Capivasertib Shortage: What Providers and Prescribers Need to Know in 2026

As oncology practices navigate an evolving treatment landscape for HR-positive, HER2-negative metastatic breast cancer, Capivasertib (Truqap) has emerged as an important therapeutic option. However, many providers are finding that prescribing this first-in-class AKT inhibitor is only half the battle — helping patients actually access it is increasingly complex.

This briefing provides a current overview of Capivasertib availability, the barriers your patients may face, and practical tools to streamline the prescribing and fulfillment process.

Timeline and Regulatory Background

Capivasertib received FDA approval on November 16, 2023, as the first AKT inhibitor for cancer treatment. Key regulatory milestones:

• November 2023: FDA approval for HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN alterations, in combination with Fulvestrant
• November 2023: FoundationOne CDx approved as companion diagnostic
• April 2024: European Medicines Agency (EMA) CHMP positive opinion
• April 2025: NHS approval in the UK
• 2024–2026: Ongoing clinical trials exploring Capivasertib in additional indications including triple-negative breast cancer and prostate cancer

The drug received fast track designation from the FDA, underscoring the unmet need for targeted therapy in this patient population.

Prescribing Implications

Patient Selection

Capivasertib is indicated for patients who meet all of the following criteria:

1. HR-positive, HER2-negative locally advanced or metastatic breast cancer
2. One or more PIK3CA, AKT1, or PTEN alterations confirmed by an FDA-approved test (FoundationOne CDx)
3. Disease progression on at least one endocrine-based regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant therapy

Dosing

The recommended dose is 400 mg orally twice daily (two 200 mg tablets), taken approximately 12 hours apart, with or without food. The schedule is 4 days on, 3 days off, repeated in 28-day cycles. Capivasertib is administered concurrently with Fulvestrant 500 mg IM.

Key dose modifications:

• Reduce to 320 mg twice daily if concomitant use of a strong CYP3A inhibitor cannot be avoided
• First dose reduction: 320 mg twice daily
• Second dose reduction: 200 mg twice daily
• Discontinue if unable to tolerate 200 mg twice daily

Monitoring Requirements

• Fasting glucose and HbA1c prior to initiation and at regular intervals (at least monthly) — hyperglycemia is a significant adverse event
• Skin assessments — rash and severe cutaneous adverse reactions (including DRESS syndrome) can occur, typically within the first 2 weeks
• Pregnancy testing prior to initiation in females of reproductive potential

Current Availability Picture

As of 2026, Capivasertib is not on the FDA Drug Shortage Database. Manufacturing supply from AstraZeneca appears stable. However, patients frequently report difficulty accessing the medication due to:

• Specialty pharmacy-only distribution: Truqap is not stocked at retail pharmacies
• Prior authorization delays: Most commercial and Medicare plans require PA, which can take 5–15 business days
• Companion diagnostic turnaround: FoundationOne CDx testing adds 1–3 weeks before prescribing can begin
• Insurance denials: Particularly when documentation of prior endocrine therapy or mutation status is incomplete

These are access barriers, not supply shortages, but they have the same practical effect of delaying treatment initiation.

Cost and Access Considerations

The wholesale acquisition cost (WAC) of Capivasertib is approximately $23,762 per 28-day cycle. Patient cost-sharing varies significantly by payer:

• Commercial insurance: Most plans cover Truqap on specialty tier with prior authorization. Copays can range from $50 to several thousand dollars per month.
• Medicare Part D: Covered with prior authorization. Patients in the coverage gap ("donut hole") may face significant out-of-pocket costs.
• Medicaid: Coverage varies by state. Prior authorization is generally required.

Financial Support Programs

• Truqap Co-Pay Savings Program: Commercially insured patients may pay as little as $0/month. No income requirements. Enroll via MyAccess360.com.
• AZ&Me Patient Assistance Program: Provides Truqap at no cost to qualifying uninsured/underinsured patients.
• AstraZeneca Access 360: Comprehensive support for PA navigation, specialty pharmacy coordination, and financial assistance. Call 844-275-2360.

Tools and Resources for Providers

Streamlining Capivasertib access for your patients starts with a few key workflows:

1. Order Companion Diagnostics Early

If a patient has HR+/HER2- metastatic breast cancer and is approaching or experiencing endocrine therapy failure, order FoundationOne CDx or equivalent NGS panel proactively. This avoids the 1–3 week testing delay once you're ready to prescribe.

2. Start Prior Authorization Before Results Return

Some payers accept PA submissions with pending genetic testing results. Work with your coding team to prepare documentation in advance so the PA can be submitted as soon as test results confirm eligibility.

3. Use AstraZeneca Access 360

Access 360 provides dedicated support for PA navigation, pharmacy coordination, and patient enrollment in financial assistance programs. They can be a significant time-saver for busy practices. Enroll patients at MyAccess360.com or call 844-275-2360.

4. Use Medfinder for Pharmacy Availability

Medfinder for Providers helps identify specialty pharmacies with Capivasertib in stock, reducing fulfillment delays. Direct your support staff to check availability when initiating new prescriptions.

5. Prepare for Common Side Effects

Proactive side effect management reduces dose interruptions and treatment discontinuation. Ensure patients understand:

• Diarrhea management (anti-diarrheal medications, hydration)
• Blood sugar monitoring (especially in patients with diabetes or pre-diabetes)
• Skin care and early reporting of rash

For detailed side effect and interaction information, see our articles on Capivasertib side effects and Capivasertib drug interactions.

Looking Ahead

Capivasertib represents a meaningful advancement for patients with PIK3CA/AKT1/PTEN-altered breast cancer who have limited options after endocrine therapy failure. As the drug matures on the market:

• Payer coverage processes are expected to become more streamlined
• Real-world data will further clarify optimal patient selection and sequencing
• Ongoing clinical trials may expand approved indications

In the meantime, proactive companion diagnostic ordering, early PA submission, and leveraging manufacturer support programs remain the most effective strategies for minimizing treatment delays.

Final Thoughts

The access challenges surrounding Capivasertib are not unique to this drug — they reflect broader systemic issues with specialty oncology medication distribution. By building efficient workflows and using available support tools, providers can significantly reduce the time between prescribing and treatment initiation.

For additional provider resources, visit Medfinder for Providers. For a guide on helping patients manage costs, see our article on how to help patients save money on Capivasertib.