Pharmacy and Therapeutics Committee Meeting Summary - February 26, 2009

Agenda and Introduction

The Medicaid Pharmacy & Therapeutics Committee met on Thursday, February 26, 2009 from 8:45 a.m. to 1:30 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 provided comment to the committee:

  1. Jeffrey Weinberg, MD - Director Clinical Research Center, St. Luke's Roosevelt Hospital, New York, NY
  2. Clifford Bassett, MD - Assistant Clinical Professor of Medicine and Otolaryngology, Long Island College Hospital, SUNY-HSCB Brooklyn, NY
  3. Peter VanZile, PharmD - Senior Regional Medical Scientist, GlaxoSmithKline
  4. Susan Abraham, MD - Associate Director National Medicine, CNS, Boehringer Ingelheim
  5. Beth D'Ambrosio, PharmD - Regional Account Scientific Associate Director, Novartis Pharmaceuticals Corporation
  6. Frank Yuen, MA, RPA-C - Clinical Affairs Manager, Endo Pharmaceuticals, Inc.

C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical review of the following therapeutic classes:

Public comments:

Topical Antibiotics

  • The Committee was asked to consider information regarding clinical trial results including mode of action, antibacterial activity, adverse effects and dosing regimen.

Nasal Antihistamines

  • The Committee was asked to consider information regarding clinical trial results including onset of action, compliance, and product taste.

Non-Ergot Dopamine Receptor Agonists

  • The Committee was asked to consider information regarding clinical trial results including approved indications, rate of absorption, dosing frequency, adverse events profile, elimination, interactions and effects on activities of daily living. A presenter also noted the 2006 American Academy of Neurology (AAN) practice parameters supporting the use of dopamine agonists as initial monotherapy in treating Parkinson's disease symptoms and lessening motor complications.

Direct Renin Inhibitors

  • The Committee was asked to consider information regarding clinical trial results including indications, safety, tolerability, adverse events, dosing and administration.

Prescription Non-Steroidal Anti-Inflammatory Drugs

  • The Committee was asked to consider information regarding clinical trial results including indications, dosing, adverse events, absorption, general warnings and precautions. The Committee was also presented information associated with a comparative effectiveness review conducted by the Oregon Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ).

Pharmacy and Therapeutics Committee Comments:

  • The Committee asked about head-to-head studies associated with the Topical Antibiotics and the incidence of bacterial resistance for the drug retapamulin. The presenter was not aware of any head-to-head studies or the prevalence of bacterial resistance as related to New York State.
  • The Committee asked for an interpretation of taste perversion associated with the Nasal Antihistamines. The presenter referred the Committee to the product literature for clarification.
  • The Committee and presenter discussed duration of clinical studies related to the Non-Ergot Dopamine Receptor Agonists, the pharmacodynamic impact on dopamine receptor regulation and the potential for dose escalation to maintain optimal therapeutic response.
  • The Committee questioned the clinical significance of the direct renin inhibitors including comparison to ACE inhibitors and ARBs and the incidence of hyperkalemia. The presenter referred the Committee to the product literature for details.
  • The Committee and the presenter discussed long term safety and tolerability associated with the oral and topical prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The presenter was not aware of any long term studies comparing oral to topical products.

D. Clinical Presentation and Discussion
Barbara Rogler, PharmD, MS, First Health Services Corporation (FHSC); Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP)

  1. Proposal to identify preferred drugs in the therapeutic class of Topical Antibiotics

    Drugs Affected: Altabax (retapamulin), Bactroban (mupirocin), mupirocin.

    Dr. Rogler presented an overview of the agents in this class noting indications, adverse reactions, warnings/precautions, and dosage and administration. She presented background information for impetigo, noting treatment may include topical antibiotics, oral antibiotics and good hygiene with antibacterial washes. Dr. Rogler noted the 2005 Infectious Diseases Society of America (IDSA) practice guidelines for treatment of impetigo. She discussed the mode of action, pharmacokinetics and drug interactions of mupirocin and retapamulin. She discussed use in pediatrics and pregnancy. In her summary, she noted that retapamulin and mupirocin have not been studied in head-to-head trials in the treatment of impetigo and retapamulin is not FDA approved for use in infections caused by methicillin resistant staphylococcus aureus (MRSA).

    Dr. Correia reported that there are only two antibiotics in the class, available in a variety of vehicles and package sizes. Both antibiotics are available in various formulations to treat impetigo and infections caused by staphylococcus aureus and streptococcus pyogenes. Retapamulin labeling specifically excludes use versus MRSA. Mupirocin cream is only approved for secondary infections due to staphylococcus aureus and streptococcus pyogenes. Mupirocin is available in a nasal ointment indicated for eradication of nasal colonization of MRSA. Dr Correia concluded that in general, each antibiotic has a place in therapy for specific applications or resistant organisms, with none of the products being preferential for overall clinical use.

  2. Proposal to identify preferred drugs in the therapeutic class of Topical Anti-Virals

    Drugs Affected: Abreva (docosanol), Denavir (penciclovir), Zovirax (acyclovir)

    Dr. Rogler presented an overview of the agents in this class noting indications, mode of action, pharmacokinetics, drug interactions, contraindications/warnings/precautions, adverse reactions and dosage and administration. She presented background information for genital herpes and herpes labialis. She discussed use of these drugs in pediatric and pregnancy populations. She provided an overview of a comparative trial between penciclovir and acyclovir but noted that comparative trials for drugs in this class are limited at this time.

    Dr. Correia restated the indications and noted the acyclovir ointment use in the treatment of genital herpes. A clinical review published in Canada was discussed, noting the occurrence of spontaneous healing rates associated with cold sores without treatment and the minimal decrease in time to recovery with treatment. In summary, Dr. Correia concluded that these products are primarily used to shorten healing time for a self limiting condition and evidence is not available to indicate significant clinical differences in outcomes between the products.

    The Committee discussed the limited use of these products in the management of herpes in immunocompromised patients as compared to oral anti-virals.

  3. Proposal to identify preferred drugs in the therapeutic class of Topical Psoriasis agents

    Drugs Affected: Psoriatec (anthralin), Dovonex (calcipotriene), Taclonex (calcipotriene/betamethasone dipropionate)

    Dr. Rogler presented an overview of the agents in this class including indications, mode of action, pharmacokinetics, contraindications/warnings, adverse reactions and dosage. She provided an overview of psoriasis including incidence and treatment options. She noted there are no head-to-head comparisons between the drugs in this class at this time, and the various treatment modalities have advantages and disadvantages based on disease severity, location, tolerability, and clinical response.

    Dr. Correia stated that comparative evidence among the drugs in the class is lacking. Topical steroids are also used for the primary treatment of psoriasis. Taclonex is a combination product containing calcipotriene and betamethasone dipropionate. Dr. Correia noted that these products may be used at different times by different patients, but there is no evidence to suggest either provides an overall advantage.

    The Committee discussed the ramifications of elevated serum calcium level and the potential for adverse events including parathyroid function and kidney stones.

  4. Proposal to identify preferred drugs in the therapeutic class of Nasal Antihistamines

    Drugs Affected: Astelin (azelastine), Astepro (azelastine), Patanase (olopatadine)

    Dr. Rogler presented an overview of the agents in this class including indications, pharmacokinetics, warnings/precautions, drug interactions, adverse reactions and dosage and administration. She noted the modes of action for the drugs in this class are similar. She provided an overview of allergic rhinitis and noted the practice guidelines from the American Academy of Allergy, Asthma & Immunology (2008) which state that intranasal corticosteroids are the most effective treatment. Dr. Rogler summarized that nasal azelastine and olopatadine offer an alternative for the management of seasonal allergic rhinitis but route of administration and taste perversion may limit use.

    Dr. Correia noted that there are three products but just two different drugs in the class. All three products are indicated for seasonal allergic rhinitis. He noted Astelin will soon be discontinued resulting in the loss of the product with the additional indication of vasomotor rhinitis and approval for use down to age 5 years. Astepro and Patanase are only indicated for 12 years and older. Astelin has been associated with the incidence of a bitter taste and nasal discomfort upon administration. The new azelastine product, Astepro, has been re-formulated in an attempt to address these characteristics. Several clinical trials were presented revealing more similarities between the products in terms of efficacy and incidence of adverse events. Dr. Correia concluded that there is a lack of head to head evidence and there does not appear to be any information available to substantiate clinically significant differences between the products.

    The Committee discussed the comparability of the onset of action and whether this is clinically significant in maintenance use seasonally, and the absence of head - to - head trials versus nasal corticosteroids.

  5. Proposal to identify preferred drugs in the therapeutic class of Non-Ergot Dopamine Receptor Agonists

    Drugs Affected: Requip (ropinirole), Requip XL (ropinirole ER), Mirapex (pramipexole), ropinirole

    Dr. Rogler provided an overview of Parkinson's disease (PD) and restless leg syndrome (RLS). She presented a summary of the agents in this class including indications, mechanism of action, pharmacokinetics, warnings, adverse reactions, and drug interactions. She discussed dosing and administration including the differences in dosing for PD and RLS, clarified that the extended release formulation of ropinirole is not indicated for RLS, and noted that medication regimens should be kept as simple as possible in PD. She commented that levodopa/carbidopa has been the cornerstone of PD treatment, and that the American Academy of Sleep Medicine (AASM) practice parameters for RLS state that levodopa/carbidopa is standard therapy. She discussed the place in therapy for the dopamine agonists noting they do not treat all features of PD, nor have they been shown to stop disease progression, and all the agents in this class carry the same warnings and precautions.

    Dr. Correia noted that there are two different drugs in the class, with one being available in an immediate release and extended release formulation. Both drugs are indicated for PD. In addition, the immediate release form of pramipexole and ropinirole are also approved for RLS. For PD, clinical comparisons between the immediate release and extended release versions of ropinirole appear to be lacking. There may be advantages and disadvantages for each product in terms of dosing regimens and potential adverse events with neither providing an overall clinical advantage. For PD and RLS, comparative efficacy or effectiveness evidence between ropinirole and pramipexole is also inconclusive. In the context of RLS, the potential for a phenomenon called augmentation was discussed, where continued use of a drug may cause symptoms to occur earlier in the day and increasing the dose of the drugs may worsen this effect. Lastly, it was noted that differences in adverse effect profiles and modes of metabolism and excretion should be considered in drug selection for different patients. Overall, there is no evidence available that any of these products are better for all patients for either PD or RLS and each may demonstrate favorable efficacy or tolerability in different circumstances.

    The Committee discussed other medical conditions that may precipitate RLS, and other treatments that may be efficacious including lifestyle changes.

  6. Review of the of Direct Renin Inhibitor therapeutic class for inclusion to the Preferred Drug Program

    Drugs Affected: Tekturna (aliskiren), Tekturna HCT (aliskiren/HCTZ)

    Dr. Rogler presented an overview of the agents in this class along with background information on hypertension. She noted the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-VII) guidelines suggest most patients will require two or more medications for adequate control of hypertension. Dr. Rogler noted the mechanism of action and pharmacokinetics of aliskiren as well as warnings/precautions, drug interactions and dosage and administration. She discussed use in special populations including pregnancy, pediatrics, geriatrics and patients with renal impairment. Dr. Rogler summarized that although the significance of aliskiren's unique mechanism of action has not been demonstrated in a reduction of morbidity and mortality, the drug offers an alternative in the treatment of hypertension.

    Dr. Correia stated there is only one drug in this class, available either alone or in a combination product with HCTZ, therefore there is no basis for a comparative review at this time. It was further explained that this class represents an ongoing area of research, with new drugs in the pipeline. Establishing this class within the PDP will allow the Committee to address any newly approved drugs as they become available.

  7. Proposal to identify preferred drugs in the therapeutic class of Skeletal Muscle Relaxants

    Drugs Affected: Amrix (cyclobenzaprine ER), baclofen, carisoprodol, carisoprodol compound, carisoprodol compound-codeine, chlorzoxazone, cyclobenzaprine, Dantrium (dantrolene), dantrolene, Fexmid (cyclobenzaprine), methocarbamol, orphenadrine, orphenadrine compound, orphenadrine compound forte, Parafon Forte DSC (chlorzoxazone), Robaxin (methocarbamol), Skelaxin (metaxalone), Soma (carisoprodol), Soma compound (carisoprodol compound), Soma compound-codeine (carisoprodol compound-codeine), tizanidine, Zanaflex (tizanidine)

    Dr. Rogler presented an overview of the agents in this class, noting the drugs for the treatment of chronic spasticity and those for the treatment of spasms associated with musculoskeletal conditions. She provided background information on spasticity, and musculoskeletal conditions such as nonspecific low back pain (LBP). Modes of action, drug interactions and dosing information were discussed. Dr. Rogler presented descriptions of carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, and orphenadrine. She noted the active metabolite of carisoprodol is meprobamate, a narcotic sedative/hypnotic with the potential to cause dependence and abuse with long term use. She concluded that comparative evidence from clinical trials is limited for this class and choice of drug may be based on adverse effects and tolerability.

    Dr. Correia noted that adequate evidence is lacking to distinguish significant differences in efficacy or safety overall among the drugs in the class, but there may be some differences in specific types of adverse events seen. Hepatotoxicity has been reported with dantrolene, tizanidine and chlorzoxazone. In addition, there are case reports of abuse and addiction to skeletal muscle relaxants, but almost all of these are associated with carisoprodol. Carisoprodol is metabolized to meprobamate, a narcotic sedative-hypnotic which is addictive. Lastly, these drugs may be grouped according to approved indications as detailed in the labeling, for use in the treatment of either chronic spasticity or painful musculoskeletal conditions. Dr. Correia concluded that there is no evidence to suggest preferential status for any of the drugs in the class, but it would seem reasonable to include products from both groups as preferred where appropriate.

    The Committee discussed the various strengths of carisoprodol currently on the market and whether the incidence of adverse effects is dose dependent. They also discussed the abuse potential associated with carisoprodol and its classification as a schedule IV controlled substance in other States.

  8. Proposal to identify preferred drugs in the therapeutic class of Prescription Non-Steroidal Anti-Inflammatory drugs (NSAIDs)

    Drugs Affected: Anaprox (naproxen sodium), Anaprox DS (naproxen sodium DS) Arthrotec (diclofenac sodium/misoprostol), Cataflam (diclofenac potassium), Clinoril (sulindac), Daypro (oxaprozin), diclofenac potassium, diclofenac sodium, diclofenac sodium XR, diflunisal, etodolac, etodolac SA, Feldene (piroxicam), fenoprofen, Flector (diclofenac epolamine), flurbiprofen, ibuprofen, Indocin (indomethacin), indomethacin, indomethacin SR, ketoprofen, ketoprofen SA, ketorolac, Mobic (meloxicam), meclofenamate, mefenamic acid, meloxicam, nabumetone, Nalfon (fenoprofen), Naprelan (naproxen sodium CR), Naprosyn (naproxen), naproxen, naproxen sodium, naproxen EC, oxaprozin, piroxicam, Ponstel (mefenamic acid), sulindac, tolmetin, Voltaren (diclofenac sodium), Voltaren XR (diclofenac sodium DR), Voltaren Gel (diclofenac sodium)

    Dr. Rogler presented an overview of the agents in this class and noted that all NSAIDs have a black box warning for patients with cardiovascular disease or cardiovascular risk factors and for use after coronary artery bypass graft surgery. Arthrotec (diclofenac/misoprostol) has an additional warning for administration during pregnancy. She discussed mechanism of action, pharmacokinetics, warnings/precautions, drug interactions, adverse reactions and use in special populations, including pregnancy, pediatrics and geriatrics. She provided an overview of the diclofenac/misoprostol combination product, diclofenac epolamine topical patch and diclofenac sodium topical gel. Dr. Rogler summarized that the available clinical data does not suggest that any one NSAID offers a clear advantage over another in terms of safety or efficacy. She noted that while the addition of misoprostol to diclofenac is efficacious in reducing gastrointestinal (GI) ulcerations, many patients have difficulty tolerating it, and proton pump inhibitors are another alternative for reduction of GI adverse affects. Dr. Rogler also noted the topical administration of diclofenac provides an alternative method of drug delivery.

    Dr. Correia explained that there are a wide variety of NSAIDs available with multiple and overlapping indications, dosing frequencies and metabolic pathways. All NSAIDs share a common set of black box warnings and other common warnings and precautions. It was noted that all NSAIDs, both oral and topical, carry warnings for the risk of gastrointestinal adverse effects. Arthrotec is a combination product, which includes a gastroprotective prostaglandin called misoprostol. Misoprostol is available separately and can be used along with any NSAID. However, misoprostol is poorly tolerated and current guidelines suggest proton pump inhibitors as preferred agents for prophylaxis of NSAID associated gastrointestinal injury. The topical products were discussed including their indications and the limited evidence in clinical comparability trials. It was noted that the diclofenac patch is only indicated for acute pain of minor strains, sprains, and contusions associated with soft tissue injuries and that diclofenac gel has only been approved for osteoarthritis of joints of the hands and knees. Clinical evidence frequently suggested that the benefit from topical NSAIDs for soft tissue injuries has been similar to that seen with placebo. Not all clinical studies have been successful in demonstrating statistically significant treatment effects. Additionally, some earlier studies were confounded by including a second ingredient, not available in the U.S. that increases topical drug absorption and has additional anti-inflammatory and analgesic properties of its own. Currently, clinical evidence comparing the safety of topical versus oral NSAIDs is lacking due to the limited duration of the studies. Dr. Correia concluded that evidence is lacking to define any clear differences in overall NSAID efficacy or that any NSAID is consistently safer or associated with fewer overall adverse events.

E. Executive Session:

The Committee recessed the public session at 11:30 A.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Topical Antibiotics, Topical Anti-Virals, Topical Psoriasis Agents, Nasal Antihistamines, Non-Ergot Dopamine Receptor Agonists, Direct Renin Inhibitors, Skeletal Muscle Relaxants and Prescription Non-Steroidal Anti-inflammatory Drugs. No official action was taken in the executive session. The executive session was recessed at 1:10 P.M.

F. 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: Identification of preferred drugs in the therapeutic class of Topical Antibiotics

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
Altabax (retapamulin), mupirocin ointment, Bactroban (mupirocin) cream

Non-preferred Drugs
Bactroban (mupirocin) ointment, Bactroban (mupirocin) nasal ointment

B. The Committee unanimously recommended the following standard clinical questions be used in the prior authorization review process:

  • Q: Has your patient experienced treatment failure with preferred drugs in the class?
  • Q: Has your patient experienced an adverse drug reaction with preferred drugs in the class?
  • Q: Is there a documented history of successful therapeutic control with a non-preferred drug and transition to a preferred drug is medically contraindicated?
Approved as Recommended
Proposal: Identification of preferred drugs in the therapeutic class of Topical Anti-Virals

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
Abreva (docosanol), Zovirax (acyclovir) ointment

Non-preferred Drugs
Denavir (penciclovir), Zovirax (acyclovir) cream

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended
Proposal: Identification of preferred drugs in the therapeutic class of Topical Psoriasis Agents

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
calcipotriene scalp solution, Dovonex (calcipotriene) cream, Psoriatec (anthralin)

Non-preferred Drugs
Dovonex (calcipotriene) scalp solution, Taclonex (calcipotriene/betamethasone dipropionate) ointment, Taclonex (calcipotriene/betamethasone dipropionate) scalp solution

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended
Proposal: Identification of preferred drugs in the therapeutic class of Nasal Antihistamines

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
Astelin (azelastine), Astepro (azelastine)

Non-preferred Drugs
Patanase (olopatadine)

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended
Proposal: Identification of preferred drugs in the therapeutic class of Non-Ergot Dopamine Receptor Agonists

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
ropinirole, Mirapex (pramipexole)

Non-preferred Drugs
Requip (ropinirole), Requip XL (ropinirole extended release)

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended
Proposal: Identification of preferred drugs in the therapeutic class of Direct Renin Inhibitors (DRIs)

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
Tekturna (aliskiren), Tekturna HCT (aliskiren/HCTZ)

Non-preferred Drugs
None

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process, should the Commissioner's final decision include a non-preferred drug.

Approved as Recommended
Proposal: Identification of preferred drugs in the therapeutic class of Skeletal Muscle Relaxants

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
baclofen, chlorzoxazone, cyclobenzaprine, dantrolene, methocarbamol, orphenadrine, orphenadrine compound, orphenadrine compound forte, tizanidine tablet

Non-preferred Drugs
Amrix (cyclobenzaprine ER), carisoprodol, carisoprodol compound, carisoprodol compound-codeine, Dantrium (dantrolene), Fexmid (cyclobenzaprine), Parafon Forte DSC (chlorzoxazone), Robaxin (methocarbamol), Skelaxin (metaxalone), Soma (carisoprodol), Soma compound (carisoprodol compound), Soma compound-codeine (carisoprodol compound-codeine), Zanaflex (tizanidine) capsule, Zanaflex (tizanidine) tablet

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended
Proposal: Identification of preferred drugs in the therapeutic class Prescription Non-Steroidal Anti-Inflammatory Drugs

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session the Committee recommended the following (by a vote of 9 to 2):

Preferred Drugs
diclofenac potassium, diclofenac sodium, diclofenac sodium XR, diflunisal, etodolac, etodolac SA, fenoprofen, flurbiprofen, ibuprofen, indomethacin, indomethacin SR, ketoprofen, ketoprofen SA, ketorolac, meclofenamate, mefenamic acid, meloxicam, nabumetone, naproxen, naproxen sodium, naproxen EC, oxaprozin, piroxicam, sulindac, tolmetin

Non-preferred Drugs
Anaprox (naproxen sodium), Anaprox DS (naproxen sodium DS), Arthrotec (diclofenac/misoprostol), Cataflam (diclofenac potassium), Clinoril (sulindac), Daypro (oxaprozin), Feldene (piroxicam), Flector (diclofenac epolamine), Indocin (indomethacin), Mobic (meloxicam), Nalfon (fenoprofen), Naprelan (naproxen sodium CR), Naprosyn (naproxen), Ponstel (mefenamic acid), Voltaren (diclofenac sodium), Voltaren XR (diclofenac sodium DR), Voltaren Gel (diclofenac sodium)

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended

G. Additional Discussion:

During the discussion of the Prescription Non-Steroidal Anti-Inflammatory Drug therapeutic class, a member stated the position that Voltaren Gel (diclofenac sodium) should also be included as a preferred drug. The Committee opposed the recommendation (by a vote of 7 to 4).

Dr. Martin (Chairperson) announced this will be Janice Gay's last meeting, and thanked her, on behalf of the Committee, for her service.

The meeting adjourned at 1:30 PM.

Meeting Summary Posted 03/24/09

H. Final Determinations

The Commissioner has determined that the Medicaid program will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs, as listed above, in the following classes: Topical Antibiotics, Topical Anti-virals, Topical Psoriasis Agents, Nasal Antihistamines, Non-Ergot Dopamine Receptor Agonists, Direct Renin Inhibitors, Skeletal Muscle Relaxants and Prescription Non-steroidal Anti-inflammatory Drugs.

Preferred Drugs will not require prior authorization

The impact of this final determination is as follows:

  • State Public Health Population:
    • Minimal effect on Medicaid enrollees, as a large majority of enrollees currently utilize preferred products.
    • Non-preferred products remain available when prior authorized.
  • Program Providers:
    • No impact on prescribers or pharmacies when utilizing preferred products. Prescribers, or their agents, will need to initiate the prior authorization process when ordering non-preferred products. Pharmacies will need to complete the prior authorization process for non-preferred products.
  • State Health Program:
    • Annual gross savings associated with these therapeutic classes under the PDP are estimated at $26M. The savings are achieved through changes in utilization to equally effective and less expensive drugs including the receipt of supplemental rebates from pharmaceutical manufacturers.

Final Determinations Posted 05/18/09