Help paying · Medicare negotiated price · pharmacy cost · cycle 2028

Kisqali (ribociclib): where help paying exists, where Medicare's negotiation stands and what pharmacies pay

Name: Kisqali access facts as data (static API file)
Creator: OmniRx
License: https://omnirx.org/license

1 assistance program lists ribociclib, each with its income ceiling and when we read it. CMS has selected Kisqali for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 1 recall entry. ClinicalTrials.gov lists 50 recruiting trials that name ribociclib.

CMS negotiated-price file, read November 6, 2026NADAC, November 4, 2026Assistance programs: 1CMS Part D spending, data year 2024Orange Book, September 2026Drugs@FDA, read November 7, 2026openFDA recalls, read November 7, 2026ClinicalTrials.gov, November 6, 2026

1assistance program lists this drug in our finder

Not yet setMedicare negotiated price: CMS lists the 2028 cycle price as effective January 1, 2028 and has not published it

6packages have a NADAC pharmacy price per unit; nothing to compare it with until CMS prices the drug

Every package CMS lists

Packages the CMS file lists for Kisqali, with NADAC per unit where the benchmark has one (per unit, as the files state).

NDC	Product	Unit	CMS price status	NADAC
00078-0860-01	(name not listed)	n/a	Selected; price takes effect January 1, 2028, not yet published	n/a
00078-0867-14	KISQALI FCT 200MG 14	EA	Selected; price takes effect January 1, 2028, not yet published	$347
00078-0867-42	KISQALI FCT 200MG(3X14) 400MG DAILY DOSE	EA	Selected; price takes effect January 1, 2028, not yet published	$347
00078-0874-21	KISQALI FCT 200MG 21	EA	Selected; price takes effect January 1, 2028, not yet published	$290
00078-0874-63	KISQALI FCT 200MG(3X21) 600mg DAILY DOSE	EA	Selected; price takes effect January 1, 2028, not yet published	$290
00078-0888-21	(name not listed)	n/a	Selected; price takes effect January 1, 2028, not yet published	n/a
00078-0895-14	KISQALI FCT 200MG(x14) (400mg dosepack)	EA	Selected; price takes effect January 1, 2028, not yet published	$347
00078-0902-21	KISQALI FCT 200MG (x21)(600mg dosepack)	EA	Selected; price takes effect January 1, 2028, not yet published	$290

When could a generic arrive

Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).

Application	Product	Latest listed patent expiry	Latest listed exclusivity expiry	Latest of the two	Set by
NDA209092	Kisqali Fct 200mg (x21) 200mg Daily Dose, Kisqali Fct 200mg(3x14) 400mg Daily Dose, Kisqali Fct 200mg(3x21) 600mg Daily Dose	October 14, 2036	January 1, 2030	October 14, 2036	patent 10799506 with its pediatric extension; 28 dated entries listed

Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.

Medicare Part D spending

CMS's Medicare Part D spending dataset reports gross spending on Kisqali of $775.49 million in 2024, across 52,578 claims and 8,782 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.

Source: CMS Medicare Part D spending by drug, reported under ribociclib-succinate and kisqali; gross spending before manufacturer rebates.

Year	Gross spending	Claims	Beneficiaries	Average spending per claim
2024	$775.49 million	52,578	8,782	$14,749
2023	$370.77 million	24,594	4,543	$15,076
2022	$166.34 million	11,958	2,108	$13,911
2021	$119.29 million	9,277	1,435	$12,859
2020	$128.74 million	10,654	1,623	$12,084

Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.

Rare-disease (orphan) designations

The FDA's orphan drug database lists 1 designation for ribociclib. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.

Designated	Designated use	Status	Sponsor
November 25, 2022	Treatment of neuroblastoma	Designated	Novartis Pharmaceuticals Corporation

Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.

Medicaid use by state

CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 10 states with the largest reimbursement are shown of 23 with data. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.

State	Medicaid-paid prescriptions	Medicaid reimbursed	Covers
AZ	267	$3,993,702	Fee-for-service only
LA	268	$3,810,724	All record types
MD	222	$3,262,838	All record types
IA	191	$3,149,036	Fee-for-service only
PR	166	$2,440,363	All record types
MA	164	$2,437,037	Fee-for-service only
WV	144	$2,145,273	All record types
OK	95	$1,742,973	Fee-for-service only
TN	118	$1,732,243	All record types
AL	116	$1,630,558	All record types

Explore every state, both years and the per-prescription figures for this drug in the Medicaid by state explorer.

Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (9 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 51 older-year figures are held and left out of the table.

Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.

Where help paying exists

Programs in our finder that list ribociclib. Each shows its income ceiling, when we read it and whether we checked it against the program's own document. Eligibility is decided by the program, not by us.

Novartis Patient Assistance Foundation manufacturer
Income at or below $63,840 for one person, $86,560 for two (NPAF eligibility tool, read 13 October 2026)
Status. The Novartis Patient Assistance Foundation page states that for patients who applied for NPAF support on or after July 27, 2026, a new Patient Enrollment Portal is used: approved patients are encouraged to use it to re-fill medication, and patients told their application is missing information are encouraged to upload documents through it. The page lists no end date. (read November 7, 2026)
Program website. Our guide to this program.

Check where your income sits against each ceiling: open the assistance finder. See what has changed and when we last verified each program on the program status board.

Label changes

FDA actions on the applications behind Kisqali dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.

Efficacy: 1

Date	Class	Application	Submissions	FDA documents
July 1, 2026	Efficacy	NDA209092	27	Label (PDF) posted July 10, 2026FDA letter posted July 6, 2026

Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.

Safety notices

FDA enforcement report entries that name a package of Kisqali by its NDC: 1 entry, newest first. FDA assigns each a class by health risk: Class I is the most serious and Class III the least. An entry records what the recalling firm reported and FDA classified; it is not advice about any package you hold.

Reported	Class	Status	Recalling firm	Reason (shortened)	Packages named
May 16, 2018D-0799-2018	Class II	Terminated	Kroger Specialty Pharmacy, Inc.	Lack of Processing Controls.	1

Source: openFDA drug enforcement reports, file read November 7, 2026. openFDA data file. All recent recalls across these drugs: drug recalls feed.

Clinical trials recruiting

ClinicalTrials.gov lists 50 interventional trials that name ribociclib and are recruiting, and 15 more not yet recruiting. By phase: Phase 2: 16, Phase 3: 13, PHASE1/PHASE2: 9, Not applicable: 7, Phase 1: 3, Phase 4: 1, Early phase 1: 1. The 10 most recently updated are below. A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.

Trial	Title and conditions	Phase	Lead sponsor	Last updated	Countries
NCT07391774	Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low TrialAnatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8	Phase 3	National Cancer Institute (NCI)	November 6, 2026	United States, Puerto Rico
NCT03424005	A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast CancerMetastatic Breast Cancer	Phase 1 / Phase 2	Hoffmann-La Roche	November 6, 2026	United States, Australia, France and 6 more
NCT07214532	Signatera-Guided CDK4/6 Inhibitor Therapy in Breast CancerBreast Neoplasms; Carcinoma, Ductal, Breast; Receptors, Estrogen (for ER-positive Requirement)	Not applicable	Natera, Inc.	November 5, 2026	United States
NCT07174336	A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)Breast Neoplasms; Neoplasm Metastasis	Phase 3	Eli Lilly and Company	November 4, 2026	United States, Argentina, Australia and 7 more
NCT07405801	A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast CancerBreast Cancer	Phase 2	Hoffmann-La Roche	November 3, 2026	United States, Argentina, Brazil and 7 more
NCT04802759	A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast CancerInoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer	Phase 1 / Phase 2	Hoffmann-La Roche	November 3, 2026	United States, Australia, Israel and 2 more
NCT06377852	The CDK4/6 Inhibitor Dosing Knowledge (CDK) StudyMetastatic Breast Cancer	Phase 3	American Society of Clinical Oncology	November 2, 2026	United States
NCT06380751	Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast CancerAdvanced Breast Cancer	Phase 3	AstraZeneca	October 30, 2026	United States, Argentina, Australia and 7 more
NCT05696626	Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 MutationMetastatic Breast Cancer	Phase 3	LeonaBio	October 29, 2026	United States, Australia, Belgium and 7 more
NCT07492641	BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic DiseaseHR+/HER2- Breast Cancer	Phase 3	BeOne Medicines	October 26, 2026	United States, Australia, Brazil and 7 more

Source: ClinicalTrials.gov, registry data processed November 6, 2026, summarized and trimmed by OmniRx. Search on ClinicalTrials.gov.

Questions

What is the Medicare negotiated price of Kisqali?

CMS has selected Kisqali for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. When CMS publishes a price it will be a Medicare Part D price agreed with the manufacturer, not what a person pays at the counter.

How does the negotiated price compare with what pharmacies pay?

No negotiated price is published yet, so there is nothing to compare with the pharmacy acquisition benchmark.

Is there help paying for Kisqali?

1 assistance program lists it in our finder. Eligibility depends on income, coverage and the program's current rules; each program's own page decides.

When could a generic version of Kisqali arrive?

For Kisqali, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA209092, October 14, 2036. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).

Can I join a clinical trial for Kisqali?

ClinicalTrials.gov lists 50 recruiting interventional trials that name ribociclib (registry data processed November 6, 2026). A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.

How much does Medicare Part D spend on Kisqali?

CMS's Medicare Part D spending dataset reports gross spending on Kisqali of $775.49 million in 2024, across 52,578 claims and 8,782 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.

For developers: this drug as data

One call returns price, generic-entry upper bound, label history, recalls, trials, assistance, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.

Example file: https://omnirx.org/api/v1/dossier/kisqali.json

The licence page sets out what a data licence covers, and the API page documents these files.

Evaluation files with receipts; contract may change; not clinical advice.

Sources and terms. CMS Medicare Drug Price Negotiation Program data file (read November 6, 2026; the CMS page states no licence or restriction); CMS NADAC from data.medicaid.gov under the labels in the OmniRx licence ledger; program details read from each program's own pages; CMS Medicare Part D spending by drug; FDA Drugs@FDA and Orange Book data files; openFDA drug enforcement reports; ClinicalTrials.gov registry data. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.