Introduction

Tirzepatide is a novel weight loss medication developed by Eli Lilly. It's classified as a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. Initially approved by the FDA for diabetes treatment in May 2022, it received additional approval for chronic weight management in adults with obesity in November 2023.

How Tirzepatide Works

Tirzepatide works by mimicking two hormones:

1. GLP-1 (glucagon-like peptide-1): This hormone induces feelings of fullness.
2. GIP (glucose-dependent insulinotropic polypeptide): This enhances the medication's effectiveness.

This dual-action mechanism sets tirzepatide apart from other weight loss medications and contributes to its increased effectiveness.

Dosage and Administration

Tirzepatide is typically administered as a once-weekly subcutaneous injection. The dosage schedule is as follows:

1. Starting dose: 2.5mg once weekly for 4 weeks
2. Increase to 5mg once weekly for 4 weeks
3. If additional glycemic control is needed, increase to 7.5mg once weekly for 4 weeks
4. Maximum dose: 15mg once weekly

Doctors may adjust this schedule based on individual patient needs and responses.

How to Inject Tirzepatide

Tirzepatide comes in a pre-filled pen for subcutaneous injection. Here's a step-by-step guide:

1. Wash your hands thoroughly.
2. Choose an injection site: abdomen, thigh, or upper arm.
3. Clean the injection site with an alcohol swab.
4. Remove the pen cap and check that the medication is clear and colorless.
5. Pinch the skin at the injection site.
6. Insert the needle at a 90-degree angle.
7. Press the injection button and hold for 5-10 seconds.
8. Remove the needle and dispose of it safely.
9. Do not rub the injection site.

Always follow your healthcare provider's specific instructions.

Side Effects

Common side effects of tirzepatide include:

1. Nausea (reported in 24.2% - 33.9% of patients)
2. Diarrhea (14.9% - 23.0%)
3. Vomiting (8.3% - 14.9%)
4. Constipation (11.7% - 17.1%)
5. Abdominal pain (10.9% - 11.5%)
6. Headache (9.1% - 12.0%)
7. Fatigue (5.1% - 7.5%)

Less common but more serious side effects may include:

1. Pancreatitis
2. Gallbladder problems
3. Hypoglycemia (especially in patients with type 2 diabetes)
4. Kidney problems
5. Severe gastrointestinal disease
6. Diabetic retinopathy complications
7. Heart rate increase
8. Suicidal behavior and ideation

It's important to note that most gastrointestinal side effects were mild to moderate and occurred mainly when the dose was increased.

The Research

SURMOUNT Trials Overview

• Primary studies: SURMOUNT trials
• Funded by: Eli Lilly
• Purpose: FDA approval process
• Significance: Main source of information for tirzepatide label

SURMOUNT 1 Trial

Participants:

• 2,539 adults
• BMI criteria: 30+ or 27+ with weight-related complication
• Exclusion: Individuals with diabetes

Method:

• Duration: 72 weeks
• Dosages: Four different doses, including placebo

Results:

• Highest dose: 20.9% average body weight loss over 72 weeks

SURMOUNT 2 Trial

Participants:

• Diabetic individuals only

Results:

• Highest dose: 14.7% average body weight loss over 72 weeks

Side Effects

Most common:

• Related to gastrointestinal system
• Similar to other GLP receptor-targeting medications (e.g., semaglutide)
• Severity: Mostly mild to moderate
• Occurrence: Mainly during dose increases

Treatment Discontinuation Rates:

• 5 mg dose: 4.3% of participants stopped treatment
• 10 mg dose: 7.1% of participants stopped treatment
• 15 mg dose: 6.2% of participants stopped treatment
• Placebo: 2.6% of participants stopped treatment

Overall Adverse Event Rates:

• Tirzepatide: 78.9% - 81.8% of participants
• Placebo: 72.0% of participants

Cost and Insurance Coverage

Without insurance, branded tirzepatide can cost over $1000 per month. Insurance coverage varies widely and depends on individual plans and medical necessity criteria. Insurance coverage for these medications is complex, depending on your insurance plan, formulary, and medical necessity. These drugs are often considered higher-tier medications, a label insurance companies use for high-cost medications. Insurance plans have specific criteria for coverage, so meeting them is crucial for affordable access.

Checking Insurance Coverage: Step-by-Step Guide

1. Review Insurance Policy Documents:

1. Review Insurance Policy Documents
   1. Check your insurance policy documents for prescription drug coverage details.
2. Check Formulary Lists:
   1. Review the formulary to find which tier tirzepatide belongs to.
3. Understand Coverage Criteria:
   1. Learn about any requirements for coverage, such as prior authorization or step therapy.
4. Consult Healthcare Providers:
   1. Discuss medication choices with your healthcare provider and ask about their experience with insurance authorization.
5. Contact the Insurance Provider:
   1. Call your insurance provider for precise information about coverage, copayments, and approval steps.
6. Utilize Online Tools:
   1. Explore online tools offered by your insurance provider for drug coverage details.

Coupons

Also known as drugmaker discount programs, manufacturer-sponsored prescription coupons, or savings cards, coupons are discounts given out by pharmaceutical companies to individuals who qualify for a prescription medication. Eli Lilly offers discounts on branded versions of tirzepatide for qualifying patients with commercial insurance, which you can read in detail here or summarized below.

Eli Lilly

Also known as drugmaker discount programs, manufacturer-sponsored prescription coupons, or savings cards, coupons are discounts given out by pharmaceutical companies to individuals who qualify for a prescription medication. For patients with commercial insurance, Eli Lilly offers discounts on tirzepatide, with various rules and restrictions.

• With insurance - card savings are subject to a maximum monthly savings of up to $150 per 1-month prescription, $300 per 2-month prescription, or $450 per 3-month prescription fill and separate maximum annual savings of up to $1800 per calendar year. Card may be used for a maximum of up to 13 prescription fills per calendar year
• Card savings are not available to patients without commercial drug insurance or who are enrolled in any state, federal, or government funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program.
• You must have commercial drug insurance that covers the branded version of tirzepatide and a prescription consistent with FDA-approved product labeling
• Without insurance - card savings are subject to a maximum monthly savings of up to $563 and a separate maximum annual savings of up to $7,319 per calendar year. Card may be used for a maximum of up to 13 prescription fills per calendar year.

Our Solution

At MD Exam, we offer affordable medications using pharmaceutical compounding, providing the same active ingredients as branded versions, namely semaglutide and tirzepatide, at lower costs. We provide the same active ingredients, semaglutide and tirzepatide, for as little as $225 a month. Compounding pharmacies play a crucial role in American healthcare by filling medication supply gaps and creating custom formulations for specialized needs. MD Exam ensures accessibility by delivering effective medication at an affordable price.

Conclusion

Tirzepatide represents a significant advancement in weight loss medication, offering substantial benefits for many patients. However, its high cost remains a barrier for some. As with any medication, it's crucial to discuss the potential benefits and risks with a healthcare provider before starting treatment.

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