and costs will be much lower.  After review, it was approved to change the carbepenem formulary workhorse agent from doripenem to meropenem, based on similar efficacy and safety, but less cost (estimates are saving over $500,000 annually by using meropenem as workhorse).  This new formulary interchange will begin July 9, 2013, when pyxis machines are expected to be stocked with meropenem.  The interchange dose nomogram from Primaxin and doripenem to meropenem will be posted in the formulary information sites.