Medicaid Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary from Previous Meeting - February 2, 2006

Agenda

The Medicaid Pharmacy and Therapeutics Committee met on Thursday, February 2, 2006 from 10:30 a.m. to 3:00 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

A. Background Materials Provided:

The Committee was provided copies of written materials submitted by interested parties in advance of the meeting.

B. Public Comment Period:

The following speakers addressed the committee:

  1. Banas, John S. MD, FACC: Couer Consulting, Chicago, IL
  2. Bell, Charles, Program Director: Consumers Union, Yonkers, NY
  3. Goldgerg, Allan I., MD: Executive Medical Director, Merck & Co.,Inc. Westpoint, PA
  4. Torosoff, MD,FACC: Assistant Professor Medicine, Albany Medical College, Albany, NY
  5. Steven Earle, PharmD, Astra Zeneca: Wilmington, DE
  6. Lewis, Robert, PharmD, Director, Cardiovascular Metabolic Medical Information and Communication, Novartis Pharmaceuticals Corp., East Hanover, NJ
  7. Horn, Angela J., MD, Manager, Medical and Scientific Affairs, Sankyo Pharma, Inc., Parsippany, NJ
  8. Henriquez, Mario, MD, FACP, FASN, Bronx Nephrology Hypertension PC, Bronx, NY
  9. Marble, Dwight A., PharmD, Senior Medical Sciences Liaison, Bristol-Myers Squibb, Rochester, NY
  10. Hicks, Carl, VP, Advocacy, Pulmonary Hypertension Association, Silver Springs, MD
  11. Govaker, David, MD, Medical Director, Pfizer, Arlington, VA
  12. Schmidt, Joanne, Pulmonary Hypertension Association, Member, Board of Trustees, Silver Springs, MD
  13. Dr. Epstein, reading the written statement of Barst, Robyn J., MD, Director, New York Presbyterian Pulmonary Hypertension Center, New York, NY
  14. Iwanowicz, Peter M., VP and Chief Policy Officer, American Lung Association of New York State, Inc., Albany, NY

C. Key Issues Raised by Interested Parties and Pharmacy and Therapeutics Committee Response:

On the topic of identification of preferred drugs in the category of Angiotensin Converting Enzyme (ACE) Inhibitors:

  • Information regarding trial results (efficacy, target organ response, use in special populations) for ramipril (Altace) was presented.
  • The Committee was asked to consider possible exceptions and to acknowledge patient response differences in certain populations. The Committee was commended for utilizing insulated, impartial evidence-based medicine in their deliberations.

On the topic of identification of preferred drugs in the category of Angiotensin Receptor Blockers/Angiotensin II Receptor Antagonists (ARBs/AIIRAs):

  • Information regarding trial results (indications, risk reduction, adverse events, decrease in hospitalizations for heart failure) and general overviews of specific drugs in this class was presented.
  • The Committee was asked to consider drugs that may be more expensive but may have more convenient dosing and could increase savings as a result of a reduction in heart failure, cardiovascular mortality and heart failure hospitalization. The Committee was also asked to consider the ability of a physician to have agents available to treat specific patient populations, such as patients with chronic kidney disease.

On the topic of Prior Authorization of Revatio (sildenafil citrate):

  • Patient advocates and other interested parties described pulmonary hypertension and its treatment options (routes of administration include: intravenous, subcutaneous, inhalation and oral) and potential issues with toxicities or the route of administration were also discussed.
  • Medicaid coverage of Revatio, with prior authorization, was supported by several speakers.
  • The manufacturer requested coverage of Revatio with a simplified prior authorization process, using two simple yes or no questions and an automated telephone system to assure appropriate utilization.

D. Pharmacy and Therapeutics Committee Questions/Responses:

  • Dr. Martin (Chairman) questioned speakers on ACE Inhibitors and ARBS whether they had any comments on the Oregon Health & Science University Drug Effectiveness Review Project (OHSU DERP), and whether the study adequately addressed their information. Not all speakers had reviewed these OSHU documents, but most felt other OHSU publications were fair and balanced.
  • Ms. Desmond (DOH) clarified that Revatio is already covered by NYS Medicaid using an interim review process, and the Committee was to consider how the drug should be subject to prior authorization under the Clinical Drug Review Program.
  • Committee members questioned interested parties on the criteria that should be used to determine a diagnosis of pulmonary hypertension including clinical tests and parameters. In response, it was noted that the World Health Organization's (WHO) criteria are appropriate.
  • Questions were raised regarding the use of Revatio including increases in recommended doses, adverse events associated with ocular changes and whether there are any studies for long term use in patients with pulmonary hypertension. It was noted that there are no such current studies, but the data is continually being collected.

E. Discussion: Review of OHSU DERP findings
Mark Helfand, MD, Oregon Health & Sciences University, Evidence-based Practice Center (OHSU EPC)

F. Clincial Presentation and Discussion: Proposal to identify preferred drugs in the category of Angiotensin Converting Enzyme Inhibitors (ACEI)

ACE Inhibitors
Drugs Affected: Accupril (quinapril HCL), Aceon (perindopril erbumine), Altace (ramipril), benazepril HCL, Capoten (captopril), captopril, enalapril maleate, fosinopril sodium, lisinopril, Lotensin (benazepril HCL), Mavik (trandolapril), moexipril HCL, Monopril (fosinopril sodium), Prinivil (lisinopril), quinapril HCL, Univasc (moexipril HCL), Vasotec (enalapril maleate), Zestril (lisinopril).

ACE Inhibitors/Diuretic Combinations
Drugs Affected: Accuretic (quinapril/hctz), benazepril HCL/hctz, Capozide (captopril/hctz), captopril/hctz, enalapril maleate/hctz, fosinopril/hctz, lisinopril/hctz, Lotensin HCT (benazepril HCL/hctz), Monopril HCT (fosinopril/hctz), Prinzide (lisinopril/hctz), Quinaretic (quinapril/hctz), Uniretic (moexipril/hctz), Vaseretic (enalapril maleate/hctz), Zestoretic (lisinopril/hctz).

Mark Helfand, MD, Oregon Health & Sciences University, Evidence-based Practice Center (OHSU EPC); Rob Coppola, PharmD, First Health Services Corporation (FHSC); Robert Correia, PharmD, NYS Department of Health, Office of Medicaid Management (DOH/OMM)

Dr. Mark Helfand (OHSU) provided a review of the process and approach used to find all OHSU drug effectiveness studies, including those that may not have been published. He described the comprehensive, systematic drug review process which is completed, the opportunities for public input into the study design, and the scope of the review process. Studies that address health outcomes including mortality, symptoms and quality of life, that provide more direct evidence, that are practice based and applicable to real patients, and that evaluate harm versus benefit and the tolerability of doses are best. Many studies do not completely address all of these topics. He reminded the Committee that the OHSU DERP reports do not make recommendations, rather provide a source of information which may be interpreted differently in different states.

Dr. Helfand presented the following key questions that were addressed by the OHSU DERP ACEI report:

  1. For adult patients with essential hypertension, heart failure, high cardiovascular risk factors, diabetic nephropathy, non-diabetic nephropathy, or recent myocardial infarction, do angiotensin converting enzyme inhibitors differ in efficacy?
  2. For adult patients with essential hypertension, heart failure, high cardiovascular risk factors, diabetic nephropathy, non-diabetic nephropathy, or recent myocardial infarction, do angiotesnsin converting enzyme inhibitors differ in safety or adverse events?
  3. Are there subgroups of patients based on demographics (age, racial groups, gender), other medications, or co-morbidities for which one angiotensin converting enzyme inhibitor is more effective or associated with fewer adverse events?

Dr. Helfand noted that current standards of therapy were not always evident in older drug trials. The report addressed this by reviewing the array of drugs that patients were on. Various trials were reviewed with the following conclusions:

  • There is evidence from head-to-head trials that, especially in heart failure (HF), many ACEIs are similar in short-term effectiveness and adverse events. Several ACEIs reduce mortality after myocardial infarction in various subgroups (no HF, asymptomatic LV dysfunction and clinical HF). There is no definitive evidence that they differ in long-term effectiveness for major cardiovascular and renal endpoints. Across indications, the evidence for mortality reductions is strongest for captopril, enalapril and ramipril.

Dr. Coppola of First Health Services Corporation (FHSC) presented further information on the category, and discussed the availability of brand and generic ACEIs and their indications, dosing and common pharmacology. He concluded that based on their review of the literature, there was not evidence to suggest differences in efficacy between any of the ACEIs, as direct comparative evidence (head-to-head trials) is lacking. In addition, there is no compelling or conclusive evidence that differences in the properties and pharmacokinetic profiles of these agents lead to any differences in efficacy or adverse event profiles. He further noted that the benefits of ACEIs in decreasing mortality rate in HF and in treating diabetic nephropathy are considered class effects.

Dr. Correia, Office of Medicaid Management, provided the Department's recommendations regarding the clinical reviews for this category of drugs. He noted that the OHSU reports were an exhaustive and comprehensive review of available evidence. These reports addressed concerns relevant to treatment efficacy and safety in the context of varied disease states as well as patient demographics, inclusive of the NYS Medicaid population. Dr. Correia noted that there is a lack of evidence to demonstrate overall comparative advantage or disadvantage between ACEIs in terms of efficacy, serious complications, adverse events, or safety. Captopril and lisinopril are drugs already in an active form and may offer an advantage for a special population, such as those with impaired liver function. Drug trials repeatedly reinforce the concept of similarity in safety and efficacy between ACEIs. No differences have emerged in long-term effectiveness for major cardiovascular or renal endpoints. Dr. Correia concluded that at this time there is not adequate evidence of any drug with overall clinical superiority in this class.

Committee members asked interested parties and manufacturers presenting drug trial information to provide new information that may be relevant to drugs under review and that a general review of the drug or a review of older drug trials is not very useful. Committee member Dr. Mark Johnson noted that interested parties speaking on behalf of particular drugs or classes should encourage the completion of additional research which addresses the impact of special populations such as minorities, HIV/AIDS populations and other subgroups of the Medicaid population.

The membership was provided sample prior authorization criteria questions based on Public Health Law and clinical considerations for discussion. These questions are applicable to both the ACEI category and the ARB/AIIRA category.

G. Clinical Presentation and Discussion: Identification of preferred drugs in the category of Angiotensin Receptor Blockers (ARBs/AIIRAs)
Mark Helfand, MD, (OHSU EPC); Rob Coppola, PharmD, (FHSC); Robert Correia, PharmD, (DOH/OMM)

ARBs/AIIRAs
Drugs Affected: Atacand (candesartan cilexetil), Avapro (irbesartan), Benicar (olmesartan medoxomil), Cozaar (losartan potassium), Diovan (valsartan), Micardis (telmisartan), Teveten (eprosartan mesylate).

ARBs/AIIRAs Diuretic Combinations
Drugs Affected: Atacand HCT (candesartan cilexetil/hctz), Avalide (irbesartan/hctz), Benicar HCT (olmesartan medoxomil/hctz), Diovan HCT (valsartan/hctz), Hyzaar (losartan/hctz), Micardis HCT (telmisartan/hctz), Teveten HCT (eprosartan/hctz).

Dr. Helfand reported on the OHSU DERP review of the ARB/AIIRA class of drugs. He noted that this class of drugs is not considered a first line approach to heart failure therapy unless patients are unable to tolerate ACEIs. Various drug trials were discussed with Dr. Helfand noting that there were no ARB/AIIRA trials in different ethnic races and no trials evaluating and reporting health outcomes. In conclusion Dr. Helfand reported that there are no published head-to-head trials which would support strong conclusions of relative efficacy and safety. Conclusions of comparable effectiveness could still be supported by consistent evidence from trials that compare the different ARB/AIIRA to a common comparator, generally a placebo. In such cases, indirect measures of comparative efficacy may be justified. However, often the other drugs the subjects were taking during the trials were not comparable or were not reported. Thus unequivocal, consistent evidence was not found regarding the differential efficacy and risks among the drugs in the ARB/AIIRA class.

Dr. Coppola provided a brief review of the pharmacology of the ARB/AIIRA class of drugs noting there is little to no difference in the pharmacology of these agents and that their effects to lower blood pressure are considered a class effect. He concluded that while ARBs/AIIRAs have a place in therapy for patients intolerant of ACEIs, their advantages are most likely a class effect and that there are no differences in outcomes that indicate an overall clinically preferential drug(s) in this class.

Dr. Correia noted that the OHSU reports were an exhaustive and comprehensive review of available evidence. These reports addressed concerns relevant to treatment efficacy and safety in the context of varied disease states as well as patient demographics, inclusive of the NYS Medicaid population. Dr. Correia stated that all ARBs/AIIRAs are FDA approved for hypertension and that their benefit in heart failure, diabetic nephropathy and left ventricular hypertrophy is thought to be a class effect, even though not all have been specifically tested for each use. FDA labeling for contraindications, warnings and adverse drug events are similar for all ARBs/AIIRAs and reinforce the concept of class effects. Dr Correia reported that active treatment trials did not use consistent comparators (other than placebo) and noted that there is a lack of head-to-head studies to evaluate relative efficacy between the various ARB/AIIRA agents. Dr. Correia concluded that at this time there is not adequate evidence to demonstrate overall clinical superiority by any one agent in this class.

The Committee asked Dr. Helfand to address the nephropathy issue (two drugs have indications for nephropathy) within this class of drugs. Dr. Helfand advised that there were conflicting results in the trials which make it difficult to see a class effect and that there were gaps in the ARB/AIIRA studies. He stated that just because no variation in studies is seen, that this could be considered a complete class effect.

The membership was provided sample prior authorization criteria questions based on Public Health Law and clinical considerations for discussion. These questions are applicable to both the ACEI category and the ARB/AIIRA category.

H. Clinical Presentation and Discussion: Prior Authorization of Revatio (sildenafil citrate) Robert Correia, PharmD, (DOH/OMM)

The Committee was asked to consider a proposal to include Revatio in the Clinical Drug Review Program. This proposal would require prior authorization to assure access to the drug for approved indications and to avoid misuse and overuse.

Dr. Correia presented the background for the request for prior authorization, noting that the FDA identifies Revatio and Viagra as the same drug in new labeling updated November 2005 and discussed issues related to Viagra's history of overuse, diversion, abuse, illegal use and over-utilization in the NYS Medicaid program. Dr. Correia described the adverse events including those related to loss of vision and other ocular events. He discussed the Department's concern regarding the very large volume of tablets which would need to be dispensed (90 tablets per prescription fill), and indicated that as a result, the use of Revatio should require a substantial review process to assure appropriate utilization to this limited PH population.

Dr. Correia then discussed the diagnostics used to confirm the presence of PH, establish the specific type of PH, and to determine the severity of PH. The five main therapies with an FDA indication for PH were discussed.

Dr Correia proposed the NYS Medicaid Pharmacy and Therapeutic Committee recommend prior authorization, using the live call line, and/or faxing confirmation of diagnosis of PH, for Revatio. He also recommended that the Committee approve the inclusion of a review of use by convicted sexual offenders, prior to approval of use. He proposed clinical criteria for the approval of Revatio use, which included confirming the diagnosis of pulmonary hypertension from adequate standards of evaluation, reinforced counseling of the patient regarding contraindications and serious risks, and the requirement that the prescriber themselves, rather than office staff, complete the PA process.

The Committee raised several concerns including how to allow access to this drug by sexual offenders who require this treatment for PH. The purpose of the NYHA/WHO Classification was raised, which is used to describe the patient's current functional status. Dr. Correia advised that this identifies essential monitoring of patient disease status and progression. Committee members asked if prior authorization review staff would have access to claims data for diagnosis information, and whether diagnosis data is available to the reviewers. It was noted that diagnosis data is not readily available from many types of claims data, and is not generally reliable. The Committee also questioned the inclusion of a criteria related to the use of the medication as an oral erectile dysfunction medication. Dr. Correia explained these criteria would help determine if there is harmful, duplicative therapy. The Committee suggested combining several individual questions to consolidate some of the criteria topics.

After further discussion and considering the information and concerns raised by the interested parties and the membership, the Committee voted unanimously to recommend the prior authorization of Revatio, using the live call line, including the ability to fax in diagnostic information, and applying a condensed set of approval criteria (see below). It was also recommended that the review process include a check to determine if the patient is a convicted sexual offender. If the Revatio is required treatment for PH for a convicted sex offender, treatment should not necessarily be denied, but enhanced monitoring or follow-up should be applied. It was also recommend that reimbursement for Revatio should be denied if there is substantial evidence of patient or provider fraud and abuse.

I. Executive Session:

The Committee adjourned the public session at 12:25 P.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: ACEI/ACEI and diuretics and the ARB/AIIRA and ARB/AIIRA and diuretics. No official action was taken in the executive session. The executive session was adjourned at 2:00 P.M.

J. Recommendations of the Pharmacy and Therapeutics Committee:

The following recommendations developed by the P&T Committee are to be submitted to the Commissioner of Health for final determination.

Description of RecommendationsCommissioner's Final Decision
Proposal: Identification of preferred drugs in the category of Angiotensin Converting Enzyme Receptor Inhibitors (ACEI) and ACEI/Diuretic Combinations
A. Based on the findings of no overall clinical superiority of drugs within this class and the financial impacts, the Committee unanimously recommended the following:

ACEI Class

Preferred Drugs Altace (ramipril), Mavik (trandolapril), benazepril (HCL), captopril, enalapril maleate, lisinopril and moexipril HCL.

Non-preferred Drugs
Accupril (quinapril HCL), Aceon (perindopril erbumine), Capoten (captopril), fosinopril sodium, Lotensin (benazepril HCL), Monopril (fosinopril sodium), Prinivil (lisinopril), quinapril HCL, Univasc (moexipril HCL), Vasotec (enalapril maleate), Zestril (lisinopril).

ACEI/Diuretic Combination Class

Preferred Drugs
Uniretic (moexipril/hctz), benazepril HCL/hctz, captopril/hctz, enalapril maleate/hctz, and lisinopril/hctz.

Non-preferred Drugs
Accuretic (quinapril/hctz), Capozide (captopril/hctz), fosinopril/hctz, Lotensin HCT (benazepril HCL/hctz), Monopril HCT (fosinopril/hctz), Prinzide (lisinopril/hctz), Quinaretic (quinapril/hctz), Vaseretic (enalapril maleate/hctz), Zestoretic (lisinopril/hctz).

B. The Committee unanimously recommended the following clinical questions be used as the basis for approving use of the non-preferred drug:

  • Q: Has your patient experienced treatment failure with a preferred ACE Inhibitor?
  • Q: Has your patient experienced an adverse drug reaction with a preferred ACE Inhibitor?
  • Q: Is there a documented history of successful therapeutic control with a non-preferred ACE Inhibitor and transition to a preferred ACE Inhibitor is medically contraindicated?
Approved as Recommended
Proposal: Identification of preferred drugs in the category of Angiotensin Receptor Blockers (ARBs/AIIRAs) and ARBs/AIIRAs/Diuretic Combinations

A. Based on the findings of no specific drug with clinical superiority within this class and the financial impacts, the Committee unanimously recommended the following:

ARB/AIIRA Class

Preferred Drugs
Benicar (olmesartan medoxomil), Cozaar (losartan potassium), Diovan (valsartan), Micardis (telmisartan).

Non-preferred Drugs
Atacand (candesartan cilexetil), Avapro (irbesartan), Teveten (eprosartan mesylate).

ARB/AIIRA/Diuretic Combination Class

Preferred Drugs
Benicar HCT (olmesartan medoxomil/hctz), Hyzaar (losartan/hctz), Diovan HCT (valsartan/hctz), Micardis HCT (telmisartan/hctz).

Non-preferred Drugs
Atacand HCT (candesartan cilexetil/hctz), Avalide (irbesartan/hctz), Teveten HCT (eprosartan/hctz).

B. The Committee unanimously recommended the above clinical questions be used in the prior authorization review process. They are reflected in the ACEI proposal above (substituting ACEI language with ARB/AIIRA language).
Approved as Recommended
Proposal: Prior Authorization of Revatio
A. The Committee unanimously recommended that Medicaid require prior authorization of Revatio under the Clinical Drug Review Program (CDRP). The following are recommended considerations:
  • utilize a live person prior authorization call line
  • assure approved use by the relevant patient population
  • reinforce essential clinical principles of patient counseling and monitoring
  • utilize a quick check for sex offender status
  • if Revatio is required treatment for PH in the sex offender population, do not deny necessary treatment
  • deny reimbursement for Revatio if there is substantial evidence of patient or provider fraud and abuse


B. The Committee unanimously recommended the following criteria be utilized in the prior authorization process of Revatio:
  1. Are you the practitioner on record primarily responsible for management of the condition requiring use of Revatio for this patient?
  2. Are you currently board certified in Pulmonary or Cardiovascular disease or is there documentation in the patient's medical record of an evaluation by a physician board certified in Pulmonary or Cardiovascular disease?
  3. What is the diagnosis documented in the patient's chart that requires treatment with Revatio?
  4. What is this patient's mean pulmonary artery pressure, either at rest or with exercise, pulmonary artery occlusion pressure, and acute pulmonary vasoreactivity as determined during right heart catheterization?
    o a. *Alternative to question 4: fax RHC report
  5. What NYHA/WHO Classification describes this patient's current functional status?
  6. Before prescribing this drug, have you inquired about regular or intermittent therapy with nitrates or drugs containing nitrates within the past 180 days, and completed counseling of this patient including strong warning against the use of any drugs containing nitrates in conjunction with Revatio?
  7. Is this patient currently using an oral erectile dysfunction medication?
  8. Have you evaluated for Retinitis Pigmentosa and completed counseling on the risk of ocular disturbances, non-artertic anterior ischemic optic neuropathy (NAION) and potential for blindness?
Criteria for approval of prior authorization approved as recommended; in addition, the prescriber's license number, and the prescription serial number (where appropriate) will be obtained.

K. Old Business:

Dr. Martin requested drug utilization data reflecting the impact the prior authorization processes that have been implemented.

Ms. Desmond advised that there is no current data available for erectile dysfunction drugs, as the NYS Medicaid program does not currently reimburse for these agents following the Governor's Executive Order related to the use of these products by sexual offenders. She also noted that the federal government will no longer provide federal participation for erectile dysfunction drugs. As Revatio is not considered an erectile dysfunction drug as discussed, it would not be affected. The Committee was also informed that the Governor has proposed legislation to permanently eliminate the coverage of erectile dysfunction drugs under the Medicaid program.

On the utilization of proton pump inhibitors, Ms. Desmond stated that because the prior authorization process is still in the grandfathering stage (approximately six months), the data may not accurately reflect the impact of prior authorization at this point. She advised that this data will be available to the membership at the next meeting.

The meeting adjourned at 3:00 PM.

L. Final Determinations:

Commissioner's Determination: Medicaid will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs in the following classes: Angiotensin Converting Enzyme Receptor Inhibitor (ACEI), ACEI/Diuretic Combination, ARB/AIIRA, and ARB/AIIRA/Diuretic Combination. Preferred drugs will not require prior authorization.

ACEIs Class

Preferred Drugs
Altace (ramipril), Mavik (trandolapril), benazepril (HCL), captopril, enalapril maleate, lisinopril and moexipril HCL.

Non-preferred Drugs
Accupril (quinapril HCL), Aceon (perindopril erbumine), Capoten (captopril), fosinopril sodium, Lotensin (benazepril HCL), Monopril (fosinopril sodium), Prinivil (lisinopril), quinapril HCL, Univasc (moexipril HCL), Vasotec (enalapril maleate), Zestril (lisinopril).

ACEI/Diuretic Combinations Class

Preferred Drugs
Uniretic (moexipril/hctz), benazepril HCL/hctz, captopril/hctz, enalapril maleate/hctz, and lisinopril/hctz.

Non-preferred Drugs
Accuretic (quinapril/hctz), Capozide (captopril/hctz), fosinopril/hctz, Lotensin HCT (benazepril HCL/hctz), Monopril HCT (fosinopril/hctz), Prinzide (lisinopril/hctz), Quinaretic (quinapril/hctz), Vaseretic (enalapril maleate/hctz), Zestoretic (lisinopril/hctz).

ARB/AIIRA Class

Preferred Drugs
Benicar (olmesartan medoxomil), Cozaar (losartan potassium), Diovan (valsartan), Micardis (telmisartan).

Non-preferred Drugs
Atacand (candesartan cilexetil), Avapro (irbesartan), Teveten (eprosartan mesylate).

ARB/AIIRA/Diuretic Combination Class

Preferred Drugs
Benicar HCT (olmesartan medoxomil/hctz), Hyzaar (losartan/hctz), Diovan HCT (valsartan/hctz), Micardis HCT (telmisartan/hctz).

Non-preferred Drugs
Atacand HCT (candesartan cilexetil/hctz), Avalide (irbesartan/hctz), Teveten HCT (eprosartan/hctz).

The impacts of this final determination are as follows:

  1. State Public Health Population:
    • Minimal effects as a large majority of Medicaid patients currently utilize those drugs which have been determined to be preferred.
    • Use of prior authorization for non-preferred products encourages use of more cost effective drugs within the same therapeutic class when appropriate.
  2. Program Providers:
    • Limited additional time and effort will be required by prescribers to complete the prior authorization process for non-preferred drugs.
  3. Fiscal Impact to State Health Program:
    • Through the changes in utilization to more cost effective drugs, and the receipt of supplemental rebates from pharmaceutical manufacturers, annual savings for the Preferred Drug Program are estimated at $157M, for SFY 06-07.

Commissioner's Determination: Medicaid will continue to reimburse for Revatio using the limited access process, and will transition Revatio to prior authorization under the Clinical Drug Review Program (CDRP) when a live interactive telephone prior authorization system is in place. Specific criteria to allow approval of Revatio under the prior authorization process were approved including the collection of the prescriber's license number, and the serial number from the prescription.

The impacts of this final determination are as follows:

  1. State Public Health Population:
    • Revatio is currently covered by Medicaid under limited circumstances using an alternative billing and prior approval process; the implementation of prior authorization will increase access to the medication, while assuring appropriate utilization and controls for fraud/abuse.
  2. Program Providers:
    • Transition Revatio to the CDRP will ease the provider's administrative burden on obtaining access to this drug for Medicaid recipients.
    • Providers will be required to confirm that the patient has the appropriate diagnosis for this medication, and to confirm that other potentially harmful effects are being avoided.
  3. Fiscal Impact to State Health Program:
    • Use of the live call line and closer monitoring of utilization will enhance the ability to detect potential fraud and abuse.
    • Minimal additional costs related to new utilization.

Posted: March 30, 2006