Pharmacy and Therapeutics Committee Meeting Summary - February 20, 2008
Agenda and Introduction
The Medicaid Pharmacy & Therapeutics Committee met on Wednesday, February 20, 2008 from 9:00 a.m. to 3:30 p.m. in Meeting Room 2, 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 provided comment to the Committee:
- Patel, Vik, PharmD, MBA, Medical Science Liaison, AMYLIN Pharmaceuticals, Boston, MA
- Busch, Robert, MD, Managing Partner, The Endocrine Group, Albany, NY
- Karle, Deirdre, Regional Account Manager, Solvay Pharmaceuticals, Milton, MA
- Gharibo, Christopher, MD, Director, Pain Medicine; Assistant Professor of Anesthesiology, New York Medical Center, Endo Pharmaceuticals, Chadds Ford, PA
- Walker, Robert D., MD, Director, Medical Sciences, MedImmune, Inc., Gaithersburg, MD
- Krilov, Leonard R., MD, Chief, Pediatric Infectious Disease; Vice Chairman of Pediatrics, Winthrop University Hospital, Mineola, NY
C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical review of the following drugs:
Public comments:
Byetta:
- The Committee was asked to consider information regarding clinical trial results including indications, mechanisms of action, A1C reduction without hypoglycemia, reductions in body weight, safety and effectiveness, sustained A1C control, as well as an analysis of the utilization of Byetta in Type II diabetes.
Marinol:
- The Committee was asked to consider information regarding clinical trial results including indications and mechanism of action for appetite stimulation and nausea and vomiting, pharmacology, as well as the reclassification of Marinol from schedule II to schedule III controlled substance.
Lidoderm:
- The Committee was asked to consider information regarding clinical trial results including safety, effectiveness, side effect profile, especially in the elderly with multiple medications and comorbidities, and dosing, as well as the benefits of using a topical patch versus an oral medication to treat pain.
Synagis:
- The Committee was asked to consider information regarding clinical trial results including the incidence of respiratory syncytial virus (RSV) and the importance of identifying infants and children at risk, indications, safety, effectiveness, post-marketing data for safety and effectiveness, dosing, the importance of avoiding delays in therapy, and in adhering to the dosing schedule. The Committee was also asked to consider a study of the impact of socioeconomics and access to healthcare on the incidence of RSV hospitalizations.
Pharmacy and Therapeutics Committee Comments:
- The Committee discussed the claims data presented during the public comment period for Byetta utilization in Type II diabetes. A Committee member inquired whether patients asked for Byetta by name in the office, and if the presenter was aware of the use of Byetta in patients with metabolic syndrome who are overweight. The presenter indicated that most of his patients taking Byetta are diabetic and do not generally ask for injectable medications.
- The Committee discussed the use of Lidoderm for indications other than the approved indication, and the presenter indicated there were case studies and empirical evidence for use in musculoskeletal pain as well as other types of neuropathic pain. The presenter also indicated that dosing as approved in the product label is reasonable for any indication.
- A Committee member inquired about the criteria used to identify which children to treat with Synagis. The presenter indicated that the American Academy of Pediatrics publishes guidelines with recommendations for the administration of Synagis, reiterated those recommendations, and noted that in his opinion, most practitioners use it judiciously. The Committee also discussed the importance of the timely administration of Synagis.
D. Clinical Presentation and Discussion
Barbara Rogler, PharmD, MS, First Health Services Corporation; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP)
1. Review of lidocaine patch (Lidoderm) for inclusion to the Clinical Drug Review Program (CDRP)
The Committee was asked to consider a proposal to include lidocaine patch (Lidoderm) in the Clinical Drug Review Program. This proposal would require prior authorization to address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health, and potential for overuse or misuse.
Dr. Rogler began with a review of post herpetic neuralgia (PHN) including its cause, symptoms, prevalence, incidence, and palliative treatment. She noted the herpes zoster vaccine, recommended for patients sixty years of age and older, has reduced the incidence of both herpes zoster and PHN. She described the lidocaine patch including strength, design, and size. She spoke about lidocaine as an amide-type anesthetic agent, including absorption from the patch, distribution, metabolism, excretion, and contraindications. She also spoke about product warnings including accidental exposure in children and excessive dosing, precautions, allergic reactions, proper application, drug interactions, and adverse reactions. She discussed use in special populations including pregnancy, nursing mothers and pediatrics. She emphasized the proper handling and disposal of the patches.
Dr. Correia stated the NYS Medicaid program proposes to add lidocaine topical patch to the CDRP, and presented the background for the proposal. He indicated Lidoderm is FDA approved only for the relief of pain associated with PHN and discussed the approved dosing for Lidoderm, as well as alternative treatments available for PHN. He noted that clinical evidence supporting unapproved uses of lidocaine patches (i.e. certain other neuropathies, lower back pain, arthritis of the knee) is either lacking or generally of poor quality, as the studies were open label, anecdotal, or case studies.
Data was presented indicating that NY Medicaid utilization of Lidoderm accounted for more than half of the national Medicaid utilization when compared to the total for all State Medicaid programs (source: CMS website -1Q07 data). The data also indicated NY Medicaid utilization was disproportionately higher than utilization within the next three largest State Medicaid programs in terms of total prescriptions (source: CMS website -1Q07 data). It was noted that Lidoderm was dispensed in quantities greater than 90 patches per month, which is inconsistent with FDA approved dosing. Data also indicated that there was utilization within NY Medicaid inconsistent with the FDA approved indication. In conclusion, Dr. Correia requested that the NYS Medicaid Pharmacy and Therapeutics Committee consider lidocaine patches for inclusion into the Clinical Drug Review Program. The CDRP prior authorization criteria should include verification of diagnosis and dosage.
The Committee discussed several concerns specific to use of Lidoderm within the NY Medicaid program, including utilization inconsistent with approved dosing, the ability to determine prescriber specialty, and utilization compared to other states with a comparable number of Medicaid enrollees. They noted that if Lidoderm utilization in NY Medicaid appears inconsistent with the approved indication, they would be interested in knowing what it was being prescribed for. They also noted that there was not a great deal of targeted advertising for this drug, and that it was not perceived as a recreational drug. Dr. Correia noted that the patch likely would not cause harm, but may be used instead of more appropriate, effective therapy. The Committee inquired about the Lidoderm clinical trials, and State staff responded that although the effectiveness of the lidocaine patch versus placebo was statistically significant, the validity of the placebo control could be considered questionable due to patients in the study who were not lidocaine naive, and may have been able to discern when they were using lidocaine patches.
After considering the information and concerns raised by the interested parties and the membership, the Committee determined that data presented may indicate overuse of lidocaine patches, as well as use inconsistent with the approved indication, within the NY Medicaid program. They recommended (by a vote of 9 to 1) to include lidocaine patch (Lidoderm) in the Clinical Drug Review Program, with approval criteria as listed in Section E, Recommendations of the Pharmacy & Therapeutics Committee. It was noted that the prescriber's determination will be final, as required by law, except in cases where there is substantial evidence of fraud or abuse.
2. Review of palivizumab (Synagis) for inclusion to the Clinical Drug Review Program (CDRP)
The Committee was asked to consider a proposal to include palivizumab (Synagis) in the Clinical Drug Review Program. This proposal would require prior authorization to address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health, and potential for overuse or misuse.
Dr. Rogler began with a review of respiratory syncytial virus (RSV). She indicated that it is the most common cause of bronchiolitis and pneumonia among infants and children less than one year of age, and that while most children recover in one to two weeks, a small percentage will require hospitalization. She described the symptoms of RSV, how it is spread, the expected RSV season, and treatment, if required. She provided some national statistics on hospitalizations and deaths associated with RSV. She then provided a review of palivizumab (Synagis), including indications, and she defined the high risk pediatric patients for whom safety and efficacy have been established. She noted that Synagis is indicated for the prevention of, not the treatment of RSV. She also spoke about dosing, dosage form, mechanism of action, pharmacokinetics, contraindications, warnings, precautions, drug interactions, and pregnancy category. She noted the importance of patient compliance with Synagis. She then presented the recommendations for the administration of Synagis from the American Academy of Pediatrics (AAP) as written in their Clinical Practice Guideline for the Diagnosis and Management of Bronchiolitis. She also presented the recommendations for the administration of Synagis from the 2006 Report of the Committee on Infectious Disease (Red Book).
Dr. Correia stated the NYS Medicaid program proposes to add palivizumab (Synagis) to the CDRP, and presented the background for the proposal. His review of Synagis included a review of the clinical evidence available regarding the efficacy, effectiveness, and safety of this product in preventing RSV in specific populations, evidence which, he noted, has continued to emerge since the original drug approval in 1998. He reiterated the high risk pediatric patient population for whom safety and efficacy have been established. He discussed clinical trials for approval of Synagis, and noted that investigators in the original approval trials and a subsequent clinical trial to evaluate safety and efficacy in children with congenital heart defects (CHD) limited the age range in the trials to 0-24 months. He then noted the current clinical practice guidelines from AAP have been expanded from the Indications for the Use of Palivizumab to the Diagnosis and Management of Bronchiolitis, including causes other than RSV, and that the current guidelines were developed with the support of the American Academy of Family Physicians, American Thoracic Society, American College of Chest Physicians, and the European Respiratory Society. They also partnered with the US Department of Health and Human Services Agency for Healthcare Research and Quality and the RTI International- University of North Carolina Evidence-based Practice Center to develop an evidence report to support these guidelines, which identify virtually the same high risk population as previously indicated.
Data was presented indicating that NY Medicaid utilization of Synagis accounted for a disproportionately high share of the national Medicaid utilization when compared to the total for all State Medicaid programs (source: CMS website -1Q07 data). Dr. Correia reiterated clinical studies in the FDA prescribing information support the use of Synagis for the prevention of RSV in certain high risk infants and children less than two years of age and not for the treatment of established RSV. In conclusion, Dr. Correia requested that the NYS Medicaid Pharmacy & Therapeutics Committee consider palivizumab for inclusion into the Clinical Drug Review Program. The CDRP prior authorization criteria should include verification of age, comorbidities, and risk factors.
The Committee agreed that appropriate utilization consistent with approved indications, and potential overuse and misuse were factors to be considered in their discussion of Synagis. In response to a question from a Committee member, State staff noted that NY Medicaid data indicated utilization inconsistent with other State Medicaid programs. A Committee member inquired whether Synagis was being provided to children over two years of age, and State staff responded that DOH has been receiving an increased number of requests for coverage of Synagis for children over two. A Committee member inquired whether Synagis was currently being provided to the appropriate high risk pediatric patients. Another Committee member noted that the majority of data presented was data compared to national utilization. A Committee member commented that the medication is effective in decreasing hospitalizations, that RSV may cause permanent damage to lungs in children with poorly functioning lungs to begin with, and that there is no other medication available to prevent RSV. Dr. Correia indicated that having prior authorization criteria in place would allow DOH to determine if Synagis was being prescribed for infants and children at risk for RSV. It was also noted that Synagis may be obtained by and administered in a prescriber's office, and the CDRP would only apply to prescriptions for Synagis that are filled at a pharmacy.
After considering the information and concerns raised by the interested parties and the membership, the Committee determined there was insufficient evidence of overuse, misuse, or utilization inconsistent with approved indications for Synagis within the NYS Medicaid program. The Committee recommended (by a vote of 9 to 1) not to include palivizumab (Synagis) in the Clinical Drug Review Program.
3. Review of exenatide (Byetta) for inclusion to the Clinical Drug Review Program (CDRP)
The Committee was asked to consider a proposal to include exenatide (Byetta) in the Clinical Drug Review Program. This proposal would require prior authorization to address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health, and potential for overuse or misuse.
Dr. Rogler presented an overview of Byetta including indications, mechanism of action, absorption, distribution, metabolism, and elimination. She noted that Byetta is indicated as adjunct therapy for patients with type II diabetes in combination with metformin, a sulfonylurea, a thiazolidinedione (TZD) or a combination of metformin and a sulfonylurea, or a TZD. She explained that since Byetta stimulates insulin secretion from pancreatic beta-cells in the presence of elevated glucose concentrations, functioning pancreatic beta-cells must be present for the medication to be effective. She discussed the three thirty-week, double blind, placebo controlled clinical trials which evaluated the safety and efficacy of Byetta in patients with type II diabetes who had not achieved glycemic control with metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea. She discussed dosing, proper handling and storage, drug interactions, contraindications, precautions, and use in special populations such as pregnancy, pediatric patients, elderly patients, and patients with end-stage renal disease or severe renal impairment. Dr. Rogler noted that Byetta is not included in the treatment algorithm on the approach to the management of hyperglycemia in type II diabetes in the Standards of Medical Care in Diabetes - 2008 and the European Association for the Study of Diabetes consensus statement. In conclusion, Dr. Rogler emphasized Byetta is indicated in type II diabetes as adjunct therapy to reduce fasting and post-prandial glucose concentration.
Dr. Correia stated the NYS Medicaid program proposes to add exenatide (Byetta) injection to the CDRP, and presented the background for the proposal. He reiterated the indication for Byetta and noted the American Diabetes Association and the European Association for the Study of Diabetes consensus statement on the approach to management of hyperglycemia in type II diabetes does not include Byetta in the treatment algorithm. He spoke about the FDA Alert from October 2007 notifying providers of an increased risk of acute pancreatitis associated with Byetta. In January 2008, the prescribing information and patient information were updated to include this information.
Data was presented indicating Byetta utilization in NY Medicaid inconsistent with FDA approved indications, including enrollees who filled a prescription for the drug, but did not having a concurrent claim for metformin, a TZD, a sulfonylurea or a combination of the agents within the NY Medicaid database. Data also indicated that enrollees without a diagnosis of type II diabetes within the database filled prescriptions for Byetta. Dr. Correia noted that the use of Byetta specifically for weight loss, other than as an adjunct in type II diabetes, is not an FDA approved use or recommended at this time due to the lack of safety and efficacy data, and that drugs used for weight loss are excludable under federal Medicaid law and are not reimbursable by NYS Medicaid. He concluded by requesting that the NYS Medicaid Pharmacy & Therapeutics Committee consider exenatide injection for inclusion into the Clinical Drug Review Program. The CDRP prior authorization criteria should include verification of the diagnosis of type II diabetes and current drug therapy.
The Committee questioned the possible use of Byetta in patients with type 1 diabetes, and questioned NY Medicaid utilization of Byetta compared to other Medicaid programs. They inquired whether DOH had data to explain utilization of Byetta in patients not on first line therapy (i.e. metformin, a sulfonylurea, TZD), or in patients without a diagnosis of type II diabetes. They then inquired whether DOH had evidence that Byetta was being used for weight loss. State staff reiterated the data available to them indicating that there were enrollees who had filled a prescription for Byetta in the absence of oral antidiabetic medications, or who did not have a diagnosis of type II diabetes within the NY Medicaid database, and that NY Medicaid utilization of Byetta was greater than a comparable number of enrollees in other States' Medicaid programs. Dr. Correia stated that he was not aware that any evidence had been presented to indicate that Byetta is appropriate or used for type I diabetes.
After considering the information and concerns raised by the interested parties and the membership, several Committee members indicated that there may be evidence of utilization inconsistent with the approved indication. The Committee recommended (by a vote of 6 to 4) to include exenatide (Byetta) in the Clinical Drug Review Program, with approval criteria as listed in Section E, Recommendations of the Pharmacy & Therapeutics Committee. The Committee indicated they would like the utilization of Byetta to be monitored and reviewed again in the future.
4. Review of fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora) for inclusion to the Clinical Drug Review Program (CDRP)
The Committee was asked to consider a proposal to include fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora) in the Clinical Drug Review Program. This proposal would require prior authorization to address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health, and potential for overuse or misuse.
Dr. Rogler began her presentation by reviewing the black box warnings common to both medications, and the additional black box warnings for Fentora. She provided an overview of fentanyl including mechanism of action, absorption, distribution, metabolism, elimination, use in special populations (elderly, pregnancy, patients with renal or hepatic impairment), drug interactions, warnings, contraindications, and the effect on the gastrointestinal tract and the respiratory system. She then spoke about Actiq and Fentora as individual agents including their dosage form, strength, indications, dosing, administration, and proper handling and disposal. She noted there is an estimated 30% greater exposure with Fentora than with Actiq, and she spoke about the Fentora Dear Doctor Safety Letter noting deaths as a result of improper patient selection. She summarized noting that both fentanyl products, although in different dosage formulations, are indicated for management of breakthrough cancer pain in patients that are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain, and should only be used in the care of cancer patients by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Dr. Correia stated the NYS Medicaid program proposes to add fentanyl lozenge (Actiq, and generics) and fentanyl buccal tablet (Fentora) to the CDRP, and presented the background for the proposal. He reiterated the very explicit indication for Actiq and Fentora, and the black box warnings for the drugs. He spoke about the Fentora Dear Doctor Safety Letter pertaining to deaths from improper patient selection and/or improper dosing. Data was presented indicating that NY Medicaid collective utilization of Actiq and Fentora accounted for a disproportionately high share of the national Medicaid utilization when compared to the total for all State Medicaid programs (source: CMS website -1Q07 data). Dr. Correia noted that both products are Schedule II controlled substances with the highest potential for overuse, abuse, diversion, and utilization inconsistent with approved indications, potentially leading to deaths. In conclusion, he requested that the NYS Medicaid Pharmacy & Therapeutics Committee consider oral transmucosal fentanyl and fentanyl buccal tablets for inclusion into the Clinical Drug Review Program. The CDRP prior authorization criteria should include verification of the diagnosis of cancer, that the healthcare professionals involved are knowledgeable of and skilled in the use of these drugs, and that the patient is opioid-tolerant prior to approval.
The Committee discussed NY Medicaid utilization of Actiq and Fentora compared to other State Medicaid programs. They inquired if enrollees taking these drugs were also taking concomitant long acting narcotics, if data was available as to who was prescribing the drugs, and if there was any data available for NY regarding diversion of, or deaths caused by these drugs. State staff indicated they did not have that data available, however data did show that approximately two-thirds of the enrollees who had filled a prescription for Actiq or Fentora did not have a diagnosis of cancer within the Medicaid database. The Committee discussed the use of these drugs for cancer diagnoses versus other chronic pain syndromes.
After considering the information and concerns raised by the interested parties and the membership, the abuse potential of the products, the increase in the number of deaths due to the general misuse of prescription medications, the black box warnings, and the possibility of utilization inconsistent with the approved indications, the Committee recommended (by a vote of 5 to 4, with 1 abstention) to include fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora) in the Clinical Drug Review Program, with approval criteria as listed in Section E, Recommendations of the Pharmacy & Therapeutics Committee.
5. Review of dronabinol (Marinol) and nabilone (Cesamet) for inclusion to the Clinical Drug Review Program (CDRP)
The Committee was asked to consider a proposal to include dronabinol (Marinol) and nabilone (Cesamet) in the Clinical Drug Review Program. This proposal would require prior authorization to address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health, and potential for overuse or misuse.
Dr. Rogler began her presentation with background information on the cannabinoid receptors in the brain which are believed to regulate nausea and vomiting. She presented information on the pharmacodynamic and pharmacokinetic profiles of the drugs, described the warnings and precautions associated with the drugs, and spoke about use in special populations including pregnancy, pediatrics and the elderly. She noted that both drugs are approved as second line therapy for chemotherapy induced nausea and vomiting (CINV) when patients fail to respond adequately to traditional antiemetics, and that Marinol is also indicated for anorexia associated with weight loss in patients with AIDS. She indicated that Cesamet is a Schedule II controlled substance with a high potential for abuse, and it is recommended that prescriptions be limited to the amount necessary for a single cycle of chemotherapy as the medication may cause an altered mental state. She also noted that Marinol is a Schedule III controlled substance with the potential to cause both psychological and physiological dependence.
Dr. Correia stated the NYS Medicaid program proposes to add dronabinol (Marinol) and nabilone (Cesamet) to the CDRP, and presented the background for the proposal. He discussed the pharmacology of the drugs as well as the prescribing information which states that the risk/benefit ratio should be evaluated prior to initiating therapy in patients with a history of seizures, cardiac disorders, substance abuse, psychiatric illness, or in patients receiving concomitant sedatives, hypnotics, or other psychoactive drugs. He discussed the 2007 Antiemetic Guidelines, in which the National Comprehensive Cancer Network with the American Cancer Society recommends either Cesamet or Marinol as a treatment option for the management of breakthrough CINV. He reiterated Marinol is approved for the treatment of anorexia in patients with AIDS. Data was presented indicating that NY Medicaid utilization of Marinol and Cesamet accounted for a disproportionately high share of the national Medicaid utilization when compared to the total for all State Medicaid programs (source: CMS website -1Q07 data). Dr. Correia concluded by requesting that the NYS Pharmacy & Therapeutics Committee consider dronabinol and nabilone for inclusion into the Clinical Drug Review Program. The CDRP prior authorization criteria should include verification of a diagnosis of cancer for either drug, or AIDS for dronabinol.
The Committee discussed the utilization of these drugs within NY Medicaid, and State staff noted that while the majority of enrollees receiving the drugs had a diagnosis of either cancer or AIDS within the NY Medicaid database, approximately 15 percent did not. The Committee discussed the treatment of anorexia, and nausea and vomiting in patients with AIDS and HIV, and a Committee member noted that Marinol is not used very often when HIV and AIDS patients are well managed. The Committee noted there was no evidence presented that these drugs were being diverted.
After considering the information and concerns raised by the interested parties and the membership, the Committee determined there was insufficient evidence of overuse, misuse, or utilization inconsistent with approved indications for Marinol and Cesamet within the NYS Medicaid program. The Committee recommended (by a vote of 9 to 1) not to include dronabinol (Marinol) and nabilone (Cesamet) in the Clinical Drug Review Program.
E. 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 Recommendations | Commissioner's Final Determination |
|---|---|
| Proposal: Inclusion of lidocaine patch (Lidoderm) in the Clinical Drug Review Program A. The Committee recommended (by a vote of 9 to 1) that Medicaid include lidocaine patch (Lidoderm) in the Clinical Drug Review Program. B. The Committee unanimously recommended the following criteria be utilized in the prior authorization process of lidocaine patch (Lidoderm):
|
Approved as Recommended |
| Proposal: Inclusion of palivizumab (Synagis) in the Clinical Drug Review Program The Committee recommended (by a vote of 9 to 1) not to include palivizumab (Synagis) in the Clinical Drug Review Program. |
Approved as Recommended |
| Proposal: Inclusion of exenatide (Byetta) in the Clinical Drug Review Program A. The Committee recommended (by a vote of 6 to 4) that Medicaid include exenatide (Byetta) in the Clinical Drug Review Program. B. The Committee unanimously recommended the following criteria be utilized in the prior authorization process of exenatide (Byetta):
| Approved as Recommended |
| Proposal: Inclusion of fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora) in the Clinical Drug Review Program A. The Committee recommended (by a vote of 5 to 4, with 1 abstention) that Medicaid include fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora) in the Clinical Drug Review Program. B. The Committee recommended (by a vote of 9 to 0, with 1 abstention) the following criteria be utilized in the prior authorization process of fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora):
| Approved as Recommended |
| Proposal: Inclusion of dronabinol (Marinol) and nabilone (Cesamet) in the Clinical Drug Review Program The Committee recommended (by a vote of 9 to 1) not to include dronabinol (Marinol) and nabilone (Cesamet) in the Clinical Drug Review Program. |
Approved as Recommended |
F. Additional Discussion:
The Committee requested utilization data and input from the DUR Program subsequent to implementation of the drugs listed above into the CDRP.
The meeting adjourned at 3:00 PM.
Meeting Summary Posted 4/8/08
H. Final Determinations
The Commissioner has determined that the Medicaid program will require prior authorization under the Clinical Drug Review Program (CDRP) for lidocaine patch (Lidoderm), exenatide (Byetta), fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora). Specific CDRP prior authorization criteria were also approved.
The impact of this final determination is as follows:
1. State Public Health Population:
- Drugs requiring prior authorization under the CDRP will continue to be covered by the Medicaid program. The prior authorization requirement will have a minimal effect on Medicaid enrollees, and will ensure the drugs are being used in a medically appropriate manner.
2. Program Providers:
- There will be a minimal impact on prescribers and pharmacies as they are familiar with the prior authorization process. The prior authorization process is simple to use and available twenty-four hours a day, seven days a week.
- Prescribers, or their agents, will need to initiate the prior authorization process when ordering these drugs. They will be asked a short series of questions to support appropriate use of the drug. Pharmacies will need to complete the prior authorization process prior to submitting the claim.
3. State Health Program and Fiscal Impact:
- Prior authorization through the CDRP will reinforce appropriate use and will also provide an additional means to detect and deter overuse and potential abuse.
- During CY 2007, total expenditure for lidocaine patch (Lidoderm), exenatide (Byetta), fentanyl lozenge (Actiq) and fentanyl buccal tablet (Fentora) was approximately $53 million. The fiscal impact will depend on changes in utilization associated with assuring the appropriate use of these drugs. Expenditures will be expected to decrease subsequent to the implementation of the prior authorization requirement.
Final Determinations Posted 06/05/08
