CF drug would lower hospitalizations, pharmacist says

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Province is concerned about cost, but expert says drug would save money in other areas

John Hawboldt

Approval of a drug for cystic fibrosis (CF) patients would benefit them and cut hospital admissions, says a pharmacist who specializes in the disease.

“It’s more expensive up front, obviously,” said John Hawboldt, the pharmacist on the cystic fibrosis team and a professor at MUN’s school of pharmacy.

“If you spend up front, you  save the money out back. … I can’t speak on other disorders. … This is where plenty of talent in Newfoundland could really help the government make evidence-based, informed decisions that will help the government save money in the long run.”

The drug — TOBI — has been covered lately under the provincial drug plan for cystic fibrosis patients who need it because of a national shortage of IV tobramycin.

When the  shortage is corrected, TOBI will no longer be covered.

 However, several other provinces cover TOBI, Hawboldt noted. Only one in the Atlantic Provinces — New Brunswick — pays for it through its provincial drug plan by special authorization. 

Hawboldt said TOBI used in the most beneficial dose costs three times that of IV tobramycin, which isn’t designed to be an inhaled drug.

He said it takes more than a half hour for CF patients to set up and prepare the IV drug for inhalation, on top of all the other drugs and treatment they must do in their day — a therapy burden of nearly three hours. Patients take the drug on a cycle — twice a day for a month, followed by a month without it.

Hawboldt’s argument is TOBI,  which takes 22 minutes to prepare, is a much better product. TOBI Podhaler, which takes just five minutes, means greater adherence to the drug regime by CF patients and better long-term quality of life.

Both those drugs cost $18,000 a year, but TOBI Podhaler is much less cumbersome, Hawboldt said.

“If it is easy, they will use it,” he said.

Hawboldt said the provincial coverage of drugs overall for CF patients is good and health professionals want to work with the government to resolve the issue.

Tobramycin by inhalation is used in cystic fibrosis patients to treat acute exacerbations of lung infection and fight chronic pseudomonas aeruginosa infection.

The patients can end up in hospital, but Hawboldt said adherence to the drug therapy can limit those occurrences.

Not following the antibiotic regime leads to lung decline, but it’s gradual, so CF patients don’t notice how sick they are getting until they hit the wall and need to be hospitalized, he said.

“Eventually what happens is the patients go in hospital more frequently, their lung function declines and they eventually get a lung transplant,” Hawboldt said.

“If we had pushed off that initial lung transplant and they would last longer, and maybe the second one — every time we push that off, we save money. We save money to the health-care system.”

According to the Department of Health, the Atlantic Common Drug Review evaluated TOBI in 2007 and 2011 and it was decided it should not be reimbursed through a provincial prescription drug program.

“The reasons for the recommendations include: current available evidence does not clearly show superiority of any one formulation over the other with regards to effectiveness or safety. There is a significant cost difference, with TOBI approximately 10 times the cost of IV tobramycin and it was suggested that a well-designed comparative trial is required to justify the increased cost of TOBI compared to the

IV tobramycin formulation,” a spokesman said.

But Hawboldt said the province is basing its cost argument on a smaller dose of the IV tobramycin that is not based in evidence, as well as pricing that is based in Nova Scotia, not Newfoundland and Labrador. When used in the more beneficial higher dose, the cost is not 10 times as much, but three times as much, he said.  And, he said, a clinical trial can’t be done on its effectiveness because IV tobramycin wasn’t intended to be used as an inhaled antibiotic in the first place, and the numbers of CF patients affected that would be required for the study is more than those in the province. As a result, the patients would be likely to succumb to their illness before enough patients could be recruited for the study.

He said other provinces don’t always stick to the Atlantic Common Drug Review decisions, as New Brunswick has done by approving TOBI under special authorization.

This province has also approved a much more costly drug — Cayston, which is $30,000 a year. That drug is only approved if patients can’t take the other therapy.

Hawboldt said TOBI has been around since 1997 and is proven to be effective, whereas Cayston has been out a year and a half.

Fifteen patients are affected by the decision. Up to 15 others are on various levels of private insurance.

Hawboldt said private companies generally follow suit if the province picks up coverage.

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Organizations: MUN, Department of Health

Geographic location: Newfoundland and Labrador, New Brunswick, Atlantic Provinces Nova Scotia

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