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FDA ADVISORY COMMITTEE 5/11/01. Robert J. Spiegel, M.D. Sr. V. P. Medical Affairs Chief Medical Officer Schering Plough. OVERVIEW. For many patients, allergies are not appropriately treated without physician management

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FDA ADVISORY COMMITTEE

5/11/01

Robert J. Spiegel, M.D.

Sr. V. P. Medical Affairs

Chief Medical Officer

Schering Plough


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OVERVIEW

  • For many patients, allergies are not appropriately treated without physician management

  • More data are necessary to support this OTC switch based on unique issues of use

  • OTC status will decrease access for many patients, and may not decrease use of first-generation anti-histamines


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OVERVIEW

For many patients, allergies are not appropriately treated without physician management

Different types of antihistamine users

Short-term vs. chronic

Comorbid diseases

Cold Use vs. Allergy Disease Management


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OVERVIEW

  • For many patients, allergies are not appropriately treated without physician management

  • More data are necessary to support this OTC switch based on unique issues of use

  • OTC status will decrease access for many patients, and may not decrease use of first-generation antihistamines


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“Data to support the OTC switch generally comes from the

following sources: efficacy trials, safety data, actual use trials, and label comprehension trials…these latter two trials may or may not be needed depending upon whether there are any unique issues related to use, warnings, or directions that need to be tested prior to marketing.”

“The switch of a prescription drug to OTC marketing requires a review of the post-marketing safety data and a determination that a consumer can adequately use the product in an OTC setting”

FDA OTC Antihistamine Review Team

4/5/01


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OVERVIEW the

  • For many patients, allergies are not appropriately treated without physician management

  • More data are necessary to support this OTC switch based on unique issues of use

  • OTC status will decrease access for many patients, and may not decrease use of first-generation antihistamines


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For many patients, allergies are not appropriately treated without Physician Management

1. Prescription status may be necessary to protect and optimize public health


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U.S. Health Care System - 2001 without Physician Management

- Evidence-based medicine

- Guideline-driven practice

- Disease management approach


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U.S. Health Care System without Physician ManagementAllergy Management - 2001

  • Diagnostic Evaluation

    • Differentiate allergic disorders from other diseases

    • Uncover previously unsuspected allergens

    • Assess comorbid conditions

  • Environmental Assessment– Antigen Testing

  • Pharmacologic Therapy

    • Antihistamines +Rx for Comorbid Conditions

    • Decongestants

    • Nasal Steroids

    • Immunotherapy

  • Follow-up, Reassessment, Compliance Management


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For many patients allergies are not appropriately treated without Physician Management

1. Prescription status may be necessary to protect and optimize public health

2. The safety profiles of the second- generation antihistamines in an OTC setting are not fully known


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2. The safety profiles of the second- generation antihistamines in an OTC setting are not fully known

  • How often will they be used to treat colds?

  • How often will patients dose incorrectly?

  • How many patients will experience exacerbation of untreated or unrecognized co-morbidities?

  • How often will patients have adverse outcomes as a result of delays in seeking medical care?


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For many patients allergies are not appropriately treated without Physician Management

1. Prescription status may be necessary to protect and optimize public health

2. The safety profiles of the second- generation antihistamines in an OTC setting are not fully known

3. Allergies are frequently chronic, complex diseases with serious co-morbidities


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Allergies are frequently chronic, complex diseases with Serious Comorbidities

Co-morbid conditions associated with allergic rhinitis

  • Asthma

  • Sinusitis

  • Otitis Media

    Children are seriously affected by allergic rhinitis

  • 10-40% of school children

  • Under treatment is related to learning and behavioral problems


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Allergies: >50 million Americans Serious Comorbidities

Asthma: 15 million Americans

4.8 million children

Asthma Prevalence

75% 1980--> 1994

Asthma Deaths

1980 - 11.5/1 million

1995 - 18.0/1 million

(5,500 deaths)


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Allergic Rhinitis and Asthma Often Co-exist Serious Comorbidities

78% of asthma patients have nasal symptoms

38% of allergic rhinitis patients have asthma

3 million Claritin® Rx’s are co-prescribed with Rx’s for asthma medications (for approximately 1.2M patients with asthma)


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Allergy-Asthma Link Serious Comorbidities

  • Treating allergic inflammation in the nose can reduce asthma symptoms and lower airway hyper-responsiveness.1,2

  • Asthmatic patients with Allergic Rhinitis have higher medical costs

  • In a longitudinal study of 783 students:3

    • Resolution of Allergic Rhinitis symptoms correlated with improvement in asthma (p=.0078)

    • Worsening of Allergic Rhinitis was associated with persistence of asthma

      1 Allergy Clin Immonol 1995;95:923-32

      2 Allergy Clin Immonol 1996;98:274-82

      3 Allergy Proc 1994;15:21-25.


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FIRST-GENERATION ANTIHISTAMINES Serious Comorbidities

Short-term/episodic use

Simple Sx relief for simple allergy patients

?co-morbidity

Frequent use in colds

SECOND-GENERATION ANTIHISTAMINES

Long-Term/chronic use

Disease management for Complex patients

Frequent co-morbidity

Not effective for colds

CHANGES IN ALLERGYMANAGEMENT


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OTC status may decrease access and not decrease use of first-generation antihistamines

Medicaid and poor patients will be unable to afford 2nd-Generation products as OTC’s

Patients currently with insurance coverage will make decisions based on out-of-pocket costs

Use of sedating antihistamines may well increase


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US and Canadian first-generation antihistaminesAntihistamine Market Share

Source: IMS Health NPA Plus and A.C. Nielsen

Note: Calculated using maximum dose per day.


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CONCLUSION first-generation antihistamines

  • Loratadine is most appropriately used as an Rx product

  • There are unique issues related to use

  • 1st Generation 2nd Generation

  • FDA Switch Principles

    -Labeling must be developed and tested

    -Actual Use Trials are necessary


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CONCLUSION first-generation antihistamines

  • Loratadine is most appropriately used as an Rx product

  • There are unique issues related to use

  • 1st Generation 2nd Generation

  • FDA Switch Principles

    -Labeling must be developed and tested

    -Actual Use Trials are necessary


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CONCLUSION first-generation antihistamines

  • Loratadine is most appropriately used as an Rx product

  • There are unique issues related to use

  • 1st Generation 2nd Generation

  • FDA Switch Principles

    -Labeling must be developed and tested

    -Actual Use Trials are necessary


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CONCLUSION first-generation antihistamines

  • Loratadine is most appropriately used as an Rx product

  • There are unique issues related to use

  • 1st Generation 2nd Generation

  • FDA Switch Principles

    -Labeling must be developed and tested

    -Actual Use Trials are necessary


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ISSUES REQUIRING ASSESSMENT FOR OTC SWITCH first-generation antihistamines

  • Ability to self-diagnose the condition

  • Assessment of risk of initial misdiagnosis

  • Assessment of risk of subsequent misdiagnosis of disease exacerbation or common co-morbid conditions

  • Assessment of risk of incorrect dosing (voluntary and/or inadvertent)

  • Assessment of safety in at-risk populations

  • Label development and comprehension


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CONCLUSION first-generation antihistamines

  • Loratadine is most appropriately used as an Rx product

  • There are unique issues related to use

  • 1st Generation 2nd Generation

  • FDA Switch Principles

    -Labeling must be developed and tested

    -Actual Use Trials are necessary


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? first-generation antihistamines

Benefit/ Risk

Benefit/ Risk

+

R

OTC

x


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Benefit/ Risk first-generation antihistamines

Benefit/ Risk

+

R

OTC

x


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QUESTIONS first-generation antihistamines


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