Generic medications play an important role in healthcare cost savings. For FDA approval, a generic drug must be identical in strength, dosage form, and route of administration and be bioequivalent. In other words, the generic drug for all intents and purposes must be the same as the brand reference drug. A biosimilar, on the other hand is approved if it shows that it is highly similar to an FDA-approved biologic product known as a reference product. In addition, a biosimilar is not labeled as bioequivalent to the reference drug. Thus, unlike a generic medication, a biosimilar is not interchangeable with the reference drug without the prescriber’s approval.
So how does a biosimilar fit into the healthcare spending equation? Biosimilar are expected to be 15-30% less expensive than the originator drugs. However, to benefit fully from this potential cost savings, the biosimilar needs to be interchangeable with its reference drug. The ability to interchange a biosimilar with its reference drug allows the pharmacist to dispense a biosimilar when the prescription is written for the reference drug, much similar to how generics are dispensed for brand name products. If a biosimilar is not interchangeable with its reference drug, it will certainly not be as readily dispensed since each request to change to a biosimilar will require the prescriber’s approval.
Currently, there are 2 biosimilars approved in the United States. Zarxio, a biosimilar version of filgrastim and Inflextra, a biosimilar to Remicade. Biosimilar for a few other blockbuster drugs such as Enbrel and Humira are expected to be approved by the FDA later this year. Experts believe biosimilars will lead to a $40 billion dollars savings over the next 10 years. To see this savings, doctors, patients, payors, and legislators will need to have a better understanding of biosimilars and how best to expand its access to patients. With the skyrocketing cost of biologic medications, biosimilars may be our knight in shining armor to rescue us from this specialty drug distress.
Submitted by Stan Leung PharmD, PHC Director of Pharmcy
Many of us have questions about the end of life option act and how it may affect our practices. When the CMA first surveyed this matter last year, about 20% of physicians who answered the survey were supportive of the legislation and 20% were very opposed to the idea. The law was passed and signed and will take effect on June 9, 2016. The following is a basic outline of what is required to work within the End of Life Option Act.
For more information, please see the excellent legal brief by the California Medical Association: CMA ON-CALL document #3459 “The California End of Life Option Act” published in January 2016.
- Adult 18 years of age or older
- Capacity to make medical decisions
- Terminal disease
The following conditions must all be met:
- Individual’s attending physician has diagnosed the individual with a terminal disease
- The individual has voluntarily expressed the wish to receive the aid-in-dying drug
- The individual is a resident of California
- The individual documents his or her request on the Request form specified in the act
- The individual has the physical and mental capacity to self-administer the drug
- The individual submits two oral requests directly to the attending physician 15 days apart
- The individual submits one written request directly to the physician
- The physician has to document each oral and written request in the medical record
- The form must be signed and dated by the individual and have two witnesses
- Attest that they know the individual or verify proof of identity
- Attest the individual voluntarily signed the form in their presence
- Attest the individual appears to be of sound mind
- Witnesses cannot be the attending or consulting physician or mental health specialist
- Only one witness can be related to the individual
Medical record documentation:
- The attending physician documents the diagnosis and prognosis and that the individual has capacity and is acting voluntarily
- The consulting physician documents the diagnosis and prognosis and that the individual has capacity and is acting voluntarily
- Mental health specialist’s evaluation if performed
- Attending physician must document informing the patient that he or she can withdraw the request at the time of the second oral request
- Attending physician’s note that all requirements have been met and documentation of the drug prescribed
- All documentation has to be sent to the California Department of Public Health
- There are five forms specified in the Act that have to be filled out
Five specific forms are required (no substitutes):
- Request for an Aid in Dying Drug to End my Life in a Humane and Dignified Manner
- Final Attestation for an Aid-in-Dying Drug to End my Life in a Humane and Dignified Manner
- Attending Physician Checklist and Compliance Form
- Consulting Physician Compliance Form
- Attending Physician Follow-up Form
Who is the attending physician?
The “attending physician” is the physician who has primary responsibility for the health care of the requesting patient and treatment of the patient’s terminal disease.
Who is a consulting physician?
The “consulting physician” must be independent from the attending physician and who is qualified by specialty or experience to make a professional diagnosis and prognosis regarding the patient’s terminal disease. The consulting physician cannot be a witness to the written request. The consultant must review the medical records and examine the patient. The consultant must determine that the individual has capacity to make medical decisions and that the individual is acting voluntarily.
Physicians are free to choose whether to participate in this Act. The health care provider who diagnoses a patient with a terminal illness must inform the patient about the right to information about the end-of-life option, but the law states: “a person that elects for reasons of conscience, morality, or ethics, not to engage in activities is not required to take any action in support of an individual’s decision under this law.” The physician does not have to advise or counsel a patient about participation in aid-in-dying activities. Providing a patient, upon request, with a referral to another provider for purposes of participating in this act is not considered “participation” in the Act.