Resources

OPKO Connect offers support for your office on behalf of your patients who have been prescribed Rayaldee® (calcifediol).

Benefits Investigation

OPKO Connect will verify the patient’s insurance coverage for Rayaldee, including identifying

Prior authorization requirements
Deductible, co-insurance, and out-of-pocket costs

Prior Authorization (PA) Assistance

OPKO Connect services are described in a circle: Benefits investigation, prior authorization support, appeals support, copay assistance programs, patient assistance programs, general support/assistance.

OPKO Connect will assist with any insurance-required PAs for Rayaldee by

Completing and submitting insurer-specific PA forms
Confirming receipt of submission by insurance and facilitating a timely review
Providing status from insurance to patients and their healthcare provider’s office

Support for Appeals if the PA is Denied

OPKO Connect will

Confirm the reason for the PA denial and provide options for appeals submission
Supply a letter of medical necessity (LMN) template specific to Rayaldee
Provide appeal status from insurance to patients and their healthcare provider’s office

Copay Assistance

Eligible, commercially insured patients can fill their Rayaldee prescription for $5 per month until the annual maximum limit is reached.

Copay card
* Eligible, commercially insured patients can fill their Rayaldee prescription for $5 per month.

Patient Assistance Program (PAP)

For patients without Rayaldee pharmacy insurance coverage, OPKO Connect has a patient assistance program offering free medication. Eligibility criteria apply and annual reenrollment is required.

Download the application for patient assistance.

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English
Spanish
Copay card
* Eligible, commercially insured patients can fill their Rayaldee prescription for $5 per month.

To receive support for your patients, please complete a Rayaldee Service Request Form (SRF) and return to OPKO Connect.

Fax 1-844-660-7083
Email opkoconnect@rxallcare.com

OPKO Connect services are available

by phone at 1-844-414-6756
or by email opkoconnect@rxallcare.com
Monday through Friday, 8am to 8pm ET

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Download a letter of medical necessity.

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Download the OPKO Connect Service Request Form.

Video player icon Mechanism of Action of Rayaldee® (calcifediol)
RPA Satellite Symposium 2019 video player icon

Rationale for Raising Current Clinical Practice Guideline Targets for Serum 25-Hydroxyvitamin D in Chronic Kidney Disease (RPA Satellite Symposium 2019)

Coming soon icon.

Discussion Around Ideal Concentrations for Serum Total 25(OH)D in Patients With Chronic Kidney Disease Stages 3 and 4 (Interview with Dr. Stuart Sprague, DO, FACP, FASN, FNKF) Coming soon!

Coming soon icon.

Importance of Monitoring and Treating Chronic Kidney Disease and Secondary Hyperparathyroidism (Interview with Dr. Charles Bishop, CEO of OPKO Renal Division) Coming soon!

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Download a checklist for you to evaluate your patients for SHPT.

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Download a resource from the National Kidney Foundation to help you streamline the conversation you have with patients about how kidney disease can lead to bone and heart disease. This information sheet includes reference levels of crucial lab values, treatment, and nutritional considerations.

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Download information for patients from the National Kidney Foundation about how kidney disease can lead to bone and heart disease. This information sheet includes a place you can write in the levels of calcium, phosphorus, parathyroid hormone, and vitamin D in your patient's blood.

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Download information for patients from the National Kidney Foundation about how kidney disease can lead to bone and heart disease.

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Download the KDIGO CKD-MBD Quick Reference Guide, which presents the recommendation statements that were updated in 2017 and those that remained unchanged from 2009.

Helpful resources for patients

Professional associations

Internet icon American Society of Nephrology (ASN)
Internet icon National Kidney Foundation (NKF)
Internet icon Renal Physicians Association (RPA)

Clinical guidelines

Internet icon KDIGO
Internet icon KDOQI

Important Safety Information

Hypercalcemia: Excessive administration of vitamin D compounds, including Rayaldee, can cause hypercalcemia and hypercalciuria. Severe hypercalcemia due to substantial overdosage of vitamin D and its metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium.
Digitalis toxicity: Potentiated by hypercalcemia of any cause. Monitor serum calcium and signs and symptoms of digitalis toxicity more frequently when initiating or adjusting the dose of Rayaldee.
Adynamic Bone Disease: Monitor for abnormally low levels of intact parathyroid hormone (iPTH) levels when using Rayaldee, and adjust dose if needed.
The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
Care should be taken while dosing Rayaldee with cytochrome P450 inhibitors, thiazides, cholestyramine or drugs stimulating microsomal hydroxylation due to the potential for drug interactions.
Serum calcium should be below 9.8 mg/dL before initiating treatment.
Monitor serum calcium, phosphorus, 25-hydroxyvitamin D and iPTH 3 months after starting therapy or changing dose.

Indication and Limitations of Use

Rayaldee® (calcifediol) extended-release 30 mcg capsules is indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Rayaldee is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis.

Important Safety Information

Hypercalcemia: Excessive administration of vitamin D compounds, including Rayaldee, can cause hypercalcemia and hypercalciuria. Severe hypercalcemia due to substantial overdosage of vitamin D and its metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium.
Digitalis toxicity: Potentiated by hypercalcemia of any cause. Monitor serum calcium and signs and symptoms of digitalis toxicity more frequently when initiating or adjusting the dose of Rayaldee.
Adynamic Bone Disease: Monitor for abnormally low levels of intact parathyroid hormone (iPTH) levels when using Rayaldee, and adjust dose if needed.
The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
Care should be taken while dosing Rayaldee with cytochrome P450 inhibitors, thiazides, cholestyramine or drugs stimulating microsomal hydroxylation due to the potential for drug interactions.
Serum calcium should be below 9.8 mg/dL before initiating treatment.
Monitor serum calcium, phosphorus, 25-hydroxyvitamin D and iPTH 3 months after starting therapy or changing dose.