VELETRI Patient Enrollment Form

VELETRI patient enrollment forms

VELETRI® (epoprostenol) for Injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases (CTD).

Patient name:

Instructions

1 Review VELETRI indication and Important Safety Information on pages 2 and 3

2 Complete patient enrollment

3 Document PAH diagnosis

4 Determine PAH clinical status

5 Complete calcium channel blocker (CCB) trial

6 Provide required documentation: right heart catheterization, echocardiogram results, and history and physical notes

7 Fax completed forms to your patient’s specialty pharmacy: Accredo Health Group Fax: 1-800-711-3526 / CVS/Caremark Fax: 1-877-943-1000

Please see accompanying full prescribing information.

Prescription

VELETRI® (epoprostenol) for Injection—continuous IV infusion administered via ambulatory pump

Patient: DOB:

Physician:

It is the responsibility of the Prescriber to complete this form with information that most accurately and completely describes the condition of the patient, regardless of the potential impact on insurance coverage or reimbursement.

WHO Group 1 PAH Diagnoses

ICD-9: 416.0 Primary Pulmonary Arterial Hypertension (Idiopathic PAH)

ICD-9: 416.0 Familial Pulmonary Arterial Hypertension (FPAH)

ICD-9: 416.8 Secondary Pulmonary Hypertension (Associated PAH)

Please specify one:

Connective Tissue Disease (eg, CREST, MCTD, Scleroderma, Lupus)

Other:

Other

ICD-9: Description:

Medical rationale for other

Patient: DOB:

Physician:

NYHA functional class: (Check only one)

Class III

Class IV

Other:

Clinical signs and symptoms: (Check all appropriate)

Fatigue

Shortness of breath or dyspnea on exertion

6-minute walk: meters Date of evaluation:

Chest pain or pressure (angina)

Syncope or near syncope

Edema or fluid retention

Increasing limitation of physical activity

Other:

Course of illness: (Check all appropriate)

Evidence of worsening heart failure

Worsening pulmonary hemodynamics

Decreasing 6-minute walk test

Change in functional class

Worsening dyspnea on exertion

Change in patient-reported symptoms

Other:

Prescriber signature: Date:

Patient: DOB:

Physician:

Prior to the initiation of VELETRI® (epoprostenol) for Injection, Medicare policy requires documentation that a calcium channel blocker (CCB) has been tried, failed, or considered and ruled out.

A CCB was not trialed because:

Patient did not meet ACCP Guidelines for Vasodilator Response

Patient is hemodynamically unstable or has history of postural hypotension

Patient has systemic hypotension

Patient has depressed cardiac output

Patient has known hypersensitivity

Patient has documented bradycardia or second- or third-degree heart block

Patient has signs of right-sided heart failure

Other:

OR

The following CCB was trialed:

CCB:

With the following response:

Pulmonary arterial pressure continued to rise

Disease continued to progress or patient remained symptomatic

Patient hypersensitive or allergic

Adverse event:

Patient became hemodynamically unstable

Other:

Prescriber signature: Date:

Patient: DOB:

Physician:

Please check each box once completed.

Right heart catheterization has been performed. Results form is attached.

Echocardiogram has been performed to rule out left-sided heart or valvular disease. Results form is attached.

Current history and physical notes with need for therapy and PAH symptoms documented. Notes are attached.

Prescriber Initials: Date: