The Pharmaceutical Research & Manufacturers of America is launching an online verification system for its member companies' patient assistance programs.

By providing a service to simplify searches for PAPs, PhRMA is taking a step to raise the profile of drug manufacturers' efforts to improve access to their products.

The website, HelpingPatients.org, allows patients to determine whether they qualify for assistance programs for any drug they are taking by submitting information about their age, state of residence, yearly household income, household size and eligibility for coverage under private or public health plans.

The site will provide web links to online forms and other information provided by the PAPs. It is expected to go online March 5.

The desire for the trade association to do more to advertise the industry's assistance programs is a recurring theme within the membership during periods of debate over drug pricing.

While the site guides users to the proper eligibility forms, patients must still fill out a separate form for each company. PhRMA hopes to simplify that process through a future expansion of the website, which would store answers to questions from the first form and automatically insert them where subsequent forms seek the same information.

The upgraded website could significantly reduce the time burden on health care providers and clinic volunteers who frequently fill out multiple forms for a single patient.

PhRMA has apparently concluded that it will not be possible to create a standardized PAP form for all member programs.

The trade association said that because of each company's different interpretation of the Health Insurance Portability & Accountability Act privacy requirements, it would be difficult to have members agree on a standard disclaimer to include in an industry-wide form.

Over the years, PhRMA has also looked at the possibility of creating an industry-wide patient assistance foundation. The HHS Inspector General has recommended that approach in the context of proposals by manufacturers to fund coverage for co-payments on drugs covered by federal programs.

Most recently, the agency told Novartis in an advisory opinion that its proposal to cover copayments for Medicare transplant recipients using cyclosporine would potentially raise antikickback concerns.

IG suggested that those concerns would be alleviated if Novartis worked through a third party foundation that offered assistance regardless of the immunosuppressant therapy used (¹ Also see "Novartis Neoral Patient Assistance Proposal Violates Kickback Laws, IG Says" - Pink Sheet, 17 February, 2003., p. 20).

PhRMA has not gone forward with the idea of setting up such a foundation. While it appears simple to start up a program with voluntary contributions from members, it is more difficult to determine how the foundation would proceed when funding runs out.

The National Organization for Rare Disorders is actively pursuing the idea of a copayment assistance program funded by multiple manufacturers.

NORD already runs several copayment assistance programs. The group notes that its programs are set up by disease - not by product - and funding is made available regardless of the therapy used. The largest program NORD currently runs is for multiple sclerosis.

Each of the existing programs is funded solely by a single manufacturer. NORD reports that it has not been successful so far in attracting other competitors in those disease classes to join in supporting the program.

NORD used to administer Sandoz' patient assistance program for cyclosporine, but after the merger with Ciba in 1995 it was transferred to a for-profit contractor.

At the time, Medicare coverage for immunosuppressants was limited to three years and the primary purpose of the program was to provide free product to indigent patients after coverage lapsed.

Novartis proposed the coverage program to IG in light of recent changes in Medicare coverage that essentially provide for lifetime coverage of immunosuppressants.

From NORD's point of view, the IG opinion reflects the agency's wariness of for-profit contractors that may be more easily viewed as paid agents of a manufacturer.

Novartis contracts with Express Scripts' specialty drug distribution group for its cyclosporine PAP. The company pointed out that most manufacturers contract with third parties to run their assistance programs.

In a Feb. 27 letter to "The Pink Sheet," Novartis VP-Transplant Business Unit Jim Harold stressed the company's "disappointment" with the IG opinion.

"The OIG implied that we were using this program as a sales tool that would cost the government more money," Harold wrote.

"In fact, our intent for this charitable proposal was merely to provide a safety net to ensure continuity of care for a limited group of financially needy transplant patients. Those patients were previously participating in our patient assistance program but were to become ineligible due to expansion of Medicare immunosuppressive coverage, and therefore would have had to pay substantial co-payments where they did not exist before."

"Moreover - and as the OIG knows - Medicare Part B now pays the same price to pharmacies for all cyclosporine products, so that Medicare's payments and patients' co-payments would not differ depending on the brand dispensed. Thus, we do not believe that our proposal would have cost the government more money, and we carefully considered that issue in designing it."

Generic versions of both cyclosporine brands are on the market.

[Editor's Note: Novartis objected to the headline used by "The Pink Sheet" for the story on the IG opinion, which implied that the agency reached a conclusion that Novartis had violated kickback laws. IG advisory opinions are intended to alert companies to potential kickback concerns the agency might have with a proposal submitted for review; any finding of an actual violation requires an analysis of intent, which is beyond the scope of the advisory process.]

PhRMA Patient Assistance Website Will Simplify Eligibility Determinations

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