Generic but not simple

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A coming surge of generic equivalents is a “phenomenon” that is greeted with both optimism and anxiety.
A coming surge of generic equivalents is a “phenomenon” that is greeted with both optimism and anxiety.

Like most everything in healthcare, it's easy to find gray areas in medication management.  

One area that's seemingly always been cut and dry, however, is drug disposal. When nursing home patients die, their drugs should follow them to the grave. 

But when a respected investigative news site last spring exposed the practice in a lengthy series on wasteful practices in healthcare, the nursing home industry took a sucker punch to the gut. 

The indisputable facts were there: As ProPublica stated in its article, “It's estimated that American taxpayers, through Medicare, spend hundreds of millions of dollars each year on drugs for nursing home patients — much of which literally go down the tubes.” 

The report noted Environmental Protection Agency estimates nearly 740 tons of drugs are “wasted” by nursing homes each year. 

That cost issue is one pebble in an avalanche now sweeping the healthcare industry on wasteful spending and practices. Also vexing providers is that long-entrenched proprietary meds are about to be challenged by a surge of generic equivalents. 

It is a phenomenon clinicians are embracing with one arm while crossing fingers on the other behind their backs. 

“This is an important discussion in the post-acute care space and a ‘slow burn' that evolves into a larger conversation around quality of care, utilization and reimbursement,” says Vishal Kuchaculla, M.D., a post-acute care medical director for TeamHealth in Boston.

FDA plowing the road?

It was an uncharacteristic move for a federal bureaucracy long criticized for the glacial pace it takes in device and drug approvals. Last fall, the Food and Drug Administration announced plans to fast-track abbreviated new drug applications (ANDAs) and 505(b)(2) applications, a major volley across the bow of some drug makers. In its announcement, the agency took note of a new Federal Trade Commission report on anticompetitive strategies suspected of delaying access to generic drugs.

It didn't take long to see the FDA meant business. In May and June alone, the agency approved 196 generic drugs — the most since the agency began tallying those numbers, the Regulatory Affairs Professionals Society reported. Shortly after that, the FDA published a list of all off-patent pharmaceuticals with limited or no competition, while announcing plans to “expedite” generic new drug applications on drugs for which fewer than three approved ANDAs existed.

Near press time, President Trump signed the FDA Reauthorization Act of 2017, which many say will increase competition in the generic drug market and help to preserve patient and provider access to critical treatments.

“Significant price spikes for generic drugs and ongoing prescription drug shortages are jeopardizing patient access to care,” the Healthcare Supply Chain Association noted in a statement. “Price spikes often occur when a lack of competition among manufacturers allows high prices to go unchecked.”

LTC generic surges

Kuchaculla points out that states, including Massachusetts, already require pharmacies to dispense generic equivalents unless noted by the provider.

“Therefore, switching from a brand to generic is already done,” he says, adding that he believes the switch “is also done for convenience and utilization concerns.”

The surge in generics in long-term care is getting noticed across several drug classes. Antipsychotics is a notable one.

“For the longest time, the only generic was Risperidone,” says T.J. Griffin, RPh., chief pharmacy officer for PharMerica. “Now Zyprexa and Seroquel are both also available in generic formulations.”

Griffin says other noticeable generic newcomers are coming to therapies to treat GERD and ulcers, cholesterol and dementia.

Bethany Bramwell, BSPharm, BCGP, director of clinical services at Guardian Pharmacy of Missouri, has also noticed the generic influx with diabetes drugs.

“Since generic prescribing is generally payor-driven and not provider-preference in the long-term care setting, the shift from brand name to generic generally occurs as soon as a generic equivalent is available and on formulary,” she says.

Weak competition hurts

Proprietary drugs have long enjoyed exclusivity in healthcare — for reasons both good and bad. It's only when they become so expensive that seniors stop taking them that alarms start sounding. 

“I think anytime there is a novel agent [such as] a brand medication with no clear generic or generic alternative, it creates an unfavorable price environment,” says Charles Worz, PharmD, ASCP's president-elect. “This makes patients make choices regarding tolerating inconvenience or tolerating side effects for a lower co-pay or lower cost.”

Worz also argues that skilled nursing facilities feel the sting in a Part A environment, faced with specialty medications for rehab patients that are “catastrophically expensive and may force the nursing center to avoid the admission or ask the family to source the medication.” For that reason, he believes, “Medicare Part A is in need of reimbursement reform from the medication perspective to help nursing centers better care for patients in that transition.”

Griffin has witnessed weak competition in the emerging biologics market.

“It isn't price gouging, but the products are so new the patents are just fresh,” he says. Some recent examples are medications for hepatitis, psoriasis and psoriatic arthritis, which “have very expensive injectable biologics with zero generic competition.”

Bramwell said she believes escalating prices on medications for COPD, diabetes (including insulins), and anticoagulants for atrial fibrillation and joint replacements, are another area of concern.

Who's the boss?

Regardless of policy shifts and payor rules, physicians continue to wield great influence on what, and to whom, medications are prescribed. Few will argue, publicly at least, that is ever a bad thing. Neither are brand name drugs.

“Brand medications can be preferred and represent the best chance of success for patients,” argues Worz, using branded oral anticoagulants as an example.

“These branded medications far exceed the benefits of warfarin in terms of ease of use, safety and fewer potential drug interaction risks,” he says. “They eliminate the need for close monitoring and, from a practical standpoint, their efficacy may be better. As nursing homes go at risk for rehospitalizations, it will be important to evaluate the use of medications that may be more expensive to the nursing home provider but increase the number of successful discharges to home and not simply which ones are the cheapest.”

Superior efficacy is another, says Griffin.

“So many Narrow Therapeutic Index medications such as Synthroid, Dilantin and Theopylline products have physician preferences for staying on the brand,” he adds. “The right reason is that any wobble at all in bioequivalence could lead to side effects or toxicity or efficacious issues. It doesn't mean that the generics can't be used. [Providers] just need to monitor them tightly and may need to adjust the dose.”

Substitution worries

Conversely, Griffin believes it is “perfectly OK” if a patient has not started on a narrow therapeutic index medication to start them on the generic and titrate doses as normal.

Kuchaculla believes while physicians will continue showing brand preference for some drugs, like those for seizures, “most payers will not pay for the brand forms without prior authorization, and if they are covered, they are tier 1 co-pays, the highest amount,” he adds.

Frank Grosso, RPh., the American Society of Consultant Pharmacists CEO and executive director, says he's particularly concerned about generic meds getting substituted during critical transitions of care.

“During a Medicare Part A stay, using the cheaper, more frequently administered medication is a way for nursing home providers to manage rising medication costs, but it doesn't prepare the patient for discharge to home,” he cautions. “Oftentimes, during a patient's stay in a nursing facility, a less expensive generic requiring two or three times a day dosing may be acceptable.” That's because a nurse is bringing the medication to the patient at the correct time and monitoring the patient vital signs and labs, Grosso explains.

“However, a more expensive therapeutic equivalent or branded medication may be available in a once-a-day dosage form, with fewer side effects and less frequent laboratory monitoring, which if used during the skilled stay and prescribed post discharge, could improve medication adherence and reduce rehospitalizations,” he cautions.

As anyone who's been involved in long-term care over the past few years can attest, that's saying quite a mouthful.