Support and Resources


Treatment Journey and Support

waves
Eligible patients may pay as little as $5 per monthly prescription with the Co-Pay Program.*

All patients will receive support from the specialty pharmacy, however patients enrolled in A·S·A·P can receive additional support to help streamline the access and reimbursement process, determine eligibility for financial assistance, and start and stay on YORVIPATH.
Learn more about A·S·A·P below.

Specialty pharmacy support throughout the treatment journey

Orsini Specialty Pharmacy logo

Orsini Specialty Pharmacy

Phone: (888) 204-7802

Fax: (877) 471-8175

orsinispecialtypharmacy.com
Pantherx Rare Pharmacy logo

PANTHERx Rare Pharmacy

Phone: (888) 379-1821

Fax: (877) 914-0604

pantherxrare.com

Remind your patients to answer calls from the numbers above and to save the number


What to know when sending directly to the specialty pharmacy: 

Checkmark
When prescribing, you'll need to provide current albumin-corrected serum calcium levels to help avoid delays during the insurance approval process
Checkmark
You and your office will work directly with the specialty pharmacy during the insurance approval process
Checkmark
The specialty pharmacy will contact your patient every 21 days with a refill reminder

Personalized Support with A·S·A·P

Overview of A·S·A·P support throughout the treatment journey


Checkmark Checkmark

Enrollment: A·S·A·P provides your patient with personalized support

Enrollment into A·S·A·P requires a completed faxed or emailed Enrollment Form and Patient Consent Form.

settings icon
  • You must indicate your patient’s current albumin-corrected serum calcium level, 24-hour urine calcium level, and serum 25(OH) vitamin D level. Serum calcium levels must be verified as current (ie, less than 14 days old) before YORVIPATH is shipped to the patient
  • If you fax in the completed paperwork, you will be sent a fax in return with a case ID; if you do not receive this fax, then A·S·A·P did not receive your initial fax
nurse icon
  • Patients can expect a welcome call from their Case Manager within 2-3 days. Be sure to remind patients to answer the A·S·A·P call from 1-844-442-7236 and save this number. You/your office will also receive a welcome call from A·S·A·P
vertical divider icon

Insurance approval process: A·S·A·P will provide authorization or appeal assistance if needed

Your FRM will review the Benefits Investigation with you/your office while an A·S·A·P representative reviews it with your patient. Your FRM may be able to provide assistance with the appeals process and authorization if needed.
Once insurance is approved, A·S·A·P will send the prescription to one of the specialty pharmacies in the limited distribution network to be filled:
  • You'll receive a fax when insurance approval is obtained that will also notify you on which specialty pharmacy will dispense YORVIPATH for your patient
  • Within another 1-3 days, patients can then expect a call from the specialty pharmacy to schedule shipment
Orsini Specialty Pharmacy logo

Orsini Specialty Pharmacy

Phone: (888) 204-7802

Fax: (877) 471-8175

orsinispecialtypharmacy.com
Pantherx Rare Pharmacy logo

PANTHERx Rare Pharmacy

Phone: (888) 379-1821

Fax: (877) 914-0604

pantherxrare.com
Remind your patients they’ll need to answer the call from one of the numbers above from the specialty pharmacy, and to save the number.
vertical divider icon

A·S·A·P will work to ensure there are no gaps in your patient’s treatment

Your dedicated A·S·A·P team will work to ensure there are no gaps in treatment if insurance coverage changes or if there is a reauthorization needed
settings icon

Your FRM may be able to help you stay updated on any payor policy changes that impact your patient.

nurse icon

Your patient’s Case Manager will also check in with your patient regularly to help ensure they stay on treatment.

Meet your dedicated A·S·A·P team

case manager

Field Reimbursement Manager (FRM)

  • Reviews submitted forms for completeness and flags any missing information
  • Advises on benefits investigation, payer documentation, resubmissions, and appeals
  • Monitors policy changes that may impact patient access
nurse icon

Case Manager

  • Confirms prescription coverage and benefits
  • Helps manage prior authorizations, reauthorizations, and appeals
  • Offers support with Co-Pay and Patient Assistance programs
  • Checks in with patients regularly to help them stay on treatment

Financial Support

co-pay program icon

Co-Pay Program

Eligible patients may pay as little as $5 per monthly prescription with the Co-Pay Program*

*Eligibility required. May have annual savings up to $12,000 for commercially insured patients. Federal and state healthcare beneficiaries are ineligible (participants in programs such as Medicaid, Medicare, Medigap, VA, DOD, or TRICARE). Offer not valid for cash-paying patients. Terms and conditions apply. See full terms and conditions and eligibility criteria here.

Patient Assistance Program

The Ascendis Patient Assistance Program can provide free treatment if your patient meets the eligibility requirements, does not have insurance or is underinsured, or is unable to afford treatment.

See full terms and conditions and eligibility criteria here.

See also

start patient icon

Start a patient on YORVIPATH

See how to enroll
resource hcp icon

Resources for HCPs and patients

View resources

INDICATION AND LIMITATIONS OF USE

YORVIPATH (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults.

  • YORVIPATH was not studied for acute post-surgical hypoparathyroidism.
  • YORVIPATH’s titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment.

Important Safety Information

CONTRAINDICATIONS

YORVIPATH is contraindicated in patients with severe hypersensitivity to palopegteriparatide or to any of its excipients. Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been observed with parathyroid hormone (PTH) analogs.

Important Safety Information

INDICATION AND LIMITATIONS OF USE

YORVIPATH (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults.

  • YORVIPATH was not studied for acute post-surgical hypoparathyroidism.
  • YORVIPATH’s titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment.

CONTRAINDICATIONS

YORVIPATH is contraindicated in patients with severe hypersensitivity to palopegteriparatide or to any of its excipients. Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been observed with parathyroid hormone (PTH) analogs.

WARNINGS AND PRECAUTIONS

Risk of Unintended Changes in Serum Calcium Levels Related to Number of Daily Injections

Use only one YORVIPATH injection to achieve the recommended once daily dosage. Using two YORVIPATH injections to achieve the recommended once daily dosage increases the variability of the total delivered dose, which can cause unintended changes in serum calcium levels, including hypercalcemia and hypocalcemia.

Serious Hypercalcemia

Serious events of hypercalcemia requiring hospitalization have been reported with YORVIPATH. The risk is highest when starting or increasing the dose of YORVIPATH but may occur at any time. Measure serum calcium 7 to 10 days after any dose change or if there are signs or symptoms of hypercalcemia, and at a minimum of every 4 to 6 weeks once the maintenance dose is achieved. Treat hypercalcemia if needed. If albumin-corrected serum calcium is greater than 12 mg/dL, withhold YORVIPATH for at least 2-3 days. For less serious hypercalcemia, adjust the dose of YORVIPATH, active vitamin D, and/or calcium supplements.

Serious Hypocalcemia

Serious events of hypocalcemia have been observed with PTH products, including YORVIPATH. The risk is highest when YORVIPATH is abruptly discontinued, but may occur at any time, even in patients who have been on stable doses of YORVIPATH. Measure serum calcium 7 to 10 days after any dose change or if there are signs or symptoms of hypocalcemia, and at a minimum of every 4 to 6 weeks once the maintenance dosage is achieved. Treat hypocalcemia if needed, and adjust the dose of YORVIPATH, active vitamin D, and/or calcium supplements if hypocalcemia occurs.

Potential Risk of Osteosarcoma

YORVIPATH is a PTH analog. An increased incidence of osteosarcoma (a malignant bone tumor) has been reported in male and female rats treated with PTH analogs, including teriparatide. Osteosarcoma occurrence in rats is dependent on teriparatide or PTH dose and treatment duration. Osteosarcoma has been reported in patients treated with teriparatide in the postmarketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of teriparatide use.

YORVIPATH is not recommended in patients who are at increased risk of osteosarcoma, such as patients with:

  • Open epiphyses. YORVIPATH is not approved in pediatric patients.
  • Metabolic bone diseases other than hypoparathyroidism, including Paget’s disease of bone.
  • Unexplained elevations of alkaline phosphatase.
  • Bone metastases or a history of skeletal malignancies.
  • History of external beam or implant radiation therapy involving the skeleton.
  • Hereditary disorders predisposing to osteosarcoma.

Instruct patients to promptly report clinical symptoms (e.g., persistent localized pain) and signs (e.g., soft tissue mass tender to palpation) that could be consistent with osteosarcoma.

Orthostatic Hypotension

Orthostatic hypotension has been reported with YORVIPATH. Associated signs and symptoms may include decreased blood pressure, dizziness (including postural dizziness), palpitations, tachycardia, presyncope, or syncope. Such symptoms can be managed by dosing at bedtime, while reclining. YORVIPATH should be administered initially when the patient can sit or lie down due to the potential of orthostatic hypotension.

Risk of Digoxin Toxicity with Concomitant Use of Digitalis Compounds

YORVIPATH increases serum calcium, and therefore, concomitant use with digoxin (which has a narrow therapeutic index) may predispose patients to digitalis toxicity if hypercalcemia develops. Digoxin efficacy may be reduced if hypocalcemia is present. When YORVIPATH is used concomitantly with digoxin, measure serum calcium and digoxin levels routinely, and monitor for signs and symptoms of digoxin toxicity. Refer to the digoxin prescribing information for dose adjustments, if needed.

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) in patients treated with YORVIPATH were injection site reactions (39%), vasodilatory signs and symptoms (28%), headache (21%), diarrhea (10%), back pain (8%), hypercalcemia (8%) and oropharyngeal pain (7%).

DRUG INTERACTIONS

Drugs Affected by Serum Calcium

Digoxin: YORVIPATH increases serum calcium, therefore, concomitant use with digoxin (which has a narrow therapeutic index) may predispose patients to digitalis toxicity if hypercalcemia develops. Digoxin efficacy may be reduced if hypocalcemia is present. When YORVIPATH is used concomitantly with digoxin, measure serum calcium and digoxin levels, and monitor for signs and symptoms of digoxin toxicity. Adjustment of the digoxin and/or YORVIPATH dose may be needed.

Drugs Known to Affect Serum Calcium

Drugs that affect serum calcium may alter the therapeutic response to YORVIPATH. Measure serum calcium more frequently when YORVIPATH is used concomitantly with these drugs, particularly after these drugs are initiated, discontinued, or dose adjusted.

USE IN SPECIFIC POPULATIONS

Pregnancy

Available data from reports of pregnancies in the clinical trials from drug development are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If YORVIPATH is administered during pregnancy, or if a patient becomes pregnant while receiving YORVIPATH, healthcare providers should report YORVIPATH exposure by calling 1‑844‑442‑7236.

Lactation

Monitor infants breastfed by females treated with YORVIPATH for symptoms of hypercalcemia or hypocalcemia. Consider monitoring serum calcium in the breastfed infant.

You are encouraged to report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1‑844‑442‑7236.

Please click here for full Prescribing Information for YORVIPATH.

Please confirm that you are a US HCP.