Medical Device Link.

New packaging styles often promise to improve patient compliance. Yet few offer hard evidence to back up their claims. Clinical proof or real-world studies supporting package formats will need to be provided for these formats to truly succeed in the healthcare marketplace.

"Packaging and drug-delivery benefits are not automatically advantaged," said John Draper, vice president, strategic planning and managed markets, for Catalent Pharma Solutions (Somerset, NJ). He spoke at the recent Healthcare Compliance Packaging Council's annual symposium on patient compliance in Baltimore.

Noting that cost accountability is the rule in today's "buyers market," Draper said that payors require evidenced-based proof of packaging value. "Packaging growth will come when packaging plays a measurable role in improving safety, lowering the cost of care, increasing adherence, and ultimately improving the clinical outcome," Draper said.

The gatekeepers are managed care organizations (MCOs). The Centers for Medicare and Medicaid Services (CMS) took a page from managed care's book in the private contractor model adopted for the Medicare Part D drug benefit. Part D enrollment as of March 2006 was 17.9 million.

MCOs have stepped up the deployment of a diverse range of formulary tools in government and private plans to favor products and packaging that reduce the cost of care, says Cornell Stamoran, vice president, strategy and corporate development, Catalent Pharma Solutions.

"CMS gave its de facto blessing to the more-aggressive formulary management practices we have seen, when they approved the companies offering prescription drugs plans in the Part D program," says Stamoran.

Formulary committees at MCOs gauge the therapeutic value of a drug against alternatives. Then, they use an arsenal of approaches to influence prescribing and patients' choices. These include requiring prior authorization before a more-expensive drug is approved, or a required referral by a specialist. Step-based therapy first requires the use of a generic. Therapeutic substitution replaces a drug with a similar, more cost-effective solution. Patients are offered multiple copayment tiers in which nonpreferred or uncovered branded drugs will be the most-expensive choice.

Stamoran says that MCO pharmaceutical benefit managers (PBMs) are cognizant of the compliance value that packaging can provide, but rarely see evidenced-based studies supporting packaging designs.

"Formulary decision makers are not happy with the consideration of compliance in studies they are seeing. They are looking for compliance-enhancing tools. They want all the clinical evidence possible to say that a drug is advantaged in outcomes. If they can see there is evidence of a compliance advantage, or good odds of leading to better outcomes, this will likely affect the formulary decision," Stamoran says.

"However, we have found that clinical studies are often not comparing drug to drug. And, less than 5% of recently published Phase 3 studies are comparing packaging alternatives. Compliance packaging should be incorporated into Phase 3 studies to provide a basis for comparison of outcomes differences," he adds.

Catalent performs primary market research to discover unmet market needs in the role of consultant for drug and package development. Catalent interviewed doctors on patients' preferred dosage forms and colors. Consulting on oral diabetes drugs, the company discovered that no drugs in the high noncompliance category were packaged in calendar packs. In addition, interviews with retail pharmacists revealed that patients converting from nebulizers to inhalers were destroying the devices with pliers to remove more of the drug. They required a new prescription and paid out-of-pocket for a replacement. "This relates to the packaging and the instructions," he says.

Catalent has also undertaken some retrospective claims-based analysis studies, comparing refill behavior obtained from drug claims to published research on hospitalization rates.

"There is an enormous body of research for the most common disease states. Outcomes research from Phase 4-type studies is often available from payors," Stamoran says.

Such information supports informed choices. "Every choice you make during drug development can have an impact on demonstrating a real, provable outcomes advantage. The earlier you think about compliance-enhancing dose-form design and packaging, the better the chances of getting a preferred brand formulary position," he says.

Though unrelated to compliance issues, cost-containment efforts by Medicare for the Part B benefit that covers doctor-administered therapies are driving packaging changes that have been more rapidly felt in the market. Medicare Part B reimbursement reform drove agency payments closer to market prices, creating incentives for doctors and payors to choose less costly therapies. Patient self-administration of drugs, such as with prefilled syringes, eliminates the cost of therapy in the doctor's office. "Drugs that do not require doctor administration are favored in today's market. CMS and private payors may favor the use of metered-dose inhalers for some conditions and patients, in order to save on equipment costs," Stamoran says.

Demonstrating how packaging might offer value to payors, caregivers, and patients requires a deeper understanding of the evolving healthcare market. Stamoran points out that each therapeutic category has different dynamics, and value is added to different drugs in different ways. Promising new packaging concepts are less likely to succeed without proof of such value. The risk is being replaced on a formulary with a more cost-effective solution.

David Vaczek
Senior Editor