May 18, 2015

Hartford genotype pioneer’s new product faces payer headwinds

PHOTO | Steve Laschever
PHOTO | Steve Laschever
Hartford bio-entrepreneur Dr. Gualberto Ruano has eyes set on mass-marketing his newest genotype testing product-service, MedTuning, via direct contact with physicians and patients and social media. Resistance among insurers to reimburse for MedTuning, which determines the best treatment and drug regimens for patients tied to their genetic makeup, is a hurdle for novel and unproven technologies.
PHOTO | Steve Laschever
Genomas Inc. founder/CEO Dr. Gualberto Ruano.

In his latest bid to expand Genomas Inc.'s roster of genetics-based testing for personalized care, Hartford physician-entrepreneur Gualberto Ruano has found health insurers still playing the role of reluctant dragons.

Insurers, Ruano says, still reimburse only a limited variety of tests that harvest patients' DNA to determine the best care regimens and drugs. Many genetic-type tests and screens, payers say, are "too experimental'' to be deemed safe and efficacious for treatment of most patients.

Insurer's reluctance to fully embrace genetic testing poses a challenge for Genomas, which is now pitching its latest genotype evaluation product, MedTuning, and other like-minded companies looking to market their products to a mass patient base. The stakes are particularly high in Connecticut, which has embraced genomic medicine as a major future industry driver.

But, Ruano isn't waiting for the dust to settle to market MedTuning. He's planning to pitch it mostly through doctor-to-doctor and patient-to-patient referrals and social media. He projects he can grow sales of the company's genetic-testing products to $2.5 million this year, up from $1.96 million in revenue in 2014.

Taking a mass-marketing page from the pharmaceutical industry, Ruano is pitching MedTuning directly at consumers whom either can afford to pay out-of-pocket around $1,500 for the genetic survey, or eventually mount enough pressure on health insurers to pay the cost.

"The need for MedTuning came from the marketplace,'' said Ruano, a personalized-medicine pioneer-inventor who founded and later sold a New Haven biopharma company in the 2000s. Genomas is affiliated with Hartford Hospital's Genetic Research Center, where Ruano is its director.

Next-generation testing

Where Genomas hit its stride providing genotype testing and evaluation to determine the most efficacious drug combinations in patients suffering depression and other mental ailments, MedTuning takes it one step further, Ruano said.

Even as medical advances occur almost daily, one of the remaining conundrums for physicians and patients is figuring out the ideal drug or drug combination, and dosage, particularly for those suffering multiple ailments such as heart disease and diabetes. Information of that kind could be invaluable to the nearly half of all Americans who regularly take some type of medication, Ruano said.

Genomas was built with that bioinformatics foundation in mind, and MedTuning is a natural outgrowth of continuing research and development and refinements, he said.

With a genetic blueprint as a guide, physicians ply MedTuning's algorithm to analyze, in real time, which of some 300 aging drug brands and their generic equivalents might work best alone, or in combination, to treat a host of patient ailments, Ruano said.

"At this point in time, timing is perfect for MedTuning because they're mostly generic yet the drugs are well-known to medical professionals. They have experience with them,'' he said.

Here's a typical situation, Ruano said, when genetic testing comes in handy: A patient with multiple ailments contacts her primary-care doctor, who refers her to several different medical specialists, each of whom prescribes a cocktail of assorted drugs. Occasionally, physicians and patients dosed with each drug, are unaware whether the drugs are working or not, or whether one or more drugs is counteracting the others, setting the patient up for an allergic reaction, or worse, poisoning or overdose. Patients often stop taking drugs if side effects are too great.

MedTuning aims to minimize those hurdles, Ruano said. Assessing patients' genotype against the myriad outcomes from a physician-prescribed drug regimen reduces patient risks while maximizing treatment results — the goal of every doctor, he said.

But genetic testing and usage of healthcare algorithms like MedTuning aren't cheap. So insurers' willingness or reluctance to pay for leading-age treatment technologies can have a major impact on whether doctors will order such tests for their patients.

Ruano said Genomas sold more than 3,000 of its genotype testing for certain patients with mental illnesses in 2014, making it the company's best year since its 2003 founding.

His own research, he said, found that many patients who have health savings accounts to compensate for their high-deductible health plans are more apt to pay for MedTuning's bioinformatics assessments.

Ruano says he cannot understand insurers' reluctance in the face of growing global evidence that treatments delivered based on patients' genotypes can be highly effective.

Uncertain waters

Three of Connecticut's top health-plan providers — Anthem Blue Cross, Aetna and Cigna — say they do pay for certain kinds of genotype testing, if they are "medically necessary." The rest aren't covered, they say, because they are deemed experimental.

Each insurer has its own criteria for when a genetic test might be covered.

Anthem, for instance, says it deems genetic testing medically necessary when: the genetic disorder is associated with a potentially significant cancer; the risk of the significant cancer from the genetic disorder can't be identified through biochemical or other testing; or a specific mutation, or set of mutations, has been established in the scientific literature to be reliably associated with the risk of developing malignancy, among other criteria.

Insurers also contend that if they paid for every genetic-based test or treatment known to exist, it would open the door to overuse or misuse by caregivers and their patients. Over testing is a major driver of U.S. healthcare costs, so it is a valid concern, say some involved in the personalized healthcare sector. Along with new or generic drugs and treatments, insurers are regularly asked to weigh the efficacy and reimbursement for everything from medical devices to new in-home care services.

Despite a number of genetic tests and treatments that have undergone rigorous peer review before being embraced as part of the standard of care, it takes lots of cash and as long as a decade, if ever, for newcomers to break out, experts say.

"When an insurer is hesitant to pay for a new drug, technology or service, it's usually because the evidence hasn't convinced them,'' said Amy M. Miller, executive vice president of the Personalized Medicine Coalition, an advocacy group in Washington D.C. Ruano is a co-founding director.

Another hurdle for unproven drugs and treatment regimens, Miller said, is that the medical community and health insurers often present them with a moving validation target.

"They'll say, 'we need evidence','' she said. "Then the innovator brings that forward, and then they'll say, 'that's not enough'. A little more transparency on both sides will help. Personalized medicine is changing the way we all experience medical care, so we have to figure out these issues.''

Into those waters wades Ruano and his MedTuning concept.

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