Minutes
Drug Utilization Review Board Meeting
June 10, 2009		

Meeting Purpose: Quarterly Open Board Meeting 6:00 P.M. - 8:00 P.M. Meeting opened at 6:03 P.M. by Chair, Dr. Balder.

Agenda Items:
I.	Welcome and Introductory Remarks
II.	Acceptance of March 2009 DUR Board Minutes
III.	Vivitrol Initiative
IV.	Synagis RetroDUR
V.	DESI/Unapproved Drugs
VI.	Clinical Updates
VII.	MassHealth Drug List
VIII.	DUR Operational Update
IX.	MassHealth Update: Paul Jeffrey

Agenda Item	Discussion	Conclusions/Follow Up	

Review of Minutes	
Motion to approve minutes as written and seconded.
	
Conclusions
Minutes approved as written.

	

Action
		
Follow Up	

Agenda Item	Discussion	Conclusions/Follow Up	

Vivitrol Initiative	

Outlined the background, compared oral naltrexone and Vivitrol, reviewed current prior authorization, utilization between 9/1/08 -2/28/09 and prior authorizations between 4/1/08-3/31/09, reviewed approvals and denials, evidence based medicine, national guidelines, cost comparison and other payors data.

It was noted that some patients may not be able to take medicine orally (i.e. esophageal cancer) which would constitute medical necessity for IM injection. It was also noted that oral is preferred before injection due to possible allergic reaction. Oral ingestion may not always provide positive results if the patient is not taking it correctly.  

Duration is one year.  

Conclusions

•	Vivitrol is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient settting.

•	Other treatments include oral naltrexone, acamprosate and disulfiram.    

•	Cost difference

•	Benefit of Vivitrol

It was recommended to change the approval criteria by adding that the prescriber provides rationale for why the injectable naltrexone would be effective after a failed trial with at least one month of oral naltrexone  
or Medical necessity for IM injection.
	
Action

	

Agenda Item	Discussion	Conclusions/Follow Up	

Synagis
RetroDUR
	
Outlined background, looked at current prior authorization criteria, reviewed 07-08 season and 08-09 season and April 09 season. Pharmacy, hospitalization and member costs were presented.  A compliance comparison for season 07-08 and 08-09 was reviewed.

It was noted that tracking has improved with the RSV system.  	
Conclusions

•	There was a downward trend in utilization over last 3 years.

•	Denial rates were consistent.

•	Compliance increased over the past season.

No recommended changes to the guideline	

Action
	 	
Follow Up	

Agenda Item	Discussion	Conclusions/Follow Up	

DESI
Unapproved
Drugs	
Reviewed the Federal Food Drug and Cosmetic Act (FDCA) of 1938. Discussed the Drug Efficacy Study Implementation (DESI) Program, the program by which the FDA reviewed the efficacy of the pre-1962 drugs. If the DESI review found the drug to be less-than-effective (LTE) and warranted withdrawal from the market, the manufacturer was issued a Notice of Opportunity for a Hearing (NOOH). Also, a Medicaid Program’s role in payment of these medications was reviewed, examples from the last CMS quarterly report were noted and next steps were discussed.

As of December 17, 2008, there were a total of 187 medications included on the quarterly report of unapproved marketed products with DESI/LTE/IRS products.

Conclusions

	

Action

	
Moving forward, MassHealth is currently identifying medications that are included on the quarterly report that have paid claims.

Adjustments to the drug list are being made to comply with the Social Security Act. 	
Follow Up

The market will be monitored and the DESI list will be updated.	

Agenda Item	Discussion	Conclusions/Follow Up	

DUR Annual Clinical Report	
There were 46 new drug reviews (NDR) and 37 new drugs placed on prior authorization. New drug reviews for three genetic disorder drugs were reviewed along with three seizure drugs. New drug reviews also included six “me-too” drugs. PA status changes took place with eight drugs. There were a total of 21 new guidelines and 62 updated guidelines. Quality assurance analysis included the presentation of 34 QA’s. Six resulted in changes in PA status and 10 resulted in modification of PA approval criteria. There were four therapeutic class reviews (TCR) completed and six new initiatives.  

It was noted that many seizure medication costs decreased due to the introduction of generic alternatives.	
Conclusions

•	NDR- 42

•	Guidelines- 21 new and 62 updates

•	QA- 34

•	TCR-4

•	Initiatives- 6	

Action	
	
Follow Up

	

Agenda Item	Discussion	Conclusions/Follow Up	
			
MassHealth Drug List Updates

Action
	There were 20 new drug additions to the MassHealth Drug List effective August 3, 2009.
Changes in prior authorization status effective August 17, 2009 include one drug in the Atypical antipsychotics class, three drugs in the 5-HT3 Receptor Antagonist class, seven powders and 11 in the miscellaneous class.  

It was asked when Topamax will go generic. Perhaps this will occur in 2010, but this is only speculation. It was further noted that prices usually begin to drop around six months from the go- generic date.  

	Conclusions

•	Therapeutic class tables will be added to the MassHealth Drug List with evaluation criteria August 3, 2009.
•	Table 5- Anti-TNF and Antipsoriatic Agents 
•	Table 44- Hepatitis Antiviral Agents
•	Table 45- Injectable Antidiabetic

Please see www.mass.gov/pharmacy for the most current changes to the MassHealth drug list.

Follow Up
	
Agenda Item	Discussion	Conclusions/Follow Up	

MassHealth DUR Operational
Overview	
Prior Authorizations from April 08-April 09 saw a rise in October 08, due to new initiative rollouts. DUR call volume was consistent with an abandonment rate about 2%. Appeals during the same timeframe saw a dip in December 08, due to hearing officer holiday vacations.  

	
Conclusions

Follow Up

The DUR metrics will continue to be monitored and evaluated.

	

MassHealth Update	
The FY 2010 state budget has been subject to numerous revisions, due to the expected stimulus package, a sales tax proposal, and service reduction proposal.  Currently the MassHealth budget stands without adult dental coverage. Dr. Jeffrey projects that the FY 2010 budget will still have to be reduced.

Regulatory changes have been moving along with language change considerations being discussed. MassHealth wants to better ensure that Medicaid is the best payer, then an audit will take place.

On May 26, 2009, the new MMIS system was a major project.  It has been very successful on the inside but not without some problems on the outside. 1.6 M member records were converted to the new system and numerically this was successful. There were no huge disasters with unpaid pharmacy claims. Updates are still needed and time will be needed to streamline all processes. It was noted that several states with new MMIS systems had to discontinue utilization due to so many problems. All in all, MassHealth is doing well updating its technology.  

The MassHealth Pharmacy Program is procuring requests for proposals for 3rd generation Pharmacy Online Processing System (POPS). The current contract expires June 30, 2010. A requested proposal for diabetes test strips was noted and MassHealth will identify preferred and non-preferred products.

The MCO procurement process awards will be announced soon.

In two-three weeks another request for the proposal for a care management program for moderate to high risk patients will take place. The implementation date will be mid-October 2009.  

The Medical Home implementation process continues. A grant that was won by Massachusetts will support 14 community health centers. MassHealth will be embarking on a separate but related effort to identify opportunities and challenges caused by multiple payers for Medical Homes with a consultant firm handling the effort.  
	
Conclusions

Follow Up

Dr. Jeffrey will continue to keep this group apprised of future changes.

Meeting adjourned at 7:45 P.M.

Respectfully Submitted,

Vincent Palumbo, R.Ph.
DUR Program Director