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Part D Assistance Program (PDAP)


What is PDAP?

PDAP provides a free supply of Renvela® (sevelamer carbonate) to eligible patients with Medicare Part D who cannot afford their copayments or co-insurance for their prescriptions.

  • The 2016 Part D Assistance Program opens on March 1, 2016.
  • Refills must be requested by the healthcare professional.
  • If less than 3 months remain in the year, the patient will receive enough medication to last until December 31.


What are the Medicare requirements of PDAP?

  • A patient may not submit any claim for compensation or reimbursement for Renvela to any third party, including a Medicare Part D plan or another public or private plan or program, while the patient is receiving free Renvela® from Sanofi's Part D Assistance Program.
  • The cost of this drug will not apply toward the patient's true out of pocket.

Who is eligible for assistance through PDAP?

  • Eligible applicants must be enrolled in a Medicare Part D Plan or MA-PD Plan and must not have any other prescription drug coverage for Renvela® or Renagel® (sevelamer hydrochloride).
  • Applicants who earn up to 300% of the Federal Poverty Level (FPL) are eligible.
  • Applicants who earn below 150% of the FPL must show proof of Low-Income Subsidy (Extra Help) denial.

What documentation is required?

  • A Renassist® Insurance Verification Form and Patient Assistance Application (PDF) must be completed and submitted to Renassist via fax or email.
  • Use the Application Assistant to complete an application by clicking here
  • A prescription signed by a healthcare professional must be included with the application.
  • Front & back copies of all insurance cards
  • Explanation of Benefits (EOB) from PDP or MA-PD.
  • For those patients who earn below 150% of the FPL but who are not eligible for the Medicare Part D Low-Income Subsidy (Extra Help):
    • The application must be accompanied by a notice of LIS denial or predecisional notice from the Social Security Administration.

What is the enrollment process?

  • The 2016 Renvela Medicare Part D Assistance Program opens on March 1, 2016. A Renassist® Insurance Verification Form and Patient Assistance Application (PDF) must be completed and submitted to Renassist via fax or email.
    • The healthcare professional and/or the patient will be contacted by fax or phone if an application is incomplete or requires additional information. Please note: incomplete applications will be returned
  • A Renassist Case Manager will contact the healthcare professional and/or the patient regarding approval or denial.
  • EnvoyHealth will ship up to a 3-month supply of free drug to the location identified on the application.
  • Qualifying patients will receive free drug through the end of the calendar year in 3-month increments.
  • A Renassist Case Manager will review your patient's insurance situation and will contact you when the supply is close to running out.
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Indication
Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride) are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information
  • Sevelamer is contraindicated in patients with bowel obstruction and in patients with known hypersensitivity to sevelamer carbonate or sevelamer hydrochloride or to any of the excipients.
  • Caution should be exercised in patients with dysphagia, swallowing disorders, and severe gastrointestinal (GI) motility disorders, including severe constipation or major GI tract surgery.
  • Common adverse events reported with sevelamer include vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation. Other events reported include pruritus, rash, fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation.
  • Uncommon cases of difficulty swallowing the Renagel or Renvela tablet have been reported. Caution should be exercised in these patients and consideration given to using Renvela suspension in patients with a history of difficulty swallowing.
  • Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take sevelamer.
  • Serum bicarbonate and chloride levels should be monitored.
  • Follow patients for reduced vitamins D, E, and K (coagulation parameters) and folic acid levels.
  • Patients should be informed to take sevelamer with meals and to adhere to their prescribed diets.

Please click here for full Prescribing Information for Renvela (PDF) or full Prescribing Information for Renagel (PDF).

Indication
Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride) are used to control phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information
  • Do not use sevelamer if you have a history of bowel obstruction.
  • Talk to your doctor if you have had difficulty swallowing or swallowing disorders; or if you have had digestive tract surgery or other digestive disorders, including severe constipation.
  • The most common side effects with sevelamer include vomiting, nausea, diarrhea, upset stomach, abdominal pain, flatulence, and constipation.
  • Cases of itching, rash, fecal impaction and, less commonly, slow bowel activity, bowel obstruction, and bowel perforation have been reported.
  • Uncommon cases of difficulty swallowing the Renagel or Renvela tablet have been reported. Talk to your doctor if you have difficulty swallowing medicines in tablet form. Renvela powder for oral suspension may be considered by your doctor if you have a history of difficulty swallowing.
  • Your doctor should monitor bicarbonate and chloride blood levels.
  • Reduced vitamins D, E, and K (clotting factors) and folic acid blood levels may be followed by your doctor.
  • Talk to your doctor when taking sevelamer with other medications.
  • Promptly contact your doctor if you experience severe abdominal pain, new or worsening constipation, or other severe intestinal symptoms while on sevelamer.
  • Take sevelamer with meals and adhere to your prescribed diet.

Please click here for full Prescribing Information for Renvela (PDF) or full Prescribing Information for Renagel (PDF).

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