Biologics

Biologics are drugs produced using living organisms, such as plants and viruses. Like all drugs, biologics are regulated by the United States Food and Drug Administration (FDA). They’re usually administered via injection or infusion. They are generally classified as specialty drugs. 

Biosimilars

A biosimilar is a biologic drug that the FDA considers very similar to another biologic medication (called the reference drug). Biosimilars are FDA-approved and carefully tested to prove they are safe and effective. A biosimilar must be used in the same way, at the same dose, and for the same condition as the reference drug. This means that they will work as well as the original biologic medication. Biosimilars are generally classified as specialty drugs.

Formulary

A formulary is a list of preferred generic and brand-name medications, approved by the Food and Drug Administration (FDA), that are covered under your Blue Shield Outpatient Prescription Drug Benefit. 

The Blue Shield Pharmacy and Therapeutics (P&T) Committee develops, maintains, and regularly updates the formulary.

The inclusion of drugs on the formulary is based on P&T committee recommendations after a review of the medical evidence and nationally recognized clinical guidelines for drug safety and effectiveness. Relative drug price is considered when safety and effectiveness are similar for drugs used to treat the same condition.

Home delivery pharmacy

Blue Shield offers an easy-to-use mail service prescription drug program through our contracted mail service pharmacy. You can save time and money using the home delivery service.  Depending on your plan, you can fill maintenance medications for supplies up to 90 or 100 days.

Maintenance medications

Maintenance drugs are those prescribed to treat a chronic or long-term medical conditions such as asthma, diabetes, high blood pressure, or high cholesterol, and are taken on an ongoing, regular basis to maintain health.

Network pharmacy

A pharmacy that has a contract with Blue Shield to provide covered services to our members. 

Participating pharmacy

"Participating pharmacy" means a pharmacy that has an agreement with Blue Shield to provide covered services to our members.

Pharmacy and Therapeutics Committee

Our Pharmacy and Therapeutics (P&T) Committee is made up of independent physicians and pharmacists who are not Blue Shield of California employees. They are expert consultants and include specialists in various fields. The P&T Committee reviews and updates the formulary list each quarter so that it includes safe and effective drugs approved by the Food and Drug Administration (FDA). They update and review medication coverage criteria to reflect current standards of practice. They also review quality assurance programs to enhance Blue Shield's quality of care. 

Prior authorization

Drug prior authorization is a process to obtain pre-approval for coverage of a prescription medication. This approval ensures that you receive medications that are safe and effective for your condition. Your doctor may provide information for a prior authorization review by calling or faxing a form to Blue Shield Pharmacy Services. Your doctor will be notified if your prescription is approved for coverage.

The Blue Shield P&T Committee determines prior authorization coverage requirements to ensure that medications are prescribed for medically necessary reasons, used safely as recommended by the FDA and in medical studies, and used when formulary alternatives have been considered first.

Drugs require prior authorization when:

  • Other drugs are recommended as first-choice treatment, based on nationally recognized clinical guidelines, the FDA, or medical literature.
  • There is no significant clinical advantage compared with other formulary drugs that treat the same condition, based on clinical study results.
  • The drug should be reserved for rare or uncommon conditions.
  • The drug has a high potential for toxicity, abuse, or misuse.
  • The dose, prescription quantity, or duration of use exceeds FDA recommendations
  • Finally, prior authorization helps keep prescription costs affordable by suggesting use of formulary drugs first.

Quantity limit

Quantity limits are limits consistent with FDA-approved and/or guideline-supported dosing or durations to minimize side effects and reduce inappropriate overuse or long-term use. These limits promote quality and safety. Limits may be per prescription or for a defined time period.

Specialty pharmacy

Specialty pharmacies fill prescriptions used to treat certain complex or chronic conditions that usually require close monitoring and special handling. You obtain specialty drugs from a Blue Shield network specialty pharmacy. Select drugs may not be available for distribution through the Network Specialty Pharmacy, in which case you may obtain it through a non-network specialty pharmacy.

Step therapy

Step therapy is the practice of beginning drug therapy for a medical condition with drugs considered first-line for safety and cost-effectiveness, then progressing to other drugs that may have more side effects or risks or that are more costly. The P&T Committee may determine that coverage of selected drugs requires step therapy with first-line drugs before covering the prescribed medication. Step therapy requirements are based on how the FDA recommends that a drug should be used, nationally recognized treatment guidelines, medical studies, information from the drug manufacturer, and the relative cost of treatment for a condition. Other common terms used for step therapy are: “prerequisite therapy,” “prior therapy,” or “step therapy protocol.”

If step therapy coverage requirements are not met for a prescription and your doctor feels that the medication is medically necessary for you, your doctor may request an exception to the coverage requirements by requesting a prior authorization review.

 

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Y0118_24_623A_C 09202024
H2819_24_623A_C Accepted 09302024

Page last updated: 10/01/2024

This information is not a complete description of benefits.

1 Specialty medications and opioids are limited to a 30-day supply.

The Formulary, pharmacy network, and/or provider network may change at any time. You will receive notice when necessary.

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California Physician’s Service DBA Blue Shield of California is an independent member of the Blue Shield Association.

For Blue Shield Medicare Advantage Plans: Blue Shield of California is an HMO, HMO D-SNP, PPO and a PDP plan with a Medicare contract and a contract with the California State Medicaid Program. Enrollment in Blue Shield of California depends on contract renewal.

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