Zelmac Cost Analysis Data Could Define Use - Committee Member

Maintenance studies for Novartis' Zelmac should include a cost analysis component, FDA Gastrointestinal Drugs Advisory Committee member Michael Wolfe, MD, said June 26.

Wolfe, who is from the Boston University School of Medicine, suggested an outcomes study with cost analyses could show that Novartis' irritable bowel syndrome treatment can "not only make the patient feel better" but also "decreases days lost from work, increases productivity and decreases all the indirect costs associated with the disease."

The committee met to discuss Zelmac (tegaserod) for use in women with constipation-predominant IBS, and recommended the product for approval (¹ (Also see "Novartis Zelmac Dosing Instructions Among Remaining Issues In FDA Review" - Pink Sheet, 3 Jul, 2000.)).

Committee member Joel Richter, MD, Cleveland Clinical Foundation, concurred that Novartis should submit cost analysis data, which should be "based on recurrent visits to physicians." In addition, "critical to a maintenance study is going to be the use of some quality-of-life indicators," he commented.

At the committee meeting, Novartis presented data that annual medical costs for irritable bowel syndrome totaled $8 bil. in the U.S. (in 1992 dollars). IBS patients also have increased physician visits for both gastrointestinal and non-GI complaints, Novartis said.

Novartis consultant Arnold Wald, MD, University of Pittsburgh Medical Center, added that IBS patients incur 74% more health care costs than do non-IBS sufferers.

Wald presented survey results showing that 30% of IBS sufferers had missed an average of 1.7 days of work in the previous 30 days. Reduced days were reported from 46% of responders. Wald said 16% had turned down promotions, 9% had changed jobs and 8% changed their work schedule due to IBS symptoms.

FDA cannot require a sponsor to submit pricing data or cost analyses as a condition of approval. However, if a company wants to promote a product as lowering the cost burden of a disease, the agency can restrict promotional materials not supported by studies.

In an April letter to Glaxo Wellcome, the manufacturer of the IBS therapy Lotronex (alosetron), FDA stated that a promotional kit directed to formularies implied that Lotronex reduced or eliminated the economic burden of IBS (² (Also see "Glaxo Lotronex Formulary Kit Faulted For Implied Claims Beyond Studies" - Pink Sheet, 22 May, 2000.)).

The Glaxo kit cited some of the same studies for the medical costs of IBS that Novartis presented. FDA's ad division faulted Glaxo's economic claims because the study "does not evaluate the impact of Lotronex on the economic burden of IBS."

Novartis will likely face a similar obstacle in convincing purchasers of the cost-effectiveness of Zelmac if it does not collect data specific to the drug.

Committee chair Stephen Hanauer, MD, University of Chicago, for example, questioned the effect that tegaserod would have on the $8 bil. cost of IBS that Novartis cited. "My sense is if this is approved," disease cost will not decrease by $1 bil., Hanauer said.

Neither Lotronex nor Zelmac address all IBS patients. Both drugs have yet to demonstrate efficacy in men, who are about 30% of the IBS population, according to Glaxo. Novartis consultant Wald estimated that 15% to 20% of the U.S. population have IBS, and about 20% consult a physician regarding the condition.

At the advisory committee review of Lotronex, Glaxo estimated that 46% of IBS sufferers have diarrhea-predominant IBS, for which Lotronex is indicated, 26% have constipation-predominant IBS, for which Zelmac was recommended, and 28% have IBS that alternates between those symptoms (³ (Also see "Glaxo Lotronex Indication Would Cover One-Third Of IBS Patients" - Pink Sheet, 22 Nov, 1999.)).

Glaxo's estimate suggests about 3 mil. Americans would be candidates for Lotronex therapy and about half that number for Zelmac. Direct-to-consumer ads could spur doctor visits by people not previously considered IBS sufferers.

However, at the Zelmac meeting the committee noted that the criteria for determining which subgroup patients belong to was unclear.

The alternator population could provide a potentially overlapping population for both drugs. Hanauer predicted patients could be prescribed both products. "I can envision" those patients "getting Zelmac one week and the next week getting another drug," he said.