Following is a P and T Committee update (from the December 17th meeting).  Starting date for specific programs is December 23, 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. 

doxylamine-pyridoxine (Diclegis) - This new product combines 2 older generic drugs, doxylamine succinate and pyridoxine, for the treatment of nausea and vomiting of pregnancy, specifically for use in pregnant women who have not improved with change in diet or other non-drug treatments. The Diclegis regimen costs about $15 - $25 per day, and using the generic products costs about $0.30 per day.  It was approved to interchange  doxylamine 25 mg and pyridoxine 25 mg generic tablets for Diclegis in similar daily regimens.  Diclegis was classified as non-formulary, not stocked.

pirbuterol (Maxair Inhaler) – This agent is an older short acting beta-2 agonist indicated for management of bronchospasms associated with obstructive airway disease. The cost for a monthly inhaler is over $500.  Albuterol is a very similar drug that is much lower in cost.  It was approved to interchange pirbuterol to albuterol inhaler on a 1:1 puff ratio, given at the same frequency.  Pirbuterol will be classified as non-formulary, not stocked.

tbo-filgrastim (Granix) – This is a “biosimilar” product essentially identical to Neupogen, manufactured by Teva. Studies show that very similar clinical results were obtained between Neupogen and Granix.  Currently, Granix is less expensive, but the pricing structure of both products may change in the coming months.  Over the next few months, physician education will be presented on Granix use.  Granix was approved for formulary status, and for now both Neupogen and Granix should be dispensed as written. 

dolutegravir (Tivicay) – This is a new integrase inhibitor used to treat HIV. The drug is given once daily with combination therapy and costs about $40/day.  There are various drug interactions associated with its use.  It was approved for formulary status.    

rifAXIMin (Xifaxan) - At the request of GI physicians, the Xifaxan 200 mg tablet was added back to the formulary to allow for more flexible dosage regimens with this drug.   Both the 200 mg and 550 mg strengths are restricted to GI and ID physicians, and to UAB in cases where another first line agent has been tried for at least 72 hours and did not product the desired response or was not tolerated.

radium Ra 223 (Xofigo) – This new radiation drug is indicated for castration-resistant prostate cancer, with symptomatic bone metastasis and no known visceral metastatic disease, and is given intravenously every 4 weeks for 6 doses. Adverse reactions include GI symptoms and bone marrow suppression.  The cost is about $12,000 per dose.  The drug was approved as formulary, restricted to Radiation Oncology in the outpatient settings.   The dosage regimen is planned in advance, and the drug is prepared at Cardinal Health radiology department in Denver, , and sent to the hospital for administration.  Each patient will be evaluated in the assessment phase for financial management, including payment and reimbursement, and an individualized plan developed.   The hospital should make a profit with the use of Xofigo.

desvenlafaxine ER (Khedezla) – This is a new dosage form of desvenlafaxine (Pristiq) that is very similar to the brand name product. Pristiq has recently gone generic.  Khedezla was classified as non-formulary, not stocked, with an automatic interchange to generic desvenalfaxine on a 1:1 dosage ratio.  

buprenorphine – There are now 3 sublingual products with this drug, Suboxone (buprenorphine plus naloxone in 2 different strengths available generically), Subutex (buprenorphine in 2 different strengths available generically), and Zubsolv (buprenorphine plus naloxone in 2 different strengths as a branded product with increased bioavailability). We currently stock the generic version of Suboxone.  Naloxone is not absorbed orally and is included to decrease the use of  these products intravenously as abuse.  It was approved to use Suboxone for Subutex and Zubsolv in equivalent strengths.   For Subutex, the conversion is a 1:1 buprenorphine dose ratio and for Zubsolv the conversion is buprenorphine 1.4 mg to Suboxone with 2 mg buprenorphine, and for Zubsolv with 5.7 mg of buprenorphine to Suboxone with 8 mg buprenorphine.  Subutex and Zubsolv were classified as non-formulary, not stocked.

zoledronic acid (Zometa) – The interchange policy from Zometa to pamidronate has been modified as follows: for patients with documented fluid restrictions, zoledronic acid may be dispensed if the larger administration volume with pamidronate (i.e. 500 ml versus 50 ml) would result in exceeding the patient’s fluid limit. 

Pentobarbital Coma Protocol – This protocol is designed for use in refractory intracranial pressure management/status epilepticus, and addresses loading and maintenance doses, infusion titration and tapering, and monitoring.

Daptomycin Dose Rounding Proposal – To decrease daptomycin waste, it was approved to round the dose to the nearest 50 mg.  For example, a 500 mg dose will be used for doses in the 475 mg  to 525 mg range. Doses less than 275 mg should for now be dispensed as written.  This should help decrease drug waste significantly and is planned to be implemented into ICare in December.  Date of implementation to be announced.