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Elena Chan PharmD Candidate UCSF Tiffany Jew PharmD, MBA Candidate USC

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Presentation on theme: "Elena Chan PharmD Candidate UCSF Tiffany Jew PharmD, MBA Candidate USC"— Presentation transcript:

1 P & T Committee Formulary Review Exubera® Insulin Human (rDNA origin) Inhalation Powder
Elena Chan PharmD Candidate UCSF Tiffany Jew PharmD, MBA Candidate USC Pro Pharma Pharmaceutical Consultants, Inc

2 Outline Overview of P&T Committee Formulary Submission Dossier
Exubera® – Inhaled Insulin Prior Authorization Criteria

3 Pharmacy and Therapeutics (P&T) Committee
The role of the P&T Committee: Objectively appraises, evaluates, and selects drugs for formulary – value, place in therapy, and impact on budget Manages formulary in light of new drugs, indications, and warnings Develop policies for educating and informing providers about new drugs and committee decisions Quality improvement Develop generic substitution and therapeutic interchange programs Develop procedures for use and access to non-formulary drugs Committee meets regularly throughout the year Members include physicians, pharmacists, administrators, and other health care professionals

4 Formulary Submission Dossier

5 Overview of Diabetes Diabetes total U.S. prevalence in 2005
20.8 million people (7% of the population) Type 1: 5-10% of diagnosed cases Type 2: 90-95% of diagnosed cases Gestational: 20-50% of those will go on to have Type 2 in the next 5-10yrs Medications used by diabetics: 57% Oral medications only 16% Insulin only 12% Insulin + Oral medications 15% None Direct and indirect costs = $132 billion in 2002 Risk factors for diabetes: genetic, sedentary lifestyle, overweight, pre-diabetes 14.6 M are diagnosed Type1: pancreas unable to produce insulin Type 2: poor diet and exercise and other factors prevent the body from sensing insulin as well as it used to Gestational: elevated glucose levels during pregnancy that may or may not resolve Pre-diabetes – lots of in Talk about measures of glycemic control (A1C, blood glucose measures). When glycemic control is not achieved then you increase the risk of complications – kidney disease, peripheral neuropathy, retinopathy; hospitalizations/doctor visits CDC National Diabetes Fact Sheet 2005

6 Product Information Exubera® is a dry powder formulation of recombinant human regular insulin that is administered via oral inhalation Indication: Diabetes mellitus type 1 and 2 Forms: Comes as 1mg or 3mg blister packs Dose: Determined from preexisting premeal insulin or by weight Administer 2-4 times/day 10min before meals

7 Pharmacology Human insulin produced by recombinant DNA technology
Insulin regulates glucose metabolism by stimulating uptake of glucose from the blood into skeletal muscle and fat and inhibiting hepatic glucose production.

8 Pharmacokinetics Exubera® SubQ Regular Insulin
After inhalation, insulin is rapidly absorbed across the pulmonary epithelium Mean time to peak serum concentration = 45minutes Bioavailability: 4.9-11% for nonsmokers 12-19% for smokers

9 Pharmacodynamics Onset of action = 10-20 min (similar to
rapid-acting insulins) Duration of action = 6 hrs (similar to regular) PD/PK differences exist among respiratory diseases. More absorption in patients with COPD and smokers Less absorption in mild asthma No differences found between age, sex, pregnancy Exubera® Package Insert. Clinical Pharmacology accessed Mar 2007

10 Warnings and Interactions
Contraindications: Hypersensitivity to Exubera®/any of its excipients Smokers/ex-smokers<6months Poorly controlled lung disease Adverse Reactions: Hypoglycemia, chest pain, dry mouth, otitis media in peds Cough, dyspnea, pharnygitis, sputum, epistaxis, decrease in pulmonary function (FEV1) Common Drug Interactions: Reduce insulin’s effect: corticosteroids, diuretics, sympathomimetics, glucagon, estrogens/progesterone, protease inhibitors, atypical antipsychotics, thyroid hormones Increase insulin’s effect: oral antidiabetics, ACE-I, fibrates, fluoxetine, MAOI’s Mask the symptoms of hypoglycemia: b-blockers, clonidine Affects absorption- leading to hypo- or hyperglycemia

11 Place in Therapy Manufacturer Recommendations:
Type 1: use in combo with longer-acting insulin Type 2: use as monotherapy or with oral diabetic meds or longer-acting insulin Effective in patients poorly controlled on oral hypoglycemics or insulin May be useful for patients who prefer inhaled over injected route for their rapid-acting insulin American Diabetes Association Recommends: Inhaled insulin not included in treatment algorithm Statements on the ADA website question the long-term safety and cost-effectiveness of inhaled insulin Other published guidelines question the efficacy of inhaled insulin in lowering A1C<7%

12 Treatment Algorithm for Type 2 Diabetes

13 Submission of Clinical Trials
The manufacturer should include: All pivotal clinical and economic studies – published and unpublished Spreadsheet or table of these trials Major conclusions from Cochrane/Agency for Health Research and Quality Allows the P&T Committee to practice “evidence-based medicine” Evaluate quality, strength of clinical trials Weigh out risks and benefits of drug, including no treatment According to the Centre for Evidence-Based Medicine, "Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.

14 Submission of Cost-Effectiveness Models
Why do we need one? Projects the value of the product taking into account both efficacy and cost How the addition of the product will affect the health plan’s formulary Determines the product’s place in therapy in the formulary Compares the product to “gold standards” What should one include? Take into account absolute and relative risk reductions, costs associated with administering this drug and its potential adverse effects Assumptions and calculations should be reasonable and accurate

15 Statement of Product Value
Allows manufacturer to communicate value of product Summarize clinical and economic data Estimate the per unit product cost Example: “Inhaled insulin was demonstrated to have similar efficacy and side effects as injectable regular insulin, but patients prefer inhaled to injected. It may improve quality of life and reduce diabetic complications in those patients that are resistant or non-adherent to injectable insulin. Although it may cost more, it may generate savings if patients achieve better glycemic control due to better compliance to insulin therapy. ”

16 Cost Comparison Table Regular Insulin (12,775 Units/year) Exubera®
1mg of Exubera® = 3 IU of Regular SC Insulin Release unit needs to be replaced every 2 weeks Cost comparison of a 70kg adult using 0.5 Units of regular insulin/kg/day Costs are calculated over a year of use Based on AWP Regular Insulin (12,775 Units/year) Exubera® (4,380 mg/year) Syringes = $221.40 Insulin vials = $787 $1008 1 chamber= $19 28 release units/year = $84 Blister packs = $3042 $3145 + +

17 PA Criteria Patients must be: For Type 1 Diabetics:
18 years or older with a diagnosis of diabetes type 1 or 2 Non-smokers No hx of COPD, asthma, or other chronic respiratory disease Documented A1C> 7% and baseline pulmonary function test For Type 1 Diabetics: Must be used with a long-acting insulin (cannot use Exubera® as monotherapy) Patient has a need for short-acting insulin to achieve glycemic control AND patient has difficulty with performing multiple injections (disability, blind)

18 PA Criteria Continued For Type 2 Diabetics:
First, must have tried and failed to achieve glycemic control w/ max doses of oral agents or are contraindicated Then, must have tried to achieve glycemic control w/ a full injectable insulin regimen (long-acting + short-acting) AND patient has difficulty with performing multiple injections (disability, blind) Exubera® must be used in combination with a long-acting insulin and oral agents (unless contraindicated)

19 Questions?

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