What should I expect from the PA process when prescribing GIMOTI?

ASPN Pharmacies has several options to meet your needs. If a PA is required, ASPN will initiate the request to your office, typically through their electronic PA (ePA) process. ePA: Where applicable, ASPN will initiate an ePA and fax the questions to your office. Thereafter, your office can: Submit the ePA in the ASPN prescriber portal, Submit the answers to the ePA questions to ASPN via fax. ASPN will then complete the electronic questionnaire with the answers provided, Submit the ePA with your office’s preferred ePA platform (eg, CoverMyMeds). Traditional PA (paper): ASPN will fax the plan’s PA form to the office for completion. Your office may: Submit the completed form to ASPN via fax, Submit the completed form directly to the insurance plan. Once submitted to the plan, ASPN will follow up with the plan every 2 business days until an outcome is determined. It takes approximately 7 business days for a plan to determine an outcome.

Savings and support through ASPN Pharmacies

ASPN Pharmacies is the only pharmacy for GIMOTI

To ensure that patients receive GIMOTI, you MUST send the prescription to
ASPN Pharmacies—NOT a local pharmacy.

To ePrescribe:

1. In your EHR, save:

ASPN Pharmacies
ZIP: 07932
NCPDP#: 3147863
NPI: 1538590690

2. Send GIMOTI
prescription to
ASPN Pharmacies

3. Remind patients to
confirm their prescription
with ASPN Pharmacies

Ask them to respond to ASPN‘s text or save 1-844-244-6684 as the contact “ASPN Pharmacies” in their phone

Alternatively, you can fax your patient’s prescription to 1-888-661-9657 or call it in to 1-844-2GIMOTI (1-844-244-6684).

Learn how the prior authorization (PA) process works

GIMOTI nasal spray may cost ≤ $20

Pay as little as $20 for Gimoti® through vitaCare Perscription Services.

GIMOTI may cost only $0 for patients whose commercial
insurance covers GIMOTI, or $20 if it does not cover GIMOTI or they pay cash.*

97% of all patients pay ≤ $20,
regardless of coverage.^1,†

Patient assistance program

For patients who need financial assistance with GIMOTI, ASPN Pharmacies may be able to help.
Contact 1-844-244-6684 for more information.

ASPN Pharmacies contact information

Phone number:
1-844-244-6684

Email:
gimoti@aspnpharmacies.com

Hours:

Monday through Friday
8:30 AM to 8:00 PM (ET)

FAQs on prescribing GIMOTI through ASPN Pharmacies

ASPN Pharmacies is a specialty pharmacy and patient services provider that empowers prescribers to digitally send and manage prescriptions for their patients. ASPN does the heavy lifting to work with patients, providers, and insurance companies to verify benefits, navigate insurance hurdles, and secure the lowest out-of-pocket cost possible. ASPN has a network of pharmacies that are chosen to support patients.

Your patients will not be able to access their medication if the prescription is sent to a local pharmacy. GIMOTI is available only through ASPN Pharmacies.

By taking a moment to answer a few questions to complete the PA process for GIMOTI, you will be advocating for your new patients and those taking oral medications who may still be experiencing symptoms. ASPN Pharmacies’ digital platform streamlines the process and allows PAs to be completed in a few steps.

The ASPN prescriber portal is a secure website that allows the prescriber, nurse, medical assistant, or other staff member to manage the prescription process, including prescription clarification and PA.

The ASPN prescriber portal is designed to ensure a smooth prescription process. You can:

View the prescription within minutes of completing it and see real-time status updates
Streamline communications with ASPN, reducing phone calls and faxes
Get flexibility to select your notification preferences

ASPN Pharmacies has several options to meet your needs. If a PA is required, ASPN will send the request to your office, typically through their electronic PA (ePA) process.

ePA:

Where applicable, ASPN will initiate an ePA and fax the questions to your office. Thereafter, your office can:

Submit the ePA in the ASPN prescriber portal
Submit the answers to the ePA questions to ASPN via fax. ASPN will then complete the electronic questionnaire with the answers provided
Submit the ePA with your office’s preferred ePA platform (eg, CoverMyMeds)

Traditional PA (paper):

ASPN will fax the plan’s PA form to your office for completion. Your office may:

Submit the completed form to ASPN via fax
Submit the completed form directly to the insurance plan

Once submitted to the plan, ASPN will follow up with the plan every 2 business days until an outcome is determined. It takes approximately 7 business days for a plan to determine an outcome.

ASPN Pharmacies will initiate a PA if it is required. ASPN primarily uses an ePA, which is submitted directly to an insurance plan. The ePA process improves the transparency of coverage criteria and accelerates decision making by the plan, improving access. Using the ePA process, ASPN can usually receive a coverage decision in 2 to 24 hours (versus days).

There are 3 ways your office can receive the PA:

Via fax from ASPN Pharmacies
Electronically through ASPN’s prescriber portal if your office is registered and verified with the portal
Through your preferred ePA platform like CoverMyMeds

ASPN Pharmacies will contact your office if a PA is denied. You can still advocate for your patient and request an appeal by completing a Letter of Medical Necessity (LMN) form. Here’s how it works:

ASPN will fax an LMN checklist along with a letter template to your office
Then, they will follow up with your office every 48 hours for up to 3 attempts
Once ASPN has received the completed LMN, they will submit it to the insurance plan and follow up every 2 business days until an outcome is determined. An appeal determination takes approximately 30 days

Eligible patients pay $0 if their commercial insurance covers GIMOTI, but patients can still get it for $20 if the PA is denied.

ASPN has an extensive network of pharmacies that should help your patients access their medication. However, certain insurance plans maintain a narrow pharmacy network to limit their costs. ASPN may still be able to find savings options for patients whose pharmacies are out-of-network. Evoke Pharma also actively works in the background to encourage insurance plans to add ASPN Pharmacies to their network.

Numerous fee-for-service and managed care plans for Medicare and Medicaid patients cover GIMOTI. Many plans currently require a PA, though Evoke Pharma is actively working with states and Medicaid and Medicare plans to improve coverage. Government-insured patients are not usually eligible for manufacturer savings programs by law, but ASPN Pharmacies can work with you to submit a tier exception in these cases to significantly lower your patients’ out-of-pocket costs.

Discover the GIMOTI difference

Reference: 1. Data on file. EVOKE PHARMA^®.

Patients are not eligible for copay assistance if they are enrolled in any state or federally funded healthcare programs, such as Medicare or Medicaid, or where prohibited by law. Certain eligibility criteria apply; for Terms and Conditions, please visit gimotirx.com/terms.

^†

Includes coverage by commercial and government insurance (as of December 2022).

Indication and Important Safety Information

INDICATION

Gimoti^® (metoclopramide) nasal spray is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Limitations of Use

GIMOTI is not recommended for use in pediatric patients, in patients with moderate or severe hepatic impairment, in patients with moderate or severe renal impairment, or in patients concurrently using strong CYP2D6 inhibitors.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: TARDIVE DYSKINESIA

Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

CONTRAINDICATIONS

GIMOTI is contraindicated in patients with a history of TD or a dystonic reaction to metoclopramide; when the stimulation of gastrointestinal motility might be dangerous (eg, in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation); in patients with pheochromocytoma or other catecholamine-releasing paragangliomas (metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor); in patients with epilepsy (metoclopramide may increase the frequency and severity of seizures); in patients with hypersensitivity to metoclopramide (reactions have included laryngeal and glossal angioedema and bronchospasm).

WARNING AND PRECAUTIONS

TARDIVE DYSKINESIA (TD): Metoclopramide can cause TD, a syndrome of potentially irreversible involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. The risk of developing TD and the likelihood that TD will become irreversible increases with the duration of treatment and the total cumulative dosage. The risk of developing TD is increased in the elderly, especially elderly women, and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with metoclopramide for longer than 12 weeks. GIMOTI is not recommended in geriatric patients as initial therapy. See Full Prescribing Information for switching geriatric patients on a stable dose of an alternative metoclopramide product to GIMOTI.

Other extrapyramidal symptoms (EPS): In addition to TD, metoclopramide may cause other EPS, parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue GIMOTI.

Neuroleptic malignant syndrome (NMS): Metoclopramide may cause a potentially fatal symptom complex called NMS. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately. Avoid GIMOTI in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics.

Depression: Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid GIMOTI use in patients with a history of depression.

Hypertension: Metoclopramide may elevate blood pressure and should be avoided in patients with hypertension or in patients taking monoamine oxidase inhibitors (MAOIs). Discontinue GIMOTI in any patient with a rapid rise in blood pressure.

Fluid Retention: Because metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue GIMOTI if any of these adverse reactions occur.

Hyperprolactinemia: As with other dopamine-D₂ receptor antagonists, metoclopramide elevates prolactin levels and may suppress pituitary gonadotropin secretion. This may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including metoclopramide.

Effects on the ability to drive and operate machinery: Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of CNS depressants or drugs associated with EPS may increase this effect (eg, alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid GIMOTI or the interacting drug, depending on the importance of the drug to the patient.

ADVERSE REACTIONS

The most common adverse reactions in patients treated with GIMOTI are dysgeusia, headache, and fatigue. In patients receiving an equivalent oral dose of metoclopramide, the most common adverse reactions were restlessness, drowsiness, fatigue, and lassitude. Adverse reactions involving the nervous system occurred after stopping oral metoclopramide, including dizziness, nervousness, and headaches.

DRUG INTERACTIONS

Avoid concomitant use with antipsychotics, MAOIs, and central nervous system (CNS) depressants. Concomitant use with strong CYP2D6 inhibitors (eg, quinidine, bupropion, fluoxetine, paroxetine) is not recommended. Use with caution with dopaminergic agonists and drugs that increase dopamine concentration. Monitor for reduced therapeutic effect when used with drugs that may have opposing effects on gastrointestinal motility (eg, antiperistaltics, anticholinergics, opiates). Monitor patients receiving GIMOTI for increased blood glucose and adjust insulin dose regimen as needed.

USE IN SPECIFIC POPULATIONS

Pregnancy: Published studies do not report a consistent pattern or a consistently increased risk of pregnancy-related adverse outcomes with oral use of metoclopramide during pregnancy. There are potential risks to the neonate during delivery following exposure to metoclopramide in utero.

Lactation: Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GIMOTI and any potential adverse effects on the breastfed child from GIMOTI or from the underlying maternal condition.

Pediatric: Metoclopramide is not recommended for use in pediatric patients due to the risk of TD and other EPS as well as the risk of methemoglobinemia in neonates.

Geriatric: Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide, especially older women. GIMOTI is not recommended as initial therapy.

Renal impairment: GIMOTI is not recommended in patients with moderate and severe renal impairment.

Hepatic impairment: GIMOTI is not recommended in patients with moderate or severe hepatic impairment.

NADH-cytochrome b₅ reductase deficiency: Metoclopramide-treated patients with NADH-cytochrome b₅ reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia.

CYP2D6 poor metabolizers: GIMOTI is not recommended in patients who are CYP2D6 poor metabolizers.

Please see complete Prescribing Information, including Boxed Warning, and Patient Information.

You may report side effects related to Evoke Pharma products by calling 1-833-4-GIMOTI (1-833-444-6684) or emailing GIMOTImedinfo@evokepharma.com. If you prefer to report side effects to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.