Avastin Coverage
Benefits Investigations
Avastin Access Solutions can conduct a benefits investigation
(BI) to help you determine if a Genentech medicine is covered, if
prior authorizations (PAs) are required, which specialty pharmacy (SP)
the health insurance plan prefers and if patient assistance might be
needed.
Potential outcomes of a BI:
- Treatment is covered
- PA is required
- Treatment is denied
A BI may be initiated once the SMN and PAN are submitted to Avastin
Access Solutions.
These can be downloaded from Forms and Documents or submitted online via My Patient Solutions.
The completion and submission of coverage- or reimbursement-related
documentation are the responsibility of the patient and health care
provider. Genentech makes no representation or guarantee concerning
coverage or reimbursement for any service or item.
Prior Authorization
Avastin Access Solutions can help you identify if a prior
authorization (PA) is necessary and offer resources as you obtain it
for your patient. PA support may be provided once the SMN and PAN are
submitted to Avastin Access Solutions.
If your patient’s request for a PA is not granted, your BioOncology Field Reimbursement Manager (BFRM) or Avastin Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.
The completion and submission of coverage- or reimbursement-related
documentation are the responsibility of the patient and health care
provider. Genentech makes no representation or guarantee concerning
coverage or reimbursement for any service or item.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
SMN=Statement of Medical Necessity.
Important Safety Information & Indication
Indication
[MCRC]
Avastin, in combination with intravenous 5‑fluorouracil-based chemotherapy, is indicated for the first‑ or second‑line treatment of patients with metastatic colorectal cancer.
Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second‑line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.
Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer.
[NSCLC]
Avastin, in combination with carboplatin and paclitaxel, is indicated for the first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer.
[mrCC]
Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma.
[rGBM]
Avastin is indicated for the treatment of recurrent glioblastoma in adults.
[CC]
Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
[OC]
Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Important Safety Information
Boxed WARNINGS
- Gastrointestinal (GI) perforation
- Serious and sometimes fatal GI perforation occurs at a higher incidence in Avastin-treated patients compared to patients treated with chemotherapy
- The incidence of GI perforation ranged from 0.3% to 3% across clinical studies
- Discontinue Avastin in patients with GI perforation
- Surgery and wound healing complications
- The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients
- Withhold Avastin for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed
- Discontinue in patients with wound healing complications requiring medical intervention
- Hemorrhage
- Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving Avastin. In clinical studies, the incidence of grade ≥3 hemorrhagic events among patients receiving Avastin ranged from 0.4% to 7%
- Do not administer Avastin to patients with serious hemorrhage or a recent history of hemoptysis (≥1/2 tsp of red blood)
- Discontinue Avastin in patients who develop grade 3-4 hemorrhage
Additional serious adverse events
- Additional serious and sometimes fatal adverse events with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
- Non-GI fistulae (<1% to 1.8%, highest in patients with cervical cancer)
- Arterial thromboembolic events (grade ≥3, 5%, highest in patients with GBM)
- Renal injury and proteinuria
- Grade 3–4 proteinuria ranged from 0.7% to 7% in clinical studies
- Nephrotic syndrome (<1%)
- Additional serious adverse events with increased incidence in the Avastin-treated arm vs chemotherapy arm included:
- Venous thromboembolism (grade ≥3, 11% seen in GOG-0240)
- Hypertension (grade 3–4, 5%–18%)
- Posterior reversible encephalopathy syndrome (PRES) (<0.5%)
- Congestive heart failure (CHF) (1%)
- Infusion reactions with the first dose of Avastin occurred in <3% of patients, and severe reactions occurred in 0.2% of patients
- Avoid use in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
- Inform females of reproductive potential of the risk of ovarian failure prior to initiating treatment with Avastin
Pregnancy warning
- Based on the mechanism of action and animal studies, Avastin may cause fetal harm
- Advise female patients that Avastin may cause fetal harm, and to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose of Avastin
- Advise nursing women that breastfeeding is not recommended during treatment with Avastin and for 6 months following their last dose of treatment
- Avastin may impair fertility
Most common adverse events
- Across studies, the most common adverse reactions observed in Avastin patients at a rate >10% were:
- Epistaxis
- Headache
- Hypertension
- Rhinitis
- Proteinuria
- Taste alteration
- Dry skin
- Rectal hemorrhage
- Lacrimation disorder
- Back pain
- Exfoliative dermatitis
Across all studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
Please see full Prescribing Information, including Boxed WARNINGS, at www.avastin.com for additional important safety information