PALSONIFY™ (paltusotine) Quick Start and Bridge Program (“Program”) Terms and Conditions

This Program provides eligible patients with a temporary supply of PALSONIFY at no cost while insurance coverage is pending or under appeal. This Program is designed to ensure continuity of care during delays in insurance coverage determination. To be eligible, all of the following criteria must be met: (1) Patient must be a U.S. resident or resident of a U.S. Territory; (2) Patient must have been diagnosed with acromegaly by a US-licensed healthcare professional (“HCP”) and have received a valid prescription for PALSONIFY; (3) Patient is uninsured, or insured and have experienced a documented delay of at least 48 hours in coverage determination after the insurer has received all required information. Patient must acknowledge and agree that: (a) this Program does not constitute health insurance; (b) the temporary provision of PALSONIFY through this Program does not constitute any guarantee of coverage under any insurance plan or program; (c) Patient and HCP agree not to submit or cause the submission of any claim for reimbursement of PALSONIFY under this Program to any insurance company or payer; (4) Patient understands that PALSONIFY received through this Program will not count toward any deductible, co-insurance, or out-of-pocket limits; (5) Patient and HCP will not sell, transfer, or otherwise dispense PALSONIFY to any other third party; (6) Patient will notify the Program immediately if their insurance status changes or they receive coverage determination; (7) Crinetics Pharmaceuticals (“Crinetics”) reserves the sole discretion to determine Program eligibility and reserves the right to change, revoke or terminate this Program for any reason at any time without notice; (8) This Program is not valid where prohibited by law, taxed, or restricted; (9) By participating in this Program, the patient authorizes Crinetics and its affiliates to collect, use, and disclose personal information as necessary to: (a) verify eligibility and insurance status; (b) coordinate with the patient’s HCP and insurer, and (c) fulfill regulatory or legal obligations; (10) Patient’s information will be protected in accordance with applicable privacy laws; and (11) Patient and HCP certify that they: (a) have read and understand these Program Terms and Conditions and that the information provided is true and accurate; and (b) agree to comply with all Program rules and requirements.

Patient Assistance Program (PAP) Terms and Conditions

The Patient Assistance Program (PAP) provides eligible patients with access to Crinetics Pharmaceuticals PALSONIFY at no cost. Assistance is provided for the remainder of the applicable coverage year, subject to continued eligibility and Program rules. To be eligible, all of the following criteria must be met: (1) Patient must be diagnosed with acromegaly by a US-licensed healthcare professional (“HCP”) and have a valid prescription; (2) Patient is a U.S. resident or resident of a U.S. Territory; (3) Patient is either uninsured, or patient’s insurance does not cover PALSONIFY; (4) Patient must meet the insurance and financial eligibility requirements as determined by the PAP, including documented total household income requirements; (5) If patient is covered by Medicare Part D, the PAP will notify the Part D plan that the patient is receiving PALSONIFY outside the Part D benefit; (6) Patient and HCP must both sign and submit a completed application for PAP; (7) Patient must re-enroll each calendar year to continue participation; (8) Patient is not enrolled in an “Alternative Funding Program” (AFP) through a pharmacy benefit manager (PBM); (9) the PAP will verify the patient’s insurance coverage quarterly while enrolled in the PAP; (10) the PAP reserves the right to request additional documentation to verify information provided to determine patient’s eligibility; (11) Any PALSONIFY provided by the PAP: (a) cannot and will not be reimbursed by Medicare, Medicaid, commercial insurance, or any other payer; and (b) will not count toward the patient’s True Out-of-Pocket Costs (TrOOP) under Medicare Part D; (12) Patient and HCP understand that the PAP PALSONIFY cannot be sold, traded, or transferred; (13) patient will notify the PAP immediately if insurance, income, or residency status changes; (14) Participation in the PAP does not create any entitlement to free drug beyond the terms of this Program; (15) Crinetics Pharmaceuticals (“Crinetics”) reserves the sole discretion to determine Program eligibility and reserves the right to change, revoke or terminate the PAP for any reason at any time without notice; (16) The PAP is not valid where prohibited by law, taxed, or restricted; (17) By participating in the PAP, the patient authorizes Crinetics and its affiliates to collect, use, and disclose personal information as necessary to: (a) verify eligibility and insurance status; (b) coordinate with the patient’s healthcare provider and insurer, and (c) fulfill regulatory or legal obligations; (18) Patient’s information will be protected in accordance with applicable privacy laws; and (19) Patient and HCP certify that they: (1) have read and understand these Program Terms and Conditions and that the information provided is true and accurate; and (b) agree to comply with all Program rules and requirements.

PALSONIFY™ Copay Card Program (“Program”) Terms & Conditions

This Program provides eligible patients with copay assistance for PALSONIFY. To be eligible and remain eligible in the Program, all of the following criteria must be met: (1) Patient must have been diagnosed with acromegaly by a US-licensed healthcare professional and have a valid prescription for PALSONIFY; (2) This Program is valid only for patients who reside in the US or a US Territory and has commercial insurance. (3) This Program is not valid: (a) for patients with Medicare, Medicaid, TRICARE, VA, DoD, Indian Health Services (IHS), or any other federal or state health care program; (b) where patient is not using insurance coverage at all, (c) where patient’s insurance plan reimburses for the entire cost of the drug, or (d) where PALSONIFY is not covered by patient’s insurance. (4) This Program has an annual benefit cap. Patient is responsible for any costs once limit is reached in a calendar year. (5) The value of this Program is exclusively for the benefit of patient and is intended to be credited towards patient out-of-pocket obligations and maximums. If the patient’s insurance company implements either an accumulator adjustment or copay maximizer program, the patient will not be eligible for, and agree not to use this Program. If patient learn their insurance company has implemented either an accumulator adjustment program or a copay maximizer program, patient agrees to immediately inform the Program; (6) Program is not valid where prohibited by federal or state law, taxed, or restricted. (7) Patient must not seek reimbursement for the value received from this Program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. (8) Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of this Program. (9) This Program may not be combined with any third-party rebate, coupon, or offer. (10) This Program will be accepted only at participating pharmacies. (11) Crinetics Pharmaceuticals (“Crinetics”) reserves the sole discretion to determine Program eligibility and reserves the right to change, revoke or terminate the Program for any reason at any time without notice; (12) The Program is not valid where prohibited by law, taxed, or restricted; (13) By participating in the Program, the patient authorizes Crinetics and its affiliates to collect, use, and disclose personal information as necessary to: (a) verify eligibility and insurance status; (b) coordinate with the patient’s healthcare provider and insurer, and (c) fulfill regulatory or legal obligations; (14) Patient’s information will be protected in accordance with applicable privacy laws; and (15) Patient certifies that they: (1) have read and understand these Program Terms and Conditions and that the information provided is true and accurate; and (b) agree to comply with all Program rules and requirements.

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What is PALSONIFY?

PALSONIFY is a prescription medicine used to treat adults with acromegaly for whom surgery was not effective or surgery is not an option
It is not known if PALSONIFY is safe and effective in children

IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking PALSONIFY?

Before taking PALSONIFY, tell your healthcare provider about all your medical conditions, including if you:

have gallbladder problems
have blood sugar control problems (low blood sugar or high blood sugar)
have problems with low heart rate
are pregnant or plan to become pregnant. It is not known if PALSONIFY will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if PALSONIFY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take PALSONIFY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PALSONIFY may affect the way other medicines work, and other medicines may affect how PALSONIFY works.

Especially tell your healthcare provider if you take any medicines that can slow the heart rate.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of PALSONIFY?

PALSONIFY may cause serious side effects including:

Gallbladder problems: PALSONIFY may cause problems with the gallbladder. Tell your healthcare provider if you have sudden pain in the upper right area of your stomach (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin or the whites of your eyes, or pale stools.
Blood sugar problems: PALSONIFY may change hormone levels, potentially causing either high blood sugar (hyperglycemia), including diabetes, or low blood sugar (hypoglycemia). Tell your healthcare provider if you have problems with high or low blood sugar. Your healthcare provider will check your blood sugar when you start taking PALSONIFY or when your dose is changed.
Heart rate problems: Tell your healthcare provider if your heart is not beating normally.
Thyroid problems: PALSONIFY may keep your thyroid from releasing thyroid hormones, leading to hypothyroidism. Your thyroid function may be checked periodically during your treatment with PALSONIFY.
Fatty stools: PALSONIFY may cause your body to have problems with absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms, including fatty stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating, or weight loss.
Low vitamin B₁₂ levels in your blood: Your healthcare provider may check your vitamin B₁₂ levels during treatment with PALSONIFY.

The most common side effects of PALSONIFY include diarrhea, pain in your stomach (abdominal) area, nausea and vomiting, decreased appetite, slow heart rate (bradycardia), high blood sugar levels (hyperglycemia), and irregular heartbeat (palpitations).

These are not all the possible side effects of PALSONIFY. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects to Crinetics Pharmaceuticals at 1‑833‑CRN‑INFO (1‑833‑276‑4636) or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including Patient Information, and talk to your doctor.