PORTLAND – The state is preparing further to limit access to costly, brand-name drugs for 210,000 Medicaid patients next month, a move that is designed to save $100 million over the next two years.

Maine joins a growing number of private insurers and states in expanding lists of drugs that can be prescribed only with prior approval from the state.

Those lists have led to lawsuits by the pharmaceutical industry, which contends states are using their poorest residents as pawns in misguided campaigns to lower prescription drug costs.

In Maine, some patient advocates and doctors worry that the state is placing cost over quality, at the risk of endangering the most fragile patients and adding an administrative burden on doctor’s offices.

“I’m not against saving money in reasonable ways. But what they’re doing now is going to affect how we practice and the choices we can make for our patients,” said Dr. David Moltz, a psychiatrist at Sweetser Family Institute Clinic in Brunswick.

The state now requires prior approval for roughly 100 drugs, in an attempt to direct doctors toward less expensive drugs the state views as medically effective. Only when the cheaper drug does not work can a doctor ask to try any of the flagged drugs.

The program is so successful that of 5 million prescriptions approved last year, less than half a percent – about 35,000 – were for drugs that require prior authorization, said Newell Augur, spokesman for the Department of Human Services.

Over the last two years, Maine saved $35 million. But against a backdrop of budget shortfalls, state officials say they want to realize greater savings.

Under the proposed changes, scheduled to take effect July 1 pending federal approval, virtually all of the thousands of drugs available to Medicaid patients are ranked based upon “cost-efficiency and clinical appropriateness,” Augur said. Preferred drugs are sometimes given a number from 1 to 4. Nonpreferred drugs are given 5 to 9.

With 10 cholesterol inhibitors, for example, seven are preferred, the remaining three are not. Unless the doctor can show medical necessity for a patient to have a nonpreferred drug, he or she first would have to prescribe at least one preferred drug before getting authorization for any of the three nonpreferred drugs.

There also could be a more elaborate scenario involving step therapy, a procedure used in only a handful of states, according to the National Conference of State Legislatures.

Step therapy applies to Nexium, for example. The popular acid-reflux drug advertised as the “purple pill” is a “7.” Before it can be prescribed, a patient first must try at least one of the two preferred drugs. If that doesn’t work, the patient would move onto the nonpreferred drug list, starting with the best-ranked drug at “5” and, if necessary, working up to Nexium.

Step therapy has been in place in Maine for more than two years, but it has been expanded to include more drugs, said John Grotton, a member of the board of pharmacists, doctors and state officials who have been working on the new preferred drug lists since March.

“I’m sure the physicians won’t think that this is the greatest thing in the world for them,” said Grotton. “But when you have five drugs and they’re clinically equal, you try to get the least expensive one.”

Psychiatrists and mental health advocates say they are particularly worried about step therapy applying to a new group of anti-psychotic drugs called “atypicals.” They worry that if the most appropriate medicine with the least side effects is not prescribed in a timely fashion, patients will grow discouraged with treatment, drop out and become psychotic.

“It will save money in the pharmacy budget, but there are other sectors that will pick up the costs,” said Carol Carothers, executive director of National Alliance of the Mentally Ill in Maine. “The secondary safety net – the emergency room, the homeless shelter, the jail, the police – becomes the safety net.”

The doctors association in Maine also is questioning the coming changes, noting that pharmaceutical manufacturers who agree to give steeper discounts through additional rebates can get their drugs on “preferred” lists.

“It appears to us that cost is what’s driving the agenda,” said Andy MacLean, general counsel for the Maine Medical Association. “Physicians understand the need to contain costs and are willing to help out, but they are concerned about further administrative burdens on their practice and negative impact on the patients.”