Drug Utilization Review (DUR) Board Meeting Summary - November 12, 2009

Agenda and Introduction

The Drug Utilization Review Board met on Thursday, November 12, 2009 from 9:00 A.M. to 5:00 P.M., in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

A. Background Materials Provided:

The DUR Board members were provided copies of materials submitted by interested parties in advance of the meeting.

B. Public Comment Period:

The following speakers provided comments to the DUR Board:

1. Rhonda M. Sanders, PharmD, BCPS, Regional Medical Specialist, GlaxoSmithKline, Fairport, NY.
2. Robert J. Wiles, National Account Manager, Bausch & Lomb Incorporated, Longmeadow, MA.

C. Key Issues Presented by Interested Parties and Discussed by the DUR Board during the Public Comment Period:

Nasal Corticosteroids
The DUR Board was asked to consider information regarding fluticasone furoate including indications, dosing, and the delivery device. The DUR Board was also presented information related to the effectiveness of treatment for nasal and ocular symptoms as well as financial impact relating to concomitant therapy with other allergy medications.

Inhaled Corticosteroids
The DUR Board was asked to consider information regarding fluticasone propionate and fluticasone propionate in combination with salmeterol including indications, adverse events and delivery devices. The DUR Board was also presented with information associated with the national asthma guidelines (including those from National Institutes of Health) as well as the use of inhaled corticosteroids in combination with other asthma medications.

Ophthalmic Fluoroquinolones
The DUR Board was asked to consider information regarding the use of besifloxacin ophthalmic suspension for the treatment of bacterial conjunctivitis. An overview of bacterial conjunctivitis was provided, as well as information regarding clinical trial results and the reported adverse effects.

The DUR Board discussed and commented on the use of other non-fluoroquinolone ophthalmic antibiotics in the treatment of conjunctivitis including the cost of besifloxacin and whether this product's efficacy has been compared to other non-fluoroquinolone ophthalmic agents.

D. Presentations and Discussions:

The following speakers presented to the DUR Board:

1. Fahr, Rita, RPh, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health
2. Lehmann, David, MD, Pharm D, Professor of Medicine and Pharmacology, State University of New York Upstate Medical University
3. Figge, James, MD, Medical Director, Office of Health Insurance Programs, New York State Department of Health
4. Finnerty, Molly, MD, Director, Bureau of Evidence Based Services & Implementation Science, NYS Psychiatric Institute, Office of Mental Health
5. Merola, Anthony, RPh, MBA, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health
6. Naioti, John, RPh, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health
7. Toohey, Monica, RPh, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health
8. Doloresco, Fred, Pharm D, Clinical Assistant Professor, School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo
9. Wrobel, Mark, Pharm D, Clinical Assistant Professor, School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo
10. Coe, Holly, Pharm D, Clinical Assistant Professor, School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo

Medication Therapy Management (MTM)
A Medicaid Medication Therapy Management (MTM) program status report was presented to the DUR Board by Rita Fahr. The DUR Board was provided the status of the State Plan Amendment (SPA) and waiver, pharmacy/pharmacists enrollment process, pharmacist training, and patient enrollment. Ms. Fahr responded to questions regarding pharmacy enrollment, pharmacist training related to continuing education credits and requirements surrounding beneficiaries' eligibility parameters related to claims history or previous health care services.

Prescriber Education Program (PEP)
Dr. Lehmann and Dr. Figge presented the Prescriber Education Program (PEP) update. Dr. Lehmann discussed several PEP modules including the training links on the NYSDOH website for bronchiolitis, diabetes, asthma and hypertension. As discussed, training videos and CME courses are also available on the website and include youth and adult cardio-metabolic and psychotropic poly-pharmacy modules. Dr. Figge noted that the PEP has an academic educational component offered as statewide on-site educational programs. These involve a combination of educational materials, phone conversations, and face-to-face visits by academic clinical pharmacists from SUNY Medical and Pharmacy campuses. Dr. Figge also provided information related to the e-prescribing initiative including SPA approval status and the financial incentives for prescribers and pharmacies. It was noted that more detailed information regarding e-prescribing will be disseminated through the Medicaid Update.

Psychiatric Services and Clinical Knowledge Enhancement System (PSYCKES)
Dr. Finnerty presented the PSYCKES update. Dr. Finnerty discussed PSYCKES being used in the participating agencies and the resulting impact on improving the safety and quality of psychotropic medication management. The DUR Board was presented the PSYCKES Continuous Quality Improvement Quarterly Report for the third quarter of this year (July to September 2009). The Board was presented project metrics including prevalence rates of poly-pharmacy in the Medicaid claims data and the number of current outliers who have had their PSYCKES clinical summary information reviewed. Also presented were clinical conversion and project impact over time statistics.

Medicaid DUR Board Activities Report
Anthony Merola provided the DUR Board activities report. Mr. Merola reviewed those Clinical Drug Review Program (CDRP) items that were previously addressed by the DUR Board and referred to the Pharmacy and Therapeutics (P&T) Committee for further evaluation. The DUR Board was provided a brief overview of the P&T Committee's recommendations in relation to the Commissioner's final determinations and implementation timelines.

Becaplermin
Dr. Holly Coe and Dr. Fred Doloresco presented the becaplermin utilization review. The Board was provided a review of becaplermin including public health concerns and the FDA black box warning associated with the risk of mortality secondary to malignancy observed in patients treated with three (3) or more tubes. The Board was also provided with NYS Medicaid claims utilization information related to potential overutilization or misuse. Prior authorization requirements from comparator state Medicaid programs were also reviewed.

Oral Bisphosphonates
The oral bisphosphonate utilization review was presented by John Naioti. The DUR Board was provided with a general overview of the products under review (i.e. once weekly and monthly formulations) including indications for use. The Board was also provided with NYS Medicaid claims utilization information specifically related to inaccuracies in the day supply provided by the pharmacy, and the importance of the accuracy of claims information, in order for the Pro-DUR editing system to function properly.

Inhaled Corticosteroids
The inhaled corticosteroid utilization review was presented by John Naioti. The DUR Board was provided with a general overview of the products under review, including indications for use. The Board was also provided with NYS Medicaid claims utilization information specifically related to inaccuracies in the day supply provided by the pharmacy, and the importance of the accuracy of claims information, in order for the Pro-DUR editing system to function properly.

Intranasal Corticosteroids
The intranasal corticosteroid utilization review was presented by John Naioti. The DUR Board was provided with a general overview of the products under review, including indications for use. The Board was also provided with NYS Medicaid claims utilization information specifically related to inaccuracies in the day supply provided by the pharmacy, and the importance of the accuracy of claims information, in order for the Pro-DUR editing system to function properly.

Diclofenac 3% Gel
The diclofenac 3% gel utilization review was presented by Monica Toohey. The DUR Board was provided with a general overview of the product, including dosing and administration, warnings and precautions, and adverse reactions. The Board was also provided with NYS Medicaid claims utilization information specifically related to quantity dispensed, frequency of dispensing, duration of therapy, and the association with factors including potential over-utilization and misuse.

Tramadol
Dr. Mark Wrobel and Dr. Fred Doloresco presented the tramadol utilization review. The DUR Board was provided with a general overview of the immediate release (IR) and extended release (ER) products and their indications and acceptable uses. The Board was also provided with NYS Medicaid claim utilization information, including quantity per claim, frequency of refills, the incidence of progression of therapy from IR to ER and acute and chronic use. Prior authorization requirements from comparator state Medicaid programs were also reviewed.

Ophthalmic Fluoroquinolones
Dr. Mark Wrobel and Dr. Fred Doloresco presented the ophthalmic fluoroquinolone (FQ) utilization review. The DUR Board was provided with a general overview of the drug class including the indications, acceptable uses and clinical considerations associated with the incidence of bacterial resistance. The Board was also provided with NYS Medicaid claims utilization information, including quantity, frequency, patient age, and progression of therapy from and to other non-FQ ophthalmic antibiotics. Prior authorization requirements from comparator state Medicaid programs were also reviewed.

E. DUR Board Discussion

The DUR Board discussed becaplermin in the context of the criteria for inclusion in the Clinical Drug Review Program (CDRP). The discussion focused on the black box warning concerning the increased rate of mortality secondary to malignancy in patients treated with three or more tubes of becaplermin, and application of a prior authorization requirement subsequent to a cumulative dose of three (3) or more tubes. The discussion also included the topic of ulcer site infection prevention and treatment.

The DUR Board discussed Pro-DUR claims system and the importance of accurate information as provided by pharmacies at the point of service. DOH staff and DUR Board members agreed that without accurate information the Pro-DUR claim system edits would not serve their intended purpose. The DUR Board discussed the limited impact point-of-service editing has on prescribers and the way in which reinforcing appropriate days supply information could improve overall pharmaceutical care, ensuring dispensing accuracy and appropriate utilization.

The DUR Board discussed factors that may be contributing to the increased utilization of diclofenac 3 % gel including similar products that are currently subject to prior authorization as non-preferred drugs on the preferred drug list. They also discussed the prevalence of an actinic keratoses diagnosis for those utilizing the drug.

The DUR Board discussed the use of tramadol in relation to other short acting opioids and addiction potential as well as transitioning patients from short acting formulations to extended-release products when treating chronic pain. They discussed step therapy and the period associated with previous utilization of tramadol or another opioid-type pain reliever. The DUR Board also discussed daily dosing of the ER dosage formulations and the cost effectiveness of dose optimization through quantity limitations.

The DUR Board discussed utilization of ophthalmic FQs associated with patient age, prescriber specialty, indications for use and the effectiveness of this class of drug in relation to other ophthalmic antibiotics.They also discussed the impact that step therapy may have on the prescriber community, and concerns with overutilization related to incidence of bacterial resistance and treatment of viral conjunctivitis.

G. DUR Board Action:

Becaplermin

The DUR Board took the following actions regarding becaplermin:

• Agreed that becaplermin met the criteria for inclusion into the CDRP.
• Recommended that the Medicaid P&T Committee consider becaplermin for CDRP inclusion.
• Recommended that the P&T Committee consider the following prior authorization questions:
  1. Has the patient been diagnosed with a lower extremity diabetic neuropathic ulcer?
  2. Is becaplermin gel being used as an adjunct to good ulcer/wound care including debridement, pressure relief and infection prevention?
  3. If the patient has an existing infection at the ulcer/wound site, is the infection being treated?
  4. Does the patient have a neoplasm at the site or any known malignancy?
  5. Is there a history of the patient using two (2) or more tubes? If so, what is the clinical rationale for using more than two (2) tubes?
• Agreed that becaplermin should have a frequency/quantity/duration limit of 2 tubes in a lifetime.
• Recommended that the P&T Committee consider the following F/Q/D prior authorization question:
  • What is the clinical rationale that would justify use greater than that supported by FDA approved labeling?

Oral Bisphosphonates

The DUR Board took the following actions regarding oral bisphosphonates:

• Agreed that quantity and frequency limits should be applied to the oral bisphosphonates dosed once weekly or once monthly to ensure appropriate utilization.
• The limits should be based on FDA approved dosing and administration labeling.
• Utilization exceeding FDA approved dosing and administration labeling limits should require prior authorization.
• The following prior authorization question will be asked when the limits are exceeded:
  • Q: What is the clinical rationale that would justify use greater than that supported by FDA approved labeling?

Inhaled Corticosteroids

The DUR Board took the following actions regarding inhaled corticosteroids:

• Agreed that quantity and frequency limits should be applied to the inhaled corticosteroids to ensure appropriate utilization.
• The limits should be based on FDA approved dosing and administration labeling.
• Utilization exceeding FDA approved dosing and administration labeling limits should require prior authorization.
• The following prior authorization question will be asked when the limits are exceeded:
  • Q: What is the clinical rationale that would justify use greater than that supported by FDA approved labeling?

Intranasal Corticosteroids

The DUR Board took the following actions regarding intranasal corticosteroids:

• Agreed that quantity and frequency limits should be applied to the intranasal corticosteroids to ensure appropriate utilization.
• The limits should be based on FDA approved dosing and administration labeling.
• Utilization exceeding FDA approved dosing and administration labeling limits should require prior authorization.
• The following prior authorization question will be asked when the limits are exceeded:
  • Q: What is the clinical rationale that would justify use greater than that supported by FDA approved labeling?

Diclofenac 3% Gel

The DUR Board took the following actions regarding diclofenac 3% gel:

• Agreed that quantity and frequency limits should be applied to diclofenac 3% gel to ensure appropriate utilization.
• The limits should be based on FDA approved labeling for indications, dosing and administration labeling.
• A maximum of one-hundred (100) grams as a ninety (90) day supply would be available once a year without prior authorization. The yearly limitation would begin upon the date of service of the initial claim at the pharmacy.
• The following prior authorization question would be asked when the limits are exceeded:
  • Q: What is the clinical rationale that would justify use greater than that supported by FDA approved labeling?
• Requested a review of utilization data for a period of six (6) months subsequent to the implementation of the quantity and frequency limitations.

Tramadol

The DUR Board took the following actions regarding tramadol:

• Agreed that quantity and frequency limits should be applied to ER formulations to ensure appropriate utilization and cost effectiveness.
• The limits should be based on FDA approved dosing and administration labeling. Utilization of tramadol ER products exceeding a maximum of thirty (30) dosage units as a thirty (30) day supply would require prior authorization.
• The following prior authorization question would be asked when the limits are exceeded:
  • Q: What is the clinical rationale that would require utilization of multiple extended-release formulations rather than dosing with a single extended-release formulation of equivalent strength?
• Agreed that step therapy limitations be applied to tramadol ER formulations based on a trial of the IR formulation in tramadol naïve patients to ensure appropriate utilization and cost effectiveness.
• Prior authorization would be required for tramadol ER formulations if the patient is tramadol naïve. For patients that have previous utilization of tramadol IR or have an established therapy on extended-release tramadol formulations, no prior authorization would be required for tramadol ER.
• The following prior authorization question would be asked when patients have no previous experience with tramadol IR prior to utilization of tramadol ER:
  • Q: What is the clinical rationale that would require utilization of tramadol ER in the absence of previous use of tramadol IR?

Ophthalmic Fluoroquinolones

The DURB took the following actions regarding ophthalmic fluoroquinolones (FQ)

• Agreed that step therapy limitations be applied for ophthalmic FQs for patients twenty-one (21) years of age or younger to ensure appropriate utilization and cost effectiveness.
• Prior authorization would be required for ophthalmic FQs for patients twenty-one (21) years of age or younger if the patient has not attempted to use a non-FQ ophthalmic antibiotic. Prior authorization would not be required for patients older than twenty-one (21) years of age.
• The following prior authorization question would be asked when patients twenty-one (21) years of age or younger have not first attempted use of a non-FQ ophthalmic antibiotic:
  • Q: What is the clinical rationale that would require utilization of an ophthalmic FQ prior to use of a non-FQ ophthalmic antibiotic?

The meeting adjourned at 3:30 pm

Meeting Summary Posted 12/14/2009