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October 7, 2013
Viewpoints: California should update policy on biosimilar drugs

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(Oct. 7 -- By Jerry Hill, Special to The Bee)

A bill now on the governor's desk - Senate Bill 598, which I authored - not only will save lives of patients with serious illnesses such as cancer, heart disease and Alzheimer's disease, but also will grow California's economy by expanding access to a new class of more affordable medicines called biosimilars.

The legislation is timely since these new treatments are expected to hit the U.S. health care market soon. But they will be off limits to patients who need them unless SB 598 becomes law, enabling the substitution of biosimilars deemed to be interchangeable by the FDA for originally prescribed biologic medicines.

Brand-name biologics are currently available domestically, but their cheaper counterparts, biosimilars, are available only in select countries around the world. The federal Food and Drug Administration is likely to approve these less expensive alternatives in the next couple of years, and in order for California pharmacists to more easily dispense biosimilars to patients, California needs to adopt legislation. That's why I authored SB 598, which received bipartisan support in the Legislature.

Once the FDA acts, the bill allows pharmacists to substitute a cheaper biosimilar for a brand-name drug, saving patients money. CalPERS estimates that the bill could save the state more than $3 million on drug costs in the first year.

Biosimilars have been used in Europe since 2006 and the cost-saving benefits are significant: On average biosimilars are 8 percent to 30 percent less expensive than the brand-name product.

Biologic and biosimilar medicines are created from living cells and injected into the body, in contrast to traditional prescription pills made from mixing chemicals. Even though these new medications make up less than 1 percent of the retail pharmacy market, they represent more than 10 percent of California's prescription drug costs because they are so complex and take so long to develop.

While the majority of biologic medicines are dispensed and administered by physicians in a hospital or clinic setting, a small percentage of patients receive them through retail pharmacies.

Under the bill, when biosimilars are automatically substituted and dispensed in a pharmacy, the pharmacist would be required to notify the physician within five days after the transaction so the doctor knows what drug the patient is taking. This is important because the automatic substitution would provide a drug to the patient that is different from what the doctor prescribed.

Physician notification ensures that a patient's record is accurate and allows the doctor to monitor a patient's immune reaction to these sensitive medications.

Physician notification is a common practice: Health care professionals regularly communicate to provide the best care for patients. Pharmacists notify physicians when they extend prescriptions from 30 to 90 days and when patients receive vaccines. For example, Walgreens performs more than 4 million physician notifications per month in California.

The California Medical Association supports the bill, reasoning that "by mirroring California's existing policy regarding access to small molecule generics SB 598 will help increase access to lifesaving medications for all Californians."

The International Myeloma Foundation also supports SB 598 "because many biologic medicines are used to treat cancers and other life-threatening conditions that can change over time, and it is important for a patient's treatment team to have records that document how and when a patient was treated with biologic therapies."

Without this legislation, pharmacists will not be able to automatically substitute cheaper biosimilars for brand-name biologics once the FDA permits their use. Absent the bill, doctors would have to specifically prescribe a lower-cost drug, resulting in fewer biosimilars being dispensed. As with generic pills, automatic substitution allows a cheaper version of the drug to be dispensed more frequently, saving patients money.

Since the FDA could authorize the use of biosimilars anytime in the coming years, it's imperative that California have the regulatory framework in place to allow these lower-cost medications to be dispensed to patients as soon as possible.

If California waits for the FDA to act, there could be a lag time between the time biosimilars hit the market and legislation is enacted allowing patients in the state to use them. This would cost patients and the state more money.

California is a leader when it comes to supporting medical innovation and patient access to health care. Just as we successfully prepared to implement the federal Affordable Care Act, we need to update our laws so patients can benefit from the next generation of lifesaving medications.

State Sen. Jerry Hill, D-San Mateo, represents the 13th Senate District.

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