Alpelisib (Piqray / Vijoice)

How Medicare covers it

Part D (forms used at home). Part A during a covered inpatient stay. No Part B clinician-administered form in the CMS Part B spending file.

What it treats

Advanced or metastatic breast cancer that is hormone receptor (HR)-positive, HER2-negative, and has a PIK3CA mutation, in adults whose cancer got worse during or after an endocrine (hormone) therapy regimen. It is used in combination with fulvestrant, and the PIK3CA mutation must be found by an FDA-approved test. Brand name Piqray.

What it is for, in depth

Piqray (alpelisib) is a targeted cancer pill used with fulvestrant to treat adults with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative and carries a PIK3CA mutation, found with an FDA-approved test on tumor tissue or blood. It is prescribed after the cancer has progressed on or after an endocrine (hormone) therapy regimen, so it is a later step in the treatment path rather than a first treatment. The usual dose is 300 mg once daily with food, continued until the disease progresses or side effects become unacceptable, with dose reductions to 250 mg and then 200 mg if needed. It comes as 50 mg, 150 mg, and 200 mg film-coated tablets, and blood sugar is checked before starting and regularly during treatment because high blood sugar is common.

How it works

It is a kinase inhibitor that blocks PI3K, mainly PI3K-alpha (PI3Kα). Changes (mutations) in the PIK3CA gene switch PI3Kα and Akt signaling on, which helps breast cancer cells grow; blocking PI3Kα slows that growth signal. In lab studies, alpelisib plus fulvestrant had more anti-tumor activity than either drug alone in estrogen receptor-positive, PIK3CA-mutated breast cancer.

How it is taken

300 mg by mouth once a day with food — two 150 mg tablets — at about the same time each day, until the cancer gets worse or side effects become unacceptable. Swallow tablets whole; do not chew, crush, or split them, and do not take a tablet that is broken or cracked. If a dose is missed, it can be taken with food within 9 hours; after 9 hours, skip it. If you vomit after a dose, do not take an extra dose that day.

Common side effects

The most common side effects, including lab changes (20% or more), are increased blood sugar (glucose), increased creatinine, diarrhea, rash, decreased lymphocyte count, increased GGT (a liver test), nausea, increased ALT (a liver test), fatigue, decreased hemoglobin, increased lipase, decreased appetite, mouth sores (stomatitis), vomiting, weight loss, decreased calcium, decreased glucose, prolonged aPTT (a clotting test), and hair loss (alopecia). In the main study, diarrhea occurred in 58%, rash in 52%, nausea in 45%, and fatigue in 42% of patients taking Piqray plus fulvestrant.

Serious warnings

Severe allergic (hypersensitivity) reactions, including anaphylaxis and anaphylactic shock — stop Piqray permanently and get treatment right away. Severe skin reactions (SCARs), including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and DRESS — stop Piqray for signs of a SCAR and never restart it if a SCAR is confirmed. Severe high blood sugar (hyperglycemia), which in some cases led to hyperglycemic hyperosmolar non-ketotic syndrome or ketoacidosis (fatal cases of ketoacidosis have been reported after approval): fasting blood sugar and HbA1c are tested before starting and checked regularly during treatment. Severe lung inflammation (pneumonitis/interstitial lung disease) — stop Piqray if it is confirmed. Severe diarrhea or colitis, which can cause dehydration and acute kidney injury. Harm to an unborn baby (embryo-fetal toxicity). Piqray has no boxed warning.

Who should be careful

People with a history of severe allergy to Piqray or any of its ingredients must not take it (it is contraindicated). People with diabetes or risk factors for high blood sugar (such as obesity, higher fasting glucose or HbA1c, use of steroid medicines, or age 75 or older) need closer blood-sugar monitoring — Piqray has not been studied in type 1 diabetes or uncontrolled type 2 diabetes. People who could become pregnant, and men with partners who could become pregnant, must use effective birth control during treatment and for 1 week after the last dose. Do not breastfeed during treatment and for 1 week after the last dose. Piqray may impair fertility in males and females.

Major interactions

Strong CYP3A4 inducers lower alpelisib levels and may make Piqray work less well — avoid using them together and consider a different drug with little or no CYP3A4 induction instead. Breast cancer resistance protein (BCRP) inhibitors raise alpelisib levels and may increase side effects — avoid them during Piqray treatment; if one cannot be avoided, watch closely for increased side effects.

Cost and saving notes

This drug is usually covered under Medicare Part D, often through a specialty pharmacy with prior authorization. If your cost is high, ask your plan about a tier exception. If you have limited income, the Extra Help (Low-Income Subsidy) program can lower your Part D premiums and drug costs. In 2027, your total yearly out-of-pocket spending on Part D drugs is capped at $2,400, and you can ask your plan to spread those costs out in monthly payments through the Medicare Prescription Payment Plan. The maker may also offer a patient support program.

Why it is in its tier

Alpelisib (Piqray / Vijoice) sits on Tier 5 in 96.91% of the plans that list it (5325 of 5495 listing plans). Tier 5 is the specialty tier — instead of a flat copay, patients usually pay a percentage of the drug's cost (coinsurance), which is why specialty drugs feel expensive even with coverage. The data-visible drivers: It is a generic product, and the CMS dashboard puts its average Part D spending at about $93,255 per beneficiary for 2024 — among the highest-cost drugs in the program, which matches where plans place it. It is listed by 100.0% of Part D plans. The tier shown is the most common one; individual plans vary.

Sources

• PIQRAY (ALPELISIB) TABLET PIQRAY (ALPELISIB) KIT [NOVARTIS PHARMACEUTICALS CORPORATION] — DailyMed
• MedlinePlus — National Library of Medicine
• MedlinePlus — Alpelisib

What official patient guides say

For Piqray, alpelisib comes as tablets you take by mouth once a day, always with food, at around the same time every day — building the dose into a regular meal keeps the routine steady. Swallow the tablets whole — do not split, chew, or crush them — and do not take a tablet that is broken, cracked, or damaged. Take it exactly as directed, no more or less and no more often, and keep taking it for as long as your doctor recommends treatment. Your doctor may lower your dose, pause treatment, or stop it depending on how you respond and how you are feeling, so keep telling your doctor how you feel. If you miss a dose, you can still take it with food if you remember within 9 hours; if more than 9 hours have passed, skip that dose and take the next one at the usual time — never take a double dose. If you vomit after a dose, do not take an extra one that day. Store the tablets at room temperature in the container they came in, tightly closed, away from excess heat and moisture, and out of reach of children.

Source: MedlinePlus — Alpelisib

Part D formulary coverage

Source: CMS Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files — Monthly file 2026-10-15 (plan year 2027), file 2027_20261008.zip (data.cms.gov dataset ed1496ea-23e7-41f1-9292-172fa842ccfb): basic drugs formulary file + plan information file, both dated 20261031 inside the zip; downloaded and aggregated 2026-10-30. Medication RxCUI sets resolved through the NLM RxNav (RxNorm) API.

What you pay

A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.

Sources: CMS Plan Benefit Package + formulary data; CMS NADAC · Checked 2026-11-07

Coverage by plan and tier

Of the 5,495 Medicare drug plans we track for 2027, 5,495 list Alpelisib (Piqray / Vijoice) — 100% of plans. Most of those plans put it on Tier 5: 5,325 plans, 96.9% of the plans that list it. Other plans place it on Tier 1 (123 plans), Tier 4 (46 plans) or Tier 2 (1 plans). For example: Aetna Medicare Dual Extra (HMO D-SNP) puts it on Tier 5; Aetna Medicare Dual Extra Care (PPO D-SNP) puts it on Tier 5; Aetna Medicare Value Plus (PPO) puts it on Tier 5. You can compare these plans side by side on our Medicare Advantage hub. A tier is not a price. What you pay also depends on whether you have met your plan's deductible, whether the drug costs a flat copay or a share of the price, and whether you get Extra Help or Medicaid.

Read next

• Part D in 2027: The $700 Deductible, the $2,400 Cap, and the $35 Insulin Rule
• Extra Help in 2027: Lower Drug Copays and Who Qualifies
• Checking Medicare Savings Programs and Extra Help

Part D spending averages (2024)

Source: CMS Medicare Part D Spending by Drug (Drug Spending Dashboard), release RY26 P04 V10, data through 2024 (DSD_PTD_RY26_P04_V10_DY24_BGM.csv), downloaded 2026-10-30

Companies covering this drug

Part D and Medicare Advantage plan sponsors that list this drug on a formulary, 50 at a time.