ASHP Defends Fees Charged To Applicants For Drug Compendium Listing

The American Society of Health-Systems Pharmacists defended its practice of charging fees to applicants seeking to have an off-label indication listed in the American Hospital Formulary Service-Drug Information as a way to build much needed resources.

The group defended the practice in comments on the draft white paper "Potential Conflict of Interest in the Production of Drug Compendia" issued for comment Oct. 22 by the Agency for Healthcare Research and Quality.

In the paper, AHRQ said the user fee arrangement may place the compendium "at risk for influence by conflict of interest" (¹ (Also see "CMS Opens Door To More Compendium Oversight In Draft White Paper" - Pink Sheet, 27 Oct, 2008.), p. 15).

In an interview, Gerald McEvoy, assistant VP of drug information at ASHP and editor-in-chief of the AHFS-DI compendium, said the white paper focused a lot of discussion on whether the user fee would place pressures on the compendium's review committee to provide favorable reviews but "the facts don't support this hypothesis."

"If you look at the determinations that we made, only 28 percent of them are favorable," McEvoy continued. "That means 72 percent of them are unfavorable."

Parallels To PDUFA

McEvoy noted that charging a fee in order to get drug data reviewed is not a foreign concept, as FDA has been doing this for years under the PDUFA user fees that pharmaceutical companies are charged to get their drugs reviewed by the agency.

To get an off-label indication listed in AHFS-DI, applicants must pay a $50,000 user fee to have their indication reviewed by ASHP's expert committee.

However, McEvoy argued that ASHP employs more stringent protections against conflict of interest than those employed by FDA. In comments to AHRQ, "we pointed out, for example, that the user fee model that FDA has now been employing for 15 years actually is less stringent in terms of firewalls than the user fee model that we are applying."

"We don't have direct communication with the applicant, nor does our expert committee, during the review process," McEvoy said. "With FDA, there is very direct communication between people that pay the user fee" and the agency.

He added that ASHP makes it clear that once an application is submitted for listing, "we are going to publish our determination, which is made independently, whether it is positive or not." Applicants do not get an opportunity to negotiate or appeal the final decision.

He also pointed out that like PDUFA fees, the compendium fees help to speed the review process.

McEvoy also noted that, like FDA, the group is constantly faced with stretched resources and the primary users of compendia provide no financial support.

"The groups that benefit from the compendia activity to date haven't been willing to pay for it," McEvoy said, adding that a preferable funding model would be if CMS supplied it with the needed resources to engage in the review process. "If the FDA had its druthers, I am sure it would prefer not to have a PDUFA user fee funding model," he said. "The same is true for us."

NCCN Offers Clarifying Comments On Bias

The National Comprehensive Cancer Network also offered written comments to AHRQ regarding the portrayal of its compendium. They mostly centered on clarifying certain process points on how it develops its drug information, and they argue that the paper "trivializes a key distinction of the NCCN compendium," which is that it has more than 800 active, volunteer, multidisciplinary, contributing experts sitting on 44 disease panels, compared to a total of nine who sit on the Thompson Microdex DrugDex compendium advisory board.

"Given the dilution of influence of medical oncologists by the presence of other subspecialties, the bias toward the use of drugs and biologics is considerably reduced," NCCN said. "Add in the broad participation of many other experts commenting through the NCCN institutional review process and the potential for bias is further diminished, along with further dilution of the influence of any one individual's potential conflict of interest."

Gold Standard Satisfied With Review

At least one of the four recognized compendia publishers - Gold Standard, which publishes the Clinical Pharmacology compendium - did not submit any comments to AHRQ in reaction to the white paper.

"We did not actually submit any comments because overall we felt that their commentary and their feelings about where Clinical stands in our conflict of interest policy was relatively positive," Kathy Vieson, VP and director of clinical references at Gold Standard said in an interview.

[Editor's note: Gold Standard owner Elsevier also is the parent company of F-D-C Reports/Windhover Information, publisher of "The Pink Sheet."]

However, Vieson added that if they had responded, they would have commented on concerns the white paper authors raised about whether the Clinical Pharmacology writers are up-to-date on current industry practices, since it is the only one of the four compendia that employs their writers in a closed system.

"Many of our specialty writers in particular are board certified in their areas of specialty or have a board certification of pharmacology," Vieson said. "We certainly encourage them to be active in areas such as societies that support their specialties, and we even have people that are still practicing part time, so [our writers are] keeping their fingers on the pulse of what is happening."

More Transparency Expected

For the moment, CMS remains silent as to what it plans to do with the information collected by the white paper authors once the draft is finalized, but Vieson is expecting this exercise to ultimately lead to CMS making the process more open.

"I think CMS is going to be asking for more and more transparency in the [compendia publishing] process, from the conflict of interest policies, the editorial processes and what the decision trees being used to make those off label determinations within compendia" are, she said. "I think that is going to have to be more transparent to the public" including patients, pharmacy benefit managers, insurance companies and regulatory bodies.

- Gregory Twachtman ([email protected])